Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) today announced it received a Complete Response letter from the U.S. Food and Drug Administration (FDA) for ceftobiprole. The New Drug Application (NDA) was originally submitted to the FDA in May 2007 for the treatment of complicated skin and skin structure infections (cSSSI), including diabetic foot infections.
The FDA has requested additional information and recommended additional clinical studies be conducted in order to consider a future approval of ceftobiprole in this indication. J&JPRD intends to discuss the best path forward with the FDA as soon as possible.
Ceftobiprole was licensed from Swiss-based Basilea Pharmaceutica Ltd. in February 2005. In March 2008, J&JPRD received an Approvable Letter regarding the ceftobiprole filing. J&JPRD responded to the FDA's Approvable Letter in August 2008. In November 2008, J&JPRD received a Complete Response letter,
which recommended additional site audits be conducted. The Company completed those audits through a third party and included the results in its June 2009 response to the FDA's Complete Response letter.
About Ceftobiprole
Ceftobiprole is a novel, broad-spectrum, anti-MRSA cephalosporin with activity against methicillin-resistant Staphylococcus aureus (MRSA), penicillin-resistant Streptococcus pneumonia and many clinically important Gram-negative bacteria, including Pseudomonas.
The regulatory review process is ongoing in Europe and other countries for the use of ceftobiprole in adults for the treatment of complicated skin and skin structure infections. Ceftobiprole is approved in Canada,
Switzerland, Russia, Azerbaijan, Ukraine and Hong Kong.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) J&JPRD is part of Johnson & Johnson, the world's most broadly based producer of healthcare products. J&JPRD is headquartered in Raritan, NJ, and has facilities throughout Asia, Europe and the United States. J&JPRD is leveraging drug discovery and drug development in a variety of therapeutic areas to address unmet medical needs worldwide.
[This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from J&JPRD or Johnson & Johnson's expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and
governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 31, 2008. Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov , www.jnj.com or on request from Johnson & Johnson. Neither J&JPRD nor Johnson & Johnson undertakes to update any forward-looking statements as a result of new information or future events or developments.
Sunday, February 7, 2010
Friday, February 5, 2010
WHO HAILS NEW GATES FOUNDATION SUPPORT FOR DECADE OF VACCINES
The World Health Organization welcomes the Bill & Melinda Gates Foundation pledge of US$ 10 billion over the next ten years to accelerate global vaccine efforts.
"The Gates Foundation’s commitment to vaccines is unprecedented, but needs to be matched by unprecedented action. It’s absolutely crucial that both governments and the private sector step up efforts to provide life-saving vaccines to children who need them most," said Dr Margaret Chan, WHO Director-General.
Vaccines and immunization have played a major role since the last century in overall health gains. Smallpox has been eradicated, polio is on the verge of being eradicated and more than 2 million deaths are averted each year.
"Building on these achievements, we can take immunization to the next level, with the expanded uptake of new vaccines against major killers such as pneumonia and rotavirus diarrhoea," said Dr Chan. "An additional two million deaths in children under five years could be prevented by 2015 through widespread use of new vaccines and a 10% increase in global vaccination coverage."
Vaccines join other proven measures, such as micronutrient supplements, oral rehydration therapy, and community delivery of antibiotics, that form an integrated approach to child health and have already brought much progress.
The Bill & Melinda Gates Foundation announcement comes on the tenth anniversary of the establishment of the Global Alliance for Vaccines and Immunization (GAVI). Dr Chan also congratulated the GAVI Alliance on their accomplishment of reaching 257 million additional children with new and underused vaccines.
"The Gates Foundation’s commitment to vaccines is unprecedented, but needs to be matched by unprecedented action. It’s absolutely crucial that both governments and the private sector step up efforts to provide life-saving vaccines to children who need them most," said Dr Margaret Chan, WHO Director-General.
Vaccines and immunization have played a major role since the last century in overall health gains. Smallpox has been eradicated, polio is on the verge of being eradicated and more than 2 million deaths are averted each year.
"Building on these achievements, we can take immunization to the next level, with the expanded uptake of new vaccines against major killers such as pneumonia and rotavirus diarrhoea," said Dr Chan. "An additional two million deaths in children under five years could be prevented by 2015 through widespread use of new vaccines and a 10% increase in global vaccination coverage."
Vaccines join other proven measures, such as micronutrient supplements, oral rehydration therapy, and community delivery of antibiotics, that form an integrated approach to child health and have already brought much progress.
The Bill & Melinda Gates Foundation announcement comes on the tenth anniversary of the establishment of the Global Alliance for Vaccines and Immunization (GAVI). Dr Chan also congratulated the GAVI Alliance on their accomplishment of reaching 257 million additional children with new and underused vaccines.
Friday, January 29, 2010
Counsyl Test to Prevent Diseases Like Those in 'Extraordinary Measures' Now at 100+ Medical Centers
Free with Insurance, New Pre-Pregnancy Test Saves Lives While Dramatically Cutting Health Care Costs
Genetic diseases like those seen in the new Harrison Ford movie "Extraordinary Measures" can now be prevented with a simple saliva test which is free with insurance for more than 100 million Americans.
The movie centers on the real-life efforts of the Crowleys, a family trying to find a cure for a rare genetic disease affecting two of the family’s three children. The condition wasn’t detected until after their children were born.
Now, couples can take a Universal Genetic Test before pregnancy to determine whether their baby is at risk for more than 100 life-threatening genetic diseases. At-risk couples may then use a well-understood procedure called IVF/PGD to protect their child from genetic disease and ensure a healthy pregnancy.
This Universal Genetic Test was invented by scientists and social entrepreneurs from Stanford and Harvard and brought to the public via a Stanford startup named Counsyl (counsyl.com). As Newsweek recently reported:
“What is the secret to improving public health while cutting costs? The question has consumed Washington, but it's being answered elsewhere, by doctors offering a new test for more than 100 rare recessive genes, some of which cause fatal diseases. The test, [offered by] Counsyl, lets potential parents assess their genomes to see if their future kids are at risk. ... This is as preventive as medicine gets: the test could eliminate all single-recessive-gene diseases.”
The test is now offered by physicians at more than 100 prestigious medical centers across the United States, including Yale Fertility Center (see counsyl.com/map), and has attracted the support of prominent academics, bioethicists,
religious leaders, families with genetic disease, and doctors from America’s largest hospitals.
Broad Support among Prominent Physicians for Universal Genetic TestingDr. Steven Ory, Past President of the American Society for Reproductive Medicine: "After 30 years in reproductive medicine, I am more optimistic about this development in genetic disease prevention than I've ever been before. The vast majority of babies born with genetic disease have no family history. That's why it's so critically important for all parents to get the Universal Genetic Test before pregnancy."
Dr. Pasquale Patrizio, Director of the Yale Fertility Center: "Every adult of reproductive age needs the Counsyl test. It is unusual in that it benefits all three parts of the health care triad: patients, doctors, and insurers. A child stricken by
preventable genetic disease often dies in infancy and costs the bereaved parents millions in medical bills. A five minute saliva test that prevents this is a money saver, a time saver, and most importantly a life saver; it really is a no-brainer."
Dr. Thomas Walsh, Director of the Male Fertility Laboratory at the University of Washington: "Genetic testing has been recommended for all adults before pregnancy since 2001, but like many topics related to planning a pregnancy, awareness of this
issue continues to lag. This test covers several key genetic diseases, including cystic fibrosis, spinal muscular atrophy, sickle cell, Tay-Sachs, and many others. The results of testing enable couples to make an informed decision before conceiving a child.”
Dr. John Marshall, Former Chairman of Ob/Gyn at Harbor-UCLA Medical Center: "Because the test can be taken in the privacy of one's home as well as in a clinical setting, it reminds me of the first 'at home pregnancy test'. This 'at home carrier test' is very similar in that the healthy adults who take it generally
test negative, with those who test positive referred for medical followup. It thus completely reshapes the debate over so-called direct-to-consumer or 'DTC' testing. Offering this test over the web as well as in a clinical setting is simply a moral imperative, as it is the only way to get needed care to people in rural areas who may be far away from large hospitals."
Dr. Michael Levy, Clinical Professor of Ob/Gyn at Georgetown & Director of IVF at Shady Grove Fertility, America's largest IVF center: "Parents who know their carrier status before pregnancy can take preventive measures to have a healthy
child. Because new techniques like PGD are used before pregnancy, they avoid the ethical dilemma of termination that was previously a roadblock to wider adoption of carrier testing."
The New Standard of Care at the Nation's Largest Fertility CentersDr. Angeline Beltsos, Medical Director of the Fertility Centers of Illinois: "Every doctor and patient wants to avoid a high-risk pregnancy. Yet many people don't know that
single gene disorders now account for more than 10% of infant deaths. The Universal Genetic Test is the next ultrasound: a non-invasive early warning system for couples to know if their baby is at risk."
Dr. Arthur Wisot, Medical Director of Reproductive Partners Medical Group in Los Angeles: "The Counsyl test is appropriate for everyone trying to conceive because it is the first test that makes it both practical and economical to screen for so
many genetic diseases. Couples can now protect their baby from developing any one of over a hundred debilitating and lethal genetic diseases with just a saliva sample. This test is the future of genetic screening."
Dr. Ian Hardy, Medical Director of Fertility Centers of New England: "We have been offering the Counsyl test to our incoming patients as part of their standard
evaluation with exceptional results. It is an easy-to-use saliva test which is covered by most insurance plans and allows couples to be screened for both common genetic diseases (like CF, SMA, PKU, and beta thalassemia) as well as dozens of rare conditions."
Dr. Kaylen Silverberg, Medical Director of Texas Fertility: "The Counsyl test replaces a battery of more expensive blood tests. It provides a couple and their physician with much more information for a fraction of the cost. Counsyl testing
represents a quantum leap forward in pre-pregnancy planning for couples — especially those concerned about having a child with a genetic disease — as it is safe, affordable, and easy to use."
Dr. Michael Soules, Medical Director of Seattle Reproductive Medicine: "The new Counsyl test is the simplest and most cost-effective way to do genetic screening as it checks for over 100 significant disorders with a single saliva sample. Enlightened insurance carriers are paying for this test as it saves them the major future expenses of covering a chronically sick child."
An Advance for Women, Minorities, and Families with Genetic Disease Professor Henry Louis Gates of Harvard University: "As the first genetic test for all ethnic groups, the Counsyl test represents a genuine breakthrough for minority health. With
one test for diverse communities, African Americans and Hispanics can benefit from a new technology that actually reduces health care disparities."
Elena Ashkinadze, Program Supervisor in Genetics, UMDNJ-Robert Wood Johnson Medical School: "Because Counsyl's test simultaneously covers diseases from many ethnic groups at a considerably lower cost than standard blood tests, it promises to make carrier testing affordable for previously underserved patient populations, including African Americans and Hispanics. The current practice is mostly to screen once a woman gets pregnant. With Counsyl's test, we can change the emphasis to pre-pregnancy screening when more options, including preimplantation genetic diagnosis, are available. Ideally, women should understand that having carrier testing before
pregnancy is as important as refraining from alcohol during pregnancy."
David Brenner, Director of the Dysautonomia Foundation: "As a parent of a child with a genetic disease, I wouldn't want another child to suffer from what my son has
endured. Nothing is more important than safeguarding the health of our children, and this test is such a simple and powerful way to prevent terrible suffering."
Rabbi David Wolpe of the Sinai Temple in Los Angeles: "Several years ago, a mother whose son was born with Tay-Sachs said to me sadly ‘The Rabbi made sure to tell us not to play Wagner's march at our wedding, but said nothing about being genetically tested.’ Ensuring that Jewish couples — and others — are offered genetic
testing is a critical task."
Professor Steven Pinker of Harvard University: "Universal genetic testing can drastically reduce the incidence of genetic diseases, and may very well eliminate many of them." Last year, Professor Pinker took the test with his wife, the novelist Rebecca Goldstein. To raise awareness of preventable genetic disease, they are now publicly announcing for the first time that both of them tested positive as carriers for familial dysautonomia. While they themselves are healthy, their children would have been at risk for this life-threatening genetic disease — underscoring that the value of genetic testing is far from hypothetical.
About Counsyl
The Universal Genetic Test was developed by Counsyl, a Stanford startup founded by social entrepreneurs and philanthropists. Counsyl's mission is to end the needless suffering of preventable genetic disease.
To ensure that every ounce of prevention enables a pound of cure, each test taken helps Counsyl fund treatments for children living with genetic disease. More than $50,000 has already been donated to nonprofits over the course of 2009. For the next month, donations will go to the John F. and Aileen A. Crowley Foundation in honor of John Crowley, the Harvard Business School graduate whose life is the basis
Genetic diseases like those seen in the new Harrison Ford movie "Extraordinary Measures" can now be prevented with a simple saliva test which is free with insurance for more than 100 million Americans.
The movie centers on the real-life efforts of the Crowleys, a family trying to find a cure for a rare genetic disease affecting two of the family’s three children. The condition wasn’t detected until after their children were born.
Now, couples can take a Universal Genetic Test before pregnancy to determine whether their baby is at risk for more than 100 life-threatening genetic diseases. At-risk couples may then use a well-understood procedure called IVF/PGD to protect their child from genetic disease and ensure a healthy pregnancy.
This Universal Genetic Test was invented by scientists and social entrepreneurs from Stanford and Harvard and brought to the public via a Stanford startup named Counsyl (counsyl.com). As Newsweek recently reported:
“What is the secret to improving public health while cutting costs? The question has consumed Washington, but it's being answered elsewhere, by doctors offering a new test for more than 100 rare recessive genes, some of which cause fatal diseases. The test, [offered by] Counsyl, lets potential parents assess their genomes to see if their future kids are at risk. ... This is as preventive as medicine gets: the test could eliminate all single-recessive-gene diseases.”
The test is now offered by physicians at more than 100 prestigious medical centers across the United States, including Yale Fertility Center (see counsyl.com/map), and has attracted the support of prominent academics, bioethicists,
religious leaders, families with genetic disease, and doctors from America’s largest hospitals.
Broad Support among Prominent Physicians for Universal Genetic TestingDr. Steven Ory, Past President of the American Society for Reproductive Medicine: "After 30 years in reproductive medicine, I am more optimistic about this development in genetic disease prevention than I've ever been before. The vast majority of babies born with genetic disease have no family history. That's why it's so critically important for all parents to get the Universal Genetic Test before pregnancy."
Dr. Pasquale Patrizio, Director of the Yale Fertility Center: "Every adult of reproductive age needs the Counsyl test. It is unusual in that it benefits all three parts of the health care triad: patients, doctors, and insurers. A child stricken by
preventable genetic disease often dies in infancy and costs the bereaved parents millions in medical bills. A five minute saliva test that prevents this is a money saver, a time saver, and most importantly a life saver; it really is a no-brainer."
Dr. Thomas Walsh, Director of the Male Fertility Laboratory at the University of Washington: "Genetic testing has been recommended for all adults before pregnancy since 2001, but like many topics related to planning a pregnancy, awareness of this
issue continues to lag. This test covers several key genetic diseases, including cystic fibrosis, spinal muscular atrophy, sickle cell, Tay-Sachs, and many others. The results of testing enable couples to make an informed decision before conceiving a child.”
Dr. John Marshall, Former Chairman of Ob/Gyn at Harbor-UCLA Medical Center: "Because the test can be taken in the privacy of one's home as well as in a clinical setting, it reminds me of the first 'at home pregnancy test'. This 'at home carrier test' is very similar in that the healthy adults who take it generally
test negative, with those who test positive referred for medical followup. It thus completely reshapes the debate over so-called direct-to-consumer or 'DTC' testing. Offering this test over the web as well as in a clinical setting is simply a moral imperative, as it is the only way to get needed care to people in rural areas who may be far away from large hospitals."
Dr. Michael Levy, Clinical Professor of Ob/Gyn at Georgetown & Director of IVF at Shady Grove Fertility, America's largest IVF center: "Parents who know their carrier status before pregnancy can take preventive measures to have a healthy
child. Because new techniques like PGD are used before pregnancy, they avoid the ethical dilemma of termination that was previously a roadblock to wider adoption of carrier testing."
The New Standard of Care at the Nation's Largest Fertility CentersDr. Angeline Beltsos, Medical Director of the Fertility Centers of Illinois: "Every doctor and patient wants to avoid a high-risk pregnancy. Yet many people don't know that
single gene disorders now account for more than 10% of infant deaths. The Universal Genetic Test is the next ultrasound: a non-invasive early warning system for couples to know if their baby is at risk."
Dr. Arthur Wisot, Medical Director of Reproductive Partners Medical Group in Los Angeles: "The Counsyl test is appropriate for everyone trying to conceive because it is the first test that makes it both practical and economical to screen for so
many genetic diseases. Couples can now protect their baby from developing any one of over a hundred debilitating and lethal genetic diseases with just a saliva sample. This test is the future of genetic screening."
Dr. Ian Hardy, Medical Director of Fertility Centers of New England: "We have been offering the Counsyl test to our incoming patients as part of their standard
evaluation with exceptional results. It is an easy-to-use saliva test which is covered by most insurance plans and allows couples to be screened for both common genetic diseases (like CF, SMA, PKU, and beta thalassemia) as well as dozens of rare conditions."
Dr. Kaylen Silverberg, Medical Director of Texas Fertility: "The Counsyl test replaces a battery of more expensive blood tests. It provides a couple and their physician with much more information for a fraction of the cost. Counsyl testing
represents a quantum leap forward in pre-pregnancy planning for couples — especially those concerned about having a child with a genetic disease — as it is safe, affordable, and easy to use."
Dr. Michael Soules, Medical Director of Seattle Reproductive Medicine: "The new Counsyl test is the simplest and most cost-effective way to do genetic screening as it checks for over 100 significant disorders with a single saliva sample. Enlightened insurance carriers are paying for this test as it saves them the major future expenses of covering a chronically sick child."
An Advance for Women, Minorities, and Families with Genetic Disease Professor Henry Louis Gates of Harvard University: "As the first genetic test for all ethnic groups, the Counsyl test represents a genuine breakthrough for minority health. With
one test for diverse communities, African Americans and Hispanics can benefit from a new technology that actually reduces health care disparities."
Elena Ashkinadze, Program Supervisor in Genetics, UMDNJ-Robert Wood Johnson Medical School: "Because Counsyl's test simultaneously covers diseases from many ethnic groups at a considerably lower cost than standard blood tests, it promises to make carrier testing affordable for previously underserved patient populations, including African Americans and Hispanics. The current practice is mostly to screen once a woman gets pregnant. With Counsyl's test, we can change the emphasis to pre-pregnancy screening when more options, including preimplantation genetic diagnosis, are available. Ideally, women should understand that having carrier testing before
pregnancy is as important as refraining from alcohol during pregnancy."
David Brenner, Director of the Dysautonomia Foundation: "As a parent of a child with a genetic disease, I wouldn't want another child to suffer from what my son has
endured. Nothing is more important than safeguarding the health of our children, and this test is such a simple and powerful way to prevent terrible suffering."
Rabbi David Wolpe of the Sinai Temple in Los Angeles: "Several years ago, a mother whose son was born with Tay-Sachs said to me sadly ‘The Rabbi made sure to tell us not to play Wagner's march at our wedding, but said nothing about being genetically tested.’ Ensuring that Jewish couples — and others — are offered genetic
testing is a critical task."
Professor Steven Pinker of Harvard University: "Universal genetic testing can drastically reduce the incidence of genetic diseases, and may very well eliminate many of them." Last year, Professor Pinker took the test with his wife, the novelist Rebecca Goldstein. To raise awareness of preventable genetic disease, they are now publicly announcing for the first time that both of them tested positive as carriers for familial dysautonomia. While they themselves are healthy, their children would have been at risk for this life-threatening genetic disease — underscoring that the value of genetic testing is far from hypothetical.
About Counsyl
The Universal Genetic Test was developed by Counsyl, a Stanford startup founded by social entrepreneurs and philanthropists. Counsyl's mission is to end the needless suffering of preventable genetic disease.
To ensure that every ounce of prevention enables a pound of cure, each test taken helps Counsyl fund treatments for children living with genetic disease. More than $50,000 has already been donated to nonprofits over the course of 2009. For the next month, donations will go to the John F. and Aileen A. Crowley Foundation in honor of John Crowley, the Harvard Business School graduate whose life is the basis
Sunday, January 24, 2010
Stimulus for Thailand’s hospitality industry
The Office of Small and Medium Enterprises Promotion (OSMEP), Impact Exhibition Management and Thailand Restaurant News magazine are inviting local and international players in the hospitality business, and entrepreneurs interested in this sector, to Thailand International Restaurant and Bar 2010 at Impact Muang Thong Thani in June 2010.
This international expo is designed to raise the standard of Thailand’s hospitality industry and giving encouragement and support to new entrepreneurs now that the economy is recovering.
Yuthasak Supasorn, OSMEP’s Director-General pointed out that the restaurant and service industry was one of Thailand’s vital sectors, with a value of two hundred thousand million baht each year, and that new business ventures were continually opening.
“As the economy continues to improve, everyone involved in this sector needs to be ready to take advantage of emerging opportunities,” he said.
“However, sustainable success in this business depends on many factors, such as location, financial support, market insight, product and service quality, customer base and network of business alliances. The Thailand International Restaurant and Bar 2010 has been organised to give players in this sector, whether they’re actual or potential, the support they need to go for that success.”
Pornphan Bulner, Assistant Director Exhibition Project of Impact Exhibition Management, explained that the expo would integrate products, services and technologies relating to restaurants, hotels, bars, coffee shops and catering to meet the needs of entrepreneurs.
“It will showcase raw materials, equipment and machinery, as well as new techniques and skill trainings for all roles in the hospitality industry. At the same time it will provide a platform for negotiation, networking and exchanging information,” she said.
“At least 150 local and international companies will exhibit their products and services on a combined space of 10,000 square meters. We’re expecting to receive more than 10,000 Thai and foreign visitors -- owners, managers, suppliers and business consultants, as well as people who are interested in running their own business.”
Thailand International Restaurant and Bar 2010 will be arranged in three zones: Cuisine for Change, World of Wine & Spirits, and Coffee (Tea & Bakery) Culture. It will also include seminars, demonstrations of recipes and cooking techniques, competitions for chefs, sommeliers and bartenders and an Asian barista championship.
Chatthaporn Yolao, Managing Director of Thailand Restaurant News magazine, said that the event would present new food trends and the latest technologies as business opportunities, and marketing information from experts. Thai SME’s would also benefit from the new relationships they make with other entrepreneurs and service providers.
“We are hoping that Thailand International Restaurant and Bar 2010 will be instrumental in raising the standard of the food and beverage and hospitality industries in Thailand, and in doing so benefit the Thai economy,” she said.
This international expo is designed to raise the standard of Thailand’s hospitality industry and giving encouragement and support to new entrepreneurs now that the economy is recovering.
Yuthasak Supasorn, OSMEP’s Director-General pointed out that the restaurant and service industry was one of Thailand’s vital sectors, with a value of two hundred thousand million baht each year, and that new business ventures were continually opening.
“As the economy continues to improve, everyone involved in this sector needs to be ready to take advantage of emerging opportunities,” he said.
“However, sustainable success in this business depends on many factors, such as location, financial support, market insight, product and service quality, customer base and network of business alliances. The Thailand International Restaurant and Bar 2010 has been organised to give players in this sector, whether they’re actual or potential, the support they need to go for that success.”
Pornphan Bulner, Assistant Director Exhibition Project of Impact Exhibition Management, explained that the expo would integrate products, services and technologies relating to restaurants, hotels, bars, coffee shops and catering to meet the needs of entrepreneurs.
“It will showcase raw materials, equipment and machinery, as well as new techniques and skill trainings for all roles in the hospitality industry. At the same time it will provide a platform for negotiation, networking and exchanging information,” she said.
“At least 150 local and international companies will exhibit their products and services on a combined space of 10,000 square meters. We’re expecting to receive more than 10,000 Thai and foreign visitors -- owners, managers, suppliers and business consultants, as well as people who are interested in running their own business.”
Thailand International Restaurant and Bar 2010 will be arranged in three zones: Cuisine for Change, World of Wine & Spirits, and Coffee (Tea & Bakery) Culture. It will also include seminars, demonstrations of recipes and cooking techniques, competitions for chefs, sommeliers and bartenders and an Asian barista championship.
Chatthaporn Yolao, Managing Director of Thailand Restaurant News magazine, said that the event would present new food trends and the latest technologies as business opportunities, and marketing information from experts. Thai SME’s would also benefit from the new relationships they make with other entrepreneurs and service providers.
“We are hoping that Thailand International Restaurant and Bar 2010 will be instrumental in raising the standard of the food and beverage and hospitality industries in Thailand, and in doing so benefit the Thai economy,” she said.
International Diabetes Federation Reports Diabetes Burden Shifting to Developing Countries
International Diabetes Federation calls for increased funding for essential medicines and for governments to make diabetes a priority in national healthcare plans
Four out of every five people with diabetes now live in developing countries, with most affected men and women being of working age.
This is according to the latest data published by the International Diabetes Federation (IDF) in the fourth edition of the IDF Diabetes Atlas. (www.diabetesatlas.org)
"It is dismal news that some 285 million people live with diabetes today. Even worse, low and middle-income countries are bearing the brunt of the disease," said IDF President Jean Claude Mbanya.
According to World Health Organization estimates, India and China will lose national income to the tune of nearly US$900 billion between 2005 and 2015 to diabetes and cardiovascular disease. IDF predicts that diabetes will cost the world economy US$376 billion in 2010 and a hundred billion more within a generation.
"Families are losing breadwinners, parents are losing children, children are losing mothers. Much of this tragic loss of life is preventable," said Prof Mbanya, who features in a BBC documentary showcasing the burden of diabetes in the developing world.
The half-hour documentary - titled Bittersweet - is being aired this week as part of BBC World's Kill or Cure series. Set in Nairobi, Kenya and Pune, India, the film shows how the South Asian subcontinent is facing a type 2 diabetes pandemic, while in Africa many countries struggle to put insulin within reach of people with type 1 diabetes.
"It's an outrage that while treatment and technology exists for people with diabetes to manage their disease, the reality is that for millions of people in low and middle-income countries, modern treatment and technology is still a dream," added Prof Mbanya.
"IDF calls for increased funding for essential medicines and for governments to make diabetes a priority in national healthcare plans."
Bittersweet will air on BBC World at 11:30GMT on 13 January (Asia Pacific only), 15:30GMT on 14 January and 02.30GMT on 15 January. The documentary can also be viewed online at http://www.rockhopper.tv/programmes/311/
About IDF
The International Diabetes Federation (IDF) is an umbrella organization of 212 member associations in 163 countries and territories, representing over 285 million people with diabetes, their families, and their healthcare providers. The mission of IDF is to promote diabetes care, prevention and a cure worldwide. Its main activities include education for people with diabetes and healthcare professionals, public awareness campaigns and the promotion and exchange of information. IDF is a non-governmental organization in official relations with WHO and associated to the United Nations' Department of Public Information. For more information, please visit www.idf.org and follow us at twitter.com/IntDiabetesFed
Four out of every five people with diabetes now live in developing countries, with most affected men and women being of working age.
This is according to the latest data published by the International Diabetes Federation (IDF) in the fourth edition of the IDF Diabetes Atlas. (www.diabetesatlas.org)
"It is dismal news that some 285 million people live with diabetes today. Even worse, low and middle-income countries are bearing the brunt of the disease," said IDF President Jean Claude Mbanya.
According to World Health Organization estimates, India and China will lose national income to the tune of nearly US$900 billion between 2005 and 2015 to diabetes and cardiovascular disease. IDF predicts that diabetes will cost the world economy US$376 billion in 2010 and a hundred billion more within a generation.
"Families are losing breadwinners, parents are losing children, children are losing mothers. Much of this tragic loss of life is preventable," said Prof Mbanya, who features in a BBC documentary showcasing the burden of diabetes in the developing world.
The half-hour documentary - titled Bittersweet - is being aired this week as part of BBC World's Kill or Cure series. Set in Nairobi, Kenya and Pune, India, the film shows how the South Asian subcontinent is facing a type 2 diabetes pandemic, while in Africa many countries struggle to put insulin within reach of people with type 1 diabetes.
"It's an outrage that while treatment and technology exists for people with diabetes to manage their disease, the reality is that for millions of people in low and middle-income countries, modern treatment and technology is still a dream," added Prof Mbanya.
"IDF calls for increased funding for essential medicines and for governments to make diabetes a priority in national healthcare plans."
Bittersweet will air on BBC World at 11:30GMT on 13 January (Asia Pacific only), 15:30GMT on 14 January and 02.30GMT on 15 January. The documentary can also be viewed online at http://www.rockhopper.tv/programmes/311/
About IDF
The International Diabetes Federation (IDF) is an umbrella organization of 212 member associations in 163 countries and territories, representing over 285 million people with diabetes, their families, and their healthcare providers. The mission of IDF is to promote diabetes care, prevention and a cure worldwide. Its main activities include education for people with diabetes and healthcare professionals, public awareness campaigns and the promotion and exchange of information. IDF is a non-governmental organization in official relations with WHO and associated to the United Nations' Department of Public Information. For more information, please visit www.idf.org and follow us at twitter.com/IntDiabetesFed
Thursday, January 21, 2010
Thailand to host 17th International Training Course for Full-Endoscopic Operations
Bumrungrad International; the Faculty of Science at Mahidol University; the Faculty of Medicine at Ramathibodi Hospital, Mahidol University; and the Department of Spine Surgery and Pain Therapy Center of Orthopaedics and Traumatology, St. Anna-Hospital in Herne, Germany, will host the 17th International Training Course for Full-Endoscopic Operations of the Lumbar, Thoracic and Cervical Spine, on
- Friday 22 January, at the Conference Center, Bumrungrad International hospital, Sukhumvit Soi 3, and
- Saturday 23 January, at the Faculty of Science, Mahidol University.
Endoscopic spine surgery has been gaining more popularity for the past decade. Today, it is regarded as a standard treatment for early disc pathology. This course is designed for both neurosurgeons and orthopaedic surgeons from domestic and international hospitals, who have a strong interest in developing the endoscopic lumbar discectomy technique for patient selection.
- Friday 22 January, at the Conference Center, Bumrungrad International hospital, Sukhumvit Soi 3, and
- Saturday 23 January, at the Faculty of Science, Mahidol University.
Endoscopic spine surgery has been gaining more popularity for the past decade. Today, it is regarded as a standard treatment for early disc pathology. This course is designed for both neurosurgeons and orthopaedic surgeons from domestic and international hospitals, who have a strong interest in developing the endoscopic lumbar discectomy technique for patient selection.
Sunday, January 17, 2010
First Non-Invasive Technology for Treatment of Uterine Fibroids Awarded MHLW Approval in Japan
InSightec's ExAblate System Uses Magnetic Resonance-Guided Focused Ultrasound to Perform Uterine Procedures Without Incisions
InSightec Ltd. announced today that Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved the company’s ExAblate® MR-guided Focused Ultrasound (MRgFUS) system for the treatment of women with uterine fibroids. “We are very pleased that the Japanese Ministry of Health has approved the
ExAblate system and that women in Japan will now have access to a noninvasive treatment option for uterine fibroids,” said Dr. Kobi Vortman, President and Chief Executive Officer of InSightec. “The approval was based on a growing body of evidence showing that ExAblate is a safe, effective, and durable treatment for this widespread, life-impacting condition. ExAblate is an outpatient procedure and patients normally return home the same day and to work within one to two days compared to lengthy hospitalizations and recovery times associated with more invasive procedures such as hysterectomy, myomectomy or UAE.”
ExAblate is currently the only noninvasive treatment for uterine fibroids approved for use in Japan. Approximately 25% Japanese women will develop symptomatic uterine fibroids, primarily during childbearing years. These benign tumors can significantly impair functionality and degrade quality of life resulting in significant work absences.
Using the ExAblate system, the physician uses the Magnetic Resonance Imaging (MRI) to visualize the patient's anatomy and then aims focused ultrasound waves at the targeted tissue to thermally ablate, or
destroy it. The MRI allows the physician to monitor and continuously adjust the treatment in real time. The patient is consciously sedated to alleviate pain and minimize motion.
A growing body of evidence supports the system's safety and efficacy, including the results of a study published in the August 2007 edition of Obstetrics and Gynecology. The study showed that ExAblate offered
women sustained relief from uterine fibroid symptoms for up to two years, with a low incidence of side effects. The 359-patient Mayo Clinic-led collaborative study also showed that destroying as much of the fibroid as possible leads to the most durable symptom relief with 85% of the participants experiencing symptom improvement after one year. Studies conducted in Japan indicate similar results.
The ExAblate system received the CE Mark for uterine fibroids in October 2002 and US Food and Drug Administration (FDA) approval in 2004. Over 5,500 women around the world have chosen to undergo the non-invasive ExAblate treatment for their symptomatic uterine fibroids over invasive surgery.
GE Healthcare is the distributor of ExAblate in Japan.
About InSightec
InSightec Ltd. is a privately held company owned by Elbit Imaging, General Electric, MediTech Advisors, LLC and employees. It was founded in 1999 to develop the breakthrough MR guided Focused Ultrasound technology and transform it into the next generation operating room. Headquartered near Haifa, Israel, the company has over 160 employees and has invested more than $130 million in research, development, and clinical investigations. Its U.S. headquarters are located in Dallas, Texas. For more information, please go to:
http://www.insightec.com/
About GE Healthcare Japan
GE Healthcare Japan Corporation provides cutting edge medical technologies and healthcare services that design the next-generation patient care model by utilizing its expertise across a wide range of areas such as medical diagnostic imaging systems and healthcare IT equipments such as CT (Computerized Tomography) systems and MR (Magnetic Resonance) imaging systems, medical diagnostic drugs, biological information monitors, drug discovery, biotechnology-based drugs, and providing support for the management of
healthcare institutes. GE Healthcare Japan Corporation was established as the core site in Japan for the healthcare business section within the General Electric Company (GE, based in the U.S.)
InSightec Ltd. announced today that Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved the company’s ExAblate® MR-guided Focused Ultrasound (MRgFUS) system for the treatment of women with uterine fibroids. “We are very pleased that the Japanese Ministry of Health has approved the
ExAblate system and that women in Japan will now have access to a noninvasive treatment option for uterine fibroids,” said Dr. Kobi Vortman, President and Chief Executive Officer of InSightec. “The approval was based on a growing body of evidence showing that ExAblate is a safe, effective, and durable treatment for this widespread, life-impacting condition. ExAblate is an outpatient procedure and patients normally return home the same day and to work within one to two days compared to lengthy hospitalizations and recovery times associated with more invasive procedures such as hysterectomy, myomectomy or UAE.”
ExAblate is currently the only noninvasive treatment for uterine fibroids approved for use in Japan. Approximately 25% Japanese women will develop symptomatic uterine fibroids, primarily during childbearing years. These benign tumors can significantly impair functionality and degrade quality of life resulting in significant work absences.
Using the ExAblate system, the physician uses the Magnetic Resonance Imaging (MRI) to visualize the patient's anatomy and then aims focused ultrasound waves at the targeted tissue to thermally ablate, or
destroy it. The MRI allows the physician to monitor and continuously adjust the treatment in real time. The patient is consciously sedated to alleviate pain and minimize motion.
A growing body of evidence supports the system's safety and efficacy, including the results of a study published in the August 2007 edition of Obstetrics and Gynecology. The study showed that ExAblate offered
women sustained relief from uterine fibroid symptoms for up to two years, with a low incidence of side effects. The 359-patient Mayo Clinic-led collaborative study also showed that destroying as much of the fibroid as possible leads to the most durable symptom relief with 85% of the participants experiencing symptom improvement after one year. Studies conducted in Japan indicate similar results.
The ExAblate system received the CE Mark for uterine fibroids in October 2002 and US Food and Drug Administration (FDA) approval in 2004. Over 5,500 women around the world have chosen to undergo the non-invasive ExAblate treatment for their symptomatic uterine fibroids over invasive surgery.
GE Healthcare is the distributor of ExAblate in Japan.
About InSightec
InSightec Ltd. is a privately held company owned by Elbit Imaging, General Electric, MediTech Advisors, LLC and employees. It was founded in 1999 to develop the breakthrough MR guided Focused Ultrasound technology and transform it into the next generation operating room. Headquartered near Haifa, Israel, the company has over 160 employees and has invested more than $130 million in research, development, and clinical investigations. Its U.S. headquarters are located in Dallas, Texas. For more information, please go to:
http://www.insightec.com/
About GE Healthcare Japan
GE Healthcare Japan Corporation provides cutting edge medical technologies and healthcare services that design the next-generation patient care model by utilizing its expertise across a wide range of areas such as medical diagnostic imaging systems and healthcare IT equipments such as CT (Computerized Tomography) systems and MR (Magnetic Resonance) imaging systems, medical diagnostic drugs, biological information monitors, drug discovery, biotechnology-based drugs, and providing support for the management of
healthcare institutes. GE Healthcare Japan Corporation was established as the core site in Japan for the healthcare business section within the General Electric Company (GE, based in the U.S.)
Saturday, January 2, 2010
Alphatec Spine Agrees to Acquire Scient'x Groupe SAS
Acquisition Creates Global Scale and Offers Revenues and Cost
Synergies, Complements Alphatec Spine's Product Portfolio and
Enhances Aging Spine Focus Combined Entity to be Third-
Largest Global Pure-Play Spinal Implant Company
Alphatec Holdings, Inc. (Nasdaq:ATEC), the parent company of Alphatec Spine, Inc., a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spine disorders, with a focus on treating conditions affecting the aging spine, announced today that it has entered into a definitive agreement to acquire Scient'x Groupe SAS, a spinal implant company headquartered in France.
The transaction is structured as an all stock transaction such that 100% of outstanding Scient'x stock will be exchanged pursuant to a fixed ratio for 24 million shares of the Company's common stock. On a pro forma basis, current Alphatec shareholders will own approximately 69% of the combined company and approximately 31% will be held by current Scient'x shareholders. The transaction is currently expected to close by the end of the first quarter of 2010 and is subject to the approval of the Company's shareholders. Subject to the closing of the transaction, the Company expects 2010 pro forma full-year revenues to be in a range of $220 million to $225 million, and pro forma full-year 2010 adjusted EBITDA to be in a range of $32 million to $35 million. The transaction is expected to be neutral to slightly positive to 2010 EPS and accretive to 2011 EPS, excluding amortization of intangible assets, transaction expenses and related restructuring charges. The Company has absorbed transaction-related costs that had a negative impact to EPS in the third quarter and are expected to negatively impact previously issued EPS guidance for the fourth quarter of 2009. The Company also expects to absorb additional transaction-related expenses in the first quarter of 2010.
The combined company will create the third-largest independent spinal company with a global span of product distribution. Scient'x is the largest privately held independent spine company outside of the United States with product distribution in over 50 countries.
The transaction was unanimously approved by a Special Committee of independent members of the Company's Board of Directors. Following such approval by the Special Committee, the Company's Board of Directors unanimously approved the acquisition agreement. Thomas Weisel Partners LLC acted as exclusive financial advisor to the Special Committee and provided a fairness opinion to the Board of Directors that the transaction was fair to the Company from a financial point of view as of the date of this press release. DLA Piper LLP (US) acted as independent counsel to the Special Committee.
The Company believes that the strategic merit of the combined business includes the following benefits to its shareholders:
* Increases scale and global presence in all major geographic markets
* Provides cross-selling opportunities in major markets to leverage
future growth across core spine products and Aging Spine products
* Strengthens and expands the Company's product portfolio with
differentiated products in all segments
* Enhances the Company's ability to educate, train and service its
spine surgeon customers
* Provides cost synergies in distribution, marketing and
administration infrastructure
* Diversifies potential future U.S. healthcare reform and regulatory
risks
Both the Company and Scient'x operate in the high growth spinal implant market. The worldwide spinal implant market in 2009 is estimated to be $8.5 to $9.0 billion with a long-term growth rate that is estimated to be between 10% and 12%.
"We believe that Scient'x is a perfect complementary strategic fit for Alphatec Spine," stated Dirk Kuyper, Alphatec Spine's President and Chief Executive Officer. Mr. Kuyper continued, "Besides the significant cost and revenue synergies the acquisition offers, Alphatec Spine will now have the opportunity to reach 50 international markets with our aging spine and core fusion technologies. This transaction moves us into position to be able to become one of the top global spine companies."
"I am pleased to have the opportunity to work closely with Oliver Burckhardt again, following our time together at Aesculap Inc. He will be instrumental in overseeing our international sales efforts and will lead the strategic marketing direction of the combined company. We believe that the combination of Alphatec Spine and Scient'x creates a complete and broad product portfolio with differentiated products addressing underserved markets with disruptive technologies," continued Mr. Kuyper.
"I am excited to be joining the Alphatec Spine team," stated Oliver Burckhardt, Scient'x's President and Chief Executive Officer. "We believe that the combined product portfolio will be among the most innovative of any spine company in the market," Mr. Burckhardt continued, "At Scient'x, we have created a global distribution network in over 50 countries with an excellent history of broad surgeon training and education that will help to drive shareholder value. We look forward to introducing Alphatec Spine's products to our customers as well as leveraging Alphatec Spine's strong U.S. presence with Scient'x's technology."
Conference Call
Alphatec Spine will host a conference call today at 1:30 p.m. PT / 4:30 p.m. ET to discuss details of the acquisition. To participate in the conference call, please visit the investor relations section of the Alphatec Spine website at www.alphatecspine.com. The dial-in numbers are (888) 510-1762 for domestic callers and (719) 325-2383 for international callers. A live webcast of the conference call will be available online from the investor relations section of the Alphatec website at www.alphatecspine.com. The webcast will be recorded and will be available on the investor relations section of Alphatec Spine's website, for at least 30 days after it is posted.
About Scient'x
Scient'x is a Guyancourt, France based medical device company that designs, develops and manufactures spinal implants and instrumentation. Scient'x was founded in 1988 and offers today a full range of implants for spinal fusions, posterior semi-rigid stabilization and a cervical total disc replacement device. Its international distribution network consists of a direct sales force in France and the U.K., a hybrid of direct sales force and distributors in Italy as well as exclusive and non-exclusive distributors in more than 50 countries including the United States. The Scient'x surgeon education and training network augments its international distribution capabilities.
Scient'x key products includes the Isobar(TM) TTL and Isobar Evolution(TM) rods, a semi-rigid rod technology used in spinal fusion surgeries, as well as an offering of cervical and lumbar implants also used predominantly in spine fusion surgeries. The Isobar(TM) products are 510(k) cleared by the FDA in the U.S. as an adjunct to fusion. Outside of the United States, Scient'x markets also a unique and proprietary ceramic-on-ceramic cervical total disc replacement device, DiscoCerv(R), which has been implanted in over 3,000 patients since its initial launch.
About Alphatec Spine
Alphatec Spine, Inc. is a wholly owned subsidiary of Alphatec Holdings, Inc. (Nasdaq:ATEC). Alphatec Spine is a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spine disorders, primarily focused on the aging spine. The Company's mission is to combine world-class customer service with innovative, surgeon-driven design that will help improve the aging patient's quality of life. The Company is poised to achieve its goal through new solutions for patients with osteoporosis, stenosis and other aging spine deformities, improved minimally invasive products and techniques and integrated biologics solutions. In addition to its US operations, the Company also markets its spine products in Europe. In Asia, the Company markets a broad line of spine and orthopedic products through its subsidiary, Alphatec Pacific, Inc. For more information, please visit www.alphatecspine.com.
Also visit the Aging Spine Center, www.agingspinecenter.com, a web-based information portal for healthcare providers and patients regarding aging spine disorders and their treatment. The Company is working with the National Osteoporosis Foundation as well as other clinical portals that provide peer-reviewed content, to populate the Aging Spine Center. The interactive website enables patients to review pertinent information about disorders that affect the aging spine in an easy-to-understand format that includes videos, graphics and questions that should be asked of caregivers. Medical information on the website includes published abstracts regarding the aging spine.
The Alphatec Spine, Inc. logo is available athttp://www.globenewswire.com/newsroom/prs/?pkgid=3520
Use of Non-GAAP Information
Alphatec provides its financial results in accordance with accounting principles generally accepted in the United States (GAAP). The Company also uses forward-looking non-GAAP financial measures in addition to and in conjunction with corresponding GAAP measures to help analyze the performance of its core business, in connection with the preparation of annual budgets, and in measuring performance for some forms of compensation. In particular, Alphatec presents (i) adjusted EBITDA, and (ii) combined pro forma financial information, which in each case are non-GAAP financial measures.
Non-GAAP financial measures reflect an additional way of viewing aspects of Alphatec's operations that, when viewed with the GAAP results, provide a more complete understanding of Alphatec's results of operations and the factors and trends affecting Alphatec's business. However, non-GAAP financial measures should be considered as a supplement to, and not as a substitute for, or superior to, the corresponding measures calculated in accordance with GAAP. Non-GAAP financial measures used by the Company may differ from the non-GAAP financial measures used by other companies, including Alphatec's competitors.
Alphatec believes the most directly comparable GAAP financial measure to adjusted EBITDA is net income (loss). Adjusted EBITDA is net income (loss) excluding the effects of interest, taxes, depreciation, amortization, stock-based compensation costs, and other non-recurring income of expense items, such as in-process research and development, expenses related to the transaction and acquisition related restructuring expenses that are expected to occur following closing.
Alphatec has not included in this presentation a reconciliation of these forward-looking non-GAAP financial measures to the most directly comparable GAAP financial measures because, due to variability and difficulty in making accurate forecasts and projections or certain information not being ascertainable or accessible, not all of the information necessary for a quantitative reconciliation of the forward-looking non-GAAP financial measures to the most directly comparable GAAP financial measures is available to the Company without unreasonable efforts. The probable significance of providing these forward-looking non-GAAP financial measures without the directly comparable GAAP financial measures is that such GAAP financial measures may be materially different from the corresponding non-GAAP financial measures.
Forward-Looking Statements
This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, as amended, which are intended to be covered by safe harbors created thereby. Shareholders are cautioned that all forward-looking statements are based largely on Alphatec's expectations and involve risks and uncertainties, some of which cannot be predicted or are beyond Alphatec's control. Statements containing a projection of revenue, EBITDA, cost and revenue synergies, additional market opportunities, future economic performance, product development timelines, the acceptance of products by the surgeon community or whether the acquisition agreement will be consummated are just a few examples of forward-looking statements. Some factors that could realistically cause results to differ materially from those projected in the forward-looking statements include the occurrence of any event, change or other circumstances that could give rise to the termination of the acquisition agreement; the outcome of any legal proceedings that have been, or may be, instituted against the Company or Scient'x related to the acquisition agreement; the inability to complete the acquisition due to the failure to obtain shareholder approval for the transaction or the failure to satisfy other conditions to completion of the transaction, including the receipt of all regulatory approvals or third-party consents related to the transaction; risks that the proposed transaction disrupts the Company's current plans and operations and the potential difficulties in employee retention as a result of the acquisition; the ability to recognize the benefits of the transaction; litigation outcomes, including without limitation product liability litigation and litigation related to the infringement of intellectual property of a third party; the impact of healthcare reform and regulations in the United States and other jurisdictions; the Company's ability to meet its financial guidance; the growth rate of the spine market related to aging and elderly patients; the ability to achieve regulatory approval for products in the Company's development pipeline and the successful adoption of such products once approved; the Company's ability to develop and expand its business in the United States, Asia and Europe; the Company's ability to compete with other competing products and with emerging new technologies; continuation of favorable third party payor reimbursement for procedures performed using the Company's products; unanticipated expenses or liabilities or other adverse events affecting cash flow or the Company's ability to successfully control its costs or achieve profitability; and the uncertainty of additional funding. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the Company's Annual Report on Form 10-K and in the Company's other filings with the Securities and Exchange Commission (the "SEC") available at the SEC's website at http://www.sec.gov.
The statements in this press release reflect the Company's expectations and beliefs as of the date of this release. The Company anticipates that subsequent events and developments will cause its expectations and beliefs to change. However, while the Company may elect to update these forward-looking statements publicly at some point in the future, the Company specifically disclaims any obligation to do so, whether as a result of new information, future events or otherwise. These forward-looking statements should not be relied upon as representing the Company's views as of any date after the date of this release.
Important Additional Information Will Be Filed with the SEC
In connection with the proposed transaction, the Company will file a proxy statement with the SEC. The proxy statement will be mailed to stockholders of Alphatec and will contain important information about Alphatec, Scient'x, the transaction and related matters. SHAREHOLDERS ARE STRONGLY ADVISED TO READ THE PROXY STATEMENT WHEN IT BECOMES AVAILABLE BECAUSE IT WILL CONTAIN IMPORTANT INFORMATION. Shareholders may obtain a free copy of the proxy statement (when available) and other documents filed by the Company from the SEC's website at http://www.sec.gov. The proxy statement (when available) and such other documents may also be obtained for free from the Company's website at http://www.alphatecspine.com or by directing such request to Alphatec Spine, Inc., Investor Relations, 5818 El Camino Real, Carlsbad, CA 92008, telephone: (760) 494-6746.
Alphatec, Scient'x and their respective directors and executive officers may be deemed to be participants in the solicitation of proxies in connection with the proposed acquisition. Information regarding Alphatec's directors and executive officers is contained in Alphatec's Annual Report on Form 10-K for the fiscal year ended December 31, 2008 and its proxy statement dated May 8, 2009, which are filed with the SEC. As of November 30, 2009, Alphatec's directors and executive officers beneficially owned approximately 41.2% of Alphatec's common stock. A more complete description of the interests of Alphatec's directors and officers in the acquisition will be available in the proxy statement relating to the acquisition.
Synergies, Complements Alphatec Spine's Product Portfolio and
Enhances Aging Spine Focus Combined Entity to be Third-
Largest Global Pure-Play Spinal Implant Company
Alphatec Holdings, Inc. (Nasdaq:ATEC), the parent company of Alphatec Spine, Inc., a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spine disorders, with a focus on treating conditions affecting the aging spine, announced today that it has entered into a definitive agreement to acquire Scient'x Groupe SAS, a spinal implant company headquartered in France.
The transaction is structured as an all stock transaction such that 100% of outstanding Scient'x stock will be exchanged pursuant to a fixed ratio for 24 million shares of the Company's common stock. On a pro forma basis, current Alphatec shareholders will own approximately 69% of the combined company and approximately 31% will be held by current Scient'x shareholders. The transaction is currently expected to close by the end of the first quarter of 2010 and is subject to the approval of the Company's shareholders. Subject to the closing of the transaction, the Company expects 2010 pro forma full-year revenues to be in a range of $220 million to $225 million, and pro forma full-year 2010 adjusted EBITDA to be in a range of $32 million to $35 million. The transaction is expected to be neutral to slightly positive to 2010 EPS and accretive to 2011 EPS, excluding amortization of intangible assets, transaction expenses and related restructuring charges. The Company has absorbed transaction-related costs that had a negative impact to EPS in the third quarter and are expected to negatively impact previously issued EPS guidance for the fourth quarter of 2009. The Company also expects to absorb additional transaction-related expenses in the first quarter of 2010.
The combined company will create the third-largest independent spinal company with a global span of product distribution. Scient'x is the largest privately held independent spine company outside of the United States with product distribution in over 50 countries.
The transaction was unanimously approved by a Special Committee of independent members of the Company's Board of Directors. Following such approval by the Special Committee, the Company's Board of Directors unanimously approved the acquisition agreement. Thomas Weisel Partners LLC acted as exclusive financial advisor to the Special Committee and provided a fairness opinion to the Board of Directors that the transaction was fair to the Company from a financial point of view as of the date of this press release. DLA Piper LLP (US) acted as independent counsel to the Special Committee.
The Company believes that the strategic merit of the combined business includes the following benefits to its shareholders:
* Increases scale and global presence in all major geographic markets
* Provides cross-selling opportunities in major markets to leverage
future growth across core spine products and Aging Spine products
* Strengthens and expands the Company's product portfolio with
differentiated products in all segments
* Enhances the Company's ability to educate, train and service its
spine surgeon customers
* Provides cost synergies in distribution, marketing and
administration infrastructure
* Diversifies potential future U.S. healthcare reform and regulatory
risks
Both the Company and Scient'x operate in the high growth spinal implant market. The worldwide spinal implant market in 2009 is estimated to be $8.5 to $9.0 billion with a long-term growth rate that is estimated to be between 10% and 12%.
"We believe that Scient'x is a perfect complementary strategic fit for Alphatec Spine," stated Dirk Kuyper, Alphatec Spine's President and Chief Executive Officer. Mr. Kuyper continued, "Besides the significant cost and revenue synergies the acquisition offers, Alphatec Spine will now have the opportunity to reach 50 international markets with our aging spine and core fusion technologies. This transaction moves us into position to be able to become one of the top global spine companies."
"I am pleased to have the opportunity to work closely with Oliver Burckhardt again, following our time together at Aesculap Inc. He will be instrumental in overseeing our international sales efforts and will lead the strategic marketing direction of the combined company. We believe that the combination of Alphatec Spine and Scient'x creates a complete and broad product portfolio with differentiated products addressing underserved markets with disruptive technologies," continued Mr. Kuyper.
"I am excited to be joining the Alphatec Spine team," stated Oliver Burckhardt, Scient'x's President and Chief Executive Officer. "We believe that the combined product portfolio will be among the most innovative of any spine company in the market," Mr. Burckhardt continued, "At Scient'x, we have created a global distribution network in over 50 countries with an excellent history of broad surgeon training and education that will help to drive shareholder value. We look forward to introducing Alphatec Spine's products to our customers as well as leveraging Alphatec Spine's strong U.S. presence with Scient'x's technology."
Conference Call
Alphatec Spine will host a conference call today at 1:30 p.m. PT / 4:30 p.m. ET to discuss details of the acquisition. To participate in the conference call, please visit the investor relations section of the Alphatec Spine website at www.alphatecspine.com. The dial-in numbers are (888) 510-1762 for domestic callers and (719) 325-2383 for international callers. A live webcast of the conference call will be available online from the investor relations section of the Alphatec website at www.alphatecspine.com. The webcast will be recorded and will be available on the investor relations section of Alphatec Spine's website, for at least 30 days after it is posted.
About Scient'x
Scient'x is a Guyancourt, France based medical device company that designs, develops and manufactures spinal implants and instrumentation. Scient'x was founded in 1988 and offers today a full range of implants for spinal fusions, posterior semi-rigid stabilization and a cervical total disc replacement device. Its international distribution network consists of a direct sales force in France and the U.K., a hybrid of direct sales force and distributors in Italy as well as exclusive and non-exclusive distributors in more than 50 countries including the United States. The Scient'x surgeon education and training network augments its international distribution capabilities.
Scient'x key products includes the Isobar(TM) TTL and Isobar Evolution(TM) rods, a semi-rigid rod technology used in spinal fusion surgeries, as well as an offering of cervical and lumbar implants also used predominantly in spine fusion surgeries. The Isobar(TM) products are 510(k) cleared by the FDA in the U.S. as an adjunct to fusion. Outside of the United States, Scient'x markets also a unique and proprietary ceramic-on-ceramic cervical total disc replacement device, DiscoCerv(R), which has been implanted in over 3,000 patients since its initial launch.
About Alphatec Spine
Alphatec Spine, Inc. is a wholly owned subsidiary of Alphatec Holdings, Inc. (Nasdaq:ATEC). Alphatec Spine is a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spine disorders, primarily focused on the aging spine. The Company's mission is to combine world-class customer service with innovative, surgeon-driven design that will help improve the aging patient's quality of life. The Company is poised to achieve its goal through new solutions for patients with osteoporosis, stenosis and other aging spine deformities, improved minimally invasive products and techniques and integrated biologics solutions. In addition to its US operations, the Company also markets its spine products in Europe. In Asia, the Company markets a broad line of spine and orthopedic products through its subsidiary, Alphatec Pacific, Inc. For more information, please visit www.alphatecspine.com.
Also visit the Aging Spine Center, www.agingspinecenter.com, a web-based information portal for healthcare providers and patients regarding aging spine disorders and their treatment. The Company is working with the National Osteoporosis Foundation as well as other clinical portals that provide peer-reviewed content, to populate the Aging Spine Center. The interactive website enables patients to review pertinent information about disorders that affect the aging spine in an easy-to-understand format that includes videos, graphics and questions that should be asked of caregivers. Medical information on the website includes published abstracts regarding the aging spine.
The Alphatec Spine, Inc. logo is available athttp://www.globenewswire.com/newsroom/prs/?pkgid=3520
Use of Non-GAAP Information
Alphatec provides its financial results in accordance with accounting principles generally accepted in the United States (GAAP). The Company also uses forward-looking non-GAAP financial measures in addition to and in conjunction with corresponding GAAP measures to help analyze the performance of its core business, in connection with the preparation of annual budgets, and in measuring performance for some forms of compensation. In particular, Alphatec presents (i) adjusted EBITDA, and (ii) combined pro forma financial information, which in each case are non-GAAP financial measures.
Non-GAAP financial measures reflect an additional way of viewing aspects of Alphatec's operations that, when viewed with the GAAP results, provide a more complete understanding of Alphatec's results of operations and the factors and trends affecting Alphatec's business. However, non-GAAP financial measures should be considered as a supplement to, and not as a substitute for, or superior to, the corresponding measures calculated in accordance with GAAP. Non-GAAP financial measures used by the Company may differ from the non-GAAP financial measures used by other companies, including Alphatec's competitors.
Alphatec believes the most directly comparable GAAP financial measure to adjusted EBITDA is net income (loss). Adjusted EBITDA is net income (loss) excluding the effects of interest, taxes, depreciation, amortization, stock-based compensation costs, and other non-recurring income of expense items, such as in-process research and development, expenses related to the transaction and acquisition related restructuring expenses that are expected to occur following closing.
Alphatec has not included in this presentation a reconciliation of these forward-looking non-GAAP financial measures to the most directly comparable GAAP financial measures because, due to variability and difficulty in making accurate forecasts and projections or certain information not being ascertainable or accessible, not all of the information necessary for a quantitative reconciliation of the forward-looking non-GAAP financial measures to the most directly comparable GAAP financial measures is available to the Company without unreasonable efforts. The probable significance of providing these forward-looking non-GAAP financial measures without the directly comparable GAAP financial measures is that such GAAP financial measures may be materially different from the corresponding non-GAAP financial measures.
Forward-Looking Statements
This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, as amended, which are intended to be covered by safe harbors created thereby. Shareholders are cautioned that all forward-looking statements are based largely on Alphatec's expectations and involve risks and uncertainties, some of which cannot be predicted or are beyond Alphatec's control. Statements containing a projection of revenue, EBITDA, cost and revenue synergies, additional market opportunities, future economic performance, product development timelines, the acceptance of products by the surgeon community or whether the acquisition agreement will be consummated are just a few examples of forward-looking statements. Some factors that could realistically cause results to differ materially from those projected in the forward-looking statements include the occurrence of any event, change or other circumstances that could give rise to the termination of the acquisition agreement; the outcome of any legal proceedings that have been, or may be, instituted against the Company or Scient'x related to the acquisition agreement; the inability to complete the acquisition due to the failure to obtain shareholder approval for the transaction or the failure to satisfy other conditions to completion of the transaction, including the receipt of all regulatory approvals or third-party consents related to the transaction; risks that the proposed transaction disrupts the Company's current plans and operations and the potential difficulties in employee retention as a result of the acquisition; the ability to recognize the benefits of the transaction; litigation outcomes, including without limitation product liability litigation and litigation related to the infringement of intellectual property of a third party; the impact of healthcare reform and regulations in the United States and other jurisdictions; the Company's ability to meet its financial guidance; the growth rate of the spine market related to aging and elderly patients; the ability to achieve regulatory approval for products in the Company's development pipeline and the successful adoption of such products once approved; the Company's ability to develop and expand its business in the United States, Asia and Europe; the Company's ability to compete with other competing products and with emerging new technologies; continuation of favorable third party payor reimbursement for procedures performed using the Company's products; unanticipated expenses or liabilities or other adverse events affecting cash flow or the Company's ability to successfully control its costs or achieve profitability; and the uncertainty of additional funding. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the Company's Annual Report on Form 10-K and in the Company's other filings with the Securities and Exchange Commission (the "SEC") available at the SEC's website at http://www.sec.gov.
The statements in this press release reflect the Company's expectations and beliefs as of the date of this release. The Company anticipates that subsequent events and developments will cause its expectations and beliefs to change. However, while the Company may elect to update these forward-looking statements publicly at some point in the future, the Company specifically disclaims any obligation to do so, whether as a result of new information, future events or otherwise. These forward-looking statements should not be relied upon as representing the Company's views as of any date after the date of this release.
Important Additional Information Will Be Filed with the SEC
In connection with the proposed transaction, the Company will file a proxy statement with the SEC. The proxy statement will be mailed to stockholders of Alphatec and will contain important information about Alphatec, Scient'x, the transaction and related matters. SHAREHOLDERS ARE STRONGLY ADVISED TO READ THE PROXY STATEMENT WHEN IT BECOMES AVAILABLE BECAUSE IT WILL CONTAIN IMPORTANT INFORMATION. Shareholders may obtain a free copy of the proxy statement (when available) and other documents filed by the Company from the SEC's website at http://www.sec.gov. The proxy statement (when available) and such other documents may also be obtained for free from the Company's website at http://www.alphatecspine.com or by directing such request to Alphatec Spine, Inc., Investor Relations, 5818 El Camino Real, Carlsbad, CA 92008, telephone: (760) 494-6746.
Alphatec, Scient'x and their respective directors and executive officers may be deemed to be participants in the solicitation of proxies in connection with the proposed acquisition. Information regarding Alphatec's directors and executive officers is contained in Alphatec's Annual Report on Form 10-K for the fiscal year ended December 31, 2008 and its proxy statement dated May 8, 2009, which are filed with the SEC. As of November 30, 2009, Alphatec's directors and executive officers beneficially owned approximately 41.2% of Alphatec's common stock. A more complete description of the interests of Alphatec's directors and officers in the acquisition will be available in the proxy statement relating to the acquisition.
Wednesday, December 16, 2009
Published in "Bone" Journal, Scientific Researches Confirm Peptan(TM) Hydrolyzed Collagen Benefits on Bone Health
Studies Conducted at INRA-AgroParisTech Laboratory Under Pr. Daniel Tomé Supervision and Published* in November 2009, in the Official Journal of the International Bone and Mineral Society "Bone", Reveal new Benefits for Peptan(TM) in Osteoporosis Prevention In response to customer concerns regarding long-term bone health, Rousselot has carried out, for several years now, many studies to demonstrate that an oral intake of Peptan(TM) may have a positive impact on osteoporosis.
Bone is a living dynamic metabolic system that relies on a maintained balance between bone formation and bone resorption. Cells called osteoblasts make bone while cells called osteoclasts resorb it. An imbalance
may lead to osteoporosis, a condition where the density and quality of bone is reduced.
Researchers conducted in vitro studies, and highlighted that Peptan(TM) in bone cell culture induced a better differentiation of osteoblasts. Those positive results have then been confirmed in vivo on ovariectomized mice, used to simulate a postmenopausal osteoporosis, which leads to a lower bone mineral density (BMD).
Animals were divided into three groups: a control group (non ovariectomized), a group of ovariectomized mice, both fed with a normal diet and a group of ovariectomized mice that received a diet containing Peptan(TM). After 12 weeks, the BMD of the group fed with Peptan(TM) is not significantly different from the BMD of control group. On the contrary the BMD of ovariectomized mice not fed with Peptan(TM) is lower.
Confirmation of Peptan(TM) benefits on bone health has been obtained by the measures of Carboxy Terminal Telopeptide (CTX), a usual marker of bone resorption. CTX is significantly lower in mice fed with
PeptanTM indicating that bone resorption is reduced.
Researchers conclude that Peptan(TM) may restore bone density in simulated post-menopausal osteoporosis by stimulating osteoblast growth and differentiation. This demonstrates the interest of Peptan(TM) as a bioactive ingredient to help preventing bone loss during aging.
*Hydrolyzed collagen improves bone metabolism and biomechanical parameters in ovariectomized mice: an in vitro and in vivo study. Guillerminet et al. Bone 2009.
Rousselot, http://www.rousselot.com
Part of VION N.V. (N.L.), Rousselot(R) is the worldwide leader in gelatine and hydrolyzed collagen. VION N.V. is an internationally operating food group that produces high-quality foods and ingredients for
humans and animals (Turnover: EUR 9.6 billion - 31,000 employees worldwide)
Bone is a living dynamic metabolic system that relies on a maintained balance between bone formation and bone resorption. Cells called osteoblasts make bone while cells called osteoclasts resorb it. An imbalance
may lead to osteoporosis, a condition where the density and quality of bone is reduced.
Researchers conducted in vitro studies, and highlighted that Peptan(TM) in bone cell culture induced a better differentiation of osteoblasts. Those positive results have then been confirmed in vivo on ovariectomized mice, used to simulate a postmenopausal osteoporosis, which leads to a lower bone mineral density (BMD).
Animals were divided into three groups: a control group (non ovariectomized), a group of ovariectomized mice, both fed with a normal diet and a group of ovariectomized mice that received a diet containing Peptan(TM). After 12 weeks, the BMD of the group fed with Peptan(TM) is not significantly different from the BMD of control group. On the contrary the BMD of ovariectomized mice not fed with Peptan(TM) is lower.
Confirmation of Peptan(TM) benefits on bone health has been obtained by the measures of Carboxy Terminal Telopeptide (CTX), a usual marker of bone resorption. CTX is significantly lower in mice fed with
PeptanTM indicating that bone resorption is reduced.
Researchers conclude that Peptan(TM) may restore bone density in simulated post-menopausal osteoporosis by stimulating osteoblast growth and differentiation. This demonstrates the interest of Peptan(TM) as a bioactive ingredient to help preventing bone loss during aging.
*Hydrolyzed collagen improves bone metabolism and biomechanical parameters in ovariectomized mice: an in vitro and in vivo study. Guillerminet et al. Bone 2009.
Rousselot, http://www.rousselot.com
Part of VION N.V. (N.L.), Rousselot(R) is the worldwide leader in gelatine and hydrolyzed collagen. VION N.V. is an internationally operating food group that produces high-quality foods and ingredients for
humans and animals (Turnover: EUR 9.6 billion - 31,000 employees worldwide)
Tuesday, December 15, 2009
Health Care, Telecommunications, And Chemicals Likely Will See More Upgrades Than Other Sectors In 2010, Article Says
Credit quality is slowly beginning to stabilize across nonfinancial industries, though rating activity remains more negative than positive, said an article published today by Standard & Poor's, titled "Three U.S. Industries With The Greatest Potential To Improve Their Credit Quality In 2010 (Premium)." As the economy slowly rebounds in 2010, we expect to see areas of improvement, though upgrades likely will trail downgrades in most sectors.
"After reviewing the distribution of outlooks and CreditWatch listings, ratings trends, the performance of bond spreads, and recent operating results, we identified three sectors that we believe have the potential to see an upturn in creditworthiness next year," said Diane Vazza, head of Standard & Poor's Global Fixed Income Research. "These three are health care, telecommunications, and chemicals."
Health care, which weathered the storm better than most sectors, has a relatively high positive bias (the proportion of issuers with a positive outlook or ratings on CreditWatch positive) and has seen relatively strong operating results.
The telecommunications sector also has fared well during the recession, despite having a number of highly leveraged companies. Improvement in economic and credit market conditions is supportive of continued stabilization and potential improvement in the credit quality of the telecommunications sector.
The chemicals sector has performed much worse than the other two sectors during the recession, though it has begun to show signs of stabilization. Given the cyclical nature of the sector, stronger economic conditions in 2010 could give credit quality a boost.
This article is part of our premium Global Fixed Income Research content, which is available to premium subscribers to RatingsDirect on the Global Credit Portal at www.globalcreditportal.com and to RatingsDirect at www.ratingsdirect.com. Ratings information can also be found on Standard & Poor's public Web site by using the Ratings search box located in the left column at www.standardandpoors.com. Members of the media may request a copy of this report by contacting the media representative provided.
"After reviewing the distribution of outlooks and CreditWatch listings, ratings trends, the performance of bond spreads, and recent operating results, we identified three sectors that we believe have the potential to see an upturn in creditworthiness next year," said Diane Vazza, head of Standard & Poor's Global Fixed Income Research. "These three are health care, telecommunications, and chemicals."
Health care, which weathered the storm better than most sectors, has a relatively high positive bias (the proportion of issuers with a positive outlook or ratings on CreditWatch positive) and has seen relatively strong operating results.
The telecommunications sector also has fared well during the recession, despite having a number of highly leveraged companies. Improvement in economic and credit market conditions is supportive of continued stabilization and potential improvement in the credit quality of the telecommunications sector.
The chemicals sector has performed much worse than the other two sectors during the recession, though it has begun to show signs of stabilization. Given the cyclical nature of the sector, stronger economic conditions in 2010 could give credit quality a boost.
This article is part of our premium Global Fixed Income Research content, which is available to premium subscribers to RatingsDirect on the Global Credit Portal at www.globalcreditportal.com and to RatingsDirect at www.ratingsdirect.com. Ratings information can also be found on Standard & Poor's public Web site by using the Ratings search box located in the left column at www.standardandpoors.com. Members of the media may request a copy of this report by contacting the media representative provided.
Accumetrics Closes 2009 with Positive Outlook
New distribution agreements, favorable clinical data, and significant capital financing position the company for continued growth in 2010 Accumetrics, Inc., developer and marketer of the VerifyNow(R) System, the first rapid and easy-to-use diagnostic system for measuring an individual's response to multiple antiplatelet agents, announced that 2009 included a doubling in the number of international and U.S. distribution agreements, as well as positive medical community support, and significant capital financing
that will take the company into 2011.
In 2009, the company continued its commitment to creating a powerful, worldwide distribution network aimed at gaining adoption of its products at end-user levels. Spanning Europe, Latin America and Asia, Accumetrics currently has partnerships with 20 leading international distributors who provide the company with local representation in over 30 countries. Latest additions to the international distribution network include Keller Medical in Germany, ZAO "Schag" in Russia and VSA Alta Complejidad S.A. in Argentina. Accumetrics continued to strengthen its U.S. presence by partnering with 10 cardiovascular specialty distributors to enhance support to the company's growing base of clinicians in the domestic hospital market. Accumetrics has
also partnered with National Distribution & Contracting, Inc. (NDC), the largest organization of independent medical supply distributors in North America, to expand its distribution network in the physician office lab
marketplace.
Increasing evidence of the clinical value of platelet reactivity testing was demonstrated in several presentations of new clinical studies including the POPular study, presented at the American Heart Association Scientific Sessions in November, and a meta-analysis presented at a symposium during the 2009 Transcatheter Cardiovascular Therapeutics (TCT ) Conference. These data also build upon the anticipation of the results of the GRAVITAS trial, which has now completed 80% enrollment.
"2009 has proven to be an outstanding year of growth for Accumetrics," said Timothy I. Still, CEO and President of Accumetrics. "We look at 2010 as a breakthrough year for the company, and are pleased to be in a position to capitalize on the growing clinical acceptance of platelet reactivity testing."
Accumetrics concluded 2009 with $17.1 million in new capital financing, which will fully support the company into 2011. Proceeds will fund a number of key 2010 milestones including expanded claims for existing products, new product development and continued expansion of commercialization efforts. About Accumetrics (www.accumetrics.com)
Accumetrics is committed to advancing medical understanding of platelet function and enhancing quality of care for patients receiving antiplatelet therapies by providing industry-leading and widely accessible diagnostic tests for rapid platelet function assessment.
Accumetrics' VerifyNow System is the first rapid and easy to use platform for measuring an individual's response to multiple antiplatelet agents. Addressing every major antiplatelet drug, including FDA-cleared products for aspirin, P2Y12 inhibitors (e.g. prasugrel (Effient(TM)) and clopidogrel (Plavix(R))), and the GP IIb/IIIa inhibitors (e.g. ReoPro(R) and Integrilin(R)), the VerifyNow System provides a valuable tool to help
physicians make more informed treatment decisions.
The Accumetrics logo and VerifyNow are registered trademarks of Accumetrics, Inc. ReoPro is a registered trademark of Centocor, Inc. Integrilin is a registered trademark of Millennium Pharmaceuticals. Plavix is a registered trademark of sanofi-aventis. Effient is a trademark of Eli Lilly and Company.
that will take the company into 2011.
In 2009, the company continued its commitment to creating a powerful, worldwide distribution network aimed at gaining adoption of its products at end-user levels. Spanning Europe, Latin America and Asia, Accumetrics currently has partnerships with 20 leading international distributors who provide the company with local representation in over 30 countries. Latest additions to the international distribution network include Keller Medical in Germany, ZAO "Schag" in Russia and VSA Alta Complejidad S.A. in Argentina. Accumetrics continued to strengthen its U.S. presence by partnering with 10 cardiovascular specialty distributors to enhance support to the company's growing base of clinicians in the domestic hospital market. Accumetrics has
also partnered with National Distribution & Contracting, Inc. (NDC), the largest organization of independent medical supply distributors in North America, to expand its distribution network in the physician office lab
marketplace.
Increasing evidence of the clinical value of platelet reactivity testing was demonstrated in several presentations of new clinical studies including the POPular study, presented at the American Heart Association Scientific Sessions in November, and a meta-analysis presented at a symposium during the 2009 Transcatheter Cardiovascular Therapeutics (TCT ) Conference. These data also build upon the anticipation of the results of the GRAVITAS trial, which has now completed 80% enrollment.
"2009 has proven to be an outstanding year of growth for Accumetrics," said Timothy I. Still, CEO and President of Accumetrics. "We look at 2010 as a breakthrough year for the company, and are pleased to be in a position to capitalize on the growing clinical acceptance of platelet reactivity testing."
Accumetrics concluded 2009 with $17.1 million in new capital financing, which will fully support the company into 2011. Proceeds will fund a number of key 2010 milestones including expanded claims for existing products, new product development and continued expansion of commercialization efforts. About Accumetrics (www.accumetrics.com)
Accumetrics is committed to advancing medical understanding of platelet function and enhancing quality of care for patients receiving antiplatelet therapies by providing industry-leading and widely accessible diagnostic tests for rapid platelet function assessment.
Accumetrics' VerifyNow System is the first rapid and easy to use platform for measuring an individual's response to multiple antiplatelet agents. Addressing every major antiplatelet drug, including FDA-cleared products for aspirin, P2Y12 inhibitors (e.g. prasugrel (Effient(TM)) and clopidogrel (Plavix(R))), and the GP IIb/IIIa inhibitors (e.g. ReoPro(R) and Integrilin(R)), the VerifyNow System provides a valuable tool to help
physicians make more informed treatment decisions.
The Accumetrics logo and VerifyNow are registered trademarks of Accumetrics, Inc. ReoPro is a registered trademark of Centocor, Inc. Integrilin is a registered trademark of Millennium Pharmaceuticals. Plavix is a registered trademark of sanofi-aventis. Effient is a trademark of Eli Lilly and Company.
MALARIA PROGRESS REPORT SHOWS THAT DEVELOPMENT AID FOR HEALTH IS WORKING
Significant progress has been made in delivering life saving malaria nets and treatments over the past few years, but the coverage of malaria programmes needs to be stepped up drastically in order to meet the Millennium Development Goals (MDGs), according to a report released today by the World Health Organization (WHO).
The World Malaria Report 2009 found that the increase in international funding commitments (US$ 1.7 billion in 2009 compared to US$ 730 million in 2006) had allowed a dramatic scale up of malaria control interventions in several countries, along with measurable reductions in malaria burden. However, the amounts available still fall short of the US$ 5 billion required annually to ensure high coverage and maximal impact worldwide.
The WHO Director-General, Dr Margaret Chan, described the findings in the report as cause for cautious optimism and said "While much remains to be done, the data presented here clearly suggest that the tremendous increase in funding for malaria control is resulting in the rapid scale up of today's control tools. This, in turn, is having a profound effect on health - especially the health of children in sub-Saharan Africa. In a nutshell, development aid for health is working."
The report found that more life-saving malaria nets and treatments were delivered in 2007 and 2008 compared to 2006.
More African households (31%) own at least one insecticide-treated net (ITN), and more children under 5 years of age used an ITN in 2008 (24%) compared to previous years. These averages are affected by low ITN ownership in several large African countries for which resources for scale-up are only now being made available. Household ITN ownership reached more than 50% in 13 of the 35 highest burden African countries.
Use of artemisinin-based combination therapies (ACTs) is increasing but remains low in most African countries with fewer than 15% of children with fever receiving an ACT.
More than one-third of the 108 malarious countries (9 African countries and 29 outside of Africa) documented reductions in malaria cases of more than 50% in 2008 compared to 2000.
Where scale-up of proven interventions has occurred, and surveillance systems are functioning, remarkable impact has been documented:
In countries and areas that have achieved high coverage with bed nets and treatment programmes (e.g. Eritrea, Rwanda, Sao Tome and Principe, Zambia and Zanzibar, the United Republic of Tanzania) recorded cases and deaths due to malaria have fallen by 50% (target set by World Health Assembly for 2010) suggesting that MDG target for malaria can be achieved if there is adequate coverage of key interventions.
Large decreases in malaria cases and deaths have been mirrored by steep declines in all-cause deaths among children less than 5 years of age suggesting that intensive efforts at malaria control could help many African countries to reach, by 2015, a two-thirds reduction in child mortality as set forth in the MDGs.
High levels of external assistance were shown to be linked to decreases in malaria incidence. However, many external funds are concentrated on smaller countries with lower disease burdens. More attention needs to be given to ensuring success in large countries that account for most malaria cases and deaths.
Parasite resistance to anti-malarial medicines and mosquito resistance to insecticides are major threats to achieving global malaria control. Confirmation of artemisinin resistance was reported in 2009, and WHO is leading a major resistance containment effort in South East Asia. Key elements in the global strategy to prevent the spread of drug resistance include: 1) Rapidly reducing the spread of malaria using malaria preventive tools 2) ensuring that all malaria infections are correctly diagnosed, effectively treated and followed-up to ensure that they do not spread the disease to others 3) halting the marketing and use of oral artemisinin monotherapies and importantly, 4) carefully monitoring the efficacy of medicines to detect early evidence of resistance.
The report noted that there was urgent need for the global community to completely fund the Global Malaria Action Plan in order to sustain early success and achieve the 2015 MDGs. The African Region had the largest increase in funding of all regions, led by investments by the Global Fund, the U.S. President's Malaria Initiative, and other agencies.
The success of malaria control efforts will be in reducing the burden of malaria and improving child survival. Investing in malaria control is not only helping the world to reach the MDGs, but is also helping to build health systems that will ensure that these development gains are sustained.
The World Malaria Report 2009 found that the increase in international funding commitments (US$ 1.7 billion in 2009 compared to US$ 730 million in 2006) had allowed a dramatic scale up of malaria control interventions in several countries, along with measurable reductions in malaria burden. However, the amounts available still fall short of the US$ 5 billion required annually to ensure high coverage and maximal impact worldwide.
The WHO Director-General, Dr Margaret Chan, described the findings in the report as cause for cautious optimism and said "While much remains to be done, the data presented here clearly suggest that the tremendous increase in funding for malaria control is resulting in the rapid scale up of today's control tools. This, in turn, is having a profound effect on health - especially the health of children in sub-Saharan Africa. In a nutshell, development aid for health is working."
The report found that more life-saving malaria nets and treatments were delivered in 2007 and 2008 compared to 2006.
More African households (31%) own at least one insecticide-treated net (ITN), and more children under 5 years of age used an ITN in 2008 (24%) compared to previous years. These averages are affected by low ITN ownership in several large African countries for which resources for scale-up are only now being made available. Household ITN ownership reached more than 50% in 13 of the 35 highest burden African countries.
Use of artemisinin-based combination therapies (ACTs) is increasing but remains low in most African countries with fewer than 15% of children with fever receiving an ACT.
More than one-third of the 108 malarious countries (9 African countries and 29 outside of Africa) documented reductions in malaria cases of more than 50% in 2008 compared to 2000.
Where scale-up of proven interventions has occurred, and surveillance systems are functioning, remarkable impact has been documented:
In countries and areas that have achieved high coverage with bed nets and treatment programmes (e.g. Eritrea, Rwanda, Sao Tome and Principe, Zambia and Zanzibar, the United Republic of Tanzania) recorded cases and deaths due to malaria have fallen by 50% (target set by World Health Assembly for 2010) suggesting that MDG target for malaria can be achieved if there is adequate coverage of key interventions.
Large decreases in malaria cases and deaths have been mirrored by steep declines in all-cause deaths among children less than 5 years of age suggesting that intensive efforts at malaria control could help many African countries to reach, by 2015, a two-thirds reduction in child mortality as set forth in the MDGs.
High levels of external assistance were shown to be linked to decreases in malaria incidence. However, many external funds are concentrated on smaller countries with lower disease burdens. More attention needs to be given to ensuring success in large countries that account for most malaria cases and deaths.
Parasite resistance to anti-malarial medicines and mosquito resistance to insecticides are major threats to achieving global malaria control. Confirmation of artemisinin resistance was reported in 2009, and WHO is leading a major resistance containment effort in South East Asia. Key elements in the global strategy to prevent the spread of drug resistance include: 1) Rapidly reducing the spread of malaria using malaria preventive tools 2) ensuring that all malaria infections are correctly diagnosed, effectively treated and followed-up to ensure that they do not spread the disease to others 3) halting the marketing and use of oral artemisinin monotherapies and importantly, 4) carefully monitoring the efficacy of medicines to detect early evidence of resistance.
The report noted that there was urgent need for the global community to completely fund the Global Malaria Action Plan in order to sustain early success and achieve the 2015 MDGs. The African Region had the largest increase in funding of all regions, led by investments by the Global Fund, the U.S. President's Malaria Initiative, and other agencies.
The success of malaria control efforts will be in reducing the burden of malaria and improving child survival. Investing in malaria control is not only helping the world to reach the MDGs, but is also helping to build health systems that will ensure that these development gains are sustained.
Thursday, November 19, 2009
BAXTER RECEIVES EMEA POSITIVE OPINION FOR H1N1 PANDEMIC INFLUENZA VACCINE
Baxter International Inc. (NYSE: BAX) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) granted its “positive opinion” for H1N1 pandemic vaccine using Baxter’s Vero cell technology. This positive opinion confirms the acceptability of Baxter’s regulatory submission to obtain final marketing authorization and licensure of the product.
Baxter H1N1 vaccine is the first cell culture-based and non-adjuvanted vaccine to receive a positive opinion in the European Union. Initial quantities of vaccine have already been delivered to a number of countries, including the UK and Ireland, for use in their national vaccination programs, and are awaiting product release subject to final marketing authorization being granted by the European Commission.
Presently, Baxter is confirming the safety and immunogenicity of Baxter H1N1 vaccine in clinical trials. The company is conducting two randomized trials in 400 healthy adults age 18 and over and in 400 children and adolescents to supplement the licensure post-approval with appropriate clinical data. These trials are evaluating the safety and immunogenicity of the vaccine at dose levels of 7.5ตg and 3.75ตg. Once countries initiate national vaccination programs using H1N1 vaccine, Baxter will also conduct a large-scale observational study with H1N1 vaccine in 9,000 people of different age groups, including children.
Preliminary safety data in adults and the elderly indicate that the vaccine is well tolerated in these age groups. The observed systemic and local reactions are similar to those generally experienced after vaccination with licensed seasonal influenza vaccines. Immunogenicity data from the first vaccination in adults are due later this month. The current dosing schedule, as specified in the EMEA mock-up licensure for H1N1 vaccine using another virus strain, calls for two 7.5 ตg doses of vaccine to be given 21 days apart. Baxter expects the data from the trial of healthy adults to indicate whether a single dose may be possible for H1N1 vaccine. This study will also determine whether a lower dose, 3.75ตg, is sufficient to induce the necessary immune response.
"We are pleased that the regulatory submission and the preliminary clinical trial data uphold the extensive work done by Baxter and the support received from key Ministries of Health in developing a pandemic vaccine,” said Hartmut J. Ehrlich, M.D., vice president of global research and development for Baxter BioScience. “We are looking forward to analyzing the immunogenicity data for our cell culture-derived, non-adjuvanted vaccine to assess the potential of a one dose regimen.”
ABOUT BAXTER’S PANDEMIC VACCINE DEVELOPMENT
Earlier this year, the EMEA granted mock-up licensure for H1N1 vaccine using a different strain with pandemic potential, which was tested in five completed clinical trials worldwide in more than 1,300 people. In addition, more than 3,500 people have been vaccinated using the same strain during an ongoing Phase III study. Mock-up licensure is a regulatory pathway for pandemic vaccines that was created by the EMEA in 2004. This pathway allows for the development, evaluation and licensure of a company’s pandemic candidate vaccine using an available influenza strain that has the potential to cause a pandemic. Once a pandemic is declared and the influenza virus strain causing the pandemic is identified, the mock-up licensure allows for fast track approval of a pandemic vaccine containing the actual pandemic strain.
Baxter received the H1N1 strain for testing and evaluation from the U.S. Centers for Disease Control and Prevention (a WHO Collaborating Center) in early May. The company then undertook pre-production testing and evaluation of the virus strain to assess its growth characteristics in the company’s proprietary Vero cell culture technology.
Baxter initiated commercial production in early June, and made its first commercial product within 12 weeks of receipt of the virus. The company produces bulk H1N1 vaccine at its large-scale commercial facility in Bohumil, Czech Republic, and then sends the vaccine to Vienna, Austria for the final formulation, fill and finish before distribution. Baxter completed production of the first batches of H1N1 vaccine in late July and initiated its first delivery within two weeks. The company continues to deliver vaccine on an ongoing basis to national public health authorities.
Baxter initiated its license application for H1N1 in July based on the EMEA published guidelines for pandemic vaccine marketing authorization. The company conducted rigorous testing of the H1N1 based vaccine and submitted additional data for vaccine development, product quality and manufacturing processes specific to that strain. Other non-E.U. countries may choose to evaluate the company’s EMEA submission and licensure as the basis for their national health authority’s authorization for use of the vaccine.
More information on H1N1 clinical trials is available at http://www.clinicaltrials.gov/ct2/results?term=baxter+h1n1
ABOUT BAXTER INTERNATIONAL INC.
Baxter International Inc., through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.
Baxter H1N1 vaccine is the first cell culture-based and non-adjuvanted vaccine to receive a positive opinion in the European Union. Initial quantities of vaccine have already been delivered to a number of countries, including the UK and Ireland, for use in their national vaccination programs, and are awaiting product release subject to final marketing authorization being granted by the European Commission.
Presently, Baxter is confirming the safety and immunogenicity of Baxter H1N1 vaccine in clinical trials. The company is conducting two randomized trials in 400 healthy adults age 18 and over and in 400 children and adolescents to supplement the licensure post-approval with appropriate clinical data. These trials are evaluating the safety and immunogenicity of the vaccine at dose levels of 7.5ตg and 3.75ตg. Once countries initiate national vaccination programs using H1N1 vaccine, Baxter will also conduct a large-scale observational study with H1N1 vaccine in 9,000 people of different age groups, including children.
Preliminary safety data in adults and the elderly indicate that the vaccine is well tolerated in these age groups. The observed systemic and local reactions are similar to those generally experienced after vaccination with licensed seasonal influenza vaccines. Immunogenicity data from the first vaccination in adults are due later this month. The current dosing schedule, as specified in the EMEA mock-up licensure for H1N1 vaccine using another virus strain, calls for two 7.5 ตg doses of vaccine to be given 21 days apart. Baxter expects the data from the trial of healthy adults to indicate whether a single dose may be possible for H1N1 vaccine. This study will also determine whether a lower dose, 3.75ตg, is sufficient to induce the necessary immune response.
"We are pleased that the regulatory submission and the preliminary clinical trial data uphold the extensive work done by Baxter and the support received from key Ministries of Health in developing a pandemic vaccine,” said Hartmut J. Ehrlich, M.D., vice president of global research and development for Baxter BioScience. “We are looking forward to analyzing the immunogenicity data for our cell culture-derived, non-adjuvanted vaccine to assess the potential of a one dose regimen.”
ABOUT BAXTER’S PANDEMIC VACCINE DEVELOPMENT
Earlier this year, the EMEA granted mock-up licensure for H1N1 vaccine using a different strain with pandemic potential, which was tested in five completed clinical trials worldwide in more than 1,300 people. In addition, more than 3,500 people have been vaccinated using the same strain during an ongoing Phase III study. Mock-up licensure is a regulatory pathway for pandemic vaccines that was created by the EMEA in 2004. This pathway allows for the development, evaluation and licensure of a company’s pandemic candidate vaccine using an available influenza strain that has the potential to cause a pandemic. Once a pandemic is declared and the influenza virus strain causing the pandemic is identified, the mock-up licensure allows for fast track approval of a pandemic vaccine containing the actual pandemic strain.
Baxter received the H1N1 strain for testing and evaluation from the U.S. Centers for Disease Control and Prevention (a WHO Collaborating Center) in early May. The company then undertook pre-production testing and evaluation of the virus strain to assess its growth characteristics in the company’s proprietary Vero cell culture technology.
Baxter initiated commercial production in early June, and made its first commercial product within 12 weeks of receipt of the virus. The company produces bulk H1N1 vaccine at its large-scale commercial facility in Bohumil, Czech Republic, and then sends the vaccine to Vienna, Austria for the final formulation, fill and finish before distribution. Baxter completed production of the first batches of H1N1 vaccine in late July and initiated its first delivery within two weeks. The company continues to deliver vaccine on an ongoing basis to national public health authorities.
Baxter initiated its license application for H1N1 in July based on the EMEA published guidelines for pandemic vaccine marketing authorization. The company conducted rigorous testing of the H1N1 based vaccine and submitted additional data for vaccine development, product quality and manufacturing processes specific to that strain. Other non-E.U. countries may choose to evaluate the company’s EMEA submission and licensure as the basis for their national health authority’s authorization for use of the vaccine.
More information on H1N1 clinical trials is available at http://www.clinicaltrials.gov/ct2/results?term=baxter+h1n1
ABOUT BAXTER INTERNATIONAL INC.
Baxter International Inc., through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.
Thursday, November 12, 2009
Living with KIDNEY DISEASE
Transplants can get patients back to a normal life When Porntip Puang-ngern became easily tired, began to lose weight and was vomiting frequently 10 years ago, she had no idea what was wrong.
Even when the doctor diagnosed her with chronic kidney disease, she remained in the dark about the illness.
"I didn't know much about kidney disease at that time. Information was hard to find, and the illness was so unfamiliar to me," said Ms Porntip, now 60 years old.
However, after similar symptoms appeared in her two sisters a few years later, kidney disease was no longer a stranger to the Puang-ngern family.
Back then, the three sisters were in and out of hospital for treatment which was to change as their illnesses progressed.
Despite oral and injected medication, the disease reached end-stage renal failure so it was necessary to undergo haemodialysis, a treatment which is tiring and time-consuming.
"It took 4-5 hours for each treatment, twice a week, and often I would feel the side effects like weakness and dizziness when I returned home," said Jongkol Puang-ngern, one of Ms Porntip's sisters.
The doctor urged them to register for donated kidneys with the Thai Red Cross Society. Finally, luck was on their side. Just a few years after they registered, the three sisters had successful organ transplants.
"Getting a new kidney and being able to live on with it is like winning the lottery. Now we're happy living life the way we used to. What we need to do is to take better care of ourselves so that our new kidneys can last for a long time," said Ms Jongkol.
Knowing your kidneys
The kidneys are a pair of bean-shaped organs on either side of the spine in your lower-middle back.
Dr Viroon Mavichak, a nephrologist at Praram 9 Hospital, says that the main function of the kidneys is to clean our body by removing waste products and excess water from the blood. All the while our organs such as the heart, lungs and liver are working, waste products are generated from the normal metabolic process. These waste products are released into the blood, and carried to the kidneys, which filter the blood and excrete the waste in the urine.
"If our kidneys function well, all the waste will be excreted, and our bodies will be fresh and clean. But if the kidneys function poorly, our bodies become polluted. Our blood will be dirty and the body dirty. That results in the malfunction of other organs. If both of your kidneys completely fail or someone took them out, you will be dead within seven days," said Dr Viroon.
Chronic and acute kidney disease
The Puang-ngern sisters
Chronic kidney disease happens when one suffers from gradual and usually permanent loss of kidney function. This happens gradually over time, usually months to years. In the end, patients will suffer end-stage renal failure, when there is total or near-total loss of kidney function and patients need dialysis or a transplant to stay alive.
Acute kidney disease, meanwhile, develops rapidly over days or weeks. It is a serious condition, but does not cause permanent damage to the kidneys, and still can be cured in time.
The chronic type, however, is more worrying as the early signs can be very subtle and many people who have the disease don't know it.
What causes chronic kidney disease?
Dr Viroon says there are various causes of kidney disease. Diabetes, high blood pressure, kidney stones, occlusion of blood vessels, gout, and kidney infections can result in chronic kidney disease, while factors such as accidents and severe diarrhoea can result in acute kidney failure.
"Chronic kidney disease that is mostly found in urban people is caused by diabetes. Diabetes can cause arterial occlusive disease which, if it continues for 10-20 years, will lead to damaged kidneys," he said.
In rural areas, however, kidney disease is mostly a result of "glomerulonephritis", a disease causing an autoimmune reaction to kidney tissue.
Who can have a kidney disease?
Dr Viroon says about 10,000 Thai people currently have a kidney disease, with an average of one new patient each day.
He said kidney disease can happen in people of all ages, even infants who are born with a kidney abnormality. But mostly, it happens to people aged 30-50 years old. People with diabetes or high blood pressure are also among the risk groups. In some cases, kidney disease can be genetically transmitted.
Dr Viroon Mavichak
How to know you have chronic kidney disease?
According to Dr Viroon, people with chronic kidney disease normally experience symptoms when their kidneys are about 80% damaged. This is because kidneys can still function normally even though they have started to deteriorate.
"Kidney disease is usually in hiding like an unseen murderer. When your kidneys are slightly damaged, you'll never know it unless you have a blood test. It's like your mobile phone battery. You can use it for 48 hours, then the power is gone and your phone will suddenly switch off," he said.
When the kidneys finally lose their function, patients will experience the following symptoms:
1. Loss of appetite, fatigue, nausea, and vomiting.
2. Swelling in the legs, ankles, feet, face or hands because the kidneys don't remove unwanted fluids in your body.
3. Change in urination. You may urinate more often. Urine may be foamy or bubbly or it may contain blood.
4. Have anaemia problems.
5. Poor function of the brain as it is not getting enough oxygen. This can result in memory problems, trouble with concentration and dizziness. If the symptoms are extreme, patients can be in a comatose state.
6. Shortness of breath and respiratory problems as extra fluid builds up in the lungs.
7. Waste build-up in the blood can result in skin rashes and itching.
8. Reduced immunity causing easy infection from germs.
9. Vomiting blood as a result of waste in the stomach.
10. Women may experience infertility problems.
How to treat chronic kidney disease
Treatment for early stages of chronic kidney disease include oral and injected medication to boost the red blood cell count. When the disease progresses to the end stage, there are normally two major treatment methods. One is haemodialysis. Patients have to spend 4-5 hours per treatment on a kidney machine, two or three times a week, to have their polluted blood filtered and sent back into the body.
"However, note that haemodialysis can only clean your blood, but it cannot replace other functions of the kidneys, such as the production of certain hormones."
The best method, he said, is a kidney transplant. There are two major channels for getting the organs. First is from donors who have died in accidents. Second is donated organs from living people, which Thai law only permits from people in the same family, or husbands and wives who can provide evidence of their relationship. The sale of kidneys is illegal.
After the transplant, patients need to take immune suppressive drugs regularly to stop the body from rejecting the new organ.
"Getting another kidney is like getting a strange object into the body, which will try and fight that object. If that process is not controlled, the transplanted kidney will fail," said the doctor.
The risk of this is especially acute in the first three months. Patients must therefore come for a regular examinations, every one or two months.
The success rate for kidney transplants is 95% if the organs were given from relatives, and 75% from deceased donors. Normally a transplanted kidney can function for 30-40 years.
Even when the doctor diagnosed her with chronic kidney disease, she remained in the dark about the illness.
"I didn't know much about kidney disease at that time. Information was hard to find, and the illness was so unfamiliar to me," said Ms Porntip, now 60 years old.
However, after similar symptoms appeared in her two sisters a few years later, kidney disease was no longer a stranger to the Puang-ngern family.
Back then, the three sisters were in and out of hospital for treatment which was to change as their illnesses progressed.
Despite oral and injected medication, the disease reached end-stage renal failure so it was necessary to undergo haemodialysis, a treatment which is tiring and time-consuming.
"It took 4-5 hours for each treatment, twice a week, and often I would feel the side effects like weakness and dizziness when I returned home," said Jongkol Puang-ngern, one of Ms Porntip's sisters.
The doctor urged them to register for donated kidneys with the Thai Red Cross Society. Finally, luck was on their side. Just a few years after they registered, the three sisters had successful organ transplants.
"Getting a new kidney and being able to live on with it is like winning the lottery. Now we're happy living life the way we used to. What we need to do is to take better care of ourselves so that our new kidneys can last for a long time," said Ms Jongkol.
Knowing your kidneys
The kidneys are a pair of bean-shaped organs on either side of the spine in your lower-middle back.
Dr Viroon Mavichak, a nephrologist at Praram 9 Hospital, says that the main function of the kidneys is to clean our body by removing waste products and excess water from the blood. All the while our organs such as the heart, lungs and liver are working, waste products are generated from the normal metabolic process. These waste products are released into the blood, and carried to the kidneys, which filter the blood and excrete the waste in the urine.
"If our kidneys function well, all the waste will be excreted, and our bodies will be fresh and clean. But if the kidneys function poorly, our bodies become polluted. Our blood will be dirty and the body dirty. That results in the malfunction of other organs. If both of your kidneys completely fail or someone took them out, you will be dead within seven days," said Dr Viroon.
Chronic and acute kidney disease
The Puang-ngern sisters
Chronic kidney disease happens when one suffers from gradual and usually permanent loss of kidney function. This happens gradually over time, usually months to years. In the end, patients will suffer end-stage renal failure, when there is total or near-total loss of kidney function and patients need dialysis or a transplant to stay alive.
Acute kidney disease, meanwhile, develops rapidly over days or weeks. It is a serious condition, but does not cause permanent damage to the kidneys, and still can be cured in time.
The chronic type, however, is more worrying as the early signs can be very subtle and many people who have the disease don't know it.
What causes chronic kidney disease?
Dr Viroon says there are various causes of kidney disease. Diabetes, high blood pressure, kidney stones, occlusion of blood vessels, gout, and kidney infections can result in chronic kidney disease, while factors such as accidents and severe diarrhoea can result in acute kidney failure.
"Chronic kidney disease that is mostly found in urban people is caused by diabetes. Diabetes can cause arterial occlusive disease which, if it continues for 10-20 years, will lead to damaged kidneys," he said.
In rural areas, however, kidney disease is mostly a result of "glomerulonephritis", a disease causing an autoimmune reaction to kidney tissue.
Who can have a kidney disease?
Dr Viroon says about 10,000 Thai people currently have a kidney disease, with an average of one new patient each day.
He said kidney disease can happen in people of all ages, even infants who are born with a kidney abnormality. But mostly, it happens to people aged 30-50 years old. People with diabetes or high blood pressure are also among the risk groups. In some cases, kidney disease can be genetically transmitted.
Dr Viroon Mavichak
How to know you have chronic kidney disease?
According to Dr Viroon, people with chronic kidney disease normally experience symptoms when their kidneys are about 80% damaged. This is because kidneys can still function normally even though they have started to deteriorate.
"Kidney disease is usually in hiding like an unseen murderer. When your kidneys are slightly damaged, you'll never know it unless you have a blood test. It's like your mobile phone battery. You can use it for 48 hours, then the power is gone and your phone will suddenly switch off," he said.
When the kidneys finally lose their function, patients will experience the following symptoms:
1. Loss of appetite, fatigue, nausea, and vomiting.
2. Swelling in the legs, ankles, feet, face or hands because the kidneys don't remove unwanted fluids in your body.
3. Change in urination. You may urinate more often. Urine may be foamy or bubbly or it may contain blood.
4. Have anaemia problems.
5. Poor function of the brain as it is not getting enough oxygen. This can result in memory problems, trouble with concentration and dizziness. If the symptoms are extreme, patients can be in a comatose state.
6. Shortness of breath and respiratory problems as extra fluid builds up in the lungs.
7. Waste build-up in the blood can result in skin rashes and itching.
8. Reduced immunity causing easy infection from germs.
9. Vomiting blood as a result of waste in the stomach.
10. Women may experience infertility problems.
How to treat chronic kidney disease
Treatment for early stages of chronic kidney disease include oral and injected medication to boost the red blood cell count. When the disease progresses to the end stage, there are normally two major treatment methods. One is haemodialysis. Patients have to spend 4-5 hours per treatment on a kidney machine, two or three times a week, to have their polluted blood filtered and sent back into the body.
"However, note that haemodialysis can only clean your blood, but it cannot replace other functions of the kidneys, such as the production of certain hormones."
The best method, he said, is a kidney transplant. There are two major channels for getting the organs. First is from donors who have died in accidents. Second is donated organs from living people, which Thai law only permits from people in the same family, or husbands and wives who can provide evidence of their relationship. The sale of kidneys is illegal.
After the transplant, patients need to take immune suppressive drugs regularly to stop the body from rejecting the new organ.
"Getting another kidney is like getting a strange object into the body, which will try and fight that object. If that process is not controlled, the transplanted kidney will fail," said the doctor.
The risk of this is especially acute in the first three months. Patients must therefore come for a regular examinations, every one or two months.
The success rate for kidney transplants is 95% if the organs were given from relatives, and 75% from deceased donors. Normally a transplanted kidney can function for 30-40 years.
Sonova buys cochlear implant maker
Swiss hearing aid firm Sonova Holding AG said yesterday it was buying cochlear implant maker Advanced Bionics Corp,based in California, for $489 million in cash.
Sonova expects the transaction, which is subject to regulatory approval, to be completed within three months.
"Sonova will offer the most comprehensive and innovative product and service portfolio covering any customer need for most types of hearing problems,"Valentin Chapero, Sonova's chief executive, said in a statement.
Privately-held Advanced Bionics was founded in 1993 and is based in Valencia,Los Angeles County. Its majority shareholder is the biotech investor Alfred Mann.
The company, which has 660 employees and sales in over 30 countries,has an 18% share of the global market in cochlear implants.
These electronic devices are surgically implanted inside the ear to stimulate the auditory nerves, allowing deaf people to hear sounds.
Sonova spokesman Holger Schimanke said there was little overlap between Sonova and Advanced Bionics, and consequently there are no plans to restructure the business.
"Advanced Bionics will continue to operate as an independent unit within the Sonova Group," Schimanke told the Associated Press."We aren't talking about any kind of job cuts, definitely not."
He said Advanced Bionics had developed "a great American technology that many people consider to be world leading, but it hasn't really taken off."
"We're going to give them the business and sales expertise to do so," said Schimanke.
Sonova expects the transaction, which is subject to regulatory approval, to be completed within three months.
"Sonova will offer the most comprehensive and innovative product and service portfolio covering any customer need for most types of hearing problems,"Valentin Chapero, Sonova's chief executive, said in a statement.
Privately-held Advanced Bionics was founded in 1993 and is based in Valencia,Los Angeles County. Its majority shareholder is the biotech investor Alfred Mann.
The company, which has 660 employees and sales in over 30 countries,has an 18% share of the global market in cochlear implants.
These electronic devices are surgically implanted inside the ear to stimulate the auditory nerves, allowing deaf people to hear sounds.
Sonova spokesman Holger Schimanke said there was little overlap between Sonova and Advanced Bionics, and consequently there are no plans to restructure the business.
"Advanced Bionics will continue to operate as an independent unit within the Sonova Group," Schimanke told the Associated Press."We aren't talking about any kind of job cuts, definitely not."
He said Advanced Bionics had developed "a great American technology that many people consider to be world leading, but it hasn't really taken off."
"We're going to give them the business and sales expertise to do so," said Schimanke.
Sunday, November 8, 2009
Bigger Merck on the prowl
The new Merck & Co has become the world's second-biggest drugmaker overnight with a huge acquisition, but it still has a fat wallet and plans more wheeling and dealing.
A day after closing its $41.1 billion purchase of longtime joint venture partner Schering-Plough Corp, Merck already "is looking to increase the number of acquisitions and licensing deals it does,"chief executive Richard Clark said on Wednesday.
The company has averaged 50 deals a year since 2003.
"We'll actually do more and maybe even try to double it," he told the Associated Press exclusively.
Clark said Merck was looking to make deals with "biotech companies that have first or best-in-class products that can build our franchises."
It has about $8 billion in cash and investments to spend.
"We've got a tremendous pipeline,with 15 late-stage candidates," Clark said.
Between those drugs and future deals,Merck is focusing on several areas, including its longtime strengths such as cardiovascular disease - with four new drugs in testing - and vaccines, adding Schering-Plough's experimental shot to prevent staph infections to Merck's array of standard child and adult vaccines.
Other targets are osteoporosis medi-cines, such as a Merck drug to replace its pioneering Fosamax, which has lost sales to generic competition, and women's health, as Schering makes contraceptive and fertility drugs.
With the Schering deal, Merck leapfrogged from No.8 to No.2 in the industry by revenue, behind Pfizer Inc - despite Clark insisting he opposed such a megadeal since he took Merck's helm
in 2005.
Merck, based in Whitehouse Station, New Jersey,and New York's Pfizer, which last month bought Wyeth for $68 billion, are now back in the positions they held a decade Clark:'We've got a ago.tremendous pipeline'Merck was the world's top-selling drugmaker in the mid-1990s, but Pfizer took the lead in 1998 when it launched an overnight success, impotence pill Viagra. Repeated mergers among other drugmakers pushed Merck further back in line.
The new Merck will start off with roughly $40 billion in annual sales, operations in more than 140 countries and more than half its sales from foreign countries - an advantage as US sales have stagnated in recent years.
"We're going to be better in emerging markets," Clark said, meaning countries such as China, India and Brazil with people now spending more on health care.
The company also is more diversified,with Schering's animal and consumer health businesses and biotech division.
"It really puts us on a global stage as a health-care leader," Clark said.
Schering-Plough, of Kenilworth, New Jersey, also brings several promising experimental drugs and some big sellers including hepatitis drugs and allergy spray Nasonex.
The companies jointly sell cholesterol drugs Vytorin and Zetia.
About 40% of Schering-Plough's top managers are staying on, but its CEO,Fred Hassan, is leaving with a severance package worth roughly $51 million.
The companies have said they expect to make about 16,000 job cuts out of their now-combined staff of 106,000 people. With no official word on those cuts,many employees are anxious.
Clark said Wednesday it would take time to decide which employees will leave and which facilities will close.
The new company is organised into five divisions, including its manufacturing operations and Merck Research Laboratories.
The others are the prescription drug business and two Schering-Plough businesses, animal health and a consumer health business with well-known brands such as Claritin allergy pills, Miralax laxative, Coppertone sun care items and the Dr Scholl's foot0care line.
A day after closing its $41.1 billion purchase of longtime joint venture partner Schering-Plough Corp, Merck already "is looking to increase the number of acquisitions and licensing deals it does,"chief executive Richard Clark said on Wednesday.
The company has averaged 50 deals a year since 2003.
"We'll actually do more and maybe even try to double it," he told the Associated Press exclusively.
Clark said Merck was looking to make deals with "biotech companies that have first or best-in-class products that can build our franchises."
It has about $8 billion in cash and investments to spend.
"We've got a tremendous pipeline,with 15 late-stage candidates," Clark said.
Between those drugs and future deals,Merck is focusing on several areas, including its longtime strengths such as cardiovascular disease - with four new drugs in testing - and vaccines, adding Schering-Plough's experimental shot to prevent staph infections to Merck's array of standard child and adult vaccines.
Other targets are osteoporosis medi-cines, such as a Merck drug to replace its pioneering Fosamax, which has lost sales to generic competition, and women's health, as Schering makes contraceptive and fertility drugs.
With the Schering deal, Merck leapfrogged from No.8 to No.2 in the industry by revenue, behind Pfizer Inc - despite Clark insisting he opposed such a megadeal since he took Merck's helm
in 2005.
Merck, based in Whitehouse Station, New Jersey,and New York's Pfizer, which last month bought Wyeth for $68 billion, are now back in the positions they held a decade Clark:'We've got a ago.tremendous pipeline'Merck was the world's top-selling drugmaker in the mid-1990s, but Pfizer took the lead in 1998 when it launched an overnight success, impotence pill Viagra. Repeated mergers among other drugmakers pushed Merck further back in line.
The new Merck will start off with roughly $40 billion in annual sales, operations in more than 140 countries and more than half its sales from foreign countries - an advantage as US sales have stagnated in recent years.
"We're going to be better in emerging markets," Clark said, meaning countries such as China, India and Brazil with people now spending more on health care.
The company also is more diversified,with Schering's animal and consumer health businesses and biotech division.
"It really puts us on a global stage as a health-care leader," Clark said.
Schering-Plough, of Kenilworth, New Jersey, also brings several promising experimental drugs and some big sellers including hepatitis drugs and allergy spray Nasonex.
The companies jointly sell cholesterol drugs Vytorin and Zetia.
About 40% of Schering-Plough's top managers are staying on, but its CEO,Fred Hassan, is leaving with a severance package worth roughly $51 million.
The companies have said they expect to make about 16,000 job cuts out of their now-combined staff of 106,000 people. With no official word on those cuts,many employees are anxious.
Clark said Wednesday it would take time to decide which employees will leave and which facilities will close.
The new company is organised into five divisions, including its manufacturing operations and Merck Research Laboratories.
The others are the prescription drug business and two Schering-Plough businesses, animal health and a consumer health business with well-known brands such as Claritin allergy pills, Miralax laxative, Coppertone sun care items and the Dr Scholl's foot0care line.
Wednesday, November 4, 2009
Patients in medical maze need advocates
Two days after surgery to replace both my knees, a social worker employed by the hospital told me that the insurance company would not pay for me to stay any longer. Seeing that I was barely able to get to the bathroom on my own, she told the company I was not ready to enter rehab and insisted that I needed at least another day in the hospital.
She was right, and I was grateful for the intervention; I was in no shape to argue with insurance bureaucrats whose goal is to save money and who had no interest in, nor any way to assess, my well-being.
As health issues go, mine was a relatively minor concern. I now realise that in the complex world of modern medicine, nearly all patients, and especially those who are critically ill, need an advocate, someone to negotiate with medical professionals, insurers and others to ensure that they are receiving optimal care.
David Wayne Smith, a disability specialist at the Arizona Arthritis Centre in Tucson, became an advocate for his 58-year-old son, who had been thrown from a horse and lay near death in a hospital room 800km away. He had several broken ribs,bruised lungs, a fractured clavicle and serious breathing problems, Smith wrote in the September-October issue of Arthritis Self-Management . For three long weeks, during which there were many close calls with death, his son lay in a drug-induced coma, his breathing maintained by a tube in his throat and a respirator.
Steeling himself against profound feelings of helplessness and fear, Smith quickly realised he had to become part of his son's treatment team as a patient advocate.
Smith began by making himself known to the hospital administrator and everyone involved with his son's care. He called the chief of the trauma centre whenever his son took a turn for the worse and got permission for himself and his son's wife to attend daily rounds when doctors discussed the patient's progress.
And when his son was ready to leave the trauma centre, Smith insisted that he be transferred to a rehabilitation centre, not a regular hospital bed.
Thanks in large part to Smith's advocacy, his son made rapid progress in rehab and in two weeks was able to go home, where his father has continued to advocate on his behalf, now to help counter the depression and anxiety that can accompany such a life-changing accident.
"I see patients routinely in this situation, patients in their thirties and forties who've been told by rheumatologists that they can no longer work and must get by on Social Security disability benefits," Smith,83, said in an interview."I work with them to find specialists who can help them improve their situation, and I encourage them to take better care of themselves.
"Many patients with rheumatoid arthritis are reluctant to have the surgery that can enable them to get back to work, or they don't take their medication,or they fail to see the proper specialists."
Smith outlined four situations that call for a patient advocate:
Patients' illnesses or injuries are life-threatening, and they are unable to act on their own behalf.(As with Smith's son, such patients may be unconscious or placed in a drug-induced coma, or otherwise heavily medicated.)
Important decisions must be immediately made regarding treatment,but patients are temporarily unable to act for themselves because of severe physical or emotional trauma.
Although otherwise competent,patients are unaware of their rights, benefits or treatment options, as may happen with patients who have cancer, heart disease or severe arthritis.
Patients lack the mental ability to make rational decisions regarding their rights, treatments and benefits.
The advocate's main role is to serve as a link between patients and their health care providers.
The advocate helps make sure that patients get needed treatments in a timely fashion and can alert doctors when patients fail to follow prescribed remedies.
Perhaps most important, patient advocates assist with continuity of care,
ensuring that critical medical information is given to new providers and helping patients connect with ancillary personnel when employment, financial,legal or other issues arise.
For example, the advocate might negotiate with an employer to adapt work responsibilities that fit the abilities of an ill or injured patient but still benefit the employer.
Sometimes, advocates also have to work with families facing role reversal issues when the family breadwinner becomes disabled.
Smith said that when illness or injury disrupted the family dynamic, communication problems were commonplace.
Smith told of a woman who served as an advocate for her husband, who had been severely injured in a traffic accident.
When the trauma surgeon said the man's leg would have to be amputated, the woman refused to consent to the surgery and instead arranged with his insurance company to have him transferred to a skilled nursing facility,where he could get both physical and occupational therapy.
The wife consulted a plastic surgeon,who repaired injuries to the man's face and sewed his thumb back on. She also closely monitored his pain medication and arranged for a unit that relieves pain through electrical nerve stimulation,arguing with the insurer that this would be a less costly and more effective approach than heavy-duty drugs.
In the end, the man's leg was saved and his face minimally scarred. He could walk without any aid or limp and was able to return to work as a clinical nurse.
An effective advocate, Smith said, has to be "knowledgeable, committed and aggressive - forceful in a positive way and a good listener".
He added that it was important to be cooperative, caring and firm, but not demanding, to foster cooperation and not antagonise the patient's health care providers.
The advocate can be a family member or friend, or a professional patient advocate, who often has a background in medical social work.
Some who work with older people are called geriatric care managers. Many patient advocates are volunteers whose compensation comes from satisfaction in helping someone recover.
It is better to avoid advocates who might have a conflict of interest that could compromise patient care.
Thus, using an advocate employed by the hospital or insurance company may not always serve the patient's best interests.
Some hospitals maintain a roster of patient advocate volunteers.
She was right, and I was grateful for the intervention; I was in no shape to argue with insurance bureaucrats whose goal is to save money and who had no interest in, nor any way to assess, my well-being.
As health issues go, mine was a relatively minor concern. I now realise that in the complex world of modern medicine, nearly all patients, and especially those who are critically ill, need an advocate, someone to negotiate with medical professionals, insurers and others to ensure that they are receiving optimal care.
David Wayne Smith, a disability specialist at the Arizona Arthritis Centre in Tucson, became an advocate for his 58-year-old son, who had been thrown from a horse and lay near death in a hospital room 800km away. He had several broken ribs,bruised lungs, a fractured clavicle and serious breathing problems, Smith wrote in the September-October issue of Arthritis Self-Management . For three long weeks, during which there were many close calls with death, his son lay in a drug-induced coma, his breathing maintained by a tube in his throat and a respirator.
Steeling himself against profound feelings of helplessness and fear, Smith quickly realised he had to become part of his son's treatment team as a patient advocate.
Smith began by making himself known to the hospital administrator and everyone involved with his son's care. He called the chief of the trauma centre whenever his son took a turn for the worse and got permission for himself and his son's wife to attend daily rounds when doctors discussed the patient's progress.
And when his son was ready to leave the trauma centre, Smith insisted that he be transferred to a rehabilitation centre, not a regular hospital bed.
Thanks in large part to Smith's advocacy, his son made rapid progress in rehab and in two weeks was able to go home, where his father has continued to advocate on his behalf, now to help counter the depression and anxiety that can accompany such a life-changing accident.
"I see patients routinely in this situation, patients in their thirties and forties who've been told by rheumatologists that they can no longer work and must get by on Social Security disability benefits," Smith,83, said in an interview."I work with them to find specialists who can help them improve their situation, and I encourage them to take better care of themselves.
"Many patients with rheumatoid arthritis are reluctant to have the surgery that can enable them to get back to work, or they don't take their medication,or they fail to see the proper specialists."
Smith outlined four situations that call for a patient advocate:
Patients' illnesses or injuries are life-threatening, and they are unable to act on their own behalf.(As with Smith's son, such patients may be unconscious or placed in a drug-induced coma, or otherwise heavily medicated.)
Important decisions must be immediately made regarding treatment,but patients are temporarily unable to act for themselves because of severe physical or emotional trauma.
Although otherwise competent,patients are unaware of their rights, benefits or treatment options, as may happen with patients who have cancer, heart disease or severe arthritis.
Patients lack the mental ability to make rational decisions regarding their rights, treatments and benefits.
The advocate's main role is to serve as a link between patients and their health care providers.
The advocate helps make sure that patients get needed treatments in a timely fashion and can alert doctors when patients fail to follow prescribed remedies.
Perhaps most important, patient advocates assist with continuity of care,
ensuring that critical medical information is given to new providers and helping patients connect with ancillary personnel when employment, financial,legal or other issues arise.
For example, the advocate might negotiate with an employer to adapt work responsibilities that fit the abilities of an ill or injured patient but still benefit the employer.
Sometimes, advocates also have to work with families facing role reversal issues when the family breadwinner becomes disabled.
Smith said that when illness or injury disrupted the family dynamic, communication problems were commonplace.
Smith told of a woman who served as an advocate for her husband, who had been severely injured in a traffic accident.
When the trauma surgeon said the man's leg would have to be amputated, the woman refused to consent to the surgery and instead arranged with his insurance company to have him transferred to a skilled nursing facility,where he could get both physical and occupational therapy.
The wife consulted a plastic surgeon,who repaired injuries to the man's face and sewed his thumb back on. She also closely monitored his pain medication and arranged for a unit that relieves pain through electrical nerve stimulation,arguing with the insurer that this would be a less costly and more effective approach than heavy-duty drugs.
In the end, the man's leg was saved and his face minimally scarred. He could walk without any aid or limp and was able to return to work as a clinical nurse.
An effective advocate, Smith said, has to be "knowledgeable, committed and aggressive - forceful in a positive way and a good listener".
He added that it was important to be cooperative, caring and firm, but not demanding, to foster cooperation and not antagonise the patient's health care providers.
The advocate can be a family member or friend, or a professional patient advocate, who often has a background in medical social work.
Some who work with older people are called geriatric care managers. Many patient advocates are volunteers whose compensation comes from satisfaction in helping someone recover.
It is better to avoid advocates who might have a conflict of interest that could compromise patient care.
Thus, using an advocate employed by the hospital or insurance company may not always serve the patient's best interests.
Some hospitals maintain a roster of patient advocate volunteers.
Public health
Remember a couple of weeks ago the government stopped reporting on the H1N1 influenza? Because it had pretty well stopped, and there were no deaths for a week? Yes, well, just kidding.Kamnuan Ungchusak, a Public Health Ministry disease control expert said to stand by for a second wave of swine flu,quite possibly worse than the first wave,which killed 182 people and closed all Bangkok schools for more than a week.The fears stem from a sudden upsurge in H1N1 cases in North America, where children in particular are being struck down by the virus. The weather is cooling,schools are resuming class and (one hopes) the tourist high season is approaching. Also, the long-promised anti-flu vaccine isn't ready, won't be for weeks, oh, make that months. All of these facts are good for flu, bad for humans. Ah, but that's not all. Permanent secretary for public health Paijit Warachit called a meeting of health and livestock officials. He fears that the H5N1 avian flu is set to strike again as well.But big problems loom, potentially political tsunami. In Thailand, in the US -where flu is already an official national emergency - and around the world,authorities have somehow botched the vaccine that would protect tens of millions from the H1N1 pandemic. Thai authorities say tests may begin in midwinter. Despite months of soothing talk and preparation, the Obama administration can't produce enough vaccine to provide shots for President Obama's daughters. The promises of vaccine have proved hollow, and governments may pay for that prevarication if the H1N1 does indeed hit hard, as feared.
Wednesday, October 28, 2009
BOON TURNS TO CHINA AFTER SELLING HOSPITAL STAKE
Property tycoon Boon Vanasin recently unloaded shares in Piyavate Hospital to Red Bull owner Chaleo Yoovidhya so he can focus more on hospital investment in China.
"China will be my latest country for investing in healthcare. I believe revenue from that industry in that country will exceed revenue from all of my businesses in Thailand, both healthcare and property, within five years," Boon said.
He said he spent much of his time in China now, overseeing construction of his hospitals. Despite the opportunities afforded by the world's most populous country, investment in China is quite difficult for foreigners, and so he finds he must be on hand there.
Boon's hospital arm, the Thonburi Hospital Group, sold its entire 40-per-cent stake in Piyavate Hospital, although he maintains his personal 5-per-cent holding and remains a director.
The group generates annual revenue of Bt3 billion from 17 hospitals, while Boon's property business generates about Bt2 billion per annum.
Boon's foreign-investment arm, WJ International Healthcare, is constructing three Chinese hospitals at a combined cost exceeding Bt1 billion, with a different Chinese partner for each one: the military, the Foreign Ministry and the Red Cross Society of China.
Boon plans to open three hospitals a year in China, serving mainly foreigners.
He said the Thonburi Hospital Group agreed to sell its shares in Piyavate Hospital roughly five months ago, obtaining Bt400 million from the deal. The money will go towards the Bt900-million expansion of Thonburi Hospital 1 and Thonburi Hospital 2.
The group will spend Bt400 million to build new outpatient and inpatient buildings at Thonburi Hospital 1, after which capacity will double in the outpatient building to serve 3,000 patients a day, while inpatient beds will increase 25 per cent to 500.
A budget of Bt500 million has been earmarked for a new outpatient building at Thonburi Hospital 2 that can serve 1,500 outpatients daily, up from 800 now.
Boon said another reason for selling the Piyavate shares were his and Chaleo's conflicting opinions on the business's direction. He wanted to embark upon a major Bt2-billion upgrade of Piyavate, in order to make it more competitive with other private hospitals, but Chaleo wants the 16-year-old hospital to grow more slowly.
Boon resigned as Piyavate's chairman but signed an agreement with Chaleo retaining the right to become Piyavate Hospital's major shareholder within three years. If he does return in that capacity, he may let his heirs hold the stake.
Piyavate CEO and president Nithi Mahanonda said Chaleo planned to bring in more doctors from several fields, cut unnecessary costs and make the most beneficial use of the hospital's facilities. After five years of losses, the hospital is expected to post a net profit next year, with revenue increasing 15 per cent.
Nithi expects revenue of Bt1 billion this year, up 25 per cent from last year. The company will book a net loss estimated at Bt60 million, an improvement from last year's Bt300-million loss.
Piyavate expects to take six years to clear its accumulated losses of Bt800 million.
Nithi said with the transaction, Chaleo's children and grandchild now hold 75 per cent of the hospital's registered capital of Bt2.1 billion, while 19 per cent is held physicians.
He said Piyavate had spent nearly Bt200 million on renovating its building and would increase the number of beds from 100 to 150 within six months. It is also adding more full- and part-time physicians to attract more patients, especially foreigners, who are higher margin.
Piyavate plans to become a top-five private hospital in the near future.
"China will be my latest country for investing in healthcare. I believe revenue from that industry in that country will exceed revenue from all of my businesses in Thailand, both healthcare and property, within five years," Boon said.
He said he spent much of his time in China now, overseeing construction of his hospitals. Despite the opportunities afforded by the world's most populous country, investment in China is quite difficult for foreigners, and so he finds he must be on hand there.
Boon's hospital arm, the Thonburi Hospital Group, sold its entire 40-per-cent stake in Piyavate Hospital, although he maintains his personal 5-per-cent holding and remains a director.
The group generates annual revenue of Bt3 billion from 17 hospitals, while Boon's property business generates about Bt2 billion per annum.
Boon's foreign-investment arm, WJ International Healthcare, is constructing three Chinese hospitals at a combined cost exceeding Bt1 billion, with a different Chinese partner for each one: the military, the Foreign Ministry and the Red Cross Society of China.
Boon plans to open three hospitals a year in China, serving mainly foreigners.
He said the Thonburi Hospital Group agreed to sell its shares in Piyavate Hospital roughly five months ago, obtaining Bt400 million from the deal. The money will go towards the Bt900-million expansion of Thonburi Hospital 1 and Thonburi Hospital 2.
The group will spend Bt400 million to build new outpatient and inpatient buildings at Thonburi Hospital 1, after which capacity will double in the outpatient building to serve 3,000 patients a day, while inpatient beds will increase 25 per cent to 500.
A budget of Bt500 million has been earmarked for a new outpatient building at Thonburi Hospital 2 that can serve 1,500 outpatients daily, up from 800 now.
Boon said another reason for selling the Piyavate shares were his and Chaleo's conflicting opinions on the business's direction. He wanted to embark upon a major Bt2-billion upgrade of Piyavate, in order to make it more competitive with other private hospitals, but Chaleo wants the 16-year-old hospital to grow more slowly.
Boon resigned as Piyavate's chairman but signed an agreement with Chaleo retaining the right to become Piyavate Hospital's major shareholder within three years. If he does return in that capacity, he may let his heirs hold the stake.
Piyavate CEO and president Nithi Mahanonda said Chaleo planned to bring in more doctors from several fields, cut unnecessary costs and make the most beneficial use of the hospital's facilities. After five years of losses, the hospital is expected to post a net profit next year, with revenue increasing 15 per cent.
Nithi expects revenue of Bt1 billion this year, up 25 per cent from last year. The company will book a net loss estimated at Bt60 million, an improvement from last year's Bt300-million loss.
Piyavate expects to take six years to clear its accumulated losses of Bt800 million.
Nithi said with the transaction, Chaleo's children and grandchild now hold 75 per cent of the hospital's registered capital of Bt2.1 billion, while 19 per cent is held physicians.
He said Piyavate had spent nearly Bt200 million on renovating its building and would increase the number of beds from 100 to 150 within six months. It is also adding more full- and part-time physicians to attract more patients, especially foreigners, who are higher margin.
Piyavate plans to become a top-five private hospital in the near future.
GE shrinks ultrasound tool
The future of ultrasound technology, as interpreted by General Electric Co, looks a bit like a flip phone crossed with an iPod.
GE chief executive Jeff Immelt unveiled a handheld ultrasound machine at the Web 2.0 Summit in San Francisco on Tuesday called the Vscan, saying it could become the "stethoscope of the 21st century."
The device folds open clamshell-style to reveal a small screen on the top half and a circular button pad on the bottom.A small attached wand can be used to generate a non-invasive scan of a patient's organs or of a fetus.
The Vscan is aimed in part at primary care doctors, who could use it instead of sending patients to get an ultrasound at a specialist's office. It could also be used by doctors in remote regions without access to hospital equipment.
Immelt said that the device, which will be available sometime next year,would be "very digitally capable" but that it would not have Wi-Fi access to wirelessly transmit ultrasound images.
The cost of the device is unknown.During the summit, Immelt declined to elaborate on the possibility that Fairfield, Connecticut-based GE will sell a stake in its NBC Universal entertainment division to cable TV operator Comcast Corp or any other company.
He said that GE "is comfortable" with the division."
GE chief executive Jeff Immelt unveiled a handheld ultrasound machine at the Web 2.0 Summit in San Francisco on Tuesday called the Vscan, saying it could become the "stethoscope of the 21st century."
The device folds open clamshell-style to reveal a small screen on the top half and a circular button pad on the bottom.A small attached wand can be used to generate a non-invasive scan of a patient's organs or of a fetus.
The Vscan is aimed in part at primary care doctors, who could use it instead of sending patients to get an ultrasound at a specialist's office. It could also be used by doctors in remote regions without access to hospital equipment.
Immelt said that the device, which will be available sometime next year,would be "very digitally capable" but that it would not have Wi-Fi access to wirelessly transmit ultrasound images.
The cost of the device is unknown.During the summit, Immelt declined to elaborate on the possibility that Fairfield, Connecticut-based GE will sell a stake in its NBC Universal entertainment division to cable TV operator Comcast Corp or any other company.
He said that GE "is comfortable" with the division."
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