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| The
Andhra Journal of Industrial News |
|
|
|
Chief Editor:
Dr. Sreenivasarao
Vepachedu |
|
Issue 36 |
5109 Kali Era, Vyaya
Year, Phalguna/Chaitra
month
2065 Vikramarka Era, Vyaya Year, Phalguna/Chaitra month 1929 Salivahana Era, Vyaya Year, Phalguna/Chaitra month 2007 AD, March |
Contents
Design Around
a Patent Without Infringing
Value
of IP is Increasing
India Proposes 35% Tax
Tekturna
Novartis Refuses
To Yank Gleevec Lawsuit
Bio-Generic Drugs are
Not Same, but Similar
Cheap Vaccine for Africa
To Stent or Not, That
is the Question!
Zelnorm Warning
FDA Warns against Acutane
Pergolide Withdrawal
Bipolar Disorder: No Treatment
The Michael J. Fox Foundation
for Parkinson's Research (MJFF)
The Atlantic Philanthropies'
Gift for UCSF
Intrinsa, Patch to boost
female sex drive
Clinical Study in India
Biotech in India
Crestor and Torcetrapib
China Market
Ranbaxy's Zolpidem Tartrate
Food security
Protecting Diversity
Design
Around a Patent Without Infringing
Prosecution history of a patent is very useful in designing around a patent. If a claim is narrowed during the prosecution for patentability reasons, it is easy to design around the introduced limitation, without infringing the patent even under the Doctrine of Equivalents (DOE). Recently, Medtronic redesigned their bone screws to avoid infringing the patents of Cross Medical, taking the advantage of the narrowed doctrine of equivalents after Festo. Thread-depth was limited to "below the rod diameter", a limitation introduced in its patent by Cross during prosecution. Medtronic modified its design by changing it to a depth above the diameter of rod. This has been tested in the courts. The district court found that the amendment was only tangentially related to the accused equivalent and found Medtronic infringed under the DOE, however, to be reversed at CAFC. Such a surrender is not tangential according to CAFC. See Cross Medical v. Medtronic (Fed. Cir. 2007).
Value of IP is Increasing
And so malpractice insurance for IP lawyers. Apparently, there's no vaccine for legal malpractice suits against IP lawyers. A fledgling San Diego biotech company is suing Foley & Lardner for allegedly missing the filing date on an international patent application. Vaxiion Therapeutics Inc., which develops new ways to deliver vaccines using genetically engineered mini-cells, claims attorneys in Foley's San Diego office missed the deadline by four days, allowing a competitor to cash in on the same intellectual property, according to a complaint filed in San Diego County Superior Court late last month. Foley allegedly represented the competitor, EnGene Inc., at the same time without notifying Vaxiion, causing a conflict, according to the suit. Vaxiion is seeking damages for undisclosed amount. The potential harm is 100 million or more, according to Vaxiion. The case is Vaxiion Therapeutics Inc. v. Foley & Lardner LLP, 877641.
A California Supreme Court decision last year let stand a lower court ruling on a malpractice award of about $30 million against Boston-based Fish & Richardson over similar allegations. In that case, Kairos Scientific Inc., a San Diego chemical digital imaging company, won the judgment after Fish's Redwood City, Calif., office failed to file a patent in a timely fashion. Claims like these are a sign of the ever-increasing value businesses place on intellectual property. The malpractice insurance has gone up significantly for IP attorneys in the last 10 years and, certainly, in the last five. Most firms take special precautions to avoid missing patent application dates because the stakes are so high.
India Proposes 35% Tax
The Government of India’s proposed budget for 2007-2008 (commencing April 1, 2007) includes extending the 35% fringe benefit tax imposed on employers to the income their employees in India recognize on exercise of compensatory stock options. The income would be the difference between the price paid for the shares and the fair market value of the shares on the date of exercise. Although still subject to some negotiation, it appears more likely than not that this law will take effect as proposed on April 1, 2007. Thus, for stock options that have already been granted to persons in India it appears to be desirable for the employer to encourage these persons to exercise these options, at least with respect to vested shares, prior to April 1, 2007, and thereby avoid this tax treatment. It appears that going forward, the terms of a stock option agreement could include a provision requiring that on exercise the employee reimburse the employer for the amount of this tax paid by the employer. This would be similar to the practice that has developed with respect to stock options granted to employees in the United Kingdom. The UK government also imposes a sizable tax on the employer when the employee exercises an in-the-money stock option, but the UK tax authority has established a process by which the employer can require the employee to reimburse the employer for this tax. With respect to India however, labor laws need to be reviewed to determine if tax shifting is permitted.
Anticipated Effect is that cash-tight enterprises can be expected will be discouraged and foreign enterprises, faced with an uncapped tax liability, will be further encouraged to reduce their investment in India in favor of other locations. http://www.mondaq.com/article.asp?articleid=46882&email_access=on
While China offers enormous, but largely unrealized, opportunities for North American biotechnology and pharmaceutical firms. Those looking to either gain a market foothold or acquire complementary capabilities, products and platform technologies may benefit from a low cost base for research and development, liberal policies toward discovery and clinical research, a large pool of qualified researchers and technologists, and ever-increasing government funding and incentives. A longer-term consideration for foreign firms is the Chinese government’s planned unification of corporate tax rates. Reports suggest that lawmakers plan to enact a bill that would eventually unify income tax rates for domestic and foreign companies at 25 per cent. Currently, the rates stand at 15 per cent for foreign companies and 33 per cent for their domestic peers. Even though this reform has resulted in a more costly operating environment, the planned unified rate is still relatively low compared with rates in developed markets.
http://www.mondaq.com/article.asp?articleid=46998&email_access=on
Tekturna
Swiss pharmaceutical maker Novartis AG has received U.S. approval for the hypertension drug Tekturna, a potential blockbuster that has shown the ability to lower blood pressure more effectively than common treatments. Tekturna is the first new type of medicine in more than a decade for treating high blood pressure. Approval from the U.S. Food and Drug Administration makes the United States the first country to allow it to be sold. Tekturna is intended eventually to replace Diovan, Novartis' best-selling drug with annual sales of $4.2 billion, whose patent will expire in 2012.
Novartis Refuses To Yank Gleevec Lawsuit
Standing strong in the face of international pressure, Novartis AG has refused to withdraw its controversial Gleevec lawsuit in India, but has slightly modified its stance against a key section of the country’s patent laws.
Bio-Generic Drugs are Not Same, but Similar
The traditional (chemical) generic drugs are identical to their brand-name versions and can be swapped or substituted for one another. That would not be the case with a generic biotech drug deemed only "similar," even though its effect on patients would be the same. Because of that complexity, the FDA and the brand-name drug industry both maintain it would be difficult to ensure the safety and effectiveness of the generics, sometimes called follow-on protein products. A bipartisan group of lawmakers recently renewed the push to give the FDA the legal authority. The FDA says it continues to develop the scientific guidelines required to consider applications from would-be manufactures of the copycat biotech drugs.
Cheap Vaccine for Africa
For the first time, Europe's largest drugs company, GSK, is starting the registration process for a vaccine from which it never expects to make money. Globorix will only be used in Africa to prevent meningitis at prices that may never cover its research costs. Experts say it is a sign that big companies are changing their business practices.
To Stent or Not, That is the Question!
Whether 'tis nobler in the mind to suffer,
The slings and arrows of outrageous fortunes (of stents),
Or to take arms against a sea of troubles (vested interests), And by opposing end them?
At issue is angioplasty, in which a tiny balloon is snaked through an artery and inflated to flatten a blockage. Mesh tubes called stents are usually placed to keep the vessel open. It is the gold standard for treating heart attacks and worsening symptoms that land people in the hospital. Doctors say no one who has chest pains should delay seeing a doctor. But in recent years, angioplasty also has become popular for treating patients with chest pain who aren't in imminent danger - despite the fact that no big studies ever proved it better than medications alone.
This month (end of March 2007) at a cardiology conference in New Orleans, doctors presented results of the first big study to test this. It found that drugs were just as good for preventing heart attacks and death in these elective cases. Angioplasty was better for chest pain early on, but that waned over time. So many people are unwilling to accept results that go against their beliefs and business interests that the study seems destined to have less impact than many believe it should. It seemed to surprise everyone that modern heart drugs worked as well as they did.
A new crop of experimental heart stents have passed some key safety and effectiveness tests and may one day offer alternatives to the controversial stents currently used to keep unclogged arteries open, doctors reported in March. One is designed to dissolve after doing its job, leaving nothing behind to trigger blood clots, a worry with the most popular stents sold now. Another attracts special cells to help the artery heal. A third is super-thin and uses a novel drug to keep scar tissue from reblocking the vessel. All are seeking a slice of the $6 billion market for these tiny mesh scaffolds, which are placed in arteries during angioplasty, an artery-clearing procedure that more than a million Americans have each year. Its popularity has faded with news that the drug-coated stents used in most of these procedures can raise the risk of blood clots many months later. Two brands are sold in the United States: Taxus, by Boston Scientific Corp., and Cypher, by Johnson & Johnson's Cordis Corp.
Abbott's Xience has a very thin metal base coated with a drug called everolimus to discourage scar tissue. It is already sold overseas; a new study aimed at getting approval in the U.S. and Japan is underway. Doctors also gave results of the first human study in the world of a temporary stent, Absorb, also made by Abbott. It is designed to hold arteries open for about six months and then completely dissolve over the next two years or so. In May, results are due on Cordis' experimental stent, CoStar. Its anti-clotting drug is contained in tiny wells designed to dissolve over time so that after about six months, the device turns into a plain metal stent. Medtronic Inc. also is seeking FDA approval for its Endeavor stent, which it claims is less likely to cause artery inflammation problems.
Yet, key questions remain about the safety of all of these devices.
Zelnorm Warning
Novartis is complying with a request from the Food and Drug Administration (FDA) to suspend US marketing and sales of Zelnorm® (tegaserod maleate), a treatment for irritable bowel syndrome (IBS) with constipation and chronic constipation. This action has been taken after Novartis notified the FDA about a retrospective analysis of data from more than 18,000 patients in the clinical trial database. This was the result of an ongoing review involving a number of health authorities including the FDA.
FDA announces the following, effective immediately:
FDA Warns against Acutane
The U.S. Food & Drug Administration (FDA) has launched a special Web page to warn consumers about the dangers of buying isotretinoin (Accutane) online. Isotretinoin is a drug approved for the treatment of severe recalcitrant nodular acne that does not respond to antibiotics. Improperly used, isotretinoin can cause severe side effects, including birth defects. Serious mental health problems have also been reported with isotretinoin use.
http://www.fda.gov/buyonline/accutane
Pergolide Withdrawal
The Food and Drug Administration said that pergolide, first developed by Eli Lilly and Co., sold under the name Permax and also in generic versions, is being withdrawn at the agency's request. Pergolide is a dopamine agonist. It is estimated that between 12,000 and 25,000 people currently use pergolide. At least 14 patients have needed to have heart valves replaced, which may be an underestimate. Withdrawal was requested after two recent studies, published in The New England Journal of Medicine, indicated high rates of valve leakage -- up to 20 percent -- in patients taking the drug. There are other drugs in the same class that can be substituted that are not associated with heart valve problems, FDA said. However, the new studies also found an increase chance of heart valve damage from another dopamine agonist, cabergoline, sold under the name Dostinex, the FDA said. Dostinex is not approved in the U.S. for the treatment of Parkinson's disease, but is used at lower doses for other disorders.
Bipolar Disorder: No Treatment
About 10 million Americans suffer from bipolar disorder, characterized by extreme mood swings from elation and manic activity to incapacitating depression, according to the National Alliance on Mental Illness. Treating bipolar disorder with antidepressants has been controversial, because some therapists worry the drugs destabilize patients. Patients seeking treatment for bipolar disorder depression are as likely to get relief from sugar pills as they are from widely used antidepressants, according to a new study in this New England Journal of Medicine. In the largest study of its kind, researchers at the University of Colorado and sites across the country gave patients Paxil, Wellbutrin or a sugar pill.
The Michael J. Fox Foundation for Parkinson's Research (MJFF)
The Michael J. Fox Foundation for Parkinson's Research (MJFF) announced on March 29th the launch of its 2007 Clinical Discovery Program and commits up to $3 million for High-Impact Clinical Research . This annual program seeks out proposals that stimulate well-designed clinical research projects focused on potentially high-impact approaches to the field of Parkinson's disease. If successful, projects funded under this program could lead to improved treatment of PD within five years and have an immediate impact on patients' lives.
The Clinical Discovery Program aims to meet the Foundation's goal of driving the delivery of promising therapies to patients and enabling researchers to bridge the gap between lab results and clinical research in a short period of time. With a comprehensive view of the field, the Foundation is ideally positioned to identify opportunities and create synergies all along the continuum from basic to clinical research.
Founded in 2000, The Michael J. Fox Foundation for Parkinson's Research is dedicated to ensuring the development of a cure for Parkinson's disease within this decade through an aggressively funded research agenda. The Foundation has funded over $90 million in research to date, either directly or through partnerships.
The Foundation launched the Clinical Discovery Program in 2004 and has awarded approximately $7 million for 12 projects under the initiative to date. The Foundation particularly seeks projects that explore new neuroprotective treatments, improvements on existing therapies, and development of treatments for unmet symptoms of PD. Consenting human subjects, either as direct research participants or as donors of biological specimens are crucial in order for an application to be considered for this program.
The Atlantic Philanthropies' Gift for UCSF
UCSF has received a $50 million gift toward construction of a new building for cardiovascular research and clinical treatment at the University’s Mission Bay campus. The grant, from The Atlantic Philanthropies (www.atlanticphilanthropies.org), is the largest single commitment from a foundation in UCSF’s history. The new building will be a collaborative center that brings basic research scientists and clinicians together under the same roof, thus accelerating their efforts to understand cardiovascular diseases, such as heart attack and stroke. It will house the existing world-renowned UCSF Cardiovascular Research Institute, known as CVRI, and will be home to a new UCSF Center for Prevention of Cardiovascular Disease with an outpatient facility that will focus on advancing ways to predict and prevent these devastating illnesses. Cardiovascular diseases are the leading cause of death and disability in the United States, accounting for roughly 950,000 deaths each year, and are expected to increase as the population ages. Those diseases include heart attack, stroke and peripheral vascular disease, as well as asthma, cystic fibrosis and other pulmonary conditions.
Intrinsa, Patch 'to boost female sex drive'
Intrinsa will only be available on prescription for women who have had an early menopause because of surgery. It is the first treatment for women with low sex drive. About a million women in the UK have had an early menopause because of surgery to remove their ovaries during hysterectomy for conditions such as heavy bleeding and pelvic pain, Procter and Gamble said. This procedure leads to a decrease in testosterone, a naturally occurring hormone in women which is a key mediator of sexual desire. A third of these women end up suffering from low sexual desire and will be entitled to the treatment on prescription. Intrinsa is a clear patch worn on the abdomen, which delivers a low dose of testosterone.
Clinical Study in India
The Institute for OneWorld Health, a US-based non-profit pharmaceutical company that develops drugs for people with neglected diseases in the developing world, today announced the selection of Odyssey Research, a Bismarck, North Dakota-based clinical trial management organization (TMO) with offices in New Delhi, India, to support its upcoming Phase 4 pharmacovigilance and access study of Paromomycin Intramuscular (IM) Injection for the treatment of visceral leishmaniasis (VL) in India. With approximately 500,000 new cases occurring annually, visceral leishmaniasis, also known as kala-azar or black fever, is the world’s second most deadly parasitic disease following malaria. Odyssey Research will perform regular monitoring of seven clinical sites for the pharmacovigilance module in the Phase 4 study. The study, scheduled to begin later this year, will be conducted in the state of Bihar, India.
Gland Pharma Limited, the Hyderabad, India-based drug manufacturer, working in collaboration with OneWorld Health, received regulatory approval from the Drug-Controller General - India (DCGI) for Paromomycin IM Injection as a treatment for VL on August 31, 2006.
Biotech in India
International Service for the Acquisition of Agri-biotech Applications (ISAAA) reported on February 20, 2007 (checkbiotech.org) that India is fast evolving as a leading biotech region in Asia, outshining China for the first time in terms of total hectare land planted with biotechnology seeds. In 2006, India’s area planted with biotech cotton grew triple-fold (India’s first commercialized biotech crop) from the last year. The total biotech hectare in India now stands at an impressive 3.8 million as against 3.5 million in China.
Quality seeds with good biotechnology are making the rise in productivity of Indian cultivators stronger. After biotech cotton, the next major crop to be traded in the Asian market will be ‘golden rice’. This variety of rice is fortified with Vitamin A - essential for vision, and the intestinal, urinary, and respiratory tracts. The biotech development is immensely important for agriculture as a whole as researchers search for ways to make a variety of crops better. Biotechnology is an important tool being rapidly adapted and used by farmers in developing countries and is greatly influencing the countries’ development and thereby, their economy.
Asian cultivators have adopted GM (genetically modified) crops that are insect-resistant, pest-resistant, and have many other additional benefits. Countries like India are making huge investments in the research of agricultural biotechnology to meet their surging needs for food, fuel, and fiber. India is expected to develop a national chain of research laboratories by infusing $80 Million in 2007. According to the RNCOS report “Indian Biotechnology Market Outlook (2006)”, biotech will greatly influence the Indian agriculture sector by developing a large number of GM seeds. Amplifying at the rate of 28.09% from 2005, the Indian biotech industry is believed to reach the level of US$ 5 Billion.
Crestor and Torcetrapib
AstraZeneca PLC's Crestor cholesterol drug slowed thickening in the neck arteries of people at low risk for heart attacks and strokes, but it failed to reverse thickening as researchers had hoped for. Thickening of arterial walls is a precursor to plaque buildup, which can lead to heart attacks and strokes. Crestor is approved primarily to reduce levels of bad cholesterol.
While Cleveland Clinic researchers report that the Pfizer's drug torcetrapib, despite raising high density lipoprotein cholesterol (HDL) or the "good" cholesterol by more than 60%, did not slow the progression of plaque buildup in the coronary arteries as measured using an ultrasound probe. All development of this drug was terminated on Dec. 2, 2006 after the safety board monitoring a separate large clinical outcomes trial reported that torcetrapib increased the risk of death and other adverse cardiovascular outcomes.
China Market
China possesses a fourth of the population in the world and has one of the largest drug markets round the world. By 2006, sales on the Chinese drug market have reached $12 billion dollars, an increase of 3.8 fold over 1998 level. A series of factors, such as an increasingly ageing population, accelerating growth of urban population as well as expansion of healthcare covering urban and rural, will grow the Chinese drug market with a growth rate of 20-25 percent per annum in next five years. China is expected to become the fifth largest drug market in the world by 2010.
Ranbaxy's Zolpidem Tartrate
Ranbaxy Laboratories Limited (RLL), announced today that the Company has received tentative approval from the Food and Drug Administration to manufacture and market Zolpidem Tartrate Tablets, 5mg and 10mg. The Office of Generic Drugs, U.S. Food and Drug Administration, has determined the Ranbaxy formulations to be bioequivalent and to have the same therapeutic effect as that of the reference listed drug Ambien(R) Tablets 5mg and 10mg of Sanofi Aventis US, LLC. The products will be manufactured at the company's Ohm Laboratories Inc. facility, based in North Brunswick, New Jersey. Total annual market sales for Zolpidem Tartrate Tablets were USD 2.12 Bn (IMS: Dec. 2006).
Food security
"The rice genebank is not just a scientific exercise in seed genetics," said Robert Zeigler, director-general of the IRRI, "but a major hedge against disaster that ensures farmers throughout the world will always have the rice varieties they need to maintain food security." For example, when waves swept ashore during the Asian tsunami in 2004, many rice crops were destroyed. IRRI used its collection to provide farmers whose land had been contaminated with seawater with varieties able to grow in salty soils. Dr Zeigler said securing long-term funding for the genebank was a welcomed exception in an uncertain world.
"Rice diversity, like all crop diversity, is at risk for the want of relatively small amounts of money," he observed. "Given that we are talking about the biological base of the global food supply, it is extraordinary that the current situation is so precarious." The Global Crop Diversity Trust, an international organisation with the responsibility of ensuring the "conservation of crop diversity in perpetuity", is also in the process of constructing a "doomsday vault" that will house samples of all the world's important food crops. The vault, which is being built into a mountainside on a remote island within the Arctic Circle, is designed to safeguard crucial agricultural resources from future catastrophes such as nuclear war, asteroid strikes and climate change.
Protecting Diversity
Two leading food crop research groups have signed a deal to ensure the long-term survival of the world's largest repository of rice varieties. The Genetic Resources Center, based in the Philippines, houses 100,000 rice samples in a disaster-proof facility. The Global Crop Diversity Trust and the International Rice Research Institute (IRRI) will provide the center with $600,000 (£311,000) each year. An estimated three billion people depend upon rice as their main food.
The money would go towards acquiring any rice varieties not currently housed in the IRRI-owned center, and ensuring the storage systems were robust to withstand disasters such as earthquakes and fires. Under the agreement, IRRI has pledged to invest $400,000 (£207,000) each year, while the Trust has promised to provide a further $200,000 (£104,000) in the form of an annual conservation grant.
Prosecution history of a patent is very useful in designing around a patent. If a claim is narrowed during the prosecution for patentability reasons, it is easy to design around the introduced limitation, without infringing the patent even under the Doctrine of Equivalents (DOE). Recently, Medtronic redesigned their bone screws to avoid infringing the patents of Cross Medical, taking the advantage of the narrowed doctrine of equivalents after Festo. Thread-depth was limited to "below the rod diameter", a limitation introduced in its patent by Cross during prosecution. Medtronic modified its design by changing it to a depth above the diameter of rod. This has been tested in the courts. The district court found that the amendment was only tangentially related to the accused equivalent and found Medtronic infringed under the DOE, however, to be reversed at CAFC. Such a surrender is not tangential according to CAFC. See Cross Medical v. Medtronic (Fed. Cir. 2007).
Value of IP is Increasing
And so malpractice insurance for IP lawyers. Apparently, there's no vaccine for legal malpractice suits against IP lawyers. A fledgling San Diego biotech company is suing Foley & Lardner for allegedly missing the filing date on an international patent application. Vaxiion Therapeutics Inc., which develops new ways to deliver vaccines using genetically engineered mini-cells, claims attorneys in Foley's San Diego office missed the deadline by four days, allowing a competitor to cash in on the same intellectual property, according to a complaint filed in San Diego County Superior Court late last month. Foley allegedly represented the competitor, EnGene Inc., at the same time without notifying Vaxiion, causing a conflict, according to the suit. Vaxiion is seeking damages for undisclosed amount. The potential harm is 100 million or more, according to Vaxiion. The case is Vaxiion Therapeutics Inc. v. Foley & Lardner LLP, 877641.
A California Supreme Court decision last year let stand a lower court ruling on a malpractice award of about $30 million against Boston-based Fish & Richardson over similar allegations. In that case, Kairos Scientific Inc., a San Diego chemical digital imaging company, won the judgment after Fish's Redwood City, Calif., office failed to file a patent in a timely fashion. Claims like these are a sign of the ever-increasing value businesses place on intellectual property. The malpractice insurance has gone up significantly for IP attorneys in the last 10 years and, certainly, in the last five. Most firms take special precautions to avoid missing patent application dates because the stakes are so high.
India Proposes 35% Tax
The Government of India’s proposed budget for 2007-2008 (commencing April 1, 2007) includes extending the 35% fringe benefit tax imposed on employers to the income their employees in India recognize on exercise of compensatory stock options. The income would be the difference between the price paid for the shares and the fair market value of the shares on the date of exercise. Although still subject to some negotiation, it appears more likely than not that this law will take effect as proposed on April 1, 2007. Thus, for stock options that have already been granted to persons in India it appears to be desirable for the employer to encourage these persons to exercise these options, at least with respect to vested shares, prior to April 1, 2007, and thereby avoid this tax treatment. It appears that going forward, the terms of a stock option agreement could include a provision requiring that on exercise the employee reimburse the employer for the amount of this tax paid by the employer. This would be similar to the practice that has developed with respect to stock options granted to employees in the United Kingdom. The UK government also imposes a sizable tax on the employer when the employee exercises an in-the-money stock option, but the UK tax authority has established a process by which the employer can require the employee to reimburse the employer for this tax. With respect to India however, labor laws need to be reviewed to determine if tax shifting is permitted.
Anticipated Effect is that cash-tight enterprises can be expected will be discouraged and foreign enterprises, faced with an uncapped tax liability, will be further encouraged to reduce their investment in India in favor of other locations. http://www.mondaq.com/article.asp?articleid=46882&email_access=on
While China offers enormous, but largely unrealized, opportunities for North American biotechnology and pharmaceutical firms. Those looking to either gain a market foothold or acquire complementary capabilities, products and platform technologies may benefit from a low cost base for research and development, liberal policies toward discovery and clinical research, a large pool of qualified researchers and technologists, and ever-increasing government funding and incentives. A longer-term consideration for foreign firms is the Chinese government’s planned unification of corporate tax rates. Reports suggest that lawmakers plan to enact a bill that would eventually unify income tax rates for domestic and foreign companies at 25 per cent. Currently, the rates stand at 15 per cent for foreign companies and 33 per cent for their domestic peers. Even though this reform has resulted in a more costly operating environment, the planned unified rate is still relatively low compared with rates in developed markets.
http://www.mondaq.com/article.asp?articleid=46998&email_access=on
Tekturna
Swiss pharmaceutical maker Novartis AG has received U.S. approval for the hypertension drug Tekturna, a potential blockbuster that has shown the ability to lower blood pressure more effectively than common treatments. Tekturna is the first new type of medicine in more than a decade for treating high blood pressure. Approval from the U.S. Food and Drug Administration makes the United States the first country to allow it to be sold. Tekturna is intended eventually to replace Diovan, Novartis' best-selling drug with annual sales of $4.2 billion, whose patent will expire in 2012.
Novartis Refuses To Yank Gleevec Lawsuit
Standing strong in the face of international pressure, Novartis AG has refused to withdraw its controversial Gleevec lawsuit in India, but has slightly modified its stance against a key section of the country’s patent laws.
Bio-Generic Drugs are Not Same, but Similar
The traditional (chemical) generic drugs are identical to their brand-name versions and can be swapped or substituted for one another. That would not be the case with a generic biotech drug deemed only "similar," even though its effect on patients would be the same. Because of that complexity, the FDA and the brand-name drug industry both maintain it would be difficult to ensure the safety and effectiveness of the generics, sometimes called follow-on protein products. A bipartisan group of lawmakers recently renewed the push to give the FDA the legal authority. The FDA says it continues to develop the scientific guidelines required to consider applications from would-be manufactures of the copycat biotech drugs.
Cheap Vaccine for Africa
For the first time, Europe's largest drugs company, GSK, is starting the registration process for a vaccine from which it never expects to make money. Globorix will only be used in Africa to prevent meningitis at prices that may never cover its research costs. Experts say it is a sign that big companies are changing their business practices.
To Stent or Not, That is the Question!
Whether 'tis nobler in the mind to suffer,
The slings and arrows of outrageous fortunes (of stents),
Or to take arms against a sea of troubles (vested interests), And by opposing end them?
At issue is angioplasty, in which a tiny balloon is snaked through an artery and inflated to flatten a blockage. Mesh tubes called stents are usually placed to keep the vessel open. It is the gold standard for treating heart attacks and worsening symptoms that land people in the hospital. Doctors say no one who has chest pains should delay seeing a doctor. But in recent years, angioplasty also has become popular for treating patients with chest pain who aren't in imminent danger - despite the fact that no big studies ever proved it better than medications alone.
This month (end of March 2007) at a cardiology conference in New Orleans, doctors presented results of the first big study to test this. It found that drugs were just as good for preventing heart attacks and death in these elective cases. Angioplasty was better for chest pain early on, but that waned over time. So many people are unwilling to accept results that go against their beliefs and business interests that the study seems destined to have less impact than many believe it should. It seemed to surprise everyone that modern heart drugs worked as well as they did.
A new crop of experimental heart stents have passed some key safety and effectiveness tests and may one day offer alternatives to the controversial stents currently used to keep unclogged arteries open, doctors reported in March. One is designed to dissolve after doing its job, leaving nothing behind to trigger blood clots, a worry with the most popular stents sold now. Another attracts special cells to help the artery heal. A third is super-thin and uses a novel drug to keep scar tissue from reblocking the vessel. All are seeking a slice of the $6 billion market for these tiny mesh scaffolds, which are placed in arteries during angioplasty, an artery-clearing procedure that more than a million Americans have each year. Its popularity has faded with news that the drug-coated stents used in most of these procedures can raise the risk of blood clots many months later. Two brands are sold in the United States: Taxus, by Boston Scientific Corp., and Cypher, by Johnson & Johnson's Cordis Corp.
Abbott's Xience has a very thin metal base coated with a drug called everolimus to discourage scar tissue. It is already sold overseas; a new study aimed at getting approval in the U.S. and Japan is underway. Doctors also gave results of the first human study in the world of a temporary stent, Absorb, also made by Abbott. It is designed to hold arteries open for about six months and then completely dissolve over the next two years or so. In May, results are due on Cordis' experimental stent, CoStar. Its anti-clotting drug is contained in tiny wells designed to dissolve over time so that after about six months, the device turns into a plain metal stent. Medtronic Inc. also is seeking FDA approval for its Endeavor stent, which it claims is less likely to cause artery inflammation problems.
Yet, key questions remain about the safety of all of these devices.
Zelnorm Warning
Novartis is complying with a request from the Food and Drug Administration (FDA) to suspend US marketing and sales of Zelnorm® (tegaserod maleate), a treatment for irritable bowel syndrome (IBS) with constipation and chronic constipation. This action has been taken after Novartis notified the FDA about a retrospective analysis of data from more than 18,000 patients in the clinical trial database. This was the result of an ongoing review involving a number of health authorities including the FDA.
FDA announces the following, effective immediately:
- At FDA’s request, Novartis Pharmaceuticals Corporation has agreed to stop selling Zelnorm.
- Patients being treated with Zelnorm should contact their physician to discuss alternative treatments for their condition.
- Patients who are taking Zelnorm should seek emergency medical care right away if they experience severe chest pain, shortness of breath, dizziness, sudden onset of weakness or difficulty walking or talking or other symptoms of a heart attack or stroke.
- Physicians who prescribe Zelnorm should work with their patients and transition them to other therapies as appropriate to their symptoms and need.
FDA Warns against Acutane
The U.S. Food & Drug Administration (FDA) has launched a special Web page to warn consumers about the dangers of buying isotretinoin (Accutane) online. Isotretinoin is a drug approved for the treatment of severe recalcitrant nodular acne that does not respond to antibiotics. Improperly used, isotretinoin can cause severe side effects, including birth defects. Serious mental health problems have also been reported with isotretinoin use.
http://www.fda.gov/buyonline/accutane
Pergolide Withdrawal
The Food and Drug Administration said that pergolide, first developed by Eli Lilly and Co., sold under the name Permax and also in generic versions, is being withdrawn at the agency's request. Pergolide is a dopamine agonist. It is estimated that between 12,000 and 25,000 people currently use pergolide. At least 14 patients have needed to have heart valves replaced, which may be an underestimate. Withdrawal was requested after two recent studies, published in The New England Journal of Medicine, indicated high rates of valve leakage -- up to 20 percent -- in patients taking the drug. There are other drugs in the same class that can be substituted that are not associated with heart valve problems, FDA said. However, the new studies also found an increase chance of heart valve damage from another dopamine agonist, cabergoline, sold under the name Dostinex, the FDA said. Dostinex is not approved in the U.S. for the treatment of Parkinson's disease, but is used at lower doses for other disorders.
Bipolar Disorder: No Treatment
About 10 million Americans suffer from bipolar disorder, characterized by extreme mood swings from elation and manic activity to incapacitating depression, according to the National Alliance on Mental Illness. Treating bipolar disorder with antidepressants has been controversial, because some therapists worry the drugs destabilize patients. Patients seeking treatment for bipolar disorder depression are as likely to get relief from sugar pills as they are from widely used antidepressants, according to a new study in this New England Journal of Medicine. In the largest study of its kind, researchers at the University of Colorado and sites across the country gave patients Paxil, Wellbutrin or a sugar pill.
The Michael J. Fox Foundation for Parkinson's Research (MJFF)
The Michael J. Fox Foundation for Parkinson's Research (MJFF) announced on March 29th the launch of its 2007 Clinical Discovery Program and commits up to $3 million for High-Impact Clinical Research . This annual program seeks out proposals that stimulate well-designed clinical research projects focused on potentially high-impact approaches to the field of Parkinson's disease. If successful, projects funded under this program could lead to improved treatment of PD within five years and have an immediate impact on patients' lives.
The Clinical Discovery Program aims to meet the Foundation's goal of driving the delivery of promising therapies to patients and enabling researchers to bridge the gap between lab results and clinical research in a short period of time. With a comprehensive view of the field, the Foundation is ideally positioned to identify opportunities and create synergies all along the continuum from basic to clinical research.
Founded in 2000, The Michael J. Fox Foundation for Parkinson's Research is dedicated to ensuring the development of a cure for Parkinson's disease within this decade through an aggressively funded research agenda. The Foundation has funded over $90 million in research to date, either directly or through partnerships.
The Foundation launched the Clinical Discovery Program in 2004 and has awarded approximately $7 million for 12 projects under the initiative to date. The Foundation particularly seeks projects that explore new neuroprotective treatments, improvements on existing therapies, and development of treatments for unmet symptoms of PD. Consenting human subjects, either as direct research participants or as donors of biological specimens are crucial in order for an application to be considered for this program.
The Atlantic Philanthropies' Gift for UCSF
UCSF has received a $50 million gift toward construction of a new building for cardiovascular research and clinical treatment at the University’s Mission Bay campus. The grant, from The Atlantic Philanthropies (www.atlanticphilanthropies.org), is the largest single commitment from a foundation in UCSF’s history. The new building will be a collaborative center that brings basic research scientists and clinicians together under the same roof, thus accelerating their efforts to understand cardiovascular diseases, such as heart attack and stroke. It will house the existing world-renowned UCSF Cardiovascular Research Institute, known as CVRI, and will be home to a new UCSF Center for Prevention of Cardiovascular Disease with an outpatient facility that will focus on advancing ways to predict and prevent these devastating illnesses. Cardiovascular diseases are the leading cause of death and disability in the United States, accounting for roughly 950,000 deaths each year, and are expected to increase as the population ages. Those diseases include heart attack, stroke and peripheral vascular disease, as well as asthma, cystic fibrosis and other pulmonary conditions.
Intrinsa, Patch 'to boost female sex drive'
Intrinsa will only be available on prescription for women who have had an early menopause because of surgery. It is the first treatment for women with low sex drive. About a million women in the UK have had an early menopause because of surgery to remove their ovaries during hysterectomy for conditions such as heavy bleeding and pelvic pain, Procter and Gamble said. This procedure leads to a decrease in testosterone, a naturally occurring hormone in women which is a key mediator of sexual desire. A third of these women end up suffering from low sexual desire and will be entitled to the treatment on prescription. Intrinsa is a clear patch worn on the abdomen, which delivers a low dose of testosterone.
Clinical Study in India
The Institute for OneWorld Health, a US-based non-profit pharmaceutical company that develops drugs for people with neglected diseases in the developing world, today announced the selection of Odyssey Research, a Bismarck, North Dakota-based clinical trial management organization (TMO) with offices in New Delhi, India, to support its upcoming Phase 4 pharmacovigilance and access study of Paromomycin Intramuscular (IM) Injection for the treatment of visceral leishmaniasis (VL) in India. With approximately 500,000 new cases occurring annually, visceral leishmaniasis, also known as kala-azar or black fever, is the world’s second most deadly parasitic disease following malaria. Odyssey Research will perform regular monitoring of seven clinical sites for the pharmacovigilance module in the Phase 4 study. The study, scheduled to begin later this year, will be conducted in the state of Bihar, India.
Gland Pharma Limited, the Hyderabad, India-based drug manufacturer, working in collaboration with OneWorld Health, received regulatory approval from the Drug-Controller General - India (DCGI) for Paromomycin IM Injection as a treatment for VL on August 31, 2006.
Biotech in India
International Service for the Acquisition of Agri-biotech Applications (ISAAA) reported on February 20, 2007 (checkbiotech.org) that India is fast evolving as a leading biotech region in Asia, outshining China for the first time in terms of total hectare land planted with biotechnology seeds. In 2006, India’s area planted with biotech cotton grew triple-fold (India’s first commercialized biotech crop) from the last year. The total biotech hectare in India now stands at an impressive 3.8 million as against 3.5 million in China.
Quality seeds with good biotechnology are making the rise in productivity of Indian cultivators stronger. After biotech cotton, the next major crop to be traded in the Asian market will be ‘golden rice’. This variety of rice is fortified with Vitamin A - essential for vision, and the intestinal, urinary, and respiratory tracts. The biotech development is immensely important for agriculture as a whole as researchers search for ways to make a variety of crops better. Biotechnology is an important tool being rapidly adapted and used by farmers in developing countries and is greatly influencing the countries’ development and thereby, their economy.
Asian cultivators have adopted GM (genetically modified) crops that are insect-resistant, pest-resistant, and have many other additional benefits. Countries like India are making huge investments in the research of agricultural biotechnology to meet their surging needs for food, fuel, and fiber. India is expected to develop a national chain of research laboratories by infusing $80 Million in 2007. According to the RNCOS report “Indian Biotechnology Market Outlook (2006)”, biotech will greatly influence the Indian agriculture sector by developing a large number of GM seeds. Amplifying at the rate of 28.09% from 2005, the Indian biotech industry is believed to reach the level of US$ 5 Billion.
Crestor and Torcetrapib
AstraZeneca PLC's Crestor cholesterol drug slowed thickening in the neck arteries of people at low risk for heart attacks and strokes, but it failed to reverse thickening as researchers had hoped for. Thickening of arterial walls is a precursor to plaque buildup, which can lead to heart attacks and strokes. Crestor is approved primarily to reduce levels of bad cholesterol.
While Cleveland Clinic researchers report that the Pfizer's drug torcetrapib, despite raising high density lipoprotein cholesterol (HDL) or the "good" cholesterol by more than 60%, did not slow the progression of plaque buildup in the coronary arteries as measured using an ultrasound probe. All development of this drug was terminated on Dec. 2, 2006 after the safety board monitoring a separate large clinical outcomes trial reported that torcetrapib increased the risk of death and other adverse cardiovascular outcomes.
China Market
China possesses a fourth of the population in the world and has one of the largest drug markets round the world. By 2006, sales on the Chinese drug market have reached $12 billion dollars, an increase of 3.8 fold over 1998 level. A series of factors, such as an increasingly ageing population, accelerating growth of urban population as well as expansion of healthcare covering urban and rural, will grow the Chinese drug market with a growth rate of 20-25 percent per annum in next five years. China is expected to become the fifth largest drug market in the world by 2010.
Ranbaxy's Zolpidem Tartrate
Ranbaxy Laboratories Limited (RLL), announced today that the Company has received tentative approval from the Food and Drug Administration to manufacture and market Zolpidem Tartrate Tablets, 5mg and 10mg. The Office of Generic Drugs, U.S. Food and Drug Administration, has determined the Ranbaxy formulations to be bioequivalent and to have the same therapeutic effect as that of the reference listed drug Ambien(R) Tablets 5mg and 10mg of Sanofi Aventis US, LLC. The products will be manufactured at the company's Ohm Laboratories Inc. facility, based in North Brunswick, New Jersey. Total annual market sales for Zolpidem Tartrate Tablets were USD 2.12 Bn (IMS: Dec. 2006).
Food security
"The rice genebank is not just a scientific exercise in seed genetics," said Robert Zeigler, director-general of the IRRI, "but a major hedge against disaster that ensures farmers throughout the world will always have the rice varieties they need to maintain food security." For example, when waves swept ashore during the Asian tsunami in 2004, many rice crops were destroyed. IRRI used its collection to provide farmers whose land had been contaminated with seawater with varieties able to grow in salty soils. Dr Zeigler said securing long-term funding for the genebank was a welcomed exception in an uncertain world.
"Rice diversity, like all crop diversity, is at risk for the want of relatively small amounts of money," he observed. "Given that we are talking about the biological base of the global food supply, it is extraordinary that the current situation is so precarious." The Global Crop Diversity Trust, an international organisation with the responsibility of ensuring the "conservation of crop diversity in perpetuity", is also in the process of constructing a "doomsday vault" that will house samples of all the world's important food crops. The vault, which is being built into a mountainside on a remote island within the Arctic Circle, is designed to safeguard crucial agricultural resources from future catastrophes such as nuclear war, asteroid strikes and climate change.
Protecting Diversity
Two leading food crop research groups have signed a deal to ensure the long-term survival of the world's largest repository of rice varieties. The Genetic Resources Center, based in the Philippines, houses 100,000 rice samples in a disaster-proof facility. The Global Crop Diversity Trust and the International Rice Research Institute (IRRI) will provide the center with $600,000 (£311,000) each year. An estimated three billion people depend upon rice as their main food.
The money would go towards acquiring any rice varieties not currently housed in the IRRI-owned center, and ensuring the storage systems were robust to withstand disasters such as earthquakes and fires. Under the agreement, IRRI has pledged to invest $400,000 (£207,000) each year, while the Trust has promised to provide a further $200,000 (£104,000) in the form of an annual conservation grant.
Source: The primary sources cited above, BBC News, New York Times (NYT), Washington Post (WP), Mercury News, Bayarea.com, Chicago Tribune, USA Today, Intellihealthnews, Deccan Chronicle (DC), the Hindu, Hindustan Times, Times of India, AP, Reuters, AFP, womenfitness.net etc.
Notice: The content of the articles is intended to provide general information. Specialist advice should be sought about your specific circumstances.
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