New Class of Drugs Fights Alzheimers
A new study suggests that a class of drugs called gamma-secretase modulators shows potential for treating Alzheimer's disease. A hallmark of Alzheimer's is so-called amyloid plaque, which develops tangles in the brain. The gamma-secretase modulators reduce the production of long pieces of amyloid beta protein that stick together and form clumps. At the same time, the drugs increase the production of shorter amyloid beta that blocks longer amyloid beta from sticking together.
Dr. Todd E. Golde, an associate professor at the Mayo Clinic Department of Neuroscience, in Jacksonville, Florida, said, “We have discovered a novel mechanism of action for a class of drugs that are currently being tested as Alzheimer's disease therapeutics.” These new drugs do not work in the same way that many other drugs do. Sometimes we think of drugs as magic bullets targeting a single entity, but this drug, by the way it works, could have three consequences that could have a benefit for Alzheimer's disease.
Dr. Golde stated, “This finding could tell us how drugs for Alzheimer's disease already in clinical trials may be working. One of the modulator drugs, tarenflurbil (Flurizan) was in a just-completed phase II clinical trial and the results should be available this summer.
One expert thinks the new research could produce a drug that could fight the development of amyloid plaque in two ways. Dr. Sam Gandy, chairman of the Alzheimer's Association's National Medical and Scientific Advisory Council, said, “This is interesting and unexpected. It might be possible to design or identify compounds that both modulate generation of amyloid beta and at the same time modulate accumulation of amyloid beta.”
Until now, anti-amyloid drugs have fallen into three broad classes: immunotherapies, anti-aggregation compounds, and secretase modulators. The new work suggests that there exist single drugs that possess both of the latter two activities, thereby supplying an anti-amyloid double whammy.
Source: Health Day News, June 11, 2008
Americans Have to Wait Until 2011
for Generic Lipitor
Generic versions of the cholesterol drug Lipitor will not be available in the United States until November 30, 2011, under the terms of a patent dispute agreement reached between Pfizer, Inc. and Ranbaxy Laboratories Ltd. of India.
Ian Read, president of worldwide pharmaceutical operations for Pfizer, said, “The agreement provides patients with access to a generic product much earlier than if Ranbaxy were unsuccessful in obtaining approval for its product and overcoming the relevant patents.”
Along with giving more certainty to the timing of generic versions of Lipitor, the agreement gives Pfizer more time to develop replacements for Lipitor before generic versions of the drug go on the market.
The deal also permits Ranbaxy to sell generic versions of Lipitor in Australia, Belgium, Canada, Germany, Italy, the Netherlands and Sweden. Pfizer and Ranbaxy also resolved conflicts over Lipitor in Brunel, Malaysia, Peru and Vietnam.
The two companies are still involved in patent infringement litigaton over Lipitor in Denmark, Finland, Portugal, Romania and Spain.
Source: Health Day News, June 18, 2008
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Lupin Receives FDA Approval for
Topiramate Tablets
Lupin Pharmaceuticals announced it has received tentative approval for the Company’s abbreviated New Drug Application (ANDA) for Topiramate tablets, 25mg, 50mg, 100mg and 200mg from the US FDA.
Lupin’s Topiramate tablets are the AB-rated generic equivalent of Ortho-McNeil’s TOPAMAX® tablets, indicated for the treatment of seizures. The brand product had annual sales of approximately $2.2 billion for the twelve months ended March 2008, based on IMS Health sales data.
Commenting on the approval, Vinita Gupta, President and Managing Director of Lupin Pharmaceuticals, Inc. said, “Lupin is pleased to receive this approval that will enable the company to offer Topiramate tablets as an affordable generic alternative that will have a measurable impact on the U.S. healthcare system.”
The product will be introduced in the market through LPI’s strong network of national wholesalers and drug stores post patent expiry in September 2008. This will strengthen Lupin’s presence in the CNS segment.
Source: PRNewswire, May 30, 2008
Wyeth Receives FDA Approval for TYGACIL
Wyeth Pharmaceuticals, a division of Wyeth, announced that the US FDA issued an approval letter for the first-in-class antibiotic TYGACIL(R) (tigecycline) for the treatment of adult patients with community-acquired pneumonia (CAP).
Before granting approval, the FDA requiested that Wyeth provide additional analyses to support the safety and efficacy of TYGACIL for the treatment of patients with CAP with illness severe enough to require hospitalization, including those who are at higher risk of mortality. The FDA requested information regarding the benefit/risk of TYGACIL for any potential of liver toxicity.
Gary L. Stiles, Executive Vice President, Chief Medical Officer, Wyeth Pharmaceuticals, stated, “We believe the data from our current clinical development program support TYGACIL as a potential therapeutic option for patients with CAP. Wyeth is committed to working with the FDA to resolve the outstanding issues for TYGACIL in order to gain approval.”
TYGACIL was approved by the FDA in June 2005 for the treatment of adult patients with complicated intra-abdominal infections and complicated skin and skin surface infections. Wyeth has achieved significant success in bringing new products to market.
CAP is defined as pneumonia acquired outside a hospital or long-term care facility. It is an infection of the lungs that results in decreased ability to function normally. Although pneumonia is not a reportable illness, it appears that up to 5.6 million cases of community-acquired pneumonia occur annually.
Source: PRNewswire, May 29, 2008
NEWS UPDATE: Indian Congressman calls
for stop to clinical trials.
News that 49 infants died during clinical trials in India has sparked anger among the nation’s congress, with some calling for all studies to be stopped while investigations take place despite the trials having an infant mortality rate (IMR) below the national average.
Look for a full update on this development in our next edition.
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