Drug maker Merck & Co (MRK) is pulling plans to introduce an antiobesity drug.
The New Jersey based company announced it is halting development of taranaband, an experimental drug to fight obesity, because of side effects found in clinical trials.
Taranabant is part of a class of once-promising antiboesity drugs known as cannabinoid-1 receptor inverse anonists or antagonists, or CB-1 receptor antagonist, which are designed to block the brain receptors that tell us when we are hungry. It’s the same area that triggers hunger in people when they smoke marijuana.
Even while Merck told analysts it planned to file for approval from the FDA in 2008, reports of psychiatric events were occurring. The company hoped it could balance the correct effective dosage while minimizing side effects. The higher the dose, the more effective the drug is in helping people lose weight, but the higher dosage also creates more side effects.
Because of the side effects and the likelihood the FDA would not approve the drug, Merck is stopping five current patient studies.
In 2007, rimonabant, a drug made by Sanofi-Aventis (SNY) also met resistance from an FDA advisory committee which recommended against approval because of psychiatric side effects. Sanofi later withdrew its application for approval.
Pfizer Inc. (PFE) has a CB-1 receptor antagonist currently in production.
The FDA has approved two weight-loss drugs for long term use, Xenical (Roche Holding AG’s) and Meridia (Abbott Laboratories’). Short term treatment for weight loss include alli ( GlaxoSmithKline) and phentermine and diethylpropion.
Merck had counted on taranabant to potentially deliver $500 million a year in sales by 2012.
This setback hurts Merck’s attempt to get new drugs onto the market before generic competition hurts sales of existing drugs. Earlier this year Merck lost FDA approval for a cholesterol drug.
Gardasil, the cervical cancer vaccine for girls, has seen sales show. The Wall Street Journal reports that shares of Merck are off more than 40 percent year to date. #