# Novartis Pushes Ahead On Pipeline Snags



## Jeffrey Roberts (Apr 15, 1987)

http://www.forbes.com/2001/11/02/1102nvs.h...yahoo&referrer= Pharmaceuticals Novartis Pushes Ahead On Pipeline Snags Matthew Herper, Forbes.com, 11.02.01, 2:15 PM ET NEW YORK - After getting its cancer drug Gleevec through the U.S. Food and Drug Administration (FDA) in record time, Novartis has hit regulatory snags on two other potential blockbusters: Zelnorm, for irritable bowel syndrome, and Xolair, an asthma treatment developed with South San Francisco-based Genentech, the first and one of the most well-regarded biotechnology companies. Recent stock performance In the past two days, Novartis (nyse: NVS - news - people) has quietly released new information about both medications, set a new timetable for getting Xolair approved and published new data on Zelnorm. In June, the FDA had sent the company a "not approvable" letter regarding Zelnorm, saying that further studies would need to be conducted before it could be approved. The long path both drugs are taking toward approval enforces a sense held by many who watch the drug industry that regulators, who are normally understandably fussy about whether a compound is safe and effective, are being even slower and more cautious than usual. Originally, Genentech (nyse: DNA - news - people) and Basel, Switzerland-based Novartis expected to introduce Xolair this year. The two firms submitted an application to the FDA way back in June 2000, but a July 2001 letter sent in reply asked for more data. Although Novartis and Genentech say their discussions with the FDA have been "productive," an amendment answering regulators' concerns won't be submitted until the end of 2002. Xolair is a biological compound, called a monoclonal antibody, that attaches itself to immunoglobin E, one of the body's defensive weapons that goes into overdrive in allergy patients. If approved, the treatment would be injected into adult sufferers of allergies and asthma. Zelnorm, formerly known as Zelmac, treats irritable bowel disorder (IBS)--a combination of constipation, stomach pain and other severe symptoms that affects up to 15% of the population, mostly women. A paper published in the scientific journal Alimentary Pharmacology & Therapeutics indicates that the drug provides rapid and sustained relief to the abdominal pain and constipation that accompany the disease. "This study provides further evidence that Zelnorm is a safe and effective treatment for IBS patients, who suffer with abdominal pain, bloating and constipation," said John F. Johanson, M.D., Clinical Associate Professor of Medicine, University of Illinois College of Medicine, in a prepared statement. "We hope that this important new therapy will soon be available to the millions of Americans who suffer with IBS and without effective treatment." Zelmac, a chemical discovered in the 1980s by chemists at what is now Novartis, almost didn't make it to the FDA. Clinical research staff balked at large-scale trials, but the drug caught the eye of Novartis Chief Executive Dan Vasella. Now, we'll see if Vasella's faith in the product was justified.


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