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REPORTERS Notebook

9/24/2007

Supplier News—Eisai has joined in a co-promotional deal with Salix Pharmaceuticals that gives them exclusive rights to co-market two ulcerative colitis drugs. The drugs are Colazal 750 mg capsules and 110 mg tablets, which are pending approval from the Food and Drug Administration.

Colazal is used for the treatment of mildly to moderately active ulcerative colitis in patients five years of age and older. “We are pleased to be working with Salix to co-promote Colazal, an important treatment for patients with ulcerative colitis,” said Lonnel Coats, president and chief operating officer for Eisai.

Salix submitted an application to the FDA in July to gain approval for an 110 mg tablet version of Colazal.

Eisai had sales of approximately $2.6 billion in its fiscal year 2006, which ended March 31.

The Food and Drug Administration recently approved generic Coreg for manufacturing. The generic, carvedilol will be available in all forms of the brand, which include, 3.125 mg, 6.25 mg, 12.5 mg and 25 mg. Coreg is used to treat high blood pressure, mild to severe chronic heart failure and left ventricular dysfunction following a heart attack.

The following companies received approval to manufacture the product: Zydus, Watson, Teva, Taro, Sandoz, Actavis, Apotex, Aurobindo, Dr. Reddy’s, Caraco, Lupin, Glenmark, Ranbaxy and Mylan.

Coreg was the 30th-best selling brand-name drug in 2006.

Pfizer and the Food and Drug Administration have found a potential human carcinogen in Pfizer ’s AIDS drug Viracept.

Tests detected during manufacturing found the presence of ethyl methane-sulfonate, which is a potential human carcinogen that may cause cancer and birth defects in animals; for humans, no data yet exists.

“Pfizer is working with the FDA to prospectively limit EMS levels in Viracept, while still considering the immediate needs of patients on therapy,” a company statement said.

Viracept is a key component of many drug cocktails used to suppress the HIV virus.

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