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Biotech / Medical : Kos Pharmaceuticals, Inc (KOSP) -- Ignore unavailable to you. Want to Upgrade?

To: IRWIN JAMES FRANKEL who wrote (108)	4/27/2005 1:31:47 PM
From: tuck	Respond to of 118

>>WOODCLIFF LAKE, N.J., April 27 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. (NYSE: BRL - News) today announced that its subsidiary, Barr Laboratories, Inc., has received final approval from the U.S. Food & Drug Administration (FDA) for its generic version of Kos Pharmaceutical, Inc.'s (Kos) Niaspan® 500 mg, 750 mg and 1000 mg Extended-Release Tablets (Niacin Extended-Release Tablets). The final approval follows the expiration of Kos' 30-month stay under the Hatch-Waxman patent challenge provisions and the resolution of the litigation between Barr and Kos regarding the Niaspan products. On April 13, 2005 Barr and Kos announced that they had entered in to Settlement and License, Co-Promotion, and Licensing and Manufacturing Agreements relating to the resolution of the patent litigation involving Kos' Niaspan products. Under the terms of the Settlement and License Agreement, Barr is permitted to launch generic versions of Niaspan and Advicor, as well as future dosage formulations, strengths or modified versions of the Products, under terms of an exclusive license commencing on September 20, 2013, approximately four years earlier than the last-to-expire Kos patent. In a separate License and Manufacturing Agreement, Barr agreed to stand ready to supply Kos Life Sciences, Inc. quantities of Niaspan 500 mg, 750 mg and 1000 mg Extended- Release Niacin Tablets and Advicor 500 mg/20 mg, 750 mg/20 mg and 1000 mg/20 mg Extended Release Niacin/Lovastatin Tablets, under or pursuant to the approval of Barr's Abbreviated New Drug Applications (ANDAs). Niacin Extended-Release Tablets, 500 mg, 750 mg and 1000 mg are approved for use as an adjunct to diet and other non-pharmacologic measures for reduction of elevated cholesterols in patients when the response to an appropriate diet and other non-pharmacologic measures has been inadequate. Cases of severe hepatic toxicity have occurred in patients who have substituted extended release tablets for immediate release tablets. Liver disease or patients who use substantial quantities of alcohol may preclude use. Niaspan 500 mg, 750 mg and 1000 mg Extended-Release Tablets had annual sales of approximately $403 million for the twelve months ended February 2005, based on IMS sales data.<< snip Cheers, Tuck