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Biotech / Medical : ANDRX (ADRX) -- Ignore unavailable to you. Want to Upgrade?

To: PAUL ROBERT ST. ONGE who wrote (53)	4/20/1998 7:19:00 PM
From: Jolie Renee	Read Replies (1) \| Respond to of 127

Monday April 20, 11:33 am Eastern Time Andrx FDA filing on top-selling ulcer drug FORT LAUDERDALE, Fla., April 20 (Reuters) - Andrx Corp. (ADRX - news) said Monday that its filing for an Abbreviated New Drug Application (ANDA) for a bioequivalent version of Prilosec has been accepted by the U.S Food and Drug Administration (FDA). In response, Swedish drug company Astra AB, the maker of Losec, which is sold in the United States under the brand name Prilosec, said it was considering legal action against Andrx for patent infringement of its top-selling anti-ulcer drug. Prilosec, a leading treatment of ulcers and gastroesophogeal reflux disease (GERD), was the No. 1 selling drug in the United States in 1997, with sales of about $2.3 billion. Its worldwide sales were roughly $4 billion. The drug is marketed in the United States by a joint venture of Astra and New Jersey-based Merck & Co Inc. (MRK - news). In a statement, Andrx said its product infringes the patent on omeprazole, the active ingredient in Prilosec. But the patent is due to expire in April 2001 and Andrx said it has no plans to market the product until the patent expires. In a statement, Andrx said it expected that any legal challenges to its product would be resolved before the expiration of the patent in three years. The company said it believes that its FDA filing for Prilosec was the first to be submitted to the U.S. agency for certification and that, as a result, its product should be entitled to 180 days of marketing exclusivity once its product is ready for sale. Andrx said its formulation of a version of Prilosec was developed using the company's patent-pending Stabilized Pellet Delivery System (SPDS). The company said its success in creating a bioequivalent form of Prilosec allows it to showcase the effectiveness of its underlying drug delivery technology.