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Replies to #94623 on Biotech Values
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genisi

05/05/10 11:46 AM

#95278 RE: Do DD #94623

KG/ACUR - no more niacin:

King Pharmaceuticals and Acura Pharmaceuticals Announce Plans to Submit an NDA for Acurox(R) Tablets Without Niacin

http://finance.yahoo.com/news/King-Pharmaceuticals-and-iw-4202527499.html?x=0&.v=1

Submission Targeted for Early 2011

BRISTOL, TN and PALATINE, IL--(Marketwire - 05/03/10) - King Pharmaceuticals, Inc. (NYSE:KG - News) and Acura Pharmaceuticals, Inc. (NASDAQ:ACUR - News) today announced that the Companies plan to develop and submit a New Drug Application (NDA) for Acurox® (oxycodone HC1) Tablets (without niacin) intended to relieve moderate to severe pain and introduce limits and impediments to potential abuse via nasal snorting of crushed tablets and intravenous injection of dissolved tablets. At an April 22, 2010 joint Advisory Committee meeting, the U.S. Food and Drug Administration (FDA) questioned the effectiveness of niacin included in the current Acurox® formulation but cited no concerns with the snorting and intravenous abuse limiting features of the product. The Companies expect to submit an NDA for Acurox® Tablets (without niacin) in early 2011.

The Companies also plan to develop and submit NDAs for two additional immediate release opioid analgesic products utilizing Acura's proprietary Aversion® Technology; Vycavert® (hydrocodone bitartrate/acetaminophen) Tablets and Acuracet® (oxycodone HCl/acetaminophen) Tablets. Like Acurox®, these additional product candidates are patent protected compositions comprising a mixture of active and inactive ingredients intended to relieve pain and introduce limits and impediments to nasal and intravenous abuse.