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Astellas Pharma seeks Japan's nod for additional indication for Celecox.

M2 PHARMA-March 30, 2011-Astellas Pharma seeks Japan's nod for additional indication for Celecox(C)2011 M2 COMMUNICATIONS

30 March 2011 - Japanese Astellas Pharma Inc (TYO: 4503) and Pfizer Japan Inc, part of US Pfizer Inc (NYSE: PFE), said today that Astellas has submitted a supplemental new drug application to Japan's Ministry of Health, Labour and Welfare (MHLW) seeking an approval for the indication of anti-inflammatory and analgesic effects in post-operation, post-trauma, and post-tooth extraction for the selective cox-2 inhibitor Celecox (celecoxib).

Originally developed by Pfizer Inc, Celecox is the first COX (cyclooxygenase)-2 targeting anti-inflammatory agent to interfere with the production of prostaglandin and other chemicals involved in inflammation by selectively inhibiting COX-2 enzyme.

Inflammation and pain in post-operation, post-trauma, and post-tooth extraction is typical condition of acute pain. Celecox selectively inhibits COX-2 enzyme which is involved in inflammation and pain and therefore is expected to be a non-steroidal anti-inflammatory drug (NSAID) with preferable efficacy and safety, the parties said.

In Japan, Celecox was launched for the indication of relief of inflammation and pain associated with rheumatoid arthritis (RA) and osteoarthritis (OA) in June 2007. Subsequently, relief of inflammation and pain associated with lumbago, scapulohumeral periarthritis, cervico-omo-brachial syndrome, and tendinists/tendosynovitis were approved as additional indications in June 2009.

For marketing of Celecox in Japan, Pfizer imports the active pharmaceutical ingredient and Astellas manufactures and distributes the finished products. Promotion is undertaken jointly by the both companies.

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Publication:M2 Pharma
Geographic Code:9JAPA
Date:Mar 30, 2011
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