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Celecoxib tabs to be launched in Japan

Tokyo, JapanTuesday, June 12, 2007, 08:00 Hrs  [IST]

Astellas Pharma Inc. and Pfizer Japan Inc. announced that their selective COX-2 inhibitor Celecox (generic name: celecoxib), a non-steroidal anti-inflammatory drug (NSAID), will become available in Japan on June 12, 2007, with the indication of "relief of inflammation and pain associated with rheumatoid arthritis (RA) and osteoarthritis (OA)". Discovered by Pfizer Inc. in the United States, celecoxib is the first anti-inflammatory agent that is designed to selectively inhibit COX-2 enzyme and thereby specifically reduces the production of prostaglandin, a chemical agent involved in inflammation. First launched in the US in 1999, celecoxib has been marketed in over 100 countries and prescribed to over 31 million patients as CelebrexR or Celebra. Astellas and Pfizer jointly developed and have obtained marketing approval for Celecox in Japan to be prescribed for relief of inflammation and pain of RA and OA in January 2007. According to the agreements for Celecox, Pfizer will import active ingredients and Astellas will manufacture and distribute the product, which will be co-promoted by Astellas and Pfizer. Astellas and Pfizer will provide and gather information to and from physicians and/or medical institutions in order to pursue appropriate use with particular emphasis. It was revealed in 1991 that cyclooxygenase has two different subtypes, COX-1 and COX-2, in the human body and that COX-1 takes part in protection of the gastrointestinal mucosa, while COX-2 is involved in inflammation and pain. Upper gastrointestinal adverse event reported for conventional non-selective NSAIDs is thought to be the consequence of inhibiting both COX-1 and COX-2 enzymes. Celecoxib is the first selective COX-2 inhibitor developed and marketed worldwide expecting to provide therapeutic benefit while avoiding GI effect. Celecoxib exhibits proven efficacy for RA and OA with twice-daily dose. Astellas and Pfizer are confident that Celecox will contribute to the RA and OA patients in Japan as a new treatment option. Astellas Pharma Inc., located in Tokyo, Japan, is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. In April 2005, the company was formed through the merger of Fujisawa Pharmaceutical Co., Ltd. and Yamanouchi Pharmaceutical Co., Ltd. The organization is committed to becoming a global mega pharmaceutical company by combining outstanding R&D and marketing capabilities and continuing to grow in the world pharmaceutical market.

 
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