Generic copies of selective COX-2 inhibitor Celecox (generic name: celecoxib), a non-steroidal anti-inflammatory drug (NSAID), was recently launched in the Japanese market.
Discovered by Pfizer Inc in the United States, celecoxib is the first anti-inflammatory agent that is designed to selectively inhibit COX-2 enzyme, reducing the production of prostaglandin, a chemical agent involved in inflammation. First launched in the U.S. in 1999, celecoxib has been marketed in over 100 countries and prescribed to over 31 million patients as CelebrexR or Celebra(R).
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. As per the terms and conditions of the agreement, Pfizer will import active ingredients, while Astellas will manufacture and distribute the product. However, the product will be co-promoted by both the companies.
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. The companies said that they are confident that celecox will contribute to the RA and OA patients in Japan as a new treatment option.
Earlier, in 1991, it was revealed that cyclooxygenase has two different subtypes, COX-1 and COX-2, in the human body. While COX-1 takes part in protection of the gastrointestinal mucosa, 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.
The drug will carry an indication of 'relief of inflammation and pain associated with rheumatoid arthritis (RA) and osteoarthritis (OA)'.