Pharmacia K.K. and Yamanouchi Pharmaceutical Co. Ltd have submitted a New Drug Application (NDA) to the Japanese Ministry of Health, Labor and Welfare for celecoxib (designated as YM177 in Japan) for several indications including the treatment of rheumatoid arthritis (RA) and osteoarthritis (OA).

Developed by Pharmacia Corporation in the United States, celecoxib is the first coxib anti-inflammatory agent to interfere with the production of prostaglandin and other chemicals involved in inflammation by selectively inhibiting COX (cyclooxygenase)-2 enzyme. First launched in the U.S. in 1999 and marketed in over 85 countries as Celebrex or Celebra, celecoxib is the number one selling brand of prescription arthritis medication with global sales of $3.1 billion in 2001.

In Japan, Pharmacia K.K. and Yamanouchi jointly developed celecoxib. After receiving regulatory approval, the two companies will co-promote celecoxib with a single brand name while Pharmacia K.K. will import bulk material and Yamanouchi will manufacture and distribute the finished product.

The existence of two enzymes called COX-1 and COX-2 in the human body was first hypothesized in 1989. COX-1 helps regulate normal cell function in the stomach and blood. COX-2 plays a role in arthritis pain and inflammation. By acting on both COX-1 and COX-2 enzymes, conventional nonselective non-steroidal anti-inflammatory drugs (NSAIDs) have often been associated with upper gastrointestinal adverse effects. Celecoxib is the first coxib product to target only the COX-2 enzyme.

According to the Japanese Health Ministry, there are more than 700,000 RA patients in Japan and the prevalence of OA among chronic arthritis is on the rise due to rapid aging of the population.