ASTELLAS, PFIZER GAIN JAPANESE APPROVAL FOR CELECOX, REVISE LIPITOR AGREEMENT

Astellas Pharma and Pfizer Japan have announced they have received Japanese regulatory approval for Celecox, a non-steroidal anti-inflammatory drug, for treating the pain and inflammation of rheumatoid arthritis and osteoarthritis.

Celecox (celecoxib), a Cox-2 inhibitor, is marketed elsewhere as Celebrex and Celebra. It was first introduced in the U.S. in 1999. The companies will announce the launch date of the drug once the pricing schedule is decided.

Astellas and Pfizer also announced they have reached a settlement regarding their marketing agreement for the cholesterol drug Lipitor (atorvastatin calcium). In Japan Astellas manufactures Lipitor, and the two companies jointly promote the drug.

Astellas had filed a declaratory judgment action to confirm that the term of the agreement will continue until 2016, when the last Lipitor patent expires, rather than 2011, when the substance patent expires. The companies decided that the agreement will extend through 2016, with no other changes. Pfizer and Astellas "are committed to the marketing and promotion of Lipitor in Japan with a renewed focus," the companies said in their release.