News Releases

May 31, 2004

Licensing of "Licofelone" from Merckle

Sumitomo Pharmaceuticals, Co., Ltd. announces the concluding on May 28 of a license agreement with Merckle GmbH (Ulm, Germany) for the anti-arthritis agent Licofelone (generic name), which provides Sumitomo Pharmaceuticals with the rights to develop and market Licofelone in Japan.

Licofelone is an anti-arthritis agent currently undergoing Phase III clinical trials by Merckle in Europe. Because it is deemed to protect the arthrodial cartilage, a function not found in nonsteroidal anti-inflammatory drugs (NSAIDs), including COX-2 (cyclooxygenase-2) selective inhibitor, the compound may become a new treatment drug for osteoarthritis. On the assumption that Licofelone will prove to be an anti-arthritis agent with a new active mechanism, and so make its own contribution to the treatment of osteoarthritis, Sumitomo Pharmaceuticals has decided to develop and launch the drug in Japan at the earliest possible date.

NSAIDs are used in Japan to treat 3.9 million patients for osteoarthritis, lumbago, cervicobrachial syndrome, and periarthritis scapulohumeralis.

In the bone-disorder and anti-inflammatory drug lines, Sumitomo Pharmaceuticals markets the Inteban (indomethacin) anti-inflammatory drug series and a Didronel (etidronate) osteoporosis treatment, and is currently developing an antirheumatic compound (SMP-114). The addition of Licofelone will make the pipeline for anti-inflammatory products, our priority therapeutic area, even more attractive.

Sumitomo Pharmaceuticals will begin efficacy and safety clinical trials for Licofelone in order to obtain new drug approval at the earliest possible date.

About Merckle GmbH

Managing Director : Dr. Philipp Merckle
Headquarters : Ulm, Germany
Established : 1881
Net sales : 52.6mil Euro (2003 in Germany)
Employees : 1,738 (2003)
Line of business : Manufacture and sale of new medical products