Conforma Therapeutics Corporation and Sumitomo Pharmaceuticals Co., Ltd. (Osaka, Japan) have reached a licensing agreement for Amrubicin HCl (Amrubicin), a third-generation, totally synthetic anthracycline anti-cancer drug.

Conforma has obtained exclusive rights, including sublicensing rights, to develop and market Amrubicin in North America and Europe. Amrubicin is currently approved and marketed in Japan for small-cell and non-small-cell lung cancer (under the brand name Calsed). Sumitomo will manufacture the product for worldwide distribution. Financial terms of the agreement were not disclosed.

Amrubicin has demonstrated better clinical results and pre-clinical results in Japan, leading to its marketing approval in December 2002. Conforma plans to initiate Phase 2 trials in the United States and Europe in early 2006.

Robert De Jager, vice president, clinical research and development and chief medical officer of Conforma says, "Pre-clinical and clinical data suggest that Amrubicin is not only more active than traditional anthracyclines but also appears to be free of the cumulative cardiotoxicity which has limited the utility of this class of drugs."

Conforma plans to investigate Amrubicin initially in small-cell lung cancer in the United States and Europe, and then expand to additional oncology indications. More than 60,000 new cases of small-cell lung cancer are diagnosed each year in the United States and Europe. Lung cancers are the primary cause of cancer deaths world wide and effective treatment options for these patients remains a major unmet need.