DARA BioSciences, Inc., a specialty pharmaceutical company,  has entered into an exclusive US agreement with Candiac based Uman Pharma Inc. for commercial rights to gemcitabine, DARA's second newly licensed anticancer agent.

In 2010, gemcitabine generated branded (GEMZAR-Eli Lilly) sales of $780 million, according to IMS data. It went off patent in 2011 in the US, and a year earlier in Europe. The drug is widely prescribed as first-line therapy for ovarian, breast, lung, and pancreatic cancers.

David J Drutz, MD, DARA's president and chief executive officer, stated, “The exclusive agreement with Uman Pharma for rights to commercialize this chemotherapeutic drug in the United States leverages DARA's existing cancer drug development programme, provides DARA with an additional commercial opportunity and further establishes a platform for adding other cancer and cancer-support products through ongoing licensing efforts. We believe there is considerable upside potential in the generic, sterile injectable cytotoxic therapies market.”

Last month, DARA acquired exclusive US rights to market Soltamox (licensed from Rosemont Pharmaceuticals Ltd.), the only oral liquid formulation of tamoxifen for breast cancer patients who have difficulty swallowing tablet formulations or simply prefer a liquid form of the widely prescribed hormone blocking therapy. DARA is targeting strategic oncology therapies and supportive care products as part of its strategic direction in the cancer market.

By partnering with Uman, a fully-integrated pharmaceutical company, DARA has aligned itself with a company that has the expertise and capability to provide cGMP-produced products for worldwide markets. DARA and Uman are working to identify future partnership opportunities for additional sterile injectable products in the oncology market.

Uman plans to file an Abbreviated New Drug Application (ANDA) for gemcitabine with the US Food and Drug Administration (FDA) later this year.

Uman Pharma is a global pharmaceutical company based in, and strengths lies in the development and manufacturing of cytotoxic and high potent sterile injectables for the oncology market.

DARA is a specialty pharmaceutical company focused on the development and commercialization of oncology treatment and supportive care products.