RALEIGH, N.C., Feb. 15, 2012 (GLOBE NEWSWIRE) -- DARA BioSciences, Inc. (Nasdaq:DARA) announced today that it entered into an exclusive U.S. agreement with 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 U.S., 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 program, 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 U.S. 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 U.S. Food and Drug Administration (FDA) later this year.
About Uman Pharma
Uman Pharma is a global pharmaceutical company based in Candiac, on the south shore of Montreal, Canada. Its strengths lie in the development and manufacturing of cytotoxic and high potent sterile injectables for the oncology market. Uman has been inspected by the FDA and anticipates approval for its first product for distribution in the U.S. in the first half of 2012.
About DARA BioSciences, Inc.
DARA is a specialty pharmaceutical company focused on the development and commercialization of oncology treatment and supportive care products. DARA sharpened its focus in oncology through its January 2012 acquisition of Oncogenerix, Inc., which holds the exclusive U.S. marketing rights to Soltamox®. Soltamox® is a novel oral liquid formulation of tamoxifen, a product used widely in the treatment and prevention of breast cancer. Soltamox® is the only FDA-approved oral liquid version of tamoxifen and fulfills a vital clinical need for patients who cannot tolerate existing tablet formulations of this drug. DARA plans to begin marketing Soltamox in the U.S. in the third quarter of 2012.
Prior to acquiring Oncogenerix, DARA was focused on the development of a cancer-support therapeutic compound, KRN5500, for the treatment of neuropathic pain in patients with cancer. KRN5500 has successfully completed a Phase 2a study and has been designated as a Fast Track Drug by the United States Food and Drug Administration. The National Cancer Institute is partnering with DARA to initiate a second Phase 2 study.
DARA is in the process of acquiring a portfolio of additional cancer and cancer-support products for the oncology market, including sterile injectable generic cytotoxic drugs.
In addition to its oncology products, DARA is developing DB959, a novel, dual delta/gamma, non TZD PPAR agonist for the treatment of type 2 diabetes and dyslipidemia. DARA has completed Phase 1 testing of DB959 and is presently pursuing opportunities to out-license this product.
DARA also has three other pre-clinical drug programs for which it intends to seek out-licensing or partnering opportunities:
- PPAR gamma/alpha/delta agonists with potential for development in metabolic or inflammatory diseases as well as selected additional indications.
- DPPIV enzyme inhibitors with potential applications in diabetes, stem cell transplantation and cancer therapy
- Carnitine palmitoyltransferase-1 enzyme inhibitors with potential applications for skin diseases including psoriasis
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