The cancer treatment portfolio of DARA BioSciences (NASDAQ:DARA) is getting bigger as the pharmaceutical company strikes a deal to market the generic version of a drug used as a first-in-line treatment for several cancers.
DARA’s deal with Canadian specialty pharmaceutical company Uman Pharma gives DARA exclusive rights to commercialize gemcitabine in the United States. But first, Uman must secure U.S. Food and Drug Administration regulatory approval for the chemotherapy drug. Branded gemcitabine, sold by Eli Lilly (NYSE:LLY) as Gemzar, generated 2010 sales of $780 million, according to IMS data. The drug is used to treat ovarian, lung, breast and pancreatic cancers. Gemzar went off patent in the United States last year; European patents expired in 2010.
According to a DARA regulatory filing, Uman is responsible for formulation, analytical and manufacturing work on the drug. Uman must also make the abbreviated new drug application for U.S. marketing approval. The distribution agreement calls for Raleigh, North Carolina-based DARA to make milestone and royalty payments for the drug. DARA’s rights to gemcitabine last seven years from the first sale of the drug.
DARA has been repositioning itself as a cancer drug provider. The company has two of its own compounds in clinical development. DB959 is set to advance into phase 2 studies as a type 2 diabetes treatment; KRN5500 is in phase 2 studies as a treatment for neuropathic pain caused by chemotherapy. But last month, DARA acquired South Carolina specialty pharmaceutical company Oncogenerix in a stock deal that gave DARA its first revenue-generating product. Oncogenerix holds the U.S. rights to Soltamox, a liquid version of breast cancer drug tamoxifen. DARA also plans to develop Oncogenerix’s work on other liquid formulations of cancer drugs. The company said it would make generic versions of injectable cancer medicines that are losing patent protection.
While gemcitabine would give DARA its second revenue-generating product, those sales won’t be coming in the near term. DARA’s filing notes that the FDA review and approval process for generics takes about three years.
