Talon Therapeutics Inc. (TLON)’s experimental blood-cancer treatment, based on a compound from the rosy periwinkle flower, is attracting potential partners and buyers, Chief Executive Officer Steven Deitcher said.
The U.S. Food and Drug Administration is set to decide by Aug. 12 whether to approve the medicine, a treatment called Marqibo for acute lymphoblastic leukemia, for patients who have failed at least two other therapies, giving the South San Francisco-based company its first marketable product.
Talon is considering selling rights to Marqibo outside the U.S., among other deals, Deitcher said. He declined to identify any of the potential buyers or partners. The company has access to $57 million in capital to market Marqibo.
“We’re in discussions with several companies that are interested in adding Marqibo to their oncology portfolio,” Deitcher said in a telephone interview yesterday. “The range of outcomes of these discussion includes launching Marqibo on our own in the U.S., to entering into a transaction designed to maximize the value of Marqibo and our other assets to our shareholders.”
The FDA rejected Marqibo as a treatment for non-Hodgkin’s lymphoma in 2005 when it was being developed by Inex Pharmaceuticals Corp. and Enzon Pharmaceuticals Inc. (ENZN)
Talon, formerly Hana Biosciences Inc., licensed Marqibo in 2006 from Inex. On March 21, Talon won the backing of a U.S. advisory panel for accelerated approval of its product. The advisers voted 7-4 that the benefits of the anti-leukemia therapy outweigh its risks. Talon’s shares have quadrupled this year. The stock was unchanged at $1.71 today at the close of trading.
Marqibo is a liposomal formulation of vincristine sulfate, a drug first developed by Eli Lilly & Co. (LLY) in the 1960s. Vincristine, known commercially as Oncovin, is used in combination with other drugs to treat non-Hodgkin’s lymphoma and acute lymphoblastic leukemia, though side effects limit the amount that can be given to patients.
Talon’s product is a nanoparticle encapsulated form of vincristine and is designed to provide prolonged circulation of the chemotherapy in the blood and accumulation at the tumor site, the company said.
About 6,050 new cases of acute lymphoblastic leukemia will be diagnosed this year, and mostly in children, according to the National Cancer Institute. Marqibo would treat adult patients with the type of acute lymphoblastic leukemia that is negative for an abnormality known as the Philadelphia chromosome and who have had multiple relapses or a disease that has progressed after taking two or more therapies.
This rare version of the disease affects about 1,400 adults in the U.S. a year, with less than 500 people failing two prior therapies, the FDA advisory panel said in its March report on Marqibo. The median survival time for patients who don’t respond to prior treatments is about three months.
The FDA is considering approving Marqibo, Talon’s lead product candidate, based on the second of three phases of clinical trials typically required. Talon has no annual revenue. Deitcher said pharmaceutical companies seem eager to make deals for cancer therapies.
“Companies are getting hungrier -- and therefore we will, and are, entertaining inquiries that we believe will become that much more voracious once our approval arrives, but it’s all going to be on bringing the most value to shareholders,” he said.
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