West Coast Editor
Hana Biosciences Inc. submitted a new drug application - the company's first - for Zensana (ondansetron) to prevent postoperative and chemotherapy-related nausea and vomiting, with a launch targeted for early next year.
Zensana also is the first oral spray 5-HT3 antagonist to deliver ondansetron, a standard anti-emetic therapy, in a convenient micromist that provides drug benefits apparently equivalent to tablets. Hana owns U.S. and Canadian rights to Zensana, in-licensed in October 2004 from NovaDel Pharma Inc., of Flemington, N.J.
At the recent meeting of the American Society of Clinical Oncology, South San Francisco-based Hana presented the full dataset from pivotal Zensana studies ZOOS-1, 2, 3 and 4.
In the single-dose study ZOOS-1, testing 42 healthy adults, 8-mg Zensana was confirmed equivalent to 8-mg Zofran (from London-based GlaxoSmithKline plc) as measured by maximum plasma concentration and "area under the curve" (AUC) metrics.
In the 15-patient multidose study ZOOS-3, Zensana was shown to be well tolerated, reaching steady-state concentrations by the second day with time-dependent pharmacokinetics. And in ZOOS-4, with 23 patients, the spray was well tolerated, with no clinically significant difference in AUC or maximum plasma concentration noted when subjects got 8-mg Zensana with or without food and water.
South San Francisco-based Hana raised $40 million in May through an institutional stock sale, about a week after closing a deal to buy three cancer drugs for $42 million from Inex Pharmaceuticals Corp., of Vancouver, British Columbia. Those drugs include Marqibo (sphingosomal vincristine) for hematological malignancies, which garnered a non-approvable letter in January 2005 after an FDA panel voted against it. (See BioWorld Today, March 20, 2006, and May 18, 2006.)
Hana plans to start a Phase III trial with Marqibo in acute lymphocytic leukemia by the end of this year, and another Phase III in non-Hodgkin's lymphoma soon afterward.
The company's stock (NASDAQ:HNAB) closed Friday at $9.07, down 43 cents.