Hana to meet with FDA to discuss Special Protocol Assessment for Marqibo

By Jennifer Lanning Drey

Portland, Ore., Oct. 30 - Hana Biosciences, Inc. will meet with the Food and Drug Administration on Tuesday to discuss a Special Protocol Assessment for Marqibo (vincristine sulfate liposomes injection), president and chief executive officer Dr. Mark J. Ahn said at the C.E. Unterberg health care conference in New York on Monday.

"We're very excited about moving this forward," Ahn said.

The company plans to conduct a phase 3 study of dexamethasone with or without Marqibo in 220 patients with relapsed or refractory acute lymphocytic leukemia. Hana has already lined up 82 sites in seven countries and hopes to start the trial late this year or in early 2007, Ahn said.

Hana also has an ongoing supporting phase 2 study of Marqibo in combination with dexamethasone in 44 patients with relapsed or refractory acute lymphocytic leukemia.

Additionally, the company is preparing for its nearest-term opportunity, which is the expected launch of Zinsana (ondansetron HCI) oral spray. Hana has filed a New Drug Application for the product candidate, and Zinsana has a Prescription Drug User Fee Act date of April 30, 2007.

"We're looking forward to bringing this product forward with a specialty sales force focused on the hematology/oncology community in the key centers and large community clinics around them," Ahn said.

Hana has four additional drugs in the clinic targeting solid tumors and cancer types including non-small cell lung cancer, acute lymphocytic leukemia, colorectal, gastric and liver cancers.

The company expects to burn roughly $19.8 million this year and last reported cash at approximately $46.0 million, Ahn said.

Hana is a biopharmaceutical company based in South San Francisco, Calif., that develops products for the treatment of cancer.

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