Hana Biosciences completes trials of Zensana oral spray for chemotherapy-induced nausea, vomiting

By Lisa Kerner

Erie, Pa., March 9 - Hana Biosciences, Inc. said pivotal studies confirm that an 8 mg dose of Zensana (ondansetron oral spray) is statistically bioequivalent to the current commercially available 8 mg ondansetron tablet, Zofran, for chemotherapy-induced nausea and vomiting.

Zensana, a multidose 5-HT3 antagonist, delivered detectible ondansetron levels at 15 minutes compared with the oral Zofran tablets at 30 minutes, according to a company news release.

The company said it has completed four clinical studies (ZOOS I-IV), including single- and multiple-dose pharmacokinetic studies and evaluation of the effects of food and water on Zensana.

In all trials, Zensana was well tolerated with no unexpected adverse events, according to the release.

Hana said it will present detailed results at the American Society of Clinical Oncology Annual Meeting on June 3. The company also plans to submit a New Drug Application with the Food and Drug Administration, with commercial launch of the product expected in 2007.

"Zensana has promising market potential as a new, convenient, alternative formulation for treating nausea and vomiting associated with chemotherapy which will help patients get on with their lives," president and chief executive officer Mark Ahn said in the release.

"Our team is excited about establishing a focused and scalable commercial presence to serve oncologists which leverages the team's development and marketing experience."

The annual U.S. market for ondansetron is about $1 billion, according to the release.

Hana acquired the exclusive rights to market the novel oral spray formulation in the United States and Canada from NovaDel Pharma, Inc.

Hana is a South San Francisco, Calif.-based biopharmaceutical company that acquires, develops and commercializes products to advance cancer care.

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