Hana says it expects to file NDA for Zensana soon

By Elaine Rigoli

Tampa, Fla., May 9 - Hana Biosciences said it recently held a voluntary meeting with the Food and Drug Administration to discuss its planned New Drug Application, which the company said remains on track for a submission in the second quarter of 2006.

Subject to FDA approval, the company plans to launch Zensana, an oral chemotherapy product, commercially in the United States in 2007.

Hana completed pivotal trials for Zensana in early 2006, which it believes met endpoints sufficient to allow for a NDA filing with the FDA under section 505(b)(2) of the Food, Drug and Cosmetic Act, a form of registration that relies on data in previously approved NDAs and published literature.

Hana licensed the exclusive rights to Zensana in the United States and Canada from NovaDel Pharma, Inc.

Hana, a biopharmaceutical company based in South San Francisco, Calif., is focused on acquiring, developing and commercializing products to advance cancer care.

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