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Hana Biosciences Submits Zensana(TM) (Ondansetron HCl) Oral Spray New Drug Application (NDA) to the U.S. Food and Drug Administration

Posted on: Friday, 30 June 2006, 09:00 CDT

Hana Biosciences (NASDAQ:HNAB), a biopharmaceutical company focused on advancing cancer care, today announced that the company has submitted a New Drug Application (NDA) for Zensana(TM) (ondansetron HCl) Oral Spray to the U.S. Food and Drug Administration (FDA) seeking marketing approval for the prevention of nausea and vomiting associated with chemotherapy, radiotherapy, and post-operative induced nausea and vomiting.

"Hana is pleased to be submitting its first NDA for Zensana(TM) which has the potential to provide a new treatment option for patients suffering from nausea and vomiting associated with chemo and radiation therapy," stated Mark Ahn, President and CEO. "This NDA marks a significant step for our company, is an example of our core competencies, and paves the way for further growth."

The NDA was filed under Section 505(b)(2) of the Food, Drug and Cosmetic Act. If approved, Hana targets commercial launch of Zensana(TM) in the United States in the first half of 2007.

About Zensana(TM) (ondansetron HCl) Oral Spray

Zensana(TM) (ondansetron HCl) is the first oral spray 5-HT3 antagonist to deliver ondansetron, a standard antiemetic therapy, in a convenient, micromist oral spray to patients suffering from chemotherapy, radiation and post-operatively induced nausea and vomiting. Based on clinical trial data presented June 3, 2006 at the American Society of Clinical Oncology (ASCO) Conference, Hana believes Zensana(TM) is statistically bioequivalent to ondansetron tablets with faster initial delivery. Ondansetron, a selective blocking agent of the hormone serotonin, is an FDA-approved active ingredient that is widely used in tablet form to prevent chemotherapy, radiation, and post-operatively induced nausea and vomiting. Many patients requiring antiemetic therapy experience discomfort or difficulty swallowing. Hana believes that the convenience of drug delivery via a spray may offer an attractive alternative to tablets and other forms of ondansetron. Hana completed bioequivalence and bioavailability clinical trials of Zensana(TM) in early 2006 and filed its NDA under Section 505(b)(2) of the Food, Drug and Cosmetic Act. A 505(b)(2) form of registration relies on data in previously approved NDAs and published literature. Hana holds the exclusive rights to market the novel oral spray formulation in the U.S. and Canada pursuant to a license from NovaDel Pharma, Inc. (AMEX:NVD).

About Hana Biosciences, Inc.

Hana Biosciences, Inc. (NASDAQ:HNAB) is a South San Francisco, CA-based biopharmaceutical company focused on acquiring, developing, and commercializing innovative products to advance cancer care. The company is committed to creating value by building a world-class team, accelerating the development of lead product candidates, expanding its pipeline by being the alliance partner of choice, and nurturing a unique company culture. Additional information on Hana Biosciences can be found at www.hanabiosciences.com.

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements involve risks and uncertainties that could cause Hana's actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are often, but not always, made through the use of words or phrases such as "anticipates,""expects,""plans,""believes,""intends," and similar words or phrases. These statements are based on current expectations, forecasts and assumptions that are subject to risks and uncertainties, which could cause actual outcomes and results to differ materially from these statements. Among other things, there can be no assurances that Hana's NDA for Zensana will be approved by the FDA. Further, even if the NDA for Zensana is approved, Hana efforts to commercialize Zensana may not be successful, which would have a material adverse effect on its financial condition and business prospects. Other risks that may affect forward-looking information contained in this press release include the possibility of being unable to obtain regulatory approval of Hana's other product candidates, the risk that the results of clinical trials may not support Hana's claims, Hana's reliance on third-party researchers to develop its product candidates, and its lack of experience in developing and commercializing pharmaceutical products. Additional risks are described in the company's Quarterly Report on Form 10-Q for the three months ended March 31, 2006 filed with the Securities and Exchange Commission. Hana assumes no obligation to update these statements, except as required by law.

Source: Business Wire

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