Healthcare Industry News: antiemetic
News Release - August 30, 2006
FDA Accepts for Review NDA Filing for Zensana(TM) (Ondansetron HCI) Oral SpraySOUTH SAN FRANCISCO, Calif.--(HSMN NewsFeed)--Aug. 30, 2006--Hana Biosciences (NASDAQ:HNAB ), a biopharmaceutical company focused on advancing cancer care, today announced the U.S. Food and Drug Administration (FDA) has accepted for review the company's New Drug Application (NDA) for Zensana(TM) (ondansetron HCI) Oral Spray. Hana submitted an NDA for Zensana to seek approval for the prevention of chemotherapy, radiation, and post-operative associated nausea and vomiting. The acceptance of the filing means the FDA has made a threshold determination that the NDA is sufficiently complete to permit a substantive review.
"With this NDA filing, we are excited to be one step closer to bringing relief to patients suffering from nausea and vomiting as a result of their cancer treatments," stated Mark Ahn, President and CEO. "We plan to continue working closely with the FDA during the review. Subject to FDA approval, we look forward to a potential commercial launch in the United States in the first half of 2007."
Hana completed bioequivalence and bioavailability clinical trials of Zensana in early 2006 and submitted its NDA under Section 505(b)(2) of the Food, Drug and Cosmetic Act on June 30, 2006. This form of registration relies on data in previously approved NDAs and published literature. The expected Prescription Drug User Fee Act (PDUFA) action date for this NDA is April 30, 2007.
About Zensana(TM) (ondansetron HCl) Oral Spray
Zensana(TM) (ondansetron HCI) Oral Spray is the first 5-HT3 antagonist to deliver ondansetron, a standard antiemetic therapy, in a convenient, micromist oral spray to patients suffering from chemotherapy, radiation, and post-operative associated nausea and vomiting. Based on clinical trial data presented June 3, 2006 at the American Society of Clinical Oncology Conference, Hana believes Zensana 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-operative associated nausea and vomiting. Many patients requiring antiemetic therapy experience dysphagia, a discomfort or difficulty swallowing tablets, due to mouth and throat sores, inflammation, or dry mouth. Hana believes that the convenience of drug delivery via an oral spray may offer an attractive alternative to tablets and other forms of ondansetron. 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 quarter ended June 30, 2006 filed with the Securities and Exchange Commission. Hana assumes no obligation to update these statements, except as required by law.
Source: Hana Biosciences
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