Hana Biosciences Reaffirms Expected Timing of First NDA Filing.SOUTH SAN FRANCISCO South San Francisco, city (1990 pop. 54,312), San Mateo co., W Calif.; inc. 1908. South San Francisco has several industrial parks; its manufactures include medical supplies and equipment, foods, paint, paper products, consumer goods, and clothing. , Calif. -- Hana Biosciences (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :HNAB), a biopharmaceutical company focused on advancing cancer care, provided an update today on its most advanced drug candidate, Zensana(TM) (ondansetron HCl ondansetron HCl (ondan´s n brand name: Zofran; drug class: antiemetic; action: ) Oral Spray. Hana completed pivotal trials for Zensana(TM) in early 2006, which it believes met endpoints sufficient to allow for a New Drug Application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) filing with the Food and Drug Administration under section 505(b)(2) of the Food, Drug and Cosmetic Act Federal Food, Drug and Cosmetic Act a regulation in the United States which requires all drugs used in animals to be approved by the Food and Drug Administration. , a form of registration that relies on data in previously approved NDAs and published literature. The Company held a voluntary meeting with the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. yesterday to discuss its planned NDA application. The Company continues to believe it remains on track for a submission in the second quarter of 2006. Subject to approval by the FDA, the company plans to commercially launch Zensana(TM) in the United States in 2007. About Zensana(TM) (ondansetron HCl) Oral Spray The Company believes that Zensana(TM) (ondansetron HCl) Oral Spray is the only multidose oral spray 5-HT3 antagonist product candidate currently in development. Zensana(TM) delivers full doses of ondansetron to patients receiving emetogenic chemotherapy. Ondansetron is FDA approved to prevent chemotherapy and radiation-induced, and post-operative nausea and vomiting Nausea and Vomiting Definition Nausea is the sensation of being about to vomit. Vomiting, or emesis, is the expelling of undigested food through the mouth. . Patients experiencing nausea and vomiting have difficulty swallowing and holding down pills. Drug delivery via a spray to the oral mucosa is designed to avoid degradation in the gastrointestinal tract and metabolism by liver enzymes -- the so-called first-pass effect. Hana licensed the exclusive rights to Zensana(TM) in the U.S. and Canada from NovaDel Pharma, Inc. (AMEX AMEX See: American Stock Exchange :NVD See National Vulnerability Database. ). 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 The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and 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 any of Hana's development efforts relating to its product candidates will be successful or that the FDA will approve Hana's planned NDA submission relating to Zensana or its other product candidates. Other risks that may affect forward-looking information contained in this press release include 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 Annual Report on Form 10-K for the year ended December 31, 2005 filed with the Securities and Exchange Commission. Hana assumes no obligation to update these statements, except as required by law. |
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