HBX Hana Biosciences

Hana Biosciences (AMEX: HBX): -- Results confirm potential of Zensana(TM) (ondansetron oral spray) as the first oral spray 5-HT3 antagonist to deliver full doses of ondansetron faster and more conveniently than tablets -- Pivotal clinical trials for 505(b)(2) registration to commence in December 2005 -- U.S. commercial launch targeted for 2007 Hana Biosciences (AMEX: HBX), a South San Francisco-based biopharmaceutical company focused on advancing cancer care, announced positive data from a completed preclinical in vivo pharmacokinetic study comparing different formulations of Zensana(TM) (ondansetron oral spray) with commercially available ondansetron solution (Zofran(R); GlaxoSmithKline). Results from the study, in male beagles, were presented at the American Association for Cancer Research-National Cancer Institute-European Organisation for Research and Treatment of Cancer (AACR-NCI-EORTC) International Conference on Molecular Targets and Cancer Therapeutics in Philadelphia. The study demonstrated enhanced bioavailability of Zensana(TM) versus currently approved ondansetron solution with a 7- and 9-fold increase in area under the concentration time curve (AUC). In addition, both ondansetron sprays demonstrated peak concentrations (Cmax) approximately four times greater than ondansetron oral solution. Time to peak concentration (Tmax) of both formulations demonstrated similar to 45% faster absorption versus the oral solution. Both oral sprays were well-tolerated. These results are consistent with an earlier pilot clinical trial, as well as other models, where administering drugs through the highly vascularized tissues surrounding the buccal and oral mucosa delivers improved systemic absorption and the potential for faster onset of action. Hana Biosciences licensed Zensana(TM) from NovaDel Pharmaceuticals (AMEX: NVD) for the United States and Canada. "Pharmacokinetic results from this study further build on a body of clinical and preclinical evidence which support the further development of Zensana(TM) in the clinical setting," stated Greg Berk, M.D., chief medical officer and vice president of Hana Biosciences. "We look forward to initiating pivotal clinical studies designed to explore the potential of Zensana(TM) as a new and convenient alternative formulation for treating nausea and vomiting associated with chemotherapy." About Zensana(TM) (Ondansetron Oral Spray) Zensana(TM) (ondansetron oral spray) is the first oral spray 5-HT3 antagonist. It conveniently delivers full doses of ondansetron faster than tablets to patients receiving emetigenic chemotherapy. Zensana allows patients to gain and maintain protection from chemotherapy, radiation and post-operative induced nausea and vomiting. Patients experiencing nausea and vomiting have difficulty swallowing and holding down pills. Drug delivery via a spray to the oral mucosa is more convenient and avoids degradation in the gastrointestinal tract and metabolism by liver enzymes -- the so-called first-pass effect. Zensana(TM) oral spray is simple to take and insures patients receive a full dose of protection from chemotherapy-induced nausea and vomiting. Zensana(TM) is being developed as a 505(b)(2) registration, will commence pivotal trials by the end of 2005, and targets a 2007 launch in the United States. About Hana Biosciences Inc. Hana Biosciences Inc. is a South San Francisco, Calif.-based biopharmaceutical company that acquires, develops, and commercializes 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 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. 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 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 pharmaceutical products. Additional risks are described in the company's Annual Report on Form 10-KSB for the year ended Dec. 31, 2004. Hana assumes no obligation to update thing statements, except as required by law.