Hana Biosciences Initiates Pivotal Trials of Zensana™, First Ondansetron Oral Spray in Chemo-Induced Nausea and Vomiting

Business Wire, Dec 12, 2005

SOUTH SAN FRANCISCO, Calif. -- Hana Biosciences (AMEX:HBX):

--Clinical trials for 505(b)(2) registration to be completed in early 2006

--Hana targets Zensana(TM) US commercial launch in 2007

Hana Biosciences (AMEX:HBX), a biopharmaceutical company focused on advancing cancer care, announced today that the Food and Drug Administration has cleared its Investigational New Drug (IND) application for Zensana(TM). Hana is initiating today a series of pivotal pharmacokinetic trials, including comparison of Zensana(TM) to the commercially available ondansetron tablet (Zofran(R); GlaxoSmithkline). Hana expects to complete these pivotal trials by early 2006 and plans to file the New Drug Application (NDA) shortly thereafter. Commercial launch of Zensana(TM) is targeted for 2007.

"Because it will help chemotherapy patients get on with their lives, Zensana(TM) has a promising market potential as a new and convenient alternative formulation for treating nausea and vomiting associated with chemotherapy," said Mark J. Ahn, PhD, President and CEO, Hana Biosciences. "We plan to develop the proprietary product rapidly so it will be available to help the thousands of patients who seek fast relief from chemo-induced nausea and vomiting."

About Zensana(TM) (Ondansetron Oral Spray)

Zensana(TM) (ondansetron oral spray) is the first multidose oral spray 5-HT3 antagonist. Zensana(TM) delivers full doses of ondansetron to patients receiving emetogenic chemotherapy. Ondansetron is approved to prevent chemotherapy and radiation-induced, and post-operative, nausea and vomiting.

Patients experiencing nausea and vomiting have difficulty swallowing and holding down pills. Drug delivery via a spray to the oral mucosa avoids degradation in the gastrointestinal tract and metabolism by liver enzymes -- the so-called first-pass effect. Hana intends to file a New Drug Application (NDA) under section 505(b)(2), a form of registration that relies on data in previously approved NDAs and published literature. Pivotal trials will be completed early 2006.

Hana acquired the exclusive rights to market the novel oral spray formulation in the US and Canada from NovaDel Pharma, Inc. (AMEX: NVD). The company targets the US launch of Zensana(TM) in 2007.

About Chemotherapy-Induced Nausea and Vomiting

According to the National Cancer Institute over 500,000 Americans received chemotherapy in 2004, and the majority of these patients received an anti-emetic such as ondansetron. Nausea and vomiting are the leading concerns of patients undergoing chemotherapy. Annual U.S. sales for ondansetron were approximately $1.0 billion, representing a 66% market share among the four approved 5-HT3 products in 2004.

About Hana Biosciences, Inc.

Hana Biosciences, Inc. (AMEX:HBX) is a South San Francisco, CA-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 these statements, except as required by law.