South San Francisco, CA (January 9, 2006) – Hana Biosciences (AMEX: HBX), a biopharmaceutical company focused on advancing cancer care, announced the positive results of pivotal clinical trial ZOOS 1 (Zensana™ Ondansetron Oral Spray), a study which definitively demonstrated Zensana™ (ondansetron oral spray) 8 mg dose is bioequivalent to the current commercially available 8 mg tablet (Zofran®; GlaxoSmithKline).
In a randomized study conducted in 32 subjects, an 8 mg dose of Zensana™ (ondansetron oral spray) met the FDA guidance for bioequivalence defined by maximum concentration (Cmax) and total exposure (AUC). In addition to meeting the primary endpoints for bioequivalence, the safety profile of Zensana™ was similar to the commercially available ondansetron 8 mg tablet, and no unexpected adverse events were observed.
Hana, as previously planned, is proceeding with additional pharmacokinetic studies which are expected to be completed by the end of first quarter 2006 and include a multiple dose study, as well as a food and water effect study.
Hana plans to file the New Drug Application (NDA) in the second quarter of 2006, with commercial launch of Zensana™ targeted for 2007.
“Zensana™ holds great promise as a new and convenient alternative formulation for treating patients suffering from nausea and vomiting associated with chemotherapy,” stated Dr. Greg Berk, Senior Vice President and Chief Medical Officer. “These results are great news for cancer patients and now pave the way for Hana to seek FDA approval and commercial launch of this exciting product.”
About Zensana™ (Ondansetron Oral Spray)
Zensana™ (ondansetron oral spray) is the first multidose oral spray 5-HT3 antagonist. Zensana™ 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. 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™ 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. (NASDAQ:HNAB - News) 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 any of Hana's development efforts relating to Marqibo and 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, including Marqibo, 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.
Remy Bernarda, 650-228-2769