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FDA Accepts for Review NDA Filing for Zensana(TM) (Ondansetron HCI) Oral Spray


2006-08-30 07:03 ET - News Release

SOUTH SAN FRANCISCO, Calif. -- (Business Wire) -- Aug. 30, 2006
Company Website: http://www.hanabiosciences.com

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.
Contacts:

Hana Biosciences, Inc.
Investor & Media:
Remy Bernarda, 650-228-2769
fax: [phone]
[e-mail]

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