Hana Biosciences (AMEX:HBX)
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From May 2019 to May 2024
Hana Biosciences, Inc. (AMEX:HBX):
-- Positive pivotal studies confirm Zensana(TM) (ondansetron oral
spray) 8 mg dose is statistically bioequivalent to the current
commercially available 8 mg ondansetron (Zofran(R)) tablet.
-- Zensana(TM) (ondansetron oral spray) delivers detectible
ondansetron levels statistically faster than oral Zofran(R)
tablets.
-- Completion of 4 registrational clinical studies, ZOOS I-IV
(Zensana(TM) Ondansetron Oral Spray), allows for NDA (new drug
application) submission under section 505(b)(2) in 2006.
-- Hana targets Zensana(TM) for US commercial launch in 2007.
Hana Biosciences (AMEX:HBX), a biopharmaceutical company focused
on advancing cancer care, announced the successful completion of all
clinical trials of Zensana(TM) (ondansetron oral spray) required for
FDA registration under section 505(b)(2).
The Zensana(TM) clinical development program, consisting of 4
clinical studies including single and multiple dose pharmacokinetic
studies, and evaluation of the effects of food and water on
Zensana(TM), are now complete. Data from the 4 studies, referred to as
ZOOS I-IV, respectively, reaffirm that Zensana(TM) 8 mg dose is
statistically bioequivalent to the current commercially available 8 mg
ondansetron (Zofran(R)) tablet, and can be conveniently administered
in multiple doses. Zensana(TM) delivered statistically faster
absorption as defined by median time to detectible drug levels of
ondansetron at 15 minutes versus the tablet at 30 minutes. In the 4
studies, Zensana(TM) was well tolerated by both men and women and did
not result in any unexpected adverse events. Details of these results
will be presented on June 3, 2006 at the ASCO Annual Meeting.
With these clinical studies complete, Hana confirms its plan to
submit a New Drug Application (NDA) in 2006, following a meeting with
the FDA. Hana targets commercial launch of Zensana(TM) in 2007.
"Zensana(TM) has promising market potential as a new, convenient
alternative formulation for treating nausea and vomiting associated
with chemotherapy which will help patients get on with their lives,"
stated Mark Ahn, PhD, President and CEO. "Our team is excited about
establishing a focused and scalable commercial presence to serve
oncologists which leverages the team's development and marketing
experience."
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.
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 US
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.