Hana Biosciences Successfully Completes Pivotal Trials of Zensana(TM), First Proprietary Ondansetron Oral Spray for Chemotherap
March 09 2006 - 7:02AM
Business Wire
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.
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