Hana Biosciences Announces Positive Results of Initial Registration Trial with Zensana(TM), First Ondansetron Oral Spray for Che
09 Janvier 2006 - 2:14PM
Business Wire
Hana Biosciences (AMEX:HBX) -- Results of pivotal study demonstrate
Zensana(TM) (ondansetron oral spray) 8 mg dose is statistically
bioequivalent to the current commercially available 8 mg
ondansetron (Zofran(R)) tablet -- Completing additional clinical
trials required for 505(b)(2) registration 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 the positive results of pivotal clinical trial ZOOS
1 (Zensana(TM) Ondansetron Oral Spray), a study which definitively
demonstrated Zensana(TM) (ondansetron oral spray) 8 mg dose is
bioequivalent to the current commercially available 8 mg tablet
(Zofran(R); GlaxoSmithKline). In a randomized study conducted in 32
subjects, an 8 mg dose of Zensana(TM) (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(TM) 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(TM) targeted for 2007.
"Zensana(TM) 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(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 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.
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