Hana Biosciences (AMEX:HBX)
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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.