New Clinical Trial to Study First Oral Spray to Reduce
Chemotherapy-Induced Nausea and Vomiting
* Oral Spray Expected to Be Faster and More Convenient Than Zofran(R) for
Active Chemotherapy Patients
SOUTH SAN FRANCISCO, Calif., Feb. 9 /PRNewswire-FirstCall/ -- Hana
Biosciences, Inc. (OTC:HNAB) (BULLETIN BOARD: HNAB) , a biopharmaceutical
company headquartered in South San Francisco, announced today an initial
clinical study that will compare the pharmacokinetic profile of the lingual
spray formulation of ondansetron to the approved oral dosage of Zofran(R), the
world's best-selling anti-emetic agent, currently marketed in the US by
GlaxoSmithKline. Annual U.S. sales for Zofran(R) were approximately $1.0
billion in 2003, and the product patent expires in June 2006.
Based on successful results of this pilot pharmacokinetic trial in healthy
volunteers, Hana intends to file an Investigational New Drug (IND) Application
to commence an abbreviated clinical development program designed to support a
505(b)(2) submission, a form of New Drug Application (NDA) that relies on data
in previously approved NDAs and published literature. If the results are
successful, Hana expects the oral spray version to be available in 2007.
Ondansetron belongs to a class of drugs known as 5HT3 antagonists that are
widely used to prevent 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 antiemetic such as
ondansetron to prevent nausea and vomiting.
Hana acquired the rights to market the novel lingual spray formulation in the
US and Canada from NovaDel Pharma, Inc. (AMEX:NVD) in 2004. The new
formulation utilizes NovaDel's patented lingual spray drug delivery technology. This is designed to enhance convenience with a multidose formulation and to
achieve more rapid onset of therapeutic activity though buccal absorption. For
chemotherapy patients seeking quicker relief of nausea and vomiting, this is
considered a desired benefit. NovaDel was awarded a patent directed to a
lingual spray version of ondansetron in 2004.
"The convenience of a mouth spray to rapidly and effectively prevent
chemotherapy-induced nausea and vomiting is a welcome addition to our anti-
emetic choices, as oral ingestion of pills can be difficult in this setting,"
said Greg Berk, MD, Chief Medical Officer and Vice President, Hana Biosciences.
Once the pharmacokinetic profile is established, Hana plans to evaluate
ondansetron lingual spray in several oncology settings, including adjuvant
breast cancer, radiation therapy, and pediatrics. "We believe the convenience
of the oral spray will provide improved quality of life for several specific
groups of patients," Dr. Berk said.
"Nausea and vomiting associated with cancer chemotherapy continue to cause
significant problems for many people, even though marked progress has been
achieved over the past several years. Research into new approaches to further
lessen these difficult side-effects is clearly needed," said Richard J. Gralla,
MD, Co-Chair of the American Society of Clinical Oncology's Antiemetic
Guideline Expert Panel.
About Hana Biosciences Hana Biosciences acquires, develops, and commercializes innovative products for
the treatment of important unmet medical needs in cancer. 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
http://www.hanabiosciences.com/.
About NovaDel Pharma NovaDel Pharma, Inc. is a specialty pharmaceutical company engaged in the
development of novel drug delivery systems for prescription and over-the-
counter drugs. The company's proprietary lingual spray technology delivery
system offers the patient the potential for (i) fast onset of action; (ii)
improved drug safety by reducing the required drug dosage and reducing side
effects; (iii) improved patient convenience and compliance; and (iv) enhanced
dosage reliability. The company plans to develop such products independently
and through collaborative arrangements with major pharmaceutical and biotech
companies. More information about NovaDel can be found on its website at
http://www.novadel.com/.
This press release contains forward-looking statements that 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 Form 8-K filed with the
Securities and Exchange Commission on August 4, 2004. Hana assumes no
obligation to update these forward-looking statements, except as required by
law. DATASOURCE: Hana Biosciences, Inc.
CONTACT: Investors, Russell Skibsted, +1-650-588-6464, , or Media, Jon Weisberg, +1-435-658-0910, , both of Hana Biosciences, Inc.
Web site: http://www.novadel.com/ Web site: http://www.hanabiosciences.com/
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