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Hana Biosciences Announces
Positive Pharmacokinetic Study Results Of Ondansetron Lingual Spray
• Pilot Pharmacokinetic Study Demonstrates
Pharmacokinetic Profile Comparable to Oral Zofran®, with Multidose Convenience
and Faster Drug Delivery
• Hana Biosciences Targets 2007 Product Launch
March 16th 2005: Hana Biosciences, Inc. (OTCBB:HNAB)
announced positive results of a pilot pharmacokinetic clinical trial that was
conducted using its proprietary lingual spray version of ondansetron
hydrochloride (the active ingredient marketed under the brand name Zofran® by
GlaxoSmithKline) for the treatment of chemotherapy-induced nausea and vomiting.
The study was designed to evaluate the pharmacokinetic profile of 8mg of the
ondansetron lingual spray to 8mg oral tablet of Zofran®. The study achieved its
goal of demonstrating the ability to deliver ondansetron via a lingual spray
technology and produce a similar pharmacokinetic profile to the currently
marketed oral tablet, with a faster drug delivery.
“We are extremely encouraged by the positive results from this initial study. We
look forward to moving ondansetron lingual spray into pivotal trials this year,”
said Mark J. Ahn, PhD, President and CEO, Hana Biosciences. “Assuming successful
results, Hana expects the oral spray version to be available in 2007.”
The study was conducted using 9 healthy male volunteers. Each volunteer was
given an 8mg Zofran® tablet and the lingual spray ondansetron at weekly
intervals. Plasma ondansetron levels were measured and analyzed for standard
pharmacokinetic parameters.
Hana’s ondansetron lingual spray demonstrated faster drug delivery than achieved
with the 8mg oral tablet. Time to measurable drug concentration was
approximately 20 minutes shorter for the spray when compared to the oral tablet.
During the first 30 minutes post-dosing, lingual spray formulation achieved
approximately four-fold increase in the total amount of drug and mean
ondansetron concentration. Noted treatment differences were statistically
significant. Importantly from the standpoint of safety, the mean maximum plasma
concentration (Cmax) and bioavailability, as measured by area-under-the-curve (AUC),
achieved during the entire 12-hour observation period for the 8mg lingual spray
did not exceed that of the oral tablet. There was no evidence of substantial
safety or tolerability issues. None of the subjects discontinued the study.
“Based on successful results of this pilot bioequivalence trial in healthy
volunteers, we intend 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,” said Greg Berk, MD, Chief
Medical Officer and Vice President, Hana Biosciences. “We also plan to study
ondansetron lingual spray in the breast cancer setting, as well as pediatrics
and radiation therapy.”
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. Annual U.S. sales for Zofran®, the
world’s leading antiemetic, were approximately $1.0 billion in 2003, and the
product patent expires in June 2006.
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 (oral tissue) 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.
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
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.
400 Oyster Point Boulevard, Suite 215 URL:
South San Francisco, CA 94080
e-mail:
info@hanabiosciences.com
www.hanabiosciences.com
Company Contact:
Investor Contact:
Russell Skibsted
e-mail: russell.skibsted@hanabiosciences.com
(650) 588-6464
Media Contact:
Jon Weisberg
e-mail: jonweisberg@inkandair.com
(435) 658-0910
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