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Hana Biosciences Presents Zensana(TM) (ondansetron HCl) Oral Spray Pivotal Trials at ASCO.


SOUTH SAN FRANCISCO South San Francisco, city (1990 pop. 54,312), San Mateo co., W Calif.; inc. 1908. South San Francisco has several industrial parks; its manufactures include medical supplies and equipment, foods, paint, paper products, consumer goods, and clothing. , Calif. -- Hana Biosciences (NASDAQ NASDAQ
 in full National Association of Securities Dealers Automated Quotations

U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on
:HNAB):

--Completion of pivotal trials confirmed Zensana(TM) (ondansetron HCl ondansetron HCl (ondan´strōn),
n brand name: Zofran;
drug class: antiemetic;
action:
) Oral Spray 8 mg dose is statistically bioequivalent bi·o·e·quiv·a·lent
n.
A value indicating the rate at which a substance enters the bloodstream and becomes available to the body.
 to the current commercially available 8 mg ondansetron (Zofran(R); GlaxoSmithKline) tablet.

--Abstract #8622: General Poster Session at ASCO ASCO American Society of Clinical Oncology
ASCO Association of Schools and Colleges of Optometry (since 1941; Rockville, Maryland)
ASCO Australian Standard Classification of Occupations
ASCO Automatic Switch Company
 on Saturday, June 3rd.

--New survey indicates medical oncologists, radiation oncologists and oncology nurses believe Zensana(TM) may be an attractive formulation for patients with chemotherapy and radiation induced nausea and vomiting Nausea and Vomiting Definition

Nausea is the sensation of being about to vomit. Vomiting, or emesis, is the expelling of undigested food through the mouth.
.

Hana Biosciences (NASDAQ:HNAB), a biopharmaceutical company focused on advancing cancer care, will present pivotal trials on their most advanced drug candidate, Zensana(TM) (ondansetron HCl) Oral Spray. As previously reported, pivotal trials were completed in early 2006 and the company believes endpoints were met for a New Drug Application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) under section 505(b)(2). Hana remains on track for a submission in the second quarter of 2006; and, upon potential approval by the FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
, the company is targeting a Zensana(TM) U.S. launch in 2007.

The company also announced that specifics on Zensana(TM) pivotal trials will be presented at the upcoming 42nd Annual Meeting of the American Society of Clinical Oncology American Society of Clinical Oncology, or ASCO, is an organization that represents all clinical oncologists. Every year, ASCO holds a large symposium where physicians and researchers meet to convey and discuss research and ideas.  (ASCO) in Atlanta. Details on the oral presentation are as follows:

--Abstract #8622: "Ondansetron Oral Spray (Zensana(TM)) versus Ondansetron Oral Tablets in a Randomized ran·dom·ize  
tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es
To make random in arrangement, especially in order to control the variables in an experiment.
, Bioavailability bioavailability /bio·avail·a·bil·i·ty/ (bi?o-ah-val?ah-bil´i-te) the degree to which a drug or other substance becomes available to the target tissue after administration.

bi·o·a·vail·a·bil·i·ty
n.
 Study in Adult Subjects." General Poster Session (Board #Z10) in Bldg B, Level 1, Hall B5 on Saturday, June 3rd from 2:00-6:00pm.

"Many patients receiving chemo che·mo
n.
Chemotherapy or a chemotherapeutic treatment.
 and radiation therapy have difficulty swallowing and are unable to tolerate ondansetron tablets and other antiemetic therapies. Drug delivery via a spray is convenient and offers a desirable substitute to tablets and other forms of ondansetron," stated Mark Ahn, PhD, President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. , Hana Biosciences. "We are excited about the potential for Zensana(TM) as an attractive alternative to provide prompt and reliable relief for chemo-induced nausea and vomiting to patients."

In addition, three surveys were recently completed by the Winokur Consulting Group (WCG WCG World Cyber Games
WCG Worldwide Church of God
WCG World Community Grid
WCG Wellington Caving Group (caving club in New Zealand)
WCG Washington Calligraphers Guild
WCG West Coast Grocery
) focusing on expanded audiences for Zensana(TM) including medical oncologists, radiation oncologists, and oncology nurses. Survey results from the WCG research concluded that Zensana(TM) ranked highest in several categories including ease of use when actively nauseated nau·se·at·ed
adj.
Affected with nausea.
, favorable route of administration, and delivery of full therapeutic dose compared to both the ondansetron (Zofran(R); GlaxoSmithKline) tablet and Orally Disintegrating Tablet The Food and Drug Administration's (FDA) definition of an orally disintegrating tablet (ODT) is: "A solid dosage form containing medicinal substances which disintegrates rapidly, usually within a matter of seconds, when placed upon the tongue.  (ODT See SCO Open Desktop.

ODT - Open Desktop
).

Zensana(TM) Survey confirms product profile

The Winokur Consulting Group (WCG) conducted a survey of medical oncologists, oncology nurses, and radiation oncologists who treat cancer patients to determine utilization and perceptions of current and emerging antiemetics for chemotherapy- and radiation-induced nausea & vomiting (CINV/RINV).

This survey was conducted to determine current trends and market potential for the introduction of Zensana(TM) (ondansetron HCl) Oral Spray, currently being developed by Hana Biosciences (HNAB) for the prevention of chemotherapy-induced nausea and vomiting (CINV CINV Chemotherapy Induced Nausea and Vomiting ) for a targeted US launch in 2007. The study consisted of a statistically significant and representative survey hematologists-oncologists (n=193), oncology nurses (n=244) and radiation oncologists (n=73) in academia and community practices during the period April-May 2006. Major conclusions were:
--  Medical oncologists:

        --  38% of oncologists surveyed would use Zensana(TM) after
            chemotherapy in at least half of their patients.

        --  Half of the respondents said they had patients who had
            some difficulty swallowing or holding down their full dose
            of antiemetic, whether a tablet or ODT.

        --  47% of oncologists surveyed believe that Zensana(TM) can
            support a price level comparable to or higher than Zofran
            ODT.

    --  Oncology nurses:

        --  90% or 9 out of 10 oncology nurses believe Zensana(TM) is
            more convenient for their patients than a tablet for the
            prevention of chemo-induced nausea and vomiting.

        --  76% of oncology nurses surveyed would recommend patients
            to receive a prescription for Zensana(TM) after
            chemotherapy in at least half of their patients.

        --  Half of the respondents said they had patients who had
            some difficulty swallowing or holding down their full dose
            of antiemetic, whether a tablet or ODT.

    --  Radiation oncologists:

        --  42% of radiation oncologists surveyed would use
            Zensana(TM) after radiotherapy in at least half of their
            patients.

        --  Half of the respondents said they had patients who had
            some difficulty swallowing or holding down their full dose
            of antiemetic, whether a tablet or ODT.

        --  43% of radiation oncologists surveyed believe that
            Zensana(TM) can support a price level comparable to or
            higher than Zofran ODT.


About Zensana(TM) (ondansetron HCl) Oral Spray

Zensana(TM) (ondansetron HCl) Oral Spray is a multidose oral spray 5-HT3 antagonist. We believe Zensana(TM) is the only multidose oral spray product candidate currently in development that delivers full doses of ondansetron to patients receiving emetogenic chemotherapy. Ondansetron is an FDA approved drug that is commonly used to prevent chemotherapy and radiation-induced, and post-operative, nausea and vomiting. Many patients experiencing nausea and vomiting may have difficulty swallowing and holding down pills, and may not tolerate other forms of ondansetron. Hana believes that drug delivery via a spray to the oral mucosa may in part avoid degradation in the gastrointestinal tract gastrointestinal tract
n.
The part of the digestive system consisting of the stomach, small intestine, and large intestine.


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. If approved by the FDA the company intends to commercially launch Zensana(TM) in the United States in the first half of 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. (NASDAQ: HNAB) 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 The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  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 often, but not always, made through the use of words or phrases such as "anticipates," "expects," "plans," "believes," "intends," and similar words or phrases. 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, including those recently licensed from INEX INEX Integrated Numerical Experiment
INEX Internet Neutral Exchange
, 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 and commercializing pharmaceutical products. Additional risks are described in the company's Quarterly Report on Form 10-Q for the three months ended March 31, 2006 filed with the Securities and Exchange Commission. Hana assumes no obligation to update these statements, except as required by law.
COPYRIGHT 2006 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2006, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:May 31, 2006
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