Printer Friendly

Hana Biosciences Announces Positive Pharmacokinetic Study Results of Ondansetron Lingual Spray; * Pilot Pharmacokinetic Study Demonstrates Pharmacokinetic Profile Comparable to Oral Zofran(R), With Multidose Convenience and Faster Drug Delivery.

SOUTH SAN FRANCISCO, Calif., March 16 /PRNewswire-FirstCall/ -- Hana Biosciences, Inc. (BULLETIN BOARD: 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(R) by GlaxoSmithKline) for the treatment of chemotherapy-induced nausea and vomiting.

The study was designed to compare the pharmacokinetic profile of 8mg of the ondansetron lingual spray to an 8mg oral tablet of Zofran(R). The study achieved its goal of demonstrating the ability to deliver ondansetron via the lingual spray technology and produce a similar pharmacokinetic profile to the currently marketed oral tablet, with 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 lingual spray version to be available in 2007."

The study was conducted using 9 healthy male volunteers. Each volunteer was given an 8mg Zofran(R) tablet and the same dose of a lingual spray version 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 achievement of measurable drug concentrations was approximately 20 minutes shorter for the spray when compared to the oral tablet. During the first 20 minutes post-dosing, the lingual spray formulation achieved statistically significant increases in the total amount of drug delivered and in the mean ondansetron concentration. 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 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(R), 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. 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 through oral mucosal 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

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

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.
 Company Contact:
 Investor Contact:
 Russell Skibsted
 (650) 588-6464

 Media Contact:
 Jon Weisberg
 (435) 658-0910

CONTACT: Investors, Russell Skibsted of Hana Biosciences, Inc., +1-650-588-6464,; or Media, Jon Weisberg, +1-435-658-0910,, for Hana Biosciences

Web site:

Web site:
COPYRIGHT 2005 PR Newswire Association LLC
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2005 Gale, Cengage Learning. All rights reserved.

Article Details
Printer friendly Cite/link Email Feedback
Publication:PR Newswire
Date:Mar 16, 2005
Previous Article:OncoGenex Technologies and Isis Pharmaceuticals Expand Antisense Drug Development Partnershp in Oncology.
Next Article:VendingData(TM) Corporation Schedules Conference Call to Present Full Year and Fourth Quarter 2004 Financial Results.

Terms of use | Copyright © 2017 Farlex, Inc. | Feedback | For webmasters