Printer Friendly
The Free Library
18,914,768 articles and books
Member login
User name  
Password 
 
Join us Forgot password?

Hana Biosciences Reports Likely Delay in Launch of Zensana(TM).


* Ongoing scale-up and stability experiments initiated by Hana indicate that there is a need to make adjustments to the formulation and/or manufacturing process

* Hana remains committed to Zensana[TM], but has put commercialization expenses on hold until this issue is resolved

* Management will host a conference call today at 5:00pm EST/2:00pm PST PST Paroxysmal supraventricular tachycardia, see there  

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), a biopharmaceutical company focused on advancing cancer care, today announced an update on the status of its 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 ) for Zensana[TM] (ondansetron HCI) Oral Spray with the U.S. Food and Drug Administration (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.
). Hana has submitted an NDA for Zensana under Section 505 (b)(2) of the Food, Drug and Cosmetic Act Federal Food, Drug and Cosmetic Act

a regulation in the United States which requires all drugs used in animals to be approved by the Food and Drug Administration.
 to seek approval for the prevention of 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.
 as a result of chemotherapy, radiation, and surgery.

Ongoing, long-term stability studies have detected small amounts of precipitated material in scale-up batches of Zensana, which may require an adjustment to the formulation and/or the manufacturing process. Hana is currently investigating this issue, and awaits results of on-going experiments. This issue is likely to delay FDA approval of Zensana beyond the expected Prescription Drug User Fee Act The Prescription Drug User Fee Act (PDUFA) was a law passed by the United States Congress in 1992 which allowed the Food and Drug Administration (FDA) to collect fees from drug manufacturers to fund the new drug approval process.  (PDUFA PDUFA Prescription Drug User Fee Act of 1992 (USA) ) action date of April 30, 2007.

"We are disappointed by this development with Zensana; however, we are committed to improving stability and pursuing FDA approval of what we believe is a high quality product of real value to patients," stated Mark Ahn, PhD, President and Chief Executive Officer. "In the meantime Adv. 1. in the meantime - during the intervening time; "meanwhile I will not think about the problem"; "meantime he was attentive to his other interests"; "in the meantime the police were notified"
meantime, meanwhile
, we are putting expenses related to Zensana commercialization on hold. We will also continue to focus our resources on the development of our high-value oncology product candidates."

Hana Biosciences' management will host a conference call regarding Zensana at 5:00pm EST EST electroshock therapy.

EST
abbr.
electroshock therapy
, 2:00pm PST. Those interested in hearing management's discussion may join the call by dialing (877) 407-9210 in the U.S./Canada. International participants may access the call by dialing (201) 689-8049. A replay of this call will be available until March 6, 2007 by dialing (877) 660-6853 U.S./Canada and (201) 612-7415 for International participants. When prompted, enter Account Number #286 and Conference ID #232441.

About Zensana[TM] (ondansetron HCl) Oral Spray

Zensana[TM] (ondansetron HCI) Oral Spray is the first 5-HT3 antagonist designed to deliver ondansetron, a standard antiemetic therapy, in a convenient, micromist oral spray to patients for the prevention of nausea and vomiting as a result of chemotherapy, radiation, and surgery. Based on clinical trial data presented June 3, 2006 at 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.  Conference, Hana believes Zensana is statistically bioequivalent to ondansetron tablets with faster initial delivery. Ondansetron, a selective blocking agent of the hormone serotonin, is an FDA-approved active ingredient that is widely used in tablet form to prevent chemotherapy, radiation, and post-operative associated nausea and vomiting. Many patients requiring antiemetic therapy experience dysphagia, a discomfort or difficulty swallowing tablets, due to mouth and throat sores, inflammation, or dry mouth. Hana believes that the convenience of drug delivery via an oral spray may offer an attractive alternative to tablets and other forms of ondansetron. Pursuant to the company's rapid product development strategy, Hana completed bioequivalence and 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.
 clinical trials of Zensana in early 2006 and submitted its NDA under Section 505(b)(2) of the Food, Drug and Cosmetic Act on June 30, 2006. This form of registration relies on published literature and the FDA's finding of safety and effectiveness for a previously approved drug product. Hana holds the exclusive rights to market the novel oral spray formulation in the U.S. and Canada pursuant to a license from NovaDel Pharma, Inc. (AMEX AMEX

See: American Stock Exchange
:NVD).

About Hana Biosciences, Inc.

Hana Biosciences, Inc. (NASDAQ:HNAB) is a South San Francisco, CA-based biopharmaceutical company focused on acquiring, developing, and commercializing 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 assurance that Hana will be able to timely, if ever, resolve the stability issues relating to Zensana or that Hana will ever be able to obtain FDA approval for Zensana. Other risks that may affect forward-looking information contained in this press release include the risk that the results of clinical trials may not support Hana's claims, Hana's reliance on third -parties to assist it in its investigation of the Zensana stability issues, 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 quarter ended June 30, 2006 filed with the Securities and Exchange Commission. Hana assumes no obligation to update these statements, except as required by law.
COPYRIGHT 2007 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2007, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

 Reader Opinion

Title:

Comment:



 

Article Details
Printer friendly Cite/link Email Feedback
Publication:Business Wire
Date:Feb 20, 2007
Words:910
Previous Article:NGA Standards Document Features OGC(R) Specifications.
Next Article:Hawaiian Telcom Approaches 100,000 High-Speed Internet Subscribers.
Topics:



Related Articles
LINGERING IN HANA IT'S MORE THAN JUST A ROADSIDE STOP ON MAUI'S FAMOUS HIGHWAY.(Travel)
HIGHWAY TO HEAVEN : ROAD TO MAUI'S HANA LEADS TO 'MOST HAWAIIAN OF ALL PLACES'.(TRAVEL)
Levine, Karen: Hana's Suitcase.(Brief Article)(Book Review)
HOTEL HANA-MAUI OFFERS BLISSFUL DISENGAGEMENT.(Travel)
Hana Biosciences Announces 2006 Corporate Goals; Key 2005 Achievements Reviewed and 2006 Objectives Announced; Annual Shareholder Meeting and a...
SAFC/VIVALIS REACH FIRST MILESTONE IN R&D COLLABORATION.(Company overview)
Hana Biosciences Initiates Marqibo(R) Phase II Clinical Trial in Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL).
Hana Biosciences Provides Talvesta(TM) (Talotrexin) for Injection Update on Clinical Trials and Upcoming Medical Conference Presentations.
Hana Biosciences Licenses Drug Candidate for the Prevention and Treatment of EGFR Inhibitor-Associated Skin Rash.
Hana Biosciences Receives Orphan Drug Designation for Marqibo(R) (Vincristine Sulfate Liposomes Injection) for the Treatment of Acute Lymphoblastic...

Terms of use | Copyright © 2010 Farlex, Inc. | Feedback | For webmasters | Submit articles