Healthcare Industry News:  analgesia 

Biopharmaceuticals

 News Release - February 7, 2007

Anesiva Announces FDA Acceptance for Filing of Zingo(TM) New Drug Application to Reduce Pain Associated With Needle Insertion Procedures in Children

SOUTH SAN FRANCISCO, Calif., Feb. 7 (HSMN NewsFeed) -- Anesiva, Inc. (Nasdaq: ANSV ) announced today that the FDA has accepted for filing the company's electronic New Drug Application (NDA)/Common Technical Document (eCTD) for marketing clearance of Zingo(TM) to treat pain associated with intravenous cannulation and venipuncture procedures in children. Acceptance for filing of an NDA/eCTD means that the FDA has found the company's submission to be sufficiently complete to review. This review is a standard review, and under the Prescription Drug User Fee Act (PDUFA), the agency makes a decision regarding marketing clearance of a product candidate within 10 months of the date of its submission. The NDA/eCTD for Zingo was submitted on November 22, 2006.

Anesiva anticipates marketing Zingo for this indication in the United States with a focused, specialty sales force and is actively seeking an international partner to make Zingo available internationally. The company filed the NDA using the eCTD format, which can be reviewed by the U.S. FDA and is also a marketing authorization format accepted by many international regulatory authorities.

"The submission and now acceptance for filing of our first NDA/eCTD underscores our commitment to develop and commercialize important new pain medications," said John P. McLaughlin, chief executive officer of Anesiva. "We look forward to collaborating with the FDA in the review and approval process of the CTD and bringing this important treatment to children."

"Based upon the positive clinical efficacy and safety data observed to date from Phase 2 clinical studies of Zingo in adults, we are actively continuing the development of this product with the initiation of a Phase 3 trial in adults later this quarter," Mr. McLaughlin added.

Clinical Data

Data from two Phase 3 clinical studies that serve as the foundation of the NDA/eCTD demonstrated that Zingo (previously known as 3268), a fast-acting, local anesthetic, provided pain relief in children undergoing venous access procedures, such as intravenous (IV) line placements. These data, which achieved statistical significance, also showed that Zingo provided pain reduction when given one to three minutes prior to the venous access procedure. The two studies collectively enrolled 1,109 patients at 15 clinical centers in the United States. Zingo was shown to be well tolerated in these studies.

Zingo Mechanism of Action and Market Potential

Zingo is a needle-free system that delivers lidocaine powder into the epidermis of the skin and provides analgesia in one to three minutes after administration. This rapid onset, which may be especially useful in pediatric populations and busy emergency room settings, means the product can be incorporated into a medical procedure allowing uninterrupted care, an important advantage over current options. In hospitals in the United States, approximately 18 million venous access procedures occur each year in pediatric patients alone.

About Anesiva and its Diverse Pipeline of Pain Products

Anesiva, Inc. is a late-stage biopharmaceutical company that seeks to be the leader in the development and commercialization of novel therapeutic treatments for pain. The company has two drug candidates in development for multiple pain-related indications. A New Drug Application (NDA) has been filed for the most advanced product, Zingo(TM). The second product in the pipeline, 4975, has been shown to reduce pain after only a single administration for weeks to months in multiple settings in numerous mid-stage clinical trials for site-specific, moderate-to-severe pain. Anesiva is based in South San Francisco, CA. For more information about Anesiva's leadership in the development of products for pain management, and an overview of the clinical challenges being addressed by its product candidates, go to http://www.anesiva.com.

Forward Looking Statements

This press release includes "forward-looking statements" within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release include, without limitation, references to the development and commercialization activities related to Zingo, the market potential for Zingo and other matters that involve known and unknown risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to differ materially from results expressed or implied by this press release. Actual results may differ materially from those contained in the forward-looking statements in this press release. Additional information concerning risk factors affecting Anesiva is contained in Anesiva's quarterly report on Form 10-Q for the quarter ended September 30, 2006.

Anesiva undertakes no obligation and does not intend to update these forward-looking statements to reflect events or circumstances occurring after this press release. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement.


Source: Anesiva

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