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Anesiva Completes Successful Meeting With FDA and Announces Plans to File New Drug Application for Pain Drug, 3268

SOUTH SAN FRANCISCO, Calif., July 12, 2006 /PRNewswire-FirstCall via COMTEX News Network/ -- Anesiva, Inc. (Nasdaq: ANSV) today announced that, based on a successful pre-filing meeting with the U.S. Food and Drug Administration, the company will file a New Drug Application (NDA) in the September/October timeframe for its lead product candidate 3268 -- a fast-acting, needle-free, local anesthetic that has been shown to significantly reduce pain associated with venipunctures, i.e., blood draws and intravenous (IV) placements. The meeting covered clinical, preclinical and manufacturing aspects of the drug, and the NDA will be filed as a Common Technical Document (CTD), which can be accepted for review under both domestic and international guidelines. If approved, 3268 could be launched in 2007 for the pediatric population.

Also during the pre-filing meeting, the FDA agreed that one additional Phase 3 trial in adults will be needed to seek a broader product label. This trial, which should take less than six months to complete, is expected to begin in the fourth quarter of this year. 3268 demonstrated statistically significant pain reduction in two Phase 3 clinical trials in children, which will form the basis of the initial NDA filing. The upcoming adult trial will, in a similar fashion to the pediatric trials, evaluate the ability of 3268 to show a reduction in pain associated with venipunctures vs. placebo.

"This regulatory strategy will enable us to launch 3268 in a stepwise manner with a sales force of 35-40 sales reps, which was always our plan. Our revenue guidance that we have provided of $150 to $200 million is unaffected. Immediately upon approval, we will work to get 3268 listed on hospital formularies, and we will focus our commercial activities on preparing for the growth of this topical local anesthetic market in advance of potential approval of the broader label to pave the way for entry into the adult emergency department and pre-surgery markets," said John P. McLaughlin, chief executive officer of Anesiva. "With its ease of use and onset of action within one to three minutes, 3268 is a highly differentiated product that may provide significant benefits over currently available therapies, which can take 30 to 60 minutes to provide analgesia, and 3268 may also enable physicians and nurses to reduce the pain and anxiety of their patients undergoing venous access procedures."

Statistically Significant Reduction in Pain

Two successfully completed Phase 3 trials involving over 1,000 patients will form the basis for the NDA. The first Phase 3 trial was conducted at six leading children's hospitals in the United States and enrolled 574 patients, three to 18 years of age. Patients received treatment with 3268 or placebo (an identical device but without drug) one to three minutes before venipuncture or intravenous line placement at the back of hand or antecubital fossa. The study met its primary endpoint by significantly reducing child-rated pain using the FACES pain scale upon needle insertion. The mean FACES score in patients treated with 3268 prior to needle insertion was significantly lower than patients treated with placebo (p = 0.007). Results from a similar pivotal Phase 3 trial, which employed an identical trial protocol and enrolled 535 pediatric patients at nine clinical centers in the United States also met its primary endpoint, demonstrating that patients treated with 3268 experienced a statistically significant reduction in pain (p = 0.002) compared to placebo. 3268 was well tolerated, and no clinically significant safety issues were observed in either study.

Each year, in U.S. hospitals, approximately 18 million venous access procedures, including IV placements, are performed in pediatric patients alone. Medical guidelines advocate the use of topical local anesthetics in pediatric procedures; however, compliance is not practical due to the limitations of currently available products. In addition to the pediatric hospital population, opportunities exist for 3268 in the adult hospital setting where it is estimated that 60 million venous access procedures occur annually in the emergency departments and approximately 27 million IV placement procedures occur prior to surgery. Furthermore, potential uses of 3268 include outpatient settings of oncology clinics and hemodialysis centers

Topical local anesthetics that ease the pain associated with venipunctures and IV placements is a highly underserved market. 3268 is a needle-free system that delivers lidocaine powder into the epidermis (top layer of skin) and provides analgesia in one to three minutes after administration. This rapid onset may be especially useful in pediatric populations and busy emergency rooms, because it enables uninterrupted care without the need to wait until the anesthesia takes effect to continue the medical procedure, which is another important advantage of 3268 over current options.

About Anesiva and its Diverse Pipeline of Pain Products

Anesiva, Inc., formerly Corgentech 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 three drug candidates in development for multiple pain-related indications, the most advanced of which, 3268, has completed Phase 3 clinical trials. 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. 1207, a new local anesthetic that is undergoing preclinical development as a topical local anesthetic, is anticipated to enter the clinic in 2006. 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: 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. Words such as "expect," "estimate," "project," "budget," "forecast," "anticipate," "intend," "plan," "may," "will," "could," "should," "believes," "predicts," "potential," "continue," and similar expressions are intended to identify such forward-looking statements. Forward-looking statements in this press release include, without limitation, projected timing of product development 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. Such risk factors include, among others: whether Anesiva can successfully develop new products and the degree to which these gain market acceptance. Actual results may differ materially from those contained in the forward-looking statements in this press release. Additional information concerning these and other risk factors is contained in Anesiva's quarterly report on Form 10-Q for the quarter ended March 31, 2006 filed with the Securities and Exchange Commission under the company's previous name, Corgentech Inc. 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, Inc.

Jennifer Cook Williams, Vice President, Investor Relations, +1-650-624-9600, or
[email protected]

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