SOUTH SAN FRANCISCO, Calif., March 28 /PRNewswire-FirstCall/ -- Anesiva, Inc. announced today that it has begun enrolling adult patients in a Phase 3 clinical study of Zingo(TM), the company’s fast-acting, local anesthetic to treat pain associated with peripheral venous access procedures. The trial is designed to enroll 700 adults undergoing intravenous cannulation or venipuncture procedures at multiple clinical centers in the United States. Patients enrolled in the trial will be randomized to receive treatment with either Zingo or placebo approximately one to three minutes prior to the peripheral venous access procedure. Anesiva has submitted a New Drug Application / Common Technical Document (NDA/eCTD) to the FDA requesting marketing clearance of Zingo to treat pain associated with intravenous cannulation and venipuncture procedures in children.
“The start of our adult trial for Zingo marks yet another important milestone in the development of this product as we move toward commercialization in our first indication, pediatrics, and plan to expand into broader patient populations over time,” said John P. McLaughlin, chief executive officer of Anesiva. “We anticipate announcing clinical data from this Phase 3 adult trial later this year and with positive data, would file a supplemental NDA for this population soon thereafter.”
New Drug Application Pending in Pediatric Patients
Under the Prescription Drug User Fee Act (PDUFA), the FDA makes a decision regarding marketing clearance of a product candidate within 10 months of the date of submission; the NDA / eCTD for Zingo was submitted on November 22, 2006. On Janurary 30, 2007, the FDA accepted the filing for review.
Data from two previously completed Phase 3 clinical studies served as the foundation of the NDA/eCTD and demonstrated that Zingo provided pain relief in children undergoing peripheral venous access procedures, such as intravenous (IV) line placements. These studies, which met the pre-specified primary endpoint, also showed that Zingo provided pain reduction when given one to three minutes prior to the peripheral venous access procedure. These 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, but the frequency and severity of skin-site abnormalities were greater in the Zingo group, particularly relating to redness of the skin. However, most skin reactions were minor, short-lived, and self limited. Zingo also met the primary endpoint and was shown to be well tolerated in several early-stage clinical trials in adults, which included over 500 patients total.
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 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 peripheral venous access procedures occur each year in pediatric patients alone, and more than 60 million occur in total in fast-paced emergency department settings.
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. In addition to 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. 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 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 Form 10-K for the year ended December 31, 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.
Anesiva, Inc.
CONTACT: Jennifer Cook Williams, Vice President, Investor Relations,Anesiva, Inc., +1-650-624-9600, or investors@anesiva.com
Web site: http://www.anesiva.com//
