Healthcare Industry News: hemodialysis
News Release - November 27, 2006
Anesiva Announces Filing of New Drug Application for Zingo(TM) to Reduce Pain Associated with Needle Insertion Procedures in ChildrenSOUTH SAN FRANCISCO, Calif., Nov. 27 (HSMN NewsFeed) -- Anesiva, Inc. (Nasdaq: ANSV ) announced today that the company has filed a New Drug Application (NDA) with the FDA for marketing clearance of Zingo(TM) to treat the pain associated with venous access procedures in children. As part of the company's continued development of Zingo, Anesiva expects to begin a follow-on clinical trial in adults in early 2007. As previously announced, Anesiva has obtained commitments to purchase approximately $45 million of its common stock, which it anticipates closing on November 28, 2006.
The company filed the NDA using the Common Technical Document (CTD) format, which can be reviewed by both the U.S. FDA and international regulatory authorities for domestic and international registration of new therapeutics.
Data from two pivotal Phase 3 clinical studies that serve as the foundation of the NDA demonstrated that Zingo (previously known as 3268), a fast-acting, local anesthetic, provided statistically significant pain relief in children undergoing venous access procedures, such as intravenous (IV) line placements. These data indicated that treatment with Zingo quickly and effectively reduced pain when given just one to three minutes prior to the venous access procedure. In addition to the positive efficacy data from the two trials, treatment with Zingo was found to be safe and well tolerated. The two studies collectively enrolled 1,109 patients at 15 clinical centers in the United States.
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 400 million venous access procedures occur each year. In pediatric patients alone, there are 18 million annual procedures. In addition to the hospital population, opportunities exist for Zingo in hemodialysis and blood donation centers, as well as physicians' offices and clinical laboratories.
About Anesiva and its Diverse Pipeline of Pain Products
Anesiva, Inc. is a biopharmaceutical company focused on the development and commercialization of novel therapeutic treatments for pain. The company has three drug candidates in development for multiple pain-related indications. Anesiva is based in South San Francisco, CA.
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 filing of the NDA for marketing clearance for Zingo, 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.
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