Company Plans to File Supplemental New Drug Application with FDA in First
SOUTH SAN FRANCISCO, Calif., Oct. 16 /PRNewswire-FirstCall/ -- Anesiva, Inc. (Nasdaq: ANSV) today announced positive top-line results from its pivotal Phase 3 trial. The multi-center, randomized, double-blind study with 699 adult patients met its primary endpoint, demonstrating less venous procedural pain in those treated with Zingo(TM) (lidocaine hydrochloride monohydrate) powder intradermal injection system compared to placebo (p= 0.003). Patients received Zingo or placebo one to three minutes prior to undergoing venous access procedures (IV insertions or blood draws). Zingo was found to be well tolerated in this patient population. Anesiva plans to file a supplemental new drug application (sNDA) with the U.S. Food and Drug Administration (FDA) in the first quarter of 2008 for the use of Zingo in adults.
"We've now shown that Zingo works in both the pediatric and adult populations. An expanded label from the FDA to include adults could greatly expand the market opportunity for us," said John P. McLaughlin, chief executive officer of Anesiva. "We have a world-class commercialization team that has significant efforts underway to prime the market for Zingo's introduction to pediatric hospitals in order to prepare for a strong launch and the development of a very successful business."
Zingo is already approved by the FDA to provide local analgesia prior to venipuncture or peripheral intravenous cannulation in children three to 18 years of age. Its onset of action is one to three minutes. Venous access procedures are among the most common procedures performed at a hospital, with more than 400 million such procedures performed each year in U.S. hospitals on adults. More than 60 million of these procedures take place in the emergency department, and another 27 million IV line placements are associated with pre- surgery procedures.
"Pain associated with venous access procedures is a common and under- addressed concern in adult patients," said K. Peony Yu, M.D., vice president, clinical research at Anesiva. "Because Zingo works within minutes, it would provide a treatment option enabling physicians to reduce the pain for their patients without interrupting the flow of care; this means they'll be more likely to use it."
Zingo, which was approved by the FDA for the pediatric population in August, is expected to be commercially available in the second quarter of 2008. Anesiva recently announced it will hire a sales force of two sales directors and 15 sales representatives to support the launch of Zingo for pediatric use. Anesiva also announced a co-promotion collaboration with Sagent Pharmaceuticals, Inc. Sagent will join with Anesiva to co-promote Zingo within hospitals as well as facilitating contract negotiations with hospitals and group purchasing organizations. Sagent's team will focus their selling efforts toward hospital pharmacists, with Anesiva promoting primarily to physicians and nurses. In addition, Sagent will manage Zingo warehousing and distribution services. The terms of the agreement provide for Sagent to earn a royalty based on Anesiva's net sales of Zingo and for Anesiva to reimburse Sagent for certain direct expenses. In addition, Anesiva has entered a joint venture with Wanbang Biopharma, a company of Fosun of Shanghai, China to establish additional manufacturing capacity for worldwide supply.
Study Details and Results
The Phase 3 study of Zingo in adults enrolled 699 patients undergoing intravenous cannulation or venipuncture procedures at multiple clinical centers in the U.S. 348 patients received placebo and 345 patients received Zingo one to three minutes before undergoing medical procedures requiring venipuncture or IV line placement at the back of hand or antecubital fossa (crux of the elbow). The primary endpoint was pain upon needle insertion utilizing the VAS pain scale. Demographic characteristics and sites of administration were evenly distributed across treatment groups.
The mean pain score in the Zingo-treated patients was significantly lower than in the placebo group (p = 0.003). Zingo was also well tolerated. The most common skin assessment findings were redness (erythema), red dots (petechiae) and swelling (edema) at the site of administration. The incidence of adverse events with Zingo was no higher than with placebo.
Zingo is a ready-to-use, single-use, needle-free system that delivers sterile lidocaine powder into the skin and provides topical, local 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 addition to the hospital setting, Zingo may be used in physicians' offices and clinical laboratories. Anesiva also intends to expand the product label beyond the pediatric population by filing an sNDA for Zingo in adults in early 2008.
About Anesiva and its Diverse Portfolio 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 one FDA-approved product, Zingo(TM) (lidocaine hydrochloride monohydrate) powder intradermal injection system, to reduce pain associated with peripheral venous access procedures in children three to 18 years of age. The second product in Anesiva's pipeline, Adlea(TM) (formerly 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: the timing and results of our clinical trials, whether Anesiva is able to manufacture its products on commercially reasonable terms, whether Anesiva can secure FDA approval for the use of Zingo in adults, and the degree to which Zingo gains 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 June 30, 2007.
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.|
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