FDA News

Anesiva Outlines Comprehensive Commercialization Plan for FDA Approved Product Zingo

(Oct 14, 2007)-- Anesiva announced key elements of the company's commercialization and launch plans for 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. In addition, at its noon briefing in New York City today, the company will review its ongoing efforts and plans to raise market awareness, gain hospital formulary acceptance and routine use, and build and expand manufacturing capacity, including:

-- creation of an Anesiva sales force of 15 reps and 2 district managers;
-- an agreement with Sagent Pharmaceuticals to co-promote Zingo focusing on pharmacy and group purchase contracts;
-- the qualification of two automated manufacturing lines that will produce commercial quantities of product;
-- availability of Zingo in commercial quantities in the second quarter of 2008;
-- the promotions of Nancy Donahue and James Carr who will spearhead Zingo sales and marketing efforts; and
-- a joint venture with Wanbang Pharmaceuticals, a company of Fosun Pharmaceuticals of China to expand production capacity for Zingo while reducing the manufacturing cost of goods for the product at minimal
additional capital expense.

"Blood draws and intravenous access procedures are a huge source of anxiety and stress for children and their parents. Despite published guidelines calling for the use of topical local anesthetics during these procedures, currently existing topical anesthetic creams and patches are not routinely used because they take 20 minutes or longer to act," stated William T. Zempsky, M.D., associate professor, Department of Pediatrics, University of Connecticut; associate director, Pain Relief Program, Connecticut Children's Medical Center, Hartford. "Zingo's rapid onset means that it can be easily incorporated into a medical procedure allowing uninterrupted care, an important advantage over current options." Dr. Zempsky will be the featured speaker at today's briefing.

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