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Anesiva Announces Pivotal Phase 3 Trial of Zingo(TM) Meets Primary Endpoint and Significantly Reduces Venous Access Pain in Adults
Date:10/16/2007

an 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 an
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SOURCE Anesiva, Inc.
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