Corporate

Corporate

Anesiva, Inc. (Nasdaq: ANSV) is a late-stage biopharmaceutical company focused on the development and commercialization of novel pharmaceutical products for pain management.

Our first product, Zingo™ (lidocaine hydrochloride monohydrate) powder intradermal injection system, is marketed in the United States for use on intact skin to reduce the pain associated with peripheral IV insertions or blood draws in children three to 18 years of age. Our second product, Adlea™, is a long-acting, non-opioid analgesic with blockbuster potential for the management of post-operative pain associated with orthopedic surgery and pain due to moderate to severe osteoarthritis.

Zingo™ (lidocaine hydrochloride monohydrate) powder intradermal injection system — marketed to provide rapid, topical, local analgesia to reduce the pain associated with peripheral IV insertions or blood draws in children three to 18 years of age. Zingo is an easy-to-administer, single-use, needle-free system containing 0.5 mg sterile lidocaine powder. The rapid onset of action allows intravenous line placement or venipuncture to begin one to three minutes after Zingo administration.

In two pivotal, randomized, double-blind, placebo-controlled Phase 3 clinical studies that together enrolled over 1000 patients, Zingo demonstrated a statistically significant reduction in pain compared to placebo in children three to 18 years of age undergoing venipuncture or peripheral IV cannulation. The most common adverse reactions were redness (erythema), red dots (petechiae) and swelling (edema) at the site of administration.

Results of a large randomized, double-blind, placebo-controlled Phase 3 clinical trial, enrolling nearly 700 adult patients, demonstrated that patients undergoing venipuncture or peripheral IV cannulation one to three minutes after treatment with Zingo experienced significantly less pain versus placebo. The incidence of adverse events was no higher in active drug group vs. patients who received placebo. The most common findings were redness (erythema), red dots (petechiae) and swelling (edema) at the site of administration. Anesiva has submitted a supplemental new drug application (sNDA) with the FDA to expand Zingo’s label indication to include adults, and expects FDA action by January 2009.

For more information on Zingo, visit www.Zingo.com, call 866-ZINGORX (866-946-4679), or send an e-mail to medinfo@anesiva.com.

Adlea™ — long-acting, non-opioid analgesic in development for the management of post-operative pain associated with orthopedic surgery and moderate-to-severe osteoarthritis. Two Phase 3 clinical trials of Adlea are ongoing: one in total knee replacement surgeries and another in bunionectomy surgeries. These trials are intended to support a broad product label of management of post-surgical pain associated with orthopedic surgeries. Adlea has already demonstrated statistically significant pain reduction in Phase 2 trials in these settings, and has shown efficacy in other post-surgical settings as well as in moderate to severe osteoarthritis, tendonitis and Morton’s neuroma.

Anesiva, Inc.
650 Gateway Boulevard
South San Francisco, CA 94080
Phone: 650-624-9600
Fax: 650-624-7540