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Published on 10/30/2006 in the Prospect News Biotech Daily.

Anesiva expects to end 2006 with $35-$40 million, will consider financing 'soon'

By Jennifer Lanning Drey

Portland, Ore., Oct. 30 - Anesiva, Inc. expects to end the year with $35 million to $40 million in cash after having used cash of about $45 million to $50 million in 2006, John P. McLaughlin, Anesiva's chief executive officer, said Monday at the C.E. Unterberg, Towbin health care conference.

When asked about how the company will be financially able to carry out all of its upcoming plans, McLaughlin said Anesiva will consider a financing "at some point soon."

He also said the company is involved in partnership discussions.

Anesiva's most advanced product is Zingo (lidocaine), a topical local anesthetic that has a target indication of pain reduction associated with venipunctures and intravenous line placements.

The company expects to complete release testing for Zingo in the second week of November and file a New Drug Application as a common technical document shortly thereafter. The timing is slightly later than Anesiva's original guidance of October for the NDA submission.

Anesiva expects Zingo to be approved with a pediatric label in 2007.

The company also plans to conduct a single phase 3 trial in adults late in 2006 and submit a New Drug Application for that label in 2007, McLaughlin said.

In addition to advancing Zingo toward commercialization, Anesiva is preparing for a fourth-quarter meeting with the Food and Drug Administration to discuss possible approval pathways for its product candidate, 4975, a long-lasting, non-opioid analgesic.

The four approval pathways the company plans to discuss are: management of post-surgical pain, management of pain in Morton's neuroma patients, management of pain in patients with end-stage osteoarthritis and management of musculoskeletal pain such as osteoarthritis and tendonitis.

The company will not simultaneously pursue all four pathways, but will begin with one or two. Those not pursued immediately will be discussed with potential partners, McLaughlin said.

Anesiva also started a phase 1 clinical trial in October for its product candidate, 1207, for neuropathic pain.

Anesiva, formerly Corgentech, is a late-stage biopharmaceutical company based in South San Francisco, Calif.


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