Anesiva Announces Adlea ACTIVE-1 Phase 3 Clinical Results, Ceasing of Zingo Commercial Operations and Res...( Conference Call Scheduled for ...),Health

Conference Call Scheduled for November 11, 2008 at 9:00 am ET

SOUTH SAN FRANCISCO, Calif., Nov. 10 /PRNewswire-FirstCall/ -- Anesiva, Inc. (Nasdaq: ANSV) today announced that the ACTIVE-1 Phase 3 trial evaluating Adlea(TM), a novel formulation of capsaicin, narrowly missed its primary endpoint of reducing post-surgical pain versus placebo (p=0.07) following bunionectomy surgery at four to 32 hours post-surgery. The same measure was highly significant (p=0.004) from four to 48 hours post-surgery. The trial also achieved a key secondary endpoint of reducing opioid use for Adlea versus placebo (p=0.012) over the four to 32 hour period. Adverse events were similar for both active treatment and placebo groups. Results of a second Phase 3 trial of Adlea, in total knee replacement surgery, will be announced next month.

"It is important to note that the four to 32 hour pain measure reflected the inpatient period where activity is most restricted," said William Houghton, M.D., Anesiva senior vice president and chief medical officer. "In contrast, non-weight bearing mobilization increased during the latter period. Thus, the longer duration four to 48 hour measure highlights important analgesic potential for Adlea. We expect this to be confirmed in the upcoming ACTIVE-2 total knee arthroplasty study which uses the same four to 48 hour analgesic measure as its primary endpoint."

Anesiva has determined that it will cease further commitments to support Zingo commercialization as a result of continued manufacturing challenges and the need to recall product in the field due to a potential non-safety related shelf life issue from a lot of unreleased product. Anesiva plans to seek a device-oriented partner for this asset. The compan
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