Anesiva (ANSV) Announces ACTIVE-1 Phase 3 Trial Evaluating Adlea Missed Primary Endpoint; Ceases Certain Operations and Delays Earnings Release

November 10, 2008 5:05 PM EST

Anesiva, Inc. (Nasdaq: ANSV) announced that the ACTIVE-1 Phase 3 trial evaluating Adlea, 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 company will also seek to license rights to the underlying drug delivery technology to third parties for use with other medications.

The company plans to meet with its joint venture partners in China to discuss the future of the relationship. Anesiva will restructure, suspend or cancel Zingo distribution agreements for ex-U.S. territories. In order to wind down ongoing product support obligations, Anesiva will process the withdrawal of Zingo devices from the U.S. supply chain.

As a result of the decision to cease Zingo commercial operations, the company has agreed to work with its lenders to accelerate repayment of its outstanding $20.0 million loan. In order to preserve its capital, the company will reduce its staffing to approximately 15 employees and reduce monthly expenditures to approximately $2.0 million, pending the results of the Adlea Phase 3 trial in total knee replacement surgery.

As a result of the foregoing, Anesiva will delay filing its quarterly report on Form 10-Q for the quarter ended September 30, 2008. The Form 10-Q will be filed as soon as reasonably practical and is expected to be filed no later than November 14, 2008.

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