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Anesiva Accelerates Its Transition to Specialty Pharma Pain Management Company
Date:9/3/2008

et, pending approval.

Adlea:

-- Anesiva announced today that it has completed patient enrollment in two multicenter, double-blind, randomized, placebo-controlled Phase 3 Adlea trials, one in bunionectomy surgeries (the ACTIVE-1 trial -- Assessment of Highly Purified Capsaicin To ImproVE Pain Management After Orthopedic Surgery), and one in total knee replacement surgeries (ACTIVE-2). The company continues to anticipate that top-line data from the trials will be available in the fourth quarter of 2008. Enrollment continues in the supportive Phase 2 trials of Adlea in total hip replacement surgeries and arthroscopic shoulder surgeries. Anesiva anticipates having top-line data from these trials in mid-2009.

-- Anesiva has re-evaluated the data package it believes will be needed for an optimal Adlea NDA filing. As a result, the company determined that the completed and ongoing trials will need to be supplemented in order to support the proposed Adlea dose and increase the number of Adlea patient exposures. Anesiva plans an additional clinical trial in total knee replacement surgeries to start in the fourth quarter of 2008. This trial is designed to enroll up to 240 patients and include an interim analysis. It will evaluate three Adlea doses and placebo. The company estimates it will take approximately one year to fully enroll. Provided the results of the completed and ongoing trials warrant, Anesiva anticipates filing a New Drug Application for Adlea in mid-2010 for the management of acute pain following orthopedic surgeries.

"I am working with Bill Houghton, M.D., who recently joined Anesiva as senior vice president and chief medical officer, and who has a strong background in the development of pain management products, to fully capitalize on the large Adlea clinical and commercial opportunity," Mr. Kranda said.

About Anesiva and its Diverse Pipeline of Pain Products

Anesiva, Inc. is a commercial-stage specialty pharmaceutical
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SOURCE Anesiva, Inc.
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Related medicine technology :

1. Anesiva Commences Phase 2 Trial of Adlea(TM) in Arthroscopic Shoulder Surgery
2. Anesiva Announces South Korea FDA Approval of Adlea(TM) Investigational New Drug Application
3. Anesiva Announces Publication of Phase 3 Zingo(TM) Data in the Journal Pediatrics
4. Anesiva Announces Pivotal Phase 3 Clinical Trial of Adlea(TM) for Reducing Post-Surgical Pain Following Total Knee Replacement
5. Anesiva Commences Phase 3 Clinical Trial of Adlea(TM) for Reducing Post-Surgical Pain Following Bunionectomy
6. Anesiva Announces Pivotal Phase 3 Trial of Zingo(TM) Meets Primary Endpoint and Significantly Reduces Venous Access Pain in Adults
7. Anesiva Defines Regulatory Pathway for Adlea with FDA
8. Anesiva Initiates Phase 2 Trial with Adlea(TM) for Pain Relief Following Total Hip Replacement Surgery
9. Anesiva Initiates New Phase 2 Trial of Adlea(TM) for Pain Relief Following Knee Replacement Surgery
10. Anesiva Completes Enrollment in Phase 3 Clinical Trial of Zingo(TM) to Treat Pain Associated With Venous Access Procedures in Adults
11. Delcath Updates Phase III Patient Enrollment as Pivotal Trial Accelerates, Durable Tumor Responses In Phase II Study Also Cited
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