Key Developments For Anesiva, Inc.
Anesiva, Inc. (ANSV.O) (Consolidated Issue listed on NASDAQ Global Market)
Anesiva, Inc. And Arcion Therapeutics, Inc. Announce Merger Agreement
Anesiva, Inc. and Arcion Therapeutics, Inc. announced the signing of a definitive merger agreement. The merger will result in a public company with a portfolio of late stage targeted pain therapeutics. The merger transaction, approved by both companies' Boards of Directors, will combine the companies under the name of Arcion Therapeutics, and is expected to close in the third quarter of 2009. Upon closing of the merger, Arcion and Anesiva shareholders will own approximately 64% and 36%, respectively, of the outstanding shares of the combined company.
Anesiva, Inc. Announces Planned Rights Offering
Anesiva, Inc. announced that it is planning to commence a rights offering of notes to its stockholders, which, would if fully subscribed, produce gross proceeds to Anesiva of an aggregate principal amount of $3,000,000. Anesiva will be distributing non-transferable rights to subscribe for and purchase notes to common stockholders of record as of 5:00 p.m., Pacific time, on March 27, 2009, (Record Date). In the offering, each common stockholder will receive a right to purchase a portion of the principal amount of notes, for each share of common stock of Anesiva owned as of 5:00 p.m., Pacific time, on the Record Date, either as a holder of record or as a beneficial owner of shares held of record on his or her behalf by brokers, dealers, custodian banks or other nominees. Stockholders will be able to exercise their rights to purchase notes in the offering until 5:00 p.m., Pacific time, on April 28, 2009, the expected expiration date of the rights offering. Anesiva, in its sole discretion, may extend the period for exercising the subscription rights.
Anesiva, Inc. Eliminates CFO Position-Form 8K
Anesiva, Inc. announced in its Form 8K that in connection with the continuous review of Company operations and cost cutting measures, the position of Chief Financial Officer (CFO) of the Company has been eliminated, and Jean-Frédéric Viret's employment with the Company was terminated effective February 18, 2009. The Company will not seek a new Chief Financial Officer at this time.
Anesiva, Inc. Announces FDA Approval Of Supplemental New Drug Application To Expand Zingo Indication
Anesiva, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Anesiva's supplemental New Drug Application (sNDA) to expand the indication for Zingo to treat the pain associated with blood draws to include adults. Zingo (lidocaine hydrochloride monohydrate) powder intradermal injection system was previously approved to treat the pain associated with peripheral IV insertions and blood draws in children three to 18 years of age. The notification was received according to PDUFA deadlines. As announced in November 2008, Anesiva ceased Zingo commercial activities to focus on the development of Adlea, its novel non-opioid, long-acting analgesic drug candidate for the management of acute pain following orthopedic surgeries. Anesiva is seeking to license Zingo as well as the underlying drug delivery technology and intellectual property.
Anesiva, Inc. Phase 3 Trial Of Adlea Meets Primary Endpoint To Reduce Pain After Total Knee Replacement Surgery
Anesiva, Inc. announced top-line results showing that the Phase 3 trial evaluating Adlea, its long-acting, non-opioid analgesic drug candidate, achieved its primary efficacy endpoint of reducing post-surgical pain versus placebo (p=0.03) following total knee arthroplasty (TKA, or total knee replacement surgery) at four to 48 hours after surgery. The trial also met its key secondary endpoint with Adlea demonstrating a highly significant reduction in opioid medication consumption compared to placebo (p=0.005). Adlea is a long-acting, non-opioid drug candidate in development for the management of acute pain following orthopedic surgery. The Phase 3 TKA trial, known as ACTIVE-2 (Assessment of highly purified Capsaicin To ImproVE pain management after orthopedic surgery), also showed that Adlea's safety profile of adverse events, wound healing, and wound sensory function were similar to placebo over the study duration.
