SOUTH SAN FRANCISCO, Calif., July 23 /PRNewswire-FirstCall/ -- Anesiva, Inc. received, as previously disclosed on its Current Report on Form 8-K filed with the Securities and Exchange Commission on April 2, 2009 and in its press release on April 1, 2009, a letter from the NASDAQ Stock Market LLC ("NASDAQ") on March 27, 2009, informing Anesiva that it was not in compliance with Marketplace Rule 4450(a)(3) (which has since been superseded by Rule 5450(b)(1)(A)) (the "Rule"), because Anesiva's stockholder's equity at December 31, 2008 was less than the minimum $10.0 million required for continued listing on The NASDAQ Global Market.
On July 17, 2009, Anesiva received a letter from NASDAQ notifying Anesiva that based on NASDAQ's further review of Anesiva and material submitted by Anesiva, Anesiva has failed to regain compliance with the Rule and that, therefore, NASDAQ has determined to delist the Company's securities from The NASDAQ Global Market.
Anesiva has requested a hearing before a NASDAQ Hearings Panel to appeal the determination to delist Anesiva's securities. Anesiva's securities will remain listed on The NASDAQ Global Market pending a decision by the Hearings Panel following the hearing.
About Anesiva
Anesiva seeks to be a leader in the development and commercialization of novel pharmaceutical products for pain management. The company's lead product candidate is Adlea, a novel small molecule formulation of capsaicin that is currently in development for the management of acute pain following orthopedic surgeries. Adlea has been shown in clinical trials to provide extended pain relief after only a single administration in multiple indications for site-specific, acute and chronic, moderate-to-severe pain.
In December 2008, Anesiva announced that a Phase 3 clinical trial of Adlea achieved its primary efficacy endpoint of reduced post-surgical pain versus placebo (p=0.03) following total knee arthroplasty (TKA) 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).
The Phase 3 TKA trial, known as ACTIVE-2, also showed that Adlea's safety profile of adverse events, wound healing, and wound sensory function were similar to placebo over the study duration.
Forward-Looking Statements
Except for historical information, this press release may be deemed to contain "forward-looking" statements. Words such as "seek," "may," "will," and similar expressions are intended to identify such forward-looking statements. Forward-looking statements in this press release include the continued listing of Anesiva's common stock on The NASDAQ Global Market and matters that involve known and unknown risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to differ materially from results expressed or implied by this press release. Such risk factors include, among others: the risk that Anesiva otherwise fails to comply with the continued listing requirements of The NASDAQ Global Market or any other NASDAQ market as well as other risks detailed from time to time in Anesiva's filings with the Securities and Exchange Commission, including the Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2009. Anesiva expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in the company's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.
Anesiva, Inc.
CONTACT: John Tran of Anesiva, Inc., +1-650-624-9600
Web Site: http://www.anesiva.com/
