SOUTH SAN FRANCISCO, Calif., April 1 /PRNewswire-FirstCall/ -- Anesiva, Inc. (Nasdaq: ANSV), a specialty pharmaceutical company focused on pain management, today announced that its consolidated financial statements for the fiscal year ended December 31, 2008, included in the Company's annual report on Form 10-K filed with the Securities and Exchange Commission on March 25, 2009, contained a going concern qualification from its independent registered public accounting firm. This announcement is being made in compliance with Nasdaq Marketplace Rule 4350(b)(1)(B), which requires separate disclosure of a recent audit opinion that contains a going concern qualification. This announcement does not represent any change or amendment to the Company's 2008 financial statements or to its annual report on Form 10-K.
Anesiva also announced that it received a letter on March 27, 2009 from The Nasdaq Stock Market ("Nasdaq") notifying the Company that it is not in compliance with Marketplace Rule 4450(a)(3) because the Company's stockholders equity at December 31, 2008, was less than the $10.0 million required for continued listing on The Nasdaq Global Market. In addition, the Company is not in compliance with Marketplace Rule 4450(b)(1) because the market value of listed securities of the Company is less than $50.0 million and the total assets and total revenue of the Company was less than $50.0 million as of December 31, 2008. In the notice, Nasdaq requested that the Company provide a plan to regain compliance with the continued listing requirements of The Nasdaq Global Market by April 13, 2009. Nasdaq will contact the Company with any questions or concerns regarding the plan. If Nasdaq does not accept the plan, it will provide the Company with a written notification that its securities will be delisted from The Nasdaq Global Market. If it receives a notification, the Company may then apply to move to The Nasdaq Capital Market or appeal Nasdaq's delisting determination to a Nasdaq Listing Qualifications Panel. The Company intends to submit a plan with Nasdaq before April 13, 2009, to maintain its listing on The Nasdaq Global Market.
This announcement is being made in compliance with Marketplace Rule 4803(a), which requires the Company to make a public announcement through the news media disclosing receipt of the Nasdaq letter and the Nasdaq rules upon which it is based.
Anesiva, Inc. 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.
Anesiva is based in South San Francisco, CA. For more information, go to www.anesiva.com.
Except for historical information, this press release may be deemed to contain "forward-looking" statements. Words such as "plan," "commence," "seek," "extend," and similar expressions are intended to identify such forward-looking statements. Forward-looking statements in this press release include 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 nature and extent of additional Adlea clinical trials that may be required by the FDA prior to Anesiva's submission of an application for approval to market Adlea, whether any clinical trials will be successful, and the ability to identify and successfully complete a strategic transaction for the assets related to Zingo. Actual results may differ materially from those contained in the forward-looking statements in this press release. Additional information concerning these and other risk factors is contained in Anesiva's annual report on Form 10-K for the year ended December 31, 2008. Anesiva undertakes no obligation to publicly update or revise any forward-looking statement in this or any prior forward-looking statements whether as a result of new information, future developments or otherwise.
|SOURCE Anesiva, Inc.|
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