August 7, 2008

Anesiva Announces Second Quarter 2008 Financial Results and Update

SOUTH SAN FRANCISCO, Calif., Aug. 7 /PRNewswire-FirstCall/ -- Anesiva, Inc. today reported financial results and accomplishments for the second quarter and six months ended June 30, 2008.

"The 2008 second quarter marked a significant advance for Anesiva as we introduced Zingo(TM) in the U.S. pediatric hospital market," said Michael L. Kranda, president and chief executive officer. "In addition, I'm pleased to report that our Phase 3 trials of Adlea(TM) for the management of acute pain following total knee replacement surgeries and bunionectomy surgeries are nearing full patient enrollment. As a result, we anticipate releasing top-line data from both trials in the fourth quarter of this year."

"While we continue to make progress in our current commercial and clinical initiatives, I am conducting a full strategic review of the company's programs, timelines and resource allocations," Mr. Kranda said. "Based on the results of this evaluation, in early September I intend to present a comprehensive forward-looking plan for Anesiva's growth as a company focused on the late-stage development and commercialization of novel products that address unmet needs in the treatment of pain." Mr. Kranda was appointed Anesiva's president, chief executive officer and member of the board of directors in June 2008.

Second Quarter 2008 Financial Results

Total operating expenses in the second quarter of 2008 were $22.1 million, including $1.6 million in non-cash stock-based compensation, compared to total operating expenses of $14.7 million, including $2.4 million in non-cash stock- based compensation, in the second quarter of 2007. For the six months ended June 30, 2008, total operating expenses were $43.9 million compared to $27.4 million for the six months ended June 30, 2007, and include $3.2 million and $4.5 million in non-cash stock-based compensation in the 2008 and 2007 periods, respectively.

Operating expenses during the quarter primarily related to the continued development and commercial preparations to launch, Zingo, a fast-acting, needle-free, local anesthetic, for the pediatric indication. Additional operating expenses related to the ongoing development of Adlea, which is being evaluated in Phase 3 trials for the treatment of acute pain following total knee replacement surgeries and bunionectomy surgeries.

For the second quarter of 2008, the net loss was $21.9 million, or $0.54 per share. In the second quarter of 2007, the net loss was $13.8 million, or $0.51 per share. The net loss for the six months ended June 30, 2008 was $43.4 million, or $1.08 per share, and for the six months ended June 30, 2007, the net loss was $25.5 million or $0.93 per share.

As of June 30, 2008, cash, cash equivalents and investments were $48.7 million compared to $90.8 million at December 31, 2007. The company believes it has sufficient resources to fund anticipated expenses for the remainder of 2008 and into 2009.

   Commercial and Product Development Updates:    Zingo   -- Following the Zingo U.S. commercial launch in late June, Anesiva began      supplying hospitals in its target pediatric market.  The early phase of      the Zingo launch is focused on supporting initial product experiences      and formulary review and acceptance processes in these institutions.    

Commenting on the initial Zingo launch, Nancy E. Donahue, senior vice president, sales and marketing, said, "While it is too early to provide meaningful sales metrics as we are just six weeks into the launch, initial qualitative feedback from healthcare providers who have used Zingo suggests that they are very pleased with its performance and ease of use. We continue to conduct training sessions for selected healthcare providers to advocate for better venous access pain management for their pediatric patients, to grow membership in RNVoice, and to experience increased visits to"

   -- The FDA accepted Anesiva's electronic sNDA filing to expand the Zingo      label indication to include adults. Under the Prescription Drug User      Fee Act (PDUFA), the agency is expected to make a decision regarding      approval by January 2009.    -- The journal Pediatrics published full results of one of the two pivotal      Phase 3 pediatric trials of Zingo.    -- Anesiva signed an exclusive Zingo licensing and distribution agreement      with Green Vision Company for territories in the Middle East, and      expanded the territories covered under the license and distribution      agreement with Sigma Tau SpA to include most of Europe.     Adlea   -- During the second quarter, Phase 3 enrollment began in a trial of Adlea      for the management of acute pain following total knee replacement      surgery. This multicenter, double-blind, placebo-controlled study will      evaluate the efficacy and safety of a single dose of Adlea or placebo      administered prior to closure of the surgical wound. Total planned      enrollment is 214 patients. Enrollment continued in a 300 patient Phase      3 trial of Adlea in patients undergoing bunionectomy surgery.    -- Anesiva initiated a Phase 2 trial with Adlea for the management of      acute pain following arthroscopic shoulder surgery. Total planned      enrollment in this multicenter, double-blind, dose-escalation, placebo-      controlled trial is 74 patients.    -- Several Adlea posters will be presented at the upcoming World Congress      on Pain, a major international meeting to be held August 17-22, 2008.      Studies to be presented will include:      * A Phase 2, 185-patient randomized, placebo-controlled, dose-        escalation study in bunionectomy surgeries, which demonstrated        statistically significant reductions in average and worst pain scores        in the 1 mg Adlea dose group compared to placebo. In addition,        patients in the 1 mg Adlea group had a statistically significantly        longer median time to first use of an opioid or another acute pain        treatment compared to placebo. This Phase 2 trial is the basis for        the ongoing Phase 3 Adlea trial in bunionectomy surgeries, which        compares the same 1 mg Adlea dose to placebo control; the primary        endpoint in both trials is reduction in pain up to 32 hours post-        surgery for Adlea versus placebo.      * An exploratory clinical study in painful osteoarthritis of the knee        in which Adlea was generally well-tolerated, particularly when        stepwise dosing was used to reduce pain on injection in this non-        surgical setting. The study also generated longer-term data        suggesting reduced pain scores compared to baseline for up to the        eight week study endpoint.      * An independent presentation on long-term follow up from a study in        herniotomy surgeries which showed that, two years post-surgery, Adlea        treatment did not differ from placebo with regard to long-term        effects on sensory function in the surgical area.      * Preclinical studies suggesting that a single, clinically relevant        dose of Adlea does not have observable adverse effects on wound and        bone healing. A separate preclinical study demonstrated that a single        dose of Adlea caused a prolonged decrease in specific neuronal        markers and the TRPV1 receptor, suggestive of desensitization of the        nerve fibers, which gradually reversed several weeks following        treatment.     Additional Development   -- Anesiva out-licensed worldwide rights to its NF-kappa B Decoy program      to Transcription Factor Therapeutics, Inc. Anesiva will receive an      upfront licensing fee, and will be entitled to receive milestone      payments totaling up to $114 million if two products are      commercialized. NF-kappa B is a protein implicated in autoimmune and      inflammatory disease processes, therapeutic areas outside Anesiva's      current focus on pain management.     About Anesiva and its Diverse Pipeline of Pain Products  

Anesiva, Inc. is a late-stage biopharmaceutical company that seeks to be the leader in the development and commercialization of novel pharmaceutical products for pain management. The company's first commercial product, Zingo(TM), is available in the U.S. for the reduction of pain associated with peripheral venous access procedures in children ages three to 18. For full Zingo prescribing information and other information, visit An sNDA is under review at FDA to expand the Zingo label indication to include adults.

The next product in Anesiva's pipeline, Adlea(TM), is currently being evaluated in Phase 3 clinical trials for the management of acute pain following orthopedic surgeries. Adlea has been shown to reduce pain after only a single administration for up to weeks to months in multiple settings based on the results of several mid-stage clinical trials for site-specific, acute and chronic, moderate-to-severe pain.

Anesiva is based in South San Francisco, CA. For more information about Anesiva's leadership in the development of products for pain management, and an overview of the clinical challenges being addressed by its product candidates, go to

Forward-Looking Statements

This press release includes "forward-looking statements" within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Words such as "expect,""estimate,""project,""budget,""forecast,""anticipate,""intend,""plan,""may,""will,""could,""should,""believes,""predicts,""potential,""continue," 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: whether Zingo gains FDA approval in the adult indication, the degree to which Zingo gains market acceptance, and whether the Adlea clinical trials will be successful. 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, 2007, and its most recent filing on Form 10-Q.

                               Anesiva, Inc.              Condensed Consolidated Statements of Operations                  (In thousands, except per share amounts)                                       For the three months For the six months                                          ended June 30,      ended June 30,                                          2008      2007      2008      2007    Contract revenues                      $302        $-      $303        $-   Operating expenses:      Manufacturing start-up costs       1,125         -     1,125         -      Research and development          13,063     8,412    26,447    15,374      Sales, general and       administrative                    7,914     6,246    16,371    12,000   Total operating expenses             22,102    14,658    43,943    27,374   Loss from operations                (21,800)  (14,658)  (43,640)  (27,374)    Interest expense and other income      (111)      820       137     1,858    Loss before minority interest       (21,911)  (13,838)  (43,503)  (25,516)    Minority interest in loss of    variable interest entity                 52         -        61         -    Net loss                           $(21,859) $(13,838) $(43,442) $(25,516)    Basic and diluted net loss per    common share                        $(0.54)   $(0.51)   $(1.08)   $(0.93)    Weighted average shares used to    compute basic and diluted net    loss per common share               40,328    27,376    40,299    27,353                                  Anesiva, Inc.                   Condensed Consolidated Balance Sheets                               (In thousands)                                                 June 30,         December 31,                                                  2008               2007                                               (Unaudited)          (Note)   Assets    Cash and cash equivalents                      $48,667            $90,840   Other current assets                             4,082              2,225   Total current assets                            52,749             93,065    Property and equipment, net                     17,733             15,276   Other assets, non-current                        1,466              1,395   Total assets                                   $71,948           $109,736    Liabilities and stockholders' equity    Current liabilities                            $15,117            $12,175   Long term obligations                            7,882              9,047   Minority interest                                  485                  -    Total stockholders' equity                      48,464             88,514   Total liabilities and stockholders' equity     $71,948           $109,736    (Note): Derived from audited financial statements at that date.  

Anesiva, Inc.

CONTACT: Carol DeGuzman, Senior Director, Investor Relations of Anesiva,Inc., +1-650-246-6898, [email protected]; or Media, Carolyn Wang ofWeissComm Partners, +1-415-946-1065, [email protected], for Anesiva, Inc.

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