Anesiva, Inc. and Sigma-Tau Announce Exclusive Marketing and Distribution Agreement for Zingo(TM) in Six European Countries

SOUTH SAN FRANCISCO, Calif., Feb. 11 /PRNewswire-FirstCall/ -- Anesiva, Inc. and Sigma-Tau SpA have announced an agreement granting an exclusive license to Sigma-Tau for the marketing and distribution of Anesiva’s Zingo(TM) (lidocaine hydrochloride monohydrate) powder intradermal injection system in six European countries: Italy, France, Germany, Netherlands, Belgium and Luxembourg. Under the terms of the agreement, Sigma-Tau will oversee all necessary regulatory filings, and will be responsible for all marketing and sales of Zingo in their territory.

“In Sigma-Tau, we have selected an experienced partner that can quickly and effectively maximize the Zingo opportunity in Europe and we look forward to an excellent collaborative relationship. Sigma-Tau has a proven commercial infrastructure, including a hospital sales force, and a strong network in Europe,” said John P. McLaughlin, chief executive officer of Anesiva. “This licensing agreement covers the majority of Europe and we are currently in advanced discussions with other potential partners for certain additional countries.”

“Sigma-Tau seeks to help improve health and quality of life for all. Our agreement to bring Zingo to European markets fits perfectly with this aim, and we are eager to make this FDA-approved product available to patients who otherwise might not have access to it for the reduction of pain associated with peripheral venous access procedures,” said Ugo Di Francesco, Executive Vice President and Chief Executive Officer at Sigma-Tau.

The agreement between Anesiva and Sigma-Tau includes an upfront payment to Anesiva and transfer price, as well as milestone payments; additional terms were not disclosed.

About Zingo(TM)

Zingo(TM) is an easy-to-administer, single-use, needle-free system that delivers sterile lidocaine powder to provide topical, local analgesia to reduce the pain associated with peripheral I.V. insertions or blood draws. Zingo’s rapid onset of action allows intravenous line placement or venipuncture to begin one to three minutes after administration. Zingo was approved by the U.S. Food and Drug Administration (FDA) in August 2007 to reduce the pain associated with peripheral I.V. insertions or blood draws in children three to 18 years of age. In clinical trials, the most common adverse events with Zingo were redness (erythema), red dots (petechiae) and swelling (edema).

About Sigma-Tau Group

Sigma-Tau is a leading research-based Italian pharmaceutical company with a 2007 consolidated turnover equal to approximately US$980 million, and over 2,500 employees worldwide. Therapeutic areas in which the company’s research and development are focused include cardiovascular disease, metabolism, oncology, immunology, and central and nervous system disorders, with 47 projects, 30 clinical indications studied with 17 proprietary molecules, most of which are new and original. Sigma-Tau has operating subsidiaries throughout Europe and the United States and maintains a presence in all of the world’s major pharmaceutical markets. For additional information about Sigma-Tau, please visit http://www.sigma-tau.it.

About Anesiva and its 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 has one FDA-approved product, Zingo(TM), for the reduction of pain associated with peripheral venous access procedures in children ages three to 18. The second product in Anesiva’s pipeline, Adlea(TM), has been shown to reduce pain after only a single administration for weeks to months in multiple settings in numerous mid-stage clinical trials for site-specific, acute and chronic, moderate-to-severe pain. Anesiva is based in South San Francisco, CA, USA. 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 http://www.anesiva.com.

CONTACT: Investor Relations, Carol DeGuzman of Anesiva, Inc.,
+1-650-246-6898, investors@anesiva.com; or media, Carolyn Wang of WeissComm
Partners, +1-415-946-1065, Carolyn@weisscommpartners.com, for Anesiva,
Inc.; or Sigma-Tau Press Office and Public Relations Dept.,
+39-06-542-64-43, corporate@sigma-tau.it

Web site: http://www.anesiva.com/
http://www.sigma-tau.it/

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