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Zingo

Generic name: lidocaine hydrochloride monohydrate
Treatment for: Local Anesthesia

Update: Zingo Now FDA Approved - August 16, 2007

Anesiva Announces FDA Acceptance for Filing of Zingo New Drug Application to Reduce Pain Associated With Needle Insertion Procedures in Children

SOUTH SAN FRANCISCO, Calif., February 7, 2007 -- Anesiva, Inc. announced today that the FDA has accepted for filing the company's electronic New Drug Application (NDA)/Common Technical Document (eCTD) for marketing clearance of Zingo to treat pain associated with intravenous cannulation and venipuncture procedures in children. Acceptance for filing of an NDA/eCTD means that the FDA has found the company's submission to be sufficiently complete to review. This review is a standard review, and under the Prescription Drug User Fee Act (PDUFA), the agency makes a decision regarding marketing clearance of a product candidate within 10 months of the date of its submission. The NDA/eCTD for Zingo was submitted on November 22, 2006.

Anesiva anticipates marketing Zingo for this indication in the United States with a focused, specialty sales force and is actively seeking an international partner to make Zingo available internationally. The company filed the NDA using the eCTD format, which can be reviewed by the U.S. FDA and is also a marketing authorization format accepted by many international regulatory authorities.

"The submission and now acceptance for filing of our first NDA/eCTD underscores our commitment to develop and commercialize important new pain medications," said John P. McLaughlin, chief executive officer of Anesiva. "We look forward to collaborating with the FDA in the review and approval process of the CTD and bringing this important treatment to children."

"Based upon the positive clinical efficacy and safety data observed to date from Phase 2 clinical studies of Zingo in adults, we are actively continuing the development of this product with the initiation of a Phase 3 trial in adults later this quarter," Mr. McLaughlin added.

Clinical Data

Data from two Phase 3 clinical studies that serve as the foundation of the NDA/eCTD demonstrated that Zingo (previously known as 3268), a fast-acting, local anesthetic, provided pain relief in children undergoing venous access procedures, such as intravenous (IV) line placements. These data, which achieved statistical significance, also howed that Zingo provided pain reduction when given one to three minutes prior to the venous access procedure. The two studies collectively enrolled 1,109 patients at 15 clinical centers in the United States. Zingo was shown to be well tolerated in these studies.

Zingo Mechanism of Action and Market Potential

Zingo is a needle-free system that delivers lidocaine powder into the epidermis of the skin and provides analgesia in one to three minutes after administration. This rapid onset, which may be especially useful in pediatric populations and busy emergency room settings, means the product can be incorporated into a medical procedure allowing uninterrupted care, an important advantage over current options. In hospitals in the United States, approximately 18 million venous access procedures occur each year in pediatric patients alone.

Posted: February 2007

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