Healthcare Industry News: Sagent Pharmaceuticals
News Release - June 30, 2008
Anesiva Launches Needle-Free Zingo(TM) to Reduce Pain from IV Starts and Blood Draws in ChildrenConference Call and Webcast Today at 1:00 pm ET / 10:00 am PT
SOUTH SAN FRANCISCO, Calif., June 30 (HSMN NewsFeed) -- Anesiva, Inc. (Nasdaq: ANSV ) today announced that it has launched its first commercial product, Zingo(TM) (lidocaine hydrochloride monohydrate) powder intradermal injection system. Zingo is an easy-to-administer, single-use, needle-free system that reduces the pain associated with peripheral intravenous (IV) line placements and blood draws in children three to 18 years of age. Zingo works quickly, within one to three minutes, to relieve pain at the needle insertion site.
"Zingo is the first easy-to-administer, fast-acting local anesthetic that could lead to a paradigm shift in the approach to venous access procedures such as drawing blood and placing IV lines in children," said William T. Zempsky, M.D., Associate Professor, Department of Pediatrics, University of Connecticut; Associate Director, Pain Relief Program, Connecticut Children's Medical Center, Hartford, who led the pediatric trials of Zingo. "Because available topical anesthetic creams can take up to 30 to 60 minutes to work, healthcare providers have had to sacrifice patient comfort when performing the numerous peripheral venous access procedures that occur each day. Zingo will be a source of relief to both them and the children and parents they deal with every day."
"The commercial launch of Zingo is a major milestone that is notable both for our company and for patients. We are fully committed to driving successful market introduction for this exciting new product," said Michael L. Kranda, Anesiva's president and chief executive officer.
Driving Penetration and Uptake for Large Unmet Need
"We are initially focusing our efforts on the children's hospitals and academic medical centers with large pediatric units which facilitate the majority of acute and chronic pediatric care. Many of the patients served in these hospitals undergo peripheral venous access procedures repeatedly, and are undertreated, indicating a significant unmet medical need," said Nancy E. Donahue, senior vice president, sales and marketing. Anesiva estimates that approximately 18 million pediatric peripheral venous access procedures are performed annually in U.S. hospitals.
Anesiva and its co-promotion partner Sagent Pharmaceuticals, Inc. are working in tandem to educate caregivers about the importance of addressing peripheral venous access pain in children, and to ensure Zingo availability through hospital pharmacies. Anesiva's seasoned team of 15 hospital-based regional account managers with an average of 14 years' industry experience, led by two directors who have a combined 30 years' experience, will drive the launch of this product in the United States. Sagent has assigned 15 field representatives, all of whom have an average of more than 18 years' hospital selling experience and whose national account representatives have an average of 25 years of hospital sales experience.
Zingo is currently manufactured with established, approved processes. Anesiva continues to pursue Zingo manufacturing scale-up in order to reduce cost of goods and meet anticipated increasing market demand.
Anesiva intends to grow a global brand for Zingo through geographically based license and distribution agreements with companies that have expertise in hospital-based markets in their territories, and has already entered into agreements for several major markets. Sigma Tau SpA will market Zingo in most major European markets; Medical Futures, Inc. is responsible for commercializing Zingo in Canada; and Green Vision Company will commercialize Zingo in several countries in the Middle East. Planning for local regulatory filings for marketing approval is underway. Discussions for license and distribution agreements in other major markets are in progress. Anesiva also has established a joint venture in China for the assembly of Zingo devices using U.S.-sourced components.
Peripheral venous access procedures are among the most frequently reported painful events in hospitalized children.(1) The American Pain Society and the American Academy of Pediatrics, among other organizations, have developed recommendations that emphasize the importance of minimizing procedural pain in children whenever possible.(2) However, despite the existence of these recommendations, children undergoing these procedures remain largely under- treated.(3)
Zingo 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 IV insertions or blood draws, approved for use in children aged three to 18. Zingo's rapid onset of action allows intravenous line placement or venipuncture to begin one to three minutes after administration. In clinical trials, the most common adverse events with Zingo were redness, red dots and swelling. For full Zingo prescribing information, go to http://www.zingo.com.
A supplemental New Drug Application (sNDA) is under FDA review to expand Zingo's indicated use to include adults. FDA action on the sNDA is anticipated by January 2009, based on the standard review period under the Prescription Drug User Fee Act (PDUFA).
Conference Call and Webcast
Anesiva management will host a conference call and webcast at 10:00 am Pacific time (1:00 pm Eastern time) today to discuss the Zingo commercial launch. Interested parties can listen to the live audio webcast by dialing (866) 616-3642 (international dial: (706) 643-3817) or by logging on to http://www.anesiva.com and going to the Investor Information page. A slide presentation that will accompany the call also will be available for download from the Investor Information page. For those unable to participate via the Internet, a 24-hour replay will be available for seven days after the call by dialing (800) 642-1687 (international dial: (706) 645-9291) and giving the following pass code: 53907567.
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.
The next product in Anesiva's pipeline, Adlea(TM), is currently being evaluated in two pivotal Phase 3 clinical trials to support an indication for the management of acute pain following orthopedic surgery. Adlea has been shown to reduce pain after only a single administration for weeks to months in multiple settings in 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 www.anesiva.com.
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, and the degree to which Zingo gains market acceptance. 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.
(1) Wong DL, Baker CM. Pain in children: comparison of assessment scales. Pediatr Nurs. 1988;14(1):9-17.
(2) American Academy of Pediatrics Committee on Psychosocial Aspects of Child and Family Health and American Pain Society Task Force on Pain in Infants, Children, and Adolescents. The assessment and management of acute pain in infants, children, and adolescents. Pediatrics. 2001;108:793-797.
(3) MacLean S, Obispo J, Young KD. The gap between pediatric emergency department procedural pain management treatments available and actual practice. Pediatr Emerg Care. 2007;23(2):87-93.
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