Healthcare Industry News: Sagent Pharmaceuticals
News Release - October 12, 2007
Anesiva Outlines Comprehensive Commercialization Plan for FDA Approved Product Zingo(TM)Significant Efforts to Expand Market and Prepare for Zingo Launch Underway
Nancy Donahue Promoted To Senior Vice President, Marketing and Sales, and James Carr Promoted To Vice President, Marketing
Additional Manufacturing Capacity in China
Details to be Presented at Investor Briefing Today at 12 p.m. Eastern Time
SOUTH SAN FRANCISCO, Calif., Oct. 12 (HSMN NewsFeed) -- Anesiva, Inc. (Nasdaq: ANSV ) today announced key elements of the company's commercialization and launch plans for Zingo(TM) (lidocaine hydrochloride monohydrate) powder intradermal injection system, to reduce pain associated with peripheral venous access procedures in children three to 18 years of age. In addition, at its noon briefing in New York City today, the company will review its ongoing efforts and plans to raise market awareness, gain hospital formulary acceptance and routine use, and build and expand manufacturing capacity, including:
-- creation of an Anesiva sales force of 15 reps and 2 district managers;
-- an agreement with Sagent Pharmaceuticals to co-promote Zingo focusing on pharmacy and group purchase contracts;
-- the qualification of two automated manufacturing lines that will produce commercial quantities of product;
-- availability of Zingo in commercial quantities in the second quarter of 2008;
-- the promotions of Nancy Donahue and James Carr who will spearhead Zingo sales and marketing efforts; and
-- a joint venture with Wanbang Pharmaceuticals, a company of Fosun Pharmaceuticals of China to expand production capacity for Zingo while reducing the manufacturing cost of goods for the product at minimal additional capital expense.
Commercial quantities of Zingo, which was approved by the FDA in August, are expected to be available in the second quarter of 2008. Today's briefing reviewing Anesiva's commercialization plans will be webcast and may be found at http://www.anesiva.com In addition to the live webcast, a replay will be available.
"Blood draws and intravenous access procedures are a huge source of anxiety and stress for children and their parents. Despite published guidelines calling for the use of topical local anesthetics during these procedures, currently existing topical anesthetic creams and patches are not routinely used because they take 20 minutes or longer to act," stated William T. Zempsky, M.D., associate professor, Department of Pediatrics, University of Connecticut; associate director, Pain Relief Program, Connecticut Children's Medical Center, Hartford. "Zingo's rapid onset means that it can be easily incorporated into a medical procedure allowing uninterrupted care, an important advantage over current options." Dr. Zempsky will be the featured speaker at today's briefing.
"We are very excited about the prospects for Zingo, given its outstanding profile and the significant interest we have received from the public and from the medical community since the product received early FDA approval in August," stated John P. McLaughlin, chief executive officer of Anesiva. "We are maximizing the time until product availability with significant efforts to build advocacy and making the need to treat IV pain top of mind among targeted customers. This is intended to expedite Zingo's acceptance on hospital formularies and drive routine use. The collaboration we are announcing today with Sagent will support these efforts by enabling us to rapidly ramp up sales and ultimately create further value for our shareholders. In the longer term, we expect our newly-formed joint venture with Fosun Pharmaceuticals in China to provide additional manufacturing capacity and help us further reduce our manufacturing costs."
Sales and Marketing Plan Being Implemented; Leadership Team In Place
Anesiva recently announced a collaboration with Sagent Pharmaceuticals, Inc., a company focused on sourcing and marketing injectable pharmaceutical products to hospitals. Anesiva will leverage the warehousing and distribution infrastructure that Sagent has in place. Additionally, Anesiva and Sagent will co-promote Zingo and have complementary roles, in which Sagent will lead the hospital contracting efforts and serve as the key selling contact for hospital pharmacists, and Anesiva will sell Zingo to nurses and physicians within the hospital. Sagent's national accounts and sales teams have a depth of experience contracting with group purchasing organizations and individual hospitals and selling into hospital pharmacy. Anesiva's selling infrastructure supporting the Zingo launch will include two sales directors and 15 sales representatives, with all team members having significant previous success at selling in the hospital environment. These synergistic selling activities are designed to more rapidly drive Zingo adoption in the hospital arena. Anesiva believes that the combined efforts will expedite market adoption and increase sales of Zingo.
In addition, the company will announce the promotion of Nancy Donahue to senior vice president, sales and marketing from the position of vice president, marketing. Also promoted is Dr. James Carr, formerly senior director, marketing, who will now serve as vice president, marketing.
"We are fortunate to have two world-class commercial experts in Nancy Donahue and James Carr at the helm of our sales and marketing efforts. They have significant experience launching and building blockbuster pharmaceutical brands," stated John P. McLaughlin, chief executive officer of Anesiva. "We are confident in the ability of our talented commercial team to launch Zingo successfully and to develop a profitable franchise."
In related news, James Z. Huang has relocated to the east coast for personal reasons and will transition to a consulting role from his position as president. Mr. Huang, who joined Anesiva in September 2002 as vice president, business development & commercial operations, will remain very involved in the company's commercialization efforts.
During the meeting, Anesiva will review many parallel activities currently underway to prepare the market for Zingo, including:
-- Outreach to target hospitals to create "Zingo advocates" on the medical and nursing staff who will support formulary acceptance.
-- Design and impending launch of http://www.manageivpain.com, a website that targets nurses with the goal of encouraging them to focus on the management of IV pain.
-- Creation and promotion of RNvoice -- an organization of influential nurses with a passion for reducing pediatric needlestick pain.
-- Creation of educational and selling tools for use by sales teams.
-- Maximizing public relations initiatives through multiple channels to raise awareness of Zingo.
The company will re-affirm its prior guidance that Zingo will likely be priced in the range of $12 - $16 per unit.
Fosun Joint Venture To Facilitate Automated Manufacturing, Increased Capacity and Cost of Goods Improvements
Anesiva will also provide information about its joint venture with Wanbang Biopharma, a Fosun company, of XuZhou, China to establish additional manufacturing capacity for worldwide supply. The additional capacity will supplement the capacity provided by automated manufacturing operations currently being qualified in the US. The China operation will assure a second source for Zingo supply, assist with ongoing efforts to reduce manufacturing costs, and provide additional capacity in upside sales scenarios.
"With the strong commercial success we expect from Zingo, we believe it is important to add production capacity beyond what we are building here in the US," said John P. McLaughlin, chief executive officer of Anesiva. "Our new joint venture will create significant additional capacity that will also help us drive down our manufacturing costs, all with only a modest up-front capital investment."
Anesiva will own 49 percent of the joint venture, which will be named Wanbang/Anesiva (Jiangsu) Pharmaceuticals Ltd. The production area will be located at an existing Wanbang facility in the city of XuZhou in Jiangsu province. Following completion of the assembly facility in XuZhou, Anesiva will seek FDA certification of the facility.
Fosun Pharmaceuticals is one of the largest pharmaceutical manufacturing, distribution and retailing organizations in China. With nearly 10,000 employees, the company manufactures and sells genetically engineered medicines, diagnostic products, Chinese prepared medicines, chemical compound medicines, biological chemical products, reagents and medical apparatus.
About Zingo, Recently FDA Approved for the Reduction of Pain Associated with Venous Access Procedures in Children Three to 18 Years of Age
Zingo is a ready-to-use, single-use, needle-free system that delivers sterile lidocaine powder into the epidermis of the skin and provides topical, local 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 addition to the hospital setting, Zingo may be used in physicians' offices and clinical laboratories. Anesiva also recently completed enrollment of a Phase 3 trial evaluating Zingo in adults with the goal of expanding the label beyond the pediatric population.
Webcast Details for Today's Zingo Analyst Meeting
Anesiva will host a webcast meeting with the investment community at 12:00 p.m. EDT, today, October 12, 2007 to discuss the company's commercialization plans for Zingo. Interested parties can listen to the live audio webcast by logging on to http://www.anesiva.com and going to the Investor Information page. A replay of the webcast will also be available through the company's website.
About Anesiva and its Diverse Portfolio of Pain Products
Anesiva, Inc. is a late-stage biopharmaceutical company that seeks to be the leader in the development and commercialization of novel therapeutic treatments for pain. The company has one FDA-approved product, Zingo(TM) (lidocaine hydrochloride monohydrate) powder intradermal injection system, to reduce pain associated with peripheral venous access procedures in children three to 18 years of age. The second product in Anesiva's pipeline, Adlea(TM) (formerly 4975), 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, 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 http://www.anesiva.com.
Anesiva 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 Anesiva can successfully manufacture and launch Zingo and the degree to which it 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 quarterly report on Form 10-Q for the quarter ended June 30, 2007.
Anesiva undertakes no obligation and does not intend to update these forward-looking statements to reflect events or circumstances occurring after this press release. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement.
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