Healthcare Industry News: Dermal Filler
News Release - March 3, 2006
Inamed's Phase 3 Study Results for Juvederm(TM) to Be Presented at the 64th Annual Meeting of the American Academy of DermatologyKey Phase 3 Study Results for Three Juvederm(TM) Formulations to Be Highlighted
Data Shows Superior Efficacy and Duration of Effect Versus Zyplast(R)
SANTA BARBARA, Calif.--(HSMN NewsFeed)--March 3, 2006--Inamed Corporation (NASDAQ:IMDC ) announced today that Phase 3 clinical data for the three formulations of Juvederm(TM) (Juvederm(TM) 24HV, Juvederm(TM) 30HV, and Juvederm(TM) 30), a next generation, non-animal, cross linked hyaluronic acid based Dermal Filler, will be presented at the 64th Annual Meeting of the American Academy of Dermatology in San Francisco, California.
The Juvederm Phase 3 data, which shows superior efficacy and duration of effect versus ZyplastŪ (cross-linked bovine collagen), will be presented today by Gary Monheit, M.D., Associate Clinical Professor of Dermatology and Ophthalmology, University of Alabama at Birmingham and President of the American Society for Dermatologic Surgery, and will also be displayed at the poster exhibit at the Moscone Convention Center beginning at 1:00 p.m. on Friday, March 3.
Based on the independent investigators' assessments, the percent of patients improved with Juvederm at 6 months was in the range of 81% - 90% vs. 36% - 45% for Zyplast. At 6 months, patient preference for Juvederm over Zyplast was in the 78% - 88% range. There were no meaningful differences in reported adverse events between Juvederm and Zyplast. Most adverse events reported were mild or moderate in nature and temporary, lasting less then 7 days.
"We are excited about the results of the Phase 3 clinical trial," said Hani Zeini, Executive Vice President - Inamed Aesthetics. "The Juvederm family of products is an important strategic advance in our facial aesthetics portfolio."
"The data underscore the benefit of adding a new generation of Dermal Filler to the current aesthetic treatments offered by physicians to patients," said Dr. Monheit. "The superior duration of effect and high patient satisfaction of the family of Juvederm products is an important advancement in the treatment of facial wrinkles."
The Company announced in the fourth quarter 2005 the submission of its Pre-market Approval Application (PMA) to the Food and Drug Administration. Inamed has an exclusive licensing agreement with the Corneal Group for the Juvederm family of products and future product line extensions in the US, Canada, and Australia and a non-exclusive agreement in certain strategically important European markets under the name HydraFill(TM).
About Inamed Corporation
Inamed is a global healthcare company with over 25 years of experience developing, manufacturing and marketing innovative, high-quality, science-based products. Current products include breast implants for aesthetic augmentation and for reconstructive surgery; a range of dermal products to treat facial wrinkles; and minimally invasive devices for obesity intervention, including the Lap-Band System for morbid obesity. The company's website is www.inamed.com.
This press release contains forward-looking statements as of March 3, 2006, including statements regarding certain clinical results of Juvederm(TM) and the development and growth of Inamed's product portfolios. These statements are based on the current intentions, beliefs and expectations of Inamed, but are subject to risks and uncertainties that could cause actual results to differ materially from those projected in these forward-looking statements. These risks and uncertainties include, among others, the results of research and development and business development activities, competition from existing and/or new products, market acceptance of the company's products, the ability to manufacture or otherwise source product to meet market demand, the content and timing of decisions by the FDA, and the factors discussed under the caption "Risks and Uncertainties" in Inamed's Annual Report on Form 10-K for the year ended December 31, 2004. We caution investors not to place undue reliance on the forward-looking statements contained in this press release. These statements speak only as of the date of this press release and Inamed does not undertake any obligation to update or revise the statements. By disclosing any information in this press release, Inamed is not acknowledging that such disclosure is required by law or that such information is material.
Juvederm(TM) is a trademark of Laboratoires D'esthetique Appliquee Corporation, a member of the Corneal Group. ZyplastŪ is a registered trademark of Inamed Corporation. All rights reserved.
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