03.03.2006 14:15:00
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Inamed's Phase 3 Study Results for Juvederm(TM) to Be Presented at the 64th Annual Meeting of the American Academy of Dermatology
Inamed Corporation (NASDAQ:IMDC) announced today that Phase 3clinical 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 bepresented at the 64th Annual Meeting of the American Academy ofDermatology in San Francisco, California.
The Juvederm Phase 3 data, which shows superior efficacy andduration of effect versus Zyplast(R) (cross-linked bovine collagen),will be presented today by Gary Monheit, M.D., Associate ClinicalProfessor of Dermatology and Ophthalmology, University of Alabama atBirmingham and President of the American Society for DermatologicSurgery, and will also be displayed at the poster exhibit at theMoscone Convention Center beginning at 1:00 p.m. on Friday, March 3.
Based on the independent investigators' assessments, the percentof patients improved with Juvederm at 6 months was in the range of 81%- 90% vs. 36% - 45% for Zyplast. At 6 months, patient preference forJuvederm over Zyplast was in the 78% - 88% range. There were nomeaningful differences in reported adverse events between Juvederm andZyplast. Most adverse events reported were mild or moderate in natureand 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. "TheJuvederm family of products is an important strategic advance in ourfacial aesthetics portfolio."
"The data underscore the benefit of adding a new generation ofdermal filler to the current aesthetic treatments offered byphysicians to patients," said Dr. Monheit. "The superior duration ofeffect and high patient satisfaction of the family of Juvedermproducts is an important advancement in the treatment of facialwrinkles."
The Company announced in the fourth quarter 2005 the submission ofits Pre-market Approval Application (PMA) to the Food and DrugAdministration. Inamed has an exclusive licensing agreement with theCorneal Group for the Juvederm family of products and future productline extensions in the US, Canada, and Australia and a non-exclusiveagreement in certain strategically important European markets underthe name HydraFill(TM).
About Inamed Corporation
Inamed is a global healthcare company with over 25 years ofexperience developing, manufacturing and marketing innovative,high-quality, science-based products. Current products include breastimplants for aesthetic augmentation and for reconstructive surgery; arange of dermal products to treat facial wrinkles; and minimallyinvasive devices for obesity intervention, including the Lap-BandSystem for morbid obesity. The company's website is www.inamed.com.
Forward-Looking Statements
This press release contains forward-looking statements as of March3, 2006, including statements regarding certain clinical results ofJuvederm(TM) and the development and growth of Inamed's productportfolios. These statements are based on the current intentions,beliefs and expectations of Inamed, but are subject to risks anduncertainties that could cause actual results to differ materiallyfrom those projected in these forward-looking statements. These risksand uncertainties include, among others, the results of research anddevelopment and business development activities, competition fromexisting and/or new products, market acceptance of the company'sproducts, the ability to manufacture or otherwise source product tomeet 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 theforward-looking statements contained in this press release. Thesestatements speak only as of the date of this press release and Inameddoes not undertake any obligation to update or revise the statements.By disclosing any information in this press release, Inamed is notacknowledging that such disclosure is required by law or that suchinformation is material.
Juvederm(TM) is a trademark of Laboratoires D'esthetique AppliqueeCorporation, a member of the Corneal Group. Zyplast(R) is a registeredtrademark of Inamed Corporation. All rights reserved.
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