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FDA Approves Hylaform Plus

SANTA BARBARA, Calif. & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Oct. 13, 2004-- INAMED Corporation (Nasdaq:IMDC) and Genzyme Corporation (Nasdaq:GENZ) today announced that the U.S. Food and Drug Administration (FDA) has granted market approval for Hylaform(R) Plus (Hylan-B gel), a large particle size hyaluronic acid-based dermal filler that is indicated for the correction of moderate to severe facial wrinkles and folds.

Hylaform Plus was developed and is manufactured by Genzyme Corporation. Inamed is Genzyme's exclusive worldwide marketing and distribution partner for Hylaform Plus.

"We are excited about the approval of Hylaform Plus, which adds to our facial aesthetic portfolio and provides new treatment options to physicians and patients in the U.S," said Hani Zeini, Executive Vice President, Inamed Aesthetics. "The approval of this important product will supply our facial business a stronger competitive offering in the U.S. marketplace."

Hylaform Plus joins Inamed's well-established, U.S. dermal filler franchise, comprised of Zyderm(R), Zyplast(R), CosmoDerm(R), CosmoPlast(R) collagen and Hylaform. Hylaform Plus is a clear, colorless product that comprises a larger mean hyaluronic gel acid particle size than Hylaform.

"Hylaform Plus gel gives physicians in the U.S. a new, effective non-surgical tool to treat the deepest wrinkles and provide optimal facial contouring," said Gary D. Monheit, MD, Associate Professor, Department of Dermatology, University of Alabama at Birmingham, and a Hylaform Plus U.S. clinical trial investigator. "Hylaform Plus is an excellent complement to the existing fillers available to us and is an important advancement in facial rejuvenation."

"We look forward to working with Inamed to bring Hylaform Plus to physicians and patients in the United States," said Ann Merrifield, President Genzyme Biosurgery. "This addition to our hyaluronic acid line will broaden the acceptance of our products among physicians by expanding their options in treating patients."

Source: Inamed Corporation

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