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Wrinkle Cream Perlane Cleared by FDA

SCOTTSDALE, Ariz., May 2, 2007 (PRIME NEWSWIRE) -- Medicis (NYSE:MRX) today announced that the U.S. Food and Drug Administration ("FDA") has approved the dermal filler Perlane for implantation into the deep dermis to superficial subcutis for the correction of moderate to severe facial folds and wrinkles, such as nasolabial folds. Perlane is the newest member of the Restylane family of products and, like Restylane, Perlane is comprised of biotechnologically engineered, non-immunogenic, stabilized hyaluronic acid gel particles, and has patent protection until at least 2017. The primary difference between Restylane and Perlane is that the hyaluronic acid gel particles in Perlane are larger than those found in Restylane. Perlane is intended to be implanted into the deep dermis to superficial layer of the subcutis to add volume to restore surface contour in facial wrinkles and folds.

The three-dimensional gel particles in Restylane and Perlane are hydrophilic molecules, attracting and binding to water molecules as they degrade, helping to maintain volume augmentation for about six months. Also distinct from other hyaluronic acid dermal fillers, Restylane and Perlane are minimally cross-linked, making them similar to the natural hyaluronic acid found in the body.

"We are pleased to announce FDA's approval of another product from the worldwide market leading Restylane family," said Jonah Shacknai, Chairman and Chief Executive Officer of Medicis. "With Perlane's approval, physicians now have a new treatment option for their patients which is designed specifically to fill areas in the skin from the deep dermis to the superficial layer of the subcutis. Perlane's larger gel particles offer enhanced volume and lifting power, ideal for wrinkle and fold correction in deeper layers of the skin. Like Restylane, Perlane also has a favorable patient safety profile. As we move forward with our aesthetic product pipeline, we anticipate being able to offer physicians and patients the gamut of high quality aesthetic products for their treatment options."

Medicis anticipates shipping Perlane during the next 30 days. McKesson will serve as U.S. distributor for Perlane. Physicians wanting to place orders for Perlane should call McKesson directly at 1-877-520-0500.

Perlane is a class III restricted medical device indicated for implantation into the deep dermis to superficial subcutis for the correction of moderate to severe facial folds and wrinkles, such as nasolabial folds. Perlane should only be administered under the supervision of a licensed practitioner. For complete product and safety information about Perlane and Restylane, please visit

Source: Medicis

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