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Sculptra

Generic name: injectable poly-L-lactic acid
Treatment for: Facial Lipoatrophy; Facial Wrinkles

Update: Sculptra Now FDA Approved - August 3, 2004

Aventis' Dermik Laboratories Announces FDA Acceptance of Filing For Sculptra to Treat Facial Lipoatrophy

BERWIN, PA., February 6, 2004 -- Dermik Laboratories, the U.S. dermatology arm of Aventis (NYSE: AVE), announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing and granted expedited review of the company's Premarket Approval Application (PMA) for Sculptra (injectable poly-L-lactic acid), a long-lasting, synthetically derived, dermal contouring agent to help restore lost facial volume in people with lipoatrophy. Facial lipoatrophy can be characterized by loss in fullness, shape and contour of the face.

Sculptra is marketed under the trade name NEW-FILL® in Europe, where it was approved by the French Notified Body G-Med (Department of Evaluation of Medical Devices) in 1999 as a wrinkles filling product. It has been used by an estimated 100,000 people in more than 30 countries throughout Europe and South America, and in Australia, for the treatment of a range of facial volume imperfections, including signs of aging, such as wrinkles, folds and sunken cheeks.

"Facial lipoatrophy is a condition that results in loss of fat in the cheeks, temples and eye sockets. The sunken cheeks, hollow eyes, indentations and wrinkling may make a person appear exhausted and unhealthy," said Dr. Sharon Levy, senior director of Scientific & Medical Affairs for Dermik Laboratories. "Lipoatrophy can result from anti-retroviral therapy in people with HIV and can have a devastating effect on self-image and confidence. The effects can be so severe that patients may even jeopardize their health by discontinuing their anti-retroviral treatment."

The objective of the studies submitted to the FDA was to determine whether Sculptra safely and effectively produced significant improvements in appearance and in restoration of lost facial volume in people with HIV. Researchers also evaluated the quality of life and anxiety and depression scores of study participants. The data from these studies are intended to show that Sculptra is well-tolerated, with adverse effects generally limited to reactions at the site of the injection.

"There is a significant unmet need in the United States for an FDA-approved lipoatrophy treatment that is safe, effective and long-lasting," said Robert J. Bitterman, president of Dermik Laboratories. "We are committed to working with the FDA to provide those who experience the symptoms of facial lipoatrophy with a treatment that can help improve their physical appearance and overall well-being."

Poly-L-lactic acid (PLLA) is synthetically derived from natural components and is a biocompatible substance that degrades to lactic acid. PLLA has been used in surgical products for more than 20 years as a component of dissolvable Vicryl 1 sutures and is used as a vehicle for several sustained release injectable medications.

According to John Leone, president of Aventis Dermatology, "The submission of the Sculptra PMA to the FDA represents a major milestone for our newly created global Aventis Dermatology division. The market and need for aesthetic dermatology is growing rapidly and Sculptra represents a significant advance for those individuals with signs of facial lipoatrophy."

1 Vicryl is a registered trademark of Ethicon, a Johnson and Johnson company.

Source: Aventis

Posted: February 2004

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