BERWYN, Pa., Feb. 5 /PRNewswire-FirstCall/ -- Dermik Laboratories, the U.S. dermatology arm of Aventis , 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(TM) (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(TM) is marketed under the trade name NEW-FILL(R) 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(TM) 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(TM) 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(TM)(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(TM) 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(TM) represents a significant advance for those individuals with signs of facial lipoatrophy."
About Dermik Laboratories
Dermik Laboratories conducts the North American business of Aventis Dermatology, the global dermatology unit of Aventis. Dermik is dedicated to providing innovative dermatological products to satisfy the needs of health care providers and patients. Dermik has expanded its core business with a new aesthetic/cosmetic dermatology focus, and continues its strong commitment to treatments for traditional skin and nail conditions, including acne, nail fungus, pre-cancerous skin lesions, psoriasis and rosacea. Its corporate headquarters are located in Berwyn, PA.
Please visit our Web sites at http://www.dermik.com/ and http://www.skinhealthsolutions.com/.
About Aventis
Aventis is dedicated to treating and preventing disease by discovering and developing innovative prescription drugs and human vaccines. In 2002, Aventis generated sales of euro 17.6 billion (US $16.6 billion), invested euro 3.1 billion (US $3 billion) in research and development and employed approximately 71,000 people in its core business. Aventis corporate headquarters are in Strasbourg, France. The company's prescription drugs business is conducted in the United States by Aventis Pharmaceuticals Inc., which is headquartered in Bridgewater, New Jersey. For more information about Aventis in the United States, please visit: http://www.aventis-us.com/.
Statements in this news release containing projections or estimates of revenues, income, earnings per share, capital expenditures, capital structure, or other financial items; plans and objectives relating to future operations, products, or services; future economic performance; or assumptions underlying or relating to any such statements, are forward-looking statements subject to risks and uncertainties. Actual results could differ materially depending on factors such as the timing and effects of regulatory actions, the results of clinical trials, the company's relative success developing and gaining market acceptance for new products, the outcome of significant litigation, and the effectiveness of patent protection. Additional information regarding risks and uncertainties is set forth in the current Annual Report on Form 20-F of Aventis on file with the Securities and Exchange Commission and in the current Annual Report - "Document de Reference" - on file with the "Commission des Operations de Bourse" in France, recently renamed "Autorite des marches financiers".
(1) Vicryl is a registered trademark of Ethicon, a Johnson and Johnson
company.
Dermik Laboratories