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[DewDiligence]

(SNY MRX AGN JNJ BFRM) FDA Approves Sculptra for Cosmetic Use

[SNY’s Sculptra was previously approved by the FDA only for lipoatrophy (facial wasting) in people with AIDS. With approval for cosmetic use generally, Sculptra joins an array of dermal fillers that includes Restylane and Perlane from MRX, Juvederm from AGN, Prevelle Silk from JNJ, and Radiesse from BFRM.

These products are not fungible, however; rather, they form a continuum from firmer and longer-lasting to softer and shorter-lasting. In general, the firmer and longer-lasting products are more painful during the injection procedure and are not as natural-looking as the softer and shorter-acting products. From the firm and long-lasting end of the spectrum to the soft and short-acting end of the spectrum, I would order the products as follows: Sculptra, Radiesse, Perlane, Restylane, Juvederm, Prevelle Silk. Sculptra consists of a polymer from the alpha-hydroxy-acid family; Radiesse consists of calcium hydroxylapatite (a component of bones and teeth); and the other products in the above list consist of hyaluronic acid in varying degrees of viscosity.

In the US, Restylane/Perlane has the leading market share, Juvederm is second, Radiesse is a distant third, Prevelle Silk (which JNJ acquired from Mentor) is fourth, and Sculptra is not yet on the radar screen of most derms and plastic surgeons.]

http://finance.yahoo.com/news/FDA-Approves-prnews-1450097164.html?x=0&.v=1

›Wednesday July 29, 2009, 12:00 pm EDT

BRIDGEWATER, N.J., July 29 /PRNewswire-FirstCall/ -- Sanofi-aventis U.S. announced today that the U.S. Food and Drug Administration (FDA) approved Sculptra®Aesthetic (injectable poly-L-lactic acid) for the correction of shallow to deep nasolabial fold (smile lines) contour deficiencies and other facial wrinkles which are treated with the appropriate injection technique in healthy patients. Sculptra®Aesthetic works gradually to offer natural-looking results that can last up to two years.

"We are excited by the FDA approval of Sculptra®Aesthetic because it changes the landscape of what physicians can offer patients seeking natural and gradual looking results from an aesthetic injectable that is long-lasting," said Doris Day, M.D., Clinical Assistant Professor of Dermatology at New York University and in private practice in New York City. "Sculptra®Aesthetic allows for a natural correction."

The FDA approval of Sculptra®Aesthetic is based on results from a randomized, comparative, evaluator-blinded, parallel group, multi-center study of 233 patients. Patients received Sculptra®Aesthetic or an approved human derived collagen for the treatment of their nasolabial fold wrinkles.

Sculptra®Aesthetic was administered in a single treatment regimen, at three week intervals, for up to 4 treatment sessions for the correction of shallow to deep nasolabial fold contour deficiencies using a deep dermal grid pattern (cross-hatch) injection technique. The Sculptra®Aesthetic patients were followed for an additional 12 months. Sculptra®Aesthetic treatment effects were maintained up to 25 months after the last treatment session, while the human derived collagen was effective up to 3 months.

"Sculptra®Aesthetic showed effective correction of the nasolabial folds, which are considered to be the hallmark signs of facial aging," said Paul Chew, M.D., Chief Science Officer/Chief Medical Officer, sanofi-aventis U.S.

No serious adverse events were reported in this study for either treatment. Commonly occurring short-term injection site reactions were bleeding, tenderness or pain/discomfort, redness, bruising, itching or swelling and were reported in both treatment groups. Other adverse events reported during the 25 month trial included small bumps and lumps, some with a delayed onset and were mild or moderate in intensity. Most side effects resolved on their own; one small lump required treatment by the healthcare provider.‹