Wall Street Journal - August 4, 2004
Jennifer Saranow and Amir Efrati, Staff Reporters of The Wall Street Journal

While the product, called Sculptra, has been approved only for the very narrow use of treating facial wasting associated with AIDS, doctors say it is likely to be employed much more widely "off-label" for cosmetic uses when it becomes available in the third quarter of this year.

That is because Sculptra, whose effects have been shown to last as long as two years, represents a new and possibly better option for patients seeking a nonpermanent but long-lasting option for regaining a youthful volume in large areas of the face such as the cheeks.

"I expect, like any other product, it will be used off label," said Peter Engelhard, a cosmetic dermatologist in Miami and consultant to Dermik Laboratories, the unit of Aventis that is marketing Sculptra. "It's the best volumizing agent we have for giving back the appearance of the apple of the check."

Sculptra is part of a new class of fillers that are believed to stimulate skin cells to increase skin volume and thus last longer. Sculptura's main ingredient, poly-L-lactic acid, is the same acid long used in dissolvable sutures.

Doctors say Sculptra's presumed effect on skin growth means it can be used in areas of the face that can't be filled in feasibly with existing fillers on the market without using extremely large amounts. Meanwhile, they say it lasts longer than the other popular large-area filler: fat.

The product, first approved in Europe five years ago to fill creases and wrinkles, is now available in more than 30 countries. The company says it has treated more than 150,000 patients.

Dermik spokesman Rob Partridge said the company went for approval to treat the AIDS-related indication first in the U.S. since it had enough data on hand to support that claim.

"We're focusing now on the cosmetic indication," Mr. Partridge said.

While Aventis and Dermik can't market Sculptra for general cosmetic use until the FDA grants that approval, doctors are free to use it as they see fit now that it is approved for sale in the U.S.

It is too soon to say whether Sculptra will prove to be a wrinkle-filling revolution, said Peter B. Fodor, a plastic surgeon in Los Angeles and president of the American Society for Aesthetic Plastic Surgery. The last such breakthrough, he says, was the FDA approval of Restylane late last year. It offered an alternative to Zyplast, a bovine collagen product to which some people were allergic.

In recent years, use of minimally invasive wrinkle treatments such as Restylane and Botox has become increasingly available and popular. According to the American Society of Plastic Surgeons, seven million minimally invasive cosmetic procedures were performed last year, up 43% from 2002. Doctors warn that there still aren't any long-term studies on the effects of Sculptra.

U.S. approval of Sculptra was based on clinical studies conducted by Dermik, based in Berwyn, Pa., involving 278 HIV-positive patients. The patients, primarily white men, were given three to six injections of Sculptra at two-week intervals and were followed for two years. Dermik, as a condition of the FDA approval for AIDS wasting, must track 100 patients for five years -- including at least 30 women and 30 patients with dark skin -- to monitor long-term effects.

"These studies were for restoring volume in the HIV face so we don't know what it will do in patients with a normal, healthy immune system, certainly not over the long term," said Rod Rohrich, a plastic surgeon in Dallas and president of the American Society of Plastic Surgeons.

Write to Jennifer Saranow at jennifer.saranow@wsj.com and Amir Efrati at amir.efrati@dowjones.com

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