Liquid Face Lift Association

Reprint from the Wall Street Journal, July 2, 2008

Johnson & Johnson said it has received U.S. Food and Drug Administration clearance to market Evolence^®, an collagen dermal filler for treating facial wrinkles. Physicians said the product marks the first significant foray by a major U.S. pharmaceutical company into the cosmetic-medicine field.

Evolence^® is the initial product for J&J's new aesthetics group, created in response to growing demand for appearance-enhancing medical treatments. Evolence^®, intended for the correction of moderate to deep facial wrinkles and folds, was developed by ColBar LifeScience, an Israeli company J&J acquired two years ago. Evolence^® has been available in many other countries since 2004.

Evolence^® is emerging in the U.S. during an economic downturn that has hit cosmetic dermatology among other luxury services. "They couldn't have picked a worse time," said Kenneth Beer, a West Palm Beach, Fla., dermatologist and J&J consultant. "But J&J isn't worried about quarter to quarter. The most salient feature of this is that it's the first time one of the 'bigs' has gotten into the sandbox."

The world-wide market for so-called dermal fillers is increasingly crowded. In the U.S., it is dominated by Medicis Pharmaceutical Corp.'s Restylane^® and Allergan Inc.'s Juvederm^®.

J&J claims Evolence^® is "a breakthrough in aesthetics," because it is made from "naturally sourced collagen," unlike Restylane^® and Juvederm^®. Evolence^® is manufactured with a patented technology and uses tendons harvested from pigs in the U.S. and Australia.

Pig and Pocketbook Issues

Physicians will welcome the arrival of a new product, but it's likely to be a "minor product, at least initially" said Ronny Gal, an analyst at Sanford C. Bernstein & Co. "Porcine products historically haven't done well, and many people prefer lab-grown products," he said. Evolence^® hasn't been a "category killer" in Europe, where hyaluronic acid-based products like Juvederm^® and Restylane^® are more popular, he added.

Dermatologists and patients may be disappointed that Evolence^®'s FDA label allows the company to claim that its effects last only six months. Some had anticipated a label of one year or even longer. Many patients who are using facial fillers to temporarily erase or reduce wrinkles are suffering from so-called wallet fatigue and are looking for longer-lasting treatments. Juvederm^® recently received FDA permission to claim its product is effective for a year, although some physicians say the study was flawed.

Monica Neufang, a J&J spokeswoman, said the company is filing additional data with the FDA to try to obtain a 12-month label. She said patients should feel comfortable with Evolence^® because many medical products, including heart valves, are derived from porcine materials. The pig tendons used in Evolence^® are harvested from animals raised for human consumption and not specifically for medical use, she said. The price of Evolence^® will be similar to or perhaps slightly more than the prices of rival products, she added.

Dr. Beer, who has injected Evolence^® outside the U.S., says it causes less post-injection bruising and swelling than Restylane^® or Juvederm^®. Noel Solish, a Toronto dermatologist who has used Evolence^® for about two years, says it can cause lumps under the skin if it is injected too superficially and not massaged immediately. J&J says it has developed a specialized training program for "accurate results."