A Food and Drug Administration advisory panel Friday endorsed competing injectable gels that combat facial wrinkles, smoothing the way for a big marketing showdown.
The panel recommended that the FDA approve Restylane by Medicis Pharmaceutical Corp. and Hylaform by Inamed Corp., collagen alternatives already available in Europe, Canada and Mexico. The FDA typically follows its experts' advice.
Cosmetic surgeons have been eagerly awaiting approval of the gels -- which enjoy an underground following in Los Angeles.
Dr. Brian Kinney, a plastic surgeon in Century City, said he had a list of 30 patients who want prescriptions as soon as Restylane or Hylaform are approved.
"I have seven or eight patients now who go to Mexico to get it," he said.
The gels use hyaluronic acid, a substance that naturally occurs in the skin, to plump out creases and smooth facial scars. Inamed's product is derived from ground rooster combs. Restylane does not contain animal products.
Analyst Thomas Gunderson of US Bancorp Piper Jaffray said combined annual sales of the gels could rapidly climb to $150 million, about double current sales of collagen. Although Restylane is the leading gel outside the United States, Gunderson predicted the business would be split evenly between Medicis of Scottsdale, Ariz., and Inamed of Santa Barbara.
The stakes are high for both firms. Medicis has placed a big bet on Restylane, licensed from Q-Med, its Swedish developer. Medicis in its last fiscal quarter said expenses rose by $30 million, or nearly 40%, as it built its sales force for Restylane.
Inamed, meanwhile, is the leading marketer of collagen, long the mainstay in wrinkle smoothing treatments. The company, which also markets breast implants, recently launched human collagen as an alternative to collagen derived from cow tissue, which causes an allergic reaction in some patients.
Analysts believe that the gels will erode collagen sales.
In a conference call after the FDA panel vote, Medicis Chief Executive Jonah Shacknai said comparing Restylane to Hylaform was like "comparing delicious, fresh-squeezed orange juice to concentrate that has been in the refrigerator a long time."
Asked for his response, Inamed Chief Executive Nicholas Teti said: "To classify a product as orange juice is an insult to the people who correct wrinkles and to patients."
Noting that Inamed has a line of anti-wrinkle treatments, he said, "We are very committed to this business. This isn't a one-trick pony for us." Inamed's partner is Genzyme Corp., a Cambridge, Mass., biotech concern that developed Hylaform and markets it under a different name to arthritis patients.
In endorsing the products, the FDA panel suggested that the agency impose certain conditions. The experts said that the gels had been insufficiently tested in people of color and that companies should conduct post-approval tests in a group of those patients. In addition, the panel said the FDA needed to address the possibility that people with egg allergies would be sensitive to Hylaform, but it stopped short of recommending that patients take an allergy test.
Trading in Medicis on the New York Stock Exchange was halted Friday. Inamed fell 33 cents to $80.68 on Nasdaq.