FDA smoothes way for wrinkle potions

2 rival injectable gels endorsed for U.S. use

November 26, 2003|By LOS ANGELES TIMES

A Food and Drug Administration advisory panel has endorsed competing injectable gels that combat facial wrinkles, smoothing the way for a big marketing showdown.

The panel recommended Friday that the FDA approve Restylane by Medicis Pharmaceutical Corp. and Hylaform by Inamed Corp., collagen alternatives available in Europe, Canada and Mexico. The FDA typically follows its experts' advice.

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 doesn't 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 the current sales of collagen.

Though Restylane is the leading gel outside the United States, Gunderson predicted that the business will be split evenly between Medicis of Scottsdale, Ariz., and Inamed of Santa Barbara, Calif.

The stakes are high for both companies. Medicis has placed a big bet on Restylane, licensed from Q-Med, its Swedish developer. The company said that in its last fiscal quarter, expenses rose by $30 million, or nearly 40 percent, as it built its sales force for Restylane.

Inamed is the leading marketer of collagen, long the mainstay in wrinkle-smoothing treatments. The company, which also markets breast implants, recently introduced human collagen as an alternative to collagen derived from cow tissue, which causes an allergic reaction in some patients.

Analysts think the gels will erode collagen sales.

In endorsing the products, the FDA panel suggested that the agency impose conditions. The experts said 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 needs to address the possibility that people with egg allergies might be sensitive to Hylaform, but it stopped short of recommending that patients be tested for allergies.

The Los Angeles Times is a Tribune Publishing newspaper.

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