Medicis will hire a 30-40 rep sales force for Q-Med's Restylane non-animal stabilized hyaluronic acid (NASHA)-based surgical wrinkle treatment in time for the product's launch, anticipated by 2004.

The Scottsdale, Ariz. company also plans to re-deploy some of its 180 existing reps to the aesthetics sales force in preparation for the launch. Restylane sales rep training will occur at the firm's national sales meeting in September.

Predicting December as a "likely target" for FDA approval of Restylane, Medicis President Jonah Shacknai described the company's sales and training initiatives during an Aug. 26 earnings call.

"Our sales operations will be absolutely ready to go" upon FDA approval, Shacknai reported. "We will be distributing Restylane directly to physicians' offices." The new hires will focus on Medicis' entire dermatological product line until Restylane is approved, he explained.

At the Thomas Weisel Partners Healthcare Tailwinds 2003 conference in Boston Sept. 4, CFO Mark Prygocki said that as part of its physician training program, Medicis "will select about 80-90 of the top injecting physicians in the country, train them, and help them be our trainers throughout the rest of the country."

Medicis cites clinical trials demonstrating that Restylane, currently available in 60 countries, lasts up to twice as long as other soft-tissue dermal fillers. The lab-created gel also may cause less allergic reactions, according to Medicis, which bought U.S. and Canadian market rights from Swedish manufacturer Q-Med in February (¹ 'The Gray Sheet' Feb. 24, 2003, In Brief).

Because the product lacks animal-based allergens, Medicis is hoping to obtain FDA approval without a skin testing requirement. In international markets, skin tests are not obligatory, allowing physicians to offer same-day injectable treatment to the 40%-50% of potential dermal filler patients who do not return after initial consultation, Medicis notes.

Prygocki predicted the lab-derived product will fare better with its target female population than Inamed's Hylaform , an animal-derived hyaluronic acid-based dermal filler. Inamed announced Aug. 13 that partner Genzyme has filed the fourth and final module of a PMA for Hylaform.

Inamed's other dermal filler offerings, human collagen-based CosmoDerm and CosmoPlast , received FDA approval in March (² 'The Gray Sheet' March 17, 2002, In Brief).

If approved, Restylane will be the only non-animal-based dermal filler in the U.S., Prygocki stated. The CFO noted that Hylaform is "derived from rooster comb," a potentially less appealing composition in the eyes of future consumers.

Medicis claims the NASHA-based filler has been applied to more than one mil. patients worldwide and will compete for a roughly $60 mil. potential market in the U.S. and Canada.

The company says it has not been notified by FDA of a possible panel review date for the PMA, but acknowledged the product could be considered by the General & Plastic Surgery Devices Panel. So far, FDA has announced only one meeting for the panel this year: the Oct. 14-15 review of Inamed's silicone gel-filled breast implant PMA (³ 'The Gray Sheet' Aug. 25, 2003, In Brief).

Shacknai expressed confidence in Restylane's approval prospects, regardless of the unclear review path. "We view that neutrally. It's neither good nor bad as far as we're concerned - it's only a question of scheduling. We believe the submission before the FDA is an extremely strong one."

Although unit price has not been determined yet, the firm plans to charge customers per vial rather than per treatment. Because Restylane lasts for six to 12 months, patients can anticipate only two treatments per year, thus increasing affordability, Medicis says.

On Aug. 25, Mentor announced its acquisition of Vitrolife AB subsidiary A-Life, manufacturer of Hyalite , a NASHA gel dermal filler undergoing preparation for a U.S. clinical trial.

European trials already have been completed and CE mark application efforts are underway. Mentor estimates the U.S. market for injectable soft-tissue fillers at $100 mil., with 750,000 facial procedures performed annually.

Medicis Lab-Derived Dermal Filler On Track For Year-End Approval – Exec

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