Biotech Values

[DewDiligence]

Wrinkle Treatments Don't Age Well

[Restylane is selling well for MRX, and Botox is a blockbuster for AGN, although more than half of its sales are non-cosmetic. I have my doubts about Artecoll, a newer dermal filler product from a private firm, for the reasons mentioned below.]

http://online.wsj.com/article/0,,SB112777715751352714,00.html

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Researchers Are Seeking
More Durable Therapies
In Quest for Rejuvenation

By RHONDA L. RUNDLE
Staff Reporter of THE WALL STREET JOURNAL
September 27, 2005

Injection fatigue is setting in among people who get regular facial antiwrinkle shots, spurring hopes for more durable rejuvenation treatments. Many new ones, as well as foreign imports, are being tested to prove their safety and effectiveness.

Botox injections help lift the upper face, and dermal fillers such as Restylane plump up sunken areas around the cheeks and chin. Cosmetic doctors say demand for these antiaging injectables is booming, especially among people in their 30s and 40s who aren't ready for a surgical facelift. But the benefits of such injections typically fade within four to six months.

"Once you give people a temporary filler, they want longer-lasting ones," says Rod Rohrich, chairman of plastic surgery at the University of Texas Southwestern Medical Center in Dallas. In the next couple of years, fillers that last two years or so will become "the gold standard," he predicts. Dr. Rohrich says he doesn't have a financial interest in any of them.

Physicians say there are hundreds of new dermal fillers under development. Many treatments sold outside the U.S. aren't available here because they haven't undergone Food and Drug Administration tests. The filler market is "exploding" with small ventures trying to hook up with established consumer companies, says David Maris, an analyst at Banc of America Securities. He credits the success of Botox and Restylane largely to the marketing prowess of their respective owners, Allergan Inc. and Medicis Pharmaceutical Corp.

Meanwhile, some relatively longer-lasting treatments, including Radiesse and Sculptra, are already available in the U.S. because they are approved for other more traditional medical uses. Under FDA rules, because of these approvals they may be used "off label" for cosmetic applications. BioForm Medical Inc., marketer of Radiesse, and Dermik Laboratories, which sells Sculptra, are sponsoring FDA tests of their antiaging treatments.

Closely held Artes Medical Inc. expects FDA approval of its wrinkle filler, Artefill, by the end of the year. The San Diego, Calif., venture claims its product would be the first permanent treatment for the nasolabial folds, or deep creases running from the nose to the corners of the lips. [However, a permanent filler may not be a great idea—if the doc botches the procedure, you’re stuck with it!] An FDA advisory panel has recommended against using it in the lips because of a higher number of complications in that area. Some Canadian doctors, who have used an earlier version of the product, called Artecoll, give it mixed reviews.

"I personally almost never use it, except for treating some permanent scars," says Michael Weinberg, a plastic surgeon in Toronto. The problem, he says, is that Artecoll can cause unsightly bumps or ridges that don't go away.

Artefill, approved in Canada in late 1998, is made from microscopic synthetic beads suspended in collagen extracted from cow hides. The beads act as a scaffold around which a patient's natural tissue grows. The collagen is absorbed by the body in a few months, but the beads remain indefinitely. The potential for foreign-body reactions to them has made the treatment controversial, especially when used in the lips.

Alastair Carruthers, a cosmetic dermasurgeon in Vancouver, stopped using Artecoll a couple of years ago after seeing a few adverse reactions. However, he says he is using it again now because the problems cleared up on their own after a couple of years. "With a good injection technique, complications are rare," he adds. Dr. Carruthers is a consultant for specialty pharmaceutical companies and is a member of the Artes clinical advisory board, but says his views on Artecoll are his own.

Some of the new therapies don't hold up as long as expected, and some require a series of injections over several weeks, physicians say. Such tradeoffs require patients to make confusing calculations about relative value, based on cost, duration and convenience. Some injections are trickier than others to administer and perform better in specific parts of the face, putting a bigger premium on the skill and experience of the cosmetic physician.

"When I started using Radiesse, I was told it would last two years or longer, but it hasn't been my experience," says Paula Moynahan, a plastic surgeon with offices in New York and Waterbury, Conn. She says Radiesse's benefits rarely last more than a year. In her experience, Sculptra lasts about two years, but it takes three or four weeks for the product to stimulate enough collagen growth so that the benefits are visible to most observers.

Dr. Moynahan, a consultant for Dermik Laboratories, says she uses many fillers with good results, but that "Sculptra is the leader of the pack." The product was approved in August 2004 to restore volume to the faces of HIV patients. Dermik, a U.S. unit of France's Sanofi-Aventis SA, one of the world's largest pharmaceutical companies, said it hopes the FDA will approve Sculptra for cosmetic use in the first half of 2007.

An advantage of Radiesse over Sculptra is that patients "will experience the immediate correction that other tissue fillers, such as Restylane" provide, without the need for multiple injections, says Adam Gridley, vice president of corporate development at San Mateo, Calif.-based BioForm Medical. The company hopes the FDA will grant approval for cosmetic use of Radiesse sometime next year.

Many of the new wrinkle fillers were demonstrated in Chicago last weekend [Sept. 24-25] at a meeting of the American Society of Plastic Surgery, a physicians' professional group. Researchers also presented their latest findings on emerging cosmetic products.

Steven Cohen, a cosmetic surgeon at Facesplus Aesthetic Facility in La Jolla, Calif., presented five-year results for 44 Artecoll patients who participated in FDA tests of the material several years ago. Patients were offered $100 to return for these follow-up evaluations, says Dr. Cohen, also a member of the Artes clinical advisory board.

"It looks like the material is holding its own -- there was no statistical change from the one-year results," Dr. Cohen said in an interview last week. There haven't been any severe reactions, although two patients developed small, minor bumps, he added. He says he plans to use the product in some of his patients once it is approved.
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