Botox vs brand X: In the war on wrinkles, who will reign supreme?

Botulinum battle brewing
Reloxin takes another step toward face-off with Botox in U.S. market

Bill Gillette
Staff Correspondent

Scottsdale, Ariz. — The stage is set — finally, some would say — for a rival to compete with Botox Cosmetic in the botulinum-toxin aesthetic-drug market.

The FDA recently announced that it is reviewing Reloxin, a botulinum-toxin anti-wrinkle injectable to which Scottsdale-based Medicis Pharmaceutical has the U.S. rights, for approval domestically. Medicis will pay its French partner Ipsen $25 million based on the FDA’s announcement and will pay an additional $75 million upon FDA approval of Reloxin. Ipsen already markets the drug for aesthetic use in 23 countries.

Still other companies are preparing botulinum-toxin drugs for FDA approval for aesthetic use, according to William Phillip Werschler, M.D., assistant clinical professor of medicine and dermatology at the University of Washington School of Medicine. He cites Mentor’s PurTox and Xeomin by Merz as examples.

“I think that if and when Reloxin is approved, it could be the opening salvo in a marketing war,” Dr. Werschler tells CST.

Allergan, which markets Botox worldwide, doesn’t seem overly concerned that its drug will no longer have the U.S. market to itself once the FDA approves Reloxin.

“We welcome competition, as we believe in patient choice and the opportunities this could lead to in expanding the overall market,” says Caroline Van Hove, vice president of corporate communications for Irvine, Calif.-based Allergan. “We are very confident in the well-established safety and efficacy history of Botox Cosmetic, and we are well prepared to compete with Reloxin in the United States.”

Omaha, Neb., dermatologist Joel Schlessinger, M.D., immediate past president of the American Society of Cosmetic Dermatology and Aesthetic Surgery, says he thinks Reloxin will be very competitive once it hits the market.

“There’s no doubt that Reloxin will compete in price, efficacy and service,” says Dr. Schlessinger, who served as an investigator in clinical trials of Reloxin. “There is evidence that Reloxin takes effect faster, may last longer and have fewer side effects. I also think people will want to try it out simply based on the fact that it’s a new product.”

Apples to Apples
According to Mitchell Wortzman, Ph.D., chief scientific officer for Medicis, head-to-head studies comparing Reloxin with Botox have not been conducted in the U.S..

“There have been comparative studies done overseas, but because they were very small trials there is no reliable scientific information comparing the two,” he says. “We’ve done quite a few clinical studies, involving more than 4,800 injections of Reloxin, and the results show the rate of ptosis was less than 1 percent with no unusual adverse effects. We feel Reloxin will be a strong entry in the market and will be something physicians find very interesting.”

CST asked Boston-based dermatologist Ranella Hirsch, M.D., to compare the two drugs.

“Like Botox, Reloxin is a type A botulinum and of a relatively similar molecular weight,” says Dr. Hirsch, who is president of the American Society of Cosmetic Dermatology and Aesthetic Surgery. “The package insert differs for Reloxin, in that it has an eight-hour length of use after reconstitution versus Botox’s four. Also, there are more units per vial with Reloxin than with Botox. However, it is not a one-to-one conversion — a common misperception among clinicians, and you need to compare apples to apples to determine price and efficacy. The key question will be differences in diffusion rates and their individual characteristics.”

Market Turf
As to how Reloxin will be marketed against a product that’s virtually become a household name — and how Botox will deal with the competition — Dr. Werschler says he thinks Medicis will come out very aggressively once the drug is approved.

“They’ll come out swinging,” he says. “Medicis will tap customer loyalty among physicians — and there’s a lot of loyalty to Medicis out there — and they may market it on a lower price-per-treatment basis. Also, Botox currently is labeled as a single-patient-use vial, which means if you use the contents on more than one patient, you’re in violation of labeling laws. Reloxin is labeled as a multi-use vial, and Medicis may use this as a marketing tool.

“Allergan, I think, will be all about Botox’s science, success, history and length of time in the market.”

Dr. Werschler appears to be right on the money in his assessment of how Allergan will respond to competition.

“Brand loyalty and trust cannot be overstated in this growing market because people want to trust their face to a brand and a company that has demonstrated its commitment to safety, quality assurance and patient care,” says Allergan’s Ms. Van Hove. Botox in general has a remarkable safety profile. The product was first approved nearly 20 years ago and today benefits 21 different patient populations across more than 75 countries, ranging from very debilitated and compromised patients to healthy individuals who want to look and feel their best.

“That said, until the FDA validates Reloxin’s available clinical data, we are unable to directly compare the two products,” she states.

And if Medicis chooses to market Reloxin based on price points, how will Allergan react?

“We do not speculate on competitive entries, and for competitive reasons we do not share our product-marketing or pricing strategies,” Ms. Van Hove says.

It’s likely Allergan will have to employ such strategies more and more, as the market so long dominated by Botox appears primed for the kind of boom involving another type of cosmetic drug.

“I think the competition in the botulinum segment will be very similar to the filler market, where many new products will come into the market,” says Dr. Schlessinger. CST