Tuesday, April 14, 2009

Botox Rival Faces Delay in FDA Marketing Approval

By Catherine Larkin and Naomi Kresge

April 14 (Bloomberg) -- Competition for the Botox shot, America’s most popular cosmetic procedure, was delayed as U.S. drug regulators discuss labeling and a strategy for evaluating and mitigating risks of the new wrinkle smoother.

Medicis Pharmaceutical Corp. and Ipsen SA, which developed the experimental Reloxin product, are in talks with the Food and Drug Administration, Boulogne-Billancourt, France-based Ipsen said today in a statement. The injection relaxes the muscles that cause forehead lines using a type of botulinum toxin similar to the one in Allergan Inc.’s Botox. The delay should be a matter of weeks, according to brokerage Aurel BGC.

“We look forward to feedback from the FDA in the near term,” David Schilansky, Ipsen’s investor relations officer, said in a telephone interview. Ipsen is in talks with the FDA about a risk-mitigation plan for both aesthetic and medical use of the drug, he said.

Reloxin may be priced 15 percent lower than Botox, helping it take almost a third of the market over time, said Gary Nachman, an analyst at Leerink Swann & Co. in New York, in a phone interview last month. He estimates annual sales of Reloxin will be $160 million by 2012.

Nachman and other analysts have said they expected the FDA to delay Reloxin approval until later this year over questions about how the company plans to track use in order to minimize potential risks seen with other botulinum toxins. Yesterday was a deadline for the FDA to make a decision on Reloxin.

Medical Uses

In December, the agency delayed a decision on Dysport, Ipsen’s version of Reloxin for medical uses, to finish work on a risk-management program to ensure safe use.

Medicis, of Scottsdale, Arizona, has rights to sell Reloxin in the U.S. Approval would trigger a $75 million payment to Ipsen, which developed the drug.

U.S. regulators will decide before the end of May on the use of Dysport for medical conditions, according to a report today by brokerage Aurel BGC.

“The company indicated to us that there’s a strong probability that the FDA will give its response on the botulinum toxin for aesthetic uses once it’s reviewed the dossier for medical indications,” according to Aurel. “The decision of the FDA is thus pushed back some weeks.”

Fashionable Drug

Allergan, which got 32 percent of its revenue from Botox sales in the fourth quarter, is cutting 5 percent of its workforce this year to brace for the competition and lower demand for cosmetic procedures in the recession.

Almost 2.5 million Americans had Botox injections last year, according to the American Society for Aesthetic Plastic Surgery. The drug was approved in 1991 for medical uses and in 2002 as a wrinkle smoother. It quickly became fashionable among aging celebrities as a non-surgical way to appear younger.

Botox earned $1.31 billion for Allergan in 2008, split between cosmetic use and treatment of neurological disorders. Allergan estimates it has an 83 percent share of the global market for neurotoxins that paralyze certain muscles or nerves.

The FDA warned consumers in February 2008 that botulinum toxins may spread beyond the site of the injection and cause botulism, a potentially deadly muscle-weakening illness. The greatest risk was seen with high doses of the drug, used by some doctors to treat limb spasms caused by cerebral palsy, an approved use in many countries outside the U.S.

Galderma, a joint venture between Nestle SA and L’Oreal SA, has European marketing rights to a version of Dysport for aesthetic uses, called Azzalure. Medicis bought rights in 2006 to develop and sell the drug for those purposes in the U.S., Canada and Japan.

Solstice Neurosciences Inc., a closely held company in Malvern, Pennsylvania, sells a botulinum toxin called Myobloc in the U.S. for cervical dystonia, a disorder that causes the head to become twisted to one side


Anonymous said...

Ipsen might have future issues. Maybe the reason Ipsen didn't get it's FDA approval was because of concerns about their ties to Iran.
There was a recent CQ article "Dual-Use Products Available to Iran Pose Threat, Say Lawmaker"
By Matt Korade, CQ Staff
And Senator Brownback has proposed legislation

Anonymous said...


Dr. Steve Fallek said...

Haven't seen much about the Mullahs wanting botox. Are they worrying about things or is it too much sun?