Botoxs First Major Adversary Faces Delay In Fda Advertising Approval
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 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.
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.
The FDA delayed a decision on Dysport, Ipsens version of Reloxin for medical uses, in December 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.
Fashionable Drug
Allergan, which got 32 percent of its revenue from Botox sales in last years fourth quarter, is cutting 5 percent of its workforce this year to brace for the prospects of new 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 LOreal 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.