Scottsdale, Ariz. — Medicis Pharmaceutical Corp., based here, has announced its plans to submit an application to the FDA for approval of U.S. sales of Reloxin, a botulinum toxin for cosmetic use that will compete with Botox, reports The Wall Street Journal.
If Reloxin sails through the regulatory process, it could be available in the U.S. in about a year.
Allergan Inc.’s Botox, to date the only FDA-approved drug of its kind for anti-wrinkle therapy, achieved $1 billion in worldwide sales last year. The introduction of Reloxin as a competitor could have a significant impact on the market Botox has cornered, especially if Reloxin is sold at a lower price than Botox. The typical cost to patients for Botox injections is at least $500.
The Journal quotes Omaha, Neb., dermatologist Joel Schlessinger, M.D., as saying, “Many dermatologists and cosmetic surgeons are excited about the possibilities for a lower-priced form of botulinum toxin.” Dr. Schlessinger participated in Reloxin tests submitted to the FDA.
Reloxin apparently isn’t the only botulinum toxin poised to threaten Botox’s U.S. monopoly. In the pipeline a year or more behind Reloxin are NT-201, from Germany’s Merz Group, and PurTox, currently in tests sponsored by Santa Barbara, Calif.-based Mentor Corp. In addition, Revance Therapeutics Inc., Mountain View, Calif., is in the process of developing a topical form of botulinum toxin.
In March 2006, Paris-based pharmaceutical firm Ipsen granted Medicis the rights to develop, distribute and commercialize Reloxin in the United States, Canada and Japan for aesthetic use.
