Executives at Irvine-based Allergan Inc. and a rival maker of a wrinkle-removing drug might have a few worry lines popping up on their foreheads today.
The Food and Drug Administration has set a deadline of today to review an application for Reloxin, a wrinkle-fighting drug being developed by Medicis Pharmaceutical Corp. of Scottsdale.
Reloxin is the closest competitor to Allergan’s blockbuster Botox, which has had the wrinkle-remover drug market to itself for years. Like Botox, Reloxin is made from a purified form of a toxin related to botulism, a type of food poisoning.
Medicis has said it expects quick approval of Reloxin. Most analysts expect it to be sold in the second half of the year.
Allergan isn’t waiting.
The drug maker held a Web seminar late last month where company officials discussed the science behind Botox, reiterated the drug’s 20-year safety record and cautioned patients about pending competitors.
“The bottom line is that no two botulinum toxins are alike,” said Mitchell Brin, chief scientific officer for Botox and Allergan senior vice president for global development.
Allergan said it put on the seminar so that “physicians are properly educated on the differences between botulinum toxin therapies and the fact that they aren’t interchangeable,” said Caroline Van Hove, the drug maker’s spokeswoman.
Medicis declined to address Allergan’s contentions for this story as it awaits an FDA decision.
At an investment conference last month, Medicis Chief Executive Jonah Shacknai said, “We think that we match very well against those companies that are selling neurotoxins now.”
Medicis’ other products include skin drugs such as Restylane, a filler for wrinkles on the lower face that competes with Allergan’s Juv & #233;derm.
Customers have shown “extraordinary interest” in Reloxin, Shacknai said.
If Reloxin is approved, Botox stands to lose some market share, according to Scott Henry, an analyst who follows Medicis for Roth Capital Partners LLC in Newport Beach.
“The first mover tends to keep two-thirds of the business, but it’s not uncommon for the second player to pick up a third,” he said.
One Comparison
That’s what happened to Viagra, Pfizer Inc.’s sexual dysfunction drug, Henry said.
“For Medicis, that’s a pretty good number,if you started from zero and you can get 30% of the market, you’re going to have something that’s going to sell $100 million to $150 million” a year, Henry said.
Botox sales, both for cosmetic and medical treatments, were $1.3 billion in 2008. Allergan has said it expects Botox sales in a slowing economy to fall about 10% this year to $1.15 billion to $1.19 billion.
The FDA may not give final approval to Reloxin this week, Henry said. The expectation among analysts and investors is that the drug will “move toward approval,” he said.
Reloxin’s approval has been delayed for several reasons, including an FDA request for Medicis to produce a plan on how it’s going to track the drug’s use in order to avoid abuse.
The drug is expected to sell for less than Botox.
Gary Nachman, an analyst with investment bank Leerink Swann & Co., recently told Reuters that he sees Reloxin selling for 15% to 20% less than Botox.
During Allergan’s seminar, the company said it hasn’t done studies comparing Botox to Reloxin.
Scott Whitcup, the drug maker’s executive vice president of research and development, said discovering other uses for Botox such as migraine headaches is a better use of Allergan’s research spending.
Reloxin also is being developed for other conditions. Ipsen, a French drug maker, holds therapeutic rights to the drug and will be submitting a separate regulatory application.
Reloxin’s cosmetic rights once belonged to Santa Barbara’s Inamed Corp., which Allergan bought for $3 billion in 2006, prevailing over Medicis.
Allergan gave the cosmetic rights to Reloxin back to Ipsen to address antitrust concerns. Ipsen later sold cosmetic rights to Medicis.
