By: John Jesitus
Comparators
Botox competitor, Myobloc (botulinum toxin type B, Solstice) earned FDA approval for cervical dystonia in 2000. In aesthetic use, Dr. Hellman says she's heard from European Myobloc users that "The biggest concern is figuring out an equivalent dose to what we use for Botox Cosmetic."
Jean D. Carruthers, M.D., a pioneer of the cosmetic use of botulinum toxin A, along with her husband, Alastair Carruthers, M.D., says, "In its current formulation, Myobloc is terribly painful on injection," and it lasts six to eight weeks, versus four to six months for Botox.
However, "It works incredibly quickly. Within a day, you start to see effects," she says.
In dose-finding research she's performed, Dr. Carruthers says, "I've been very impressed with the elegance of its effect."
Nevertheless, she says that Elan Pharmaceuticals, Myobloc's then-manufacturer, suspended this testing and withdrew the product from U.S. cosmetic use.
Dr. Carruthers is clinical professor of ophthalmology, University of British Columbia, Vancouver.
On the regulatory horizon is another product, Reloxin (botulinum toxin A, Medicis), which will compete directly with Botox, Dr. Kaplan says. It likely will earn FDA approval for treating glabellar lines around the third quarter of 2009, says Peter Bye, senior analyst with Jefferies & Co., New York.
"I'm excited to see it," Dr. Carruthers says. "It's about time we had a comparator."
A matter of ratio
Dr. Hellman says perhaps the most important practical difference is that "In a ratio of three units of Reloxin to one unit of Botox, Reloxin has slightly faster onset, and people say it lasts longer."
However, Dr. Carruthers says that at a ratio of 2.5 units of Dysport (Reloxin's name abroad) to one unit of Botox, Dysport has been shown to wear off about a month sooner (Lowe PL, Patnaik R, Lowe NJ. Dermatol Surg. 2005 Dec;31(12):1651-1654).
"It seems Reloxin has more of a tendency to spread a little further than Botox," injection volumes aside, Dr. Hellman says.
In hyperhidrosis, Dr. Kaplan says, "Spread will be a good thing. (But) for cosmetic indications around the eyes, spread could create undesired side effects," such as eyelid drooping.
Still, Dr. Hellman says, "We're all looking forward to this competing product," because competition could reduce U.S. prices of both Botox and Reloxin.
"It's my understanding that in the Middle East and Europe, the same Botox that Allergan sells in the United States sells for considerably less," she says.
However, market penetration could be tough for Reloxin, Dr. Rubinstein says. "In many countries abroad, Reloxin hasn't gotten a foothold, even though its price is often lower. Botox carries strong brand loyalty."
Dr. Hellman says many people consider Botox to be the aspirin of the new millennium. "It's something people do with ease. They're very familiar with it, and it's a very helpful, easy remedy to help make people look younger," she says.
And physicians say they appreciate the quality of Botox.
"Although we haven't always liked the way Allergan has increased the price of Botox, I feel very confident that the company employs the highest quality control standards," Dr. Kaplan says.
"And when I pick up a vial of Botox, it'll be the same concentration, strength and purity as the vial I picked up six or 12 months ago.
"I'd have to feel that same certainty with anything new that came on the market," he says.
Looking ahead
Future competitors likely will include PurTox (botulinum toxin type A, Johnson & Johnson/Mentor), which has completed FDA testing and could reach the U.S. market by 2011, Mr. Bye says.
Xeomin (botulinum toxin type A, Merz) is undergoing trials for cervical dystonia and cosmetic indications, he says, predicting it will gain U.S. approval in late 2011 or perhaps 2012.
"Comparative studies in the therapeutic world have shown that Xeomin seems to be just as good as Botox, but perhaps it doesn't last quite as long," Dr. Carruthers says.
Overall, she says, "It's exciting to live in a Renaissance world where new things are coming along. We have an economic recession, but there's still such an interest in appearance — perhaps even more so, because people want to keep looking fresh" to pursue or maintain jobs.
Because of such steady popularity, Dr. Carruthers says, "It could be seen as a good time to launch a new neurotoxin."
Disclosures: Dr. Carruthers is a consultant for Allergan and a principal investigator on a lower-face study of Botox and Juvéderm (hyaluronic acid, Allergan), but owns no Allergan stock. Mr. Bye and Drs. Hellman, Rubinstein and Kaplan report no relevant financial interests.
