Botox May Get $1 Billion Face Lift as Allergan Migraine Drug
About $50 million of $1.3 billion in revenue generated last year by Botox came from its unapproved use as a migraine treatment, said Larry Biegelsen, an analyst at Wells Fargo Advisors LLC in New York. Study results being reported at a medical conference tomorrow will determine whether the drug is effective for that use, a finding that may boost sales by as much as 75 percent, said Peter Bye, a Jefferies & Co. analyst.
Allergan already has submitted the findings to a medical journal and expects to supply the data to U.S. regulators before Sept. 30, said Caroline Van Hove, a spokeswoman for the Irvine, California, company. The results may lead insurers to pay for the treatment even before its approved in the U.S., Bye said.
“Theoretically, its huge,” Bye said in a telephone interview from his New York office. “It could add as much as $1 billion or more a year, if the datas good enough.”
Allergan rose 32 cents to $55.24 in New York Stock Exchange composite trading yesterday. The company has jumped 37 percent this year, in part on speculation by investors that the company may be acquired.
The drug, a purified form of the poison botulinum, is administered by doctors as an injection. It helps to smooth wrinkles in facial skin by paralyzing the muscles underneath. Scientists dont know how Botox helps to prevent migraines.
Pain Messages
At first, doctors thought muscle spasms were being quelled by Botox, making the headaches less painful, said Alexander Mauskop, a neurologist at the New York Headache Center in Manhattan. Now, researchers say the drug may stop pain messages from reaching the brain, preventing a cycle of escalating communication that culminates in a migraine, according to Mauskop, who participated in the trials and said he has received speakers fees from Allergan.
The drugmaker began researching Botox for migraines after doctors such as Richard Glogau, a dermatologist at the University of California San Francisco, linked the drug to migraine relief in case studies. Glogau in November 2000 reported at the American Society of Dermatologic Surgery meeting that patients given Botox to remove frown lines also reported having fewer migraines.
Current treatments for migraines include painkillers and the generic drug ergotamine, which lessens the severity of headaches already under way. The best-selling treatment, with $1.3 billion in 2008 sales, is Imitrex, made by London-based GlaxoSmithKline Plc. That drug, available as a generic since last year, is used to prevent an attack when patients feel it is imminent.
No Approved Drugs
No drugs have been approved for so-called chronic migraine, when patients have headaches on 15 or more days a month. Unapproved generic drugs used for this purpose include beta blockers and Topamax, made by New Brunswick, New Jersey-based Johnson & Johnson. Not all patients respond to them, Bye, the Jeffries analyst, said.
If the findings to be presented this weekend at the International Headache Congress in Philadelphia are positive, the FDA may move quickly to approval since the drug would answer an unmet need, Biegelsen of Wells Fargo said.
Immediate Revenue
Bye said Allergan may also see added revenue immediately. Migraines can entail “hidden” costs to insurers such as visits to the emergency room and lost work days, increasing the pressure to cover any drug that may be helpful, he said. A positive finding would be if the drug can cut the days patients have migraines by three or more, Bye said.
Allergans Van Hove declined to comment on potential sales of Botox as a headache treatment, since it hasnt yet been approved for that use by the U.S. Food and Drug Administration. While companies must limit marketing to uses allowed by the agency, doctors in the U.S. may prescribe any FDA-approved treatments as they see fit.
The two Botox trials are both 56 weeks long, Van Hove said. One enrolled 679 chronic-migraine patients and the other had 705.
Extreme Headaches
Migraines are extreme headaches that can cause nausea, vomiting and sensitivity to light. They can be triggered by anxiety, stress, exposure to light, caffeine, alcohol, hunger, or sleeplessness, according to the American Medical Associations Web site. Scientists arent sure what causes them