Sept. 9 (Bloomberg) -- Allergan Inc.’s Botox, sold as a wrinkle- smoothing beauty aid since 1991, may be rejuvenated as a drug that prevents migraine headaches and is worth a potential $1 billion in added sales yearly.
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, it’s 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 data’s 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 don’t 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 speaker’s 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.
The Allergan studies test Botox in patients with chronic migraines, said Morris Levin, the director of the Dartmouth Headache Center in Lebanon, New Hampshire. To prevent headaches, Botox is injected into areas where migraine sufferers feel the most pain every three months, he 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.
Allergan’s Van Hove declined to comment on potential sales of Botox as a headache treatment, since it hasn’t 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 Association’s Web site. Scientists aren’t sure what causes them
About 1 in 4 women will experience a migraine during her life, and 2 in 25 men will have a migraine at least once, the Chicago-based AMA says.
Preliminary data from the studies were released on Sept. 11, 2008. In one trial, Botox injections were better than placebo shots at decreasing the number of days patients had headaches, though the frequency of headaches was similar. In the second, Botox led to more reduction in the number of headache episodes and the number of headache days.
Allergan changed its measure of what constitutes success in the second study, said Corey Davis, an analyst for Jefferies & Co. in New York, in a telephone interview.
“It’s taken Allergan over a year to put together the data to file the drug application, which strikes me as immediately suspicious,” Davis said.
Crystal Muilenburg, an Allergan spokeswoman, said it “takes time” to properly review and interpret results.
25 Percent Difference
To matter to patients, the fuller data will have to show Botox outperforming the placebo by at least 25 percent, Davis said. Most pain treatments have placebo effects, which is why it’s important that Botox outperform a dummy treatment.
Allergan stands to boost sales from the added use, partly because the doses used for treating migraines are much higher than for cosmetic use, Davis said. Smoothing a brow takes about 25 units of the drug; migraines require 200 or more. A vial of 100 units costs $609.98 on drugstore.com.
The American Academy of Neurology said in guidelines released in May 2008, before the preliminary results, that Botox shouldn’t be prescribed for headaches because research didn’t yet support its use.
David Simpson, the director of the clinical neurophysiology labs at Mount Sinai Medical Center in New York and the guidelines author, said if new data supporting Botox’s use are published in a peer-reviewed journal, “we can definitely amend the guidelines.”
15 Years of Use
Mauskop, at the New York Headache Center, said he started using Botox for migraines about 15 years ago.
“We find it to be very effective after other treatments fail, and it’s extremely safe,” he said by telephone.
“I use it in my practice and I’ve had mixed results,” Dartmouth’s Levin said in a telephone interview. The headache treatment lasts about three months, according to Levin, who said he participated in the Allergan trials. The injection then needs to be repeated, he said.
“I have lots of patients who see me every three months for their Botox treatments,” Levin said. “I ask them how they’re doing and they say, ‘I was good until last week.’”
Allergan is also exploring Botox for use in strokes. In May, the FDA declined to approve the drug for patients who have suffered a stroke until Allergan develops a safety plan.
In April, U.S. regulators said that Botox must carry the strictest U.S. warning about the risks of botulinum, which is potentially deadly. The warning applies to all botulinum toxins used to smooth forehead lines or treat neurological disorders. Botox is sometimes used by doctors to treat arm and leg spasms, uses not approved by the FDA.
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