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Botox May Get 1$ Billion Dollar Lift!
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 it is 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 94 cents, or 1.7 percent, to $56.18 at 4:05
p.m. in New York Stock Exchange composite trading. The company
has jumped 39 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.
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.
For More Information Call Nova Cosmetic Center 407-226-0609
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