Relief for Migraine Sufferers Boosts Allergan’s Stock after Fed Crackdown

For migraine sufferers, the recent FDA approval of Botox as a migraine treatment gives them access to the only thing that might actually work—injections of Botox.

Migraine victims have long awaited a drug that would avoid migraines, not just treat them after they start. Studies prove Botox’s ability to block nerves that cause a migraine. In one study, chronic migraine sufferers getting Botox injections had 9 fewer days of headaches per month compared with those receiving a placebo, who reported 6.7 fewer.

In another study that was funded by Allergan, Botox users reported 7.8 fewer days per month of any headaches (including migraines) compared with 6.4 days’ fewer headaches reported by those receiving the placebo injections.

Guilty Plea

Allergan had previously been ordered by the Justice Department to pay $375 million in fines for unauthorized promotion of Botox for headaches and cerebral palsy from 2000 to 2005. The fine was lowered to $350 million upon Allergan’s willingness to plead guilty to the charges. Allergan was also ordered to forfeit $25 million in assets and to stick to a 5-year mandated plan to disclose any payments to doctors and annually certify that their various divisions meet federal health care requirements.

Who can use it?

Men and women who have a migraine headache at least 15 days a month with pain lasting at least four hours qualify for treatment. It is assumed that health insurance carriers will approve this as a covered expense, since no other treatment has provided similar results. Treatment includes multiple injections around the neck and head every 3 months.

Allergan spokesperson, Caroline Van Hove, believes that insurers are unlikely to fight coverage of the drug since “this is a population that hasn’t responded to any of the conventional treatments.” Botox was cleared for migraine treatment earlier this summer in the UK and the company anticipates approvals in the rest of Europe and Canada yet this year.

Stock Market Reaction

Allergan (AGN) is running around $72 per share this month (Oct 2010). A month ago it was averaging $66 per share. The company, which generated $1.3 billion in 2009 sales, may earn $1 billion more in annual revenue with the migraine approval, said Aaron Gal, a Sanford C. Bernstein & Co. analyst in New York, in a May 2010 report.

AAFPRS: Non-Invasive Procedures Continue to Rise

A recent article from the Examiner analyzed the latest plastic surgery statistics released by the American Academy of Facial Plastic and Reconstructive Surgery (AAFPRS). Not unlike last year, the AAFPRS survey reported a significant increase in non-invasive treatments amongst their 2009 plastic surgery trends.

According to the AAFPRS, non-invasive cosmetic treatments rose 47% in 2009. The Examiner sites the current economic standing as an influencer in consumer behaviors. Dermal fillers and botulinum toxin A injections are growing in popularity because, even though their results are temporary, they are much more cost effective compared to invasive surgery.

Of the physicians surveyed, another 80% reported that patients were seeking non-invasive treatments as means to staying competitive in the workplace. The procedures with the largest amount of growth were as follows:
• Poly-l-lactic acid (Sculptra®)-up 71%
• Chemical peels-up 52%
• Hyaluronic acid (Juvederm®, Restylane®)-up 48%
• Botulinum toxin type A (Botox®, Dysport®)-up 45%

The majority of surgeons surveyed (77%) reported that patients are also more educated about their plastic surgery options. Patients are spending more time researching different procedures, costs, recovery time and physician qualifications before even stepping into a surgeon’s office.

The survey also found that women continue to be the majority of facial plastic surgery candidates, accounting for 84% of all non-invasive and surgical procedures.

The surgical procedures with the increases and decreases were:
• Ablative skin resurfacing (up 57%)
• Revision surgery (up 18%)
• Facelifts (up 14%)
• Lip augmentation (DOWN 52%)
• Rhinoplasty (DOWN 13%)

As we continue to see FDA approval for new products such as Xeomin and PurTox, the number of non-invasive procedures performed will surely continue to rise. New non-invasive technologies are continually being developed and put on the market.

Patients Need Less Botox® Over Time for Same Results

A recent study performed by Oregon Health & Science University shows that patients can decrease the frequency of Botox® injections after approximately two years and still see similar cosmetic benefits.

The study was run by Roger A. Dailey, M.D., F.A.C.S., professor and Lester Jones Endowed Chair of oculofacial plastic surgery in the OHSU School of Medicine. "After two years of treatment at recommended intervals, patients can potentially cut the frequency, and thus the cost, of their Botox® treatments by half," said Dailey.

Dailey’s study was presented at the American Society for Aesthetic Plastic Surgery conference in Washington, D.C., on April 24. Allergan, Inc., the maker of Botox® Cosmetic, sponsored the study with an unrestricted educational grant.

The study also found Botox® to have a wrinkle-preventing—or prophylactic—effect. Patients who were administered injections between their 30s and 50s not only eliminated existing wrinkles, but also prevent new wrinkles from forming.

Previous studies suggested that patients should be injected with Botox® every three months in the glabellar region—the area between the eyebrows—to maintain a wrinkle-free appearance. According to Dailey, the frequency and cost of the treatment deterred some patients from starting or continuing a Botox® regimen.

The study monitored 50 women between the ages of 30 and 50. The women were injected regularly with Botox® over the course of two years. "We found that after the patient receives Botox© Cosmetic injections every four months for two years, the frequency of the injections can be changed to every six months and still achieve good results," said Dailey. "This demonstrates patients have the ability to achieve good results with broader treatment schedules and ultimately at a lower overall treatment cost.”

According to the American Society for Aesthetic Plastic Surgery, 2,557,068 patients underwent Botox® treatments in 2009 (257,786 of which were men). Botox® was approved by the FDA for cosmetic purposes in 2002.

Botox Rival Issues a "Pepsi Challenge"

Remember the Pepsi Challenge? Commercials showing everyday folks surprising themselves by how much more they enjoyed Pepsi than Coke in a blind taste-test?

Medicis Pharmaceutical Corp. is taking its Botox competitor, Dysport, to the streets with a similar come-on. According to the Dysport Challenge, consumers can enjoy a two-pronged wrinkle option: use Medicis' generous rebates to try Dysport, but if you don’t like it as much as Botox, they’ll give you $75 toward your next Botox injection.

Over the year since Dysport gained FDA approval, it has captured less than 10% of Botox’s marketshare. Spurred by growing competition at its heals, Allergan has been pushing Botox into consumer awareness as a treatment for migraines and sweating. In fact, although such off-label uses for Botox aren’t technically approved by the FDA, they account for over 50% of the drug’s annual revenue.

While this kind of marketing may be raising eyebrows among medical ethicists, we don’t see a problem with it. After all, the Dysport promotion is targeted at cosmetic patients. How is this unlike a competition between Maybelline and Cover Girl mascaras?

Drs. Jason Pozner & David J. Goldberg
Sanctuary Medical Aesthetic Center, Boca Raton
Sanctuary Plastic Surgery, Boca Raton
Skin Laser Surgery Specialists of NY/NJ

New botulinum based filler on the way

Plastic Surgery Practice is reporting today that a "next generation" neurotoxin based on Botulinum toxin type A is on the way, via an agreement between Medicis Corporation and Revance Therapeutics.


"Under the terms of the agreement, Medicis will pay Revance $10 million at signing, as well as milestone payments totaling approximately $94 million upon successful completion of certain clinical, regulatory, and commercial milestones; and a royalty based on sales and supply price, the total of which is equivalent to a double-digit percentage of net sales."

The terms of the agreement indicate that nothing will begin happening with this until 2010.

Thanks for reading,

Dr. David J. Goldberg
Sanctuary Medical Aesthetic Center, Boca Raton
Skin Laser Surgery Specialists of NY/NJ

Dr. Jason Pozner
Sanctuary Medical Aesthetic Center, Boca Raton
Sanctuary Plastic Surgery, Boca Raton

Actress: Steroids are to Athletes as Botox is to Her?

Actress Rachel Weisz (best known for being in The Mummy) is in the news today for comparing the use of Botox and other wrinkle-killing injections to the use of performance-enhancing drugs for athletes.


"Rachel told Harper's Bazaar magazine: "It should be banned for actors, as steroids are for sportsmen."

The distinction that we would like to make is that steroids have known, well documented, life-long complications. Botox, when used solely for cosmetic purposes, has virtually no long-term side effects.

Should they ban makeup, lighting, and photoshop touch-ups on the movie posters?

Dr. David J. Goldberg
Sanctuary Medical Aesthetic Center, Boca Raton
Skin Laser Surgery Specialists of NY/NJ

Dr. Jason Pozner
Sanctuary Medical Aesthetic Center, Boca Raton
Sanctuary Plastic Surgery, Boca Raton

Botox a cure for baldness?

Colin Stewart at the OC Register's In Your Face blog wrote yesterday about a story in Britain's Daily Telegraph featuring Beverly Hills plastic surgeon Dr. Simon Ourian, who claims that he has been having success regrowing patients' hair with Botox.

"It’s not a claim that’s made by Botox-maker Allergan of Irvine. The announcement came from cosmetic surgeon Dr. Simon Ourian of Beverly Hills, who says injections in patients’ scalps have produced hair growth.

“It doesn’t make sense that Botox would cure baldness,” says Dr. Christopher Zachary, chairman of the UCI Department of Dermatology. “I have injected men numerous times high on the [forehead] and have never seen any hair growth.”

“It simply does not make sense, physiologically. I think he might have the same success if he injected lemonade,” says bariatric surgeon Dr. Brian B. Quebbemann of Newport Beach."

We're going to throw in our own two cents here: we wish.

Dr. Jason Pozner
Sanctuary Medical Aesthetic Center, Boca Raton
Sanctuary Plastic Surgery, Boca Raton

Dr. David J. Goldberg
Sanctuary Medical Aesthetic Center, Boca Raton
Skin Laser Surgery Specialists of NY/NJ

Interview with Global Medical News Network: Rundown of upcoming filler products

Dr. David J. Goldberg
Sanctuary Medical Aesthetic Center, Boca Raton
Skin Laser Surgery Specialists of NY/NJ

Dr. Jason Pozner
Sanctuary Medical Aesthetic Center, Boca Raton
Sanctuary Plastic Surgery, Boca Raton

Another delay for Reloxin

From Bloomberg:
"April 14 (Bloomberg) -- Competition for the Botox shot, America’s most popular cosmetic procedure, was delayed as U.S. drug regulators discuss labeling and a strategy for evaluating and mitigating risks of the new wrinkle smoother.

Medicis Pharmaceutical Corp. and Ipsen SA, which developed the experimental Reloxin product, are in talks with the Food and Drug Administration, Boulogne-Billancourt, France-based Ipsen said today in a statement. The injection relaxes the muscles that cause forehead lines using a type of botulinum toxin similar to the one in Allergan Inc.’s Botox. The delay should be a matter of weeks, according to brokerage Aurel BGC."

This isn't the first time Reloxin has gotten delayed; early last year, the FDA rejected Medicis' initial application, citing a paperwork snafu.

Dr. Jason Pozner
Sanctuary Medical Aesthetic Center

Dr. David J. Goldberg
Sanctuary Medical Aesthetic Center
Skin Laser Surgery Specialists of NY/NJ

Synthetic Snake Venom: Is it just snake oil?

From the Telegraph:

"A new cream claims to smooth wrinkles using a synthetic form of the poison produced by Asian temple viper snakes.

The £6 tubes of Lacura Wrinkle Stop contain a compound called Syn-Ake, which mimics the snake's paralysing venom. It promises to block the nerve signals which cause facial muscles to contract and can lead to lines.

Tests show that twice-daily application of the cream for four weeks may reduce the appearance of wrinkles by 52 per cent. "

This is interesting. Lots of drugs come from toxin, so there may be actual benefits from this.

Dr. David J. Goldberg
Sanctuary Medical Aesthetic Center
Skin Laser Surgery Specialists of NY/NJ

Dr. Jason Pozner
Sanctuary Medical Aesthetic Center