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.

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

Palomar: Over the Counter clearance for a consumer laser wrinkle-removal device

24-7 Wall Street.com broke some cosmetic medicine news last week:

"Palomar Medical Technologies Inc. (NASDAQ: PMTI) is seeing shares surge to new heights not seen in 18-months. The company is the first to receive FDA approval for over-the-counter clearance for a new, patented home use laser device that for the treatment of periorbital wrinkles (for eyes, like crows feet). The beauty of this, no pun intended, is that it is part of a Johnson & Johnson (NYSE: JNJ) partnership and that may lead to much greater use. This one will not exactly kill the entire Botox market for Allergan, Inc. (NYSE: AGN), but even for one such possible replacement the idea of a home-use laser has to be a bit more enticing than getting stuck with a needle full of Botulinum toxins."


Palomar's entry into the home use cosmetic device market simply expands the 5 year growth of such technologies. Palomar's home unit for skin rejuvenation joins other home use devices such as Tanda and Zeno for acne and the Tria and Silk'n for hair removal. What is clear is that home devices will expand the continued interest in non-surgical skin health. At the same time, it must be emphasized that such low powered technologies will never be as effective as those that are used in a physician's office.

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

Study continues Reloxin's path to FDA approval: How is it different from Botox?

A study released on Monday afternoon regarding Reloxin is making headlines. Many may wonder why, since it has been discussed in the U.S. media for at least a year and has been used even longer than that in Europe as Dysport.

If you want to check out the study yourself, click here for a PDF.



Dr. Goldberg says:

"This Reloxin study is important because it represents the first published US study involving an alternative to Botox®. It should be noted that although this is the first published US study on Reloxin, this wrinkle softening agent is not new. Reloxin, called Dysport in Europe, is a very popular alternative to Botox® over there. It has been shown to be both safe and effective.

This first US study will be far from the last. We and others are currently involved in several other Reloxin trials. Many of these trials involve evaluating injections of Reloxin every few months and over the course of several years.

Reloxin will be the first US competitor to Botox®. It will not be the last. We and others are studying even more alternatives such as Mentor's Purtox and Merz's Xeomin. The future is exciting for non-invasive cosmetic treatments."

Disclaimer: we know the authors of this study very well and I am on the Reloxin advisory board.

American consumers are interested in the bottom line of this product. Other research seems to say that it has a faster onset than Botox®, and a softer look. It is a good option for using on patients with resistance to Botox®. But generally, Reloxin will be very similar to Botox® and patients should not have any different expectations.

Link:
Medicis' Reloxin May Vie with Botox in U.S. to Clear Wrinkles [Bloomberg News]

Dr. Jason Pozner
Sanctuary Medical Aesthetic Center

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

Here Comes Latisse

We've blogged about it here and here, and Natasha Singer of the NY Times is also on the scene, with today's article "Love the Long Eyelashes. Who's Your Doctor?"

The article cites annual revenue estimates for Allergan's upcoming eye-lash lengthening drug Latisse, ranging from $80 million in 2012 (via Gary Nachman of Leerink Swan), to $500 million "long-term" (coming from Allergan CEO David Pyott).

The meat of the article comes here:

"Allergan held a clinical trial with about 280 volunteers, half of whom used Latisse daily for 16 weeks. The study results were reviewed by the Food and Drug Administration, which approved the drug in late December. In that study, eyelashes typically grew 25 percent longer, 106 percent thicker and 18 percent darker. While 3.6 percent of patients experienced eye itching and red eyes, none had a change of eye color, Allergan said."

Stay tuned for more on this... articles like this hint that Latisse may become a household name next to Botox someday.

Dr. Jason Pozner
Sanctuary Medical Aesthetic Center

Dr. David J. Goldberg
Sanctuary Medical Aesthetic Center
Skin and Laser Surgery Specialists of New York/New Jersey

Selling Botox on Ebay: Not a Good Idea

A woman in Mansfield, Texas is selling Botox on Ebay for about 95 cents per unit, which is literally pennies on the dollar for its fair market value.

This is very illegal, and very dangerous. She intends to sell this to cost-conscious people without any medical training, for use on themselves.

On her Instructions and FAQs page on BotoxDepot.com (her website since 2005), she outlines how to inject oneself, with tips like, "Do three-four for each crowsfoot, five for your forehead midway between your eyebrows and hairline, and if you have that frown line between your brows then do three more evenly spaced there. That's it- you are done. Just saved yourself a couple hundred bucks! It will last just as if you had it done in a spa- about 5-6 months before you can start to tell it is fading."

On her website, she also sells Restylane, but spelled as Restylin.

She also assures everyone that her products are genuine and she is a MedSpa worker in Dallas, and thus can get the product very cheaply. Something doesn't add up, as Allergan wholesales Botox to legitimate doctors for 5-6 times more than what she's selling it at.

Several news stations in Dallas are working on this right now, and law enforcement won't be far behind.

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

Dr. Jason Pozner
Sanctuary Medical Aesthetic Center

Breaking: FDA extends review date for Reloxin

Reuters is reporting that the FDA has extended the initial review of Ipsen's botulinum Type A toxin product, Reloxin, anticipated as the first American competitor to Botox.

According to Ipsen, the FDA also confirmed that their Wales facility for manufacturing the product is in compliance with their regulations.

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

Update: Latisse approved by the FDA

To update a previous blog item, the eye-lash booster Latisse has been approved by the FDA. Expect to see it being sold in cosmetic practices sometime in February.

To recap, Latisse was originally a glaucoma drug called Lumigan, which has been in use for the last seven years. Patients reported side effects of enhanced eyelashes, which led Allergan to explore cosmetic applications for the drug. This is similar to Botox's birth as a treatment for excessive blinking that happened to smooth nearby wrinkles.

Thanks for reading,

Dr. Jason Pozner
Sanctuary Medical Aesthetic Center

Dr. David J. Goldberg
Sanctuary Medical Aesthetic Center
Skin and Laser Surgery Specialists of New York/New Jersey

Another arrest in cosmetic surgery...

Another arrest in plastic surgery today... from the article:


"A dermatologist was arrested Thursday after being indicted on charges that he injected patients at his West Hollywood clinic with fake Botox that could have caused a muscle-paralyzing condition.

Dr. David Cary Hansen, who works out of a Sunset Boulevard clinic called Skinsation, is accused of buying a dozen vials of a form of botulinum toxin type A, which was not approved by the U.S. Food and Drug Administration for use on people, the U.S. attorney's office said."

It's never a bad idea to ask to see the actual vial of Botox or filler before it gets injected. If a product is too cheap to be true, then it's probably fake. Only go to a reputable doctor, you really get what you pay for.

Dr. Jason Pozner
Sanctuary Medical Aesthetic Center

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

Reloxin preferred over Botox in tests?

I just returned from a Pharmadura meeting in Dallas, which centered around the upcoming FDA approval for Botox competitor Reloxin. It's called Dysport in Europe and is to be distributed by Medicis in North America.

The advantages of Reloxin are its faster onset and "softer" look. Some proponents claim there is a longer lastings effect, but this is not certain at present. Anecdotal evidence from patients in the U.S. FDA trials who were Botox users are that these patients preferred Reloxin. Adverse incidents from the FDA trials are less then those experienced with the Botox trials, but his may be due to the fact that the physicians in the trials are more experienced injectors.

We await FDA approval and hope to have Reloxin for clinical use by first quarter 2009.

Dr. Jason Pozner
Sanctuary Medical Aesthetic Center

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

Pliaglis quietly pulled from market

It was launched with a lot of fanfare, but Galderma announced that they are discontinuing Pliaglis, which was a topical analgesic that would create a mask of lidocaine and tetracaine.

From Pliaglis.com...

"We took this action because of recurring inconsistent viscosity (thickness) of the product formulation. Our testing has found significant levels of variability in the viscosity parameter, resulting in a thicker cream which can make application of the product difficult."

After pulling the mask off, the application area would, in theory, be numb and ready to inject, thus eliminating the need for a separate injection of lidocaine.

It's a shame, it was highly effective, but varied in consistency due to compounding pharmacies.

Some injectors mix a little lidocaine with the Botox or filler, if requested by the patient.

Dr. David Goldberg
SMAC

Good News and Bad News From New ASPS Study

From the study:

" -- 59% of respondents say the economy has had an impact on their
plans for cosmetic plastic surgery. That's up 9% from six
months ago.
-- 48% of the survey participants are less likely to schedule a
consultation appointment now compared to 30% six months ago.
-- 27% of the survey participants indicated they were considering
less expensive options, compared with 20% six months ago."

As for surgeons:
"
-- 62% report a decrease
-- Region most affected - Northeast and Southeast
-- Region least affected - Midwest
"
Cosmetic surgery by its very nature is a luxury, and this is not a shock to anyone. Dr. Pozner at Sanctuary Plastic Surgery still is very busy with correctional and revision surgery, which is a big priority for many patients. However, the silver lining here is for cosmetic dermatologists:

-- 73% (almost 3 out of 4) report an increased or stable demand for
procedures like Botox(R), chemical peels, and hyaluronic fillers.

This is why we're still booming: these procedures are less expensive, less invasive, less stressful, and people don't have to miss work to have them.

With these factors, lipstick might get replaced by Botox as the recession-proof cosmetic. According to the Wall Street Journal, lipstick sales are down 6% compared to 2007, while lip gloss is down 14%. At the same time, studies like this suggest that Botox use may very well increase.

Thank you,

Dr. David Goldberg
SMAC
Skin Laser & Surgery Specialists