Allergan CEO David Pyott

Allergan CEO David Pyott is bullish on Botox’s potential as a salve for chronic migraine. He’s also betting on a next-gen dihydroergotamine (DHE) – Levadex – from MAP Pharmaceuticals.

It’s hard to know whether migraine sufferers will get behind Botox as a treatment; migraine patients are notoriously allergic to doctor visits, and many go undiagnosed. But for the worst kinds of migraines, particularly those that don’t respond to triptans or currently marketed DHEs, patients will probably be willing to try just about anything. Allergan CEO David Pyott, and MAP Pharmaceuticals CEO Tim Nelson, see headroom for growth in the category.

In 2009, the migraine market slipped into a steady decline after Imitrex, the go-to member of the triptan class, lost its patent (and blockbuster sales). Many of Imitrex’s classmates – Maxalt, Amerge, Zomig, and others – will face generic competition this year, if they aren’t facing it already. That makes Botox for migraine a difficult sell – it’s for chronic migraine, firstly, and it costs exponentially more than generic Imitrex – but during a 4Q earnings call yesterday Pyott said the migraine indication is performing “better than planned.” Around 4,600 physicians have been trained to give the injection, to date, said Pyott. “The vast majority of neurologists will inject for as long as three injection cycles,” even if they’re skeptical about the drug’s efficacy for migraine,” he Pyott. He’s hoping they’ll be convinced after that.

Branded print ads for Botox migraine will launch in women’s magazines this month, and an unbranded disease awareness campaign on television “has worked – the click-through on the website is positive,” said Pyott, adding that Allergan’s internal consumer surveys have shown “a high level of satisfaction” among patients.

After an upfront payment of $60 million last February, MAP Pharmaceuticals scored a $20 million milestone payment last August, when it filed Levadex with FDA. The company could receive up to $97 million more from Allergan if all goes well with the regulatory process; the PDUFA date on Levadex is March 26. Levadex, like Valeant Pharmaceuticals’ Migranal, is a DHE, but Migranal is a nasal spray, while Levadex is inhaled. The benefit with inhalation means that the drug sidesteps first pass metabolism en route to the brain – it avoids the GI tract, and potential dilution. At JP Morgan’s 30^th Annual Healthcare Conference in January, MAP CEO Tim Nelson said that Levadex “works faster, and has fewer side effects, than the triptans.” He added that 29 million scripts for migraine were written in 2008, and close to half of them were written off-label. After triptan, “41 percent of the scripts were for opioids, and 28 percent were anti-depressants,” said Nelson. MAP will hire 50 specialty sales reps if Levadex gets the FDA go-ahead, and will expand the drug into pediatrics and other neurological conditions later on, he said.

Levadex won’t compete directly with Botox for migraine; the former is for acute migraine, the latter for chronic migraine. Nelson said Allergan’s expertise in managed care, reimbursement and experience with FDA, makes it a good partner for Levadex. MAP is also looking for “a partner in Asia, and in ex-US in general,” said Nelson.

At $40 to $80, with a ceiling at $100 per dose, though, Levadex may be as tough a sell as Botox. But then again, migraine sufferers only want one thing when the pain sets in: for it to be gone.

The emailed invitation to attend Allergan’s Facial Aesthetics Advisory Panel, which was reproduced, criticized, and circulated on the Association of Healthcare Journalists’ listserv, said the panel’s goal is to “engage in a discussion about current facial aesthetics, trends and innovations, perceived gaps in data, and any questions, concerns or misperceptions your readers may have about products and treatments.” Allergan makes Botox Cosmetic, Juvederm (a dermal filler) and Latisse, an eyelash enhancer.

Reporters agreeing to attend the two-hour event and sit on the panel stand to earn the equivalent of $125 an hour. “As a seasoned reporter in this space, we would greatly value your feedback, and we’d like to offer you a stipend of $250 for your attendance and insights,” the invitation states.

Elizabeth Fishman, associate dean for communications at Columbia University’s Graduate School of Journalism, said in an email that she had “never heard of reporters being offered ‘stipends’ for their ‘attendance and insights’ about a company or product that they cover.” Fishman added that in 10 years at CBS News, she was never offered financial compensation by a third party in exchange for editorial coverage. “To accept any such compensation would be breaking a fundamental CBS News standard, and I am quite sure, would break standards at other news organizations as well,” she said.

The Allergan stipend doesn’t obligate reporters to write about Allergan or its products, and while providing a stipend and free lunch to journalists, in exchange for their attendance at an event featuring discussions about products they potentially cover, is ethically dubious, it’s not illegal. However, companies hoping to gain the trust of patients and other stakeholders, or hoping to simply avoid negative reputational spillover, will want to avoid the kind of public relations exposure that casts them in the role of media briber. Blaming a third party for mistakes doesn’t amount to an abdication of responsibility.

According to a Q1 release, Allergan’s facial aesthetics portfolio, combined with its breast aesthetics products, accounted for 29% of the company’s $4.8 billion in revenues  for 2010. Botox, which is indicated for cosmetic and non-cosmetic uses including chronic migraine, upper limb spasticity, cervical dystonia and other indications, represented 30% of Allergan’s revenues in 2010, according to company data.

J&J received a violation letter in response to a journal ad for its topical anti-inflammatory cream Ertaczo, emblazoned with the words “Crush. Kill. Destroy,” in large, orange letters. FDA states that the company is way off-base in touting total annihilation of athlete’s foot, rather that a decrease and potential for cure.

“Although [trial] results show modest effectiveness, they clearly do not support the claims that Ertaczo ‘wipes out’ or crushes, kills, and destroys tinea infections,” DDMAC wrote in the letter.

FDA also took issue with the suggested claims that Erataczo is approved for all patients. In fact, the drug is not approved for patients less than 12 years old.

Allergen got an even harsher letter, stating that its journal advertisement for the acne gel Aczone is a complete misrepresentation of the results of a clinical study, and that the ad “grossly overstates the efficacy of the drug by presenting only the most favorable result for Aczone.”

The ad stated that patients could see a reduction in acne by as much as 24 percent in two weeks. The study FDA is referring to showed that at two weeks, patients showed only a 2 percent decrease in inflammatory lesions.

Finally, Galderma received a warning letter regarding professional visual aids for its skin discoloration cream Tri-Luma. According to DDMAC, the ads “suggest uses for Tri-Luma that have not been approved by FDA, and thus create new  ‘intended uses’ for the drug for which the product lacks adequate directions, broaden indication for Tri-Luma, and omit and minimize important risk information for the drug.”