Allergan's Potential Baldness Cure Clears One Hurdle, Heads for the Hard Part

Last Updated Aug 19, 2011 12:48 PM EDT

Allergan (AGN) R&D chief Scott Whitcup is suddenly markedly more voluble about the chances of the eyelash-lengthening drug Latisse turning into a cure for baldness. The drug is now in Phase II testing on 600 patients, he told investors on the company's Q2 2011 conference call.

When Allergan talked about Latisse last year, the idea of using it on male-pattern baldness -- or any other kind of baldness -- was purely speculative. Only four lab monkeys had grown hair using a similar drug. Since then the drug has passed Phase I testing, which involves figuring out a dose size and making sure it's safe to test on humans. Now, Latisse for baldness is "optimally resourced" in Allergan's R&D budget, Whitcup said, and if any positive data emerge Allergan will go immediately to Phase III -- mass testing to prove in a statistically significant way it's both effective and safe.

You can track the progress of the test on 300 men here. Note that Allergan's control group is not men using a placebo but men using Rogaine. Clearly, Allergan wants to see if this thing can grow more hair than the market leader. Weird note: One of the test criteria is "Willingness to have micro-dot-tattoo applied to scalp." That is probably to ensure that the drug is placed in exactly the same place, once a day, for six months, according to the trial regimen.

The 300 women are being recruited here. They are being ranked against a weaker solution of Rogaine; the use here is more for thinning hair than outright baldness.

Both trials use the same two measures for their results: A robust, objective measure in the form of a physical count of hairs per square centimeter; and then the rather more woolly "self assessment," in which patients make up a score based how they feel they've improved. It will be interesting to see which of those indicators Allergan leans on more heavily when it presents its results.

Here is everything that Whitcup said about Latisse in development:

... clearly, this is a program that we've optimally resourced, given the huge market potential. So the Phase I was just testing the overall formulation, making sure that it was stable, making sure that it was tolerated. So we probably have some of the Phase I data at R&D Day.
But it's really the Phase II data that will be proof of concept. That depending on enrollment and feedback probably won't be available till end of sort of, I'd say, latter part of next year. Clearly, we'll be monitoring this and as we start getting any positive feedback, we'll gear up, so that once we get the proof of concept data, we could go to Phase III right away.
The good news is that the FDA regulatory pathway is well delineated as there are other products that have been approved. The negative is it's not quick. You've got to go through all of the steps that FDA requires and that will be 2 Phase III trials following a proof of concept study. And as you pointed out, we see a potential market, not only for male-pattern baldness which is a huge market, but the animal data suggests that for female hair thinning, that could be a very beneficial product as well.
If Latisse enters Phase III late next year, then the very earliest date for approval of a new drug for baldness would be 2013 or 2014. Allergan's stock, meanwhile, is already pricing in the potential: When the company first mentioned the product, AGN was at $54.80. It was at $63.72 this time last year when it gave another update. Now, despite the market turmoil, AGN is at $72.91 at the time of writing.

Hat tip to the O.C. Register.

Image by Stibbens, CC.