Biotech Values

[DewDiligence]

FDA Approves Latisse (f.k.a. Lumilash)



[If ever there was a product where efficacy was proven, it would be this. Latisse, which has the same active ingredient as AGN’s Lumigan for glaucoma, is applied topically to the eyelashes to enhance growth for cosmetic purposes. I think Latisse will easily outsell Lumigan, which does about $500M annually, and end up being a substantial product for AGN. The economics are ideal: users pay out of pocket and they have to keep using the product forever or their eyelashes return to baseline.

The only concern re FDA approval was staining of the iris, but the Agency evidently didn’t consider this a serious problem. It seems as though the FDA has a split personality these days: products for aesthetic medicine often get a pass on modest safety issues while drugs for serious medical conditions frequently do not. Go figure.]

http://www.reuters.com/article/marketsNews/idINN2630137620081226

›Fri Dec 26, 2008 2:58pm EST

BOSTON, Dec 26 (Reuters) - Allergan Inc (AGN), the maker of Botox, said on Friday that the U.S. Food and Drug Administration has approved its eyelash-thickening drug Latisse.

Latisse is designed to treat a condition known as hypotrichosis of the eyelashes, which means a person does not have enough eyelashes.

The active ingredient in Latisse is bimatroprost, the same ingredient that is in Allergan's glaucoma treatment Lumigan. Patients taking Lumigan found a side effect of the drug to be eyelash growth, prompting Allergan to study it for the new use.

Latisse is a once-daily prescription treatment that is applied to the base of the upper eyelash with a sterile, single-use-per-eye disposable applicator. Once treatment is stopped, eyelashes will gradually return to where they were prior to treatment.

Allergan said it estimates global peak sales of Latisse solution could top $500 million a year.

Gary Nachman, an analyst at Leerink Swann, said that while approval was expected, "in this cautious environment, every approval through the FDA should be viewed positively."

Latisse is the first prescription product for lengthening eyelashes, making sales forecasting a little difficult.

Larry Biegelsen, an analyst at Wachovia, said he agrees with the company's forecast of more than $500 million. However, "we think the initial uptake will be muted due to the economic situation."

Biegelsen forecasts sales of $30 million in 2009, growing to $310 million in 2012. Leerink Swann's Nachman said he expects the drug to generate sales of $20 million in 2009, growing to $80 million in 2012. [These forecasts are way too low, IMO.]

"We believe the opportunity for Latisse could be much larger, but we still need to do more work on this largely unpioneered market," he said. [What the heck does this mean?]

Latisse is a structural prostaglandin analog, a lipid compound derived from fatty acids designed to bind to prostaglandin receptors. These receptors are present in hair and are thought to be involved in the development and regrowth of the hair follicle.

Side effects of Latisse can include eye redness, itchy eyes and a darkening of the eyelid skin. Though not reported in clinical studies, Allergan said Latisse may also cause the colored part of the eye to become browner, a condition that might be permanent. [This is a known side effect of Lumigan, however.]

Allergan said it expects to launch the product in the first quarter of 2009. Allergan's shares rose 1.1 percent to $36.85 on the New York Stock Exchange.‹