This whole "cosmeceutical" thing probably shouldn't be in "Medicine & Health" but we did call your attention to today's news item back on 27 July 2007: Drug maker Allergan announced at a stock analyst's meeting this afternoon that it is filing a New Drug Application (NDA) for a cosmetic form of its anti-glaucoma drug bimatoprost (Lumigan®) as a result of it side effect in increasing the number and thickness of eyelashes.
Allergan (nyse: AGN) has completed its clinical trial program demonstrating that its patented formulation of bimatoprost, when applied directly to the base of the eyelashes, results in significant eyelash growth, the company said.
Too bad for the cosmeceutical/supplement companies that have been selling knockoffs of this prostaglandin analog, at prices in the range of US$150-160 for a month's supply. We noted in November that the US FDA seized the inventory of one such company for selling an unapproved drug . Then, we saw action by Allergan's itself back in January against the Jan Marini.
I find it quite interesting that Allergan is pursuing approval for use of this agent as a drug rather than a cosmetic. The US FDA does not recognize the product category of "cosmeceutical" but it does regulate food, drugs, and cosmetics under legislation surprisingly named the Federal Food, Drug, and Cosmetic Act. So this new product will be both a drug and a cosmetic.
And why might Allergan want to get into the cosmetics business?
The global mascara market is presently estimated to be $3.7 billion annually. If approved by the FDA for eyelash growth, which Allergan currently anticipates in 2009, the company estimates global peak sales of bimatoprost for this indication could exceed $500 million per year.
Allergan has exclusive U.S. and foreign patents on the use of bimatoprost and other prostaglandins and prostaglandin analogs as a treatment to stimulate natural eyelash growth.
If approved by the FDA, Allergan's bimatoprost product for eyelash growth will be available by prescription only to consumers in the United States. (source)
With this being a prescription product with a niche cosmetic use, I can almost guarantee it will be more expensive than the same product marketed to treat glaucoma.
Expect some backlash from consumers and the cosmeceutical industry..
For previous links and commentary on eyelash-enhancing products:
For fuller, thicker lashes...a glaucoma treatment
Forty lashes for a cosmeceutical company
Jan Marini finally bats a lash at FDA, Allergan
*Hat tip to pharmacology professor emeritus G Victor Rossi, PhD, for planting this statement in my noggin' where it has remained, and has been used, for 25 years.