Jan Marini Skin Research, a small California company that sells a popular cosmetic product to make eyelashes look longer, is suspending U.S. sales of the product to avoid further conflict with the Food and Drug Administration as well as a costly patent battle with drug maker Allergan Inc.
Jan Marini, chief executive of the closely held San Jose, Calif., firm, said her representatives started notifying customers late last week that it would no longer sell Age Intervention Eyelash Conditioner in the U.S. Marini and several other companies sell eyelash products that contain ingredients that are similar to those in prescription drugs for an eye disease.
In November, the FDA dispatched agents to seize several thousand tubes of a similar, discontinued Jan Marini product that the agency called a "misbranded drug." The FDA hasn't acted against the reformulated version of the product that the Marini firm is now withdrawing from the U.S. market. Ms. Marini says she isn't aware of any safety complaints related to either the original formulation or the new one.
Ms. Marini said the decision will allow her to focus her attention on the rest of her skin-care products business. She said she doesn't know if the FDA will allow sales of eyelash conditioners like hers that blur the line between cosmetics and drugs, but "I don't think this issue is going away."
Another concern for the company was a burgeoning conflict with Allergan over patents. Allergan, which is believed to be testing an eyelash product called Lumilash, modeled on its glaucoma drug Lumigan, in November sued seven eyelash-product companies alleging patent infringement.
"It's unfortunate that this product is no longer available from Jan Marini because it truly does grow the eyelashes and has a quantifiable benefit," unlike many so-called cosmeceuticals, said Joel Schlessinger, an Omaha, Neb., dermatologist who sells it in his office and on his LovelySkin.com Web site. Confusion over its regulatory status shows the need for a third regulatory track for cosmeceuticals, separate from those for drugs and cosmetics, he added.
Last week, Allergan said it has dropped one of the lawsuit defendants upon assurance that its product uses a different mechanism that doesn't violate Allergan patents. Underscoring its intention to aggressively defend "the fruits of our scientists and other hard work," Allergan said it has "no intention of settling any case in a manner that would empower a defendant to continue to infringe our intellectual property portfolio."
Jan Marini Skin Research doesn't disclose financial results, but Ms. Marini said the eyelash conditioner product has been its top seller and accounted for roughly 30% of sales. The tubes have typically sold for $160 in physician offices, spas and online. <<
>> Allergan Announces Intent to File New Drug Application for Bimatoprost as Novel Treatment to Stimulate Natural Eyelash Growth
Wednesday June 4, 12:00 am ET
IRVINE, Calif.--(BUSINESS WIRE)--Allergan, Inc. (NYSE:AGN ) announced today that it intends to file a New Drug Application by end of the third quarter of 2008 with the U.S. Food and Drug Administration (FDA) for bimatoprost, a synthetic prostaglandin analog, as a treatment to stimulate eyelash growth. Allergan 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.
"Our exploration of bimatoprost as an eyelash growth enhancer reflects our continuing commitment to offer innovative medical aesthetic treatments that are science-based, with the clinically proven safety and efficacy that consumers have come to trust Allergan to provide,” said Scott Whitcup, M.D., Allergan’s Executive Vice President, Research and Development. “We are pleased with the results of our clinical program and believe this innovative product, if approved, could meet a significant and currently unmet demand in the medical aesthetic marketplace.”
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.
“The development of this innovative product stems from our 60-year expertise and leadership in prescription eye care products,” said David E.I. Pyott, Allergan’s Chairman of the Board and Chief Executive Officer. “As the largest medical aesthetics company worldwide, we are particularly pleased with the prospect of bringing to market yet another science-based medical treatment that fits into our overall facial aesthetics product portfolio and further reflects our commitment to the Science of Rejuvenation™.” <<
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