Jan Marini Skin Research (JMSR) is suspending sales of its two Age Intervention eyelash products in the U.S. - citing an uncertain regulatory environment and the daunting prospect of litigation - and focusing on its core skin-care line and opportunities abroad.

In a Jan. 9 interview with "The Rose Sheet," company founder and CEO Jan Marini acknowledged that Age Intervention Eyelash Conditioner and Age Intervention Masses of Lashes Performance Mascara have been "fantastic" products, commanding roughly 30 percent of the firm's domestic sales.

However, certain factors have arisen and compelled the company to reevaluate its strategy in connection with the products, which launched through physicians' offices as a means of conditioning eyelashes and improving their volume, texture and density.

In November, FDA announced that it had seized approximately $2 mil. worth of JMSR's Age Intervention Eyelash product from the company's San Jose, Calif. facility (Also see "Jan Marini Focused On Damage Control Following FDA Seizure Of Eyelash Item" - HBW Insight, 26 November, 2007., p. 3).

JMSR issued its own statement, stressing that Age Intervention Eyelash had not been manufactured or distributed in over a year.

It noted also that Age Intervention Eyelash's reformulated successor - Age Intervention Eyelash Conditioner - did not contain the drug ingredient at issue - bimatoprost - approved by FDA for treating glaucoma.

Bimatoprost has been reported anecdotally to stimulate eyelash growth in glaucoma patients.

The firm's second-generation eyelash products are formulated with an ophthalmic prostaglandin, whereas bimatoprost is a prostamide.

Nevertheless, CEO Marini said the company suspects that FDA is eyeing prostaglandin analogs as well.

"The FDA is looking at this category of product - it's not just us, it's other products that are very similar in the marketplace - and I think the bottom line is that it's unpredictable," she said.

In addition, JMSR is one of a number of companies being sued by pharmaceutical giant Allergan for patent infringement.

Allergan markets the bimatoprost-based drug Lumigan , indicated for reducing eye pressure in patients with open-angle glaucoma or ocular hypertension.

"We're absolutely confident that we're not infringing on any patents, but the resources [and] the time it would take to defend that position is something we have to consider," Marini said.

"[We] could go down that road many millions of dollars and then maybe not even have a product in the end because ... FDA is deciding how they are going to treat this particular category," she observed.

Instead, JMSR has opted to focus on its business overseas.

The company currently does business in 84 countries outside of the U.S. and is looking to expand its presence to other markets. China is among the first on its radar.

"We have a wonderful, growing international market. We don't have quite the same challenges in that market," Marini noted.

Furthermore, JMSR - founded in 1994 - has a portfolio of 90 other products besides its Age Intervention eyelash offerings.

The firm also markets Age Intervention items for the hands, face and hair, as well as targeted Transformation, Antioxidant and Therapeutic skin-care ranges.

"Before I ever even dreamed of inventing the eyelash product, we had a tremendous physician following," the CEO said.

- Ryan Nelson (r.nelson@elsevier.com)

Jan Marini Ceases Eyelash Product Sales Due To Allergan Suit, FDA Threat

More from Archive

More from HBW Insight