Israeli firm’s novel acne treatment ‘foams up’ to IPO

Set to enter Phase III tests, Foamix’s fix for pimples looks like a winner as the company prepares to go public

Individual with a case of back acne (Courtesy James Heilman, MD)
Individual with a case of back acne (Courtesy James Heilman, MD)

Foam is for more than just bubble baths — an Israeli medical development firm has found dozens of beneficial uses. One of the most promising is an acne treatment that researchers say is more effective and safer than products now on the market.  Other Foamix-inspired roles for foam are delivering treatments for infections and afflictions of the skin, uterus, vagina, and other sensitive areas of the body. All this has driven the company toward going public.

With 55 registered patents and 135 pending approval, Foamix is well-placed to raise up to $75 million in an initial public offering, which the company filed with the NASDAQ exchange several weeks ago. Foamix’s secret sauce is its 4% minocycline foam formulation for the treatment of acne, which is set to enter Phase III studies and testing next year, the last stage before final FDA approval.

Acne, the scourge of teenagers everywhere, provides over the counter and prescription treatment makers with a huge opportunity. The market for preparations to beat pimples is worth $3 billion worldwide, and it’s growing. For mild cases, there are the topical treatments like Clearasil, which use benzoyl peroxide and other chemicals to clear pores and eliminate pimples. “Heavier” cases require prescription treatment. The most popular and best-performing on the market are Solodyn pills, which contain minocycline, an antibiotic, as the main active ingredient.

Minocycline is an effective treatment for acne, but it has some undesirable side-effects, such as vertigo and dizziness, stomach upset, diarrhea, mouth sores, and other unwanted symptoms. Even more serious conditions can develop, researchers say, because minocycline can penetrate the prostate, brain, and central nervous system.

The key would be to harness the power of minocycline to fight acne, while avoiding the internal misfortunes that can develop. Foamix, after over a decade of work, has figured out how to do that.

Among the company’s patents is one for the development of a stable, patient-friendly topical foam containing up to 4% minocycline, appropriate for use directly on moderate to severe cases of acne. In studies the company has done, the number of inflammatory lesions (pimples of various kinds) decreased by 72%, with a 73% decrease in non-inflammatory lesions by the end of the 12-week treatment cycle. The clinical phase II trial was conducted with 150 patients with moderate to severe acne, receiving the Foamix formula once a day. Notably, there were zero side effects reported with the treatment.

Perhaps even more importantly, at least from a marketing perspective, was the fact that 86% of the patients receiving minocycline 4% foam rated the drug as “very highly” or as “highly” better than other drugs they had used, while 92% indicated that they prefer the foam over alternative topical products they have used in the past. That’s an important statistic for Foamix, which believes that foam is the next wave in topical treatment. Foam, says the company, spreads smoothly, gently, and easily on large body surfaces and is quickly absorbed into problem areas.

While acne may be Foamix’s biggest potential market, the company is developing applications for other skin issues. Foamix’s AcycloFoam product contains an active ingredient of Acyclovir 5%, used to treat genital herpes. The easy-on and easy-absorbing foam is much preferred by patients who are being treated for the painful disease, Foamix researchers found during tests. An estrogen-based foam product produced by the company can be effective in treating the symptoms of menopause and atrophic vaginitis. Foamix’s Clobetasol Propionate Foam can be used to treat psoriasis, eczema, and other painful skin conditions — a $3.2 billion market in the US alone.

The company can even one-up Clearasil, Proactiv, Neutrogena, and the others that produce treatments for the topical treatment of light acne. Foamix has developed Salicylic Acid Foam, which works faster and absorbs better than the other rub-on paste formulations, the company’s research indicates.

The IPO is expected to be filed this month, NASDAQ officials said. Foamix already has several partnerships for development of its products, most notably with the US division of Germany’s Merz Pharmaceuticals, and also has a product of its own on the market -– Scytera, a foam-based treatment for psoriasis.

“We are very proud to enter this cooperation with Merz for an important product opportunity utilizing our proprietary technology platforms,” said Dr. Dov Tamarkin, CEO of Foamix Ltd. “We continue to significantly diversify our existing and future product portfolio through both internal product development programs and external collaboration with innovative healthcare companies like Merz North America. We anticipate that this collaboration will lead to potential significant business growth in the future.”

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