The first commercial product developed for the American market by Israeli biotech start-up Foamix has received FDA approval, the company announced last week.
Finacea Foam, a 15% solution of azelaic acid for the treatment of skin condition rosacea, was developed together with pharmaceutical giant Bayer.
Rosacea is a skin condition characterized by small and superficial dilated blood vessels, often on the face. It affects both sexes, but is almost three times more common in women, and in its light-to-moderate form is usually treated with topical treatments.
Among the most popular treatments is Finacea, which has been available in gel form and now is available as a foam, a form Foamix believes is better than rubs or gels. Foam, the company believes, is more effective for topical treatments, because it can be applied to large skin areas more quickly, is readily absorbed without leaving residue and is highly tolerated due to its use of gentle ingredients that are generally recognized as safe.
One of the biggest advantages of its technology, the company says, is the ability to develop treatments that do not contain water – ensuring greater safety for users. Microorganisms require water to grow and reproduce, while water-free foam formulations absorb the moisture they need from the air only upon application – meaning that bacteria, molds and fungi won’t grow during storage.
Topical formulations that contain low water content are generally thick and greasy, and require extensive rubbing for efficient topical application. Foams, on the other hand, are structurally soft, easy to apply and spread readily onto the skin.
Foamix’s next product set for FDA approval is a 4% minocycline foam formulation for the treatment of acne, currently in Phase III studies. Minocycline is an effective treatment for acne, but has some undesirable side effects, such as vertigo and dizziness, stomach upset, diarrhea and mouth sores. Even more serious conditions can develop, researchers say, because minocycline has an easier time penetrating the prostate, brain, and central nervous system.
Foamix, after over a decade of work, has figured out how to harness the power of minocycline to fight acne while avoiding the internal misfortunes that could develop. 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. And, there were zero side effects reported with the treatment.
Perhaps 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 formerly 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, for example, 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.
Meanwhile, said Foamix CEO Dov Tamarkin, the new Finacea formulation is “an important milestone for Foamix, as this is the first prescription product developed using our technology to be FDA approved for sale in the United States. We are proud of the progress made in our partnership with Bayer, and pleased that this product will be available to help people living with mild to moderate papulopustular rosacea.”