PRZOOM - /newswire/ -
Rehovot, Israel, 2011/01/18 - The first-in-class topical minocycline product, protected by 4 patent applications, is directed for the treatment of rosacea, acne, skin Infections and chronic wounds.
Foamix Ltd., a clinical-stage specialty pharmaceutical company focused on the development of proprietary dermatological and gynecologic topical products, today announced enrollment of the first patient in a Phase II trial of its Topical Minocycline Foam. The double-blind, placebo controlled dose range finding study aims to demonstrate efficacy and safety in patients suffering from Rosacea.
Foamix’s has successfully developed a topical form of Minocycline, despite the inherent instability of this drug. The product has a unique pharmacological profile. In laboratory studies, it effectively killed Streptococcus pyogenes, Pseudomonas aeruginosa, Staphylococcus aureus and methicillin-resistant Staphylococcus aureus (MRSA), as well as Propionbacterium acnes, the causative microorganism in acne; it was also shown to inhibit apoptosis in UVB-induced human skin inflammation. Skin penetration studies demonstrated high occurrence of the drug in the viable layers of the skin, which should facilitate high efficacy of the drug. The same studies also revealed that the drug is not delivered transdermally, indicating that its topical application will not involve any systemic adverse effects.
“There is a huge demand for new safe and effective topical treatments for rosacea.” said Dov Tamarkin, PhD., CEO of Foamix. “Based on its pharmacological profile, Topical Minocycline represents a strong alternative to the existing topical rosacea drugs. The initiation of our Phase 2 trial is a significant achievement for Foamix. Not only does it represent a development accomplishment in terms of product stability, but it is an important step in our strategy of taking our drugs into advanced development phases," he added.
The Company also recently received the approval for a Phase II study in pediatric patients with Impetigo, which will be initiated shortly; and an additional clinical study in Acne patients is under preparation.
According to IMS, the current U.S. sales of oral Minocycline and its analog Doxycycline are in excess of $1.2 billion.
Rosacea is a dermatologic condition that affects approximately 14 million adults in the U.S. It primarily affects the face and is characterized by the appearance of inflammatory lesions (papules and pustules), erythema (skin redness) and telangiectasia (spider veins). If allowed to progress to a moderate to severe condition, Rosacea can cause itching, pain and thickening of the skin. The current U.S. market size for Rosacea is estimated to be approximately $500 million.
Foamix Ltd. (foamix.co.il) is a clinical-stage, privately held specialty pharma company, focused on the development of proprietary topical foam and OilGel™ products for prescription, OTC and cosmetic applications. Foamix creates advanced products with improved convenience, higher compliance and better efficacy, which are backed by an extensive patent portfolio. The company’s development capabilities range from initial development of the formulations to scale-up, GMP manufacturing, preclinical and clinical studies.
Foamix partners with leading pharmaceutical companies, including Galderma, Intendis (Bayer’s dermatology company), Dr. Reddy's and Ferndale Laboratories.
Foamix has a strong in-house pipeline of dermatological and gynecological drugs. The Company’s lead product, Topical Minocycline, is currently in Phase II clinical studies.
To date, Foamix has 9 issued patents in the United States, covering its foam and OilGel™ technology platforms. The company has an additional 150 applications and patents worldwide, of which more than 60 applications are filed in the U.S.