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Santa Brings FDA and Health Canada Approvals for New Dermatology Products
Published Monday, December 21, 2015 by Fred Zucker
Regulatory approval of products is what pharmaceutical companies wish for as they spend years developing their products. For Oculus Innovative Sciences (NASDAQ: OCLS) and Cipher Pharmaceuticals (NASDAQ: CPHR)(TSX: CPH), the wishes were answered before Christmas, with both companies getting the green light from regulators to commercialize their respective products. Foamix Pharmaceuticals (NASDAQ: FOMX), hasn’t reached the end of the regulatory path with FDX104, but the company moved one step closer this month with releasing positive top-line results from a phase 2 trial.

Foamix evaluated FDX 104, a topical foam containing 4% doxycycline, in the mid-stage trial for the prevention of moderate-to-severe skin rashes in patients treated with the epidermal growth factor receptor antibody inhibitors (EGFRI) cetuximab (Erbitux®, Eli Lilly) or panitumumab (Vectibix®, Amgen) for head and neck and colon cancers, among others. An acne-like rash is the most common side effect of EGFRI drugs and when severe can lead to discontinuing treatment. The results of the phase 2 trial showed a statistically significant effect of FDX104 in reducing the severity of the antibody-induced rash.

Mississauga, Ontario-based Cipher Pharmaceuticals won the approval of Health Canada for Beteflam (betamethasone valerate topical patch), a novel treatment of mild to moderate plaque psoriasis of the elbows and knees for a maximum duration of 30 days in adult patients. In the second quarter of 2016, Beteflam will join Epuris, Vaniqa, and Actikerall as dermatology products marketed by Cipher in Canada.

Oculus Innovative Sciences received FDA 510(k) clearance for SebDerm Gel, a prescription product for managing and relieving the burning, itching, erythema, scaling, and pain experienced with seborrhea and seborrheic dermatitis. Oculus’ Microcyn Technology, a patented process to create a pH neutral solution of hypochlorous acid and hypochlorite, underscores the product.

Seborrheic dermatitis, also known generically as dandruff (although it doesn’t exclusively present on the scalp) in adults and cradle cap in infants, affects about 25 percent of Americans, creating a more than $1 billion market for over-the-counter treatments alone. SebDerm, which is expected to be on pharmacy shelves in Q2 2016, adds to a growing product portfolio at Oculus and its dermatology division, InterDerm Pharmaceuticals.

Research suggests that yeast and fungi, more specifically Malassezia yeast and the fungus Pityrosporum, play a factor in seborrheic dermatitis. Hypochlorous acid is known to rapidly destroy a wide range of pathogens, including bacteria, spores and fungi, supporting the effectiveness of SebDerm. It’s worth noting that today’s prescription shampoos with ketoconazole can be very drying and that live yeast can theoretically develop resistance to the active ingredient in these shampoos. The Microcyn technology at the heart of SebDerm Gel has a hydrating component to it and is a swift pathogen destroyer (reduces resistance risk), meaning the new product could be a valuable alternative for dermatologists versus many of today’s prescribed therapies.

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