Cipher Pharmaceuticals Inc., a growing specialty pharmaceutical company focused on dermatology, announced that the Beteflam Patch (previously called the Betesil Patch) has been accepted for review by Health Canada. The Beteflam Patch is a novel, patent-protected, self-adhesive medicated plaster containing 0.1% betamethasone valerate, for the treatment of inflammatory skin conditions such as chronic plaque psoriasis (CPP).
Topical corticosteroids remain the primary treatment for steroid-responsive inflammatory skin diseases, including mild to moderate CPP. Occlusion with plastic film dressings is a widely accepted procedure to enhance their efficacy, especially in the treatment of psoriasis. The Beteflam Patch is applied once-daily to the affected region and may be cut to fit the particular size and shape of the psoriatic lesion thereby reducing potential contact of the steroid with healthy areas of skin. The occlusive format of the Beteflam Patch provides a consistent distribution, delivery and absorption of the active ingredient and enhances the potency of the corticosteroid. The patch also helps to moisturize the skin, which accelerates healing and provides a protective barrier that reduces local trauma to the lesion due to scratching and prevents transfer of fluids from the lesion onto clothing.
"Chronic plaque psoriasis is the most prevalent form of psoriasis, found in about 90% of subjects with the disease, and can profoundly impact the quality of life for patients," said Shawn O'Brien, president & chief executive officer of Cipher. "If approved, the Beteflam Patch will represent a promising new product in our growing Canadian dermatology portfolio and an attractive treatment option for Canadians who suffer from this disease."
Cipher licensed the Canadian rights to the Beteflam Patch in 2012 from Institut Biochimique SA (IBSA), a pharmaceutical company based in Switzerland. The efficacy and safety of the product has been established in two successful phase III trials and one successful phase IV trial conducted by IBSA. IBSA recently published positive results from a large non-inferiority study, which compared the product to Dovobet (betamethasone plus calcipotriol), a commonly prescribed combination product containing a corticosteroid and a vitamin D analogue.
Acceptance for review by Health Canada resulted in a CDN$150,000 milestone payment from Cipher to IBSA.
Psoriasis is a chronic, autoimmune disease that appears on the skin, typically occurring in young adulthood and persisting for decades. It is estimated that approximately 500,000 people in Canada are living with psoriasis. It occurs when the immune system sends out faulty signals that speed up the growth cycle of skin cells. The most common form is plaque psoriasis, which appears as raised, red patches covered with a silvery-white buildup of dead skin cells. Treatment of psoriasis involves the application of topical corticosteroids for mild cases, progressing to combination therapy with systemic immunomodulators for moderate and severe disease. The goal of treatment is to relieve the signs and symptoms of the disease by minimizing the frequency and intensity of the plaques thereby improving the patient's quality of life.