Canada gets topical patch for psoriasis

[Fred]

Health Canada has approved Beteflam (betamethasone valerate topical patch), a novel, patent-protected treatment of mild to moderate plaque psoriasis of the elbows and knees for a maximum duration of 30 days in adult patients.

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Cipher Pharmaceuticals Inc. today nnounced that Health Canada has approved PrBeteflam™ (betamethasone valerate topical patch), a novel, patent-protected treatment of mild to moderate plaque psoriasis of the elbows and knees for a maximum duration of 30 days in adult patients.

"We are pleased to make Beteflam available as a valuable new treatment option to Canadian dermatologists and to the patients who suffer from this disease," said Shawn O'Brien, President and CEO of Cipher. "Psoriasis affects one million Canadians1 and can profoundly impact the quality of life for many patients. Once the product is launched in Q2 2016, Beteflam is expected to be our fourth marketed product in Canada behind Epuris®, Vaniqa®, and Actikerall™. With potentially six commercial products on the Canadian market by the end of 2016, we have multiple new near-term revenue streams as we work toward our goal of reaching $50 million in annual sales in our Canadian dermatology business."

Topical corticosteroids remain the primary treatment for steroid-responsive inflammatory skin diseases, including mild to moderate chronic plaque psoriasis. Occlusion with plastic film dressings is a widely accepted procedure to enhance their efficacy, especially in the treatment of psoriasis. Beteflam is a patch that 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.

Cipher licensed the Canadian rights to Beteflam from Institut Biochimique SA ("IBSA"). The efficacy and safety of Beteflam was demonstrated by two randomized, active-controlled studies involving 555 patients with mild-to-moderate chronic plaque psoriasis, of which 281 patients received Beteflam. The results of the clinical program demonstrated that the clinical efficacy of  Beteflam  was superior to that of  betamethasone valerate 0.1% cream and comparable to that of Dovobet 50 µg calcipotriol plus 0.5 mg betamethasone dipropionate ointment. The commonly reported adverse drug reactions that occurred in patients using Beteflam were skin and subcutaneous tissue disorders, occurring in < 5% of patients treated.

Source: cipherpharma.com