Cipher Pharmaceuticals Inc., a rapidly growing specialty pharmaceutical dermatology company, announced the Canadian launch of Actikerall (0.5% fluorouracil and 10% salicylic acid), indicated for the topical treatment of slightly palpable and/or moderately thick hyperkeratotic actinic keratosis (Grade I/II) of the face, forehead, and balding scalp in immunocompetent adult patients. Actinic keratosis, also known as solar keratosis, is a skin condition caused by exposure to ultraviolet radiation.
Cipher acquired Actikerall from Almirall S.A. in May, 2015. The product represents the third marketed product in Cipher's growing Canadian dermatology portfolio.
"We're excited to introduce Actikerall as a new treatment option for Canadians who suffer from actinic keratosis," said Shawn O'Brien, president & CEO of Cipher. "Today, 60 per cent of all Canadians over the age of 40 have at least one lesion, and it is expected that the incidence will increase as the population ages."
Joan Chypyha, GM of Cipher Canada added, "We're executing on our plan to grow the Canadian portfolio. Since mid-2015, we have added Vaniqa and Actikerall, with Beteflam expected to launch in early Q2 2016. Moreover, we have a strong pipeline of four other products nearing commercialization: Dermadexin, Pruridexin, Sitavig and Ozenoxacin. In total, we expect to have six products on the Canadian market in 2016 and eight in 2017."
The efficacy of Actikerall was established in a randomized, double-blind, placebo and active-controlled clinical trial of 470 patients with actinic keratosis (Grade I/II). In this trial, 74.5 per cent of actinic keratosis lesions treated for up to 12 weeks with Actikerall were clear at 8 weeks post-treatment and, in the long-term follow-up study, 85.8 per cent of lesions treated with Actikerall remained clear 12 months post-treatment. The most frequent adverse reactions were categorized as application site reactions: irritation/burning (86.1 per cent), inflammation (73.3 per cent), pruritus (44.9 per cent), pain (25.1 per cent) and erythema (11.2 per cent).