Cipher Pharma Announces Canadian Launch Of Actikerall
MISSISSAUGA, ON, Feb. 22, 2016 /PRNewswire/ - Cipher Pharmaceuticals Inc. (NASDAQ:CPHR; TSX:CPH) ("Cipher" or "the Company") today 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 patients1. Actinic keratosis, also known as solar keratosis, is a skin condition caused by exposure to ultraviolet radiation2. 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% of all Canadians2 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% 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% of lesions treated with Actikerall remained clear 12 months post-treatment3,4. The most frequent adverse reactions were categorized as application site reactions: irritation/burning (86.1%), inflammation (73.3%), pruritus (44.9%), pain (25.1%) and erythema (11.2%)1.
Actikerall (fluorouracil and salicylic acid) Product Monograph, date of preparation: August 7, 2015
Stockfleth E, Kerl H, Zwingers T, Willers C. Low-dose 5-fluorouracil in combination with salicylic acid as a new lesion-directed option to treat topically actinic keratosis: histological and clinical study results. Br J Dermatol. 2011; 165:1101-8
Stockfleth E, Zwingers T, Willers C. Recurrence rates and patient assessed outcomes of 0.5% 5-fluorouracil in combination with salicylic acid treating actinic keratoses. Eur J Dermatol. 2012;22:370-4.
About Cipher Pharmaceuticals Inc.
Cipher Pharmaceuticals (NASDAQ:CPHR; TSX:CPH) is a rapidly growing specialty pharmaceutical dermatology company with a diversified portfolio of commercial-stage products with the goal of becoming the most customer-centric dermatology company in North America.
Cipher completed seven transactions in 2015, including the acquisition of Innocutis and its nine branded dermatology products, to build its U.S. commercial presence, expand its Canadian dermatology franchise and broaden its pipeline. Cipher is well-capitalized to drive long-term, sustained earnings growth by leveraging its proven clinical development capabilities and efficient commercial execution. For more information, visit www.cipherpharma.com.
Statements made in this news release may be forward-looking and therefore subject to various risks and uncertainties. The words "may", "will", "could", "should", "would", "suspect", "outlook", "believe", "plan", "anticipate", "estimate", "expect", "intend", "forecast", "objective", "hope" and "continue" (or the negative thereof), and words and expressions of similar import, are intended to identify forward-looking statements. Certain material factors or assumptions are applied in making forward-looking statements and actual results may differ materially from those expressed or implied in such statements. Factors that could cause results to vary include those identified in the Company's Annual Information Form, Form 40-F and other filings with Canadian and U.S. securities regulatory authorities. These factors include, but are not limited to our ability to enter into in-licensing, development, manufacturing and marketing and distribution agreements with other pharmaceutical companies and keep such agreements in effect; our dependency on three products; integration difficulties and other risks if we acquire or in-license technologies or product candidates; reliance on third parties for the marketing of our products; the product approval process is highly unpredictable; the timing of completion of clinical trials; reliance on third parties to manufacture our products; we may be subject to product liability claims; unexpected product safety or efficacy concerns may arise; generate revenue from a limited number of distribution and supply agreements; the pharmaceutical industry is highly competitive; requirements for additional capital to fund future operations; dependence on key managerial personnel and external collaborators; no assurance that we will receive regulatory approvals in the U.S., Canada or any other jurisdictions; limitations on reimbursement in the healthcare industry; limited reimbursement for products by government authorities and third-party payor policies; various laws pertaining to health care fraud and abuse; reliance on the success of strategic investments and partnerships; the publication of negative results of clinical trials; unpredictable development goals and projected time frames; rising insurance costs; ability to enforce covenants not to compete; risks associated with the industry in which it operates; foreign currency risk; the potential violation of intellectual property rights of third parties; our efforts to obtain, protect or enforce our patents and other intellectual property rights related to our products; changes in U.S., Canadian or foreign patent law; litigation in the pharmaceutical industry concerning the manufacture and supply of novel versions of existing drugs that are the subject of conflicting patent rights; inability to protect our trademarks from infringement; shareholders may be further diluted; volatility of our share price; a significant shareholder; we do not currently intend to pay dividends; and our operating results may fluctuate significantly; we may be unsuccessful in evaluating material risks involved in complete and future acquisitions; we may be unable to identify, acquire or integrate acquisition targets successfully; operations in the U.S.; and inability to meet covenants on our credit facilities.. All forward-looking statements presented herein should be considered in conjunction with such filings. Except as required by Canadian or U.S. securities laws, the Company does not undertake to update any forward-looking statements; such statements speak only as of the date made.
SOURCE Cipher Pharmaceuticals Inc.