MISSISSAUGA, ON, April 6, 2016 /PRNewswire/ - Cipher Pharmaceuticals Inc. (NASDAQ: CPHR; TSX:CPH) ("Cipher" or "the Company") today announced it has received Health Canada approvals for SD Cream and AD Cream (also known as Dermadexin and Pruridexin). Both products were approved in Canada by the Natural and Non-Prescription Health Products Directorate. In addition European approval of Helioclin® Pruritus SD Cream (also known as Pruridexin) was achieved.
Helioclin® Dermatitis SD Cream (also known as Dermadexin) was approved in Europe in 2014 and with the approval of Helioclin® Pruritus SD Cream last week as a Class III medical device, Cipher is now in a position to partner to launch and grow a product line with significant potential in the European market.
In Canada, the SD Cream is a patent-protected topical barrier-repair cream for the management and relief of the signs and symptoms of seborrheic dermatitis (such as erythema, scaling and pruritis). AD Cream is a patent-protected topical cream for the management and relief of the signs and symptoms of atopic and contact dermatitis (such as erythema, scaling and pruritus).
"We continue to deliver on our key regulatory milestones and our plan to expand the Canadian product portfolio," said Shawn O'Brien, President & Chief Executive Officer of Cipher. "These products target chronic inflammatory conditions that we believe are insufficiently addressed today. While we finalize our commercialization plans in Canada, we are very focused on obtaining U.S. approvals for both products, which we are targeting later this year."
Cipher acquired the worldwide rights to these two products from Astion Pharma A/S in February, 2015. Dermadexin has been tested in two vehicle-controlled, multicenter clinical trials (452 patients) where it displayed a marked and statistically significant effect on the symptoms of facial seborrhoeic dermatitis. Pruridexin has been tested in two vehicle-controlled, multicenter clinical trials (367 patients) and displayed a marked and statistically significant effect on the pruritus.
In Canada, Cipher plans to market the products through its internal sales team. The Company expects to out-license Helioclin® Pruritus SD Cream and Helioclin® Dermatitis SD Cream in Europe.
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.