MISSISSAUGA, ON, Feb. 16, 2016 /CNW/ - Cipher Pharmaceuticals Inc. (NASDAQ: CPHR; TSX:CPH) ("Cipher" or "the Company") today announced that its New Drug Submission for Sitavig™ has been accepted for review by Health Canada. Sitavig (acyclovir mucoadhesive buccal tablets) is proposed for the treatment of recurrent herpes labialis (cold sores) in adults.
"Cold sores are one of the most common viral skin infections, affecting one in five Canadians," said Shawn O'Brien, President and CEO of Cipher. "In addition to the pain, this is a highly stigmatizing disorder. If approved, Sitavig will represent an attractive treatment option for the many Canadians who suffer from cold sores and another key addition to our growing Canadian dermatology portfolio."
In the United States, Sitavig® is approved as a single-dose prescription cold sore treatment. Based on proprietary Lauriad® technology from Onxeo S.A, Sitavig is a 50 mg mucoadhesive tablet, which the patient places inside the lip on the upper gum and, in clinical trials, has been seen to deliver acyclovir to the site of the cold sore infection.
"The Health Canada submission for Sitavig is a joint achievement for Cipher and Onxeo that reflects great collaboration and regulatory work by the two companies over the past several months," said Judith Greciet, CEO of Onxeo S.A. "Should Sitavig receive approval in Canada, it will strengthen the brand in North America and increase the availability of the product for patients suffering from cold sores."
Cipher acquired the North American distribution rights to Sitavig with the April 2015 acquisition of INNOCUTIS Holdings LLC, which originally licensed the product from Onxeo S.A. Cipher plans to market Sitavig through its Canadian sales force.
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.
Onxeo has the vision to become a global leader and pioneer in oncology, with a focus on orphan or rare cancers, through developing innovative therapeutic alternatives designed to "make the difference". The Onxeo team is determined to develop innovative medicines that provide patients with hope and significantly improve their lives.
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.
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