Cipher Pharmaceuticals Out-Licenses Rights to ASF-1096 for Anorectal Disorders
MISSISSAUGA, ON, June 20, 2016 /PRNewswire/ - Cipher Pharmaceuticals Inc. (NASDAQ:CPHR; TSX:CPH) ("Cipher" or "the Company") today announced that Edesa Biotech Inc. ("Edesa") has licensed the rights to ASF-1096 (R-salbutamol) for use in anorectal disorders. ASF-1096 is a phase II product candidate that Cipher is investigating as a treatment for selected inflammatory skin disorders. Cipher acquired the global rights to the product in February 2015. Under this agreement, Cipher retains all rights to ASF-1096 for dermatological conditions.
ASF-1096 is the first dermatological agent selectively targeting the ?2-adrenoceptor of dermal inflammatory cells including keratinocytes and various infiltrating leukocytes. When applied topically, ASF-1096 penetrates through the stratum corneum and binds to ?2-adrenoceptors, leading to immunomodulatory effects by reducing inflammatory reactions mediated by CD4+ lymphocytes and other types of ?2-adrenoceptor presenting leukocytes. This results in a decrease of pro-inflammatory gene products such as IL-2, TNF-?, and IFN-?. ASF-1096 was granted Orphan Drug Status by the European Medicines Agency for the treatment of cutaneous forms of Lupus Erythematosus.
"Given its novel anti-inflammatory properties, we believe ASF-1096 has promise as a compound to treat a range of anorectal disorders, and we're pleased to partner with Edesa to move the clinical development forward for these indications while we remain focused on dermatology," said Shawn O'Brien, President & CEO of Cipher. "We will continue to pursue opportunities to monetize our commercial products and product candidates in regions and indications that are not on our strategic roadmap."
Dr. Michael Brooks, VP of Corporate Development at Edesa, added: "We are very excited to work with Cipher and to explore the utility of ASF-1096 in anorectal indications."
Specific terms of the agreement were not disclosed.
About Edesa Biotech IncEdesa Biotech Inc. (http://www.edesabiotech.com/) has several products currently in development that target dermatological and gastrointestinal disorders. The company's focus is on treating underserved areas in Dermatology and Gastroenterology.
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.
Through multiple transactions, including the acquisition of Innocutis and its nine branded dermatology products, Cipher has built its U.S. commercial presence, expanded its Canadian dermatology franchise and broadened 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.
Forward-Looking StatementsStatements 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 a limited number of products; integration difficulties and other risks if we acquire or in-license technologies or product candidates; reliance on third parties for the marketing of certain 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; we generate license 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; certain of our products are subject to regulation as controlled substances; 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; we may be unsuccessful in evaluating material risks involved in completed and future acquisitions; we may be unable to identify, acquire or integrate acquisition targets successfully; operations in the U.S.; inability to meet covenants under our debt obligations; compliance with privacy and security regulation; our policies regarding returns, allowances and chargebacks may reduce revenues; certain regulations could restrict our activities; additional regulatory burden and controls over financial reporting; reliance on third parties to perform certain services; general commercial litigation, class actions, other litigation claims and regulatory actions; being a foreign private issuer may limit the information available to U.S. shareholders; we may lose our foreign private issuer status which could result in significant additional costs; 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 laws; litigation in the pharmaceutical industry concerning the manufacture and supply of novel and generic versions of existing drugs; 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; our operating results may fluctuate significantly; and our debt obligations will have priority over the Common Shares in the event of a liquidation, dissolution or winding up. 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.