MISSISSAUGA, ON, Oct. 10, 2017 /CNW/ - Cipher Pharmaceuticals Inc. (TSX:CPH) (“Cipher” or “the Company”) today commented on the impact from Hurricane Maria to its manufacturing partner’s facilities in Puerto Rico. Galephar Pharmaceutical Research (“Galephar”) operates two manufacturing facilities in Puerto Rico. The facility in Humacao manufactures Absorica®, Epuris®, and Lipofen® products, and the facility in Juncos manufactures Conzip® and Durela® products.
Galephar has informed Cipher that the facility in Juncos sustained some minor weather-related damage that has been repaired. Galephar also informed the Company that the facility in Humacao sustained damage to the exterior of the production building; however, the production suites and equipment were unaffected. Clean-up and repair work at the Humacao facility has commenced and is ongoing. Galephar expects to have the Humacao facility operational by mid- to late-November 2017.
Based on current inventory levels with the Company’s various distribution partners, recent and pending product shipments, and the current timeline for the resumption of production at the Humacao facility, Cipher does not anticipate an interruption in Absorica or Epuris supply. Further, no material impact is anticipated across Cipher’s full product portfolio.
The Company continues to monitor the situation closely and will provide an update on the status of the facilities and product supply as additional information becomes available.
About Cipher Pharmaceuticals Inc.
Cipher (TSX:CPH) is a specialty pharmaceutical company with a robust and diversified portfolio of commercial and early to late-stage products. Cipher acquires products that fulfill unmet medical needs, manages the required clinical development and regulatory approval process, and markets those products either directly in Canada or indirectly through partners in Canada, the U.S., and South America. For more information, visit www.cipherpharma.com.
Forward-Looking Statements
Statements in this press 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. Forward statements in this press release include statements with respect to repairs and the status of operations at Galephar’s manufacturing facilities, the anticipated timeframe for operations to resume at Galephar’s Humaceo facility and the anticipated impact of damage to Galephar’s facilities on the supply of product by Cipher.
By their very nature, forward-looking statements involve inherent risks and uncertainties, both general and specific, which give rise to the possibility that predictions, forecasts, projections and other forward-looking statements will not be achieved. 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. We caution readers not to place undue reliance on these statements as a number of important factors, many of which are beyond our control, could cause our actual results to differ materially from the beliefs, plans, objectives, expectations, anticipations, estimates and intentions expressed in such forward-looking statements. With respect to forward-looking statements contained in this press release, these factors may include the ability of Galephar to complete repairs at its Humaceo facility in a timely manner, the impact of damage to local infrastructure, the ability of Galephar and its contractors to source necessary materials and labour to complete necessary repairs, and damage to the Galephar’s facilities, in particular its Humaceo facility, may be greater than initially accessed or determined.
Other factors that could cause actual results to differ materially from the beliefs, plans, objectives, expectations, anticipations, estimates and intentions expressed in forward-looking statements made by Cipher may 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 future 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; current uncertainty surrounding health care regulation in the United States; 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; inability to meet covenants under our long term debt arrangement; compliance with privacy and security regulation; our policies regarding returns, allowances and chargebacks may reduce revenues; certain current and future 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; the effects of our delisting from the NASDAQ Global Market (the “NASDAQ”) and deregistration of our Common Shares under the U.S. Securities Exchange Act of 1934, as amended (the “U.S. Exchange Act”); the difficulty for shareholders to realize in the United States upon judgments of U.S. courts predicated upon civil liability of the Company and its directors and officers who are not residents of the United States; certain adverse tax rules applicable to U.S. holders of our Common Shares if we are a passive foreign investment company for U.S. federal income tax purposes; 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 if we issue securities to raise capital; volatility of our share price; the actions of 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.
We caution that the foregoing list of important factors that may affect future results is not exhaustive. When reviewing our forward-looking statements, investors and others should carefully consider the foregoing factors and other uncertainties and potential events. Additional information about factors that may cause actual results to differ materially from expectations, and about material factors or assumptions applied in making forward-looking statements, may be found in the “Risk Factors” section of our Annual Information Form and in our Management’s Discussion and Analysis of Operating Results and Financial Position for the year ended December 31, 2016, and elsewhere in our filings with Canadian securities regulators. Except as required by Canadian securities law, we do not undertake to update any forward-looking statements, whether written or oral, that may be made from time to time by us or on our behalf; such statements speak only as of the date made. The forward-looking statements included herein are expressly qualified in their entirety by this cautionary language.
SOURCE Cipher Pharmaceuticals Inc.
