MISSISSAUGA, ON, Feb. 11 /PRNewswire-FirstCall/ - Cipher PharmaceuticalsInc. (TSX: DND) today announced that the U.S. Food and Drug Administration(FDA) has suggested an additional statistical sensitivity analysis of existingclinical data on CIP-TRAMADOL ER, Cipher's extended-release tramadolformulation, as a means to potentially satisfy the requirements for approval.
In December 2007, Cipher appealed the decision in the Agency's May 2007Approvable Letter through the Formal Dispute Resolution process. On February1, 2008, the Company announced that it received a written response from theFDA regarding its first stage of appeal. In the response, the Acting Directorof the Office of Drug Evaluation II, Center for Drug Evaluation and Researchsupported the Division's approvable action. In a subsequent discussion withCipher, the Agency informed Cipher of the new analysis as an alternative tocontinuing the Formal Dispute Resolution process.
As a consequence, Cipher is suspending its appeal at this time and expectsto meet with the Division in the near future to obtain further details on theadditional analysis.
About Cipher Pharmaceuticals Inc.
Cipher Pharmaceuticals is a drug development company focused oncommercializing novel formulations of successful, currently marketed moleculesusing advanced drug delivery technologies. Cipher's strategy is to in-licenseproducts that incorporate proven drug delivery technologies and advance themthrough the clinical development and regulatory approval stages, after whichthe products are out-licensed to international partners. Because Cipher'sproducts are based on proven technology platforms applied to currentlymarketed drugs, they are expected to have lower approval risk, shorterdevelopment timelines and significantly lower development costs. The Company'slead compound, CIP-FENOFIBRATE, received final approval from the U.S. Food andDrug Administration and Health Canada in the first quarter of 2006. Theproduct is being marketed in the United States by ProEthic Pharmaceuticalsunder the label Lipofen(TM). In addition, Cipher is developing formulations ofthe pain reliever tramadol and the acne treatment isotretinoin.
Cipher is listed on the Toronto Stock Exchange under the symbol 'DND' andhas approximately 24 million shares outstanding. For more information, pleasevisit www.cipherpharma.com.
Statements made in this news release, other than those concerninghistorical financial information, may be forward-looking and therefore subjectto various risks and uncertainties. Some forward-looking statements may beidentified by words like "may", "will", "anticipate", "estimate", "expect","intend", or "continue" or the negative thereof or similar variations. Certainmaterial factors or assumptions are applied in making forward-lookingstatements and actual results may differ materially from those expressed orimplied in such statements. Factors that could cause results to vary includethose identified in the Company's Annual Information Form and other filingswith Canadian securities regulatory authorities, such as the applicability ofpatents and proprietary technology; possible patent litigation; regulatoryapproval of products in the Company's pipeline; changes in governmentregulation or regulatory approval processes; government and third-party payerreimbursement; dependence on strategic partnerships for product candidates andtechnologies, marketing and R&D services; meeting projected drug developmenttimelines and goals; intensifying competition; rapid technological change inthe pharmaceutical industry; anticipated future losses; the ability to accesscapital to fund R&D; and the ability to attract and retain key personnel. Allforward-looking statements presented herein should be considered inconjunction with such filings. The Company does not undertake to update anyforward-look