Healthcare Industry News: ProEthic Pharmaceuticals
News Release - February 11, 2008
Cipher provides CIP-TRAMADOL ER regulatory updateMISSISSAUGA, ON, Feb. 11 (HSMN NewsFeed) - Cipher Pharmaceuticals Inc. (TSX: DND ) today announced that the U.S. Food and Drug Administration (FDA) has suggested an additional statistical sensitivity analysis of existing clinical data on CIP-TRAMADOL ER, Cipher's extended-release tramadol formulation, as a means to potentially satisfy the requirements for approval.
In December 2007, Cipher appealed the decision in the Agency's May 2007 Approvable Letter through the Formal Dispute Resolution process. On February 1, 2008, the Company announced that it received a written response from the FDA regarding its first stage of appeal. In the response, the Acting Director of the Office of Drug Evaluation II, Center for Drug Evaluation and Research supported the Division's approvable action. In a subsequent discussion with Cipher, the Agency informed Cipher of the new analysis as an alternative to continuing the Formal Dispute Resolution process.
As a consequence, Cipher is suspending its appeal at this time and expects to meet with the Division in the near future to obtain further details on the additional analysis.
About Cipher Pharmaceuticals Inc.
Cipher Pharmaceuticals is a drug development company focused on commercializing novel formulations of successful, currently marketed molecules using advanced drug delivery technologies. Cipher's strategy is to in-license products that incorporate proven drug delivery technologies and advance them through the clinical development and regulatory approval stages, after which the products are out-licensed to international partners. Because Cipher's products are based on proven technology platforms applied to currently marketed drugs, they are expected to have lower approval risk, shorter development timelines and significantly lower development costs. The Company's lead compound, CIP-FENOFIBRATE, received final approval from the U.S. Food and Drug Administration and Health Canada in the first quarter of 2006. The product is being marketed in the United States by ProEthic Pharmaceuticals under the label Lipofen(TM). In addition, Cipher is developing formulations of the pain reliever tramadol and the acne treatment isotretinoin.
Cipher is listed on the Toronto Stock Exchange under the symbol 'DND' and has approximately 24 million shares outstanding. For more information, please visit www.cipherpharma.com.
Statements made in this news release, other than those concerning historical financial information, may be forward-looking and therefore subject to various risks and uncertainties. Some forward-looking statements may be identified by words like "may", "will", "anticipate", "estimate", "expect", "intend", or "continue" or the negative thereof or similar variations. 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 and other filings with Canadian securities regulatory authorities, such as the applicability of patents and proprietary technology; possible patent litigation; regulatory approval of products in the Company's pipeline; changes in government regulation or regulatory approval processes; government and third-party payer reimbursement; dependence on strategic partnerships for product candidates and technologies, marketing and R&D services; meeting projected drug development timelines and goals; intensifying competition; rapid technological change in the pharmaceutical industry; anticipated future losses; the ability to access capital to fund R&D; and the ability to attract and retain key personnel. All forward-looking statements presented herein should be considered in conjunction with such filings. The Company does not undertake to update any forward-looking statements; such statements speak only as of the date made.
Source: Cipher Pharmaceuticals
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