Healthcare Industry News: ProEthic Pharmaceuticals
News Release - May 13, 2008
Cipher provides regulatory update for CIP-TRAMADOL ERMISSISSAUGA, ON, May 13 (HSMN NewsFeed) - Cipher Pharmaceuticals Inc. (TSX: DND ) today announced that a revised New Drug Application (NDA) has been submitted to the U.S. Food and Drug Administration (FDA) for CIP-TRAMADOL ER, its extended-release formulation of tramadol. In May 2007, the Company received an approvable letter from the FDA pertaining to its NDA for CIP-TRAMADOL ER.
Cipher's revised NDA includes data from additional pharmacokinetic studies conducted by the Company comparing CIP-TRAMADOL ER to UltramŽ ER.
After considering feedback from the FDA appeal process and the results of the additional statistical sensitivity analysis of existing data suggested by the FDA, Cipher and its advisors concluded that submitting the revised NDA provided the most expeditious path to final regulatory approval.
Subject to FDA acceptance for filing, Cipher expects the review to be completed by October 2008. It is possible that the submission could trigger patent infringement litigation and a stay of up to 30 months under the Hatch-Waxman Act.
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 LipofenŽ. In addition, Cipher is developing formulations of the pain reliever tramadol (FDA approvable letter in May 2007) and the acne treatment isotretinoin (FDA approvable letter in April 2007).
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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