MISSISSAUGA, ON, May 3 /CNW/ - Cipher Pharmaceuticals Inc. (TSX: DND - News) today announced that it has received an approvable letter from the U.S. Food and Drug Administration (FDA) pertaining to its New Drug Application (NDA) for CIP-TRAMADOL ER, the Company's once-daily formulation of tramadol.
In its letter, the FDA indicated that Cipher's application is approvable subject to the resolution of certain issues, including chemistry, manufacturing and controls (CMC) and a request for an additional adequate clinical trial to provide further efficacy data. While Cipher believes its submission includes sufficient data to support regulatory approval, the Company requires clarification from the FDA on the issues raised in the action letter before determining the path forward. Cipher anticipates meeting with the FDA shortly to discuss these matters.
Cipher submitted its NDA for CIP-TRAMADOL ER in June 2006 and the NDA was accepted for review during the third quarter of 2006. The NDA contains data from six pharmacokinetic studies and five Phase III studies (three of these providing pivotal efficacy data and two providing long-term safety data).
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. Cipher currently has three late-stage drugs in its pipeline. 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. In addition, Cipher is developing formulations of the pain reliever tramadol (currently under regulatory review by the FDA) and the acne treatment isotretinoin (currently under regulatory review by the FDA).
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.
For further information
Craig Armitage, Investor Relations, The Equicom Group, (416) 815-0700 ext 278, (416) 815-0080 fax, email@example.com
Larry Andrews, President & Chief Executive Officer, Cipher Pharmaceuticals, (905) 602-5840 ext 24, (905) 602-0628 fax, firstname.lastname@example.org
Source: Cipher Pharmaceuticals Inc.
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