Healthcare Industry News: tretinoin
News Release - April 10, 2007
Cipher Pharmaceuticals comments on Ortho-McNeil Citizen Petition
MISSISSAUGA, ON, April 10 (Healthcare Sales & Marketing Network) - Cipher Pharmaceuticals Inc. (TSX: DND ) today commented on a Citizen Petition submitted recently to the U.S. Food and Drug Administration (FDA) by Ortho-McNeil, Inc. regarding "tramadol for once-daily dosing." In the Citizen Petition, Ortho-McNeil requests a determination "that any versions of tramadol for once-daily dosing will not be approved prior to expiration of the three-year period of exclusivity for Ultram ER," which expires in September 2008. The Company believes that its New Drug Application for CIP-TRAMADOL ER, an extended-release capsule formulation of the pain medication tramadol, satisfies all statutory and regulatory requirements for approval. The Company has already provided its views to the FDA on the three-year exclusivity, and expects the FDA to address this issue in conjunction with its consideration of the Company's anticipated approval.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.
Forward-Looking Statements
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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