Toronto Stock Exchange Symbol: DND
MISSISSAUGA, ON, April 1 /CNW/ - Cipher Pharmaceuticals Inc. (TSX: DND) today announced that it has reached the enrollment mid-point in its Phase III safety study of CIP-ISOTRETINOIN, the Company's novel, patented formulation of isotretinoin, which is used in the treatment of severe, nodular acne. To date, more than 400 patients have been enrolled. Achieving this milestone triggers a US$2.0 million milestone payment from Ranbaxy Pharmaceuticals Inc., Cipher's U.S. marketing and distribution partner.
"Our clinical investigators are doing an excellent job in patient recruitment and follow-up and we are pleased with the study's progress," said Dr. Jason A. Gross, Pharm.D., Vice President of Scientific Affairs for Cipher. "We look forward to working closely with Ranbaxy Pharmaceuticals as we advance this pivotal clinical study and prepare to submit the findings to the FDA."
The Phase III safety study is randomized, double-blinded trial comparing the safety profile of CIP-ISOTRETINOIN to an FDA-approved, commercially available isotretinoin product. The study is currently being conducted at 50 sites in the U.S. and Canada with a planned duration of 18 months. The study is being conducted under a Special Protocol Assessment that was granted by the U.S. Food and Drug Administration.
About Cipher Pharmaceuticals Inc.
Cipher Pharmaceuticals is a commercial-stage 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 is being marketed in the United States by Kowa Pharmaceuticals America under the label Lipofen(R). In addition, Cipher is developing formulations of the pain reliever tramadol (tentative FDA approval in February 2009) 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. The words "may", "will", "could", "should", "would", "suspect", "outlook", "believe", "plan", "anticipate", "estimate", "expect", "intend", "forecast", "objective", "hope" and "continue" (or the negative thereof), and words and expressions of similar import, are intended to identify forward-looking statements. 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. Except as required by Canadian securities laws, the Company does not undertake to update any forward-looking statements; such statements speak only as of the date made.
SOURCE Cipher Pharmaceuticals Inc.
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