Toronto Stock Exchange Symbol: DND
MISSISSAUGA, ON, Oct. 29 /PRNewswire-FirstCall/ - Cipher Pharmaceuticals Inc. (TSX: DND) today announced that it has completed patient enrolment 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. The Phase III safety study is being conducted under a Special Protocol Assessment that was granted by the U.S. Food and Drug Administration (FDA). The study is a randomized, double-blinded trial comparing the safety profile of CIP-ISOTRETINOIN to an FDA-approved, commercially available isotretinoin product. A total of 931 patients were enrolled in the trial, of which 626 have completed treatment to date.
"This is the largest, most comprehensive trial conducted on isotretinoin, and we are pleased that the clinical investigators, working with our internal team, met this important clinical milestone on target," said Dr. Jason Gross, Cipher's Vice President of Scientific Affairs. "Following an estimated six-month treatment period, the last subject enrolled should complete treatment in April 2011. We expect to have top-line study results in early Q3 2011, which would be followed by an FDA submission in Q4 2011."
Mr. Larry Andrews, President and CEO of Cipher, added: "Isotretinoin remains the most effective treatment for severe, nodular acne. We believe our product's unique attributes, particularly the more consistent absorption profile, would provide a significant advancement in the treatment of this disease and offer dermatologists an excellent alternative. We look forward to completing this final clinical study as Cipher and its partner, Ranbaxy Pharmaceuticals, work toward commercialization of the product in the $700 million U.S. isotretinoin market."
In the clinical studies that formed the basis of its New Drug Application with the FDA, CIP-ISOTRETINOIN demonstrated significantly more consistent absorption under variable dietary conditions compared with existing isotretinoin products on the market. To achieve optimal absorption, current isotretinoin formulations are prescribed to be taken with meals, which proves to be a compliance challenge for many teenagers. CIP-ISOTRETINOIN uses the patent-protected Lidose® drug delivery system, which delivers super-bioavailability for relatively water-insoluble compounds. Cipher was issued a patent for CIP-ISOTRETINOIN by the United States Patent and Trademark Office in 2008.
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®. Cipher's second product, an extended-release version of the pain reliever tramadol, received FDA approval in May 2010 and the Company's third product, a novel formulation of the acne treatment isotretinoin, is in its final Phase III safety study.
Cipher is listed on the Toronto Stock Exchange under the symbol 'DND' and has approximately 24 million shares outstanding. For more information, please visit href="http://www.cipherpharma.com/">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.