Cipher Pharmaceuticals Announces Top-Line Results of Cip-Isotretinoin Phase III Safety Study
Toronto Stock Exchange Symbol: DND
MISSISSAUGA, ON, June 7, 2011 /CNW/ - Cipher Pharmaceuticals Inc. (TSX: DND) today provided top-line safety and efficacy results from the Phase III safety study of CIP-ISOTRETINOIN, the Company's novel, patented formulation of isotretinoin for the treatment of severe, nodular acne. The 925-patient study was a randomized, double-blinded trial comparing the safety profile of CIP-ISOTRETINOIN to a commercially available isotretinoin product.
Summary of Results From a safety perspective, the top-line data was positive showing no overall statistical differences in the adverse event profile between the two products. The most frequent side effects that were observed were dry skin and dry lips. In addition, initial statistics on psychiatric disorders, eye disorders, ear disorders, musculoskeletal, vascular disorders, cardiac disorders, and gastrointestinal disorders, illustrate there are no significant differences in the extent of adverse events between CIP-ISOTRETINOIN and the reference product.
The efficacy component of the study had two co-primary endpoints: (1) the total change in lesion counts between baseline and at the end of week 20; and (2) the total number of subjects that had at least a 90% clearing at the end of 20 weeks of treatment. These two co-primary endpoints were analyzed using the per-protocol population (PP) as well as the intent-to-treat population (ITT). The PP analysis comprised all subjects who completed the study according to the protocol. In this analysis both co-primary endpoints met the non-inferiority margins established for the study. The ITT population comprised all subjects who entered the study, including those who did not conclude the study for whatever reason. Those who dropped out early were assigned treatment efficacy scores based on the last observation recorded for that subject, also known as last observation carried forward (LOCF). In the LOCF analysis of the ITT population, the first primary endpoint was achieved while the second endpoint fell slightly outside the non-inferiority margin target.
"These results show CIP-ISOTRETINOIN has a safety profile that mirrors commercially available isotretinoin products, which was the key outcome we were hoping for from this study," said Dr. Jason Gross, Cipher's Vice President of Scientific and Medical Affairs. "In addition, this comprehensive study yielded valuable and substantial efficacy data to support our FDA submission later this year."
The safety, efficacy, and population pharmacokinetic data generated from this study, together with previously submitted data, will be used to complete a revised New Drug Application (NDA) being prepared for submission to the FDA in Q4 2011. The FDA review of this submission under PDUFA is expected to be six months.
Study Design The study was a randomized, double-blinded non inferiority trial comparing CIP-ISOTRETINOIN to a commercially available isotretinoin product in patients with severe, nodular acne. The study was approved by the FDA under a Special Protocol Assessment and conducted in the United States and Canada at 50 sites. Of the 925 patients who enrolled in the study, 813 patients completed the 20-week trial. As per the protocol, subjects were directed to always take their medication with meals.
About CIP-ISOTRETINOIN In the pharmacokinetic studies that formed the basis of its original NDA, CIP-ISOTRETINOIN demonstrated more consistent absorption under variable dietary conditions compared with existing isotretinoin products. 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 more consistent 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, just completed 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 www.cipherpharma.com<http://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.
For further information: Craig Armitage Larry Andrews Investor Relations President and CEO The Equicom Group Cipher Pharmaceuticals (416) 815-0700 ext 278 (905) 602-5840 ext 324 (416) 815-0080 fax (905) 602-0628 fax firstname.lastname@example.org
Posted: June 2011