Toronto Stock Exchange Symbol: DND
MISSISSAUGA, ON, Oct. 7 /CNW/ - Cipher Pharmaceuticals Inc. (TSX: DND) today announced that it has enrolled the first patient 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 study is randomized, double-blinded trial comparing the safety profile of CIP-ISOTRETINOIN to an FDA-approved, commercially available isotretinoin product. The study will be conducted at 50 sites in the U.S. and Canada, and is expected to enroll more than 800 patients over an 18-month period. The study is being conducted under a Special Protocol Assessment ("SPA") that was granted by the U.S. Food and Drug Administration ("FDA").
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(R) 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.
"We are pleased to reach this clinical development milestone for our novel isotretinoin formulation," said Larry Andrews. "Isotretinoin is the most effective treatment for severe, nodular acne. We believe this product's unique attributes, particularly the more consistent absorption profile, would provide a significant advancement in the treatment of severe acne and offer dermatologists an excellent alternative. We look forward to working closely with our U.S. marketing partner, Ranbaxy Pharmaceuticals, as we advance this final clinical study and prepare for the commercialization of the product in the $700 million U.S. isotretinoin market."
As previously disclosed, Ranbaxy Pharmaceuticals is reimbursing Cipher for all costs associated with the clinical studies required to obtain FDA approval, up to a predetermined cap. Any additional development costs associated with initial FDA approval will be shared equally. Cipher is responsible for all product development activities, including management of the clinical studies required by the FDA to secure NDA 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. 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. The product 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. 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. 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.
For further information: For further information: Craig Armitage, Investor Relations, The Equicom Group, (416) 815-0700 ext 278, (416) 815-0080 fax, firstname.lastname@example.org; Larry Andrews, President and CEO, Cipher Pharmaceuticals, (905) 602-5840 ext 324, (905) 602-0628 fax, email@example.com