Cipher Pharmaceuticals Tramadol Fails Phase 3 Trial; Stock Tumbles 25%

MISSISSAUGA, ON, Sept. 11 /CNW/ - Cipher Pharmaceuticals Inc. (TSX: DND - News) today announced preliminary results from the 02.05 Phase III study of CIP-TRAMADOL ER, an extended-release capsule formulation of the pain medication tramadol. While all three active treatment groups in the study demonstrated a reduction in pain from baseline, the 02.05 efficacy results did not achieve a statistically significant effect relative to placebo with respect to the primary endpoint. A higher than anticipated placebo effect was observed in the control arm. Cipher's New Drug Application (NDA) for CIP-TRAMADOL ER has been accepted for review by the U.S. Food and Drug Administration (FDA) as disclosed by the Company on September 5, 2006. In January 2006, Cipher announced that it had been advised by the FDA that its existing clinical data package met the requirements to file a NDA. The NDA contains data from six completed pharmacokinetic studies and five Phase III studies (three of these providing pivotal efficacy data and two providing long-term safety data). Data analysis on the 02.05 trial is continuing and Cipher will provide the final report on the 02.05 trial to the FDA once it is available.

"The clinical package we submitted to the FDA in June met the requirements for a complete NDA submission as evidenced by the fact it has now been accepted for review. We believe there is sufficient data in the package to support regulatory approval," said Larry Andrews, President and Chief Executive Officer of Cipher Pharmaceuticals. "The 02.05 trial is the latest in a series of six Phase III trials completed by Cipher for CIP-TRAMADOL ER. The high placebo effect observed is disappointing; however, this is not an uncommon occurrence in placebo controlled pain trials. We intend to complete our analysis of the 02.05 study and assess the potential contribution that the higher than anticipated placebo effect may have had on the outcome. This analysis will form part of the final report on the study".

The 02.05 study enrolled 860 patients in a double-blind randomized fixed-dose trial designed to compare efficacy and safety of CIP-TRAMADOL ER with placebo. The primary efficacy endpoint of the study was WOMAC pain intensity. The trial was conducted over a 12-week treatment period in patients with moderate to moderately severe chronic pain from osteoarthritis of the knee or hip. Patients were randomly assigned to one of four arms, a placebo arm and three active arms consisting of a 100 mg, 200 mg, or 300 mg dose of CIP-TRAMADOL ER. Patients in the 100 mg arm were on 100 mg for the entire 12-week period, while patients in the 200 mg and 300 mg arms were titrated up from 100 mg to the respective dosage.

About CIP-TRAMADOL ER

Tramadol is a synthetic opioid that is used to treat moderate to moderately severe pain, which is commonly associated with osteoarthritis, without the severe side-effect profile of morphine and other opioids. Cipher's CIP-TRAMADOL ER capsule is a novel formulation that delivers sustained-release drug delivery properties with once-daily dosing. CIP-TRAMADOL ER uses oral controlled-release bead technology developed by Cipher's technology partner, Galephar Pharmaceutical Research.

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 and the acne treatment isotretinoin.

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.

For further information

Ross Marshall, Investor Relations, The Equicom Group, (416) 815-0700 ext 238, (416) 815-0080 fax, rmarshall@equicomgroup.com Larry Andrews, President & Chief Executive Officer, Cipher Pharmaceuticals, (905) 602-5840 ext 24, (905) 602-0628 fax, landrews@cipherpharma.com

Source: Cipher Pharmaceuticals Inc.

Back to news