Healthcare Industry News:  chronic pain 

Biopharmaceuticals Drug Delivery FDA

 News Release - February 17, 2009

Cipher receives tentative FDA approval for extended-release tramadol capsules

MISSISSAUGA, ON, Feb. 17 (Healthcare Sales & Marketing Network) - Cipher Pharmaceuticals Inc. (TSX: DND ) today announced that it has received tentative approval from the U.S. Food and Drug Administration (FDA) for CIP-TRAMADOL ER, the Company's extended-release formulation of the analgesic tramadol, which is indicated for the management of moderate to moderately severe chronic pain such as osteoarthritis. While the product meets all the FDA's requirements for manufacturing quality, clinical safety and efficacy, the Company must resolve certain patent issues related to the reference product, UltramŽ ER, before CIP-TRAMADOL ER is commercialized.

"Tentative approval of our extended-release tramadol is another important achievement for our organization and validates the safety and efficacy of this product, which has an attractive profile for a chronic pain medication," said Larry Andrews, President and CEO of Cipher. "We are working diligently on the remaining steps toward commercialization, including securing a U.S. marketing partner and addressing the outstanding intellectual property issues."

Cipher's revised New Drug Application (NDA) for CIP-TRAMADOL ER was submitted in Q2 2008 as a 505(b)(2) application. Since there are issued U.S. patents for the approved product held by a third party, Cipher was required to certify to the FDA concerning any patents listed in the FDA's Orange Book publication at the time of submission. Cipher's application contained a paragraph III certification acknowledging that the listed patent had not expired and that final approval would be sought after patent expiration in 2014. A paragraph IV certification, which states that the listed patent is invalid, unenforceable, or will not be infringed by the manufacture or sale of the drug, may trigger patent infringement litigation and a stay of up to 30 months under the Hatch-Waxman Act. To date, this certification has not been filed.

CIP-TRAMADOL ER capsules are based on patented oral controlled-release bead technology and feature both immediate-release and extended-release properties.

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 LipofenŽ. 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.

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. 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

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