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Cipher's CIP-TRAMADOL ER New Drug Application Accepted For Review

06 Sep 2006

Today announced that the Company's New Drug Application (NDA) for CIP-TRAMADOL ER, an extended-release capsule formulation of the pain medication tramadol, has been accepted for review by the U.S. Food and Drug Administration (FDA).

MISSISSAUGA, Canada | Sep 05, 2006 | Cipher Pharmaceuticals Inc. (TSX: DND) today announced that the Company's New Drug

Application (NDA) for CIP-TRAMADOL ER, an extended-release capsule formulation of the pain medication tramadol, has been accepted for review by the U.S. Food and Drug Administration (FDA). Cipher submitted its CIP-TRAMADOL ER NDA on June 29, 2006 and it will be reviewed under the standard 10-month review period providing an action date under the Prescription Drug User Fee Act (PDUFA) of May 3, 2007. "The acceptance of the CIP-TRAMADOL ER NDA for review is a significant step forward toward regulatory approval. In the very near future, we expect to receive top-line data from the CIP-TRAMADOL ER 02.05 Phase III study," said Larry Andrews, President and Chief Executive Officer of Cipher Pharmaceuticals. "Although pain relief is a competitive market, we believe that the size of the market together with the unique attributes of CIP-TRAMADOL ER, including rapid absorption, sustainable therapeutic plasma levels at 24 hours and comparable absorption under fed and fasted conditions, present a significant opportunity for our innovative formulation."

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, This e-mail address is being protected from spam bots, you need JavaScript enabled to view it ; Larry Andrews, President & Chief Executive Officer, Cipher Pharmaceuticals, (905) 602-5840 ext 24, (905) 602-0628 fax, This e-mail address is being protected from spam bots, you need JavaScript enabled to view it

SOURCE: Cipher Pharmaceuticals Inc

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