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Cipher Provides Product Update on Cip-Isotretinoin and Cip-Tramadol ER

MISSISSAUGA, ON, Jan. 8 /CNW/ - Cipher Pharmaceuticals Inc., an emerging specialty pharmaceutical company, today provided an update on recent developments with its products.

Cip-Isotretinoin

In June 2007, Cipher appealed the position taken by the U.S. Food and Drug Administration (FDA) in its approvable letter for Cip-Isotretinoin, Cipher's novel formulation of the acne medication isotretinoin. Subsequently, the Company has had two meetings with the FDA as part of the first stage of the formal dispute resolution process. In its most recent response to Cipher, the representative from the FDA agreed with the Division of Dermatology and Dental Product's original view that a clinical study is needed to further demonstrate the safety of Cip-Isotretinoin. The Company has chosen to place the formal dispute resolution process on hold, and has requested a meeting with the Division to discuss their views on the appropriate design of a phase III safety study. Cipher may still choose to continue the formal dispute resolution process, however, regulations do not allow the Company to pursue both options concurrently.

"In the appeal response and subsequent discussions with the FDA, we were encouraged to work closely with the Division should we choose to pursue a safety study. At this time, we feel it is prudent to further explore this option so that we fully understand the FDA's expectations concerning study design, following which we will determine the best path forward," said Larry Andrews, President and CEO of Cipher. "Our discussions with the FDA have been constructive and have strengthened our belief that our product could represent an advance in the treatment of severe acne. We expect to meet with the FDA in late January 2008."

Cip-Tramadol ER

In December 2007, Cipher announced that it had appealed the position taken by the FDA in its approvable letter for the Company's extended-release formulation of tramadol, using the FDA's Formal Dispute Resolution process. Cipher received an approvable letter from the FDA in May 2007 pertaining to its New Drug Application (NDA) for Cip-Tramadol ER.

The Company met with the FDA on December 17, 2007 and expects a response by the end of January.

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 ProEthic Pharmaceuticals under the label Lipofen(TM). 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: Craig Armitage, Investor Relations, The Equicom Group, (416) 815-0700 ext 278, (416) 815-0080 fax, carmitage@equicomgroup.com;
Larry Andrews, President and CEO, Cipher Pharmaceuticals, (905) 602-5840 ext
324, (905) 602-0628 fax, landrews@cipherpharma.com

Posted: January 2008

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