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Cipher's revised NDA for CIP-TRAMADOL ER accepted for review by FDA
Date:6/17/2008

Toronto Stock Exchange Symbol: DND

MISSISSAUGA, ON, June 17 /PRNewswire-FirstCall/ - Cipher Pharmaceuticals Inc. (TSX: DND) today announced that its revised New Drug Application (NDA) for CIP-TRAMADOL ER, its extended-release formulation of tramadol, has been accepted for review by the U.S. Food and Drug Administration (FDA). Cipher expects the review to be completed by October 2008.

In May 2007, the Company received an approvable letter from the FDA pertaining to its original NDA for CIP-TRAMADOL ER. Cipher's revised NDA includes data from additional pharmacokinetic studies conducted by the Company comparing CIP-TRAMADOL ER to Ultram(R) ER. It is possible that the submission could trigger patent infringement litigation and a stay of up to 30 months under the Hatch-Waxman Act.

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(R). In addition, Cipher is developing formulations of the pain reliever tramadol (FDA approvable letter in May 2007) and the acne treatment isotretinoin (FDA approvable letter in April 2007).

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SOURCE Cipher Pharmaceuticals Inc.
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