Further stay of Cipher's NDA for CIP-TRAMADOL ER terminated

Cipher Pharmaceuticals Inc. (TSX: DND) today announced a final judgment (the "Cipher Judgment") has been entered in favour of Cipher in relation to pending patent litigation with Purdue Pharma Products L.P. and Napp Pharmaceutical Group Ltd. (together "Purdue") in the United States District Court for the Eastern District of Virginia (the "Court"). The patent litigation involves the Company's New Drug Application ("NDA"), filed with the U.S. Food and Drug Administration ("FDA"), for CIP-TRAMADOL ER, an extended-release tramadol product. The Cipher Judgment terminates any further stay of FDA approval of Cipher's NDA under the applicable provisions of the Hatch-Waxman Act. Cipher plans to move forward to obtain FDA final approval as part of its broader CIP-TRAMADOL ER commercialization strategy. The Company continues to conduct ongoing discussions with potential commercial partners interested in licensing CIP-TRAMADOL ER.

The final judgment in favour of Cipher holds that the patents-in-suit are invalid for obviousness based on a prior decision of the United States District Court for the District of Delaware, dated August 14, 2009, invalidating the Orange Book-listed patents for Ultram(R) ER in litigation filed by Purdue against Par Pharmaceutical, Inc. ("Par"). That decision in the Par litigation is currently under appeal before the United States Court of Appeals for the Federal Circuit. Cipher anticipates that Purdue may appeal the Cipher Judgment as well, though Purdue has not yet done so.

Cipher filed a revised NDA for CIP-TRAMADOL ER in Q2 2008, and received tentative FDA approval in February 2009. In Q3 2009, the Company filed a Paragraph IV Certification with the FDA, which states that the relevant patent listed in the FDA's "Orange Book" for Ultram(R) ER is invalid, unenforceable, and/or will not be infringed by the manufacture or sale of Cipher's drug product. Under the applicable provisions of the Hatch-Waxman Act, this patent challenge can delay or stay final FDA approval of Cipher's NDA by 30 months, or until the patent challenge is resolved, whichever occurs first. The Cipher Judgment terminates any further stay of Cipher's NDA under the applicable provisions of the Hatch-Waxman Act.

SOURCE Cipher Pharmaceuticals Inc.


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