Cipher receives Health Canada approval of CIP-Fenofibrate

By Elaine Rigoli

Tampa, Fla., Feb. 21 - Cipher Pharmaceuticals, Inc. announced Tuesday that it has received final approval from Health Canada for CIP-Fenofibrate, the company's formulation of the active ingredient fenofibrate, used to treat hyperlipidemia.

Cipher announced in January that it received final approval for CIP-Fenofibrate in the United States from the Food and Drug Administration.

Health Canada has issued a notice of compliance for CIP-Fenofibrate that allows for the product to be marketed in Canada.

The notification came after the Federal Court of Canada advised Cipher it would dismiss the legal proceedings brought by Fournier-Pharma, Inc. and Laboratoires Fournier SA related to the second of two patent issues.

The dismissal cleared the path for Health Canada to issue final approval for CIP-Fenofibrate, according to a company news release.

"We are pleased to have this important milestone behind us," said Cipher president Larry Andrews, in the release.

"The approval from Health Canada clears the path to market for CIP-Fenofibrate and will allow ongoing discussions with interested commercial partners for Canada to proceed."

In April 2004, the Therapeutic Products Directorate of the Canadian Health Protection Branch completed its review of Cipher's new drug submission for CIP-Fenofibrate and confirmed there were no outstanding review issues.

Health Canada approval for CIP-Fenofibrate had been on hold since that time pending the outcome of the legal proceedings, according to the release.

The first patent case, in March 2003, related to Canadian patent no. 2,219,475 and Lipidil Supra 100 mg and 160 mg fenofibrate tablets.

During the first quarter of 2005, the Federal Court of Canada ruled in favor of Cipher. Fournier subsequently appealed the decision. That appeal was dismissed by the Federal Court of Appeal on Oct. 11, 2005 with costs awarded to Cipher, according to the release.

Just prior to that trial ruling, Fournier listed a second patent, Canadian patent no. 2,372,576 on the patent registry and brought forward a second proceeding.

The most recent court decision relates to the second patent. On its motion for a dismissal, Cipher was able to convince the federal court that Fournier had not made out a case that justified proceeding to trial.

The presiding prothonotary, or first officer of the court, stated that she was granting the motion to dismiss, which allowed Health Canada to provide final approval of CIP-Fenofibrate.

Cipher is a Mississauga, Ont.-based drug development company focused on commercializing novel formulations of successful, currently marketed molecules using advanced drug delivery technologies.

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