MISSISSAUGA, ON, Feb. 20 /PRNewswire-FirstCall/ - Cipher Pharmaceuticals Inc. today announced that it has received final approval from Health Canada for CIP-Fenofibrate, the Company’s novel formulation of the active ingredient fenofibrate, which is used in the treatment of hyperlipidemia. Health Canada has issued a Notice of Compliance for CIP- Fenofibrate which allows for the product to be marketed in Canada. The notification came after the Federal Court of Canada advised the Company it would dismiss the legal proceedings brought by Fournier-Pharma Inc. and Laboratoires Fournier S.A. related to the second of two patent issues. The dismissal cleared the path for Health Canada to issue final approval for CIP- Fenofibrate. Cipher announced in January 2006 that it received final approval for CIP-Fenofibrate in the United States from the U.S. Food and Drug Administration.
“We are pleased to have this important milestone behind us,” commented Larry Andrews, President of Cipher Pharmaceuticals Inc. “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 its novel formulation of 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.
The first patent case brought forward by Fournier-Pharma Inc. and Laboratoires Fournier S.A. (“Fournier”) in March 2003 under the Patented Medicines (Notice of Compliance) Regulations related to Canadian Patent No. 2,219,475 (the “475 Patent”) and LIPIDIL SUPRA 100 mg and 160 mg fenofibrate tablets. During the first quarter of 2005, the Federal Court of Canada ruled in favour of Cipher. Just prior to that trial ruling, Fournier listed a second patent, Canadian Patent No. 2,372,576 (the “576 Patent”) on the Patent Registry and brought forward a second proceeding. Fournier subsequently appealed the 475 Patent decision. That appeal was dismissed by the Federal Court of Appeal on October 11, 2005 with costs awarded to Cipher.
The most recent decision from the Federal Court of Canada relates to the 576 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 of the Federal Court stated that she was granting the motion to dismiss, with an Order and reasons to follow, which has allowed Health Canada to provide final approval of CIP-Fenofibrate.
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 in January 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 21 million shares outstanding. For more information, please visit www.cipherpharma.com.
Statements made in this news release, other than those concerning historical financial information, should be considered forward-looking and subject to various risks and uncertainties. Such forward-looking statements are based on management’s beliefs and assumptions regarding the information currently available. The Company’s actual results could differ materially from those expressed in the forward-looking statements. Factors that could cause results to vary include, among other things, those expressed in the Company’s filings with Canadian securities regulatory authorities. All information presented herein should be read in conjunction with such filings.
Cipher Pharmaceuticals Inc.
CONTACT: please contact: Ross Marshall, Investor Relations, The EquicomGroup, (416) 815-0700 ext 238, (416) 815-0080 fax,rmarshall@equicomgroup.com; Larry Andrews, President, CipherPharmaceuticals, (905) 602-5840 ext 24, (905) 602-0628 fax,landrews@cipherpharma.com
