MISSISSAUGA, ON, Jan. 13 /PRNewswire-FirstCall/ - Cipher Pharmaceuticals Inc. (TSX: DND - News) today announced that it has received final approval from the U.S. Food and Drug Administration (FDA) for CIP-Fenofibrate, the Company's novel formulation of the active ingredient fenofibrate, which is used in the treatment of hyperlipidemia. CIP-Fenofibrate, approved under the label as Lipofen(TM), targets a large and growing market as the three existing novel fenofibrate formulations are forecasted to exceed $1 billion in annual U.S. sales.
"CIP-Fenofibrate is the first product from our pipeline to successfully receive FDA approval and we are actively pursuing opportunities to secure a U.S. commercial distribution agreement," said Larry Andrews, President of Cipher Pharmaceuticals. "CIP-Fenofibrate is one of three late-stage products in our pipeline. With an application for CIP-Isotretinoin under review with the FDA and preparations underway to file the CIP-Tramadol application with the FDA in the first half of 2006, we believe that the approval of CIP-Fenofibrate represents the first of a number of significant milestone events for Cipher."
CIP-Fenofibrate received approval for three unique fenofibrate dosages: 50, 100 and 150 mg, with the 150 mg strength equivalent to Tricor® 160 mg under fed conditions. With CIP-Fenofibrate, the extent of absorption is increased under high-fat conditions relative to low-fat conditions.
The approval provides for the use of CIP-Fenofibrate as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total-cholesterol (Total-C), triglycerides, apolipoprotein B (Apo B), and to increase high-density lipoprotein (HDL-C) in adult patients with primary hypercholesterolemia or mixed dyslipidemia (Frederickson Type IIa, IIb) in addition to the treatment of adult patients with hypertriglyceridemia (Frederickson Types IV and V hyperlipidemia).
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.
Source: Cipher Pharmaceuticals Inc.
