FDA approves Cipher's CIP-Fenofibrate used to treat hyperlipidemia

By E. Janene Geiss

Philadelphia, Jan. 13 - Cipher Pharmaceuticals Inc. announced Friday that it has received final approval from the Food and Drug Administration 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, targets a large and growing market as the three existing novel fenofibrate formulations are forecasted to exceed $1 billion in annual U.S. sales, according to a company news release.

"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," president Larry Andrews said in the release.

CIP-Fenofibrate is one of three late-stage products in the company's pipeline, officials said.

An application for CIP-Isotretinoin is under review with the FDA, and preparations are underway to file the CIP-Tramadol application with the FDA in the first half of 2006, officials said.

"We believe that the approval of CIP-Fenofibrate represents the first of a number of significant milestone events for Cipher," Andrews added in the release.

CIP-Fenofibrate received approval for three fenofibrate dosages: 50 mg, 100 mg 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, total cholesterol, triglycerides, apolipoprotein B and to increase high-density lipoprotein in adult patients with primary hypercholesterolemia or mixed dyslipidemia in addition to the treatment of adult patients with hypertriglyceridemia.

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

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