Reliant Pharmaceuticals and Pronova Biocare AS Announce FDA Approval of omega-3 acid ethyl ester

01-Dec-2004

Reliant Pharmaceuticals, Inc. and Pronova Biocare AS announced that the two companies have reached agreement for Reliant to market Omacor(R) (omega-3 acid ethyl esters) in the U.S. following the product's recent approval by the Food and Drug Administration (FDA). Under the terms of the agreement, Reliant will have exclusive marketing and distribution rights in the U.S. and will maintain the New Drug Application (NDA).

Omacor, which contains highly concentrated ethyl esters of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), was approved by the FDA on November 10, 2004 as an adjunct to diet for the reduction of triglycerides in adult patients with very high triglyceride levels (greater than or equal to 500 mg/dL). Omacor has previously been approved in Europe and Asia, where Pronova's partners include Pfizer, SPA, Sigma Tau, Solvay and AstraZeneca, and is currently used by more than 200,000 patients worldwide.

"Omacor, which is available solely by prescription, is the only patented omega-3 derived pharmaceutical product approved by the FDA based on clinical studies demonstrating safety and efficacy in patients," said Dr. Ernest Mario, Reliant's Chairman and Chief Executive Officer. "In placebo controlled clinical trials, Omacor has been documented to effectively reduce triglycerides by a median of 45% in patients with very high levels. Pronova's manufacturing process provides extremely high concentrations of the active patented pharmaceutical ingredients for the treatment of hypertriglyceridemia. In addition, the proprietary manufacturing process effectively eliminates heavy metals and other environmental pollutants commonly detected in many omega-3 products. With Omacor, physicians now have a prescription triglyceride-lowering alternative with no therapeutic equivalent that offers an excellent efficacy and safety profile."

"We are very pleased to have Reliant as our U.S. marketing partner for Omacor," said Dr. Egil Bodd, Chief Executive Officer of Pronova. "Reliant's strong cardiovascular and lipid management franchises make the company a perfect partner for Omacor."

"This agreement represents Reliant's third European partnership, and we are extremely excited to be working with Pronova to launch Omacor in the U.S.," added Dr. Stefan Aigner, EVP of Business Development at Reliant. "This partnership further strengthens Reliant's position as the partner of choice for European companies that wish to bring their products to the U.S. marketplace."

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