LIBERTY CORNER, N.J. and OSLO, Norway, Nov 29, 2004 /PRNewswire via COMTEX/ -- Reliant Pharmaceuticals, Inc. and Pronova Biocare AS today 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."
About Reliant Pharmaceuticals, Inc.
Reliant Pharmaceuticals is a privately held company with integrated sales, marketing and development expertise focused on selling promotionally sensitive pharmaceutical products to high-prescribing primary care physicians across the U.S., as well as to select specialists. The company acquires and develops branded pharmaceutical products, as well as products in mid- to late-stage clinical development, that typically have FDA-granted marketing exclusivity or long-term patent protection. Reliant enhances the value of its product portfolio by applying highly focused marketing campaigns and by implementing strategies to extend the life cycles of the products it sells. These strategies include applying drug delivery technologies and formulation advancements that increase safety, improve convenience and compliance, and enhance therapeutic value. Reliant's sales force infrastructure has grown with its product portfolio and is comprised of nearly 1,000 sales professionals nationwide.
About Pronova Biocare AS
Pronova Biocare is the world's leading supplier of omega-3 fatty acids for human consumption. Pronova Biocare AS is a limited company owned by Ferd Private Equity and Norsk Hydro ASA. It has a strong international orientation and is a leader in the research, development, manufacture and marketing of omega-3 derived products. Its core business areas are pharmaceuticals and dietary and nutritional supplements. Pronova Biocare's head office is in Oslo, Norway, and it has modern production facilities in Sandefjord and Alesund, Norway.
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To the extent any statements made in this release contain information that is not historical, these statements are essentially forward looking and are subject to risks and uncertainties, including the difficulty of predicting FDA approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, availability of raw materials, the regulatory environment, fluctuations in operating results and other risks detailed from time to time in the company's filings with the Securities and Exchange Commission.