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New Data Submitted To FDA Supporting Use Of Omacor With A Statin To Reduce High Triglycerides

September 03, 2017

Reliant Pharmaceuticals today announced a submission to the U.S. Food and Drug Administration (FDA) to seek approval for the expanded use of Omacor (omega-3-acid ethyl esters) as an adjunct to diet and statin therapy in adults whose triglyceride levels are high (200-499 mg/dL).  As part of this filing, Reliant submitted new data from the recently completed Combination of Omacor and Simvastatin (COMBOS) trial that evaluated the efficacy and safety of Omacor as an adjunct to diet and simvastatin therapy for the treatment of high triglycerides.  COMBOS is a randomized, double-blind, placebo-controlled, parallel-group study including 254 patients.

"Currently, Omacor may help up to 5 million Americans whose triglyceride levels are very high," said Steven Ketchum, Ph.D., Senior Vice President, Research and Development, Reliant Pharmaceuticals.  "There are an estimated 27 million Americans who struggle to control high triglycerides.  By seeking this expanded indication, Omacor may serve as a safe, new treatment option for adults whose triglyceride levels remain high in spite of statin therapy."

Omacor is the first and only FDA-approved, prescription omega-3 fatty acid product, and has been proven safe and effective in clinical studies as an adjunct to diet to reduce very high triglycerides (≥500 mg/dL) in adult patients.  Very high triglycerides (≥500 mg/dL) impact 4-5 million people in the United States.  Omacor contains the key omega-3 components, eicosapentaenoic acid (465 mg) and docosahexaenoic acid (375 mg), to reduce very high triglycerides, and is naturally derived through a unique, patented process that consistently creates a highly concentrated and purified prescription medicine.

When Omacor was granted FDA approval in 2004, the FDA issued an approvable letter for the use of Omacor as an adjunct to diet and statin therapy to reduce high triglyceride levels (200-499 mg/dL) in adult patients.  Submission of this response is intended to demonstrate the safety and efficacy of the expanded use of Omacor before FDA approval is granted.

  About High Triglycerides

Like the other types of cholesterol, triglycerides are fats (lipids) that, in balanced and moderate amounts, perform significant and important functions in the body. Triglycerides are derived from either fats ingested from food or other energy sources like carbohydrates in the body.  After a meal, the calories that are not used immediately by tissues are then converted into triglycerides and distributed among fat cells to be stored.  Hormones found in the body then regulate the release of triglycerides from fat tissue so they may be used for energy between meals.  According to the American Heart Association (AHA), a normal level of triglycerides is below 150 mg/dL.  Like cholesterol, triglyceride levels can be detected by a blood test.  A high triglyceride level causes a condition known as hypertriglyceridemia, which is linked to the occurrence of heart disease in some people.

  Important Omacor Safety Information

Omacor is used along with a low-fat and low-cholesterol diet to lower very high triglycerides (fats) in adults. Before taking Omacor, your healthcare provider should help you try to control your very high triglyceride levels by: losing weight if you are overweight, increasing physical exercise, lowering alcohol use, treating diseases such as diabetes and low thyroid hormone levels (hypothyroidism), and adjusting other medications that may raise triglyceride levels such as certain blood pressure medications and estrogens.

  Omacor should be used with caution in people allergic to fish.  Treatment to reduce very high triglyceride levels may result in elevations in LDL-C and non-HDL-C in some individuals.  The effect of Omacor on cardiovascular morbidity and mortality in patients with very high triglyceride levels has not been determined.

  Tell your healthcare provider about all your medical conditions, including if you have liver problems, are pregnant, are trying to become pregnant or are breast-feeding.  Tell your healthcare provider if you take blood thinners.  If you take both Omacor and a blood thinner, your healthcare provider should monitor your clinical response.

  The most common side effects observed in Omacor clinical trials were belching, infection, flu symptoms, upset stomach, rash and change in your sense of taste. 

  For more detailed information about Omacor, ask your healthcare provider or go to omacorrx.

  About Reliant Pharmaceuticals

Reliant Pharmaceuticals is a pharmaceutical company with integrated sales, marketing and development expertise that markets a portfolio of branded cardiovascular pharmaceutical products.  Reliant focuses on marketing promotionally sensitive pharmaceutical products to the high prescribing primary care, cardiovascular and specialist physician markets in the United States.  Reliant also acquires rights to and develops product candidates in mid- to late-stage clinical development.  Reliant's sales force infrastructure is comprised of approximately 825 sales professionals nationwide.

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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.