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For Immediate Release

RELIANT PHARMACEUTICALS ANNOUNCES U.S. LAUNCH OF OMACOR®, FIRST PRESCRIPTION OMEGA-3 PRODUCT For the treatment of very high triglyceride levels

October 5, 2005

LIBERTY CORNER, N.J. -- Reliant Pharmaceuticals, Inc. today announced the U.S. launch of its new lipid-regulating drug Omacor® (omega-3-acid ethyl esters) as an adjunct to diet for the treatment of adults with very high levels of triglycerides (TG), defined as 500 milligrams/deciliter (mg/dL) or higher.1 Omacor is the first and only U.S. Food and Drug Administration (FDA)-approved prescription omega-3 fatty acid product clinically proven to reduce very high TG levels, a serious medical condition that affects up to six million Americans. 1-4 It is also the first new class of treatment for very high TG levels in more than seven years.

The launch of Omacor in the United States further demonstrates Reliant's commitment to providing patients with safe and proven cardiovascular and lipid-regulating therapies," said Dr. Ernest Mario, Reliant's Chairman and Chief Executive Officer. "Only Omacor delivers the triglyceride-lowering benefits of omega-3 fatty acids as a pure, clinically proven and FDA-approved prescription drug. 1,2,5 The unique, patented manufacturing process for Omacor results in a highly purified, highly concentrated capsule that contains 90 percent omega-3-acid ethyl esters. 1,5 Dietary supplements typically contain less than 50 percent omega-3 fatty acids, and, unlike Omacor, are not FDA regulated as to content, purity and clinical benefit as are prescription drugs."6,7

Omacor: Delivering on the Promise of Omega-3 Fatty Acids for Very High Triglyceride Levels

In two randomized, placebo-controlled trials, Omacor 4 grams/day reduced TG levels by a median of 45 percent (p<0.0001) in patients with very high TG levels. Omacor was very well tolerated in controlled studies.1

Each one-gram Omacor gel capsule contains 90 percent omega-3-acid ethyl esters and is available only by prescription. 1,2 The FDA-regulated and approved manufacturing process ensures a pure, consistent, proven concentration of omega-3-acid ethyl esters while helping to eliminate concerns about mercury and other environmental toxins. 5 Currently, there are no FDA regulations specific to dietary supplements that establish a minimum standard of practice for manufacturing. Dietary supplements are not approved for the treatment of specific diseases or medical conditions.

“Omacor provides what the supplements lack: the consistency, reliability and established efficacy of a prescription drug,“ said Christie Ballantyne, M.D., Director of the Center for Cardiovascular Disease Prevention, Methodist DeBakey Heart Center, Houston, Texas. “With Omacor, we can effectively lower very high triglyceride levels with the convenience of once-daily dosing and the confidence of a potent, proven, FDA-approved omega-3 medication.”

The FDA and the American Heart Association recommend that patients taking higher doses of omega-3 fatty acid products (greater than two and three grams per day, respectively) for the treatment of very high triglyceride levels be managed under a physician's care. 8,9

TGs and Health

TGs, along with low-density lipoprotein cholesterol (LDL-C), very-low-density lipoprotein cholesterol (VLDL-C), and high-density lipoprotein cholesterol (HDL-C), comprise the plasma lipid profile, which, when persistently abnormal, can impact cardiovascular health.

An estimated five to six million Americans have very high TG levels, and many more are potentially at risk due to the increasing incidence of obesity and diabetes _ major causes of very high TG levels. 3,4,10,12 According to a recent survey conducted by KRC Research Inc., nearly half of Americans are not aware of how TGs affect health, and nearly 70 percent have never spoken to their doctor about their TG levels. 13

Additional Information About Omacor

In November 2004, the FDA approved Omacor® as an adjunct to diet to reduce very high triglyceride levels (≥500 mg/dL) in adult patients. Excess body weight and excess alcohol intake may be important factors in hypertriglyceridemia (HTG) and should be addressed before initiating any drug therapy. Exercise can be an important ancillary measure. Diseases contributing to hyperlipidemia (such as hypothyroidism or diabetes mellitus) should be looked for and adequately treated. Certain drugs (estrogen, thiazide diuretics and beta blockers) are sometimes associated with very significant rises in plasma TG levels. Discontinuation of the specific agent may obviate the need for specific drug therapy for HTG. The use of lipid-regulating agents should be considered only when reasonable attempts have been made to obtain satisfactory results with non-drug methods. The patient should be advised that use of lipid-regulating agents does not reduce the importance of adhering to diet.

Omacor is contraindicated in patients who exhibit hypersensitivity to any component of this medication. Laboratory studies should be performed periodically to measure the patient's TG levels during Omacor therapy. Omacor therapy should be withdrawn in patients who do not have an adequate response after two months of treatment. Omacor should be used with caution in patients with known sensitivity or allergy to fish.

Alanine aminotransferase levels should be monitored periodically during Omacor therapy. Treatment to reduce very high TG levels may result in elevations in LDL-C in some individuals. As with any lipid-regulating product, LDL-C levels should be monitored periodically during Omacor therapy. Some studies with omega-3 fatty acids demonstrated prolongation of bleeding time. The prolongation of bleeding time reported in these studies has not exceeded normal limits and did not produce clinically significant bleeding episodes. Clinical studies have not been done to thoroughly examine the effect of Omacor and concomitant anticoagulants. Patients receiving Omacor and anticoagulants should be monitored via history and physical exam; additional blood testing is not required.

There are no adequate and well-controlled studies of Omacor in pregnant women. Omacor should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known if omega-3-acid ethyl esters are excreted in human milk. Caution should be exercised when Omacor is administered to women who are breastfeeding.

The effect of Omacor on the risk of pancreatitis in patients with very high TG levels has not been evaluated. The effect of Omacor on cardiovascular mortality and morbidity in patients with very high TG levels has not been determined. Omacor was well tolerated in controlled studies. The most common adverse events reported were: burping, flu syndrome, upset stomach, back pain, rash, and change in taste (taste perversion).

Each one-gram Omacor gel capsule contains 465 mg eicosapentaenoic acid (EPA) and 375 mg of docosahexaenoic acid (DHA) ethyl esters. The recommended dose of Omacor is four, one-gram capsules daily. For important safety information about Omacor, please see full prescribing information.

The active pharmaceutical ingredient (API) in Omacor is manufactured by Pronova Biocare AS. The API of Omacor is encapsulated and bottled by Cardinal Health.

For further information, please go to www.omacorrx.com.

About Reliant Pharmaceuticals, Inc.

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 1,000 sales professionals nationwide.

“Safe Harbor” statement under the Private Securities Litigation Reform Act of 1995. 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.

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 _lesund, Norway.

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References

  1. Omacor [package insert]. Reliant Pharmaceuticals. Inc. Liberty Corner, NJ, 2005.
  2. Food and Drug Administration. Electronic Orange Book: Approved Drug Products With Therapeutic Equivalence Evaluations. Available at: http://www.accessdata.fda. gov/scripts/cder/ob/docs/temptn.cfm. Accessed July 27, 2005.
  3. U.S. Census Bureau. Population. In: Statistical Abstract of the United States 2004-2005. Available at: http://www.census.gov/prod/www/statistical-abstract-04.html. Accessed August 2, 2005.
  4. National Cholesterol Education Program. Third report of the expert panel on detection, evaluation, and treatment of high blood cholesterol in adults. 2000.
  5. United States Patent and Trademark Office. United States Patent No. 5,502,077, Breivik et al, March 26, 1996. Available at: http://www.uspto.gov. Accessed September 8, 2005.
  6. Consumer Reports. Omega-3 oil: fish or pills? July 2003. Available at: http://www. consumerreports.org/main/content/display_report.jsp?FOLDER<>folder_id=341777& ASSORTMENT<>ast_id=93463&bmUID=1125423794625. Accessed August 30, 2005.
  7. Food and Drug Administration. Overview of dietary supplements. Updated January 4, 2004. Available at: http://www.cfsan.fda.gov/~dms/ds-oview.html. Accessed July 27, 2005.
  8. Kris-Etherton P, Harris WS, Appel LJ, for the Nutrition Committee. Fish consumption, fish oil, omega-3 fatty acids and cardiovascular disease. Circulation. 2002;106:2747-2757.
  9. Food and Drug Administration. Summary of qualified health claims permitted. Updated August 2005. Available at: http://www.cfsan.fda.gov/~dms/qhc-sum.htmt. Accessed August 24, 2005.
  10. U.S. Department of Health and Human Services. Health, United States, 2004: With Chartbook on Trends in the Health of Americans. Available at: http://www.cdc.gov/nchs/data/hus/hus04trend.pdf#069. Accessed August 23, 2005.
  11. National Diabetes Surveillance System. 1999 Surveillance Report. Available at: http://www.cdc.gov/diabetes/statistics/surv199/chap2/figure1.htm. Accessed August 23, 2005.
  12. American Association of Clinical Endocrinologists. The insulin resistance syndrome and obesity fact sheet. 2002. Available at: http://www.aace.com/pub/irscc/irsfs.php. Accessed July 29, 2005.
  13. KRC Research Inc. Hypertriglyceridemia awareness consumer survey. Questionnaire, August, 2005.

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