LIBERTY CORNER, N.J., Oct. 5 /PRNewswire/ -- Reliant Pharmaceuticals, Inc.
today announced the U.S. launch of its new lipid-regulating drug Omacor(R)
(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
Omacor: Delivering on the Promise of Omega-3 Fatty Acids for Very High
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.(7)
"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(R) as an adjunct to diet to
reduce very high triglyceride levels (greater than or equal to 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
For further information, please go to http://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
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
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
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
3. U.S. Census Bureau. Population. In: Statistical Abstract of the
United States 2004-2005. Available at:
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
id=341777&ASSORTMENT<>ast_id=93463&bmUID=1125423794625 . Accessed August 30,
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.html . Accessed August 24,
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 :
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.