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Hill & Knowlton (UK) Ltd
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INEGY™ (Ezetimibe/Simvastatin) Receives First Approval in Europe

Greater Cholesterol Reduction through Dual Inhibition in Germany

MUNICH, GERMANY, APRIL 02, 2004 – Merck & Co., Inc. and Schering-Plough Corporation today announced the regulatory approval of INEGY™ in Germany. INEGY is the first product to reduce low-density lipoprotein cholesterol (LDL-C or ‘bad’ cholesterol) through Dual Inhibition of both cholesterol production in the liver and absorption in the intestine. Germany is the first European country to give regulatory approval for INEGY. The approval in Germany represents the first step in seeking marketing approval throughout the European Union (EU) under the EU’s mutual recognition procedure. Ezetimibe/simvastatin has also been approved in Mexico.

“INEGY is an important treatment that offers more LDL-C-lowering compared to statins alone, and will, therefore, allow significantly more patients in Europe to reach their LDL-C targets,” said Professor Heiner Greten, Universitatskrankenhaus, Eppendorf, Medizinische Klinik, Hamburg, Germany.

To provide physicians with choices for dosing based on patients’ needs, INEGY, which contains both ezetimibe and simvastatin, will be available in several tablet strengths – ezetimibe 10 mg with simvastatin 10, 20, 40 or 80 mg.

Ezetimibe with simvastatin more efficacious than atorvastatin as demonstrated in studies presented at ACC

The regulatory approval of INEGY is based on extensive clinical data that has shown INEGY provides greater LDL-C-reduction than statin alone.

Ezetimibe with simvastatin, the active ingredients in INEGY, have been shown to be significantly more effective at reducing LDL-C than atorvastatin (LIPITOR®) across all dosages. New data released this month at the American College of Cardiology from a 24-week study of ezetimibe 10 mg taken with simvastatin (doses ranging from 10 mg to 80 mg) compared to atorvastatin alone (does ranging from 10 mg to 80 mg) showed greater LDL-C reductions in patients taking ezetimibe/simvastatin compared to patients taking atorvastatin across the dosing ranges. After six weeks of therapy, patients taking ezetimibe 10 mg with simvastatin 10 mg and patients taking ezetimibe 10 mg with simvastatin 20 mg experienced greater LDL-C reductions (46 percent and 50 percent, respectively) compared to atorvastatin 10 mg, which produced a 37 percent reduction. In addition, as each treatment group was titrated through the dosing ranges, ezetimibe with simvastatin provided greater LDL-C reductions than at
orvastatin at all points in the treatment period. 1

What is Dual Inhibition?

Cholesterol in the body originates from two main sources: production by hepatic and extra hepatic tissues and absorption in the intestine. Cholesterol-lowering agents (statins) reduce cholesterol levels by single inhibition, that is, by inhibiting the synthesis (production) of cholesterol in the liver. Ezetimibe, the first cholesterol absorption inhibitor, works by inhibiting intestinal absorption of cholesterol, both dietary and the cholesterol which is a component of bile. INEGY provides Dual Inhibition by targeting both of the main sources of cholesterol in the body, production and absorption, providing significantly more effective reduction of LDL-C plasma levels.


INEGY will be marketed by a partnership between Merck & Co., Inc. and Schering-Plough Corporation. Ezetimibe/Simvastatin is also currently under review by the Food and Drug Administration for marketing approval in the United States.

About Merck

Merck & Co., Inc. which operates in many countries as Merck Sharp & Dohme, is a global research-driven pharmaceutical products company. Merck discovers, develops, manufactures and markets a broad range of innovative products to improve human and animal health, directly and through its joint ventures.

About Schering-Plough

Schering-Plough Corporation is a research-based company engaged in the discovery, development, manufacturing and marketing of pharmaceutical products worldwide.


This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements include statements regarding product development. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward- looking statements in this press release should be evaluated together with the many uncertainties that affect the Company’s business, particularly those mentioned in the cautionary statements in Item 1 of its Form 10-K for the year ended Dec. 31, 2003, and in its periodic reports on Form 10-Q and Form 8-K (if any) which we incorporate by reference.


1. 1. American College of Cardiology Annual Congress 2004. Efficacy of ezetimibe coadministered with simvastatin versus atorvastatin in patients with hypercholesterolemia. Ballantyne C et al.

Company Contacts:

Joe Azzinaro

Merck, Sharp & Dohme

+1 908 423 4263

Investor Contact:
Mark Stejbach

Merck, Sharp & Dohme

+1 908 423 5185

Heike Schulz

Merck, Sharp & Dohme

+ 49 89 4561 1927

Mary Fran Faraji

Schering-Plough Corp.

+1 908 298 7109

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