New Cholesterol-Lowering Drugs Available

Agreement Makes New Cholesterol-Lowering Drugs Available

New Zealanders with high cholesterol will benefit from a new agreement signed between the Pharmaceutical Management Agency (PHARMAC) and pharmaceutical company Merck Sharp & Dohme New Zealand (MSD NZ).

Under the agreement, PHARMAC will fully fund the first in a new class of cholesterol-lowering medicines, EZETROL® (ezetimibe, MSP), from 1 July this year under a Special Authority which specifies which patients will be eligible for the medicine. The agreement also provides for the funding, subject to registration, of a new combination cholesterol-lowering medicine VYTORIN, which combines the actions of both EZETROL, a cholesterol absorption inhibitor, and statin (simvastatin) therapy. VYTORIN is currently being evaluated by Medsafe for Ministerial Consent and registration.

MSD NZ Managing Director Alister Brown said the agreement was a milestone in the treatment of cardiovascular disease in New Zealand. “This is highly significant for both patients and doctors: This will be the first new class of cholesterol-lowering agent introduced in New Zealand for 15 years and New Zealanders will be gaining the benefits of these exciting new medicines before many other parts of the world, including Australia.

“In a market that has recently been characterised by lack of access to new medicines, PHARMAC’s decision is a welcome development that will truly benefit patients.”

Mr Brown said one key benefit of the new drugs was that patients would be able to control their cholesterol levels at much lower drug doses. “Medically, this is a big step forward that addresses a real need among cardiologists for new tools to fight cardiovascular disease.”

He said EZETROL had been available for a short time in New Zealand and was already being prescribed for patients who were paying for it themselves.

A third part of the agreement involved MSD’s well-known statin LIPEX® (simvastatin, MSD) which PHARMAC has agreed to fund till the end of the decade, including a new 80mg dose, said Mr Brown. “LIPEX is still a very important option for cholesterol control, with more than 150,000 patients currently on the medicine in New Zealand. Globally, it has been the most prescribed statin medicine over the past decade and has more evidence than any other statin medicine that it reduces deaths and cardiovascular events.

“We are thrilled that this agreement gives those patients, and others for whom LIPEX is the best option, confidence that the medicine will continue to be available and funded.”

The agreement has been hailed by leading cardiologists as an important and welcome achievement for the treatment of heart disease in New Zealand. (more) Professor of Cardiology at the Green Lane Clinical Centre, Professor Harvey White, said the effects of the new drug were “astonishing.”

“Adding ezetimibe to a low dose of a statin drug is equivalent, in terms of effects on cholesterol levels, to using a top dose of a statin. It is exciting to be able to prescribe this drug and to be able to lower cholesterol levels to international goals, which will likely have a huge impact on stroke and heart attack rates in New Zealand.” Auckland cardiologist and Senior Lecturer in Cardiology at the University of Auckland School of Medicine, Dr Chris Ellis, said ezetimibe was a major advance for lowering cholesterol. “It will be helpful for many patients, and adds benefit to patients already on simvastatin (LIPEX), although I remain disappointed that PHARMAC will not fully fund ezetimibe for use with all statins in New Zealand. Ongoing clinical trials should further demonstrate the effectiveness of ezetimibe.”

Professor in Human Nutrition and Medicine at the University of Otago, Professor Jim Mann said the re-imbursement of ezetimibe in New Zealand was “wonderful news”.

“Life expectancy has significantly improved since the introduction of statins. However, for patients who are not adequately controlled on statins or who can’t tolerate a full dose, ezetimibe is a welcome addition to the range of treatments available."

Ends

For further information contact:

Ron Murray Merck Sharp & Dohme NZ Ltd Phone 09 523 6112; Mobile 021 243 9873; email ron_murray@merck.com

About EZETROL

EZETROL (ezetimibe), a cholesterol absorption inhibitor, has been developed and is being marketed by Merck & Co., Inc. (NYSE:MRK) and Schering-Plough Corporation (NYSE:SGP) in connection with a partnership formed by both companies to develop and market worldwide (excluding Japan) new prescription medicines in cholesterol management.

EZETROL is marketed in New Zealand by Merck Sharp & Dohme NZ Ltd, and has been available since June 2003.

What you need to know about EZETROL (ezetimibe)

EZETROL® (ezetimibe) is a medicine used to reduce the amount of cholesterol and triglycerides in your blood, either in conjunction with another cholesterol lowering medicine called a statin or on its own. Before you take EZETROL discuss with your doctor the risks and benefits associated with taking EZETROL, also tell your doctor about any other medication you may be on or if you are allergic to anything. You should not take EZETROL if you are allergic to any component of the medicine. Be sure to tell your doctor if you are pregnant or breast-feeding or have any liver disease. Most commonly reported adverse reactions for EZETROL alone were: headache, abdominal pain and diarrhoea. Most commonly reported adverse reactions for EZETROL combined with a statin were: headache, fatigue, abdominal pain, constipation, diarrhoea, flatulence, nausea, increased liver enzymes (ALT and AST), and myalgia. Do not be alarmed by these possible adverse effects, you may not experience any of them, tell your doctor if you experience any adverse effect. Full “Consumer Medicine Information” is available upon request, ring 0800 500 673. EZETROL is available by prescription only and a charge may apply for this medicine up until 1 July 2004, please consult with your doctor or pharmacist. Tablets: 10mg tablets

® EZETROL and VYTORIN are registered trademarks of a joint venture between Merck & Co, Inc. and Schering-Plough Corporation, USA. PRESCRIPTION MEDICINE.

About LIPEX

The clinical benefits of LIPEX have been documented in numerous large scale clinical trials including the landmark Heart Protection Study (HPS) and the Scandinavian Simvastatin Survival Study (4S). The HPS was the largest clinical study with a statin ever conducted that conclusively demonstrated that long-term therapy (5 years) with LIPEX 40mg saved lives and significantly reduced the risk of heart attack and stroke in a broad range of high risk patients, especially those with CHD and diabetes, and with average or below-average cholesterol levels. The landmark Scandinavian Simvastatin Survival Study 4S was the first to show that LIPEX reduced the risk of all-cause mortality by 30 percent, and the risk of coronary mortality by 42 percent, in patients with CHD and total cholesterol in the range 5.5 – 8.0 mmol/L (212-309 mg/dL) and triglycerides ≤ 2.5 mmol/L (221 mg/dL) at baseline.

What you should know about LIPEX®

LIPEX® (simvastatin, MSD) belongs to a group of medicines known as HMG-CoA reductase inhibitors and is used to lower high cholesterol and triglyceride levels and reduce the health risks associated with coronary heart disease. If you have coronary heart disease, diabetes, history of stroke, or other vessel disease (regardless of the amount of cholesterol in your blood), LIPEX can prolong your life by reducing the risk of heart attack or stroke; reduce the need for surgery to increase blood flow to the legs and major organs such as the heart; and reduce the need for hospitalisation for chest pain (angina). Before you take LIPEX discuss with your doctor the risks and benefits associated with taking LIPEX, also tell your doctor about any other medication you may be on or if you are allergic to anything. You should not take LIPEX if you are allergic to any component of the medicine or if you are pregnant or breast feeding. Be sure to tell your doctor if you have any liver disease or muscle pain. Most commonly reported adverse reactions include: constipation, diarrhoea, wind, stomach upset, feeling sick, headache, dizziness and muscle pain. Do not be alarmed by this possible list of adverse effects, you may not experience any of them, tell your doctor if you experience any adverse effect.

Full “Consumer Medicine Information” is available upon request, phone 0800 500 673. LIPEX is available fully funded by prescription only, please consult with your doctor or pharmacist. Tablets: 10, 20, 40mg

LIPEX® is the Merck registered trademark for simvastatin.

Check with your doctor that EZETROL® and LIPEX® are right for you. Normal doctor’s fees will apply. About Merck Merck & Co., Inc., which operates in many countries as Merck Sharp & Dohme, is a global research-driven pharmaceutical products and services company. Merck discovers, develops, manufactures and markets a broad range of innovative products to improve human and animal health, directly or 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.

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