Merck has signed a research and drug development agreement with FoxHollow Technologies, which represents the first pharmaceutical-medical device partnership aimed at identifying cardiovascular biomarkers for use as diagnostics and as tools for drug development.
The pharmacogenomics collaboration will focus on analysing atherosclerotic plaque removed from patient arteries to identify new biomarkers of atherosclerotic disease progression. The studies will be used for use in the development of cardiovascular compounds in Merck's drug pipeline.
Under the terms of the three-year agreement, Merck will analyse the collected plaque samples to identify biomarkers and profiling compounds using these biomarker platforms.
FoxHollow's decision to enter this lucrative deal will see the maker of catheter systems for removing arterial plaque, providing access to these atherosclerotic plaque samples.
The samples have been collected from patients who have cardiovascular disease and have been treated with FoxHollow's SilverHawk Plaque Excision System.
"We currently assess risk of heart disease using blood markers such as cholesterol, blood pressure, blood sugar and CRP, but none of these provides a direct view of the immediate cause of disease which is atherosclerotic plaque," said Richard Pasternak, vice president of Clinical Research at Merck.
"Our collaboration with FoxHollow has the potential to provide insight on cardiovascular disease and to accelerate development of novel drugs for this widespread health issue," he added.
The SilverHawk System is a minimally invasive catheter system used to remove atherosclerotic plaque, which blocks blood flow in the arteries. The device is used to treat peripheral arterial disease, a condition that affects 12 million Americans and can lead to severe, debilitating leg pain, and possibly, amputation.
Regarding financial details, Merck will make initial cash payments of $9 million(€7.3 million) to FoxHollow to cover the first year of the collaboration. If Merck elects to continue the collaboration, then it will pay FoxHollow additional payments of up to $31 million in the following two years.
FoxHollow will also receive milestone payments and royalties based upon achieving program objectives.
There are two main theories about why atherosclerosis develops: High levels of cholesterol in the blood injure the artery's lining, causing an inflammatory reaction and enabling cholesterol and other fatty materials to accumulate there.
Or repeated injury to the artery's wall may occur through various mechanisms involving the immune system or through direct toxicity. In both cases, there are changes that can lead to the formation of atheromas.
Sales of anti-atherosclerotic agents have reached $9 billion (€7.3 billion) in 2000. This has been driven by the need for better and less expensive diagnostic tools such as biomarkers, risk evaluation tools and imaging tests.
In addition, the greater usage of existing therapies; more single-pill combinations to improve compliance and better evidence for use of emerging therapies will continue to shape the market's future.
Merck is just one of a number of companies responding to this need, having one drug candidate in preclincal trials and one other, c-8834, in phase I clinical trials.
There is currently no cure for atherosclerosis. The main treatment goal is to prevent significant narrowing of the arteries so that symptoms never develop and vital organs are never damaged.
Since high cholesterol has been proven to be a precursor to atherosclerosis, medication to lower its level may be necessary. There are currently five classes of cholesterol-lowering medications
HMG-CoA reductase inhibitors block an enzyme called HMG-CoA reductase, which controls the production of cholesterol in the liver. These include Mevacor (lovastatin) ,Zocor (simvastatin), Pravachol (pravastatin), Lescol (fluvastatin), Crestor (rosuvastatin), and Lipitor (atorvastatin).
Bile acid-binding resins include Questran (cholestyramine), Colestid (colestipol) and Niacin.
Fibrates, which are primarily effective in lowering triglycerides and, to a lesser extent, in increasing HDL-cholesterol levels include Lopid (gemfibrozil) and Tricor (fenofibrate)
Cholesterol-absorption inhibitors, which are the newest class of cholesterol lowering agents, include Zetia (Ezetimibe), which is currently the only one on the market.