Well KOSP itself finally figured out that the NIH guidelines were worth some PR and released something after the market closed today. Despite being a little slow here, they were up very nicely today (about 20%).
Wednesday May 16, 4:15 pm Eastern Time
Press Release
SOURCE: Kos Pharmaceuticals, Inc.
Kos Pharmaceuticals Commends ATP III for Aggressive Cholesterol Management
New Guidelines Triple Indicated Patient Population
MIAMI, May 16 /PRNewswire/ -- Kos Pharmaceuticals, Inc. (Nasdaq: KOSP - news) commented today on the new guidelines issued by the National Cholesterol Education Program (``NCEP'') Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. The Panel's recommended aggressive approach to treating cholesterol disorders with drug therapy nearly triples the number of patients who should be taking cholesterol modifiers.
The report, known as Adult Treatment Panel (``ATP'') III, which is summarized in today's issue of the Journal of the American Medical Association, revises recommendations last issued in 1993 for the treatment of high blood cholesterol.
While the primary emphasis of ATP III continues to be identifying and more aggressively treating elevated LDL (``bad'') cholesterol, more than half of the key changes in the guidelines focus on the importance of identifying and treating lipid disorders beyond LDL cholesterol. This increased focus on the importance of multiple lipid risk factors is consistent with the emerging science that many leading lipid researchers have been advocating in recent years, and it is the basis for Kos' strategy of developing cholesterol therapies that modify multiple lipid risk factors.
Among the principal new features of ATP III that focus on lipid disorders beyond LDL cholesterol are an increase in the threshold for low HDL (``good'') cholesterol to 40 mg/dL (from 35 mg/dL) and lowering the thresholds for triglyceride classifications in order to give more attention to moderate disorders. The report also raises the cardiac risk level for persons with diabetes but without coronary heart disease (``CHD''), most of whom have multiple lipid and other cardiac risk factors, to the equivalent of persons with CHD. ATP III also newly identifies, as a high-risk category for aggressive therapy, persons with ``metabolic syndrome,'' a condition that represents a constellation of lipid and non-lipid abnormalities such as high triglycerides, low HDL, obesity and hypertension. The report also highlights the value of aggressive combination therapy, where appropriate, in patients with multiple risk factors.
``The new NCEP guidelines suggest that a more aggressive treatment strategy, such as niacin in combination with an LDL-lowering statin, that targets all lipid parameters may significantly reduce heart disease rates for many patients,'' said Thomas A. Pearson, MD, PhD, Chairman of the Department of Community and Preventive Medicine at the University of Rochester School of Medicine and a member of the American Heart Association's Nutrition Committee and its Task Force on Risk Reduction. ``Patients with multiple lipid abnormalities are at a higher risk for developing cardiovascular disease, the number-one killer in this country,'' according to Dr. Pearson.
The ATP III panel strongly encourages medical practitioners to be more aggressive and broadly utilize cholesterol altering medications to treat high- risk patients with dyslipidemia. Accordingly, the guidelines nearly triple, to 36 million, the number of patients who should be immediately placed on cholesterol medications. The report also estimated that there are 65 million people in the U.S. who have high cholesterol levels. Currently, only 9 million patients are on drug therapy, while the U.S. cholesterol market is approaching $10 billion in annual revenue.
Many people with cholesterol disorders suffer from multiple lipid risk factors, including not only elevated LDL cholesterol, but also abnormal levels of HDL cholesterol, triglycerides and Lp(a), an emerging lipid risk factor. Niacin has long been recognized as the most potent agent available to simultaneously increase HDL cholesterol and reduce LDL cholesterol, triglycerides, and Lp(a). Niaspan®, Kos Pharmaceutical's proprietary niacin formulation, is the only once-daily niacin therapy approved by the United States Food and Drug Administration (``FDA'') for the treatment of multiple lipid disorders, improving HDL and triglyceride levels up to 32 percent and 35 percent, respectively. The company has also developed and submitted to the FDA a new product, Advicor(TM), consisting of Niaspan and an LDL-lowering statin drug for the treatment of mixed lipid disorders. Kos entered into a co-marketing alliance with DuPont Pharmaceuticals Company for Advicor and, subject to marketing clearance by the FDA, Kos and Dupont plan to commercialize Advicor early in 2002.
``We are extremely pleased that the ATP III report clearly recognizes the need for aggressive therapy with high risk patients, including, where appropriate, the intensive use of combination therapy,'' said Daniel M. Bell, President and Chief Executive Officer of Kos. ``ATP III certainly validates, in a more public way, our strategy of developing therapies that address multiple lipid risk factors. In Niaspan, we created the first patient friendly 'beyond-LDL drug,' which is frequently used to complement the effects of statins in modifying multiple lipid disorders. This approach, already being widely utilized today, was the genesis for our new Advicor product, which, subject to FDA approval, would be the first combination drug for the treatment of mixed dyslipidemia.''
Niaspan is Kos Pharmaceuticals' proprietary once-daily niacin formulation for the treatment of cholesterol disorders. Kos Pharmaceuticals, Inc. is a fully integrated specialty pharmaceutical company engaged in developing and commercializing proprietary prescription pharmaceutical products, primarily for the treatment of chronic cardiovascular and respiratory diseases. Kos has drug delivery capabilities in both solid-dose and aerosolized formulation technologies. |
