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| |  Posicor Gets FDA Approval For High Blood Pressure, Angina NUTLEY, N.J., June 24, 1997 -- Stalking the 'silent killer' that is high blood pressure, and treating angina, a painful heart condition, are the twin goals of a new drug with a novel mechanism of action. The U.S. Food and Drug Administration (FDA) has approved Posicor(R) (mibefradil dihydrochloride), the first of a new class of tetralol calcium antagonists, for the once-daily treatment of hypertension and chronic stable angina pectoris. Posicor will be marketed by Roche Laboratories Inc., the marketing and sales subsidiary of Hoffmann-La Roche Inc. Hypertension, or high blood pressure affects an estimated 50 million people in the United States and is known as the 'silent killer' because it usually has no symptoms. Nearly seven million Americans suffer from angina, a condition often characterized by recurring chest pain. Both diseases can be linked to heart attack and death. Classified by The World Health Organization (WHO) as the first of a new category of tetralol calcium antagonists, Posicor is the only hypertension and angina treatment that, at therapeutic doses, selectively blocks T-type calcium channels of blood vessels, while also blocking L-type calcium channels. All other calcium antagonists block L-type calcium channels alone. "T-channel block is a reason for renewed optimism," said R. Kent Hermsmeyer, Ph.D., Senior Scientist, Oregon Regional Primate Research Center, Beaverton, Oregon. "Posicor is the only drug, which decreases blood pressure while at the same time decreasing heart rate and not weakening the heart's contractile function." "The Framingham Heart Study has shown us that decreasing heart rate is associated with decreased heart disease and deaths," continued Dr. Hermsmeyer. Posicor, taken once-daily, controls blood pressure consistently and smoothly over the full 24-hour interval. Posicor also reduces the number of anginal attacks and improves the exercise capacity of patients with chronic stable angina pectoris. In studies of 3,400 patients, the incidence of side effects was low. "Bothersome reactions to drugs are the main reason why patients stop taking their medication," said Barry Massie, M.D., Professor of Medicine, University of California at San Francisco. "A drug that had fewer side effects would certainly improve patient compliance and our ability to control blood pressure." Historically, diagnosis and treatment of high blood pressure has been less than optimal. Of an estimated 50 million people who have high blood pressure, only 34 million are diagnosed. Of those who have been diagnosed, only 26 million take medication, and only 12 million people are adequately controlled, according to the National Center for Health Statistics. High blood pressure puts both the heart and arteries under great strain. The chest pain that characterizes angina is caused by the heart muscle receiving an insufficient supply of blood. Clinical studies demonstrate that Posicor works equally well in a variety of patient populations, including men, women, and older adults. In addition, studies indicate that the drug works equally well in African Americans, as well as in patients with kidney disease. In these studies, Posicor was generally well tolerated at a once-daily dose of up to 100 mg. Most side effects (adverse reactions) were transient and of only mild or moderate intensity. The most common side effects included headache and runny nose. At doses of 50 mg. and 100 mg. the rate of discontinuation of Posicor due to adverse reactions was similar to that of placebo. Posicor should not be used in combination with Seldane(R), Hismanal(R) and Propulsid(R). Posicor will be dispensed in 50 mg. and 100 mg. tablets. In addition to availability of the drug in the United States, Posicor was recently cleared for marketing for the treatment of hypertension and chronic stable angina pectoris in the Netherlands, the lead country for the Pan-European registration procedure, Switzerland, and several Latin American countries. Hoffmann-La Roche Inc. is a research-intensive pharmaceutical company that discovers, develops, manufactures and markets prescription drugs in key therapeutic areas including virology, infectious diseases, cardiology, oncology, transplantation, dermatology and obesity. More information on: Hoffmann-La Roche Inc., Posicor, Seldane,Hismanal
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