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CONGESTIVE HEART FAILURE DRUG FROM BOOTS PHARMACEUTICALS NOW AVAILABLE FOR PRESCRIPTION

 NEW YORK, March 2 /PRNewswire/ -- Boots Pharmaceuticals, Inc., announced today that MANOPLAX (flosequinan) Tablets, the first of a new class of vasodilating drugs for the treatment of congestive heart failure (CHF) in symptomatic patients who are not responding or are intolerant to conventional therapy, is now available for prescription. MANOPLAX, believed to be an IP3 attenuator, is a convenient once-daily tablet and has been developed as an adjunctive treatment, as opposed to first-line therapy.
 Approved for use last December, MANOPLAX is indicated for patients not responding adequately to diuretics (with or without digitalis), who have not responded adequately to a regimen including angiotensin converting enzyme (ACE) inhibitors or who cannot tolerate an ACE inhibitor. ACE inhibitors have been shown to reduce mortality among CHF patients. MANOPLAX should not be substituted for an ACE inhibitor.
 "CHF is threatening to become an epidemic, especially among our increasingly aging population," said Milton Packer, M.D., professor of medicine, Columbia University College of Physicians and Surgeons, New York. "We have been engaged in an ongoing search for an oral direct-acting, arterial and venous vasodilating drug useful in the treatment of patients who can't tolerate or are still symptomatic despite being treated with current CHF therapies. This is significant because MANOPLAX dilates all blood vessels that affect blood flow and pressure, thereby relieving the burden on the heart."
 Added Carter Eckert, president and CEO of Boots Pharmaceuticals, Inc., at a news briefing to announce the availability of MANOPLAX: "Paradoxically, while CHF is the only cardiovascular disease that has grown in magnitude in the U.S. over the last 10 years, the number of treatment options has remained limited. Before the availability of MANOPLAX, only two drugs, both angiotensin converting enzyme (ACE) inhibitors, had been approved in the last decade as chronic therapies for CHF." Many patients continue to suffer the debilitating effects of CHF, despite diuretics, digitalis and ACE inhibitor therapy. MANOPLAX has been demonstrated to provide symptomatic relief to these patients.
 Approximately 3 million Americans, and 15 million people worldwide, suffer from CHF, a degenerative, incurable and ultimately fatal disease. Despite medical advances, mortality is greater than 50 percent for most CHF patients within five years of their initial diagnosis. The occurrence of heart failure increases progressively with age from about 1 percent prevalence in those aged 50-59, to a prevalence of about 10 percent in people aged 80-89.
 FACET Study Results
 The results of the recent Flosequinan-ACE Inhibitor Trial (FACET), a clinical study of 322 patients with mild or moderate CHF, demonstrated for the first time that adding MANOPLAX (flosequinan) Tablets to the current regimen of drugs -- the combination of a diuretic, digoxin and an ACE inhibitor -- was safe, effective and provides further relief of heart failure symptoms. Patients in the double-blind 16-week trial were randomly assigned to treatment with MANOPLAX 100 mg once daily, 75 mg twice daily or placebo.
 "Patients who received MANOPLAX in the FACET study exercised longer, which suggests that adding the new drug will prove to be of benefit to many of the hundreds of thousands of CHF patients who remain symptomatic despite optimal triple therapy," said Barry M. Massie, M.D., professor of medicine, University of California, San Francisco. He presented preliminary results of FACET at the November 1992 Scientific Sessions of the American Heart Association.
 "Reducing debilitating symptoms such as breathlessness and fatigue will help this group of congestive heart failure patients to be more active," added Massie.
 "While we now know that MANOPLAX provides symptom relief to these CHF patients, we do not know yet whether it can improve survival," said Massie. To that end, Boots is now sponsoring an extensive five- year trial to evaluate the effect of MANOPLAX on mortality. Called the Prospective Randomized Flosequinan Longevity Evaluation (PROFILE), the mortality study began in 1991. It includes 3,500 patients with moderate and severe NYHA Class III-IV CHF. Results of the PROFILE study are expected in 1995.
 A Distinct New Class of Drug Therapy
 MANOPLAX, the first oral direct-acting arterial and venous vasodilator, belongs to a distinct new class of cardiovascular drugs with a novel mechanism of action thought to result by attenuating levels of inositol triphosphate (IP3) and/or by attenuating protein kinase C activity. IP3 is an intracellual mediator of vascular smooth muscle contraction.
 Researchers believe MANOPLAX affects factors in the sarcoplasmic reticulum which control the release of intracellular calcium, lessening the constriction of arteries and veins. The dilating action makes it easier for the failing heart to pump, thereby increasing cardiac output and improving circulation.
 "The drug has been tested in more than 2,200 symptomatic CHF patients in more than 300 clinical centers," explained Neil Kurtz, M.D., senior vice president of research and development at Boots. "The studies clearly demonstrate that MANOPLAX is well tolerated, effective and has a favorable safety profile. MANOPLAX has also been safely administered to patients with impaired renal function (serum creatinine up to 3 mg/dl) in clinical trials."
 The most common side effect is headache, which generally disappears with continued use of the drug. Other side effects include tachycardia, palpitations, hypotension, dizziness, taste disturbance and a small incidence of liver abnormalities.
 MANOPLAX is available by prescription in 50 mg, 75 mg and 100 mg tablets. For patients receiving concomitant ACE inhibitors, the initial dose of MANOPLAX should be 50 mg once daily, titrating up, if tolerated, to 100 mg once daily at about weekly intervals. The recommended daily maintenance dose is 100 mg.
 Once-A-Day Action of MANOPLAX
 Kurtz said the convenient once-a-day dosing of MANOPLAX is possible because flosequinan is rapidly and extensively absorbed and then converted by the liver to a longer-acting sulfone metabolite. Both have similar pharmacologic activity. "This long duration of action allows MANOPLAX to be effective when given once a day," he explained.
 Costs Associated with CHF
 CHF accounts for more hospitalizations than any other condition in the United States. More than 400,000 new cases are reported each year, resulting in some 900,000 hospitalizations. The costs associated with CHF are significant. According to the National Heart, Lung and Blood Institute, $4.7 billion in costs associated with patient care (i.e. lab fees, hospital stays) was spent on the treatment of CHF in 1987. Based on figures from 1991, CHF accounted for 4.8 million hospital days. The average hospital stay associated with CHF is seven days.
 There is no known cure for the disease except heart transplantation. Up to 25 percent of CHF patients suitable for transplantation die while waiting for a donor organ. People who are severely debilitated or are aged 65 and over are not considered appropriate candidates for transplantation.
 One common characteristic of heart failure is severe damage to the heart muscle. The damage may have occurred over many years from such conditions as coronary artery disease or high blood pressure. More sudden damage may occur from a heart attack, a severe viral infection of the heart muscle or a bacterial infection of the heart valves.
 Boots Pharmaceuticals
 Boots researchers in Nottingham, England, discovered the compound in 1979. The drug has been in clinical trials in the United States since 1985 and has been available for prescription in the United Kingdom since Sept. 19, 1992. Boots Pharmaceuticals, Inc., in the United States submitted its new drug application to the Food and Drug Administration in 1990. The company received marketing approval on Dec. 30, 1992. The drug will be jointly marketed by Boots Pharmaceuticals, Inc., and Parke-Davis Division of Warner-Lambert Company.
 -0- 3/2/93
 /NOTE: For full prescribing information, call Sydney Stephenson at 202-973-0371.
 A video news release and B-roll is available for unrestricted use:
 Feed Time: 1:30-2:30 p.m. EST, today.
 Coordinates: C-Band, Telstar 301, Transponder 12-V, Audio 6.2 and 6.8.
 MANOPLAX is a registered trademark./
 /CONTACT: John Seng, 202-973-0360; Bob Schwadron, 212-626-6554; or Tom Thurman, 708-405-7434, all for Boots Pharmaceuticals/


CO: Boots Pharmaceuticals, Inc. ST: New York IN: MTC SU: PDT

MH-TW -- DC003 -- 1840 03/02/93 10:06 EST
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