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 NEW YORK, Dec. 2 /PRNewswire/ -- In a major study, researchers have found a new drug 48 percent more effective than aspirin at reducing the risk of initial stroke during the first year of treatment -- the year of greatest danger. And, over a five-year period, the medication, introduced at a news briefing, cut the overall risk for stroke by 24 percent when compared with aspirin, Syntex Corporation (NYSE: SYN) announced.
 Ticlid(R) (ticlopidine hydrochloride) is now available for marketing in the United States to reduce the risk of stroke from a blood clot (thrombotic stroke) in men and women who have experienced a stroke warning sign. It is also indicated for patients who have suffered a thrombotic stroke and are at risk for recurrent stroke.
 Because Ticlid is associated with a risk of neutropenia, a serious side effect, it should be reserved for patients who cannot take aspirin where indicated for prevention of stroke. To detect the possible occurrence of neutropenia, patients using Ticlid will require blood count monitoring during the first three months on medication.
 "Ticlid is a significant advance for many stroke-threatened patients," said Donald Easton, M.D., professor and chairman for the program in neurology at Brown University and neurologist-in-chief at Rhode Island Hospital. "This includes women. No medication before Ticlid was proven or approved to reduce the risk of stroke in women."
 Data from two major studies involving 4,142 men and women at high risk of stroke were presented. One study comparing Ticlid with aspirin, conducted at 56 medical centers in the United States and Canada, was the largest ever carried out on stroke prevention in patients known to be vulnerable to stroke. During the first year, when the risk of stroke is greatest, the reduction is risk of stroke compared to aspirin was 48 percent. The reduction was similar in men and women. Over the five- year duration of the study, Ticlid significantly reduced the overall risk of fatal and nonfatal stroke by 24 percent compared with aspirin.
 Stroke is the third leading cause of death in America after heart disease and cancer, killing approximately 150,000 people annually. Stroke is also the leading cause of adult disability. Five hundred thousand new strokes occur each year, and there are almost 3,000,000 stroke survivors in the United States.
 "We believe Ticlid has the potential to play a major role in lowering the risk of stroke," said Paul Freiman, chairman and chief executive officer of Syntex Corporation.
 Ticlid Effective in Women
 Ticlid is effective for women as well as men. In the study comparing Ticlid with aspirin, the risk reduction for fatal and nonfatal stroke was 36 percent for women who had experienced a stroke warning sign. A 34 percent reduction was shown in the recurrent stroke study comparing Ticlid with placebo.
 Women accounted for about 35 percent of the study population in the study that compared Ticlid with aspirin and 40 percent in the recurrent stroke study. Other stroke studies have failed to establish aspirin's benefits for women or have had insufficient numbers of women to prove aspirin to be effective.
 Mechanism of Action
 Ticlid is structurally and biochemically different from all currently used antithrombotic agents. It belongs to a class of drugs known as platelet aggregation inhibitors. Platelets are disk-shaped blood cells that contain numerous prepacked, extraordinarily potent molecules. When triggered by various stimuli, they clump together or aggregate. In healthy people, platelet aggregation is important in the control of bleeding (hemostasis). In people at risk of atherothrombotic stroke, however, platelets adhere to the walls of damaged arteries and form a mass that can impede blood flow to the brain (a condition known as thrombosis).
 A chemical called adenosine diphosphate (ADP) is an important mediator of platelet aggregation. ADP is the go-between common to many stimuli that cause platelets to bind into a mass that forms an obstructing blood clot (thrombus). Ticlid interferes with the binding of platelets initiated by ADP and also interferes with other mechanisms activating ADP.
 Ticlid Compared With Aspirin
 Before the introduction of Ticlid, the only medication approved by the FDA for reducing stroke risk was aspirin. Aspirin does not block the aggregation induced by ADP. Aspirin is not indicated for recurrent stroke, but for the prevention of primary stroke. It is also recommended only for men, not women.
 Side-Effects Profile
 In clinical trials with Ticlid, 21 percent of patients discontinued therapy due to an adverse event. Diarrhea, which occurred in 12.5 percent of the study participants, is the most common adverse side effect associated with Ticlid. Nausea (7.0 percent) and diarrhea side effects were usually mild and typically resolved within one to two weeks without discontinuation of therapy.
 The most serious side effect of Ticlid is neutropenia, a condition in which a component of white blood cells, neutrophils, is reduced. Neutrophils play a critical role in protecting against infection.
 In clinical trials, neutropenia occurred within the first three months of Ticlid therapy in 2.4 percent of patients, was serious in 0.8 percent of patients, and was reversible when the drug was discontinued. In the comparison study of Ticlid and aspirin, the incidence of serious adverse effects was similar in both groups (1.37 percent among Ticlid patients, 1.38 percent with aspirin), although the types of effects were different.
 Monitoring Program
 Regular monitoring for neutropenia during the first three months of therapy -- complete blood counts (CBCs) every other week -- can reduce the risk of severe neutropenia.
 To ensure that neutropenia is detected quickly so that affected patients can be promptly removed from the medication, Syntex has set up the Patient CBC Monitoring Program for Ticlid. This plan offers physicians patient education materials as well as overnight service to transport patients' biweekly blood samples to one central laboratory for standardized measurements. Critical values are communicated to physicians within 24 hours by telephone.
 Through support from Syntex, the laboratory service is available at no additional cost to all patients, although patients are not obligated to use this special service.
 Another Benefit of Ticlid
 An additional benefit of Ticlid is that the drug's pharmacokinetics (movement through the body) remain virtually unchanged in patients across a wide range of adult age groups. According to N. Jean Warner, M.D., clinical research group director of Syntex Research, this means that no dosage adjustment is generally necessary in the elderly.
 "Since stroke is most common among persons over age 60," she said, "the ability to prescribe Ticlid without making age-related dosage adjustments provides a higher margin of comfort to physicians in stroke prevention therapy."
 The findings of studies undertaken to evaluate the pharmacokinetics of Ticlid in individuals with mildly impaired kidney function also suggest that no alteration of dosage is generally necessary in this group.
 Dosage Information
 Ticlid is supplied as 250 mg tablets. The recommended dosage is 250 mg twice a day with food.
 Ticlid Marketing Details
 Syntex Corporation received approval to market Ticlid from the Food and Drug Administration on Oct. 31, 1991. Syntex licenses Ticlid from the French pharmaceutical company Sanofi; Syntex has marketing rights in the United States, Canada, Mexico, Australia, and New Zealand.
 Sanofi introduced Ticlid in France in 1978. Ticlid is marketed by Sanofi or its other licensees in 45 other countries, including Germany, Japan, Italy, and Spain. It has been marketed by Syntex in Mexico since 1986 and in Canada since September 1991.
 Syntex Corporation is a multinational company that discovers, develops, manufactures, and markets prescription medicines that treat serious human diseases and save lives. Syntex also develops, manufactures, and markets animal pharmaceutical products and medical diagnostic systems.
 A news story on this new drug is available via satellite:
 Tuesday, Dec. 3, 1:30-2 p.m. (EST)
 Telstar 301, Transponder 12V
 Dual Audio 6.2 & 6.8
 For more information or to request a hard copy, call Anne Crays at 312-951-0619.
 -0- 12/2/91
 /CONTACT: Linda Thomas of Syntex, 415-852-1321, or Maureen Galvin of GTFH Public Relations, 212-886-3129, for Syntex/
 (SYN) CO: Syntex Corporation ST: California IN: MTC SU:

JT-OS -- NYFNS3 -- 8170 12/02/91 07:32 EST
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Date:Dec 2, 1991

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