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SYNTEX RECEIVES FDA APPROVAL TO MARKET CARDENE(R) SR FOR TREATING HYPERTENSION

 SYNTEX RECEIVES FDA APPROVAL TO MARKET
 CARDENE(R) SR FOR TREATING HYPERTENSION
 PALO ALTO, CA, Feb. 28 /PRNewswire/ -- Syntex Corp. (NYSE: SYN) said today that the company has received permission from the U.S. Food and Drug Administration (FDA) to market Cardene(R) SR (nicardipine hydrochloride) in the United States. Cardene SR capsules, the sustained-release formulation of the calcium-channel blocker Cardene, will be prescribed by physicians for twice-daily use for the treatment of hypertension (high blood pressure).
 Syntex has marketed Cardene in the United States since 1989. Cardene capsules are currently prescribed by physicians for three-times-a-day use for the treatment of angina and hypertension.
 The efficacy of Cardene SR in treating hypertension was demonstrated in four randomized, double-blind controlled clinical trials, in which Cardene SR was compared with placebo and with the currently marketed formulation of Cardene. In these studies, there was less variability in the blood-pressure-lowering effect over the course of a day with Cardene SR than with the currently marketed formulation of Cardene, which was administered three times a day.
 The most frequent adverse events seen in clinical trials were those commonly associated with drugs that work by dilating the blood vessels: flushing, headache, pedal edema and dizziness. The type and frequency of adverse events for Cardene SR were similar to those experienced with the currently marketed formulation of Cardene.
 Timothy C. Fagan, M.D., associate professor of medicine and pharmacology at the University of Arizona, who was an investigator in the clinical studies, said, "The blood pressure of patients taking Cardene SR in our trials was significantly reduced with all dose-levels studied. We found that this new formulation of Cardene provides excellent control of high blood pressure."
 Hypertension is associated with increased risk of heart attack, stroke and sudden death. According to the American Heart Association (AHA), more than 60 million American adults and children have high blood pressure. African-Americans have a one-third greater chance of developing high blood pressure than do non-hispanic white Americans, according to the AHA.
 In the University of Arizona clinical trial, one third of the patients studied were African-Americans. Dr. Fagan said these patients responded as well to Cardene SR as did the white patients in the study. African-Americans comprised 17 percent of all patients participating in the clinical trials that formed the basis of Syntex's submission to the FDA.
 Women comprised 46 percent of all patients participating in these clinical trials.
 Cardene SR will be supplied in 30, 45 and 60 mg capsules. It is expected to be available to patients in July.
 The safety and efficacy of Cardene and Cardene SR have been demonstrated in approximately 4.3 billion patient days of therapy worldwide. Syntex, which licenses Cardene from Yamanouchi Pharmaceutical Co. Ltd. markets Cardene in nine countries. The company also currently markets Cardene SR in the United Kingdom.
 "We are pleased that the FDA has cleared Cardene SR for marketing," said Paul E. Freiman, chairman and chief executive officer, Syntex Corp. "It adds an important new alternative that physicians can prescribe when treating patients with hypertension."
 Cardene SR is one of six new Syntex products approved for marketing by the FDA in the past three years. The other products are: Toradol(R) IM (injectable) and Toradol Oral, potent non-narcotic pain relievers prescribed for the short-term management of pain; Ticlid(R), an anti-platelet aggregator prescribed for stroke risk reduction in men and women at risk of a first or recurrent stroke; Synarel(R), a gonadotropin-releasing hormone agonist prescribed for the management of endometriosis; and Cytovene(R), an antiviral compound prescribed to treat sight-threatening cytomegalovirus (CMV) infections in immunocompromised patients, including people with AIDS.
 Syntex Corp. is a multinational healthcare company that discovers, develops, manufactures and markets prescription medicines that treat serious human diseases. Syntex also develops, manufactures and markets animal pharmaceutical products and medical diagnostic systems.
 - 0 - 2/28/92
 /CONTACT: Linda Thomas, 415-852-1321; or Jan R. Potts, 415-855-5052, both of Syntex Corp./
 (SYN) CO: Syntex Corp. ST: California IN: MTC SU:


RM -- SJ002 -- 3837 02/28/92 15:42 EST
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Date:Feb 28, 1992
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