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FDA APPROVES MARKETING OF SYNTEX'S CYTOVENE FOR ADDITIONAL INDICATION -- PREVENTION OF CMV INFECTION IN TRANSPLANT PATIENTS

 FDA APPROVES MARKETING OF SYNTEX'S CYTOVENE FOR ADDITIONAL INDICATION -- PREVENTION OF CMV INFECTION IN TRANSPLANT PATIENTS
 PALO ALTO, Calif., May 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 Cytovene (ganciclovir sodium) for an additional indication -- the prevention of cytomegalovirus (CMV) disease in transplant patients at risk for CMV disease.
 Syntex has marketed Cytovene in the United States since 1989 for the treatment of CMV retinitis in immunocompromised individuals, including patients with acquired immunodeficiency syndrome (AIDS).
 Approximately 50 percent of the adult population in the United States carries cytomegalovirus antibodies -- evidence of prior CMV infection. The virus usually remains latent (inactive) in individuals with normal immune systems. However, when a person's immune system is damaged by disease, or, as is the case with transplant patients, is suppressed by medication, the virus can become active. There is an approximately 50 percent fatality rate among transplant patients from CMV-induced pneumonia.
 "We at Syntex are pleased that Cytovene has been approved for marketing to prevent CMV disease in transplant patients," said Paul E. Freiman, Syntex chairman and chief executive officer. "Until now, CMV has taken a great toll on transplant patients.
 It's heartening that one of our products can potentially make a significant difference in these patients' lives."
 In the past, when transplant patients developed severe CMV infections, their doctors had to reduce or stop the immunosuppressive medications that these patients must take to prevent rejection. The discontinuation of medication left them at high risk of rejection and loss of the transplanted organ.
 In two randomized, double-blind, placebo-controlled studies -- one of heart-transplant recipients and the other of bone-marrow- transplant recipients -- Cytovene significantly reduced the incidence of CMV disease.
 In the heart-transplant study, "all patients were treated from day one to day 28 following transplant," according to Dr. Thomas Merigan, Becker Professor of Medicine at the Stanford University School of Medicine and director of the Center for AIDS Research at the Stanford Medical Center, principal investigator of the study.
 In this study, 112 patients were carrying the virus before their transplant. Forty-six percent of these previously infected patients who received placebo during the trial developed active disease, while only 9 percent who were treated with Cytovene developed active CMV disease. "This study shows that, for heart-transplant patients who were previously infected with CMV, Cytovene truly does prevent the CMV virus from becoming active," Merigan said.
 Of the 72 patients participating in the bone-marrow study, 43 percent of those receiving placebo developed active CMV disease, while only 3 percent of those receiving Cytovene did.
 In a third study, a randomized unblinded study of 40 bone-marrow recipients, the incidence of CMV disease was significantly lower in the group treated with Cytovene (20 percent developed CMV disease) than it was in the control group (70 percent developed CMV disease).
 Cytovene is a unique antiviral compound that inhibits replication of CMV by interfering with the virus's ability to produce DNA. Like other antiviral medicines, Cytovene does not eliminate the virus from the body: rather, it delays the spread of infection to healthy cells.
 Because of Cytovene's known, potentially serious side effects -- lowered white blood cell and platelet counts -- careful monitoring of patients treated with Cytovene is essential. Moderate kidney impairment has also been observed in some patients. In most cases, these side effects immediately resolve when Cytovene treatment is discontinued.
 Cytovene was discovered and developed by Syntex Research. It is supplied as a sterile powder, which is reconstituted and diluted for intravenous administration.
 Cytovene for use in transplant patients is the most recent of several licenses Syntex has received from the FDA for new indications and new formulations of five important new Syntex medicines. The five, all of which were approved for marketing in the last three-and- a-half years, are: Toradol IM (injectable) and Toradol Oral, effective non-opoid, non-steroidal anti-inflammatory pain-relievers prescribed for the limited-duration management of pain; Ticlid, an anti-platelet aggregator prescribed for stroke risk reduction in women who are at risk of a first or recurrent stroke, men at risk of a recurrent stroke and male TIA patients who cannot take aspirin; Synarel, a gonadotropin-releasing hormone agonist prescribed for the management of endometriosis and to treat central precocious puberty; Cytovene; and Cardene and Cardene SR, calcium-channel blockers marketed for the treatment of hypertension (high blood pressure). Cardene is also prescribed for the treatment of angina.
 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- 5/28/92
 /CONTACT: Jan Potts, 415-855-5052, or Linda Thomas, 415-852-1321, both of Syntex/
 (SYN) CO: Syntex Corp. ST: California IN: SU:


MM -- SJ001 -- 4821 05/28/92 14:28 EDT
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Date:May 28, 1992
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