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EXOSURF(R) NEONATAL(TM) LINKED TO INCREASED SURVIVAL IN LARGER INFANTS WITH RESPIRATORY DISTRESS SYNDROME

 EXOSURF(R) NEONATAL(TM) LINKED TO INCREASED SURVIVAL IN
 LARGER INFANTS WITH RESPIRATORY DISTRESS SYNDROME
 RESEARCH TRIANGLE PARK, N.C., Dec. 12 /PRNewswire/ -- Burroughs Wellcome Co.'s Exosurf(R) Neonatal(TM) (colfosceril palmitate/cetyl alcohol/tyloxapol) synthetic surfactant has been shown to improve the rate of survival and lessen complications associated with Respiratory Distress Syndrome (RDS) in larger premature infants, according to a study published in today's "New England Journal of Medicine."
 "While the efficacy of synthetic surfactant has been widely tested in small premature infants, its effects in larger (more than 1,250 grams) premature infants had remained largely unexplored," said Dr. Walker Long, senior clinical research scientist at Burroughs Wellcome Co. "Unfortunately, RDS affects premature infants at all birth weights."
 RDS affects about 50,000 babies each year and is a leading cause of death and disability among premature infants. Infants with RDS have immature lungs that lack surfactant, a substance that maintains the bubble-like shape of the small lung sacs or alveoli. Without surfactant, infants have stiff lungs that often collapse.
 Study Shows Increased Survival and Fewer Complications
 The study, reported in "The New England Journal of Medicine," is the largest placebo-controlled surfactant trial ever conducted, and involved more than 1,200 infants at 36 institutions throughout the United States and Canada. Study results showed that in the first 28 days of life there were fewer deaths due to RDS, lower overall neonatal mortality, lower incidence of bleeding in the brain, and a lower incidence of chronic lung disease in the surfactant group than in the placebo group.
 The study also determined that there were dramatic reductions in the frequency of a number of other complications of RDS and prematurity such as lung rupture, seizures, low blood pressure and meningitis.
 The authors also noted that infants who received surfactant spent significantly fewer days receiving oxygen, mechanical ventilation and any form of respiratory support. Furthermore, the use of high-frequency ventilation was significantly reduced, and use of extracorporeal membrane oxygenation (ECMO) was eliminated. Across-the-board improvements in clinical outcome were also evident in the reduced need for a variety of medications in the surfactant group.
 "Our trial clearly indicated that relatively large premature infants with RDS derive the most benefit from surfactant replacement," Long said. "Withholding surfactant from larger infants with RDS who are receiving ventilation -- because they are thought to have a good prognosis without such treatment -- is not justifiable."
 Significance of Study in Larger Infants
 Determining the effects of surfactant in relatively larger premature infants is particularly important because half of all premature infants who experience RDS weigh more than 1,250 grams at birth. The authors pointed out that the potential risks and benefits of surfactant are likely to vary with birth weight, as does the outcome of RDS. Because in larger infants with RDS only the pulmonary system is likely to be immature, it may be possible to obtain clearer evidence on surfactant's true effects in RDS in this population than in smaller infants.
 A total of 1,237 premature infants with RDS, who weighed at least 1,250 grams at birth, were enrolled in the trial. Of the total, 623 infants were randomly assigned to receive an air placebo and 614 were randomly assigned to two intratracheal installations of Exosurf Neonatal.
 The only potential safety problems identified were an increase in frequency of apnea of prematurity (a temporary cessation in breathing) and a possible increase in the incidence of pulmonary hemorrhage. The authors noted that apnea proved to be a marker of improved survival in both treated and control groups, rather than an adverse effect.
 The authors of "The New England Journal of Medicine" article included: Drs. Walker Long, Burroughs Wellcome; Anthony Corbet, Baylor College of Medicine; Robert Cotton, Vanderbilt University; Sherry Courtney, Wright State University; Gail McGuiness, University of Iowa at Iowa City; Donnal Walker, University of Arkansas at Little Rock; John Watts, McMaster University; John Smyth, University of British Columbia; Harry Bard, University of Montreal; and Victor Chernick, University of Manitoba.
 Surfactant therapy was cited earlier this year by the National Center for Health Statistics as contributing to a six percent decline in deaths among premature infants in 1990. The decline in infant mortality from 9.7 to 9.1 deaths per 1,000 is the largest single drop in recent years.
 Burroughs Wellcome Co. introduced Exosurf Neonatal in August, 1990. Controlled clinical trials began in 1986 and involved 4,400 infants in the United States and Canada, making Exosurf Neonatal the most widely studied surfactant in history. In addition, more than 11,000 infants received Exosurf Neonatal through an expanded access (Treatment IND) program in effect in 1989 and 1990.
 Exosurf Neonatal is supplied as a sterile lyophilized (freeze-dried) powder that is reconstituted with sterile water and administered through the infant's ventilator tube without removing the infant from the ventilator. Because it is completely synthetic, Exosurf Neonatal can be stored at room temperature for prolonged periods of time. There is also little potential for viral contamination or for any possible immunologic or infection risks.
 Exosurf Neonatal was invented by Dr. John Clements of the University of San Francisco and was developed, tested and manufactured by Burroughs Wellcome Co. of Research Triangle Park, N.C. A research-based pharmaceutical company, Burroughs Wellcome is a wholly owned subsidiary of The Wellcome Foundation Ltd. of London.
 -0- 12/12/91
 /CONTACT: Kathy Bartlett, 919-248-4302, or Sharon Haggerty, 919-248-8611, both of Burroughs Wellcome Co./ CO: Burroughs Wellcome Co. ST: North Carolina IN: MTC SU: PDT


CM -- CH001 -- 1760 12/12/91 08:03 EST
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Date:Dec 12, 1991
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