European Committee For Proprietary Medicinal Products

21.05.1999, 19:11

Adopts Positive Opinion On Synagis(TM) For Prevention of RSV Abbott Park, Ill. and Gaithersburg, Md. (ots-PRNewswire) -Abbott Laboratories (NYSE: ABT) and MedImmune, Inc. (Nasdaq:MEDI) today announced that the European Union's Committee forProprietary Medicinal Products (CPMP) has adopted a positiveopinion on Synagis(TM) (palivizumab), a monoclonal antibodydeveloped for the prevention of a serious lower respiratory tractdisease caused by Respiratory Syncytial Virus (RSV). RSV is themost common cause of lower respiratory infections in infants andchildren worldwide. The CPMP opinion now will be considered bythe European Commission, which will make a final decisionregarding the issue of a marketing authorization. Synagis will be the only preventive treatment in Europe forRSV in pediatric patients under two years old who suffer fromlung problems due to chronic broncopulmonary dysplasia (BPD) orprematurity (less than or equal to 35 weeks gestational age).Synagis is administered monthly during peak RSV season with anintramuscular (IM) injection to pediatric patients at high riskfrom RSV. During the peak season in Europe, more than 50 percent ofhospitalizations due to respiratory infections in children under2 involve RSV. Recommendation for approval of Synagis is based ona large, randomized study demonstrating a 55 percent reduction inthe incidence of hospitalization due to RSV infections in high-risk pediatric patients. "The positive opinion is a major step forward in makingSynagis available for children at high risk for RSV," said DavidGoffredo, vice president, European operations, AbbottLaboratories. The positive opinion follows approvals in several markets,including Argentina, Australia, Brazil, Colombia, Kuwait, Mexicoand the United States. In December 1997, Abbott Laboratories and MedImmune, Inc.,formed an exclusive worldwide marketing alliance to commercializeSynagis. Abbott has the exclusive right to market and distributeSynagis outside the United States. In the U.S., where Synagis wasapproved for marketing in June 1998, MedImmune and Abbott have anagreement to co-promote the product. About Abbott Laboratories Abbott Laboratories is a global, diversified health carecompany devoted to the discovery, development, manufacturing andmarketing of pharmaceutical, diagnostic, nutritional and hospitalproducts. Abbott Laboratories is located in Abbott Park, Ill. Thecompany employs 56,000 people and markets its products in morethan 130 countries. About MedImmune MedImmune, Inc., located in Gaithersburg, Md., is abiotechnology company focused on developing and marketingproducts that address medical needs in areas such as infectiousdisease, transplantation medicine, autoimmune disorders andcancer. MedImmune markets three products through its hospital-based sales force and has five new product candidates in clinicaltrials. This announcement may contain, in addition to historicalinformation, certain forward-looking statements that involverisks and uncertainties. Such statements reflect management'scurrent views and are based on certain assumptions. Actualresults could differ materially from those currently anticipatedas a result of a number of factors, including risks anduncertainties discussed in both companies' filings with the U.S.Securities and Exchange Commission. ots Original Text Service:Abbott Laboratories Internet: http://www.newsaktuell.de Contact:Laureen Cassidy of Abbott Laboratories, (USA) 847-938-7743; orMark E. Kaufmann, (USA) 301-417-0770, ext. 321, or William C.Roberts, (USA) 301-417-0770, ext. 358, both of MedImmune, Inc.Company News On-Call: http://www.prnewswire.com/comp/110328.htmlor fax, 800-758-5804, ext. 110328 Web site:http://www.abbott.com

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