Abbott Announces Approval of Breakthrough Prevention for
1.09.1999, 14:44
RSV in Europe / Synagis(TM) now available in Europe ABBOTT PARK, Ill., and GAITHERSBURG, Md. (PROTEXT) - AbbottLaboratories and MedImmune, Inc. today announced the EuropeanCommission granted a marketing authorization for Synagis(TM)(palivizumab) for the prevention of serious lower respiratorytract disease requiring hospitalization caused by respiratorysyncytial virus (RSV) in high-risk infants. Synagis is indicatedfor use in infants born prematurely (less than or equal to 35weeks gestational age), and infants and children with chronicbronchopulmonary dysplasia (BPD), a chronic lung disease. Synagis, the first monoclonal antibody to be licensed in theUnited States for any infectious disease, is also the firstproduct to deliver safe and effective RSV protection with asimple intramuscular (IM) injection. The injection can beadministered in the primary health-care provider's office once amonth during the RSV season -- typically November to April inEurope. RSV is the most common cause of lower respiratory infectionsin infants and children worldwide. In fact, half of all childrenaround the world develop RSV infections by the age of one year,and by the age of two, virtually all children have been infected.In high-risk children infected with RSV, 70 percent may requirehospitalization, 25 percent may require mechanical ventilationand some may die as a result of RSV infection. "RSV can be a life-threatening disease for premature babiesand young children with BPD," says David Goffredo, vicepresident, European operations, Abbott. "Synagis has thepotential to enhance patient care, reduce costs associated withprolonged hospital stays and reassure parents that they aretaking an important step to help improve their child's health andwell-being." The U.S. Food and Drug Administration (FDA) approved Synagisfor marketing in June 1998. RSV Studies A placebo-controlled, randomized study -- one of the largeststudies ever conducted in premature infants -- showed Synagisreduced the risk of hospitalization due to RSV by 55 percent.Studies were conducted in premature infants, including those withBPD. The most frequently reported adverse reactions were fever,nervousness and injection site reaction, however these rates weresimilar in the treatment versus placebo groups. In addition to its success in preventing RSV, Synagis does notinterfere with normal childhood vaccines including the measles-mumps-rubella vaccine and the varicella virus vaccine. About RSV Common symptoms of RSV include a low-grade fever, runny noseand cough. The cough may be accompanied by wheezing anddifficulty in breathing, which can indicate that the virus hasmoved to the lower respiratory tract. RSV spreads easily fromperson to person via sneezing or coughing, or from hands touchingthe nose or eyes and then coming in contact with another personor object. The chance of spreading the virus within a family isvery high; many times, school-aged children introduce the virusinto the family. Despite strict infection control procedures,hospital nursery units, day care centers, and other similarinstitutions are also at high-risk for RSV outbreaks. "Synagis represents a major breakthrough in RSV prevention,"said William Dempsey, senior vice president, InternationalOperations, Abbott Laboratories. "Abbott believes Synagis willprovide high-risk children with even greater protection againstthis disease." "We are pleased with the European Commission's decision toapprove Synagis for marketing in Europe," commented Melvin D.Booth, president and chief operating officer at MedImmune. "RSVis a worldwide problem, and we, with our colleagues at Abbott,want to make Synagis globally available." 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. 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. 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, 847-938-7743; or WilliamRoberts of MedImmune, Inc., 301-527-4358 Company News On-Call:http://www.prnewswire.com/comp/110328.html or fax, 800-758-5804,ext. 110328 Web site: http://www.abbott.com
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