Fda Grants Orphan Drug Status To Astrazeneca For Merrem I.V. To Research Treatment For Cystic Fibrosis

FDA GRANTS ORPHAN DRUG STATUS TO ASTRAZENECA FOR MERREM ® I.V. TO RESEARCH TREATMENT FOR CYSTIC FIBROSIS Hope for CF patients at risk for developing life-threatening lung infections The U.S. Food and Drug Administration (FDA) announced today that it has granted AstraZeneca USA orphan drug status for its anti-infective medicine, Merrem ® I.V. Currently, Merrem ® I.V. is indicated in the USA for intra-abdominal infections in adults and children, and bacterial meningitis in children three months of age and older. Outside the USA, Merrem ® is licensed for use in a wide range of infections. The orphan drug designation enables AstraZeneca to continue researching new indications for Merrem ® I.V., specifically for the management of acute pulmonary exacerbations in Cystic Fibrosis (CF) patients with chronic lower respiratory tract infections with susceptible organisms. Cystic Fibrosis is a rare genetic disease, affecting 30,000 children and adults in the United States. 1 Orphan drug status benefits patients by enabling manufacturers to develop and make available drugs for diseases and conditions rare in the United States. Lung infections, obstructed breathing and diabetes are frequent complications of Cystic Fibrosis, a genetic disease that causes the body to produce abnormally thick mucus within cells lining organs such as the lungs and pancreas due to the faulty transport of salt to their outer surfaces. While the disease affects less than 100,000 children and adults worldwide, millions of people are symptomless carriers of the CF gene. The disease has no cure, and of the nearly 2,500 babies born in the United States with Cystic Fibrosis, most will have a reduced life expectancy. 2 "The commitment of the Food and Drug Administration is critical to any company exploring treatments for rare diseases," said Ronald Krall, Vice President of Clinical Development and Medical Affairs at AstraZeneca. "This support will allow us to enhance our research with Merrem ® I.V. and may help thousands of CF sufferers around the world who regularly suffer from severe lung infections." Further enquires to: Steve Brown, tel: +44 (020) 7304 5033 Lucy Williams, tel: +44 (020) 7304 5034 Mikael Widell, tel: +46 8 553 264 28/+46 703 119 960 Rachel Bloom, tel: +1 (302) 886 7858 NOTE TO NEWS EDITORS Merrem® I.V. is indicated in the USA as single agent therapy for the treatment of the following infections when caused by susceptible strains of the designated microorganisms in adult and paediatric patients in the USA (additional indications are registered in other countries): * Intra-abdominal infections: Complicated appendicitis and peritonitis caused by susceptible organisms: viridans group streptococci, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Bacteroides fragilis, * thetaiotaomicron, and Peptostreptococcus species. * Bacterial Meningitis (paediatric patients greater than or equal to 3 months of age only): Bacterial meningitis caused by susceptible organisms: Streptococcus pneumoniae, Haemophilus influenzae (beta-lactamase and non- beta-lactamase-producing strains), and Neisseria meningitidis. Facts about Cystic Fibrosis Cystic Fibrosis is a genetic disease affecting approximately 30,000 children and adults in the United States. One in 31 Americans is an unknowing, symptomless carrier of the gene that causes Cystic Fibrosis. People with Cystic Fibrosis must inherit the defective gene from both their mother and father. When two people carrying the defective gene conceive a child, there is a 25 per cent chance that the child will have Cystic Fibrosis, a 50 per cent chance that the child will be a symptomless carrier of the gene, and a 25 percent chance that the child will not carry the gene.3 1 Cystic Fibrosis Foundation, Facts about Cystic Fibrosis. 2 National Institute of Health, Facts about Cystic Fibrosis. 3 Cystic Fibrosis Foundation, Facts about Cystic Fibrosis. ------------------------------------------------------------ Please visit http://www.bit.se for further information The following files are available for download: http://www.bit.se/bitonline/2000/05/15/20000515BIT00680/bit0001.doc http://www.bit.se/bitonline/2000/05/15/20000515BIT00680/bit0002.pdf