FDA approves AstraZeneca's sterile facility to manufacture and distribute MERREM I.V.

FDA APPROVES ASTRAZENECA'S STERILE FACILITY TO MANUFACTURE AND DISTRIBUTE MERREM I.V. Creates increased u.s. supply of broad spectrum antibiotic The U.S. Food and Drug Administration (FDA) recently approved AstraZeneca's Newark, Del.-based sterile facility to aseptically fill, package and distribute its antibiotic, MERREM® I.V.. Currently, MERREM I.V. is indicated for intra-abdominal infections in adults and children, and bacterial meningitis in children three months of age and older. Production at the dedicated, 50,000 square foot aseptic $XXm filling facility is well underway. According to the Newark site's Executive Director & General Manager, Ron Matthews, "This state-of-the-art facility has the capacity to meet demand for the U.S. and other world markets for this important medicine." The Newark sterile facility for MERREM is located on the same campus as AstraZeneca's manufacturing and distribution facilities for a number of key products such as NOLVADEX®, SEROQUEL®, ARIMIDEX®, and DIPRIVAN®. Prior to the construction of this sterile facility, MERREM was produced by a contract manufacturer. "The approval of the Newark sterile facility represents an important step in having greater control over the manufacturing process for MERREM I.V. We are keenly aware of the need to provide this medicine for those seriously ill patients who do not respond to conventional antibiotics," said C.G. Johansson, president and CEO, AstraZeneca LP. May 15, 2000 Further Enquiries: Steve Brown, tel +44 (0)20 7304 5033 Lucy Williams, tel +44 (0)20 7304 5034 Mikael Widell, tel +44 (0)20 7304 5030 NOTES TO NEWS EDITORS: MERREM I.V. is indicated as single agent therapy for the treatment of the following infections when caused by susceptible strains of the designated microorganisms in adult and pediatric patients: * Intra-abdominal infections: Complicated appendicitis and peritonitis caused by susceptible organisms: viridans group streptococci, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Bacteroides fragilis, B thetaiotaomicron, and Peptostreptococcus species. * Bacterial Meningitis (pediatric patients greater than or equal to 3 months of age only): Bacterial meningitis caused by susceptible organisms: Streptococcus pneumoniae, Haemophilus influenzae (b-lactamase and non-b lactamase-producing strains), and Neisseria meningitidis. ------------------------------------------------------------ Please visit http://www.bit.se for further information The following files are available for download: http://www.bit.se/bitonline/2000/05/15/20000515BIT00310/bit0001.doc http://www.bit.se/bitonline/2000/05/15/20000515BIT00310/bit0002.pdf