Chirocaine Designated Approvable by FDA.LONDON--(BUSINESS WIRE)--March 1, 1999--Chiroscience Group plc today announced that it has received an Approvable Letter from the United States Food and Drug Administration United States Food and Drug Administration (FDA), n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics. (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) for Chirocaine, its long-acting local anesthetic local anesthetic n. An agent that, when applied directly to mucous membranes or when injected about the nerves, produces loss of sensation by inhibiting nerve excitation or conduction. . The Approvable Letter represents the last step in the regulatory process before FDA approval of the New Drug Application. The Company is in advanced discussions with the FDA regarding final printed labeling. Dr. John Padfield, Chief Executive of Chiroscience Group plc, commented: "This important decision is consistent with Chiroscience's belief that, following the final FDA review of the product labeling and approval of its New Drug Application, Chirocaine will be regarded as an important addition to the range of drugs used in anesthesia and pain." This document is intended to provide information on Chiroscience to interested members of the public and not to provide product information to health professionals. Chiroscience Group plc Chiroscience is an emerging pharmaceutical company which uses its diverse technology platform to discover, develop and bring to market novel medicines for improved healthcare. It has three businesses: Chiroscience R&D, Rapigene and ChiroTech. Chiroscience R&D's focus is on innovative small molecule drugs and related diagnostics in the therapeutic areas of inflammatory disease, pain, osteoporosis, cancer and autoimmune diseases Autoimmune diseases A group of diseases, like rheumatoid arthritis and systemic lupus erythematosus, in which immune cells turn on the body, attacking various tissues and organs. Mentioned in: Complement Deficiencies, Premature Menopause . Its technology platform allows the conception and development of receptor-based and enzyme-inhibiting small molecule drugs with high selectivity of action. Rapigene is involved in the creation and provision of genomic technologies and services to partner companies and to Chiroscience's drug discovery programs. Its DNA analysis DNA analysis Any technique used to analyze genes and DNA. See Chromosome walking, DNA fingerprinting, Footprinting, In situ hybridization, Jeffries' probe, Jumping libraries, PCR, RFLP analysis, Southern blot hybridization. systems comprise of DNA hybridization, DNA DNA: see nucleic acid. DNA or deoxyribonucleic acid One of two types of nucleic acid (the other is RNA); a complex organic compound found in all living cells and many viruses. It is the chemical substance of genes. arrays and mass spectrometry tags. ChiroTech provides chiral chi·ral adj. Of or relating to the structural characteristic of a molecule that makes it impossible to superimpose it on its mirror image. chi·ral technology services to pharmaceutical and related industries, including Chiroscience R&D. Chiroscience financial highlights for the six months to August 31, 1998 (unaudited): -- Revenues increased to(pound)11.4 million (H1 1997:(pound)9.2 million); net loss for the period(pound)11.4 million (H1 1997: (pound)14.4 million) -- ChiroTech contributed sales of (pound)6.8 million (H1 1997: (pound)5.9 million); Chiroscience's drug discovery business contributed revenues of (pound)4.5 million (H1 1997: (pound)3.3 million). -- Investment in research and development of (pound)13.5 million (1H 1997: (pound)19.0 million). -- Current cash reserves of (pound)59 million as at September 24, 1998. Chiroscience Group plc is listed on the London Stock Exchange London Stock Exchange London marketplace for securities. It was formed in 1773 by a group of stockbrokers who had been doing business informally in local coffeehouses. and is based in Cambridge and Stevenage, UK, and Seattle, Washington, USA. Additional information on Chiroscience can be accessed on the company's home page: http://www.chiroscience.com. |
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