NME/NAS launches in 2005/6 APRIL 2007 SOURCE: CMR INTERNATIONAL PERFORMANCE METRICS PROGRAM © THOMSON REUTERS Your use of these materials is subject to the terms and conditions hereof. Please read the disclaimer carefully before using these materials.

Profile of New Launches Chapter 2 Profile of New Launches Figure 2.1 NME/NAS launches in 2005/6 Key message In 2006, 25 NMEs and 29 NASs (including NMEs) were launched. Though this represents an increase in launches in 2005-2006 in comparison to the twenty-year low in 2004, it is well below the numbers launched earlier in the decade and in the late 1990s. Methodology To compile this analysis, annual surveys of the global pharmaceutical industry were undertaken to identify all new molecular entities launched for the first time anywhere in the world. Key Definitions New Molecular Entity (NME): A new chemical entity or biological (including products of biotechnology) that has not been previously available for therapeutic use in man and are destined to be made available as a ‘prescription only medicine’, to be used for the cure, alleviation, treatment, prevention or in vivo diagnosis of diseases in man. Vaccines, new salts, pro drugs, metabolites and esters of existing compounds and certain biological compounds (e.g. antigens) are not classified as NMEs. Combination products are excluded from the list unless one or more of the constituents of the combination product has never been previously available. New Active Substance (NAS): The active ingredient that is intended to furnish pharmacological activity or other direct effect to a pharmaceutical product. This may be a chemical, biological, biotech or radiopharmaceutical substance that is or is destined to be made available as a 'prescription only medicine', to be used for the cure, alleviation, treatment, prevention or in vivo diagnosis of diseases in humans. The term also includes: an isomer, mixture of isomers, a complex or derivative or salt of a chemical substance previously available as a medicinal product but differing in properties with regard to safety and efficacy from that chemical substance previously available; a biological or biotech substance previously available as a medicinal product, but differing in molecular structure, nature of source material or manufacturing process and which will require clinical investigation; a radiopharmaceutical substance that is a radionuclide or a ligand not previously available as a medicinal product. Alternatively, the coupling mechanism linking the molecule and the radionuclide has not been previously available. CMR International Performance Metrics Programme / Source Annual Survey of New Molecular Entity First Launches / New Medicine Launches 2006. A complete guide to New Molecular Entities (NMEs) launched world-wide. SOURCE: CMR INTERNATIONAL PERFORMANCE METRICS PROGRAM © THOMSON REUTERS

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