The Wealth of Women s Health

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1 84 years of Organon The Wealth of Women s Health Dr. Saal van Zwanenberg Organon Company Presentation history 3/27/2013 1

2 84 years of Organon 1923 The founding of Organon by Dr. Saal van Zwanenberg. President of Zwanenberg s Slachterijen en Fabrieken. Organon s first product is insulin, originally discovered in The hormone estrogen is described for the first time in the Organon laboratories Isolation and purification of gonadotropins Prolan A (Follicle Stimulating Hormone, FSH) and Prolan B (Luteinizing Hormone, LH) from pituitary glands. Organon s first own building in Oss Introduction of Pregnyl (urinary hcg collected from pregnant women) Women s Health Review R&D Feb

3 84 years of Organon 1949 Isolation and purification of heparin 1962 Organon launches its first contraceptive pill, Lyndiol. (50 µg EE/Lynestrenol) 1963 Isolation and purification of Human Menopausal Gonadotropin (hmg) from urine of menopausal women Organon split off API into independent company: Diosynth / Chefaro, OT Organon s 50th anniversary! Women s Health Review R&D Feb

4 Diagnostica

5 1923 Start van Zwanenberg, van Oss, Laqeur 1962 Immunochemische zwangerschapstest Tausk, Polderman 1963 Immunodiagnostica Schuurs 1971 Enzyme Immunoassay (EIA) Van Weemen, Schuurs 1981 Sol Particle Immunoassay (SPIA) Leuvering, Thal, Schuurs 1930 Start (Chemische Fabriek Rotterdam) 1971 Chefaro International Brons, Vorstman Receptvrije geneesmiddelen, thuis diagnostica 2000 Chefaro OMEGA Pharma 1972 Start Organon Teknika (OT) Van Dommelen, Sistermans, Spolders Nefrologie (dialyse), Apparatuur, Anesthesie, Diagnostica (Bloedbank, Klinisch Lab.) [Organon: diagnostica/huisarts] 2001 OT biómérieux

6 Women s Health at Organon 1981 Introduction of Marvelon, low-dose contraceptive pill. (followed by Mercilon 88, Gracial 92, Laurina 01) 1988 Introduction of Livial in UK/NL, HRT 1995 Diosynth begins producing recombinant Follicle Stimulating Hormone (rfsh). Pill crisis (3 rd generation progestogen s) 1996 Introduction of Puregon,Follistim rfsh 1999 Launch of Implanon, a three-year contraceptive implant. Cerazette, the first estrogen-free oral contraceptive in Europe. Women s Health Review R&D Feb

7 Women s Health at Organon 2000 Launch of Puregon Pen (Europe, US 03) Orgalutran, GnRH antagonist approved by EMEA/FDA Organon STARS in R&D (Global Venture Teams) 2002 Launch of NuvaRing in the USA once-a-month contraceptive, a flexible vaginal ring Introduction of NuvaRing in Europe and Brazil. Asenapine Org 5222 Bridion Elonva Nomac/E2 EVA technology (Nuvaring/Implanon) 2005 Follistim / Puregon in Japan and China 2006 One million children born following treatment with Puregon. Implanon receives approval in US. NuvaRing approved in Australia Phase III program for Nomac/E2 pill Phase III program for corifollitropin (long-acting FSH) Extensive Life-cycle Management EVA technology * Implanon NXT / Virtue-ring / medicated-iud Women s Health Review R&D Feb

8 Our Past 2007

9 Women s Health Portfolio 2009: LF/LO to Market Puregon pen Nuvaring TSR Implanon NXT Corifollitropin alfa Nomac/E2 (ring) Medicated IUS Oral LH ERα agonists NoSteP Oral FSH (SPRM) Comb SERM/SPRM AR agonists ERß agonist CC-kiss GPR54 Oral PTH CART FSH ago Contr. ERα antagonist AR antagonist Lead Finding projects 29 Lead Op PreClin Phase I Phase II Phase III LCM Lead Op PreClin Phase I Phase II Phase III LCM Lead Op PreClin Phase I Phase II Phase III LCM Lead Op PreClin Phase I Phase II Phase III Lead Op PreClin Phase I Phase II Phase III Lead Op PreClin Phase I Phase II Lead Op PreClin Phase I Lead Op PreClin Phase I Lead Op PreClin Phase I Lead Op PreClin Lead Op PreClin Lead Op PreClin Lead Op PreClin Lead Op Lead Op Lead Op Lead Op Lead Op Lead Op Lead Op PreClin CONFIDENTIAL Program Introductions Women s Health DC 11/11/09 9

10 Our Past

11 2013 MSD in Oss Founded in Oss in 1923 N.V. Organon Focus on Human Health Activities: MSD Development Center Oss (DCO) Manufacturing Operations API (active pharmaceutical ingredients) Manufacturing Operations Biotech (active ingredients) Manufacturing Operations Pharmaceuticals (POO; production, packaging and logistics) Global Support Functions Employees in Oss: approx. 3,100 11

12 MSD in Oss Oss Moleneind: DCO, POO, API, Biotech Oss De Geer: API en Biotech Boxtel: API/Biochemical 12

13 MSD Development Center Oss part of the MRL network

14 MSD Development Center Oss On July 1st 2011 the MSD Development Center Oss has started This is a new center for innovative development DCO is part of MSD s world-wide R&D group (Merck Research Laboratories) Approximately 400 people of the 3100 at the MSD Oss site are employed in the DCO DCO has new area s of focus but is building on historical expertise and capabilities 14

15 Development Center Oss Product development for Emerging Markets (EM) and Product Value Enhancement (PVE): Pharmaceutical development of products for EM (concept to registration and launch) New applications, formulations, routes for Merck in-line and pipe-line products (PVE) An International/Global Support Center in the MRL Development network building on existing expertise in Oss

16 One site multiple activities Labs and offices LSP MSD Development Center Oss Shared facilities 16

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