Annual Report 2014 Delivering Growth
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R&D Update Call 2020
R&D Update Call 2020 Luciano Rossetti, Global Head of Research & Development Rehan Verjee, Head of the Global Innovative Medicine Franchises & President of EMD Serono Joern-Peter Halle, Head of Research Klaus Edvardsen, Head of Oncology Development September 25, 2020 Disclaimer Publication of Merck KGaA, Darmstadt, Germany. In the United States and Canada the group of companies affiliated with Merck KGaA, Darmstadt, Germany operates under individual business names (EMD Serono, Millipore Sigma, EMD Performance Materials). To reflect such fact and to avoid any misconceptions of the reader of the publication certain logos, terms and business descriptions of the publication have been substituted or additional descriptions have been added. This version of the publication, therefore, slightly deviates from the otherwise identical version of the publication provided outside the United States and Canada. 2 Disclaimer Cautionary Note Regarding Forward-Looking Statements and financial indicators This communication may include “forward-looking statements.” Statements that include words such as “anticipate,” “expect,” “should,” “would,” “intend,” “plan,” “project,” “seek,” “believe,” “will,” and other words of similar meaning in connection with future events or future operating or financial performance are often used to identify forward-looking statements. All statements in this communication, other than those relating to historical information or current conditions, are forward-looking statements. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements in the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to a number of risks and uncertainties, many of which are beyond control of Merck KGaA, Darmstadt, Germany, which could cause actual results to differ materially from such statements. -
Certificate ISO 14001 From
CERTIFICATE This is to certify that Merck KGaA Frankfurter Strasse 250 64293 Darmstadt Germany with the organizational units/sites as listed in the annex has implemented and maintains an Environmental Management System. Scope: Development, production and distribution of pharmaceuticals, chemical products and analytical systems. Through an audit, documented in a report, it was verified that the management system fulfills the requirements of the following standard: ISO 14001 : 2015 Certificate registration no. 005356 UM15 Valid from 2020-12-17 Valid until 2023-12-16 Date of certification 2020-11-18 DQS GmbH Markus Bleher Managing Director Accredited Body: DQS GmbH, August-Schanz-Straße 21, 60433 Frankfurt am Main, Germany 1 / 19 Annex to certificate Registration No. 005356 UM15 Merck KGaA Frankfurter Strasse 250 64293 Darmstadt Germany Location Scope 005356 Development, production and distribution of Merck KGaA pharmaceuticals, chemical products and Frankfurter Straße 250 analytical systems. 64293 Darmstadt Including: Real Estate GmbH Merck Performance Materials Germany GmbH Merck Healthcare KGaA With regional offices at: Roesslerstrasse 96 64293 Darmstadt Waldstrasse 3 64331 Weiterstadt 450237 Merck S.A. Production and distribution of pharmaceuticals Estrada dos Bandeirantes, 1099 and chemical products. Rio de Janeiro - RJ 22710-571 Brazil 450240 Merck Serono SA Production and distribution of Zone Industrielle de l´Ouriettaz pharmaceuticals. 1170 Aubonne Switzerland 450325 Merck Serono SA Development and production of Corsier-sur-Vevey pharmaceuticals. Rte de Fenil 25 1804 Fenil-sur-Vevey Switzerland This annex (edition: 2020-11-18) is only valid in connection with the above-mentioned certificate. 2 / 19 Annex to certificate Registration No. 005356 UM15 Merck KGaA Frankfurter Strasse 250 64293 Darmstadt Germany Location Scope 450241 Merck & Cie Production of chemical products. -
Low Discontinuation Rate and Side-Effect Burden After Switching to Cladribine Tablets: Canadian Experience from the Advevatm Patient Support Program
Low discontinuation rate and side-effect burden after switching to cladribine tablets: Canadian experience from the advevaTM patient support program Jiwon Oh1, Paul Giacomini2, Virginia Devonshire3, Fraser Clift4, Caroline Lemieux5, Meritxell Sabidó6, Arthur Allignol6, Mark S. Freedman7 1Division of Neurology, Department of Medicine, St Michael's Hospital, University of Toronto, Toronto, ON, Canada. 2Department of Neurology, Montreal Neurological Institute, McGill University, Montreal, QC, Canada. 3Division of Neurology, Department of Medicine, University of British Columbia MS/NMO Center, Vancouver, BC, Canada. 4Department of Neurology, Memorial University of Newfoundland, St. John's, Newfoundland and Labrador, Canada. 5EMD Inc., Mississauga, Canada; a business of Merck KGaA, Darmstadt, Germany. 6Global Epidemiology Department, Merck KGaA, Darmstadt, Germany. 7Department of Medicine, Division of Neurology, Ottawa Hospital Research Institute, University of Ottawa, Ottawa, ON, Canada. ACTRIMS-ECTRIMS 2020 Virtual Congress | 11-13 September DISCLOSURES This study was sponsored by EMD Inc., Canada (a business of Merck KGaA, Darmstadt, Germany), who reviewed and provided feedback on the poster. The authors had full control of the poster, and provided their final approval of all content Jiwon Oh has received research support from Biogen-Idec, Roche, and EMD Serono and has received personal compensation for consulting from EMD Serono, Sanofi-Genzyme, Biogen-Idec, Roche, Celgene, and Novartis Paul Giacomini has received research or educational -
Adding Cetuximab to Paclitaxel and Carboplatin for First-Line
www.nature.com/bjc ARTICLE Clinical Study Adding cetuximab to paclitaxel and carboplatin for first-line treatment of carcinoma of unknown primary (CUP): results of the Phase 2 AIO trial PACET-CUP Gunnar Folprecht1, Karolin Trautmann1, Alexander Stein2, Gerdt Huebner3, Michael Stahl4, Stefan Kasper5, Albrecht Kretzschmar6, Claus-Henning Köhne7, Viktor Grünwald 8,9, Ralf-Dieter Hofheinz10, Katharina Schütte1, Harald Löffler11, Carsten Bokemeyer2, Alwin Krämer12 and Arbeitsgemeinschaft Internistische Onkologie (AIO) - CUP Group BACKGROUND: Patients with carcinoma of unknown primary (CUP) have a dismal prognosis, even when treated with multi-agent chemotherapy. We hypothesised that adding the epidermal growth-factor receptor (EGFR) inhibitor cetuximab to standard first-line chemotherapy with paclitaxel and carboplatin would improve PFS and RR in unfavourable CUP. METHODS: This open-labelled, multicentre Phase 2 study included patients with unfavourable, untreated adeno- or undifferentiated CUP. Patients were randomised to receive either paclitaxel/carboplatin (group A) or paclitaxel/carboplatin plus cetuximab (group B) every 3 weeks for a maximum of 6 cycles followed by cetuximab maintenance in group B. The primary endpoint was PFS in the two groups. Secondary endpoints were RR, toxicity and overall survival (OS). RESULTS: One-hundred-and-fifty patients were randomised (group A = 72, group B = 78). The median PFS and OS for all patients were 3.8 and 8.1 months (95% confidence interval (CI): 2.9–4.8 and 6.8–9.5). There was no significant difference in PFS (3.7 vs 4.6 months, HR 0.98) or OS (8.1 vs 7.4, HR 1.1) between the two treatment groups. -
Geschäftsbericht 2017
350 Geschäftsbericht 2017 1668 Auszug aus dem „Apotheken-Privileg“ des Landesherren für den Unternehmensgründer FRIEDRICH JACOB MERCK: „ [Er soll die Apotheke] der ordnung gemeess mit guten frischen, zu ein= und anderen Curen dienlichen heil- samen Medicamentis und wahren also genugsamlich versehen, und damit fort und fort würklich continuiren, daß kein Mangel erscheine.“ 2018 STEFAN OSCHMANN Vorsitzender der Geschäftsleitung und CEO von Merck „ Wissenschaftliche Neu- gierde treibt uns seit 350 Jahren an. Durch sie wurden wir Techno logie- Pioniere. Und jetzt gestalten wir die digi tale Revolution mit.“ DIE ZUKUNFT SPRICHT SIMON CLARK sechs Jungforscherinnen und -forscher promoviert im Bereich Atmosphä- rische Physik an der University of Exeter. Auch in seinen YouTube- Videos geht es vor allem um physi- kalische Themen. „ Die Dinge verbessern sich nur, wenn es Leute gibt, die ver- rückte Ideen haben und etwas Neues ausprobieren.“ Treibt Merck frische Ideen voran? Die Antwort finden Sie auf Seite 10. SAMUEL CUNHA ist ein brasilianischer Parasitologe, der seine Leidenschaft für Biologie mit vielen Fans auf YouTube teilt. „ Um leidenschaftlich zu bleiben, muss man immer an die Zukunft denken, an das mögliche Ergebnis seiner Arbeit.“ Wie hält es Merck mit diesem Grundsatz? Die Antwort lesen Sie auf Seite 11. EVA AMSEN ist promovierte Biochemikerin, Autorin und Wissenschaftsvermittlerin in London. „ Für Wissen- schaftler ist es wichtig, dass sie sich nicht nur mit ihren Kollegen austauschen, sondern auch mit Menschen aus völlig anderen Bereichen – zum Bei- spiel mit Künstlern.“ Wird interdisziplinärer Austausch bei Merck gelebt? Die Antwort lesen Sie auf Seite 13. INÉS DAWSON ist promovierte Biologin in Oxford und beliebte YouTuberin. „ Forschung und Kreativität sollten Hand in Hand gehen, da nicht alle Probleme eine eindeutige Lösung haben.“ Fördert Merck Kreativität? Die Antwort finden Sie auf Seite 14. -
Serono and Amgen Sign License Agreement for Multiple Sclerosis Product
Serono And Amgen Sign License Agreement For Multiple Sclerosis Product November 13, 2002 FOR IMMEDIATE RELEASE THOUSAND OAKS, California, USA and GENEVA, SWITZERLAND - November 13, 2002 - Amgen Inc. (NASDAQ:AMGN) and Serono S.A. (virt-x: SEO and NYSE: SRA). Amgen and Serono announced today that they have signed a license and commercialization agreement by which Serono will sell the marketed drug Novantrone® (mitoxantrone for injection concentrate) in the United States. Novantrone is approved by the FDA in the United States for secondary progressive, progressive relapsing and worsening relapsing-remitting multiple sclerosis, as well as for certain forms of cancer in the United States. The terms were undisclosed. Novantrone was acquired by Amgen in connection with Amgen's acquisition of Immunex Corporation in July 2002. The drug was approved by the FDA for MS indications in October, 2000, and had U.S. sales of $71 million last year. It has also been approved for certain oncology indications since 1987. Full prescribing information for Novantrone can be obtained by visiting www.novantrone.com. Closing of the transaction is subject to review and clearance by U.S. regulatory authorities. Amgen is a global biotechnology company that discovers, develops, manufactures and markets important human therapeutics based on advances in cellular and molecular biology. Serono is a global biotechnology leader with six recombinant products on the market, Gonal-F®, Luveris®, Ovidrel®/Ovitrelle®, Rebif®, Serostim® and Saizen® (somatropin). (Luveris® is not approved in the USA). This news release contains forward-looking statements that involve significant risks and uncertainties, including the possibility that the license transaction will not close or that the companies may be required to modify aspects of the transaction to achieve regulatory approval, and other risks and uncertainties including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including its most recent Form 10-Q. -
Rationale and Design of Classic-MS Study
Rationale and Design of Classic-MS METHODS Study Evaluating Long-Term Efficacy for • Following pre-baseline screening and assessment for eligibility, long-term Table 2. CLASSIC-MS Schedule of Data Collection Patients with Multiple Sclerosis Treated retrospective data will be obtained from medical records at Study Visit 1; prospective data will be collected at Study Visits 1 and 2. Assessments & Procedures Screening Study Visit 1* Study Visit 2† with Cladribine Tablets • Patients will be enrolled during 17 months between Q3 2019–Q4 2020. Informed consent X • The last Patient Last Visit is expected in Q1 2021. 1 2 3 4 5 6,7 8 9 A. Boyko , J. Correale , G. Edan , M.S. Freedman , G. Giovannoni , X. Montalban , K. Rammohan , T. Leist , Inclusion and exclusion 10 11 12 13 12 GET POSTER PDF X D. Stefoski ,B. Yamout , B. Garcia-Alonso , A. Aydemir , E. Verdun Di Cantogno , on behalf of the CLASSIC-MS Copies of this poster obtained criteria Study Group through QR (Quick Response) code Figure 1. CLASSIC-MS Study Visit and Data Collection Sociodemographic and are for personal use only and may X clinical characteristics 1Pirogov Russian National Research Medical University, Moscow, Russia; 2FLENI Institute, Buenos Aires, Argentina; 3Department of not be reproduced without written 4 permission of the authors Neurology, University Hospital of Rennes, France; University of Ottawa and the Ottawa Hospital Research Institute, Ottawa, ON, Key: Prospective Data Collection Canada; 5Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK; 6Division of Neurology, St Michael’s Hospital, University of Toronto, Toronto, ON, Canada; 7Department of Neurology-Neuroimmunology, Prospective data collected atas StudyStudy VisiVisitt Physical examination X 8 Centre d’Esclerosi Múltiple de Catalunya (Cemcat), Hospital Universitario Vall d’Hebron, Barcelona, Spain; University of Miami School Retrospective data obtained from medical chart review and/or in-house study databases. -
Expert Opinion on the Use of Cladribine Tablets in Clinical Practice
Expert Opinion on the Use of Cladribine METHODS • The consensus program was based on a multi-step modified Delphi • A comprehensive literature review was performed for each question. The Tablets in Clinical Practice methodology, which took place between April 2018 and April 2019. level of evidence was assessed and agreed by the SC.4 • A Steering Committee (SC) of nine international MS experts led the program. • A questionnaire was developed by the SC with draft answers based on The SC in turn was supported by an extended faculty (EF, n=33) of practicing available evidence from the literature review, combined with their expert P. Soelberg Sørensen1, D. Centonze2, G. Giovannoni3, X. Montalban4,5, D. Selchen5, P. Vermersch6, H. Wiendl7, B. Yamout8, neurologists caring for MS patients. A total of 19 countries were represented opinion, where evidence was lacking. The questionnaire was completed H. Salloukh9, P. Rieckmann10 in the program. The role of the EF was to review available evidence, remotely via an on-line platform by the EF. complete a questionnaire and finally vote on draft recommendations. 1Danish Multiple Sclerosis Center, Department of Neurology, University of Copenhagen and Rigshospitalet, Copenhagen, Denmark; 2Unit of GET POSTER PDF • The results from the questionnaire were incorporated into draft clinical Neurology and Neurorehabilitation, IRCCS Neuromed, Pozzilli (IS), Italy; 3Blizard Institute, Barts and The London School of Medicine and Dentistry, Copies of this poster obtained • The SC identified practical clinical questions concerning the use of cladribine recommendations, which were then voted on by the SC and EF members. 4 Queen Mary University of London, London, UK; Department of Neurology, Neuroimmunology, Multiple Sclerosis Centre of Catalonia (Cemcat), Vall through QR (Quick Response) tablets and prioritized the most important 11 questions to be addressed, d’Hebron University Hospital, Barcelona, Spain; 5University of Toronto, Division of Neurology, St. -
Merck Serono the Biopharma Division of Merck
Merck Serono The Biopharma Division of Merck September 16, 2014 Merck Our aspiration is to make great things happen Merck is the oldest pharmaceutical and chemical company in the world founded in 1668 in Darmstadt, Germany Merck is a publicly listed company on the DAX at the Frankfurt Stock exchange. The Merck family holds 70% of the shares Total Revenues : €11 billion in 2013 EBITDA Pre : €3.25 billion Around 38,000 employees in 66 countries 2 Our History Merck was founded by Friedrich Jacob Merck (1621-1678) when he acquired the Angel Pharmacy (Engel-Apotheke) in 1668 Heinrich Emanuel Merck (1794–1855) begins production on an industrial scale Merck and the US pharmaceutical company Merck, Sharp & Dohme have been two independent companies since 1917. Today, we are Merck worldwide (except for Canada and the US where we are known as EMD). 3 Our Corporate Structure Merck Group Merck Consumer Performance Merck Serono Health Materials Millipore • Oncology • Everyday health • Liquid Crystals • BioScience • ImmunoOncology protection • Pigments • Lab Solutions • Immunology/NDD • Women‘s and & Cosmetics • Process Solutions • Fertility children‘s health • Endocrinology & • Cough and cold General Medicine Biosimilars Allergopharma Pharma Business Merck Serono at a Glance We operate under the Group: Largest division of Merck name EMD Serono in Established: January 5, 2007 North America Business: Biopharmaceuticals Employees: ~15,000 Total Revenues: €6.3 billion in 2013 Headquarters: Darmstadt, Germany Global reach: Products commercialized in 150 -
Mitoxantrone in Multiple Sclerosis: 1- MEDLINE and 2- Cochrane Library
SHOULD THE MUHC USE MITOXANTRONE IN THE TREATMENT OF MULTIPLE SCLEROSIS? A Technology Assessment By The Technology Assessment Unit (TAU) of the McGill University Health Centre (MUHC) Dec 2, 2002. 1 This analysis was prepared for the Technology Assessment Unit (TAU) of the McGill University Health Centre (MUHC) by Chantal Bourgault PhD, Medical Scientist of the TAU. and Maurice McGregor MD, Cardiology Division, MUHC. and approved and adopted by the committee of the TAU: J. Barkun, W. Brodie, J. Brophy, J. Johnston, M. Kaplow, J. MacPhail, G. Pekeles, R. Rajan, J. Ritchie, F. Salevsky, S. Suissa, M. McGregor. With the additional members: J. Antel, D.Arnold, A.Bar-Or, J.Chambers-Evans, Y.Lapierre and A. Lynch. Acknowledgments The expert assistance of the following individuals is gratefully acknowledged: Consultants: Yves Lapierre MD. Head, Multiple Sclerosis Clinic, Montreal Neurological Hospital of the MUHC. John Penrod PhD. Centre for the Analysis of Cost Effective Care, MUHC. Reviewers: Jack Antel MD. Coordinator, MS Programme, Montreal Neurological Institute, MUHC. Amit Bar-Or MD. Neurologist, MS Clinic, Montreal Neurological Institute, MUHC. Douglas Arnold MD. Neurologist, MS Clinic, Montreal Neurological Institute, MUHC. J. Chambers-Evans. Chair, Adult Clinic Ethics Committee, MUHC. Information Sources: Ms Linda Maruska. Department of Quality Management, MUHC. (Cost Data) Mr Gilles Gaudet. Department of Finance, MUHC. (Cost Data). Mr Andre Bonnici. Coordinator, Pharmacy and Therapeutics Ctee, MUHC.(Cost Data). Ms Diane Lowden. Clinical Nurse Specialist, MS. Programme. (MS Clinic Data). 2 Invitation. This document was designed to assist decision-making in the McGill University Health Centre. Others are welcome to make use of it, preferably with acknowledgment. -
'No Free Lunch'
11-12/2013 December Markets and Companies Information Technology The Middle East and China THE NEWSPAPER FOR THE Adaptability is more important are catching up to the than ever as the fourth industrial chemical-producing West. CHEMICAL AND revolution takes off. Page 5 LIFE SCIENCE MARKETS Page 9 N EWSFLOW Markets and Companies: ‘No Free Lunch’ Merck KGaA offers £1.6 billion for AZ Materials. Bjørn Lomborg on the Give and Take in Greenhouse Gas Reduction Allessa to cut a third of its work- force. New Thinking – Bjørn Lomborg plants over a 10-year period, be- tray the fact that there is no sense might not be a household name in DuPont says it will spin off its Per- of economic reality. We are not the chemical industry, but the mention formance Chemicals unit. going to cut carbon emissions sig- of his name in environmental activist nificantly, as long as it is very, very costly.” EU Commissioner demands unified circles seems to provoke one of two framework for shale gas in Europe. reactions: adoration or distain. Lom- Lomborg On The Energy Transition borg, a Danish academic who rose to China is looking for new targets for The 2011 Fukushima disaster its abundant fuel. notoriety in 2001 with his controversial rocked many countries using nu- book “The Skeptical Environmentalist,” clear power to the core; it seemed Dow gears up to sell its Chlor-Alkali that no one was more chilled than can be found on a handful of top 50 or and Epoxy units. German Chancellor Angela Merkel top 100 lists for the world’s top intel- and her reigning party of Christian More on Pages 2-8 ▶ Democrats. -
MERCK Kgaa DARMSTADT, GERMANY
MERCK KGaA DARMSTADT, GERMANY Annual Financial Statements 2016 DISCLAIMER Publication of Merck KGaA, Darmstadt, Germany. In the United States and Canada the subsidiaries of Merck KGaA, Darmstadt, Germany, operate as EMD Serono in Healthcare, MilliporeSig- ma in Life Science and EMD Performance Materials. To reflect such fact and to avoid any misconception of the reader of the publication certain logos, terms and names of businesses of the publication have been substituted or additional descriptions have been added. This version of the publication, therefore, slightly deviates from the otherwise identical version of the publication provided outside the United States and Canada. For nearly 350 years, curious people at our company have been bringing ideas to life. As a global science and technology company, a passion for research and discovery is our most valuable resource. With our three business sectors, namely Healthcare, Life Science and Performance Materials, we improve the quality of life of patients, in- crease the success of our customers, and offer solutions for diverse challenges. Curiosity is and remains our strongest driving force for future-oriented innovations. Annual Financial Statements 3 Combined Management Annual Financial Statements Report 112 – 158 03 – 110 112 Balance Sheet as of December 31, 2016 113 Income Statement from the period 003 Fundamental Information about the Group from January 1 to December 31, 2016 003 The Group 114 Notes to the Annual Financial Statements 010 Objectives and strategies 115 Notes to the Balance Sheet 016 Internal Management System 125 Notes to the Income Statement 020 Corporate Responsibility 129 Other Disclosures 028 Research and development 132 Members of the Executive Board of Merck KGaA, 040 People Darmstadt, Germany 133 Supervisory Board 046 Report on Economic Position 134 Disclosures in accordance with section 160 (1) no.