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SCIENCE, PEOPLE, AFFORDABLE MEDICINES SCIENCE, PEOPLE, AFFORDABLE MEDICINES SYNTHON.COM 2 SYNTHON IS A COMPANY COMMITTED TO DELIVERING QUALITY MEDICINES AT SUSTAINABLE PRICING THROUGH INNOVATIVE SCIENCE SCIENCE-DRIVEN INNOVATION Good health is something we all desire and deserve. We believe everyone on the planet is entitled to access to quality medicines at sustainable pricing. We will put our SCIENCE, PEOPLE, AFFORDABLE MEDICINES cutting-edge science, ability to innovate and talented people into action to provide solutions for health care challenges today and tomorrow. Innovation and continuous improvement are the heart beat of our company. We work to develop therapies that address the needs of people worldwide and help improve their health and well-being. With our portfolio of innovative products we will provide treatment options for patients in selected therapeutic areas with high unmet medical need. Through the provision of high-quality generic medicines we make treatments more affordable and increase access to important remedies. To make this happen, we hold ourselves to the highest standards of 2 SYNTHON.COM scientific and operational excellence in everything we do – from the discovery phase in R&D through production and to delivery of our products to our customers - across every technological platform. A GROWING, GLOBAL OPERATION Our products are currently approved by regulatory agencies in over 90 countries. We have globally-oriented API or drug product manufacturing facilities in the Czech Republic, SCIENCE, PEOPLE, AFFORDABLE MEDICINES Argentina and Spain. In Chile, our ultramodern multi-purpose drug product site is compliant with local and European GMP standards and contains highly advanced facilities varying from development to large-scale production of tablets, capsules and pre-filled syringes. Furthermore, our facilities in Mexico and Chile manufacture and package products for the local markets. With our state-of-the-art biopharmaceutical laboratories and GMP facilities for the manufacture of monoclonal antibodies and the production of antibody-drug conjugates (ADCs) - up to Phase III clinical trials and early launches - in our main campus in the Netherlands, our worldwide infrastructure is fully rigged up, positioning us to SYNTHON.COM deliver on our ambitions. We continue to invest and expand globally and are continually looking to find partners for our products in all major markets. Synthon’s strategy from its inception included development of a vertically integrated organization. Today, we control every facet of the development chain beginning with the production of raw materials through to the manufacture and sale of our products. This is, and has always been, one of our greatest strengths in enabling us to deliver high-quality medicines to 4 the people most in need of them. 6 SYNTHON.COM SCIENCE, PEOPLE, AFFORDABLE MEDICINES OUR STRATEGY Synthon’s ambition is to become a recognized leader in specialty pharmaceuticals. The vertically-integrated model we developed for small molecule generics is expanding as we continuously strive to improve our R&D capabilities, global regulatory and IP expertise, and world-class manufacturing and supply chain operations. And we have extended this model to our new biological and new chemical entity technological platforms. Our innovative R&D and proven ability to manufacture and distribute high-quality pharmaceuticals positions us well for our future in specialty pharmaceuticals. SCIENCE, PEOPLE, AFFORDABLE MEDICINES 8 SYNTHON.COM GROWING R&D CAPABILITIES Research and development remain vital to the overall value chain and are essential to our company. We therefore invest heavily in basic and applied research. In addition to chemical and (bio)pharmaceutical R&D, we carry out analytical and clinical research worldwide. We have our own fully-functional clinical drug development unit which is well-equipped to take our development phase compounds into clinical trials - up to and including Phase III. SCIENCE, PEOPLE, AFFORDABLE MEDICINES SYNTHON.COM 10 Small molecule generics continue to form the backbone of our product portfolio. Our generic pipeline is rich with research projects and pending regulatory applications. Recent product launches in our major markets include linezolid in Croatia and Slovakia for the treatment of serious infections caused by Gram-positive bacteria that are resistant to several antibiotics, and, following a fast approval process, aripiprazole - a product used predominantly for the treatment of schizophrenia - in Germany. In addition, we launched celecoxib - indicated for the relief of the signs and symptoms of osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, and for the management of acute pain in adults - all over Europe on expiration of the compound patent. Further we brought sevelamer carbonate tablets to the European DISTINCTIVE IN GENERICS market - for the control of serum phosphorus in patients with chronic kidney disease. In Western Europe we launched eplerenone used in the management of chronic heart failure - and zoledronic acid solution for infusion - for the treatment of men and post-menopausal women with osteoporosis or osteoporosis caused by treatment with steroids, and patients with Paget’s disease of the bone. In selected markets we launched bortezomib lyophilized powder for injections for the treatment of progressive multiple myeloma in patients who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplantation, as well as pemetrexed - used in the treatment of pleural mesothelioma and non-small cell lung cancer. 12 SYNTHON.COM SCIENCE, PEOPLE, AFFORDABLE MEDICINES PROMISING BIOPHARMACEUTICAL PIPELINE Synthon started its biopharmaceutical franchise (the development of biopharmaceutical medicines based on therapeutic proteins) in 2007. The franchise focuses on new molecular entity development. This highly-innovative business covers a wide spectrum of technologies, including complex medicinal chemistry, cell line development, bioanalytical chemistry and protein production, conjugation, purification and formulation. Our principal technology platforms include antibody-drug conjugate (ADC) technology, comprising a unique linker-drug platform to generate next generation ADC candidates. In 2014, we brought our most advanced ADC candidate SYD985 to the clinic for a two-part first-in-human Phase I study. Our portfolio of new molecular entities is well-positioned to encompass multiple clinical-stage programs in the coming years and reflects our focus and commitment to bring medicines for treating medically-complex and serious conditions to patients with a high unmet medical need, notably in oncology and autoimmune diseases. 14 SYNTHON.COM SCIENCE, PEOPLE, AFFORDABLE MEDICINES We believe in a collaborative model based upon strong partnerships with leading scientists, research institutions and marketing partners. Our strategy of developing robust business-to-business partnerships enables us to share knowledge with and draw upon the specialist skills of partner companies to manage costs, deliver short product development cycle times and bring much-needed products to market. Such has been the success of our efforts that in the past decade, the number of marketing partners has jumped from around 60 to almost 200 today. In terms of partnering our clinical innovative programs, we are in a position to choose the optimum commercial path for each program. We look to partner a technology or product candidate at an appropriate pre-market stage or value inflection point. STRENGTH THROUGH COLLABORATIVE PARTNERSHIPS SCIENCE, PEOPLE, AFFORDABLE MEDICINES 16 SYNTHON.COM INTELLECTUAL PROPERTY Intellectual property rights will remain a crucial factor in the pharmaceutical industry. We actively promote and defend our interests worldwide, particularly with regard to patent and regulatory issues. To this end, we have access to high quality legal representation and patent attorneys. By having the right legal expertise at hand, we can proactively ensure that our interests are fully protected and a seamless and effective business operation is maintained. 18 SYNTHON.COM SCIENCE, PEOPLE, AFFORDABLE MEDICINES REGULATORY AFFAIRS We provide our customers with a complete product, including all components necessary for trouble-free registration, wherever in the world. In practical terms, this means that our experts are familiar – down to the smallest detail – with increasingly stringent and ever-changing regulatory regimes in more than 90 countries. We compile registration files, compliant with the chemical, pharmaceutical and clinical requirements of regulatory authorities, such as the EMA, FDA and TGA. In cases where we out-license a biopharmaceutical before regulatory submission, our counterparts can count on detailed documentation and support that can eventually be used to build a dossier for submission. OUR PRODUCTS Our products are all high-quality, efficacious and affordable medicines, often supported by our own strong patents, guaranteeing a long product lifespan. Our global commercial generic portfolio includes* Allergy Levocetirizine Montelukast Oncology Urticaria / allergic rhinitis Asthma / allergy tab 5 mg chewable 4/5 mg; tab 10 mg Anti-infective inf bag 2 mg/ml 300 ml Anti-infective Linezolid Cardiovascular Bisoprolol Bisoprolol HCT Dobutamine Doxazosin Eplerenone Simvastatin Hypertension Hypertension Heart Failure Hypertension / BPH Heart failure / left ventricular dysfunction Hypercholesterolemia tab 5/10 mg tab 5+12.5/10+25 mg inj 12.5 mg/ml - 20 ml tab 2/4/8 mg tab 25/50 mg tab 5/10/20/40/80 mg Anastrozole Bicalutamide Bortezomib Exemestane Ibandronate Imatinib Letrozole Zoledronic acid 20 vial 4mg/5ml Osteoporosis Osteoporosis Osteoporosis tab 150 mg, pfs 3mg/3ml tab 60 mg sol 5mg/100ml Arthritis cap 100/200 mg Hypertension / BPH Chronic kidney failure BPH tab 2/4/8 mg tab 800 mg mr cap 0.4 mg, mr tab 0.4 mg tab 50 mg, vial 2mg/2ml, 6mg/6ml tab 100/400 mg tab 2.5 mg Skeletal Ibandronate Raloxifene Zoledronic acid Celecoxib Schizophrenia Schizophrenia Alzheimer Depression Sedation Depression Epilepsy Alzheimer Anesthetic / Insomnia Schizophrenia Depression Parkinson / RLS Anesthetic / Sedation Insomnia Insomnia tab 1 mg tab 50/150 mg lyo 1 mg/vial; lyo 3.5 mg/vial tab 25 mg Pain Central Nervous System Aripiprazole Clozapine Donepezil Escitalopram Flumazenil Fluvoxamine Levetiracetam Memantine Midazolam Olanzapine Paroxetine Pramipexole Propofol Zolpidem Zopiclone Breast cancer Prostate cancer Multiple myeloma Breast cancer Skeletal events related to bone metastases Chronic myeloid leukemia Breast cancer Skeletal events related to bone metastases tab 5/10/15/20/30 mg tab 25/100 mg tab 5/10 mg tab 10/15/20 mg inj 0.1 mg/ml - 5/10 ml tab 50/100 mg tab 250/500/750/1000 mg; sol 100mg/ml 150 ml, 300 ml tab 5/10/15/20 mg inj 1 mg/ml - 5ml; inj 5 mg/ml - 1/3/10ml tab 2.5/5/7.5/10 mg tab 20 mg; drops 20mg/20 drops – 20ml flask tab 0.125/0.25/0.5/1.0/1.5 mg inj 1%: 20/50/100 ml, 2%: 50ml tab 5/10 mg tab 3.75/5/7.5 mg Urology Doxazosin Sevelamer Tamsulosin * Please note that the reference date for this product list is September, 2015. Our portfolio of approved products differs from country to country. In addition to the above mentioned commercial products, Synthon owns a rich pipeline of research projects and pending regulatory applications for multiple products. 1991 _ 1993 _ 1997 _ 2014 _ Founded in The Netherlands Launched first product: generic dobutamine Opened office in North Carolina, USA New monoclonal antibody production facility established in the Netherlands _ SYNTHON.COM SCIENCE, PEOPLE, AFFORDABLE MEDICINES New plant dedicated to the manufacture of API to support our MS product line opens in Argentina 1998 _ 2000 _ 2001 _ Acquired drug product manufacturing facility in Spain Acquired API production facility in Blansko, the Czech Republic Acquired API production facility in Argentina 2003 _ 2006 _ 2007 _ Introduced simvastatin Introduced tamsulosin Acquired Laboratorios Rider in Chile Launched biopharmaceuticals business 2009 _ 2010 _ 2011 _ Opened new R&D and production unit in the Czech Republic Acquired Laboratorios Nafar in Mexico Opening new biopharmaceutical lab in Nijmegen, The Netherlands _ Opened office in Moscow, Russia 2012 _ Multi-purpose GMP drug product manufacturing facility in Chile in business _ Inauguration of R&D pilot plant in Argentina 22 _ _ Opened office in South Korea _ Licensed biosimilar trastuzumab to Amgen/Watson (now Amgen/Actavis) _ Acquired Syntarga in The Netherlands 2013 _ New antibody-drug conjugation (ADC) facility with high-potent clean room suite and cutting edge QC laboratories operational _ New facility for linker-drug production opens in Blansko, Czech Republic LEADERSHIP BY EXAMPLE Synthon was founded in 1991, and within two years its creative vision and passion for making healthcare more affordable led to the development of dobutamine, a sympathomimetic drug used in the treatment of heart failure and cardiogenic shock. The success of this first product out of the blocks led to rapid international growth. Synthon grew over the course of its first decade from a small Nijmegen-based outfit employing less than a hundred people into a fully-fledged specialty pharma company with laboratories, offices and production plants all around the world. A headcount of more than 1,500 highly educated people around the world, strong profits and a sound financial foundation are the core ingredients to successfully delivering what we do best: affordable medicines to those in need. This would not have been possible without the right combination of technical expertise, business discipline and entrepreneurial capability at every level of management. 24 SYNTHON.COM SCIENCE, PEOPLE, AFFORDABLE MEDICINES A CORE OF TALENTED PEOPLE Our success stands or falls with the quality of our people. Our company is our people. We aren´t just content to bring together a group of talented scientists. We openly seek people who share the same values and are both entrepreneurial in attitude and able to work selflessly as part of a team for the good of our company and our ambitious goals. People with the drive to contribute to the creation of new and effective medicines. We keep the pride and satisfaction of our highly committed group of colleagues at the center while building our company. Together we will continue our work to unlock our opportunities and bring important medicines – irrespective of whether they are complex generics or new molecular entities – to our ultimate focal point: the patient. SCIENCE, PEOPLE, AFFORDABLE MEDICINES GLOBAL PRESENCE Nijmegen, The Netherlands Synthon Headquarters Barcelona, Spain Synthon Hispania Blansko, Czech Republic Synthon s.r.o. Durham, NC, United States of America Synthon Pharmaceuticals, Inc. San Lorenzo, Argentina Synthon Argentina S.A. Santiago, Chile Laboratorios Rider Ltda Guadalajara, Mexico Laboratorios Nafar Moscow, Russia Synthon LLC 26 SYNTHON.COM Seoul, South Korea Synthon Korea Co. Ltd. CONTACT Would you like to learn more about Synthon? Please visit www.synthon.com If you are interested in our product portfolio, please feel free to contact us. SCIENCE, PEOPLE, AFFORDABLE MEDICINES Business Development Generics [email protected] (+31) 24 37 27 700 Business Development Biopharmaceuticals [email protected] (+31) 24 37 27 700 If you would like to know more about job opportunities, please visit www.synthon.com and click on Careers. Editorial coordination Synthon Holding BV Corporate Communications Nijmegen, The Netherlands SYNTHON.COM Design Zuiderlicht Maastricht, The Netherlands Printing Drukkerij Tesink Zutphen, The Netherlands September 2015 © Synthon Holding BV 28 www.synthon.com Disclaimer Copyright © 2015 Synthon Holding BV. All rights reserved. Reproduction of the content in other publications is permitted. However, credit to Synthon would be appreciated. This brochure contains information on pharmaceutical products and has been composed for healthcare professionals. It has been composed with the greatest possible care. It may however contain inconsistencies and for that reason it cannot be relied upon. Synthon is not liable for any consequences as a result of the reliance on any information contained in this brochure.