DSM Sinochem Pharmaceuticals

Transcription

1 DSM Sinochem Pharmaceuticals 140 years of innovation February 2015 Cover photo: daisy in gras, istock

2 Safe Harbor Statement Although diligent care has been used to ensure that the information provided herein is accurate, nothing contained herein can be construed to imply any representation or warranty as to the accuracy, currency or completeness of this information nor can it be construed to imply any other representation or warranty of any kind, including the implied warranties of merchantability, fitness for a particular purpose or non-infringement. DSP has no obligation to update the statements contained in this presentation, unless required by law. The content of this document is subject to change without further notice. Product offers are explicitly not made in respect of those jurisdictions where valid third party patent rights related to such products are in force. In such jurisdictions the advertised products are only offered for regulatory purposes insofar allowed under local provisions like the Bolar provisions in the US and 2004/27/EC in Europe. The English language version of this document is leading. Page 1

3 OUR WORLD

4 Our world is changing fast With over 7 billion people living on our planet and life expectancies on the rise there is a greater need than ever to fight illness and battle infections. Quality medications are essential. Responsible and sustainable production of these is vital for our and future generations quality of life. Quality, Reliability and Sustainability become ever more important! DSM Sinochem Pharmaceuticals helps customers and marketing partners to successfully navigate this dynamic landscape by providing high quality, compliant and sustainable solutions that help you stay ahead of the competition. Page 3

5 OUR COMPANY

6 Leading the way: 140 years of innovation Our history 1869 The company is founded as the Nederlandsche Gist- en Spiritusfabriek First Dutch company to found a workers council s 1990s 1998 Production of Penicillin G starts (initially under the code name BACINOL). SSP s and SSC s follow soon. Rise to become the world s no.1 Penicillin G producer as Gist-Brocades. Global expansion of the production and sales network through acquisitions and JV s. DSM acquires Gist-brocades. The newly formed leader in beta-lactam antibiotics is called DSM Anti-Infectives (DAI) Purimox is introduced to the world. It is the first enzymatically produced Amoxicillin. Purimox is the first member of the DSMPureActives family of enzymatically produced green Antibiotic APIs Opening of the Zor-F, the worlds only enzymatic, direct-route 7-ADCA plant Global roll-out of enzymatic technology for beta-lactam APIs to all sites In a Joint Venture Sinochem of China acquires 50% of DAI from DSM to form DSM Sinochem Pharmaceuticals First enzymatically produced statin (Atorvastatin from DSP) introduced to the world Forward integration into the value chain by developing drug products (finished dosage formulations). Opening of new enzymatic multi-product plant for the research, development and production of new SSCs using proprietary biotechnology in China. Page 5

7 Antibiotic pioneers - code name BACINOL Innovation is in our genes: in the 1940s DSP pioneered industrial antibiotic production When the Netherlands were occupied during World War II, a team at Nederlandsche Gist-en Spiritusfabriek (today DSM Sinochem Pharmaceuticals) secretly isolated, characterized, and produced penicillin - working under the code name BACINOL. This secret 18-month project, which was completely independent of the acclaimed American and British efforts to produce penicillin, was conducted under far more challenging circumstances, without access to the scientific literature, corroborating data, and much in the way of valuable fermentation equipment. Penicillin cultures in milk bottles from the 1940s Page 6

8 DSM Sinochem Pharmaceuticals Who we are We are the global frontrunner in enzymatically produced green beta-lactam antibiotics and next generation statins. We combine our unique skills in fermentation and bio-catalysis to provide high quality products based on our fully vertically integrated global manufacturing and distribution capabilities. Our quality standards and our unique technology platform allows us to provide our customers and marketing partners with life-saving medicines in a sustainable and responsible way. Founded in 1869 and today headquartered in Singapore, we have operations in China, India, Egypt, the Netherlands, Spain the US and Mexico and are a 50/50 Joint Venture of DSM and Sinochem. We are here to make a difference keeping our customers ahead of the competition with top quality products and services and the highest standards of quality, reliability and sustainability. Page 7

9 Our parent companies at a glance Sinochem is a global Fortune 500 company and one of China s key state owned enterprises. DSM is a global science-based company active in health, nutrition and materials. 40,000 employees USD 50 billion turnover Several listed subsidiaries Industries Energy Agriculture Chemicals Real Estate Finance 22,000 employees EUR 9 billion turnover Listed at Euronext Industries Life Sciences Materials Sciences Page 8

10 DSM Sinochem Pharmaceuticals Our Mission Our purpose is to provide high quality and reliable products for people in need of healthcare. We do this by continuously exploring innovative technologies that positively impact patient care and care for the environment. Creating high quality life-saving solutions is at the very heart of what we do We began innovating 140 years ago and have led the way ever since. DSP looks back at over 140 years of innovation, from fermentation and microbiology in the late 1800s, over penicillin production development in the 1940s, the enzymatic revolution in antibiotic production in the 2000s to new state-of-the-art formulations for generic pharmaceuticals today. By continuously exploring and mastering new (bio)technologies we deliver products that exceed customers expectations and positively impact patient care. Page 9

11 Our Promise: Peace of Mind It summarizes what we stand for: Quality Reliability - Sustainability We produce nearly all our APIs using our unique enzymatic biotechnology. We constantly strive for excellence and for innovation and have set new industry standards in quality and sustainability for all our products; leading the way by producing Sustainable Antibiotics and solutions with drastically lower environmental footprints compared to similar medicines. Our medicines offer the highest QUALITY in the market. Our global footprint and strong track record in RELIABILITY makes us a supplier you can trust. We believe SUSTAINABILITY is a must! For us it as a key business driver. Page 10

12 Company overview Our market position We are the leading manufacturer of green, enzymatically produced beta-lactam antibiotics and next generation statins. To better serve our customers needs we are expanding our API portfolio and our ability to offer our products as Drug Products (finished dosage formulations) in selected markets. Our markets We have a strong track record in regulated markets in the western economies but also have a strong focus and local production sites in the rapidly growing markets in Asia and Latin America. Our customers We cater to leading global pharmaceutical companies, as well as to leading regional pharmaceutical companies on all continents. Page 11

13 Our organization: global and local Think global Our global corporate staff supports our strong regional units. This unique setup allows us to keep a birds eye perspective, act on a global level and constantly improve our products and services. Act local Four regional units and two global units for Drug Products and new API are the cornerstones of our customer relations. Together they span the entire globe. Individually they are close to you, our customer. Headquarters Singapore Asia Middle East Africa Gurgaon, India China Beijing, China Europe America Delft, NL Mexico Latin America Ramos Arizpe, Mexico Drug Products Global New APIs Global regional global Page 12

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15 Sustainability: our core value and To us, achieving sustainability means simultaneously pursuing economic performance, environmental quality and social responsibility. In other words, creating value on the three dimensions of People, Planet and Profit. P P P People We treat our people and the people we influence with respect to positively impact their lives. Great people are our biggest asset. Planet We believe that caring for the planet is a moral obligation and a necessity. We also believe it provides unique business opportunities and success not only for ourselves but for society at large. Profit We need to earn sustainable financial results to enable profitable growth for our company today and in the future and that address the interests of our shareholders. Page 14

16 a key business driver for DSP Based on a strong technology position P P P People: patient safety and wellness Pure, safe and compliant medicines that ensure patient safety and wellness. Reduced toxicity of active ingredient, due to absence of almost all chemicals and solvents in our products. Odorless and better taste due to the absence of residual solvents. Planet: environmentally friendly Up to 64% reduction of CO2 emissions Up to 70% reduction of energy consumption Up to 100% reduction of emissions to air (elimination of VOCs) Profit: highest efficiencies for formulators Higher yield due to higher purity (less overages required, longer retest period) Improved machine efficiency due to better flowablility Very large batch size resulting in less testing and administration at QC departments Relief of registration efforts due to minimal impurities Guaranteed activity of active substance over shelf life *all savings based on LCAs and the DSP Sustainability Review 2013 Page 15

17 OUR API SOLUTIONS 16

18 Our APIs solutions mean one thing for you: Peace of Mind Peace of Mind Superior product quality throughout our portfolio. Full traceability of our entire supply chain. Reliable, long-term partners for the sourcing of key raw materials. The best technology and quality We are the inventor of industrial enzymatic APIs production and make the highest quality product available*. Nearly 500 patents guard our innovations in the area of eco-friendly (bio)technology and production process for our high quality, sustainable antibiotics and statins API. Reliable regulatory and after sales service Mastering the ever stricter regulatory environment can be challenging. Our dedicated regulatory affairs and technical after sales service teams around the globe are there to help you navigate these challenging waters. Close to you, close to your business. *based on Purimox compared to next best alternative Page 17

19 Advanced and sustainable (bio)technology for your benefit Traditional pharmaceutical and in particular antibiotic production is associated with a substantial negative impact on our environment. By integrating biology and chemistry into a cutting-edge enzymatic process we have developed the most eco-friendly production process available and set new industry standards in quality and sustainability. Enzymatic technology for antibiotics Our green beta-lactam antibiotics are made through natural fermentation and enzymatic conversion ensuring the absence of almost all chemicals thereby significantly reducing the toxicity of the active ingredients. Enzymatic technology for statins We have extended our enzymatic technology to our statins. We use an innovative, fully backward integrated enzymatic process, protected by several patents. This allows us to manufacture superior statins with higher purity, increased efficacy and without using hazardous chemicals. Freedom To Operate We have Freedom To Operate (FTO) for all the markets where we offer our unique products. You benefit from our successful track record and experience in the dynamic regulatory affairs field, resulting in Peace of Mind for you. Page 18

20 Strong regulatory support and after sales service We take our responsibility to all stakeholders very seriously. Consequently we conduct all our business around the globe in a compliant manner and follow the ethical business values of DSP. Strong compliance culture All our sites are fully compliant: Compliance to ICH Q7 Compliance to EU GMP part II for APIs Regulatory approvals for our APIs in many markets around the globe Global integrated Global Quality integrated Quality Analytical support Technical support Regulatory support Regulatory dossiers available for many countries around the globe Assisting customers in answering regulatory questions form authorities Supporting our customers with readily available regulatory statements Strong track record in regulatory submissions and affairs Risk prevention & Traceability Innovation Regulatory expertise Page 19

21 Unique manufacturing capabilities and product quality Quality at source Quality management system to assure qualification of all suppliers Reliable & long term partners for sourcing key raw materials Following the ethical business values of DSP Quality in action Advanced process control systems to ensure consistency and quality according to cgmp State of the art analytical technology Comprehensive document review before DSP product release Common audit findings shared across sites globally Quality in achievements Full traceability of the entire supply chain Commitment to sustainability Page 20

22 Our sustainable antibiotics: the PureActives Glucose Direct route Penicillin Direct route 7-ADCA 6-APA Cephalosporin API s Penicillin API s Drug Product / Finished Dosage Formulations Market leader in sustainable beta-lactam APIs - biggest class of APIs within anti-infectives Technology leader - most efficient and eco-friendly process PureActives - all APIs are produced with our proprietary enzymatic technology Our vision of integrating biology and chemistry resulted in the development of the green route to our penicillins & cephalosporins. These enzymatic processes form the basis of a new brand of Active Pharmaceutical Ingredients. Page 21

23 A new generation of environmentally friendly API Today, we are proud that our PureActives are the world s purest and most environmentally friendly produced antibiotic APIs with significant benefits in terms of Quality, Reliability and Sustainability for customers, end users and the environment. Page 22

24 A new PureActive : enzymatically produced Atorvastatin We developed our own unique production process to manufacture Atorvastatin Excellent quality fully meets USP and EU monograph (CEP available) Unique, fully backward integrated, enzymatic production process Toll manufactured in India at FDA compliant facilities Unique DSP process Protected by several DSP patents Industry average Less Steps 5-6 Steps 8-9 Steps Technology Breakthrough Proprietary enzymatic process Common process used by many players Extra chemical steps to compensate DSP enzymatic process Not using ATS-8 or hazardous butyl lithium Backward integration Full backward integration Using hazardous butyl lithium. Sourcing key intermediate (ATS-5, ATS-8, ATV-1) Page 23

25 Our API product portfolio Page 24

26 Our API product portfolio (continued) *under development Page 25

27 OUR DRUG PRODUCTS 26

28 Peace of Mind with a one-stop-shop for Drug Products On the basis of our unique APIs, we offer our marketing partners a one-stop-shop solution for worry-free generic Drug Products. Based on our vertically integrated production capabilities and paired with our extensive regulatory knowhow, doing business with DSP enables you to focus on what truly counts: your business and your customers. Founded in 1869, DSP looks back at over 140 years of innovation, from fermentation and microbiology in the late 1800s, over penicillin production development in the 1940s, the enzymatic revolution in antibiotic production in the 2000s, the first enzymatic statin, to new state-of-the-art formulations for generic pharmaceuticals today. Page 27

29 B2B Drug Products with a unique value proposition We have the advantage of using our own high quality APIs, the PureActives, in our beta-lactam and statin products, which deliver unique quality and performance in the finished dosage formulation. Fully backward integrated with own APIs Competitive cost position Control of supply chain means security of supply Customers as Partners No drug products sold under the name of DSP Exclusive supply under the name of customers High quality State of the art formulations One-stop-shop for latest dossiers Page 28

30 Regulatory support and after sales service We take our responsibility to all stakeholders very seriously. Consequently we conduct all our business around the globe in a compliant manner and follow the ethical business values of DSP. Strong compliance culture All our CRO s & CMO s are fully compliant: Compliance to ICH Q guidelines Compliance to EU GMP part I, III for Drug Products (Finished Dosages) Regulatory submissions in many markets around the globe Global integrated Global Quality integrated Quality Regulatory support Regulatory dossiers available for many countries around the globe Assisting customers in answering regulatory questions form authorities Supporting our customers with readily available regulatory statements In-house dedicated R&D and RA teams to support our customers Strong track record in regulatory submissions and affairs Technical support Innovation Regulatory expertise Page 29

31 Our Drug Product Portfolio Beta-lactam antibiotics Amoxicillin Amoxicillin/Clavulanic Acid Statins Atorvastatin Rosuvastatin Fungins Caspofungin Page 30

32 Beta-lactam antibiotics portfolio Page 31

33 Beta-lactam antibiotics value proposition Fully backward integrated with own APIs Global manufacturing network Unique portfolio of enzymatically produced molecules ( ) Customers as Partners Your success is our success Not competing in developed markets High quality Up-to-date new own dossiers DP manufacturing according to cgmp Page 32

34 Statins portfolio and value proposition Fully backward integrated with own APIs Backward integrated with own unique green APIs ( ) Dedicated state-of-the-art statins plant means security and reliability of supply Customers as Partners In time for patent expiry in Western Europe Non competing with our customers in their end markets High quality New state-of-the-art formulations All strengths and optimized cost for packaging Page 33

35 Fungins portfolio and value proposition Fully backward integrated with own APIs Backward integrated with own APIs Security and reliability of supply Customers as Partners First entry opportunity: through non-infringing formulation enabling launch promptly after compound patent expiry Non competing with our customers in their end markets High quality Stable formulation of highly complex and costly molecule Up-to-date new own dossier, DP manufacturing at specialist CMO according to cgmp Page 34

36 Our full Drug Product portfolio Page 35

37 Contact us Website: Sales inquiries: General inquiries: Page 36

38 Let s make this world a better place, TOGETHER 37 Copyright 2015 DSM Sinochem Pharmaceuticals. All rights reserved.