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DSM Sinochem Pharmaceuticals140 years of innovation
February 2015 Cover photo: daisy in gras, istock
Safe Harbor Statement
Page 1
Although diligent care has been used to ensure that the information provided herein is accurate, nothingcontained herein can be construed to imply any representation or warranty as to the accuracy, currency orcompleteness of this information nor can it be construed to imply any other representation or warranty of anykind, 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. Thecontent 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 rightsrelated to such products are in force. In such jurisdictions the advertised products are only offered forregulatory purposes insofar allowed under local provisions like the Bolar provisions in the US and 2004/27/EC inEurope.
The English language version of this document is leading.
OUR WORLD
Our world is changing fast
With over 7 billion people living on our planet andlife expectancies on the rise there is a greaterneed than ever to fight illness and battleinfections. Quality medications are essential.Responsible and sustainable production of these isvital for our and future generations quality of life.
Quality, Reliability and Sustainabilitybecome ever more important!
DSM Sinochem Pharmaceuticals helps customersand marketing partners to successfully navigatethis dynamic landscape by providing high quality,compliant and sustainable solutions that help youstay ahead of the competition.
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OUR COMPANY
Leading the way: 140 years of innovationOur history
1869 The company is founded as the “Nederlandsche Gist- en Spiritusfabriek”.1879 First Dutch company to found a workers council.
1940 Production of Penicillin G starts (initially under the code name BACINOL). SSP’s andSSC’s follow soon.
1970s Rise to become the world’s no.1 Penicillin G producer as “Gist-Brocades”.
1990s Global expansion of the production and sales network through acquisitions and JV’s.
1998 DSM acquires Gist-brocades. The newly formed leader in beta-lactam antibiotics iscalled DSM Anti-Infectives (DAI).
2003Purimox® is introduced to the world. It is the first enzymatically producedAmoxicillin. Purimox® is the first member of the DSMPureActives™ family ofenzymatically produced green Antibiotic APIs.
2005 Opening of the Zor-F, the worlds only enzymatic, direct-route 7-ADCA plant.
2005-2011 Global roll-out of enzymatic technology for beta-lactam APIs to all sites.
2011 In a Joint Venture Sinochem of China acquires 50% of DAI from DSM to form DSMSinochem Pharmaceuticals.
2012 First enzymatically produced statin (Atorvastatin from DSP) introduced to the world.
2012 Forward integration into the value chain by developing drug products (finisheddosage formulations).
2013 Opening of new enzymatic multi-product plant for the research, development andproduction of new SSCs using proprietary biotechnology in China.
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Antibiotic pioneers - code name BACINOL
When the Netherlands were occupied during World War II, a team at Nederlandsche Gist-enSpiritusfabriek (today DSM Sinochem Pharmaceuticals) secretly isolated, characterized, and producedpenicillin - working under the code name “BACINOL.“
This secret 18-month project, which was completely independent of the acclaimed American andBritish 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 valuablefermentation equipment.
Innovation is in our genes: in the 1940s DSP pioneered industrial antibiotic production
Penicillin cultures in milk bottles from the 1940s
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DSM Sinochem Pharmaceuticals
Who we areWe are the global frontrunner in enzymatically produced green beta-lactam antibiotics andnext generation statins.We combine our unique skills in fermentation and bio-catalysis to provide high qualityproducts based on our fully vertically integrated global manufacturing and distributioncapabilities. Our quality standards and our unique technology platform allows us to provideour customers and marketing partners with life-saving medicines in a sustainable andresponsible 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 andSinochem.
We are here to make a difference – keeping our customers ahead of the competition withtop quality products and services and the highest standards of quality, reliability andsustainability.
Page 7
Our parent companies at a glance
• 22,000 employees• EUR 9 billion turnover• Listed at Euronext
Industries• Life Sciences• Materials Sciences
• 40,000 employees• USD 50 billion turnover• Several listed subsidiaries
Industries• Energy• Agriculture• Chemicals• Real Estate• Finance
DSM is a global science-based companyactive in health, nutrition and materials.
Sinochem is a global Fortune 500 companyand one of China’s key state ownedenterprises.
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DSM Sinochem Pharmaceuticals
Creating high quality life-saving solutions is at the very heart of what we doWe 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 thelate 1800s, over penicillin production development in the 1940s, the enzymatic revolutionin antibiotic production in the 2000s to new state-of-the-art formulations for genericpharmaceuticals today.By continuously exploring and mastering new (bio)technologies we deliver products thatexceed customers’ expectations and positively impact patient care.
Our MissionOur purpose is to provide high quality and reliable products for people in need ofhealthcare. We do this by continuously exploring innovative technologies that positivelyimpact patient care and care for the environment.
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Our Promise: Peace of Mind
We produce nearly all our APIs using our unique enzymatic biotechnology. We constantlystrive for excellence and for innovation and have set new industry standards in quality andsustainability for all our products; leading the way by producing Sustainable Antibiotics andsolutions with drastically lower environmental footprints compared to similar medicines.
It summarizes what we stand for: Quality – Reliability - Sustainability
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
Company overview
Our market position
We are the leading manufacturer of green,enzymatically produced beta-lactamantibiotics and next generation statins. Tobetter serve our customers needs we areexpanding our API portfolio and our ability tooffer our products as Drug Products (finisheddosage formulations) in selected markets.
Our markets
We have a strong track record in regulatedmarkets in the western economies but alsohave a strong focus and local production sitesin the rapidly growing markets in Asia andLatin America.
Our customersWe cater to leading global pharmaceuticalcompanies, as well as to leading regionalpharmaceutical companies on all continents.
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Think globalOur global corporate staff supports our strong regionalunits. This unique setup allows us to keep a birds eyeperspective, act on a global level and constantlyimprove our products and services.
Act localFour regional units and two global units for DrugProducts and new API are the cornerstones of ourcustomer relations. Together they span the entireglobe. Individually they are close to you, our customer.
Our organization: global and localAs
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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.
PeopleWe treat our people and the people we influence withrespect to positively impact their lives. Great people areour biggest asset.
ProfitWe need to earn sustainable financial results to enableprofitable growth for our company today and in the futureand that address the interests of our shareholders.
PlanetWe believe that caring for the planet is a moral obligationand a necessity. We also believe it provides unique businessopportunities and success not only for ourselves but forsociety at large.
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P
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…a key business driver for DSP
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
Based on a strong technology position
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OUR API SOLUTIONS
Our APIs solutions mean one thing for you: Peace of Mind
Peace of MindSuperior product quality throughout our portfolio.Full traceability of our entire supply chain.Reliable, long-term partners for the sourcing of keyraw materials.
Mastering the ever stricter regulatory environmentcan be challenging. Our dedicated regulatory affairsand technical after sales service teams around theglobe are there to help you navigate thesechallenging waters. Close to you, close to yourbusiness.
Reliable regulatory and after sales service
The best technology and qualityWe are the inventor of industrial enzymatic APIsproduction and make the highest quality productavailable*. Nearly 500 patents guard our innovationsin the area of eco-friendly (bio)technology andproduction process for our high quality, sustainableantibiotics and statins API.
*based on Purimox® compared to next best alternative Page 17
Advanced and sustainable (bio)technology for your benefit
Enzymatic technology for antibioticsOur green beta-lactam antibiotics are made through natural fermentationand enzymatic conversion ensuring the absence of almost all chemicalsthereby significantly reducing the toxicity of the active ingredients.
We have Freedom To Operate (FTO) for all the markets where we offer ourunique products. You benefit from our successful track record andexperience in the dynamic regulatory affairs field, resulting in Peace ofMind for you.
Freedom To Operate
Enzymatic technology for statinsWe have extended our enzymatic technology to our statins. We use aninnovative, fully backward integrated enzymatic process, protected byseveral patents. This allows us to manufacture superior statins with higherpurity, increased efficacy and without using hazardous chemicals.
Traditional pharmaceutical and in particular antibiotic production is associated with asubstantial negative impact on our environment. By integrating biology and chemistry into acutting-edge enzymatic process we have developed the most eco-friendly production processavailable and set new industry standards in quality and sustainability.
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Strong regulatory support and after sales service
We take our responsibility to all stakeholders very seriously. Consequently we conduct all ourbusiness around the globe in a compliant manner and follow the ethical business values of DSP.
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
Regulatory expertise
Technical supportAnalytical support
Risk prevention& Traceability
Global integrated Quality
Innovation
Global integrated Quality
Strong compliance cultureAll 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
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Unique manufacturing capabilities and product quality
Quality at sourceQuality management system to assure qualification of all suppliersReliable & long term partners for sourcing key raw materialsFollowing 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
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Our sustainable antibiotics: the PureActives™
CephalosporinAPI’s
PenicillinAPI’s
Drug Product/ FinishedDosage
Formulations
7-ADCA
6-APA
PenicillinGlucose
Direct route
Direct route
• 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 toour penicillins & cephalosporins. These enzymatic processes form the basis of a new brand ofActive Pharmaceutical Ingredients.
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A new generation of environmentally friendly API
Today, we are proud that our PureActives™ are the world’s purest and mostenvironmentally friendly produced antibiotic APIs with significant benefits in terms ofQuality, Reliability and Sustainability for customers, end users and the environment.
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A new PureActive™: enzymatically produced Atorvastatin
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DSP process Industry average
Unique Protected by several DSPpatents
Common process used by manyplayers
Less Steps 5-6 Steps 8-9 Steps
TechnologyBreakthrough
• Proprietary enzymaticprocess
• Not using ATS-8 orhazardous butyl lithium
• Extra chemical steps tocompensate DSPenzymatic process
• Using hazardous butyllithium.
Backward integration • Full backwardintegration
• Sourcing key intermediate(ATS-5, ATS-8, ATV-1)
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
We developed our own unique production process to manufacture Atorvastatin
Our API product portfolio
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Our API product portfolio (continued)
*under development Page 25
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OUR DRUG PRODUCTS
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-shopsolution for worry-free generic Drug Products. Based on our vertically integratedproduction capabilities and paired with our extensive regulatory knowhow, doingbusiness with DSP enables you to focus on what truly counts: your business and yourcustomers.
Founded in 1869, DSP looks back at over 140 years of innovation, from fermentation andmicrobiology in the late 1800s, over penicillin production development in the 1940s, theenzymatic revolution in antibiotic production in the 2000s, the first enzymatic statin, tonew state-of-the-art formulations for generic pharmaceuticals today.
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B2B Drug Products with a unique value proposition
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Fully backward integrated with own APIsCompetitive cost positionControl 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
We have the advantage of using our own high quality APIs, the PureActives™, in ourbeta-lactam and statin products, which deliver unique quality and performance in thefinished dosage formulation.
Regulatory support and after sales service
We take our responsibility to all stakeholders very seriously. Consequently we conduct all ourbusiness around the globe in a compliant manner and follow the ethical business values of DSP.
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
Regulatory expertiseTechnical support
Global integrated Quality
Innovation
Global integrated Quality
Strong compliance cultureAll 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
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Our Drug Product Portfolio
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Beta-lactam antibiotics
Statins
Fungins
• Amoxicillin• Amoxicillin/Clavulanic Acid
• Atorvastatin• Rosuvastatin
• Caspofungin
Beta-lactam antibiotics portfolio
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Beta-lactam antibiotics value proposition
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Fully backward integrated with own APIsGlobal manufacturing networkUnique 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
Statins portfolio and value proposition
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Fully backward integrated with own APIsBackward 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
Fungins portfolio and value proposition
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Fully backward integrated with own APIsBackward integrated with own APIsSecurity 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
Our full Drug Product portfolio
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Contact us
Website: www.dsm-sinochem.com
Sales inquiries: [email protected]
General inquiries: [email protected]
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Let’s make this worlda better place,
TOGETHER
Copyright © 2015 DSM Sinochem Pharmaceuticals. All rights reserved.