Healthcare in Bavariawww.invest-in-bavaria.com

Invest in Bavaria – The Business Promotion Agency of the Stateof Bavaria

The one-stop all-round service Invest in Bavaria is the Business Promotion Agency of the State of Bavaria. Since 1999, it has been helping companies from Germany and abroad to build up or extend a base in Bavaria. Invest in Bavaria puts togethercustomised information, helps to find the ideal location in Bavaria and arranges the contacts needed for im-plementing projects: with government agencies and associations as well as with important local networks. Theservices offered by Invest in Bavaria are free of charge and all inquiries are, of course, treated confidentially.The Business Promotion Agency of the State of Bavaria is a reliable and competent partner for every phase ofthe investment project.

Planning and PreparationThe better the information about potential sites, the easier it is to reach a sound and efficient investment decision. Invest in Bavaria provides companies interested in Bavaria with comparable and reliable facts andfigures about the market and business environment, industry and technology networks or funding and financ-ing instruments.

Choice of LocationProject-related location criteria are jointly developed to meet the wishes and needs of the investor. Invest inBavaria uses this requirement profile to draw up concrete proposals of potential sites, to identify suitable com-mercial properties and industrial real estate and to organise on-the-spot site inspections.

Location ImplementationOnce the location has been chosen, Invest in Bavaria makes sure that the companies receive local supportfrom the right partners. It investigates funding options, organises contacts with appropriate funding institutionsand – if required – with possible financing partners. Invest in Bavaria also offers its assistance with tax, legaland administration issues, ensuring straightforward and smooth coordination with the relevant authorities fora particular project, the regional business development organisations or specialised service providers.

Site DevelopmentEven after the new business has been set up, Invest in Bavaria is still on hand for interested companies. In-formation on the promotion of business in Bavaria, like the trade fair participation program, all the way to tipsabout useful corporate databases and industry networks and arranging contacts with foreign communities aretypical examples of the wide range of services offered by Invest in Bavaria. And if it is a matter of expandingan existing facility, Invest in Bavaria will be standing by ready to offer help, advice and good contacts.

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The life science sector develops key technologies of the 21st century like no other sector and is highlyinnovative. Added value and sustainable growth can only be achieved by means of innovations. Bavariais well prepared for this challenge. With global industry leaders like Siemens, GE, Novartis, Roche,but especially due to the research-oriented and committed small and medium sized enterprises, theFree State of Bavaria is a healthcare site that is unique in Europe.

In order to create innovations, research facilities must be available. Bavaria offers the best conditionsin this regard: with 13 Max Planck Institutes, three Helmholtz Centres and eight Fraunhofer Institutes,Bavaria enables a close networking of research and practical implementation. Eleven universities and17 universities of applied sciences create a climate for a direct entrepreneurial implementation of thelatest research results and produce highly qualified experts for Bavarian companies.

Also citizens benefit from this lively climate of innovation: the comprehensive availability of more than400 hospitals and 300 prevention and rehabilitation facilities ensures the involvement of everybody onthe medical progress.

The complex healthcare sector is closely linked in all segments and assumes an extraordinary role in thetechnology policy of the Free State of Bavaria. Especially through the targeted bundling of differentpartners from various sectors, Bavaria initiated an effective cluster policy in 2006. In particular, thehigh-tech companies on site benefit from this, as the connection and the interchange between scienceand economics is considerably simplified and accelerated. Specific frameworks have been used inorder to establish uniform standards in the areas of standardisation and legislation. These contributesubstantially to targeted research in order to continue being a global leader in this segment.

In order to provide investors with access to this extraordinary potential, representatives of the FreeState of Bavaria are available as points of contact in metropolises of more than 20 countries. Theycooperate closely with Invest in Bavaria, the Bavarian Business Promotion Agency. Invest in Bavariasupports investors comprehensively, confidentially and free of charge. From the initial conversationon the choice of location to the groundbreaking ceremony and the continuous follow-up care, the teamof the Business Promotion Agency supports companies together with its country and sector experts.

This brochure presents the strong position of Bavaria in life sciences and makes clear why the freestate is an ideal place for business development and innovation. It provides an overview of all theexcellent companies from biotechnology, medical technology and pharmaceuticals that you as an investor can work with and tells the success stories behind the people and the products which are”Made in Bavaria”!

Martin ZeilDeputy Prime Minister of Bavaria Bavarian Minister of Economic Affairs, Infrastructure, Transport and Technology

Preface

Martin ZeilDeputy Prime Minister of Bavaria Bavarian Minister of Economic Affairs, Infrastructure, Transportand Technology

04Invest in Bavaria

03 Preface

Martin ZeilDeputy Prime Minister of Bavaria Bavarian Minister of Economic Affairs, Infrastructure, Transport and Technology

Bavaria06 Bavaria – Location for Biotechnology and Medical Technology

Overview

07 ”The launch of the tech campus is expected for 2015”

Interview with Dr. Thomas Diefenthal, Managing Director, BioPark Regensburg GmbH

08 ”Our location is essentially characterised by its further education establishments”

Interview with Dirk Jung, COO, joint operating company IGZ BioMed/ZmK mbH

10 ”Bavaria is a leading medical technology region”

Interview with Prof. Dr. Michael Nerlich, Chairman, Forum MedTech Pharma e.V.

12 ”Synergies between drug development and medical technology are especially valuable”

Interview with Prof. Dr. Horst Domdey, BioM, and Prof. Dr.-Ing. Erich R. Reinhardt, Medical Valley EMN e.V.

13 Bavarian research excellence in Biotechnology and medical technology

Pioneering concepts are developing in the Free State thanks to academic and economic cooperation

15 The highlight from Erlangen

Testing directly in the hospital

16 Pharmaceutical and medical technology companies in Bavaria

Overview, trends and developments

Biotech in Bavaria18 ”Willingness to found companies is spreading like a virus”

Interview with Prof. Dr. Axel Ullrich, Director, Department of Molecular Biology, Max Planck Institute of Biochemistry

19 Fit for the Medicine of the Future

Focus on “Personalised Medicine” in Munich

20 Land of the Biotech Pioneers

Innovation in Bavaria comes from small and medium sized enterprises

21 ”IZB will continue to grow”

Interview with Dr. Peter Hanns Zobel, Managing Director, IZB GmbH

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24 ”It is important that business models are scalable”

Interview with Helmut Jeggle, Athos Service GmbH, and Michael Motschmann, MIG Verwaltungs AG

25 ”Since 1998, approximately EUR 2 billion have been invested in site expansion projects”

Interview with Claus Haberda, Site Manager, Roche Penzberg

26 ”The acquisition of Micromet is the largest single investment Amgen has ever made”

Interview with Richard Paulson, VP & General Manager, Amgen GmbH in Germany

MedTech in Bavaria27 ”A win-win situation for both sides; the economy and university research”

Interview with Prof. Dr. Willi A. Kalender, Director, Institute for Medical Physics, Friedrich-Alexander-Universität Erlangen-Nürnberg

28 Trendsetter for health

From recent start-ups to global market leaders, small and medium-sized companies in Bavaria are driving forward advancement in medical technology.

29 ”The location can compete with international leading centres”

Interview with Dr. Peter Terhart, Chairman, S-Refit AG

31 The Healthcare of Tomorrow

Four examples from Medical Valley EMN

32 ”Bavaria’s university hospitals are absolutely world class”

Interview with Michael Sigmund, Head of Communications, Siemens Healthcare

33 Success with eye laser technology

Wavelight GmbH: Synergy potential in the Alcon Group

Invest in Bavaria

ImprintBavarian Ministry of Economic Affairs,Infrastructure, Transport and TechnologyInvest in BavariaPrinzregentenstraße 2880538 MunichGermany

Tel.: +49 89 2162-2642Fax: +49 89 2162-2803

www.invest-in-bavaria.com

Design and realisationGoingPublic Media AGHofmannstraße 7a81379 MunichGermany

Tel.: +49 89 2000339-0Fax: +49 89 2000339-39

Project managementMarkus Hofelich, Martin Bellof

Overall designHolger Aderhold

Across the globe, Bavaria is mainly known for itstourist highlights: Neuschwanstein Castle, the mostvisited German attraction, as well as the pano -ramic view of the Bavarian Alps with the highestmountain in Germany, the Zugspitze. Furthermore,Bavaria signifies culinary delights and lifestyle,beer gardens, hearty food and good beer. Thesame is true of the Oktoberfest, the largest publicfestival in the world. The unique combinationof the great scenic beauty, culture and culinarydelights attract more than 25 million visitors eachyear; the highest number of visitors throughoutGermany. But Bavaria is also a booming businesslocation and high-tech region. Several globalplayers, among them seven of the 30 corporationslisted in the Dax, Germany's blue chip stock mar- ket index, have their headquarters in Bavaria.BMW, Audi, Siemens and Adidas are only a fewexamples for the variety of companies with inter- national standing located in Bavaria. Bavaria isalso an innovation hub. Both the diesel engineand the MP3 format as well as soccer shoes withscrew studs were developed in Bavaria. Evenin the field of life science the Free State ofBavaria is a national and international leader.

Investments in high tech pay offEUR 800 million – this is the sum the free stateof Bavaria has so far invested in the construction

of the Biotech and MedTech hub Bavaria. Suc-cessfully. Today, Bavaria is one of the threetop locations for biotechnology in Europe. In anational comparison, Bavaria is in the lead. Themedical technology developed in Bavaria alsoleads on both a national and international level.25,000 jobs depend on the industries of Biotechand biopharmaceuticals; in medical technologyalone, 45,000 jobs in the Leading-Edge Clusterof the Medical Valley European MetropolitanRegion Nuremberg. Besides a vast amount ofsmall and medium sized enterprises (SME’s), glob-ally operating multinational healthcare groupsdecided on Bavaria as their location. RocheDiagnostics operates one of the worldwidelargest biopharmaceutical research and produc-tion sites in Penzberg on more than 350,000m².Siemens Sector Healthcare, global market leaderin the field of imaging diagnostics, has its head-quarters in Erlangen.

Growth Segment: Bavarian BiotechnologyIn the past 15 years, five biotechnology clustershave developed in Bavaria. In the biotechnologyregions of Wuerzburg, Regensburg and Munich,the focus is on biotechnology with a healthcareaspect. The other two clusters, Freising-Weihen -stephan and Straubing, are more specialised ongreen or white biotechnology. In order to support

Bavaria – Location for Biotechnologyand Medical Technology

Overview

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Dedicated biotechnology and medical technology centres in BavariaSource: own research

Bio-Region Startup centre Rentable space Tenants Employees

Munich IZB Martinsried/Freising 23,000 m² > 60 700

Regensburg BioPark Regensburg 18,000 m² > 30 550

Franconia IGZ Würzburg 5,000 m² > 20 300

Nuremberg-Erlangen Medical Valley Center 5,000 m² > 30 200

Employees: Number of employees of the tenants in the respective startup centre

and make better use of the particularities andstrengths of the different regions, individual net-work organisations have been formed that areresponsible for the management of the respec-tive clusters: the BioM Biotech Cluster Develop-ment GmbH manages the metropolitan region ofMunich as well as the neighbouring cluster ofFreising-Weihenstephan; the BioPark Regens-burg GmbH manages the region of Regensburgand the IGZ Bio-Med/ZmK represents the regionof Wuerzburg. Their objective is the developmentand marketing of the respective cluster in the in-terest of the founders, companies and scientistsin each of the locations, as well as a networkingof companies, universities, research facilities,university hospitals, chambers and associations,

investors, funding authorities, advisers and otherworkers in the cluster. The BioM Biotech ClusterDevelopment GmbH has been coordinating andnetworking all biotechnology activities withinBavaria across since 2006.

Metropolitan Region Munich – Pioneer inBiotechnology Startup centres are a special component of eachregional cluster. They provide the infrastructurethat biotechnology startups need for the growthof their company, especially laboratories and office spaces. Various important players of theGerman biotechnology industry originate fromthe Innovation and Startup Centre (IZB) in Mar-tinsried and Freising-Weihenstephan, founded

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”The launch of the tech campus is expectedfor 2015”

Interview with Dr. Thomas Diefenthal, Managing Director, BioPark Regensburg GmbH

What characterises BioRegio Regensburgas part of the Biotech cluster of Bavaria?In 1999, a centre for biotechnology was createdon the Regensburg University campus under themotto ”small but mighty”. Due to the principle of”short routes”, in the east of Bavaria it was possibleto address company founders, the medium-sizedindustry and external companies willing to relocate.Both sides have been benefitting from the integrationof this network into the Bavarian Bio tech cluster.The Leading-Edge Cluster in Munich is being linked toinnovative companies situated in the outer regionsof the Free State; at the same time, these compa-nies receive access to the extensive services andinformation provided by the regional initiatives.

There are many interdisciplinary projects inRegensburg. How did this come about?Regensburg’s consistent and innovative businesspromotion forms the basis for this. In addition,

the decision-makers involved often know oneanother personally due to the geographicalproximity. Ideas can then be implemented inprojects quickly. Firstly, projects were createdwith life sciences companies, i.e. pharmaceutical,analytics, diagnostics and medical technologyfirms. Other areas followed, such as sensorsystems. Since automation in all areas of aBiotech lab or in the processing industry, e.g.foodstuffs, has been booming, this sector isalso expanding. Due to the comparably shortdevelopment times, such companies are suc-cessful on the market even today.

What do you imagine the location of Regensburg will be like in ten years?The neighbouring tech campus to be commis-sioned in 2015 will accommodate a multitudeof companies, which started out in the BioParkRegensburg.

Dr. Thomas Diefenthal isManaging Director of BioParkRegensburg GmbH. He alsocoordinates the BioRegio Regensburg biotechnologycluster and is the deputyspeaker of the GermanBioRegionen working group.

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in 1995 and 2007, respectively: Morphosys and Micromet (now Amgen Research GmbH) as wellas Corimmun were founded in this centre. TheMunich site is characterised in particular by itsproximity to first-class centres for fundamentalresearch. The Bavarian capital is home to threebiological-medical Max Planck Institutes for biochemistry, neurobiology and psychiatry, oneHelmholtz Zentrum München (German ResearchCentre for Environment and Health), the Fraun-hofer Headquarters, the Gene Center Munich that,since 1984, has played a pioneering role bothscientifically and organisationally in the Germanresearch community, the two universities of appliedsciences of Weihenstephan-Triesdorf and Munichas well as two of the best German universities,the Technische Universität München and Ludwig-Maximilians-Universität. Additionally, it is hometo two university hospitals (Klinikum der Univer-sität München and Klinikum rechts der Isar) and 60other hospitals in Munich and its surroundings.

m4 – Leading-Edge Clusterof Personalised MedicineIn 2010, the German Ministry of Education andResearch honoured the Munich consortium “m4 –Personalised Medicine and Targeted Therapies”in the second round of the Leading-Edge Clustercompetition as one of the five Leading-EdgeClusters. The vision of this Leading-Edge Clusteris to establish itself as an international modelarea and area of excellence for personalised and targeted therapy. For this purpose, funds in theamount of approximately EUR 100 million areavailable for a period of five years; about half ofthese funds have been contributed by the compa-nies involved. The BioM Biotech Cluster Develop-ment GmbH assumes the management.

Regensburg – Interdisciplinary CooperationThe BioPark Regensburg GmbH is not only in chargeof the cluster management but also operates astartup centre with the same name on the campus

”Our location is essentially characterised byits further education establishments”

Interview with Dirk Jung, COO, joint operating company IGZ BioMed/ZmK mbH

Can you briefly introduce the Biomed region of Wuerzburg?We are a location which is essentially charac-terised by its further education establishments.Many of our tenants come from the Universityof Wuerzburg or the Wuerzburg-Schweinfurt Uni- versity of Applied Sciences. The change in theculture of promotion has resulted in spin-off com-panies today consisting of rather small groupsof founders, who remain in further educationfor a comparably long amount of time. This thusreduces influence being exerted by venturecapitalists at a very early stage. The UniversityHospital is also significant for our life scienceslandscape. We hope to soon be able to housethe first spin-off companies from the hospital.

Which sectors are represented within IGZ?From the beginning, IGZ was topically split intotwo or three areas: on the one hand, there wasbiotechnology and biomedicine, on the other hand,

there was information and communication tech-nology, and also, at the interface, bioinformatics.We have now expanded the topics of IGZ to in-clude closely-related scientific areas. In this way,we can also offer highly qualified niche suppliersideal starting conditions in the medical technologyservice.

How intense is the collaboration withother cluster regions?For us, ’founding companies from one’s ownmeans’ and ’corporate maintenance’ are keyphrases. But for this, local and national network-ing is absolutely necessary; this actively illustratesexchange on the part of the individual bioregions,as well as cooperation at interdisciplinary level.At the moment, we are intensifying our efforts toestablish contact between the spin-off founders,established firms and further education establish-ments. In this way, we hope to get solutions fromscience to the questions posed by business.

Dirk Jung is COO of IGZ Würzburg and

Deputy Managing Director of Congress-Tourismus-

Wirtschaft of the City of Wuerzburg.

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of the University of Regensburg. Located in theBioPark are mainly companies of the field ofbiotechnology and medical technology as wellas related service providers. Furthermore, thereare eight non-academic research institutes orproject groups within the BioPark, among themtwo Fraun hofer Project Groups (Diagnosis andTreatment of Tumors, Metabolic Disease andDisease associated with Ageing and SensorTechnology Materials). This demonstrates theproximity to non-academic research units. Inaddition, a number of research networks havebeen formed in the region of Regensburg. Thelatest example is the Centre for InterventionalImmunology that pools existing medical andscientific excellence in immunotherapy andtransplantation medicine in eastern Bavaria.

Wuerzburg – Centre of Competence for BiomedicineThe Innovation and Startup Centre (IGZ) Würzburgis the largest startup centre in northern Bavariaand is home to companies in life sciences and IT.It is located in direct vicinity to the University ofWuerzburg and the University of Applied Scienceas well as numerous research facilities. For com-panies in biotechnology and medical technology,the proximity to the renowned department forbiomedicine of the university as well as the uni-versity hospital is of particular importance. Notleast for this reason, Wuerzburg is recognised asa centre of competence for biomedicine.

Strong Starting Situation for Bavaria’s Biotech-SME’sThe importance of Bavaria for biotechnology be-comes very clear in a national comparison. More

than half of the more than 320 companies locatedin Bavaria in biotechnology and pharmaceuticalsare small and medium sized enterprises (SMEs).This represents around 30 per cent of GermanSMEs in biotechnology. The specific focus of thesecompanies is the development of new therapeu-tics and diagnostics. Their “drug candidates” aretested worldwide in over 80 clinical trials. Morethan 100 candidates in research and preclinicalstudies ensure a steady supply.

Medical Valley – Leading-Edge Cluster forMedical TechnologyWhen talking about German medical technology,the Medical Valley European Metropolitan Re-gion of Nuremberg (EMN) cannot be ignored.The Medical Valley EMN is the leading regionfor medical technology within Germany. Like them4 in Munich, it was honoured in 2010 by theGerman Ministry of Education and Research asnational Leading-Edge Cluster. It is characterisedby a high concentration of excellence in medicaltechnology. Approximately 500 companies operatein the Medical Valley, among them numerousglobal players and many market leaders. TheMedical Valley Center is the foundational coreof the cluster. In its direct vicinity are more than70 institutes with medical engineering orienta-tion in Friedrich-Alexander Universität Erlangen-Nürnberg and universities for applied sciences,more than 20 non-academic research facilitiesclosely linked to medical technology (amongthem Fraunhofer and Max Planck Institutes) aswell as more than 65 hospitals. The unusualdensity of partners together with the interna-tional market and competitive position of indi- vidual companies provide ideal conditions for

Bavarian Biotech SMEs’ staff since 2006Source: Bavarian Biotech Report 2011/12, BioM Biotech Cluster Development GmbH

Bavarian Biotech SMEs by field of expertiseSource: Bavarian Biotech Report 2011/12, BioM Biotech Cluster Development GmbH

201120102009200820072006

4,016

3,7933,715

3,460

3,290

3,030

+32,5%

Therapeutics/Diagnostics Agriculture, Food, EnvironmentDevices/Reagents

DNA-/Proteinanalysis Preclinical ServicesBioinformatics

65

39%

10%16

7%

11

25%42

11%19

8%

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puts Bavaria in front of countries like France orItaly. In particular, SMEs play a specific role inthe medical technology of Bavaria. The majorityof companies located here are SMEs. Companieswith less than 50 employees even make up morethan half of all medical engineering companies.

Conclusion The future prospects for the healthcare siteBavaria are consistently positive. Strong funda-mental research, ideal infrastructure, a highdegree of networking and interest in activecooperation are responsible for the positive im-pulses that originate from Bavaria. Biotechnolo-gy and medical technology are important pillarsof the Bavarian and German economies andshould remain this way in the future. The Ger-man and Bavarian governments demonstratethis with their continuous investments in thesesectors.

Martin Bellof

the transfer of ideas into products and services.The Medical Valley is being developed, coordi-nated and marketed by an association with thesame name. The recipe for success of the clusteris the close contact between highly specialisedresearch institutes, internationally establishedmarket leaders as well as growing and mediumFurthermore, the largest German network of theGerman health sector (more than 620 membersfrom 14 countries), Forum MedTech Pharma, islocated in the Medical Valley EMN. The asso ci-ation offers the players of the sector various opportunities for national and international networking.

Strong SMEs in the Field of Medical TechnologyThe actual strength of Bavarian medical technol-ogy becomes clear on a closer inspection of itsturnover. EUR 7 billion, almost one third of thetotal turnover of EUR 22 billion in German med-ical technology, are produced in Bavaria. This

”Bavaria is a leading medical technology region”

Interview with Prof. Dr. Michael Nerlich, Chairman, Forum MedTech Pharma e.V. devices in Germany are created in Bavaria.Bavaria is number one when considering thetotal turnover generated in the field of med-ical technology, and it comes second as regardsthe number of employees. Bavaria can thus becalled a leading medical technology region, andrightly so.

What trends can be observed in medicaltechnology?In the area of technology, the far-reaching collection of information technology, the trendtowards devices for out-patient or even domes-tic care, or even the ever-growing interplay ofthe medicine technology, biotechnology andpharmaceuticals sectors, in the form of combi-nation products, for instance, are important cur-rent developments. The sector is devoting itsenergies to even greater technological chal-lenges resulting from the requirement of ensur-ing efficiency in the case of innovations anddealing with the issue of cost reimbursementfor products and services.

What role does the Forum MedTech Pharmanetwork play for the healthcare sector inBavaria?As the biggest network of its kind in Europe,Forum MedTech Pharma is a platform for trans-regional and international networking. Regionalnetworks and clusters such as Medical ValleyEMN or the Biotech cluster in Munich give riseto close connections. Their regionally focusedcommitment is perfectly complemented by thetrans-regional network activities. As a nationaland international link, the association ensuresthe extensive consideration of all phases of thevalue added chain – from research and devel-opment, over production, supplier networks,clinical trials and application, to internationalmarketing. In addition, interfaces between thedisciplines of medicine technology, biotechnol-ogy and pharmaceuticals are being created.

How significant is Bavaria for medicaltechnology in Germany?30 per cent of all medical technology productsand even 60 per cent of all electromedical

Prof. Dr. Michael Nerlich ishead of the Department forAccident Surgery at Regens-burg University Hospital. Heis also Chairman of ForumMedTech Pharma e.V.

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Bavarian Bio-Regions engaged in healthcareSource: own presentation

Erlangen

Munich

Regensburg

Nuremberg

Wuerzburg

Freising-Weihenstephan

Europe Germany

Bavaria

Professor Domdey, what significance doesthe Munich Biotech Cluster have in Germanyand how does it differ from other locations?Domdey: In the area of drug development, theMunich Biotech Cluster m4 is, without a doubt,the most successful biotechnology location inGermany. We are proud that patients are alreadybenefiting from four drugs that were developedhere. With more than 300 life science companiesand a good 130 small and medium-sized compa-nies, we are also counted among the Europeanmarket leaders. What characterises Munich andwhat promotes both innovation and translationis the close dovetailing of excellent science andthe Biotech industry.

Professor Reinhardt, what is the USP ofMedical Valley EMN compared with othermedical technology clusters in Germany?Reinhardt: Global players such as Siemensand many SMEs are developing innovativemedical technology in Medical Valley EMN.Even in the early stages of the innovationprocess, they work closely with partners inscience and healthcare. This is how a sustain-able problem solving capability has arisen,that, together with the technological capabili-ties of partners, marks the innovative strengthof Medical Valley.

What is your vision for the Munich BiotechCluster in 10 years?Domdey: Munich has devoted its energies todrug development, especially to the future trendof ”personalised medicine”, and is purposefullyimproving the corresponding framework condi-tions, such as the biobanking infrastructure. Inaddition to the well-filled drug pipeline, Munichoffers unique technology platforms. Especiallybecause of large international partners of com- panies such as Morphosys, Wilex, 4SC, Pierisor Proteros, the perception abroad is very positiveand will improve further still.

Where do you see Medical Valley in 10years?Reinhardt: By 2022 many innovations from Me -dical Valley EMN will have revealed, that theyare able to provide a sustainable contributionto healthcare efficiency and effectiveness. Ini tialassessments by some Leading-Edge Clusterprojects show that, in Germany alone, EUR7.5 billion could be saved per year – withoutloss of quality. Through innovations in structureand processes, Medical Valley EMN will developinto a model region for optimal healthcare withthe highest credentials.

In the m4 – personalised Medicine pro-gramme, you are planning to work moreclosely together with Medical Valley. Whatbenefits do you see in doing this?Domdey: I am convinced that through the interplayof precise diagnostics and targeted therapiest, abetter and more cost-effective provision of health-care services can be achieved. Synergies betweendrug development and medical technology areespecially valuable in order to transfer innovativeconcepts into clinical practices.

How realistic is it that both regions are ad-vancing together to become the leadingEuropean cluster in personalised medicinewithin Europe?Reinhardt: Personalised medicine is a focal pointfor research and development worldwide, as know -ledge about the effects of medication enables ac- curate and individual treatment. Strong coopera-tion between the medical technology and phar-maceutical sectors is therefore indispensible forthe development of necessary technology. If thetwo strongest places in Bavaria in this sectorpooled their abilities, the best conditions in whichto form a Europe-wide leading working group inthe area of personalised medicine would exist.

Interview conducted by Markus Hofelich.

”Synergies between drug developmentand medical technology are especiallyvaluable”Interview with Prof. Dr. Horst Domdey, BioM, and Prof. Dr.-Ing. Erich R. Reinhardt, Medical Valley EMN e.V.

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Prof. Dr. Horst Domdey isManaging Director of BioM

Biotech Cluster DevelopmentGmbH and speaker of the

Bavarian Biotechnology Cluster.

Prof. Dr.-Ing. Erich R. Reinhardtis Chairman of the

Medical Valley EMN.

Numerous institutes in Bavarian universitiesand other establishments are devoting their en-ergies to medical technology and biotechnology.The outstanding position of Bavarian universitieshas been underpinned as part of the excellenceinitiatives, while the Centre for Higher EducationDevelopment (CHE) is listing several Bavarianfaculties in the leading group of its researchranking. A multitude of support is now beingoffered for clinical studies, in order to over-come the hurdles. Activities for ”personalised

medicine”, i.e. several academic cooperations,are considered to be especially pioneering.

Interdisciplinary approaches are shapingthe scenePerforming precise operations with robot sys-tems is no longer a dream of the future. Indeed,lightweight robot arms, which a doctor cancontrol remotely, have been developed at theInstitute of Robotics and Mechatronics of theGerman Aerospace Center (DLR) in Oberpfaffen-hofen. Another DLR Institute, the Institute ofAtmospheric Physics, is devoting itself to theprevention of skin cancer through use of satel-lites. Interdisciplinary approaches such as thesehave long since characterised research in medicaltechnology and biotechnology, too. The ”MunichCenter of Health Sciences” (MC-Health) of Lud-wig-Maximilians-Universität (LMU) also pursuesan interdisciplinary approach like the MunichHelmholtz Centre, Europe’s leading researchcentre for ”Environmental Health”. Munich isinternationally recognised as being the locationfor biomedical basic research and its clinicalapplication. Ludwig-Maximilians-Universität andTechnische Universität München (TUM) play a keyrole. At the latter’s central Institute of MedicalEngineering (IMETUM), the disciplines are entwined;specialities range from the "Medical ElectronicsInnovation Centre" to the "Heinz Nixdorf Profes-sorship for Medical Electronics". The Max PlanckSociety accommodates one of its biggest biologi-cal-medical research concentrations in Munichwith the Institutes of Biochemistry, Neurobiologyand Psychiatry. An example of the close network-ing is the Excellence Cluster Center for Integrat-ed Protein Science Munich (CIPSM). At the JuliusMaximilian University of Wuerzburg, the Inter-disciplinary Center for Clinical Research (IZKF)is the internal research promotion tool. TheFriedrich-Alexander-Universität Erlangen-Nürn-berg is home to a Centre for Medical Physics andTechnology; while at the University of Regensburg,

Bavarian research excellence in Bio -technology and medical technology

Pioneering concepts are developing in theFree State thanks to academic and economiccooperation

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Two locations of the Bavarian Biotech and MedTech research community that are rich in variety: TechnischeUniversität München (top) and University of AugsburgPhotos: © Helmholtz-Zentrum München/TUM, Universität Augsburg

a Telemedicine Centre has been built. The Fraun-hofer Society is dealing with issues relating tomedical technology at several locations, suchas in Erlangen (image processing), Fuerth (X-raytechnology) and Regensburg (tumourous andmetabolic diseases). There are also technologyprojects at the Bundeswehr University Munich,from sensor systems for prosthetic arms tocomputer simulation for injecting bone cement.At the University of Passau, the Faculty of Com-puter Science and Mathematics is dealing withdigital image processing for computer tomographs,while the University of Augsburg has made aname for itself with a legal research establish-ment for medical device law. Further educationcertificates can be acquired for this purpose atthe university’s Centre for Further Educationand Knowledge Transfer (ZWW) – a phenomenonwhich is unique in Germany.

Clinical studies at a number of locationsInnovation hurdles in medical technology are notsomething that the experts have had to deal withsince VDI/VDE Innovation und Technik GmbHtackled this thorny issue with a study. Consul-tancy and support in the case of clinical studiesare now gaining in significance. For studies suchas these, there are several starting points – pri-marily, but not limited to, the university hospitalsin Munich, Erlangen, Regensburg and Wuerzburg,or the German Heart Centre in Munich. Thecoordination serves as a ”Bavarian Network forClinical Studies” (BayernNetz) with a branchoffice at the university hospital Klinikum rechtsder Isar (on the right of the river Isar) in Munich.Clinical studies are thus to be made easier foreven smaller companies. Centres for clinicalstudies are also being run at several universi-ties. The LMU is involved in an ongoing basis inclinical and epidemiological studies, both inindividual hospitals and in establishments suchas the "Clinical Study Center" (CSCLMU), the"Coordination Centre for Surgical Studies" (KCS)or the Comprehensive Cancer Center (CCCLMU).Clinical studies are also possible at the MunichTumour Centre (TZM). The translation of resultsfrom basic research and pre-clinical studies toclinical practice is also being ascribed a greatdeal of importance at the Faculty for Medicine atTU München, for instance at the Klinikum rechtsder Isar. The Helmholtz Zentrum München alsonurtures collaboration with industrial partners.Clinical studies can also be conducted at otherBavarian establishments, such as the AsklepiosFachkliniken München-Gauting – primarily in tho-

racic oncology and in in-terventional broncholo-gy – or at the MunichMunicipal HospitalGroup. What needsto be observed duringclinical studies isoften underestimatedby developers. ”In thefirst instance, they areshocked”, confirmsDr. Bernd Gebhardt,Manager of the Centerfor Clinical Studies (CCS)at the Friedrich-Alexan -der-Universität Erlangen-Nürnberg. But he helpsthe hospitals with thecomplex organisational,business-related and legal tasks. Support such asthis is now attracting circles.

Strategy concept for personalised medicineKey research principles are being developed inBavaria for the field of ”personalised medicine”,which may well usher in a profound change tomedicine and a new dimension of drug devel-opment by way of an individual focus. Thisapplies, for instance, to the work undertakenon depression by Professor Florian Holsboer,who works at the Max Planck Institute ofPsychiatry in Munich, to the work examiningthe development of Herceptin (the only person-alised cancer drug for many years) undertakenby Professor Axel Ullrich, who is now Directorof the Max Planck Institute of Biochemistry, orthat of Professor Matthias Mann at the MaxPlanck Institute of Biochemistry in Martinsriednear Munich, which looks into innovative tech-nologies for proteins. In the Munich Metropoli-tan Area, biotechnology and pharmaceuticalcompanies, hospitals and scientific instituteshave come together with the cluster manage-ment company BioM for a strategy conceptentitled ”m4 – Personalised Medicine and Tar-geted Therapies”. Within around 40 researchprojects, the work of interdisciplinary academicresearch and industrial, mainly medium-sizedpartners, is being brought together. The respon-sible company, BioM Biotech Cluster Develop-ment GmbH, is working closely with partners atuniversities and other research establishments,as well as service providers.

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Bavaria

Within around 40 research projects interdisciplinary academic research and industrial partners are being brought together.

Photos: © BVMed-Bilderpool, Fraunhofer IBMT

Small and medium-sized companies are oftenfaced with a mountain of problems when itcomes to testing new medical technology solu-tions and devices. What has to be observed?What is to be documented? How do you obtainapproval? In Erlangen, there is help to overcomethe mountain: with "Metean".

All-inclusive – from the idea to marketingThe ”Metean” Medical Technology Test andDemonstration Centre of the Fraunhofer Institutefor Integrated Circuits (IIS) in Erlangen is a keyproject within the Fraunhofer ”Personal Health”cluster of innovation, which bundles differentcompetencies within the Fraunhofer Society. Itsvision is to prevent illnesses through providingmedical remote support. Healthcare researchprojects form the most important focal point ofMetean’s work. Clinical studies are conducted incooperation with hospitals, university institutes,health insurance firms and companies. At the

fore are improvementsthrough use of telemed-icine systems and ser -vices – both in the caseof the transition fromin-patient to out-pa-tient treatment andsupport, and in the caseof healthcare quality.The experts at Meteanare aspiring to coverthe entire chain of theinnovation and develop-ment process, from theidea over feasibilityanalyses, tests and val-idations, to certificationand approval – and notleast rapid marketing.

Fast user feedbackis catered forThe highlight at Meteanis close involvement inUniversitätsklinikumErlangen (Erlangen

university hospital), the infrastructure of whichcan thus be used for external partners. The Testand Demonstration Centre is situated directly onthe premises of the university hospital. Togetherwith the medical staff, the new innovations aresubjected to testing within everyday hospital life –and if the worst comes to the worst, problems arediscovered immediately. The findings are thenpassed on to the relevant company without delay.Fast user feedback is thus catered for, such thatno unnecessary time is wasted and relevantramifications can be drawn. The staff at Meteanbelieve that they can help small and medium-sized companies especially to overcome inno-vation hurdles and to find a way through the statu-tory, regulatory, economic and technical regula-tions with their multitude of basic conditions.

Highly personal: the tracksuit that instructsits userIn the Fraunhofer Institute for Integrated Circuits,the Image Processing and Medical Technology(BMT) department is primarily devoting itsenergies to medical image processing, medicalsensor systems, medical communication andbiosignal processing. Indeed, the ”Hemacam”product, a computer-assisted microscope systemfor haematology, was developed at Metean.One example of the intensive work being under-taken on the topic of personalised medicine isa so-called fitness companion, a sub-project ofthe ”FitForAge” Bayerischer Forschungsstiftungs -verbund (Bavarian Research Foundation Associa-tion). It is an intelligent tracksuit, which providesan individual health and fitness program, evalu-ates the data measured, provides the user withfeedback on his activities and thus instructs himin gymnastic or rehabilitation exercises – in anentirely personal manner, as it were. To date,this suit has primarily been used in movementprogrammes for the elderly or rehabilitation pa-tients. But in the future, it is also to be offeredto young people, for games or virtual competi-tions, for instance.

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The highlight from Erlangen

Testing directly in the hospital

Campus of Friedrich-Alexander-Universität Erlangen-Nürnberg Photo: © Friedrich-Alexander-Universität Erlangen-Nürnberg

Representatives of both the pharmaceutical andthe medical technology industry are companieswith an above-average level of commitment toresearch and development. With research ex-penditure amounting to more than 10 per centof company turnover, they are both innovationdrivers and business drivers in equal measure.In addition to numerous small and medium-sizedcompanies, global players such as SiemensHealthcare, Roche Diagnostics, GE Healthcare,Novartis Pharma, Fresenius Medical Care orGlaxoSmithKline are also represented in Bavariawith research and production sites.

An attractive location for global playersIn the field of drug development, Germany shookoff its role as ”the world’s pharmacy” many yearsago. Numerous so-called pharmaceutical giantshave relocated both their research and develop-ment sites and their production facilities abroad.But it is a different situation in the area of prom-ising drugs produced using biotechnology. Here,Germany has established itself as the biggestproduction site in Europe and, on a globalscale, is the world number 2, following the US.Companies such as Roche Diagnostics are re-sponsible for this development. Through makingcontinuous investments in its Bavarian site inPenzberg, Roche Diagnostics has expanded tobecome the Roche Group’s biggest biotechnolo-gy research, development and production centrewithin Europe, with more than 4,500 employees.As a pioneer to a certain extent, Roche hascommitted itself to personalised medicine as acore element of its business strategy. Generallyspeaking, the concept of personalised medicinerequires the patient to be characterised on thebasis of so-called biomarkers, which allow forsaid patient to be assigned to a patient groupfor which tailored treatment is available. Withregard to the co-development of diagnostics andtreatment required for this, in Bavaria Roche isbenefiting from the group’s globally uniquelocation, where research, development andproduction of the two business divisions, Phar-maceuticals and Diagnostics, are combined.

Fantastic research infrastructure and excellently trained staffA key tool during the development of new activeagents and drugs is testing them on individualsas part of clinical studies. Here, Bavarian com-panies are benefiting from the fantastic researchinfrastructure and excellently trained staff in awell-developed network of in-patient and out-patient medical care establishments. Over thelast few years, there has been a further con-siderable increase especially in the number ofapproval studies performed in Germany duringthe early phases I and II. Global players such asNovartis Pharma with just under 1,800 employeesat the Nuremberg site have strengthened Ger-many, where it is currently conducting around180 ongoing studies, to make it the most impor-tant clinical research location after the US.The situation is a similar one for the Germansubsidiaries of the international pharmaceuticalgiants such as GlaxoSmithKline, MSD and Daiichi -Sankyo, which also have their headquarters inthe Munich Metropolitan Area. Beyond pure salessubsidiaries, firms have increasingly been invest-ing in the expansion of their clinical researchsites over the last few years.

Medical technology from Bavaria: Leadingposition for electromedical devicesIn the field of medical technology, Bavaria coversaround 30 per cent of Germany’s entire medicaltechnology production. Electromedical deviceproduction occupies a leading position, with ashare of more than 60 per cent. In addition toa multitude of small and medium-sized compa-nies, Siemens Healthcare (which has research,development and production sites in the Nurem-berg Metropolitan Area), one of the world’sbiggest suppliers in healthcare, is responsiblefor this. With more than 50,000 employees theworld over, the company is a specialist in thedifferent areas of imaging and is the globalmarket leader in the magnetic resonance to-mography (MRT) sector. In addition to computertomography (CT), MRT has established itself asone of the most important imaging procedures

Pharmaceutical and medical technology companies in Bavaria

Overview, trends and developments

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Bavaria

and especially allows for the representation ofsoft tissue, such as that of the brain or internalorgans. At present, MRT is increasingly gainingin significance in hybrid imaging, as a combi-nation made up of MRT and positron emissiontomography (PET). Due to the simultaneousmeasurement of morphology and function onthe one hand and metabolism on the otherhand, considerable advancements are possiblein the case of clinical diagnostics, as well as inthe development of new biomarkers in person-alised medicine. Here, too, extreme technicalefforts are required in order to render PET de-tectors usable within strong magnetic fields.In addition to the continual further developmentof its diagnostic systems and devices, SiemensHealthcare is pursuing a long-term strategy forthe future by merging patient data from imagingand laboratory diagnostic procedures usingits own in-house IT systems. The company is

hoping to achieve an improvement in patientmanagement in the case of early detection, di-agnosis and treatment and thus an associatedreduction in healthcare costs.

Efficiency and integration: The future ofhealthcareAchieving integration in healthcare is also thestrategy of Fresenius, the world’s leading sup-plier of products and services for individualswith chronic kidney failure. More than everysecond dialysis machine in the world hasbeen developed and produced at Fresenius’Bavarian site in Schweinfurt. On the basis ofthis business field, over the last few yearsFresenius has developed other divisions and isnowadays not just combining the developmentand production of medicine products and drugs,but also patient care with some hospitals andspecial clinics in an integrated healthcare group.On the way to allowing for the best possiblehealthcare within a restricted budget, the in-creasing integration of different areas frommedical technology and pharmaceuticals, diagnostics and treatment, is proving itself as a common strategy of large groups especially.The cooperation with different solution providersfrom the area of modern communication tech-nology is also playing an important role in thisdevelopment.

SummaryBavaria as a pharmaceutical and medicaltechnology location is occupying an excellentposition in the global environment and hasextensive potential to consolidate and furtherbuild on this international leading position.Accordingly, a large majority of companies arerating the prospects for the future as positive –based on the opportunities gleaned through newmarkets, demographic development, a high levelof innovation and the outstanding reputation of”Made in Bavaria” healthcare products.

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Bavaria

Bavaria as a pharmaceutical and medical technology location is occupying an excellent position in the global environmentPhotos: © Archiv, Ioana Drutu

Professor Ullrich, can you briefly introducethe MPIB and the focal points of its research?We are part of one of the most successful research organisations in Germany, the MaxPlanck Society. Within our institute, eight departments and more than 30 research groupscontribute to the latest findings in the areas ofbiochemistry, cell biology, structural biology,biophysics and molecular science. The classicresearch areas of our institute are developingincreasingly in the direction of structural andsystem biology, genetics and new imagingmethods – bioinformatics is playing a majorrole, too. Basic biomedical research is anotherimportant aspect, as faults in cellular signaltransmission or defective protein structures canresult in illnesses such as cancer, diabetes orAlzheimer’s. The work of our scientists thus also

helps to better under-stand the developmentof these illnesses andforms a basis for newtherapy strategies.

What significancedoes the MPIB havefor the Germanbiotechnology sec-tor?I think an importantone. Some MPIB em-ployees played a cen-tral role in the develop-ment of the sector. Inthe Seventies, Prof.Peter Hofschneider, forinstance, was one ofthe first founders inthe area of biotechnol-ogy at European level.Prof. Horst Domdey,who was greatly in-volved in expandingthe biotechnology loca-tion of Bavaria and

who today manages BioM Biotech Cluster Devel-opment GmbH, had a laboratory at the MPIBand played a decisive role in establishing mo-lecular-biological methods. And, I suppose, mypast experiences in the first Biotech company inthe world, Genentech, also helped. I think that acertain role model function was assigned to me,which inspired others. What’s more, the MaxPlanck Society has also provided the premiseson which the Martinsried Biotechnology Innova-tion and Startup Center is located.

You founded three companies withinMartinsried, including Kinaxo GmbH,which was recently sold to Evotec. Howwould you evaluate the founding environ-ment in Bavaria?For some time now, I have had the feelingthat among scientists, the willingness tofound companies is spreading like a virus. Itis unbelievably exciting to watch. Prof. Domdey,who acts as a promoter and advocate for theMunich and Bavaria region, is largely responsi-ble for this. The environment for founding com-panies is very good. Academic and non-academicresearch establishments, founder centres anduniversity hospitals are situated in direct prox-imity to one another and are in regular con-tact. I myself recently co-founded a companyagain and I am also considering another com-mitment.

You often travel abroad due to your profes-sional activities. What strengths do youconsider Bavaria as a location to have inan international comparison?One of the biggest strengths of Bavaria as abusiness location is the political support. Whenplayers from politics recognise economic poten-tial, they work consistently on tapping into thispotential, too. I personally was therefore notsurprised that the German biotechnology adven-ture started in Bavaria.

The interview was conducted by Martin Bellof.

”Willingness to found companies isspreading like a virus”

Interview with Prof. Dr. Axel Ullrich, Director, Department of Molecular Biology,Max Planck Institute of Biochemistry (MPIB)

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Biotech in Bavaria

Prof. Dr. Axel Ullrich is director of the Department

of Molecular Biology at MPIBand a pioneering

Biotech-entrepreneur.

Located in Munich/Martinsried –Max Planck Institutes of Biochemistry and Neurobiology.

Photos: © Max Planck Institute of Biochemistry

Despite enormous medical progress, the effec-tiveness of many medications is hugely limited.Even for the most common medical drugs, suchas those against hypertension, the desired ef-fect fails to appear for more than one third ofthe patients. The reasons for this are the differ-ent biological causes of illnesses and the diver-sity of the medically relevant dispositions aswell as the life circumstances of each individual.These diverse individual factors define whethera medicine takes effect, shows no effect at allor even shows undesirable side effects.

Munich Leading-Edge Cluster m4

The Munich Leading-Edge Cluster m4 has setitself the task to develop effective and safemedications for serious illnesses such as cancer,cardiovascular diseases or autoimmune diseaseson the basis of personalised medicine. Person-alised medicine pursues the strategy that amore detailed molecular diagnostic prior to thedrug administration can lead to a better assess-ment of which substance is suited best forwhich patient. With an accompanying diag-nostic product that tests so called biomarkers,the patients are categorised in specific sub-groups of diseases (“stratified”). Afterwards,each group is treated with a specific therapy

if available: currently,only 26 ”personalised”therapy options areapproved in Germany,the main share of themin the field of oncology.”However, the inter-national pharmaceu-tical sector shows aclear trend towardspersonalisation”, saysProf. Domdey, thespeaker of the Lead-ing-Edge Cluster m4.Only with clearly de-fined patient groupsis it possible to over-

come the high efficiency and safety hurdles givenby the regulatory authorities.

Source of Inspiration for the Entire RegionMore than 100 biotechnology companies andacademic groups work in Munich’s m4 consortiumon 40 research and development projects spon-sored by the federal ministry BMBF. ”The projectsturned out to be a source of inspiration for theentire region and have strengthened Munich’sprofile as a top site for innovative drug develop-ment“, announces Prof. Domdey with pride. ”Fur-thermore, several comprehensive infrastructureprojects improve the framework conditions.”

m4 Biobank AllianceIn order to discover new biomarkers and statis-tically prove their medical relevance, human biospec-imens are required, especially tissue from sourcessuch as tumour biopsies that are linked to the clin-ical data of the anonymous donor. In the m4 BiobankAlliance, the Technische Universität, the Ludwig-Maximilians-Universität and the Helmholtz Zentrumjoined forces for a more efficient use of their bioban -king resources. Scientists as well as the researchingpharmaceutical and biotechnology industry benefitfrom the joint quality standards and a central access.

m4 Trial Service CenterBiomarkers offer new challenges, but also newchances for the implementation of clinical trials:on the one hand, the study becomes more com-plex; on the other hand, biomarkers can helpstratify patients and allow statements on whichpatient groups would specifically benefit fromtherapy. The design of such biomarker-drivenclinical trials is the focus of the m4 Trial ServiceCenter. Here, companies receive advice andexpertise on the topic of biomarkers – from thedesign of the study to the approval. These andother projects, such as those for training andtechnology transfer, help to make the Munichlocation fit for the medicine of the future.

Dr. Georg Kääb and Dr. Almut Graebsch

Fit for the Medicine of the Future

Focus on ”Personalised Medicine” in Munich

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Biotech in Bavaria

Personalised Health Care - how it worksSource: m4 – Personalized Medicine in Munich, BioM Biotech Cluster Development GmbH

Biomarker Diagnostics

Personalised Health Care

Thanks to a multitude of small and medium-sizedcompanies within an environment characterisedby entrepreneurial spirit, Bavaria has turnedinto an exciting location for the biotechnologysector in Germany.

Excellent Culture of InnovationIn Bavaria, a great deal of importance is attachedto creativity. For more than two decades now,young innovative companies – often createdas spin-offs of scientific institutions – primarilyin the area of red biotechnology have beenpushing a development which becomes mani-fest in impressive figures. The companies –166 in total – today account for more than30 per cent of all small and medium-sizedbusinesses in Germany, and time and again,they attract the attention of investors. Bavariathus received almost half of Germany’s nationalventure capital provided for biotechnology in2011. In the same year, the federal state wasthe only region in which international compa-nies within the sector had set up shop. Andthere are good reasons for this development.

One of them is the excellent scientific infra-structure with its renowned research institutesand further education establishments. Indeed,the universities in Munich, Regensburg andWuerzburg are affiliated to both the MaxPlanck Institutes and the Helmholtz ZentrumMünchen. Intensive exchange between scienceand companies, which are promoted by theBavarian Ministry of Economics and to which –not least – the subsidiaries of renowned phar-maceutical companies also make a consider-able contribution, is being pushed forward byregional clusters and national networks. Bavariahas not only turned the resultant culture of in-novation into a hub, but also to a biotechnologydriver in Germany. The more than 80 potentialtreatment candidates at an advanced clinicaltrial stage and a wealth of pre-clinical studiesare testament to this. But the many small andmedium-sized companies are increasinglycapable of earning money, too. During thetime from 2008 to 2011, they increased theirturnovers by 30 per cent to more than EUR 510million, while at the same time the number of

Land of the Biotech Pioneers

Innovation in Bavaria comes from small andmedium sized enterprises

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Biotech in Bavaria

Product pipelines of 4SC, Antisense Pharma, Morphosys and WilexSource: own research

4SC Wilex

0 5 10 15 20 25 30

MorphosysAntisense Pharma

Research

Preclinical

Phase I

Phase II

Phase III

individuals employed within the sector grewfrom around 3,400 to more than 4,000 membersof staff. Income from partnerships and licenceagreements with large pharmaceutical and Biotechcompanies also contribute to the generation ofturnover, as do revenues from the provision ofknow-how and services based on independentlydeveloped technology platforms.

Commercially Successful, TooOne of the flagships of the location is theantibody specialist Morphosys AG, which wasfounded two decades ago and has its head-quarters in Munich. In 1999, it was the firstGerman Biotech IPO to successfully make thejump to the stock exchange and it has leadingtechnologies, which are used for research pur-poses, in diagnostics and in the manufacture

of drugs. Through alliances with the world’smost significant pharmaceutical companies,Morphosys has built up an extensive pipelineof more than 70 potential drug candidates – fortreating cancer, rheumatoid arthritis and Alzheimer’sto name but a few examples. The partnershipsand the marketing of in-house technologiesnowadays allow companies to completelyself-fund their own research activities and togenerate stable operating profits. A key foun-dation for this development is the HumanCombinational Antibody Library (HuCAL),which has been built up over the years. As oneof the many highlights in the company’s history,in spring 2012 Morphosys recorded the first everfurther development of a HuCAL antibody for thetreatment of Alzheimer’s patients in an approval-relevant study.

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Biotech in Bavaria

”IZB will continue to grow”

Interview with Dr. Peter Hanns Zobel, Managing Director, IZB GmbH

Dr. Zobel, can you briefly introduce IZB?IZB was founded back in 1995. Its objective is toprovide founders of biotechnology start-ups withthe required building infrastructure. To this end,we offer laboratories and offices with flexibletenancy agreements. IZB has experienced stronggrowth since it was founded. On a total surfacearea of more than 23,000 m² at the Martinsriedand Freising-Weihenstephan sites, we presentlyaccommodate just under 60 companies. Beyondthe infrastructure, we also arrange contacts withinour far-reaching network of scientists, companiesand investors and devote our energies to ourtenants at trade fairs and events.

When do your tenants leave IZB?Generally, we plan with a period of around fiveto seven years. By then, the companies have forthe most part reached a size which would go be-yond the scope of IZB’s walls. But because labo-ratory space is thin on the ground on the com-mercial property market, in individual cases wealso accommodate companies beyond this time.

What success stories can trace their rootsback to IZB?

Since IZB was founded, around 50 companieshave left. Most of them are successful eventoday. Nowadays, two companies that origi-nated in Martinsried stand out especially. Firstly, there is Micromet, which was takenover by Amgen for USD 1.2 billion, and sec-ondly, there is Corimmun, for which Johnson &Johnson, an American pharmaceutical firm,paid USD 100 million. When correspondingmilestones are reached, this sum can evenmore than double.

What do you imagine IZB will be like inten years?By 2022, our campus will have continued togrow and will have turned into the best bio -tech location in Europe. The connection theunderground railway, which will be completedby then, and a boarding house will further im-prove the infrastructure of our campus. The”faculty club” in our boarding house will allowfor more intensive exchange in the campusnetwork and make it even more prolific. I alsofirmly believe that by then the first Biotechblockbuster from Martinsried will have comeinto being.

Dr. Peter Hanns Zobel is theManaging Director of the Biotechnology Innovation andStartup Center (IZB) with sitesin Martinsried and Freising.

Growth-Oriented StrategiesIn addition, many of the other initial founders haveexpanded their business models over the yearsand developed promising growth strategies. Forinstance, Wilex AG, which is researching differ-ent types of cancer in the area of detection andtargeted treatment and was created from aclinical group of researchers at TU München,nowadays generates turnover amounting to themillions and still on the increase. One of mostadvanced products of the product portfolios isan imaging diagnostics tool named Redactane.This tool serves to better distinguish betweenbenign and malignant kidney tumours. But Wilexhas also purposefully expanded its spectrum ofservices by way of acquisitions and it offersservices relating to pre-clinical contract research.A large portion of the turnovers already gener-ates comes from US licence agreements forthe potential Rencarex product which aims toprevent metastases in the kidneys. A successfulincrease in capital, which was achieved onlyrecently, provides evidence of the trust investorsplace in the company, which is also listed on thestock exchange.

Efficient Use of Financial ResourcesTime and again, Biotech companies are show-ing that it is possible to widely distribute thedevelopment risk and, at the same time, exploit

synergies through a multitude of projects. Oneof these companies is 4SC AG, which is basedat IZB Martinsried and has created a largepipeline for drugs to treat cancer and autoim-mune diseases. This results in continuallygrowing income. To this end, 4SC is concludinglicence agreements with partners from thepharmaceutical and Biotech industries startingfrom a particular phase, so that it can thentackle the final clinical phase and the marketlaunch together with the partners. An example

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Biotech in Bavaria

Morphosys was founded two decades ago. Today the antibody specialist can be seen as a flagship for Germany's biotechnology industry.

Photo: © Morphosys AG

Shareholder structure of 4SC, Antisense Pharma, Morphosys und WilexSource: own research

Company Selection of significant investors Listed company Free float*

4SC** Santo Holding (48,1 %), FCP (9,91 %), DVCG/VCG (6,13 %), Heidelberg Capital (5,86 %)

yes 24,50 %

Antisense Pharma*** MIG Verwaltungs AG, S-Refit, gcf - Global Chance Fund, GAF – Global Asset Fund, kfw Mittelstandsbank, Bayern Kapital

no –

Morphosys Novartis Pharma (ca. 7 %), Astra Zeneca (ca. 5 %) yes ca. 88 %

Wilex dievini Hopp Bio Tech Holding (31,16 %), Verwaltungsgesellschaftdes Golf Club St. Leon-Rot (12,85 %), UCB (15,71 %), TVM CapitalFonds (4,5 %), Merlin Fonds (3,44 %)

yes 30,81 %

* Free float as defined by Deutsche Börse ** management estimates *** percentages not given

of this is the licence agreement concluded withthe Japanese partner Yakult Honsha in 2011 forthe purpose of commercialising the cancer drugResminostat; this agreement outlined terms forthe revenues from advance payments, milestonepayments and subsequent commissions. Throughthe subsidiary 4SC Discovery GmbH, the companyalso markets its know-how as a service providerfor the pharmaceutical industry. Thanks to acapital increase, 4SC was recently also able tosecure additional funding.

Attractive for Risk CapitalWith the help of venture capital and private in-vestors, Antisense Pharma GmbH based in BioParkRegensburg is developing innovative drugs to fightagainst aggressive tumour-induced diseases. Indoing this, the company is relying on the immensepotential of the active ingredient Trabersen, whichcan assist the human immune system in fightingtumours and simultaneously inhibit the spreadingof cancer cells. The company, which was foundedin 1998, has already been recognised with theDeutscher Gründerpreis (German Business FounderAward) and the Bayerischer Innovationspreis(Bavarian Innovation Award) and to date, it hascollected more than EUR 90 million in venturecapital. For the venture capitalists, it is an inter-esting investment, because Antisense Pharma isspecifically focusing on pre-clinical and early

clinical studies, in order to reach the aspiredmilestones for a multitude of indicators quicker.This reduces the corporate risk and, at the sametime, increases the opportunities for successfulpartnerships and lucrative licence agreements.

Sights Set on International CompaniesBut the innovative force of the Biotech compa-nies has not only been capturing the interest ofcooperation partners of late. Increasingly, theinternational pharmaceuticals industry is alsoprepared to acquire the ideas developed inBavaria by way of purchasing entire companies.An outstanding example of this is the takeover ofCorImmun GmbH, which is based in Martinsried,by Janssen-Cilag GmbH, a subsidiary of pharma-ceutical giant Johnson & Johnson. Although theheart failure treatment projects being realised bythe Biotech start-up, which was only founded in2006, are still in an early trial phase, the pharma-ceutical giant effected the complete takeover insummer 2012 to the tune of USD 100 millionaccording to media speculation. And this certainlyisn’t an isolated case. Four years beforehand,the second-biggest Japanese pharmaceuticalcompany, Daiichi Sankyo, was prepared to paythe handsome sum of EUR 150 million to purchaseU3 Pharma AG. The takeover of the company, whichspecialises in researching monoclonal antibodiesand which was founded based on research resultsof the Max Planck Institute of Biochemistry inMartinsried, allowed for the further developmentof promising cancer treatments.

Looking Optimistically to the FutureInternational companies’ interest in the BavarianBiotech sector shines a light on what the manysmaller and medium-sized companies have tooffer in terms of creativity and implementability.With their innovative clout in an extraordinaryenvironment, they will also attract the interestof investors from all over the world in the future.The latest example of this is the newly-foundedsubsidiary of the US venture capital specialistMPM Capital in Munich. From the metropolis onthe Isar river, the life science investor is wantingto look out for suitable investment opportunities inEurope.

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Biotech in Bavaria

Created from a clinical group of researchers at TU München,Wilex AG today generates growing seven-digit turnovers.Photo: © Wilex AG

Athos Service GmbH, which is ownedby the Strüngmann brothers who foundedHexal, and MIG Fonds are counted amongthe most important venture capitalists inthe German Biotech industry. How manycompanies from the life sciences sectordo you currently have shares in, and howmuch have you invested to date? Howwill you continue to build on your com-mitment?Jeggle: At present, we have shares in 12 lifescience companies and in total, we have invest-ed or committed just over EUR 700 million. Weare currently devoting more of our energies tothe corporate development of the more matureportfolio companies and we are only having anopportunistic look around for new shareholdingopportunities.Motschmann: To date, MIG Fonds have investedaround EUR 225 million in 18 life sciences com-panies. There are always attractive life scienceinvestments in our shareholding pipeline, butthese are in competition with other shareholdingopportunities from other sectors.

What investment strategy are you pursuing?Which companies are you interested in?Jeggle: As a family-owned firm, we tend tothink more in terms of generations. It is thus

important for us toidentify partnersthat suit us and areready to tread newpaths with us. Overthe last 5 years,we have built upa demanding port-folio in the area ofbiotechnology. Here,the focal point hasbeen the area ofpersonalised medi-cine in oncology.But we have alsotested other indica-tions, such as thecentral nervous

system, and we have expanded our portfolio toinclude our latest shareholding, Affiris in Vienna.The challenge for us is to optimally supervisethis portfolio using the required resources andassistance. In our partnership with Affiris, weare increasingly concentrating on advancedphase II projects.Motschmann: Because we regularly invest fromnew funds, we are constantly on the lookout fornew investment opportunities. But to all intentsand purposes, these can indeed come from theportfolio of another MIG Fonds company. Gener-ally speaking, companies are developing furtherat a rapid pace. A portfolio company from an ”old”fund may well be a completely different companytoday than it was at the time when the initialinvestment was made, not just in terms of itsdegree of maturity, but also with regard to theresidual risk, the remaining holding period andof course the anticipated return. As far as thebasic technologies and sectors are concerned,we are fairly opportunistic. It is important thatbusiness models are scalable, ideally have aglobal dimension and satisfy long-term require-ments, such as the topics of health, resourcesand mobility.

From an investor’s perspective, how doyou rate Bavaria as a Biotech and medicaltechnology location?Motschmann: For us, the location of Bavariais very attractive, which is also reflected in ourportfolio. At present, we have shares in somecompanies in the two metropolitan areas ofMunich and Nuremberg-Erlangen. The twocluster management hubs do a good job,especially in relation to rapid integration ofstart-ups. This in turn results in brisk exchangeamong companies and enables synergies.The fact that not only is there excellent basicscience in the direct vicinity of the clusters,but also the headquarters of large companies,certainly boosts the attractiveness of the loca-tion further.

The Interview was conducted by Markus Hofelich.

”It is important that business modelsare scalable”

Interview with Helmut Jeggle, Athos Service GmbH, and Michael Motschmann, MIG Verwaltungs AG

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Biotech in Bavaria

Michael Motschmann is amember of the MIG executiveboard. He is responsible for

the selection and supervisionof investments.

Mr. Helmut Jeggle is respon-sible for the life science ini-tiatives at ATHOS Service

GmbH, the Family Office ofthe Strüngmann brothers.

Types of investors and their participation in financing roundsSource: Ernst & Young, 2012

0 10 20 30 40 50 60 70in %

Savings banks and governmental promotion tools

Funds for Private Investors

Family Offices

Private Investors

Corporate Investors

Venture Capital(foreign countries)

Venture Capital(Germany)

How did it come about that Penzberg is nowthe largest biotechnology centre in Europeand one of the most important biotechnolo-gy sites of the Roche Group worldwide?The birthplace of industrial biotechnology is regard-ed to be in Tutzing at Lake Starnberg. In Tutzing, thecompany Boehringer Mannheim began focussingits efforts on researching and developing newbiochemical methods to aid disease diagnosisafter tWorld War II. From 1972, this company division in Penzberg embarked on a further expansion project. A former mine site providedthe ideal area for increasing the company’s pro-duction capacities. Since then, there have beenconstant investments in the Penzberg site – in-vestments in research, development and the pro-duction of medicines and diagnostics. Knowledgeof biochemistry extends from the time of classicbiotechnology to today’s modern biotechnology.Since Roche’s takeover in 1998 alone, approxi-mately EUR 2 billion have been invested in thesite’s expansion, which in fact is one of the largestbiotechnology centres in Europe to date. More-over, employee expertise and their enthusiasm forwork, networking of the pharmaceutical and diag-nostics business areas in the context of person-alised medicine, reliability when implementingprojects and, last but not least, close collaborationwith politicians and authorities are all absolutelyessential for success.

Roche continues its expansion venture of thebiotechnology site in Penzberg. In 2011, theSwiss pharmaceutical company invested EUR158 million in the research and developmentof therapeutic proteins. What objectives areyou currently pursuing? What other invest-ments are planned in Penzberg? This investment is of great significance as it com-pletes the value-added chain at the Penzberg site;from research previously carried out to technicaldevelopment and the production of biopharma-ceutical active ingredients to be launched on themarket. The objective was to improve the devel-opment of production processes for protein-basedactive ingredients and the availability of pre-clin-ical and clinical studies which use biotechnological

active ingredients. This reinforces Penzberg’sname as the ”Centre of Excellent for TherapeuticProteins”. As a general principle, large investmentsare discussed in the Roche Group; initially inde-pendent of a location and based on their necessity.Penzberg must always request these investmentsand they are therefore keen to impress with theirhigh levels of productivity and excellent innovativestrength.

What role does personalised medicine playtoday and in the future for Roche? What areRoche’s special strengths and the strengthsof the Penzberg site in particular in this area?We are fully convinced that the future lies in per-sonalised medicine. It is precisely for this reasonthat it represents a key element of the Rochestrategy. In Penzberg, scientists from the diag-nostics and pharmaceutical sectors are workingin close collaboration on new therapies. Thisgenerates synergies which are not evident at otherRoche sites.

Generally speaking, how do youview the biotechnology and phar-maceutical sector in Bavaria?The Bavarian state has introduced ini-tiatives that promote both high-qualitytraining (MINT initiative, elite universi-ties) and cross-linking between scienceand industry (Leading-edge clusters,IZB Martinsried and Bayern Innovativ).Politics in Bavaria has also laid goodfoundations for high-tech companies,which has resulted in Bavaria’s biotechindustry being ranked among the bestworldwide. However, we must continueto ensure that research and developmentin particular remain attractive in Germany.Furthermore, I am of the opinion thatthe detrimental effects of the health-care reforms for the pharmaceuticalindustry should also be discussed inthe context of job security.

The interview was conducted byMarkus Hofelich.

”Since 1998, approximately EUR 2 billion have been invested in site expansion projects”

Interview with Claus Haberda, Site Manager, Roche Penzberg

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Biotech in Bavaria

Claus Haberda is Site Manag-er at Roche in Penzberg.

Constant investments through Roche as well asgood foundations laid by politics in Bavaria madePenzberg one of the biggest Biotech locations inEurope.Photo: © Roche Penzberg

Mr. Paulson, this year, Amgen acquiredMicromet for USD 1.16 billion. It was thelargest ever transaction involving a Ger-man biotechnology company. What makesMicromet so special?Amgen has always been committed to developingthe most innovative new medicines, based on themost advanced understanding of disease states,to treat patients with serious illnesses. Micromethad brought excellent scientists together, and builta promising late-stage cancer drug pipeline, aswell as an R&D engine with the potential togenerate many more cancer drug candidates wellinto the future. We believe the Bispecific T cellEngager (BiTE) antibody technology developed byMicromet is one of the most exciting platforms inthe world, to develop safe, effective new medi-cines for cancer patients. Amgen and Micrometwere an excellent fit, given our people and ourcorporate cultures, both of which were science-based and values-driven. We wanted to put Mi-cromet’s science and people right at the heart ofAmgen’s continuously growing R&D efforts, andthat’s exactly the role they will play, as the new

Amgen Research (Mu-nich) GmbH. This isthe largest single in-vestment Amgen hasever made, and it sig-nals our commitment topursuing the very bestmedical science, boththrough our in-houseR&D capabilities, andthrough technologiesand compounds frompartners around theworld.

What is the potentialyou see for Amgen,from the BiTE tech-nology platform?With BiTE, we see thepotential for a wholenew generation of novel

therapies, to help patients with cancers that areinsufficiently treatable today, and for whom othermedicines are not working. For example, themolecule blinatumomab is in development rightnow for a type of blood cancer – acute lymphoblas-tic leukemia (ALL) – for patients who have ex-hausted all other treatment avenues. In clinicalstudies, this drug has also shown to be active insome patients with non-Hodgkin’s Lymphoma,as well as those with ALL. The BiTE technologytakes a new approach to treating cancer. It aimsto enable a patient’s own natural defenses – theimmune system – to mobilize the body’s T cellsto reach cancer cells, attack them, and induceapoptosis (programmed cell death) of just thecancer cells. If successful, this should result inmedicines that are both extremely effective infighting tumours, and also safe and well-toleratedby patients. BiTE is a unique, innovative andclinically confirmed platform. And Amgen’s skillin developing and manufacturing complex bio-pharmaceutical treatments will advance thistechnology, with the potential to benefit millionsof patients around the world.

How important is the German market forAmgen in terms of R&D and sales?Germany is vital to the future of Amgen, and wehave a strong and growing presence here. WithAmgen Research in Regensburg and AmgenResearch in Munich, we are the only global Amgenaffiliate with both research and clinical facilities.That’s a testament to the strength of medicalscience and R&D in Germany. At the momentwe have approximately 100 active studies underway across Germany. In Germany we are theleading Biotech company delivering new andinnovative medicines to treat serious illnessessuch as cancer, osteoporosis and kidney diseases.We are proud that we have introduced threenew products in the last two years for the indi-cations skeletal-related events, metastaticcolorectal carcinoma and osteoporosis.

The interview was conducted by Markus Hofelich.

”The acquisition of Micromet is thelargest single investment Amgen hasever made”

Interview with Richard Paulson, VP & General Manager, Amgen GmbH in Germany

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Biotech in Bavaria

Richard Paulson is VP & General Manager at Amgen GmbH in Germany.

With sites in Regensburg and Munich, Germany is Amgen’s only global affiliate with both research and clinical facilities.

Photo: © Amgen GmbH, Deutschland

Professor Kalender, you have been the Di-rector of the Institute for Medical Physicssince its establishment in 1995 – What setsthe institute apart?The decisive characteristic of the IMP is probablyits close collaboration with industrial partners forvirtually all research projects. Moreover, as a resultof the activities of our institute, research organi-sations have been birthed in Bavaria, nation-wideand throughout Europe, which are heavily sub-sidised. Even from today’s perspective, the decisionof the Universität Erlangen-Nürnberg to set up theIMP was also a stroke of luck for me personally.This allowed me to freely choose research topics,contact any competence partners and launchcooperative ventures with the industrial sector.

What have been the most ground-breakingresearch results of your institute to date? Here I would simply like to mention Cardio-CT andefforts to reduce the radiation dose in computedtomography. Cardio-CT, i.e. the non-invasiveexamination of the heart which uses computedtomography, is based on spiral CT technology;technology which I developed during my time atSiemens where I was able to demonstrate its scopefor heart imaging. The method was first fully im-plemented and clinically tested in the universityenvironment in direct cooperation with cardiologistsand radiologists. Moreover, the concepts of dosisreduction with tube current modulation and auto-matic dose stabilisation, which were developed inthe late 1990s, are based on spiral CT technologyand were first used at the Universität Erlangen.Today, both methods are used around the globe.Collaboration with Siemens was crucial in bothcases and a great success for all those involved.

The university is part of the Medical Valleyin which around 180 dedicated medicaltechnology companies are located. Whatmakes the combination of research andbusiness stand out?The climate in Bavaria in this respect has been verypositive for a long time; the guidelines providedby the Bavarian Research Foundation mean that

”A win-win situation for both sides; theeconomy and university research”

Interview with Prof. Dr. Willi A. Kalender, Director, Institute for Medical Physics(IMP), Friedrich-Alexander-Universität Erlangen-Nürnberg

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MedTech in Bavaria

Prof. Willi A. Kalender isDirector of the Institute forMedical Physics at theFriedrich-Alexander-Univer-sität Erlangen-Nürnberg, as well as founder and managing director of CT Imaging GmbH, Erlangen.

Evolution of third-party funds raised by IMPSource: IMP

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Volume of third-party funds raised

Examples for significant IMP research projects

FORBILD (Bay. Forschungsstiftung)

MEDBILD (Bay. Forschungsstiftung)

orthoMiT(BMBF)

FP 6/EU Dose(Europäische Union)

FP 7/Breast CT (Europäische Union)

Forschergruppe FOR661 (DFG)

funding is only guaranteed for research projectswhen industrial partners are also involved andare willing to meet at least 50 per cent of the costsincurred. In the medical technology sector, thisapproach has proven to be successful over a periodof many years and it was once again reaffirmedby the establishment of the Medical Valley Clusterwhich was funded by the German Federal Ministryof Education and Research (BMBF). The universityis represented in a large number of funded projects;a win-win situation for both sides – the economyand university research.

You often travel on business to the USA.What are the strengths of the Bavarian region when compared internationally?In my opinion, the level of education representsa particular strength of the Bavarian region. InBavaria and Germany as a whole, an excellentprofessional and vocational education systemhas been established for many years. However,this is unfortunately not taken into account ininternational comparisons. Generally the numberof university graduates is recorded but not thequality of their degree results. Moreover, voca-tional training is rarely considered. Our specialisedstaff – technicians, precision mechanics, mecha-tronics technicians etc. – have undergone excel-lent training in both handicraft and vocational workby international standards.

The interview was conducted by Martin Bellof.

Be it computer tomographs or highly sensitivemeasuring devices, high-tech implants or laserapplications, Bavaria occupies an internationallyleading position in numerous key technologieswithin the field of medical technology. It is prima-rily the more than 250 small and medium-sizedcompanies which are time and again pushingforward this development and are reinforcingthe location’s leading role within Germany.

Innovative companies in an excellent environmentBavaria is synonymous with almost a third ofmedical technology production and even withmore than 60 per cent of electromedical deviceproduction in Germany. The companies are alsosuccessful on the global markets with their in-novations, achieving an export rate of around70 per cent, and are presently a key economicfactor with more than 30,000 employees. Indeed,the trend appears to be climbing further. InMedical Valley European Metropolitan RegionNuremberg alone, around 100 new companieshave been founded since 1998. In their researchprojects and developments, they can count onthe proximity to more than 65 hospitals, morethan 70 chairs at universities and universities ofapplied sciences and 20 non-academic researchinstitutes. In addition, the university hospitalsin Munich, Regensburg and Wuerzburg aresynonymous with the scientific potential of thelocation. No less important are institutions suchas the German Aerospace Centre and the Fraun-hofer and Max Planck Institutes. The companiesbenefit in the case of all the cross-sector andcross-technology cooperations, which are pur-posefully promoted by the Forum MedTech Pharmanetwork created by the Bavarian Ministry forEconomic Affairs. Last but not least, the sector’srapid start-up scene is enjoying a disproportion-ately high level of commitment from venturecapitalists, whereby publicly financed seed fundsplay just as important a role as private investors.National figures confirm the significance of med-ical technology. In 2011, it was counted amongthe three sectors that attracted the greatest level

of interest with regard to venture capital, recordingcapital inflows of EUR 66 million and a total of77 investments.

Pioneers and market leadersMedical technology in Bavaria therefore alsohas a good reputation, because it can demon-strate ground-breaking successes in many areas.One of these renowned pioneering companies isPeter Brehm GmbH, which is based in Weisendorf.In the middle of the 1980s, the company devel-oped a cement-free hip implant made fromtitanium together with the Accident Surgerydepartment of Friedrich-Alexander-UniversitätErlangen-Nürnberg. During the same decade,the company made a splash with the artificialreplica of a knee joint, and a decade later therefollowed the first robot-suitable hip implant. Atthe start of this millennium, the company ulti-mately created a new quality level with regardto the durability of artificial joints with the clinicalintroduction of the Brehm precision knee system.This was also met with resonance on an inter-national level. In the case of the hip revisionimplants, which enable the exchange of individualparts, the pioneers from Franconia have long sincebeen the market leaders in Europe.

Innovations in the area of imaging devices foruse in ultra-modern operating theatres alsohave a long-standing tradition in Bavaria. ZiehmImaging GmbH based in Nuremberg, for instance,was founded 40 yearsago and since then ithas pushed develop-ment in mobile X-raytechnology to the fore.In 2006, the Franconianfirm thus positivelyushered in a new im-aging era with thefirst fully digital, mo-bile C-arm. Ziehm Im-aging is being spurredon by its own innova-tive force, by investing

Trendsetter for health

Small and medium-sized companies are drivingforward advancement in medical technology

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MedTech in Bavaria

In 2008, Human Optics launched the first foldable artificial iris on the market and thus helped individuals with eye problems

to enjoy improved sight again.Photo: © HumanOptics

15 per cent of its turnover in research anddevelopment each year.

Demand from all over the worldHumanOptics AG, which was founded in 1999 inErlangen, is synonymous with innovations in thearea of optical medical technology. Seven yearsafter it was created, the company, which wasinitially financed with venture capital, made thejump to the Frankfurt stock exchange. In 2008,HumanOptics then made the professional worldmarvel, as it launched the first foldable artificialiris on the market and thus helped individualswith eye problems to enjoy improved sight again.The company also produces intraocular lenses,which are used in treating cataracts. Here, theestimated market growth lies at six to eight percent yearly and the lenses are therefore growingin significance as an alternative to laser treat-ments. With its sales network in more than 40

countries, the optical specialist can in the futureeven benefit from the above-average opportunitiesfor growth in Asia. Prospects such as these makeinvestors prick up their ears, too. In February 2012,the Swiss holding company Medipart AG becamethe majority shareholder.

Successful service providersBavarian medical technology hasn’t just createdefficient networks. Service providers, which helpother companies in developing and producinginnovations, have also sprouted. One of theseproviders is Corscience GmbH & Co. KG basedin Erlangen, which was founded at the start ofthe millennium and primarily focuses its energieson the development of diagnostic and treatmentdevices for cardiovascular diseases. In addition tothe services, the B2B company offers completedbasic technologies as well as production of deviceson customer order. One of its latest developments

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MedTech in Bavaria

”The location can compete with internationalleading centres”

Interview with Dr. Peter Terhart, Chairman, S-Refit AG

Dr. Terhart, what makes Bavaria as a loca-tion for medical technology so special andthus interesting to investors, too?The research and medical treatment infrastructurethat has grown over the years is just as much aninternational example as the corporate landscapein the sector of medical technology. Furthermore,the Free State’s high-tech offensive has usheredin a key development process. It is indeed a marathonas opposed to a sprint. But even now, the locationcan compete with international leading centres.Key reforms in patent systems have contributedto this, as has the foundation of an organisationfor better commercial exploitation. This is the baseon which leading research thrives and this attractsinvestors.

Which areas are companies, in which S-Refit is currently invested, operating?One of the most interesting examples is Cerbomed,which is based in Erlangen. By way of nerve simu-lation with electrical pulses, it is developing new

treatments for neurological diseases such as de-pression, pains and epilepsy. There is still an im-mense requirement for this on a global scale. Aceos,which is based in Fuerth, is synonymous with thetrend towards preventative measures in health-care. Among other things, it has developed a newmeasuring device for efficient endurance training.

Can you help the companies beyond thestart phase?A nucleus is created with us in Bavaria, both inBioPark Regensburg and in Medical Valley EMN.Afterwards, the companies have to strike out ontheir own at some point. If we, together withSparkasse Erlangen, invest through medTECHCapital Fonds which was initiated by SparkasseErlangen, we want to make the companies at-tractive to other investors, too. And that works.Generally speaking, we are currently recording,among other things, a high level of interest inBavarian companies on the part of large medicaltechnology funds from Switzerland.

Dr. Peter Terhart is headingS-Refit as sole member of theManagement Board. He is alsoChairman of the Board of theGerman Private Equity andVenture Capital Association.

is a small sensor, which detects cardiac arrestor apnoea within a few seconds through beingstuck on to the throat of an unconscious individ-ual; it can thus provide rapid information for im-plementing immediate measures.

From the university to starting a companyThere certainly isn’t a lack of promising start-ups nowadays. As a specialist in the computertomography (CT) sector, CT Imaging, whichwas created as a spin-off from the Institute ofMedical Physics (IMP) of the Friedrich-Alexander-Universität Erlangen-Nürnberg, is thus developingnew procedures for medical imaging and imageprocessing. The company already has eight patentsissued and 11 patents published, and is focusingon high-resolution CT systems, which are just asmuch in demand among pharmaceutical compa-nies as well as among further education estab-lishments and industrial users. The world’s firstdual source micro CT system, for instance, withits extremely short scan times is used in researchwith regard to in vivo small animal imaging. Inturn, a dedicated mammography system allowsfor tumours in the female breast to be diagnosedat an early stage. As the leading project in theMedical Valley top cluster, this breast CT isbeing promoted by the Federal Ministry of Edu-cation and Research (BMBF). Metrilus GmbH,which was founded from the Friedrich-Alexander-Universität Erlangen-Nürnberg in 2010, was alsoable to make use of aid money from the BMBF.The company has also already been honouredwith prize money as the winner of the Northern

Bavaria Business Plan Competition. MetrilusGmbH develops software products for real-time recording of 3D data for so-called time-of-flight cameras. Among other things, thistechnology enables more efficient respiratorymeasurements or clearer recording of beatinghearts, too.

Venture capital for new ideasCerbomed GmbH based in Erlangen is countedamong the companies, which in addition topublic aid money can also build on solid fundingthrough venture capital. The firm, which wasfounded in 2005, was provided with assistanceby a whole range of venture capital firms earlyon, in order to enable the development of aninnovative neuro simulation technology. It isaiming to allow individuals with neurologicaland psychiatric diseases to have an improvedquality of life while simultaneously incurringfewer treatment costs. The company has alsoreceived European approval (CE symbol) forseveral indications, including one in August2012 for the vagus nerve simulation in thetreatment of chronic pain. All too often, drugshave not achieved the desired effect for this in-dication, which is among the most widespreadconditions in industrialised countries. Cerbomedis thus symptomatic for what medical technologyfrom Bavaria can achieve: helping people and,at the same time, tapping into an immensemarket potential.

Norbert HofmannInvest in Bavaria

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MedTech in Bavaria

Product focus of selected MedTech-SMEsSource: own research

Company Product focus Founded

Ziehm Imaging GmbH Mobile X-ray based imaging – focus on intraoperative imaging and innovative X-ray technology

1972

Peter Brehm GmbH Spine-, hip- and knee-implants 1981

CT Imaging GmbH Medical Imaging and Image Processing – focus on Computed Tomography systems including Micro-CT

1997

Human Optics AG Ocular implants – focus on intraocular lenses, Add-on lenses and artificial iris 1999

Corscience GmbH & Co. KG Cardiovascular therapy and diagnostics – focus on vital parameter sensor systems, electro -therapy, algorithm, wireless transmission technologies as well approval and production

2001

Cerbomed GmbH Neuromodulation – focus on transcutaneous Vagus Nerve Stimulation for patients withhard-to-treat neurological and psychiatric illnesses

2005

Metrilus GmbH Special applications 3D cameras – focus on Time-of-Flight (ToF) cameras 2010

In Medical Valley EMN and thus in Bavaria, in-terdisciplinary teams of researchers from busi-ness and science are developing solutions forthe healthcare of tomorrow along the leadingthemes of Diagnostic Imaging, Intelligent Sen-sors, Treatment Systems and Ophthalmology.

Diagnostic Imaging – ”Breast Cancer Comput-erized Tomography Scan” Research ProjectOn average, every eighth woman in Europe andNorth America develops breast cancer during thecourse of her life. Being diagnosed as early aspossible is definitive to the disease being treatedsuccessfully. In the ”Breast Cancer CT Scan/Inte-grated Breast Care" projects, concepts for a gentlyand highly sensitive diagnosis of breast cancerare being developed, which record the entire careprocess for women with a risk of breast cancer.A central element of the project is the transitionfrom the 2D mammography to the 3D layered im-aging, which allows breast cancer to be detectedeven earlier on and exposes patients to a lowerdose of X-rays and contrast agent.

Intelligent Sensors – ”Barrier-Free HealthAssistance” Research ProjectIn addition to stroke, dementia is known as oneof the ”epidemics of the 21st century”. The forecast

for Germany by 2050 is that the number of peo-ple suffering from dementia will increase by 100per cent to 2 million. In the ”Barrier-Free HealthAssistance” project, partners in the cluster aredeveloping telemedicine solutions and serviceconcepts that allow senile dementia patients tolive in their own home for longer and, at the sametime, to relieve carers and relatives of their bur-den. It is thus a declared objective of the projectto considerably reduce the costs for this group ofpatients, their relatives and the health insurancecompanies.

Treatment Systems – ”Osteofit 2030” Research ProjectIn 2004, of the total healthcare costs in Germany(which amounted to EUR 225 billion), more than5 per cent was spent on rheumatoid arthritis, os-teoarthritis and osteoporosis (for the purposesof comparison, cancer was 8 per cent). As demo-graphics are changing, these costs will increaseeven further. In the ”Osteofit 2030” project, newrevision and individual implants with new, nano-structured surfaces are being developed withinthe cluster to reduce the rate of infection andspeed up the growing process. Due to the longerservice lives of the implants and better treatment,there is considerable potential for savings to bemade and patients’ quality of life will enhanceconsiderably.

Ophthalmology – ”Low-Cost Fundus CameraSystem” Research ProjectIn third-world countries, the health of many peopleis alarming – medical care is only possible in limitedcircumstances due to a deficient infrastructure andthe high costs of modern devices, among otherthings. A low-cost telemedicine Fundus camerasystem is being developed in Medical Valley EMNfor detecting diabetic and hypertensive retinopathyand glaucoma early on in third-world countries.With this system, health organisations in devel-oping countries can prevent diabetic blindnessamong other things with a small medical infra-structure.

Jörg Trinkwalter

The Healthcare of Tomorrow

Four examples from Medical Valley EMN

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MedTech in Bavaria

Importance of breast cancer prevention –Diagnostic Imaging plays a key role in early diagnosisSource: American Cancer Society

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Chance of survival 15 years after diagnosis Treatment expenses (USD)

Early diagnosis increases survival rates �and reduces treatment expenses!

The technological and medical activities ofSiemens AG are pooled together at the Sie -mens Healthcare branch, based in Erlangen.What is your unique selling point and howdo you assert yourselves on the market inlight of the international competition?Siemens Healthcare is one of the global marketleaders in the imaging sector. This is thanks to ourimpressive innovative strength and our extensiveexpertise in the area of medical technology devel-opment. In fact, it is precisely these strengths thatenable Siemens to continue to launch ground-breaking technologies onto the market whichopen new windows of opportunity for medicaldiagnostics – such as our Biograph mMR system;the world’s first integrated whole-body molecu-lar MR system with simultaneous data acquisi-tion technology. In light of the growing cost pres-sure in the healthcare sector worldwide, it isbecoming increasingly important that cost-ef-fective, and particularly long-term, viable solu-tions, are made available. It is only then that weare able to position ourselves effectively againstthe international competition. In this sector alone,Siemens has developed many different systemsover the past two years – from the X-ray machineto the MRI scanner – which have also been suc-cessful in emerging countries.

What pioneering new technologies areyou currently working on? We are continuing to work intensively towardsdeveloping technologies that reduce the dose

of radiation required –for example, we areendeavouring to createnew reconstruction al-gorithms for computertomography. In addition,we are developing effi-cient software toolsfor the imaging sector,which will help us sup-port the diagnostic pro -cesses of our clients forvarious disease patterns

such as Alzheimer’s. In the laboratory diagnos-tics sector, we embarked on a partnership withIllumina in 2011 – a market leader in the areaof genetic sequencing – in order to further de-velop next-generation sequencing technology forthe prompt and precise detection and treatmentof infectious diseases. Furthermore, as part of oursector initiative ”Agenda 2013”, we have decidedto expand our range of systems available in themid-price range.

With which key players from the MedicalValley MedTech cluster do you cooperateintensively? An important and long-term cooperation partnerfor us is the Universitätsklinikum Erlangen (Er-langen university hospital). For example, we areworking together to develop a range of innovativediagnosis methods for breast cancer; the Fraun-hofer Institute is also involved here as a projectpartner. We have also established excellentpartnerships with a few SMEs from the MedicalValley, such as sepp.med GmbH in the IT health-care sector. Moreover, there are a number of otherpartners and medium-sized companies which areinvolved with subcontracted activities.

What, in your view, are the overall strengthsof the MedTech location in Bavaria whencompared internationally?Bavaria’s university hospitals and non-universitymedical institutes are what I can only describe as”world class” in many areas which are importantfor medical technology – for example, minimallyinvasive medical treatment. Such an environmentis of utmost importance for innovative medicaltechnology manufacturers such as Siemens, aswe require clinical expertise from high-ranking,practising doctors so that we develop the righttechnologies. Furthermore, we also benefit greatlyfrom the excellent academic training providedhere in Bavaria which results in many highlyqualified staff for the medical technology sector.

The interview was conducted by Markus Hofelich.

”Bavaria’s university hospitals are absolutely world class”

Interview with Michael Sigmund, Head of Communications, Siemens Healthcare

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MedTech in Bavaria

Siemens Healthcare is one of the global market leaders in the imaging sector.

Photo: © Siemens Healthcare

Michael Sigmund is Head ofthe Communications Depart-ment at Siemens Healthcare.He is also a board member at

Medical Valley EMN andForum MedTech Pharma.

The Erlangen region represents an attractive andsuccessful network in the medical technologysector. It is also from this field that the eye laserspecialist Wavelight was birthed. Eleven yearsafter its establishment, Wavelight was taken overby the US company Alcon and today plays a keyrole in the refractive surgery sector.

Ups and downs on the Frankfurt Stock MarketThe medical technology company Wavelight fea-tures among the most remarkable start-ups of the1990s in Bavaria. After its launch in the MedTechstronghold (Erlangen) by the former Chairman ofthe board, Max Reindl, the company progressedto become a technological leader in the area ofrefractive surgery. In 1999, Wavelight was listedon the Neuer Markt of the Frankfurt Stock Market.Following the closure of the Neuer Markt, Wave-light switched to the Prime Standard stock marketsegment in January 2003. However, even the com-pany itself did not always have a smooth ride. Aftera rapid initial growth phase and attempts to branchinto other areas of medical technology, the shareprice plummeted. From this point on, Wavelightfocused again on its core business – refractivesurgery – and sold all its other business divisions.

Takeover by AlconIn 2007, the US companyAlcon Inc. secured a major-ity stake in Wavelight fol-lowing the presentation ofa takeover bid to the share-holders. Back then, Alconwas a subsidiary companyof the Swiss Nestlé Group,belonging to the largestproduct suppliers involvedin ophthalmology world-wide. The motivation be-hind the takeover was tocapitalise on the synergypotential in the companynetwork, especially in theareas of marketing, sales,research and development,

in order to make the laser systems provided bythe Erlanger company even more successful onthe market. Since 2009, Wavelight has been awholly owned subsidiary of Alcon Inc.; a compa-ny itself which was sold by Nestlé to the Swisspharmaceutical company Novartis in 2010.

Precision is crucialWith around 230 employees, today Wavelight isranked among the leading companies worldwidein the development and production of moderndiagnostic and surgical technology for correctingvision defects. It’s all about developing and pro-ducing innovative laser systems for ophthalmicsurgery. The clients are clinics and ophthalmolo-gists. ”Our laser and diagnostic systems enablea very careful and highly precise correction of vi-sion defects”, explains managing director MartinReichelt. ”In refractive surgery, Wavelight has cre-ated a platform to allow for treatments especiallytailored to the patient’s needs." Since 2004, thecompany has manufactured all its products in thenewly-built production site based in Pressath, theUpper Palatinate. ”Laser production is high-preci-sion work and in Germany we have an excellentlytrained workforce for this purpose”, says Reichelt.Moreover, as the company headquarters, Erlangenprovides an opportunity for excellent cooperationwith the university there and an impressive net-work of suppliers and service providers from theregion.

A large eye care budgetWith Alcon, into which the former company CibaVision – with its contact lens products – wasintegrated, Novartis is keen to cover the entire spec-trum of ophthalmology and is currently presentwith its products in roughly 180 countries aroundthe globe. The Group operates branches or salesoffices in 75 countries. Therefore, significant in-vestments are being made in the areas of researchand development in particular, with the largestGroup budget for this sector worldwide: approxi-mately USD 5 billion for a period of 5 years.

Bernd Frank

Success with eye laser technology

Wavelight GmbH: Synergy potential in theAlcon Group

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MedTech in Bavaria

World-class laser and diagnostic systems are invented in Bavaria.Today, Wavelight is a fully owned subsidiary of Novartis. Photos: © Wavelight GmbH

Prof. Dr. Axel Ullrich, Director, Department of Molecular Biology, Max Planck Institute of Biochemistry:

”One of the biggest strengths of Bavaria as a business location is the political support.When players from politics recognise economic potential, they work consistently on tap-ping into this potential, too. I personally was therefore not surprised that the Germanbiotechnology adventure started in Bavaria.”

Prof. Dr. Willi A. Kalender, Director, Institute for Medical Physics, Friedrich-Alexander-Universität Erlangen-Nürnberg:

”In my opinion, the level of education represents a particular strength of the Bavarian region.In Bavaria and Germany as a whole, an excellent professional and vocational educationsystem has been established for many years. Our specialised staff have undergone excellenttraining in both handicraft and vocational work by international standards.”

Richard Paulson, VP & General Manager, Amgen GmbH in Germany:

”With Amgen Research in Regensburg and Amgen Research in Munich, we are the onlyglobal Amgen affiliate with both research and clinical facilities. That’s a testament to thestrength of medical science and R&D in Germany.”

Michael Sigmund, Head of Communications, Siemens Healthcare:

”Bavaria’s university hospitals and non-university medical institutes are what I can onlydescribe as ‘world class’ in many areas which are important for medical technology – forexample, minimally invasive medical treatment. Such an environment is of utmost impor-tance for innovative medical technology manufacturers such as Siemens.”

Expert statements regarding Bavaria as a healthcare location

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Invest in Bavaria – The Business Promotion Agency of the Bavarian Ministry ofEconomic Affairs, Infrastructure, Transport and Technology and Bayern International

Edition September 2012

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