BioTOP-Report. Biotech and Pharma in Berlin-Brandenburg

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1 BioTOP-Report 2013 Biotech and Pharma in Berlin-Brandenburg

2 BioTOP-Report Content Editorial Unique Chances to Create Value in Biotechnology and Life Sciences 3 Biotechnology More Companies, More Employees and New Deals 4 Pharma The German Capital Region: Highly Attractive for the Pharmaceutical Industry 14 Diagnostics An Excellent Location for the Development of Innovative Diagnostics 18 Industrial Biotechnology Focus: Biopolymers and Bio-based Plastics 22 Global Business New Markets and Horizons for Global Business 25 Business Location Excellent Services for Berlin-Brandenburg 28 Technology Transfer Technology Transfer between Science and Business 30 Life Sciences A Science and Research Hub 34 Know-how in Systems Medicine and Systems Biology 36 Biotech Biotech Parks The BioCampus Network Berlin-Brandenburg 50 Addresses 55 Publisher: Berlin Partner für Wirtschaft und Technologie GmbH BioTOP Berlin-Brandenburg Fasanenstraße Berlin Germany Phone Fax biotop@biotop.de Editor: Yvonne Küchler Design & Production: supiran.de Translation: Textbüro Reul GmbH Frankfurt Photos/Figures: BioTOP or Authors and: Page 10 Ralfpoller*, Wladimir Bulgar*; Page 13 Werner Popp (Profile organobalance), Vanillla * (Profile BPI); Page 14 Phartisan*, Idrutu*; Page 18 Stratum*, Stanislav Perov*; Page 20 Alx, fotolia.com (Profile Dr. Nothgi); Page 22 BASF; Page 25 C. Keating*, Moth*; Seite 32 Bayer HealthCare; Page 33 Eric1513*, Jankaliciak*, Grafoo*, Eraxion*, Kjpargeter*, Andrey Armyagov*; Page 37 Christoph Heidrich; Page 40 Illustration: webersupiran, photo Sofiaworld *; Page 41 Paulus Rusyanto*, Collpicto*, 18percentgrey*; Page 46 Natalia Pavlichenko*/Patho (Profile Predemtec) *dreamstime.com

3 BioTOP-Report Editorial The German Capital Region Unique Chances to Create Value in Biotechnology and Life Sciences In an emerging health environment, manufacturers of drugs, diagnostics and devices will need to be able to prove not only the safety and efficacy but also the value of their products. Thus all players in the value chain reaching from scientific institutions and biotech companies to clinics and healthcare providers are rethinking their products, services and business models. They find perfect conditions in Berlin-Brandenburg. Dr. Kai Bindseil Cluster Manager HealthCapital Director BioTOP Berlin-Brandenburg Obviously, most participants in the value chain have realised that cooperation is the most important factor for success and are shaping their cooperation strategies: kkcross-innovation at the interface of life sciences, information technology and engineering takes place everywhere. This innovation sector will not only create value through new tools and cost reduction in healthcare delivery, but also enable all of us to take control of our own health and wellness. The most recent example is the Joint Lab for Bioelectronics of the Technische Universität Berlin and the Leibniz Institute for Microelectronics. Berlin-Brandenburg is indeed the European hotspot for collaboration. More than 200 biotechnology and 30 pharmaceutical companies benefit from close cooperation with five universities and more than a dozen institutes of the Helmholtz, Max Planck, Fraunhofer and Leibniz societies and associations, as well as more than 130 hospitals among them Europe s largest university hospital: Charité Universitätsmedizin Berlin. As a consequence, the sector has grown more than 6% in 2012 and is growing continuously since 10 years. This fertile ground will be further strengthened with the new master plan for the healthcare industry. BioTOP is pleased to present the most important developments in life sciences, pharma and biotechnology in our new annual report. We hope you enjoy reading our report, and we invite you to play an active role in one of the most vibrant European life sciences networks. Don t hesitate to contact us. kkbasic and clinical research of the Max Delbrück Center of Molecular Medicine (MDC) and the Charité Universitätsmedizin Berlin will come together in the Berlin Institute of Health (BIH) to create the new flagship of German life sciences. Dr. Kai Bindseil kkscientific excellence and development experience will team up in the CoLaborator, established by Bayer to incubate startups. kkentrepreneurial skills will be strengthened in the Entrepreneurial Network University of the Freie Universität Berlin, Charité and several companies. 3

4 BioTOP-Report Biotechnology More Companies, More Employees and New Deals The positive development of the regional corporate landscape got new momentum in The number of employees in the sector rose by 6.5 %. Compared to average growth rates of 3.5% during recent years, this has been a clear and very welcome sign of the dynamism in the Berlin-Brandenburg region, where 222 companies now employ a workforce numbering 4,348 people. Development of the Companies in 2012 BioTOP conducted its anual survey of regional companies for the year 2012 to obtain a comprehensive overview of the current development of the corporate scene. During 2012, twelve new companies joined the ranks of surveyed companies, of which nine were newly founded and three included in the survey for the first time. Five companies ceased operations or moved to a different region. The new companies are still smaller firms focusing on services and product development in the field of biomedicine. As an example, we refer to t-cell Europe, which received funding from the High-Tech Gründerfonds (HTGF). The aim of t-cell Europe, a spin-off of the Berlin-Brandenburg Centre for Regenerative Therapies, is to use its patented platform technology to develop and market new t-cell-based regenerative therapies. The company s first reference product will be a t-cell product for kidney transplants. Another interesting start-up is Drug Response Dx GmbH in Hennigsdorf. DRDx is developing a robust companion diagnostic test which permits secure stratification regarding failure in TNFα blocker (TBA) therapy for rheumatism patients and therefore addresses a very big market. The sizes of companies barely changed during the past few years. Smaller enterprises with less than ten employees make up 63% of all companies, but these firms also account for only app. 15% of all employees. More than 54% of those employed in the regional biotech sector work in the 19 companies with more than 50 employees. The thematic focus of the industry also remained unchanged during recent years and continues lie on biomedicine, and here particularly diagnostics. MARCH BIONNALE in Berlin 10 years of success Biggest biotech industry meeting in Berlin-Brandenburg celebrates its jubilee APRIL 2012 NOXXON's NOX-A12 delays recidivation in preclinical glioblastoma model ++++ Epigenomics AG enrolls first participant in its FIT comparative study with Epi procolon MAY 2012 MOLOGEN AG: Promising start in financial year 2012, quarterly record presented ++++ ifp and Romer Labs join in world-wide sales cooperation for EnzymeFast food test kits JUNE 2012 ORGANOBALANCE presents new research results on ACHEMA 2012: Extended application range for yeast strains in biotechnological production ++++ CellTrend GmbH and One Lambda Inc. agree to world-wide sales contract ++++ United States Patent and Trademark Office grants co.don AG patent for production of autologous spinal disc cell transplants ++++ NOXXON initiates phase IIa study of anti-ccl2/mcp-1 Spiegelmer NOX-E36 for treatment of diabetic neuropathy ++++ ATLAS Biolabs extends spectrum of services by Variant AnalysisTM and ireporttm by Ingenuity Systems for data analysis and interpretation JULY 2012 Epigenomics appreciates reimbursement of Septin-9 blood test for early recognition of colon cancer by Swiss Life in France ++++ MOLOGEN AG capital increase of 22 million Euros AUGUST 2012 co.don AG reaches another milestone on the path to central approval; Recruitment phase for clinical phase II trial completed successfully ++++ Merck buys Biochrom AG ++++ Indian pharma firm Piramal invests in molecular imaging in Germany SEPTEMBER 2012 Epigenomics AG announces changes in executive board ++++ Charité and Sanofi extend partnership by diabetes alliance ++++ MOLOGEN AG: Current data of kidney cancer therapy MGN1601 shows further improved results OCTOBER years Klosterfrau Berlin GmbH ++++ ATLAS Biolabs takes part in European projects on the research of DNA repair and cell aging ++++ co.don AG from Teltow presents gentle alternative preserve joints instead of replacing them 4

5 BioTOP-Report Biotechnology Deals and Product Developments Dr. Claudia Ulbrich CEO t-cell Europe GmbH Our T-cell-based therapies, unique throughout the world, can help prevent organ rejection following transplant procedures, thus significantly reducing the need for immunosuppressive drugs. With the new funds of EUR 5.5 million raised in our most recent financing round, we aim to commence clinical trials already in 2014, so that we can expeditiously move forward with proof-of-concept at the patient level, then proceed with negotiations to license our proprietary technology to a pharmaceutical industry partner. T-cell therapy will not completely eliminate the need for immunosuppressive support. However, even if the amount of immunosuppressive drugs required can be reduced by one half, the costs of our therapy will be quickly recovered, generating net patient savings. Just for one specific application, T reg therapy following kidney transplantation, we estimate a current market potential of more than one billion euros per year. A number of companies closed new cooperation agreements in 2012 and achieved major milestones in product development and approval. We present some examples of these dynamic activities: MOLOGEN presented outstanding results in its clinical development programmes from a first evaluation of the colon cancer study with the active pharmaceutical ingredient MGN1703. The evaluation performed in May 2012 demonstrated the effectiveness of MGN1703 as a maintenance therapy for metastasised colon cancer impressively. MOLOGEN also plans to investigate the effect of MGN1703 in lung cancer therapy in the future. In October 2012, the company presented promising new data from its kidney cancer study with MGN1601. They showed a clear survival advantage for patients who fully completed the prescribed therapy programme compared to patients who had to terminate the therapy early due to the severity of their cancer disease. Furthermore, MOLOGEN completed the preclinical phase of its MIDGE -based Leishmaniasis vaccine MGN1331 in June 2012 with good results. NOVEMBER 2012 Alacris Theranostics GmbH signs agreement with GSK to apply Alacris Mod- CellTM system in the early phase of cancer research ++++ Entry to the pharma market: Tönnies invests 21 million Euro, majority shareholder at Heparin specialist Pharma Action DECEMBER 2012 NOXXON initiates phase IIa study on anaemia of chronical illness with anti- Hepcidin Spiegelmer NOX-H Epigenomics releases more data on the results of a direct comparative study between Epi ProColon and FIT JANUARY 2013 Epigenomics AG hands in fourth module at FDA completes application for approval as planned ++++ co.don AG applied for approval of joint cartilage product chondrosphere in the EU ++++ Shire discovered the Munich-based RNA specialist Ethris for itself. In cooperation the two companies want to find therapies for rare diseases MARCH 2013 BIOTECON Diagnostics GmbH extends its robot segment ++++ Epigenomics AG collects 5,0 million Euros through capital increase ++++ New research collective INNO-TRACE develops innovative contrast agents for tumour imaging APRIL 2013 Europe's largest clinical laboratory at Campus Virchow-Klinikum: Labor Berlin inaugurates new site MAY 2013 Bayer HealthCare presents new incubator model for biotech start-ups in Berlin JUNE 2013 Alacris Theranostics GmbH announces Illumina CSPro certificate for next generation sequencing ++++ Humedics co-founder Martin Stockmann receives Von-Langenbeck Prize for development of LiMAx test FEBRUARY 2013 Epigenomics receives notice about grant of priority review status and acceptance of the hand-in of the PMA application for Epi procolon from the FDA ++++ Innovation forum Biopolymers and Bio-based Plastics in Schwarzheide 5

6 BioTOP-Report Biotechnology NOXXON Pharma AG, a biopharmaceutical company and pioneering developer of the new active agent class spiegelmers, successfully advanced its product pipeline. Its latest candidate agent NOX-H94 is already the third spiegelmer to have reached the Phase II trial stage. This is one of four Phase IIa trials NOXXON began in The others are investigating NOX-E36 in diabetic nephropathy therapy, NOX-A12 in the therapy of chronic lymphatic leukaemia and NOX-A12 for treatment of multiple myeloma. The trial for anaemia of this chronic disease is the fourth Phase II trial NOXXON launched in The German-American molecular diagnostics corporation Epigenomics AG made important progress with the approval of Epi procolon in the USA and the development of its marketing strategy for this blood-based test for early detection of colon cancer. The next major milestone will now be the marketing launch of the product on the world s most important market the USA. Number of Employees According to Company Size Number of employees '03 '04 '05 '06 '07 '08 '09 '10 '11 '12 '03 '04 '05 '06 '07 '08 '09 '10 '11 '12 '03 '04 '05 '06 '07 '08 '09 '10 '11 ' companies 1-10 employees 61 companies employees 20 companies > 51 employees In comparison to the previous year, the average number of employees per company increased by 2,7 % in the 1-10 category and 1,8 % in the category. The average number of employees in the category > 50 employees increased by 10%. (Source: Own survey, BioTOP database, 222 companies questioned, June 2013) 6

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8 BioTOP-Report Biotechnology Epigenomics also found a new partner in BioChain, a leading clinical diagnostics provider for oncological and genetic tests. This company will offer Epigenomics customers the Septin9 test through its independent Chinese reference laboratory in Beijing and thereby prepare the ground for Epigenomics market entry in China. The Institut für Produktqualität (ifp) and Romer Labs, a globally leading company in the field of food diagnostics, have agreed on the joint launch of a new product line for enzymatic food analytics. The two companies are expanding their existing cooperation with this global marketing collaboration. The new Enzyme- Fast product line transfers the traditional enzymatic methods to a microtiter plate kit format, thereby providing a significant advantage in routine food analytics. CellTrend GmbH announced its partnership with the American company One Lambda Inc. The aim of this cooperation is to supply transplantation centres worldwide with innovative diagnostic products developed by CellTrend. Under the agreement, One Lambda will receive the exclusive global distribution license for the immunoassay EIA for quantitative determination of anti-angiotensin II-receptor 1 antibodies (AT1R). AT1R is involved in a range of neurohumoral systems and expressed in many organs, including the heart, liver, lung and kidneys. The Indian corporation Piramal took over the molecular imaging pipeline of Bayer Healthcare in April The acquired PET radiopharmaceuticals have been researched and developed further since then in the Berlin laboratories of Piramal Imaging. The portfolio also includes the rights to florbetaben, a highly specific substance for determination of beta-amyloid deposits in the brain, which is a marker for Alzheimer s disease. A Phase-III trial of florbetaben was completed successfully. With the development of its innovative PET radiopharmaceuticals for molecular imaging, Piramal is focused on a key future field in modern medicine. Alacris Theranostics GmbH closed an agreement with GlaxoSmithKline (GSK) which entitles GSK to use the proprietary ModCellTM system of Alacris for pharmaceuticals stratification with its own data from the early stages of cancer research at GSK. The system was developed at the Max Planck Institute for Molecular Genetics and licensed exclusively to Alacris. Dr. Ludger Dinkelborg Managing Director of Piramal Imaging GmbH co.don AG in Teltow, one of the leading manufacturers of endogenous cartilage cell transplants for the treatment of joint and disc damage, achieved a further milestone on the road to central approval. Recruitment for the clinical Phase-II trial was successfully completed in June In this clinical long-term study, 75 patients with cartilage defects in the knee joint were treated with co.don chondrosphere, an endogenous matrix-associated transplant of patient cartilage cells. The extensive approval documentation was filed with the European pharmaceuticals agency EMA in London at the end of the year. Biochrom AG announced that Merck closed a definitive agreement on the acquisition of Biochrom AG on 22 August The acquisition is subject to the usual preconditions for execution such as approval by the competent anti-trust authority. The Berlin location of Biochrom AG is being retained. The activities of Biochrom are being integrated into the Process Solutions business unit of Merck Millipore. In the Piramal Group s cluster-based thinking, the Berlin location unequivocally represents know-how and a long tradition in the field of diagnostic imaging. After all, this is where the first contrast medium was invented back in the 1930s. There is top personnel here: the training situation is excellent, both in companies like Bayer and in the local academic institutions. We collaborate closely with eminent experts from Charité hospital a key partner for clinical trials - in the field of molecular imaging and in the diagnosis of Alzheimer s disease In the capital region are many small companies in the fields of radiopharmaceuticals and diagnostics, and many service providers supporting clinical research. Berlin is a global metropolis offering a high quality of life, the kind of place where people like to live and work. That makes it easy to recruit international experts. 8

9 AAT TGA CAC ACG TTC GCC GAT AAG GAA GTT ATG GAA CCT GGA CCA TCA CGA TAA AAC GGA CAA TTA CCC GAT TGG AAA ATC GAA ACC GAA TCA GCC AGT CAA GAA GCT TTC GAC TGC GTA TTG CAA GGC CAC CAG TAG CAC ACG TGC GGA ACG ACA TAA ACT GGA ACA AGA TCC AAA GCT TAT TGG AAG TGC CCG CCA STudieS & ConSulTinG GCA TAC CAA TGC ATG CAC GGA AGG TTC GTA TTA ACT AGA GAT CAT TCT AAC CCT TAT AGC GTT ConferenCeS AAG GAG ATC CCC TTG ACC GGC CGG T TT TCC CTC CTG GCG GTG TCA AAT CAG TGA CGA CCG TGT ACA ACA BookSTC TCG CCA TAA CGT TGG CTT AAA GCT TAG GCC GCC ACG GAA ACG GGT GAC GGG AAT CCA ACC GAC AGA ATT TGA TV & VideoAC TCC GCA CAT TTG CGA GCT AGA ACG TAA GCC TAG GCT CAA AAC GCA TGT GCC GAT CAA GAA TGC AAG GAT CorporATe publishing T TT GGA GAA CTA ACA TCT AGA ATC CAG CTT ACC AGA TGC AAG ATC TTG GGA GGC ACT GAG GTA internet CTC CGC ACG TCC AAT GGA ATC GTA TAA CCA AGG GTT TCC ACA GCC TGA GCC GAT ATC GTA AGG TGA CAA GAA MAGAzineSGA TTC GTC CTC AGT ACG TCA TAG CAA ACT CAC TCA ACC CAA GGA GTT GTA CTA CTG CGC GAA CTT ACG CGA event MAnAGeMenT TA GCG TCG ACG CAC CAA TGC ACC GCC AAC GCC CAG TCC ATT AGA GAG TCA TAA GAC GCA GCA CAA CAC GCT GTT CCC GGA TGC ACA GCC AGG ACT CTT TGC AGC GGC AAA GCA CAT CCA AGA GAA TGG GAC ACG TGC CAC ACC GGC GCA TGT TGA CAC AAT CAG CCT GAT TAG CAC CAG TAA GCT AGA CAA ACA TCT We CreATe know ledg e! TGG AGT GTT CTC AAG GAA TGA CGA TGT GCC TTG ACC TCG ACG GTT ACT ACG TCC TGC ATG TTG CGA TTG GGA AGA AAA CTC BIOCOM AG Lützowstraße Berlin Germany Tel. +49 (0) Fax +49 (0)

10 BioTOP-Report Biotechnology GLYCOTOPE moved two products into Phase II clinical development. After successfully completing Phase I of its glyco-optimised therapeutic antibody PankoMabTM, the company moved the compound to Phase II clinical development in ovarian cancer, with further indications planned. After successful completion of Phase I, GLYCOTOPE also advanced its glyco-optimised therapeutic protein FSH-GEXTM into Phase II clinical development in in-vitro fertilisation. The Financing Situation The financial position of the region s biotech industry is stable overall, and the consolidation efforts during recent years are now paying off. The business models of most companies are commercially feasible and generating free funds for investments and growth. Companies with high capital needs successfully acquired new funds for their product developments or market approvals in Capital increases of listed companies alone injected more than 40 million into the respective companies, headed by MOLO- GEN AG, which generated 25 million. Apart from these public placements, there were no major financing events with two exceptions: The first outstanding exception was the takeover of the molecular imaging pipeline of Bayer Healthcare by the Piramal Group into the newly founded company Piramal Imaging. Europe s leading pork marketing company Tönnies joined the ranks of financially strong private investors in the pharmaceuticals sector. Tönnies acquired the majority in the company Pharma Action in Berlin. The companies aim to manufacture the coagulation inhibitor heparin jointly in future. This active substance is obtained from the intestinal mucus of pigs and administered to patients during operations or in the case of cardiac illness. Private venture capital transactions were not significant. Once more, the most active investor was IBB Beteiligungsgesellschaft with two first and two follow-up investments and the HTGF with two start-up funding investments. It should be noted that these are both public-sector investors. The private VC business remains dissatisfying. It is therefore time to create new drivers and incentives for venture capital. Public-sector institutions remain very important to the financing of product developments and investments. The two states Berlin Employees in Biotech SMEs Number of employees '03 '04 '05 '06 '07 '08 '09 '10 '11 '12 Employment rose to in This is a growth of 6,5% in comparison to the previous year. The number of companies went up to 222, reflecting the arrival of 10 companies and five departures. (Source: Internal survey, BioTOP database, 222 companies questioned, June 2013) 10

11 BioTOP-Report Biotechnology and Brandenburg alone disbursed more than 37 million in support funds to regional life sciences companies, while the German federal government provided a similar amount of project support funding. The leverage effect of these funds resulted in private investments of comparable dimensions. When compared to purely private investments, it is clear how important public funding programmes are to permit new product developments and as a multiplier for private fundings. Conclusion obtaining it successfully, thereby demonstrating that investments in the life sciences are attractive for both institutional and private investors. Apart from public-sector portfolio investors, however, the venture capital market remains weak a phenomenon that has been observable for many years. Although it is good and proper that the regional and federal governments support the research and development of innovative and promising projects with appropriate funds and thereby secure highly qualified jobs for the future, the commitment of private investors and the associated conditions must be developed further and improved. Overall, the economic and financial situation of the regional biotech industry is solid. Most companies are financing themselves with own funds, while companies requiring external capital are Market Segments of Companies % Number of companies 30 14% 40 18% 0 '03 '04 '05 '06 '07 '08 '09 '10 '11 '12 '03 '04 '05 '06 '07 '08 '09 '10 '11 '12 '03 '04 '05 '06 '07 '08 '09 '10 '11 '12 Agriculture/Food White Biotechnology /Environmental Biotechnology Biomedicine Most companies focus on biomedicine. A total of 83 % of companies, focus primarily on development in the areas of new diagnostics, drug development and associated services or technologies. 14 % of the companies are active in the agriculture / food sector, white biotechnology / environmental biotechnology amounts to 18 % of all entries. (Source: Internal survey, BioTOP database, responses from 222 companies, multiple entries, June 2013) 11

12 BioTOP-Report Metanomics Health GmbH Metanomics Health a BASF Group company applies comprehensive Metabolite Profiling (metabolomics) with biomedical data interpretation. Metabolite Profiling is defined as the parallel analysis of multiple endogenous and xenobiotic metabolites in biological systems. The core expertise of Metanomics Health resides in discovery and validation of biomarkers. Technologies kkmetabolite profiling platform with more than 75 GC-MS and LC-MS/MS instruments kkwide metabolite coverage via combination of unbiased and targeted platforms kkunique tox mode of action prediction through MetaMap Tox database kkexcellence in systems correlation analysis of complex gene function relationships Major R&D-Topics In cooperation with academic institutes and clinical experts Metanomics Health is running a large-scale diagnostic biomarker program. Areas include metabolic syndrome, heart failure, prostate cancer and multiple sclerosis to mention a few. Market Segments Metanomics Health provides its services to pharmaceutical, diagnostics and nutrition companies. Technology applications include: kkmechanism of action studies kkmechanism of toxicity studies kktranslational and clinical biomarker development (e.g. PK/PD, patient stratification, efficacy and safety markers) kkcompanion diagnostic development kkcell culture & bioprocess optimization Address Metanomics Health GmbH Tegeler Weg Berlin Germany Contact Dr. Tim Bölke Managing Director Phone Fax company.info@metanomics-health.de nanopet Pharma GmbH nanopet is a biopharmaceutical company specialized on R&D, manufacturing and marketing of innovative drug substances for Diagnostic Imaging. We focus on relevant cardiovascular, oncological and neurological indications as well as on regenerative medicine. Nanotechnology is a key element of our business. We operate in three major areas. The first nanoparticular tracers for clinical PET: nanopet prepares the clinical development of its patented technology platform: inorganic nanoparticular tracers for cell- and molecular-specific positron emission tomography (PET). Viscover imaging agents a landmark in small animal imaging: As animal imaging is rapidly gaining relevance in pharmaceutical research, we are delighted to offer you an exciting portfolio of specialized preclinical imaging agents covering the principal imaging modalities (MRI, CT, Ultrasound, Optical Imaging, SPECT & PET). Get a detailed insight into our product portfolio and download a free copy of our imaging guide on long-standing industry expertise our team has attained in the pharmaceutical research & development. Address nanopet Pharma GmbH Robert-Koch-Platz Berlin Germany Contact Dr. Andreas Briel CEO Phone imaging@nanopet-pharma.com Consulting and Service tailored to your needs: As a technology and service provider, we offer our expertise to biopharmaceutical companies and imaging equipment manufacturers. Our customers benefit from the 12

13 BioTOP-Report ORGANOBALANCE GmbH Exploring and managing microbial biodiversity ORGANOBALANCE explores the potential of probiotic bacteria and yeasts for new product developments in food, feed, personal care, and for the pharmaceutical industry or the production of fine chemicals. From a large collection of microorganisms, specific strains are selected to e.g. inactivate pathogens, produce new bioactives, neutralize malodorous or toxic substances and synthesize high titers of valuable compounds. ORGANOBALANCE draws on natural resources, which are gathered in the company-owned collection of microbial strains, mostly originating from foodstuffs. ORGANOBALANCE uses its OASSYS bioassays for highly efficient screenings. The platform allows to quickly identify the most suitable strains from the microbial collection for targeted applications. ORGANOBALANCE has a broad expertise in the field of yeast metabolic engineering. This includes designing and developing new production strains for industrial biotechnology applications. Specific strains of Saccharomyces cerevisiae, which carry engineered biosynthesis pathways for the environmentally friendly production of carboxylic acids, terpenoids, steroids and other lipid compounds are available. ORGANOBALANCE works in collaboration with partners and grants licenses for own product developments. Address ORGANOBALANCE GmbH Gustav-Meyer-Allee Berlin Germany Contact Dr. Christine Lang CEO Phone Fax info@organobalance.com Our experience is your success! The German Pharmaceutical Industry Association (BPI Bundesverband der Pharmazeutischen Industrie e.v.) consists of approximately 240 pharmaceutical companies. These include not only the classic pharmaceutical firms and service-providers, but also biotechnology companies and manufacturers of medical devices. All of our members use our association as a platform for information and communication to develop collaborative responses to the diverse challenges they face. Our team consists of highly qualified experts in all fields which are necessary to generate a sustainable benefit for pharmaceutical companies, e.g. market access, regulatory affairs, law, biotechnology and political affairs. Interested in being a member? Feel free to contact us! info@bpi.de Phone: Start Up-Companies are eligible for reduced membership fees while having the possibility to participate in all activities of our association. 13

14 BioTOP-Report Pharma The German Capital Region: Highly Attractive for the Pharmaceutical Industry The pharmaceutical industry is an important economic factor and job motor in the German capital region. According to a study by the Cologne Institute for Economic Research 1 commissioned by the Association of Research-Based Pharmaceutical Companies (vfa), the number of people employed in the industry in Berlin grew since 2009, in contrast to the national trend. Whereas jobs in the pharmaceuticals sector declined by 2.6 % in Germany as a whole, in Berlin the number of employees grew by 1.5 % to 9,589. One in eleven employees in the German pharmaceutical industry works in Berlin. With sales worth 5.6 billion, Bayer, Berlin Chemie, Pfizer, Sanofi and the more than 20 other pharmaceutical manufacturers form the industry in the German capital with the highest revenues. With 17 % of Berlin s total industrial production, pharmaceutical companies come in first position, ahead of electrical engineering and mechanical engineering. Berlin-Brandenburg is a highly attractive location for pharmaceutical companies. International companies in the industry like Takeda, which recently arrived in Berlin, are not just attracted by Berlin as the German capital. The many research facilities, hospitals and biomedical companies in the region provide pharmaceutical companies with an infrastructure that will become increasingly important to them in future. The industry faces major challenges: stricter approval regulations for new active substances, declining prices, expiring patents and mounting competition from generics manufacturers present the need for new business strategies. The core terms often raised in this context are: personalised medicine and networks. Dr. Norbert Gerbsch Deputy Director General of the German Pharmaceutical Industry Association (BPI) A strong economic, medical and innovative basis and an excellent research landscape are important characteristics of a Health Capital with special relevance for pharmaceutical companies. Berlin and Brandenburg offer all of those characteristics. It is therefore not surprising that the number of pharmaceutical companies is steadily increasing: The region provides an extremely attractive surrounding for an industry which relies on qualified personnel and needs to reinvent itself in the face of the challenges of the biological revolution, demographic change, budgetary pressures in health systems, and health benefit assessment. And: The German capital region is a center for decision makers. As the German Pharmaceutical Industry Association, we are located here in order to participate thoroughly in the discussions about healthcare reforms and to maintain an ongoing dialogue with the public as well as other partners for the health sector Kirchhoff, Jasmina, Die Pharma-Industrie in Berlin: Ergebnisse der Mitgliederbefragung des Verbandes forschender Pharma-Unternehmen (vfa) Wirtschaftsdaten

15 Get Old Pfizer researches to develop the medicines of today and tomorrow We at Pfizer are committed to applying science and our global resources to improve health and well-being at every stage of life. We strive to provide access to safe, effective and affordable medicines and related health care services to the people who need them.

16 BioTOP-Report Pharma Personalised Medicine and Networks Many pharmaceutical and biotech companies in Berlin-Brandenburg are pursuing concepts in the field of personalised medicine and therefore present themselves as potential cooperation partners. For example, Alacris Theranostics GmbH specialises in the development of new processes in personalised medicine for cancer patients, focusing in particular on the development of new approaches in diagnostics, therapy and drug stratification. Metanomics Health, a BASF Group company, on the other hand, offers targeted and non-targeted metabolite profiling to healthcare customers in industry and academia. Alongside companies focussed on developing companion diagnostics, the region is home to many specialised service providers and subcontractors which concentrate on the early phases of pharmaceuticals development and are highly regarded internationally for their specialist know-how. Caprotech GmbH, whose Caprotecs Capture Compound Mass Spectrometry (CCMS) permits the function-specific isolation and identification of proteins, serves as an example. The system offers both the identification of the mechanism of action of a molecule and determination of its interaction partners, which may be responsible for side effects. Another biotech company, EPO GmbH, provides a unique and outstanding source for cancer research projects. They offer the right models for every preclinical development phase, from target identification and validation to translational research. In many of the region s academic institutions, research into a number of topics in personalised medicine is under way. The potential is huge and diverse, which makes it all the more important that it has now been concentrated and highlighted by the establishment of two new beacons. The first is the Berlin Institute of Health (BIH) which brings together the patient-focused research expertise of Charité Universitätsmedizin Berlin and the basic research of the Max Delbrück Centre for Molecular Medicine (MDC) even more closely than before in a joint institution. The second is the Integrative Research Institute (IRI) for the Life Sciences, which was founded in Berlin in early March 2013 and whose interdisciplinary work will extend from knowledge about life at the molecular level to complex organisms (see page 36). Jean-Luc Delay Managing Director Takeda Pharma Vertrieb GmbH & Co. KG As a global company, we want to be present in the German capital. Takeda is Japan's as well as Asia's largest pharmaceutical manufacturer, and Berlin offers several advantages to us: proximity to the governmental and regulatory bodies, to important industry associations such as the Association of Research-Based Pharmaceutical Manufacturers (vfa), and to other pharmaceutical companies. From Berlin, we direct all activities for the German market. And: one of our two production sites is also located in the Berlin region. The Takeda plant in Oranienburg is a state-of-the-art production facility for various types of tablets and capsules. Berlin-Brandenburg offers a broad portfolio of potential answers to the challenges facing the pharmaceutical industry, in particular with regards to the integration of different players from the science and biomedical services sectors in the early phases of development. The project OncoTrack is an impressive example. An Outstanding Network for Personalised Therapies OncoTrack is a consortium of more than 80 scientists that has launched one of Europe s largest collaborative research projects between academia and industry to develop and assess novel approaches for the identification of new markers for colon cancer. The project brings together top scientists from European academic institutions offering a wide range of expertise, and partners them with pharmaceutical companies. Consortium members from the Berlin-Brandenburg area play a vital role in the project, with six partners from clinics (Charité), non-university research institutes (Max Planck Institute for Molecular Genetics), the pharmaceutical industry (Bayer HealthCare Pharmaceuticals, Pfizer) and SMEs (Alacris Theranostics, EPO Experimental Pharmacology & Oncology). The goal of OncoTrack is to improve our understanding of the variable make-up of tumours and how it affects the way an individual patient responds to treatment. This project is one example how our understanding of the fundamental biology of colon cancer can be advanced and will open the door for personalised therapeutic management of cancer patients. 16

17 You need commitment, focus and passion to find new ways to fight the diseases of this world: innovation is at the heart of it. Innovation for better health. Our commitment is to bring to patients around the world quality medicines for use in diag nosing, combating and preventing disease. Every day we work against time, researching new pathways, new molecules, new technologies complementing our own capabilities with exper tise of innovative partners from science and industry. The success of this work is evidenced in new m e d i c i n e s for areas with significant unmet medicalneed such as oncology, cardiovascular and blood diseases, as well as gynecology and ophthalmology. Our aim is a better quality of life for all.

18 BioTOP-Report Diagnostics An Excellent Location for the Development of Innovative Diagnostics In Berlin-Brandenburg bioanalysis is a focus area of research and development. Some 100 companies and more than 20 research facilities present the entire value chain from biomarker identification through clinical validation to the production of in vitro-diagnostics. Early, specific and reliable laboratory diagnostics makes a key contribution to disease detection, therapy optimisation, and prevention. Its importance can therefore barely be overrated, given the many challenges facing our healthcare systems. Progress in biomedical basic research and the development of new analytical techniques and methods has resulted in a tremendous increase in the performance of diagnostic laboratories over the past decades. New sensor-actor molecules, autonomous biosensors, genome, proteome and glycan-based multiplex analytics as well as metabolomics platforms provide the foundation for the development and implementation of innovative biomarker strategies. Companion diagnostics for personalised medicine are rapidly gaining in importance based on these new insights and developments. In light of this, Berlin-Brandenburg has become an internationally leading location for research and development in laboratory medicine and for the implementation of clinical studies. The wide range of specialised hospitals, clinics for both basic and advanced care as well as the high-performance university medicine at the Dr. Florian Kainzinger Managing Director Labor Berlin Charité Vivantes GmbH Charité provide access to patient cohorts of the urban and rural population with some 180 different ethnic backgrounds and covering virtually all medical themes. The development of the German capital region as an internationally desired location for diagnostics development is an outstanding example for the successful implementation of the Common Innovation Strategy of the States of Berlin and Brandenburg (innobb) and a major component of the HealthCapital cluster. Diagnostic know-how for outstanding development and patient care Labor Berlin Charité Vivantes GmbH is Europe s largest clinical laboratory, providing optimal conditions for driving the development of innovative diagnostics in cooperation with leading companies like BioMérieux, Roche Diagnostics and Thermo Fisher Scientific. Labor Berlin is participating in the development of a fully integrated automation solution in microbiology and has introduced a platform for next-generation sequencing (NGS) into routine analysis. Since April 2013, the clinical laboratory has been standardising its operations in a single location at the Charité Campus Vir- With our new central location, we have established the foundation for intensive interdisciplinary exchange between the specialist laboratories and for the integration of clinical expertise. This high expertise, methodological competence and our high routine sample volumes of more than 35 million analyses per annum for more than 400,000 hospital and some one million outpatients contribute to optimal patient care, while also forming an ideal basis for the development of improved IVD technologies. 18

19 BioTOP-Report Diagnostics chow-klinikum. More than 10,000 hospital beds in and around Berlin will be provided with high-performance diagnostics from this new location. Efficient technology transfer based on regional networks BioResponse and DiagnostikNet BB have emerged as company-driven networks whose intensive cooperation with science has resulted in innovative product developments like the AK- LIDES system, which have become international market leaders. The Centre for Molecular Diagnostics and Bioanalysis (ZMDB) has driven regional and international cooperation between science and industry as a successful platform for know-how and technology transfer since Through the ZMDB, Berlin-Brandenburg has maintained close links with nine leading European diagnostics regions since 2010 as part of the European Diagnostics Cluster Alliance (EDCA), offering regional SMEs specific market access support services. The Technology Forum In vitro-diagnostics and Bioanalysis organised by the ZMDB has been held in the capital region for the past five years and is proving to be an excellent platform for initiating sustainable dialogue between fundamental research and industrial as well as clinical application. The 5th Technology Forum in June 2013 focused on mass spectrometry, protein arrays and aptamer-based biosensors. A specially designed partnering event for diagnostics companies and research institutes permitted meeting new cooperation partners from Europe and was aimed at fostering and encouraging potential growth opportunities. Achieve innovation, shape the future Start shot for young technology companies High Tech Gruenderfonds is your partner for Seed Stage investing. We help out young, high potential startups in the early phases of technology and product development, as well as successful launching. Our assistance is not limited to our cash investments, instead we strive to add long term added-value to portfolio companies through our extensive network of professional and our accredited coaches. High-Tech Gründerfonds Management GmbH Software Internet & Telecommunication Media & E-commerce Life Science Material Science Nanotechnology & Chemistry Energy Automation Photonics Industrial Software Schlegelstraße Bonn Phone: +49 (0) Fax: +49 (0) info@htgf.de http: // INVESTORS OF HIGH-TECH GRUENDERFONDS II 19

20 BioTOP-Report Dr. Notghi Contract Research GmbH Full service CRO Dr. Notghi Contract Research GmbH is a high quality service provider for large, medium and small-sized companies in the pharmaceutical, generics and biotechnology industries. Our full-service offerings include Statistics, Clinical Monitoring, Medical Writing, Data Management, Study Management, Pharmacovigilance, Regulatory Affairs, IT Solutions, & Training Solutions. For 14 years, our clients have benefited from our broad expertise in clinical research to meet their business challenges. We have successfully supported and advised hundred of companies in the conduct and management of national and international projects, enabling them to bring their reliable and successful products to market in ever shorter periods of time. Founded by Dr. Arman Notghi, the company has its headquarters in Berlin as well as an office in Istanbul, Turkey. Dr. Notghi Contract Research GmbH has enjoyed continuous and stable growth thanks to the confidence placed in us by our longstanding customers and the dedication of our employees. With over 90 specialized employees available across Europe for our clients, we can rapidly and efficiently respond to a wide range of requirements. The Dr. Notghi Academy, located in Berlin, qualifies drug safety officers, clinical research associates and data managers, offers specialist workshops and global learning & development solutions for the Pharmaceutical industry. Address Dr. Notghi Contract Research GmbH Zimmerstraße Berlin Contact Melanie Wurzel Deputy CEO Phone Fax contact@notghi.com Benefit from our Competence PAREXEL International PAREXEL International is a leading global bio/pharmaceutical services organization, providing a broad range of knowledge-based contract research, consulting and medical communications services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, PAREXEL has developed significant expertise across the development and commercialization continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, medical education and reimbursement. Perceptive Informatics, Inc., a subsidiary of PAREXEL, provides advanced technology solutions, including medical imaging, to facilitate the clinical development process. Headquartered near Boston, Massachusetts, PAREXEL operates in 78 locations throughout 52 countries around the world, and has approximately 14,400 employees. PAREXEL has a long-standing presence in Berlin, where over 1,500 employees are located. Clients can benefit from state-ofthe-art technologies and equipment provided through PAREXEL s medical imaging lab and Early Phase Units, which provide a safe, high-quality environment for early phase development activities in a hospital setting. The PAREXEL Academy located in Berlin qualifies clinical research associates and clinical data managers, and offers a course for a Bachelor of Science degree in Clinical Research, validated by a British university. Address PAREXEL International GmbH Klinikum Westend Haus 18 Spandauer Damm Berlin Germany Contact Dr. Ulf Schneider Corporate Senior Vice President and Chief Administrative Officer Phone Fax Ulf.Schneider@PAREXEL.com 20

21 Tradition and Innovation based in Berlin Research is carried out here Our research focuses on: analytical chemistry, pharmaceutical development and clinical research. Our findings lead to innovative and proven quality compounds. In this way, we improve quality of life for many people. Here we produce... The main focus of our product portfolio is medication for pain and diabetes therapy as well as for the treatment of disease relating to the cardiac and circulatory system or the thyroid gland. Patients have placed their trust in our medicines for over 100 years. From here we apply our know how on the market... Especially in the eastern European markets; there we have over 31 representative offices. We supply patients worldwide within the Italian Menarini Group network. BERLIN-CHEMIE, a company in the Menarini Group, stands for tradition and innovation from Berlin. For more information: BERLIN-CHEMIE AG Glienicker Weg Berlin Phone:

22 BioTOP-Report Industrial Biotechnology Focus: Biopolymers and Bio-based Plastics Bioplastics are still niche products today, but that is due to change soon. The reason: Bioplastics offer enormous potential for business and the environment. They are expected to find application in many industries soon, be it as biodegradable mulch foil for agriculture, green packaging for food, or light-construction components for cars. Germany is investing increasingly in the development of biopolymers and bioplastics, for example as part of its national research strategy BioÖkonomie The term bioplastics designates three types of materials: biobased plastics, i.e. plastics produced on the basis of biomass, petroleum-based biologically degradable plastics and those which are both, i.e. bio-based and biologically degradable. Biopolymers are the precursor of bio-based plastics. Biopolymers either occur naturally (like cellulose, starch, lignin and proteins) or they are biotechnologically manufactured polymers (like bacterial cellulose) or polymers whose synthesis components are made of renewable raw materials (like sugar or vegetable oils). Alongside the bio-based versions of classical polymers produced on the basis of petroleum (like PE, PP or PA) the so-called dropin solutions there are now new polymers like PLA or PHA. Biopolymer market set to grow in the coming years Market analyses predict an exciting future for the use of biopolymers with above-average growth. According to the Nova Institute, production capacity worldwide is to reach 12 million tons by 2020, tripling the volume of A great variety of materials and products is expected. The number of manufacturers, processing companies and, above all, users is set to rise strongly during the coming years. Materials made of biopolymers will be used in a wide range of application areas: in the packaging industry, the life sciences, in architecture and the design industry, in agriculture and forestry or in light construction for example in the transport industry. One great advantage of the biopolymers is that they are based on renewable resources and therefore reduce petroleum consumption. In addition, some biopolymers and bio-based plastics (e.g. PLA) have special characteristics which cannot be achieved with petroleum-based polymers, or only at considerable expense. Since the production of biopolymers and bio-based plastics is to grow strongly in the next few years, we can expect that rising production volumes and increased market penetration will reduce the presently still existing disadvantages in terms of both cost and optimised processing methods. High potentials for cross-innovations Plastics are everywhere and everyday life is no longer conceivable without them. Items of daily use like pens, USB sticks, mobile phone covers, breadboxes, toys or citrus presses many products are already on the market in bio-based versions. Innovative products are also being developed which use the specificity of biopolymers, e.g. more environment-friendly disinfestation systems for forestry, protein foils for bio-diapers, components for facade casings or packaging foils made of stale bread. When developing new system solutions, it is essential to involve both the raw material supplier and end user from the start to create Dr. Karl Heinz Tebel Chairman of the managing board of BASF Schwarzheide GmbH Cluster spokesman for plastics and chemistry of the state of Brandenburg As cluster spokesman for plastics and chemistry of the state of Brandenburg, I am pleased that the establishment of the Innovationszentrum Bioplastics Lausitz succeeded in close cooperation of Fraunhofer Institute for Applied Polymer Research with Kunststoffverbund Berlin/Brandenburg (KuVBB) and BASF, and innovative approaches to dealing with this interesting group of products are investigated at the newly launched Fraunhofer- Competence Centre for Bioplastics Processing at the BASF site in Schwarzheide. I am certain that such projects and initiatives pave the way for additional businesses to settle in Brandenburg. 22