BioTOP-Report. Biotech and Pharma in Berlin-Brandenburg

Transcription

1 BioTOP-Report 2014 Biotech and Pharma in Berlin-Brandenburg

2 BioTOP-Report 2014 Content Editorial The German Capital Region Biotechnology and Life Sciences are Ready for the Future 3 Biotechnology The Capital Region New Jobs and New Companies 4 Pharma Attractive Location 14 Glycoscience Glyco Research for Innovations in Health Industry 18 Bioelectronics The Joint Lab Bioelectronics A New Platform for the Integration of Microelectronics into Life Sciences 20 Business Location Excellent Services for Berlin-Brandenburg 24 Spotlight on European Business and Internationalization The Enterprise Europe Network Berlin-Brandenburg 26 Biotech Parks The BioCampus Network Berlin-Brandenburg 34 Addresses 39 Publisher: Berlin Partner für Wirtschaft und Technologie GmbH BioTOP Berlin-Brandenburg Fasanenstraße Berlin Germany Phone Fax biotop@biotop.de Editor: Volker Erb Design & Production: webersupiran.berlin Translation: Kate Abbott Berlin Photos/Figures: BioTOP or authors and: Page 14 Paulus Rusyanto/dreamstime.com, Sean Pavone/dreamstime.com Page 21 Warenemy/dreamstime.com, Collpicto/dreamstime.com Page 27 adimas/fotolia (Profile Alacris), Noah Clayton/co.don (Profile co.don) Page 30 Werner Popp (Profile organobalance).

3 BioTOP-Report 2014 Editorial The German Capital Region Biotechnology and Life Sciences are Ready for the Future Berlin-Brandenburg is an extremely attractive location for research and its translation into industrial applications. The establishment of the Berlin Institute of Health, successful spin-offs and inward investment show that the German capital region provides top conditions for the healthcare industry. Berlin is the start-up capital of Germany! With its new Healthcare Industries master plan, the capital region is setting the course for the sector s development until Basic research, innovation, spin-offs and application in the future, these will remain the four pillars that determine the successful implementation of the cluster strategy in Berlin-Brandenburg. Biotechnology/pharmaceuticals, medical technology and the healthcare industries are the focal areas. In the coming years, biotechnology/pharmaceuticals development will feature: The creation of new translation platforms in basic research, clinical research and industrial biotechnology Max Planck and Fraunhofer Research, as well as the Helmholtz and Leibnitz Institutes, are drivers of technology transfer and pioneers of innovative technologies and products. Development of new growth fields in the life sciences with interdisciplinary technologies Cross innovation at the interface of microsystems technology, microelectronics, photonics and surface engineering and thin films open up completely new opportunities for analytics, automation and hardware development and along with this, for growth, value creation and cost reduction. Value chain expansion via inward investment and industrial location expansion With more than 200 biotechnology companies, over 30 research institutions and over 130 clinics and hospitals, Berlin-Brandenburg is already a European hot spot for the life sciences. Growth in expertise, players and investment will reinforce the capital region s leading position in the international markets. Concentration on therapy development through new system medicine strategies The Max Delbrück Center for Molecular Medicine and Charité Universitätsmedizin Berlin are the umbrella for the new flagship of German biomedicine. In diagnostics, focus on the development of companion diagnostics Laboratory medicine, applied research, SMEs and the pharmaceuticals industry are pooling their activities for therapy optimization in personalized medicine. This new edition of the BioTOP Report provides you with an exciting, informative overview of the development in the capital region s industries. With themes such as glyco-engineering technology and bioelectronics, it underscores internationally outstanding activities. We wish you reading pleasure and invite you to commit to Berlin-Brandenburg as a place to develop your business. Reach out and contact us! In regenerative medicine, concentration on the development of new cell therapies The Berlin-Brandenburg Center for Regenerative Therapies (BCRT), biotechnology SMEs and pharmaceuticals partners in the international Regenerative Medicine Coalition are part of a high-performance product development network. Focus on the sustainable use of biological resources for medical applications in industrial biotechnology The Leibniz Institute for Agricultural Engineering, university-related research and biotechnology SMEs are successfully implementing the federal government s bioeconomics strategy and contributing to the strength of the healthcare industries. Prof. Dr. Peter Seeberger Expert Circle Spokesman Biotech/Pharma Dr. Günter Peine Head of BioTOP Berlin-Brandenburg 3

4 BioTOP-Report Biotechnology Biotechnology The Capital Region New Jobs and New Companies The growth trend of recent years continues in Employee numbers have grown by 5.6 % (last year, 6.5 %). Currently, 232 companies employ 4,586 people. The constant momentum is accompanied by many newly founded businesses. kk According to the latest BioTOP survey, 232 biotechnology companies are active in the Berlin-Brandenburg region. This means the company base has expanded by a total of 10 companies against last year. kk A total of 14 companies have stopped doing business in the region, either shutting down completely or relocating. kk The addition of 24 companies more than compensated for this loss. Of the new companies, we count 6 additions due to inward investment and new registration and particularly notable 18 start-ups. kk The current base of 232 companies has created 352 new jobs. This translates into a growth rate of over 8 percent. kk After subtracting the 114 jobs lost due to business shut-downs, the sector in the region gained a total of 273 jobs, adding up to regional employment growth of 5.6 % in the sector. For many years, biotechnology region Berlin-Brandenburg has been on a steady growth course. One of the sector s leading regions in Germany and Europe, it hosted 18 start-ups last year alone a figure to note. This speaks volumes in favor of the location s general conditions and the commitment of the many players involved and their start-up-related activities. And above all, underscores the courage of the many company founders who are seeking their fortune in this highly sophisticated sector. Smaller companies dominate the region s business landscape: 139 companies in the sector have less than 10 employees. Only 13% of the total jobs are located in these companies, however. Over 53% of the sector s employees in the region work for the 19 companies with more than 50 employees. The majority of these companies (88%) focus on the areas of new therapeutic agents, diagnostic products and biopharmaceuticals services; followed by 19% in the agriculture/food sectors and 13% in the industrial biotechnology sector (multiple mentions). The start-ups still have little effect on the job market. At their launch, none of these companies had more than 10 employees. 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 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 Schwarz heide 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 JULY 13 Berlin-Brandenburg Healthcare Industries cluster HealthCapital launches new website: Caprotec expands alliance with Bayer +++ EZAG AG in participation via subsidiary OctreoPharm Sciences GmbH +++ caprotec bioanalytics GmbH and Bayer CropScience enter into second research collaboration +++ NOXXON Pharma completes patient recruitment for phase IIa study in diabetic nephropathy +++ Romer Labs and the Institute for Product Quality (ifp) launch new AgraQuant F.A.S.T. AUGUST 13 Bayer HealthCare concludes partnership and license agreement with Compugen Ltd. for the research, development and marketing of antibody-based drugs for cancer immunotherapy. +++ caprotec bioanalytics GmbH and Syngenta International AG announce research collaboration +++ Epigenomics AG agreement with YA Global Master SPV Ltd. brings funding of up to 5 million SEPTEMBER 13 Eckert & Ziegler BEBIG s.a. takes over prostate cancer implantation business of American company Biocompatibles Inc. for $5 million +++ Myelo Therapeutics GmbH successfully completes funding round for the development of adjuvant cancer therapy OCTOBER 13 Epigenomics and Polymedco sign commercialization agreement for Epi procolon for the North American market +++ Sugar is life: GlycoUniverse successfully launched in Campus Buch +++ Cell Medica, a leading company in the T-cell 4

5 BioTOPics Juni 2014 (3:02) BioTOP-Report Biotechnology Dr. Matthias Schroff CEO MOLOGEN AG Key milestones achieved MOLOGEN completed a successful fiscal year 2013 with three different product candidates in clinical development for the first time. The final evaluations for the completed clinical trials of MGN1703 and MGN1601 provided very positive data, and with MGN1404 (a product that combats malignant melanoma), the company launched the clinical development phase of another product candidate within the framework of a partnership, contributing to an expansion of its pipeline. For its most advanced product candidate, the cancer immunotherapy MGN1703, MOLOGEN was also able to present very positive clinical data from the final evaluation of a phase II trial in colorectal cancer (IMPACT study) in For the most part, the preparations for a phase III pivotal study in this indication were completed in the course of the last fiscal year. Glycotope specializes in the glycosylation of proteins. Glycotope has a broad portfolio of drugs in clinical development, including the new cancer drugs, PankoMab-GEX and CetuGEX, both in phase IIb trials. PankoMab-GEX is the first fully glycosylated and glyco-optimized human antibody for a novel tumor-specific carbohydrate-protein mixed epitope (TA-MUC1) abundantly present in a larger set of tumor indications, metastases and cancer We are well aware that our company s success is also due to the conditions that Berlin and the capital region offer. Whether research collaboration (FU Berlin) or clinical studies with Charité Universitätsmedizin and its departments we benefit from the close scientific network. The availability of qualified personell is also a key advantage, which surely ties into the high quality of life in Berlin. Berlin is a city for conferences and conventions and many of our sector associations have their headquarters here. This is another reason why Berlin is an excellent location for medical biotechnology. As a research company, we appreciate the fact that Berlin is one of the world's leading regions and innovative locations in the field of life sciences. stem cells. Additional Glycotope products include TrasGEX, which has successfully completed its phase I/IIa trial and the improved fertility hormone FSH-GEX, which is expected to begin two phase III clinical trials in Biopharmaceuticals company NOXXON Pharma is a pioneer in the development of a new class of proprietary therapeutic agents called Spiegelmers, which are chemically synthesized L-ste- therapy field, opens a central European production facility in Berlin-Buch +++ ProBioGen upholds strong patent position in viral vaccine manufacturing field NOVEMBER 13 Glycotopes Fully Human and Glycooptimized Recombinant FSH-GEX exhibits superior activity and excellent tolerability in phase II clinical trial for in vitro fertilization +++ The methylated SHOX2 biomarker from Epigenomics shows promising results for therapy-related monitoring of lung cancer patients +++ SCIENION s sciflexarrayer receives product technology innovation award from Materials Science Society AVS +++ The NeuroPro Alliance, a joint venture between the Technical University of Applied Sciences Wildau, nanopet Pharma GmbH and AudioCure Pharma GmbH, receives research award. DECEMBER 13 OMEICOS Therapeutics: new drug for atrial fibrillation in model systems tests positively +++ Contichrom systems from KNAUER receive Berlin-Brandenburg Innovation Award +++ ProBioGen announces expansion of commercial licenses with emergent biosolutions for AGE1.CR viral vaccine manufacturing production platform JANUARY 14 Improved diagnostics for sepsis-associated liver dysfunction with LiMAx test from Humedics GmbH +++ Epigenomics starts trading on US OTCQX market +++ Cell Medica announces European Union orphan drug designation for Cytovir ADV +++ ward-winning Ostendum Lab-on-a-Chip nanodevices are produced with SCIENION's sciflexarrayer SX FEBRUARY 14 The Swedish-German company Amal Therapeutics SA has acquired investors for a seed financing round +++ mivenion GmbH receives FDA approval for Xiralite Fluorescence Imaging System X4 for microcirculation visualization million for Mologen MARCH 14 Glycotope GmbH raises 55 million +++ FDA Advisory Committee Provides Recommendations for Epigenomics' Colorectal Cancer Screening Blood Test APRIL 14 Alacris Theranostics GmbH announces partnership with Walldorfer SAP AG +++ On May 14, Bayer HealthCare opened its first German CoLaborator in Berlin-Mitte on the company's premises +++ Bayer Pharma AG participates in the High-Tech Startup Fund II +++ International pharmaceutical company Takeda extends production facility in Oranienburg 5

6 BioTOP-Report Biotechnology reoisomer RNA aptamers and a non-immunogenic alternative to antibodies. NOXXON is approaching the completion of multiple proof-of-concept studies with a diversified portfolio of clinical-stage Spiegelmer therapeutic agents exhibiting high safety and tolerability, and promising signs of efficacy. Emapticap pegol (NOX-E36), an anti-ccl2/mcp-1 Spiegelmer, is currently in a phase IIa study in patients with diabetic nephropathy. Olaptesed pegol (NOX-A12), an anti-cxcl12/sdf-1 Spiegelmer, is currently in phase IIa studies in two hematological cancers: multiple myeloma and chronic lymphocytic leukemia. Lexaptepid pegol (NOX-H94), an anti-hepcidin Spiegelmer, has shown efficacy in a subset of anemic cancer patients with functional iron deficiency in a pilot study where the pharmacodynamic parameters of iron metabolism and erythropoiesis were positively influenced and hemoglobin levels increased following lexaptepid mono-therapy. The product will also be evaluated in a phase IIa study in dialysis patients with ESA-hyporesponsive anemia Number of employees Number of Employees According to Company Size '04 '05 '06 '07 '08 '09 '10 '11 '12 '13 '04 '05 '06 '07 '08 '09 '10 '11 '12 '13 '04 '05 '06 '07 '08 '09 '10 '11 '12 ' companies 1-10 employees 74 companies employees 19 companies > 51 employees In comparison to the previous year, the average number of employees per company decreased by 9,2 % in the 1-10 category and increased 15,9 % in the category. The average number of employees in the category > 50 employees increased by 3,7 %. (Source: Own survey, BioTOP database, 232 companies questioned, February 2014) 6

7 BioTOP-Report Biotechnology Epigenomics, a molecular diagnostics company in the process of developing and commercializing a pipeline of proprietary products for the screening and diagnosis of cancer, announced the outcome of a meeting of the Molecular and Clinical Genetics Panel of the FDA s Medical Devices Advisory Committee held in conjunction with its premarket approval for its blood-based colorectal cancer screening test Epi procolon. The members of the Medical Devices Advisory Committee voted favorably, determining that the benefits of Epi procolon do outweigh the risks for use in patients who meet the criteria. Caprotec bioanalytics and Syngenta International AG announced a joint research agreement in which Syngenta will gain access to caprotec s proprietary capture compound mass spectrometry technology. The companies will work together to profile the interactions of one of Syngenta s novel active compounds with the proteome in its relevant plant biological system. caprotec s platform enables the unbiased evaluation of the interactions of small molecules with protein mixtures in a targeted and directed manner, which facilitates the identification and elucidation of tractable targets and accelerates the development of promising leads. Cell Medica announced that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products has issued a positive opinion on an application for orphan designation of a novel T cell immunotherapy under development by the company. The cell therapy Cytovir ADV targets the treatment of adenovirus infections in patients following allogeneic hematopoietic stem cell (bone marrow) transplant. It is comprised of adenovirus-specific T cells derived from allogeneic donor leukocytes, expanded ex vivo Number of employees Employees in Biotech SMEs '04 '05 '06 '07 '08 '09 '10 '11 ' Employment rose to in This is a growth of 5,6 % in comparison to the previous year. The number of companies went up to 232, reflecting the arrival of 24 companies (18 start-ups) and 14 departures. (Source: Internal survey, BioTOP database, 232 companies questioned, February 2014) '13 co.don is one of the world s leading specialists in the cultivation of cells for the joint-preserving treatment of articular cartilage and intervertebral disk defects. Using the company s patented therapeutic products, doctors are able to avoid joint and intervertebral disk prostheses in many cases. An increasing number of orthopedists, orthopedic surgeons and neurosurgeons are relying on this regenerative therapeutic procedure. This minimally invasive method for articular cartilage regeneration has been successful with approx. 6,000 patients in Germany. Experts estimate the overall European market to have a potential annual worth of approx. 1.2 billion. With its current infusion of capital, co.don is paving the way for the EU-wide approval of its biological therapeutic co.don chondrotransplant DISC an autologous method for treating intervertebral disk damage. MetrioPharm was able to complete the regulatory pre-clinical study package. The most important outcome was MP1032 s superior safety profile as confirmed by the results from the various regulatory pharmacology and toxicology studies conducted throughout the past year. The results of these tests surpassed all ambitious expectations. Repeated daily administration of up to 150(!) times the normal therapeutic dose for 28 consecutive days did not cause any side-effects or adverse events whatsoever. A clean safety profile is a highly valuable asset for a new drug. With the impeccable animal safety data obtained for MP1032 an important foundation for entering clinical Phase I trials in 2014 was laid. For the first time, MP1032 can now be tested directly in humans. 7

8 BioTOP-Report Biotechnology ProBioGen is an internationally operating technology provider and contract development and manufacturing organization (CDMO) with almost 20 years of experience in cell culture, process development and GMP manufacturing. A competent and reliable CDMO partner, ProBioGen offers customized solutions for even the most challenging development and manufacturing requirements. ProBioGen has signed its latest GlymaxX ADCC technology deal with a top-10 pharmaceuticals company for a therapeutic antibody platform. Investment in the Region In recent months, these companies have acquired financing of almost 100 million. Glycotope GmbH has led the field with a new financing round of 55 million. Investors have supplied the company with 130 million in the past few years. One of the largest in Europe, the latest round of financing has attracted international attention. It will be exciting to see how Glycotope s future develops. The listed companies have also obtained a new infusion of money. Mologen and Epigenomics have been able to financially safeguard their next steps with new capital increases, for example. High-Tech Gründerfonds (HTGF) and IBB Beteiligungsgesellschaft, one of the most active venture capital financiers in Germany, were among the most responsive financiers in the Dr. Karen Uhlmann COO/Co-CEO Omeicos Therapeutics GmbH Dr. Robert Fischer CSO/Co-CEO Omeicos Therapeutics GmbH early-stage area again in Subsidies from the states of Berlin and Brandenburg, which contributed project-related funding volumes of 42 Mio. Euro to life sciences companies alone, supplemented private funding. Investment helps not only the companies involved, but is also relevant for the development of the overall biotechnology region, generating useful growth effects above and beyond its benefits to individual companies. Conclusion The Berlin-Brandenburg biotechnology region has enjoyed a constant growth trend for years. The companies in the sector have again proven their competitiveness in 2013/2014. After many years of developing products and conducting the studies required by the certifying authorities, the near future will show whether the investments have paid off. Most of the biopharmaceutical companies are doing so well that is safe to be optimistic, although the risk remains high. The region s pool of highly specialized service providers is only one of the factors upon which this excellent economic development is based. The companies in the sector grow organically and are typically less dependent on external investors. They important sector delivers constant, sustainable growth for the Berlin-Brandenburg region. Relatively strong fluctuation is typical of the still-young biotechnology sector. Established companies go and new ones come to take their place. The high number of start-ups, which ultimately compensate for failed business ventures, is another reason for optimism. To ensure the successful development of these young companies, private investors must actively participate in early-stage financing again. OMEICOS Therapeutics is working on a new drug for the treatment of atrial fibrillation, and would like to implement the clinical development by the end of The demand for a new atrial fibrillation treatment is high and with it, its commercial potential. All of the medicines available now to the majority of patients have a limited effect, and some of them go hand in hand with highly problematic side effects. Working with their partners at the Texas Southwestern Medical Center, scientists at the Max Delbrück Center for Molecular Medicine (MDC) Berlin-Buch have identified a metabolism product of the Omega 3 fatty acid with an anti-arrhythmic effect. Based on this product, they have synthesized drug candidate OMT-33. The fact that the active ingredient can be further developed for commercial use as part of a start-up is due to the very good general conditions existing before the company was even established. OMEICOS received its initial financial support from the MDC PreGO-Bio funds and Helmholtz Enterprise, the spin-off support project of the Helmholtz Association. The company received seed financing through a High-Tech Gründerfonds participation and ProFIt funding from the state of Berlin, which is co-funded with capital from the European Fund for Regional Development (EFRE). With its BioTech Park, Campus Berlin-Buch provides the ideal framework conditions and an outstanding infrastructure for our product development phase. Of course the direct proximity to MDC is essential to our success. OMEICOS and MDC will continue to work in close partnership. And our cooperation with the Campus' BBB Management GmbH also makes the location very attractive for us. 8

9 vfa bio represents the biotech interests within the German Association of Research-Based Pharmaceutical Companies (vfa). vfa campaigns for the interests of 45 worldwide leading pharmaceutical companies in the fields of health, research and economy. vfa bio seeks to exploit the therapeutic and economic potential of biotechnology to make Germany the leading biotech location in Europe. Medical biotechnology is vfa bio s topic. We primarily deal with: Medical progress provided by biopharmaceuticals - benefit for patients, physicians and society as a whole Access to biopharmaceuticals for patients Business location Germany and regulatory and economic framework for research, development and production of biopharmaceutical Biosimilars Orphan medicinal products (medicines for rare diseases) Advanced therapies such as gene and cell therapy and tissue engineering products Bild: vfa / Martin Joppen

10 BioTOP-Report Biotechnology Till Erdmann Managing Director Myelo Therapeutics GmbH Dirk Pleimes Managing Director and Chief Medical Officer Myelo Therapeutics GmbH But they will only do so if the general conditions for venture capital are significantly improved. The political decision makers seem to agree on this objective now all they have to do is adopt relevant new laws. The Start-Up Capital is Booming For many years, the Berlin-Brandenburg region has been generating international headlines as the start-up capital of Germany. Hardly a week goes by without a new start-up being founded, a major financing round being concluded or a major corporation committing to act as an accelerator or incubator. The region is booming; it s an international hot spot. However, this has more to do with IT and web-based applications start-ups. We are a young pharmaceutical company that develops new therapies in fields of application with high medical needs. With a clear strategy for developing our innovative active ingredient Myelo001 for treating chemotherapy-induced neutropenia, we have successfully obtained the support of a series of strategic investors, including IBB Beteiligungsgesellschaft, Eckert Life Science Accelerator (ELSA) and Valenta Pharmaceuticals. The German capital region provides a high concentration of science and research, clinics and business, as well as a high quality of life. It is predestined to be a location for pharmaceutical companies. The technology parks and networks that are part of the Healthcare Industries cluster represent an outstanding infrastructure for translating the latest scientific findings into innovative products Market Segments of Companies % Number of companies % 45 19% 0 '04 '05 '06 '07 '08 '09 '10 '11 '12 '13 '04 '05 '06 '07 '08 '09 '10 '11 '12 '13 '04 '05 '06 '07 '08 '09 '10 '11 '12 '13 Agriculture/Food White Biotechnology /Environmental Biotechnology Biomedicine Most companies focus on biomedicine. A total of 88 % of companies, focus primarily on development in the areas of new diagnostics, drug development and associated services or technologies. 13 % of the companies are active in the agriculture / food sector, white biotechnology / environmental biotechnology amounts to 19 % of all entries. (Source: Internal survey, BioTOP database, responses from 232 companies, multiple entries, February 2014) 10

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12 BioTOP-Report Biotechnology Does this status relate at all to start-ups in the life sciences? At first glance, perhaps not. But take a closer look: The large number of players (founders, investors and incubators), the university support programs and many start-up competitions, and the range of various activities create a start-up-compatible atmosphere, which has a positive impact on the start-up scene in the life sciences. Putting it simply, the spillover effect is high. There have not been as many life sciences start-ups in years as there were in the last half of fiscal year 2013/2014. And the striking thing about them is that some of the new companies are focusing on new drug development. Here are a few examples of recent start-ups and their concepts: OMEICOS Therapeutics is a spin-off of the Max Delbrück Center for Molecular Medicine. It develops synthetic compounds with Our Business: Committed to Improving Health 12 For more than 230 years, Takeda has been serving society with innovative medicines. Now, with new healthcare solutions from prevention to care and cure, we are determined to help even more people enjoy their lives to the fullest. Of our 30,000 employees worldwide, 1,700 are working in Germany to develop, produce and market a broad range of medicines to help patients reclaim valuable moments of life from illness. innovative modes of action for the treatment of various human diseases. The company is working on a new drug for the treatment of atrial fibrillation, the most common type of human cardiac arrhythmia. Myelo Therapeutics has developed a drug for the prophylactic treatment of post-chemotherapy patients whose blood contains too few white blood cells (neutropenia) or platelets (thrombocytopenia). Venture capital investors IBB Beteiligungsgesellschaft with their VC Fonds Technologie Berlin, Eckert Wagniskapital und Frühphasenfinanzierung and JSC Valenta Pharmaceuticals are in the company s financing consortium. Amal Therapeutics, a company with facilities in Geneva and Berlin, is developing a vaccine consisting of a recombinant protein with a cell-penetrating peptide acting as a vector. The unique property of this platform is its ability to trigger a highly integrated, multi-epitopic cellular immune response to cancer cells. DexLeChem, a TU Berlin spin-off, provides development services to the chemiwww.takeda.de

13 BioTOP-Report Biotechnology Financing and Added Value Venture Capital for companies in Berlin cal-pharmaceutical industries for making production processes more chiral, meaning to convert substances with spatially complex designs into water-based processes. The catalyst is not modified before re-use. With this resource-conserving reaction process control, customers drug and fragrance manufacturers benefit from more cost-efficient, environmentally friendly production processes. GlycoUniverse is a technology spin-off of the Max Planck Institute of Colloids and Interfaces. The company specializes in the automated development and synthetic production of complex sugars. With GlycoUniverse s state-of-the-art oligosaccharide synthesizer GLYCONEER, the process of synthesizing complex carbohydrates that formerly took months or years can be completed in a matter of days or even hours. The high number of start-ups is the result of a critical mass of players, activities and initiatives in the start-up area, its welldeveloped infrastructure and excellent location factors as well. These include the seven biotechnology parks that make affordable laboratories and technical infrastructure available, and the many scientific institutes that produce highly skilled specialists. The universities join in with comprehensive spin-off support programs, some of which are triggered by the federal government s EXIST-Gründungskultur - Die Gründerhochschule competition. Pharmaceuticals giant Bayer Healthcare has also discovered the region s potential, providing the technical infrastructure, professional support and expertise of an established pharmaceuticals company to young companies via its CoLaborator, opened in May. Another important element is the many business plan competitions in which founders receive initial feedback for their business concepts. With 140 events, a network of over 200 consultants and over 500 business plan submissions per year, the Berlin-Brandenburg Business Plan Competition is one of the largest competitions of this type in Germany. IBB Beteiligungsgesellschaft mbh offers equity financing for high tech companies in Berlin. For our fund VC Fonds Technologie Berlin ( 52m) we are looking for investment opportunities in the biotechnology and medical technology sector. Our investment approach is based on hands-on involvement and active management support for each portfolio company, delivered by our highly experienced investment team. VC Fonds Technologie Berlin not only provides capital, but also helps execute the business plan. Are you interested? Please do not hesitate to contact us. IBB Beteiligungsgesellschaft mbh Mrs. Ute Mercker / Mr. Christian Seegers Bundesallee Berlin / Germany Phone: +49 (0) The momentum in the Berlin-Brandenburg region is powerful especially at the interface of IT and the life sciences. There are a variety of names for this new area, including ehealth, ithealth, dhealth and mhealth. What they all designate is the successful fusion of the two fields, facilitated by web-based applications in the medical sector. This development is still young, but with its unique density of IT and life sciences players, the Berlin-Brandenburg location is particularly suitable for generating new companies. The first companies have already been founded; take Caterna, an online school for visual exercises, or NeuroNation, the new digital brain-jogging platform for example. There are many new companies in this new field, and in XL Health, it even has a financially strong investor specialized in digital health. Selected portfolio companies: VC Fonds Technologie Berlin was set up as a joint initiative of Investitionsbank Berlin (IBB) and the State of Berlin. It is co-financed by the European Regional Development Fund (ERDF). 13

14 BioTOP-Report Pharma Pharma Attractive Location The capital region has developed into one of Germany s most important, attractive centers for the medical and healthcare industries. Based on the significant growth of the pharmaceuticals industry in Berlin, these sectors are the growth engine of the regional industry. Currently, the sectors employ approx. 10,000 people in the German capital region. This means that pharmaceuticals companies account for around one in every 10 jobs in the regional industry and every 11th employee in the pharmaceuticals sector in German works in Berlin. Above all, the sectors benefit from the capital region s excellent scientific environment and clinical research landscape, the proximity to decision-makers in the healthcare system and the ready availability of well-educated skilled specialists. A steadily growing number of global players and medium-sized companies are setting up business here or moving their corporate headquarters to Berlin and the capital region, to take advantage of these location assets. With over 220 companies, Berlin is also a leading global location in the biotechnology sector and the pharmaceuticals industry has created a close, innovative network with these partners. The Berlin-Brandenburg region has an outstanding position in several sectors that the experts certify as having a strong growth outlook due to their excellence in innovation. The pharmaceuticals sector's innovative excellence pays doubly for Berlin-Brandenburg, which is also one of the country's leading research locations. The partnership between pharmaceuticals companies, clinics and hospitals and scientific institutions guarantees ultra modern patient healthcare of a uniquely high quality, and the innovations of the pharmaceuticals companies are creating and securing the jobs of the future for the region. The current investment and activities of the local pharmaceuticals sector are proof of Berlin's appeal and bear witness to the companies' commitment to the capital region. Bayer has paid billions to conclude the takeover of Norwegian cancer treatment specialists Algeta. Bayer made the move to strengthen its position in the tumor medication area. The company is also increasing its commitment to young, innovative technology companies. In May 2014, it launched the CoLaborator incubator program. An incubator model for biotechnology start-ups, CoLaborator was tested in San Francisco (Mission Bay) two years ago. In the specially equipped research building, up to 10 innovative biotechnology companies can now get to work thanks to Bayer. Globally active corporations are located along the Spree River: Bayer Healthcare, Berlin-Chemie, Pfizer Deutschland, Sanofi Deutschland and since 2011, Takeda. The capital region is also home to over 20 medium-sized pharmaceuticals companies, including several world market leaders. Within the next two years, Berlin-Chemie will invest 40 million in the expansion of its location, continuing to develop its position as one of the sector's leading employers. Dr. Rainer Uppenkamp CEO Berlin-Chemie AG In Berlin, we find an excellent scientific and commercial environment. This is an important basis for further investments and the expansion of our location in the south-east of the city. In addition required extensions are planned, among others a new building for the quality control, a new staff canteen, an extension of the office capacity for the administrative area and the resulting infrastructural measures in the form of new roads, paths and parking facilities for our employees. 14

15 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.

16 BioTOP-Report Pharma Alfonso Casal CEO PharmaMar GmbH Our presence in Germany, the European State Member with the largest population in the EU and strong research capabilities is an important step in our European expansion. From our offices in Berlin we coordinate our commercial operations as well as supporting other corporate activities in Germany. Berlin as Capital city, with important competence centers for the treatment of cancer and strong international orientation represents a very good opportunity for the development of our activities. The partnership between Sanofi and Charité that began in May 2010 with a focus on the area of stroke research has proven fruitful. The partners have signed an agreement to a second joint research partnership, this time with a focus on diabetes. The scientists and clinicians of both parties will also collaborate in a diabetes alliance in the future. The alliance aims to improve understanding of the medical requirements and approaches to the disease of diabetes and, in joint projects, to implement them as therapies and make them available to patients more quickly. After the acquisition of Nycomed in 2011, Takeda moved its German headquarters to Berlin and took over the Oranienburg-based production plant. Oranienburg has a long tradition as a location for pharmaceuticals production. In the past 20 years, the plant there has expanded continuously. It now has a production capacity of 7.6 billion pills and capsules per year 98 percent of which are exported worldwide. The Oranienburg facility is considered one of the main competence centers within Takeda's global production network. Takeda plans to expand the Oranienburg facility's production capacity within the next few years. An important new player, Teva Specialty Medicines, has recently set up business in Berlin. Newly founded Teva Specialty Medicines is Teva Pharmaceuticals' Original Products division in Berlin. Its primary area of success is neurology. Teva is the leader in generics in Germany and an expert in innovative brand business. At a January 2014 press conference in Berlin, Aristo Pharma presented a new formulation of a proven drug for treating severe and extreme pain. The special formlulation was designed for targeted retardation and 24-hour continuous analgesia when taken once a day. Founded in 2008, the company belongs to a growing group of German companies headquartered in Berlin. DR. KADE acquired Takeda s OTC business for the German market in April With this move, the traditional Berlin company has added well-known brands to its current OTC portfolio and made an investment in the future. In conjunction with the expansion of its OTC business, the company has added new employees in its Berlin and Constance locations. PharmaMar is a Spanish member of the Zeltia Group, a leader in the development of anti-tumor drugs of marine origin. PharmaMar started its activities in Germany in 2007, when the EMA granted it marketing authorization for Yondelis in the treatment of soft tissue sarcomas. Two years later, Yondelis was approved for the treatment of ovarian cancer. In 2013, the company established PharmaMar GmbH in Berlin. These current examples are only an indication of the pharmaceuticals industry activity in Berlin-Brandenburg but they illustrate the extent to which the opportunities here are multi-faceted. They range from close partnerships with regional biotechnology startups and partnerships with science to location expansion and inward investment. The range of opportunities and the strategic options they generate make the Berlin-Brandenburg region highly attractive. Dr. Hans-Christian Meyer Site Manager Takeda Plant Oranienburg Pharmaceutical development and production has a long tradition in the area of Berlin-Brandenburg. The roots of our production plant in Oranienburg trace back to the 19th century. Today, our site plays a pivotal role as a competence center for solid forms such as tablets and capsules within the worldwide pharmaceutical production network of Takeda. The support of the Investitionsbank des Landes Brandenburg helps us to further expand production capabilities, be prepared for future growth and create new jobs. 16

17 We for the life Modern research, development and manufacturing of innovative medicines in Berlin-Adlershof this is what BERLIN-CHEMIE stands for. Research and production are based not only on our experience of over one hundred years but also on our successful search for new therapeutic pathways and possibilities. The success we have gained around the world and the growth of BERLIN-CHEMIE are an endorsement of our high standards. For more information: BERLIN-CHEMIE AG Glienicker Weg Berlin Phone:

18 BioTOP-Report Glycoscience Glycoscience Glyco Research for Innovations in Health Industry Alongside genome and proteome research, the study of sugars glycoscience, is increasingly gaining importance. As our knowledge about the function of sugar structures in a variety of biological processes grows, the areas of application for glycoscience are also growing and affecting other fields in the Healthcare Industries cluster such as diagnostics, drug development, regenerative medicine and industrial biotechnology. Sugars can develop complex structures, glycans, and can be even bound to proteins in which case they are called glycoproteins. Glycans are important for a wide variety of biological processes. They control cell-cell communication and the function and stability of proteins, and play an important role in the immune response. Carbohydrate metabolism malfunctions are typically associated with neurodegenerative diseases, infections and cancer. Exploiting high potential for interdisciplinary technologies Glycan structures, as molecules expressed due to illness, can be used as significant diagnostic parameters and can serve as differentiation markers for regenerative medicine. Glycan-based molecules can also be used as vaccines e.g. for malaria and HIV. Glycoscience also contributes to the development of drugs, innovative foods and human-compatible biomaterials. When considering the diverse application fields of glycoscience, it is apparent that the capital region occupies an outstanding position. Berlin-Brandenburg is a technology leader in the chemical synthesis of glycans, and in glycan analytics it offers internationally significant expertise. We also provide excellent conditions for applications in the fields with high cross-innovation potential. The region is a leading international location for research and development in diagnostics and the implementation of clinical studies and also has highly productive drug and nutrition research. With the university hospital Charité Universitätsmedizin Berlin globally acknowledged medical expertise is also present in the region. growth period in recent years and the acquisition of 55 million in venture capital, Glycotope now has over 180 employees and is a world leader in glycobiotechnology. The objective is to turn Berlin-Brandenburg into a leading international center for glycoscience research and translation for the development of diagnostic and pharmaceutical products, cell-based therapies and new materials for medical applications by employing an expansion strategy. We will also be working to intensify the technology transfer based on regional networks and stabilize the communication between science and industry. GlycanForum, the international conference that takes place in Berlin every year, presents the current status and outlook for glycoscience in biomedicine. It is organized with the support of the Center for Molecular Diagnostics and Bioanalysis (ZMDB) and BioTOP Berlin-Brandenburg. The most important conference in the world with regard to glycoscience, GlycanForum is an outstanding open exchange platform for business, industry and users. With a subtheme of "The leading scientists of Asia," the 7th conference in 2013 was focused on the topics of healthcare, material science, analytics and synthesis. Establishing a glyco hub in the capital region Research, whether university-related, independent or clinical, forms the outstanding scientific basis of the region. The Charité has been honing its expertise in the fields of glycoanalytics and glycodesign for many years. The director of the Max Planck Institute of Colloids and Interfaces in Potsdam (MPIKG) and internationally renowned glycoscientist Professor Peter Seeberger discovered and developed the total synthesis of complex carbohydrates. GlykoUniverse, a spin-off company, will distribute the completely automated carbohydrate synthesizer. There are other excellent companies in the region as well. Located in Berlin, Scienion GmbH is distinguished in the field of glycan microarray technology for molecular diagnostics. Glycotope GmbH is specialized in optimizing sugar structures of glycoproteins and developing therapeutic antibodies for cancer cells. In the wake of a strong Dr. Véronique Blanchard Head of Glycoanalytics working group at the Institute of Laboratory Medicine, Clinical Chemistry and Pathobiochemistry, Charité Universitätsmedizin Berlin As a location for glycoscience, the capital region is unique in Europe. You find the entire spectrum here, from basic research to manufacturing industry, which creates the ideal conditions for efficiently translating research innovations to industry and clinics. At Charité, we are researching the potential of glycanbased biomarkers in tumor diagnostics and in bioanalytics for the quality assurance of stem cell preparation, and developing a glycan microarray platform for diagnostics. 18

19 Corporate Finance Consulting for Life Science Companies With more than 15 years of experience, Portus Corporate Finance supports technology focused companies in all areas of financing. We base our work on solid know-how, years of experience and reliable business partners. Portus Corporate Finance GmbH Friedrichstr. 81 D Berlin Tel (030) Fax (030) If you are looking for advise and support in the areas of Company and Project Funding Company Succession / M&A Finance Management / CFO-Services Consulting and Coaching Establishment of Businesses please don t hesitate to contact us! UHY Deutschland AG is a joint venture of long established auditing and consulting firms with a total of 250 employees and partners. As a member of UHY International, a global association of independent accounting and consulting firms with over 7,600 employees, we can provide audit, accounting, tax and consulting services in 275 business centres across the globe. UHY Deutschland AG has extensive experience in financial and consulting services for life sciences companies for many years. We offer the following services: Audits of financial and consolidated statements under the German Commercial Code (HGB) and IFRS Accounting & Reporting Due diligence (financial and tax) and business valuations Consulting services on IPOs Business Advisory Mergers & Acquisitions (M&A) German and international taxation We have offices in Berlin/Bremen/Cologne/Frankfurt/Hamburg/Munich/Stuttgart For further information please contact Dr. Ulla Peters UHY Deutschland AG Wirtschaftsprüfungsgesellschaft Zimmerstraße Berlin Phone Fax

20 BioTOP-Report Bioelectronics Bioelectronics The Joint Lab Bioelectronics A New Platform for the Integration of Microelectronics into Life Sciences The introduction of new experimental techniques causes a major advantage in the field of biology. Well-known examples are the invention of optical and electron microscopy, without which the fundamental structures of life as cells and cell organelles could not have been discovered. The next paradigm shift may very well be triggered by applying microelectronics and its developing field of bioelectronics at its interdisciplinary interface with the life sciences. This positive outlook is mainly a result of the phenomenon called scaling in microelectronics: for the last few decades, minimum feature dimensions have continuously become smaller by a factor of around two every second year. At first glance, this seems to be a minor development relating to an uninteresting technical parameter, since we have become accustomed to working with increasingly powerful computers and to storing higher and higher data volumes on a single flash memory. For the life sciences, however, scaling is a major advance. It has taken microelectronics or more accurately, nanoelectronics, to the same structural levels at which the molecular mechanisms of life operate. Particularly interesting perspectives arise for biosensorics, in which semiconductor preparation technology can be applied to the fabrication of cost-effective diagnostic systems. Bioelectronics is also significant for the process analytical techniques (PAT) for monitoring, regulating and increasing the efficiency of bioprocesses. The Berlin-Brandenburg region is eager to take advantage of this development and therefore, IHP in Frankfurt (Oder) and the TU Berlin Institute of Biotechnology have founded Joint Lab Bioelectronics. This step will intensify the interdisciplinary exchange between the two disciplines and expand biotechnology students knowledge of the basics of microelectronics. Prof. Dr. Peter Neubauer Technische Universität Berlin Institute for Biotechnology Chair for Bioprocess Engineering The Joint Lab Bioelectronics aims to advance the field of Bio- Process Analytical Technologies by connecting sensor specialists and bioengineers. JANUARY 2013 Charité and FU are jointly successful in the competition "EXIST-Gründungskultur Die Gründerhochschule" of the German Federal Ministry of Economics and Technology +++ German Research Foundation extends collaborative research centre (SBF 650) at Charité ten million Euros for research on immunological therapy FEBRUARY 2013 Humboldt research award gets Ivy-League professor Klaas van Wijk to Potsdam +++ Biopolymers strong future field with high potential for innovation presents itself in Schorfheide MARCH 2013 Hasso-Plattner-Institut speeds up personalised medicine with new data bank technology +++ Integrative Research Institute for Life Sciences (IRI) founded in Berlin +++ Paul Ehrlich- and Ludwig Darmstaedter Prize goes to MDC scientist Dr. James Poulet APRIL 2013 Charité and Sorbonne found Virchow-Villermé Centre for Public Health +++ EU- OPENSCREEN included in the new BMBF-roadmap for large research infrastructures MAY 2013 New laboratory building of MDC opened named after physiologist Max Rubner +++ Stem cell researchers in Germany pool their expertise. They found the German Stem Cell Network (GSCN) on May 7 th Evaluators praise Berlin Institute of Health (BIH). Enst Theodor Rietschel becomes chairman JUNE 13 BIH officially opened +++ Charité Universitätsmedizin Berlin once more reaches rank 1 of Focus-ranking "Germany's best hospital" JULY 2013 Prof. Angelika Eggert receives Einstein professorship and takes over as head of the Children's Clinic with focal areas of oncology and hematology +++ Scientists from the A*STAR Genome Institute Singapore and the Max Planck Institute for Molecular Genetics (MPIMG) in Berlin decode the communication network in human embryonic stem cells +++ Scientists from Charité and the MDC, working in cooperation with colleagues in Kiel, Boston, Zurich and London, discover a new gene for hereditary heart failure +++ Scientists working with Peter Seeberger (MPIKG) in Potsdam-Golm have developed a simple, cheap and reliable test for Yersinia pestis, the bacteria that caused the plague AUGUST th protein structure decoded at BESSY II +++ The World Health Summit 2013 in Berlin in August 2013 discussed solutions for global healthcare with regard to Research and Innovation. +++ BPI and vfa present national plans of action for the quick diagnosis and more effective treatment of rare diseases SEPTEMBER 2013 Scientists at Charité and MDC discover sugar withdrawal as an innovative cancer therapy approach +++ Technische Universität Berlin and Leibniz Institute IHP Frankfurt (Oder) have established Joint Lab Bioelectronics, a laboratory for joint interdisciplinary research +++ Charité and Harvard sign a cooperation agreement aimed at accelerating clinical translation, primarily in the cell and tissue technology field +++ Prof. Annette Grüters-Kieslich, Charité Dean, receives the 20