Report on Polish Biotech & Pharma

Report on Polish Biotech & Pharma

Polish Biotech & Pharma is a Sector Promotion Programme under the project system implemented by the Polish Ministry of Economy entitled: The Promotion of Polish Economy in International Markets, Sub-measure 6.5.1 of the Operational Programme Innovative Economy (OPIE). The programme aims to support individual entrepreneurs in a variety of promotional events and international expansion, which contributes to building a strong brand for the Polish biotech and pharmaceutical industry. It includes diverse forms of promotion, such as participation in international fairs, trade missions, conferences, foreign press study visits, investor study visits, and matchmaking meetings (B2B). These activities are supported by a professional advisory service and a series of specialized training in foreign trade and the registration of products in foreign markets. Scheduled events will take place in different countries, mainly in Germany, the USA, Russia, China, Switzerland and Spain. The Sector Promotion Programme for Polish Biotech & Pharma allows for a direct promotion of Polish companies and is an opportunity to obtain prospective business partners among the leading companies from the biotechnology and pharmaceutical industries. The project is implemented by a consortium of the companies Ageron Polska and Ageron Internacional, in collaboration with Bio-Tech Consulting. It would be a pleasure to assist you with any questions concerning Polish biotechnology and pharmaceutical companies. For more information please visit the programme s website: www.biotech-pharma.pl The direction of development of Polish biotechnology and pharmacy Polish biotech and pharma companies Biotechnology and pharmaceutical clusters, biotech platforms and consortia, company organizations and business support institutions Technology parks operating for pharmaceutical and biotechnology companies Science and education for the development of the biotechnology and pharmacy industry Financial support from public funds for innovative projects in the biotech and pharmacy sector Selected innovative biotech and pharmaceutical projects conducted within the framework of the Operational Programme Innovative Economy (OPIE) 1 2 3 4 5 6 7

1. The direction of development of Polish biotechnology and pharmacy Therapies based on the achievements of molecular biology and genetic engineering technology are playing an increasing role in modern medicine. The dynamic development of a new generation of biotechnological drugs and personalized medicine is possible only due to the success of life and medical sciences. The economic success of biotech and pharmaceutical companies, including those from Poland, is increasingly determined by the ability to quickly implement the results of research and by the creation of innovative products with a view, primarily, to the global market, not as previously the local one. This fact has already caused deep changes both to the mindset and functioning of the Polish scientific and (bio)business environment. Despite the fact that therapies based on biotechnological drugs are increasingly implemented in practice, apart from recombinant insulin produced by the Bioton company, no modern biotechnological drug is produced in Poland. This situation is slowly changing and, gradually, both biotech companies (MABION S.A. is the leader in this group) and large pharmaceutical companies (e.g. ZF POLPHARMA S.A.) are beginning to implement technology for biosimilars production. It is to be expected that, because of the size of the Polish drug market (sale value is estimated at about 30 billion PLN a year) and the availability of resources necessary for the development of this drug sector (see: chapters 5 and 6), biosimilars are one of the main focuses for development of the Polish biotech and pharma industry. Moreover, there are an increasing number of biotechnological drugs whose patent protection is expiring. Technology for the production of biotechnological drugs is much more advanced and requires more qualifications than the technology Increasing engagement of financial circles in the development of Polish biotech and pharma sector is a tendency, which will certainly intensify in the next years. for the production of classic generic drugs. Mastering this technology is one of the first and most important steps to be taken before undertaking the more ambitious task facing the Polish biotech and pharma industry developing new innovative biotechnological drugs and introducing them into the market. There is a clear tendency to leave behind the previous business model, consisting of the production of generic drugs, and to start working on new innovative drugs. This tendency is visible both in the case of companies producing traditional generic drugs (Adamed Group, Celon Pharma Sp. z o.o.) and also when it comes to the newly-established companies whose work combines some elements of biotechnology and pharmacy (Selvita S.A., Blirt S.A., Celther POLSKA Sp. z o.o., Stem Cells Spin S.A., Proteon Pharmaceuticals S.A.). These companies work on producing new drugs with a view to the global market. The motto Polish biotech and pharma go global is the strategic direction for an increasing group of young dynamic companies from the biotech and pharma industry. 1 Despite the fact that the number of biotechnological companies in Poland is still low (about 70), the sector is growing dynamically. Over half of the companies have been established in the last 5 years. Nevertheless, the real boom for biotech startup companies is still ahead. A high number of scientific teams conducting biotechnological R&D projects, systematically developed infrastructure necessary for the functioning of such companies (incubators, technology parks), qualified personnel (see chapter 5), increased interest in application research, including raised awareness of the importance of proper patent protection for research results among Polish scientists all of these create good conditions for establishing innovative startup companies. The development of the biotech and pharma sector stimulates the possibility of obtaining funds for innovative products, both from European Union funds and financial instruments created by the Polish government (e.g. by such institutions as the National Center for Research and Development, Polish Agency for Enterprise Development, National Capital Fund). Nevertheless, the influence of private investors, both individual and institutional (e.g. venture capital funds) is equally important for its success and dynamics. Investors have already noticed the potential of the industry, which is indicated, for example, by the valuation of biotech companies listed on the Warsaw NewConnect stock exchange market. The increasing engagement of financial circles in the development of the Polish biotech and pharma sector is a tendency, which will certainly intensify in the future years. This tendency will be the most objective indicator of the sector s development and potential.

2. Polish biotech and pharma companies Currently there are about 70 biotechnology companies (figure 2.1) and over 140 pharmaceutical companies (figure 2.2) in Poland. An interesting group of biotechnology companies are the so-called core biotech companies. These companies focus their activity mainly on developing new innovative biotechnology products. R&D represents at least 50% of their total activity. These companies use recombinant DNA technology, modern technologies of molecular biology, cell biology and tissue engineering in developing new technologies. They constitute still a small (15% of the total number of biotech companies in Poland), but very dynamic group with great development potential. 2 The vast majority of Polish biotech companies work on new innovative products, which are at different implementation stages. Innovative drugs constitute the majority of these products (figure 2.3), both biosimilars and new original biotechnology drugs. A significant number of companies from this sector operate through combining some elements of biotechnology and traditional pharmacy (e.g. Adamed or Celon Pharma). They produce traditional generic drugs and conduct research on new original biotechnology drugs. An interesting group of biotechnology companies are the so-called core biotech companies. R&D represents at least 50% of their total activity. Polish producers of generic drugs also realize the importance of biotechnology for the development of modern innovative biopharmacy. ZF Polpharma S.A., the largest Polish company producing generic drugs can serve as a good example. It has created a special research and development department, Polpharma BiologicS, whose main task is to develop both original biotechnology drugs and biosimilars, implement their production and introduce them into the market. What is characteristic of both Polish biotech companies and generic drug producers is their openness to cooperation with foreign partners. Work on innovative drugs and/or new generations of already existing drugs with market authorization stimulate Polish companies to implement new technologies for production on an industrial scale. Mabion S.A. is an example of a biotechnology company implementing the production of biotechnology drugs humanized monoclonal antibodies used in tumor treatment. The company implements technology of production of recombinant proteins using modern orbital shake bioreactors. The technology has been used mainly in modern research and development laboratories. Mabion will be one of the first companies in the world to use it in industrial production. What is characteristic of both Polish biotech companies and generic drug producers is their openness towards cooperation with foreign partners. Polish companies actively participate in international events (CPhI, BioConvention) and co-created BioForum (www.cebioforum.com) a Central European cooperation platform for biotech and pharma companies.

14 12 13 10 8 11 10 10 9 9 6 4 5 2 0 Warszawa+ Kraków Wrocław Gdańsk, Gdynia Figure 2.1. Biotech companies in Poland. Poznań Łódź Other 2 30 36 75 Pharma manufacturers Foreign subsidiaries Distributors Figure 2.2. Pharma companies in Poland. 0% 5% 10% 15% 20% 25% New cosmetics 23% Drugs for metabolic dis. 21% Oncology drugs 16% Food supplements 12% Immunology drugs 8% API Neurodegenerative dis. drugs 5% 5% Molecular biology tools 3% Other 7% Figure 2.3. The main groups of innovative products to be implemented by the Polish biotech companies in 2012-2017.

3. Biotechnology and pharmaceutical clusters, biotech platforms and consortia, company organizations and business support institutions 3 Nutribiomed Cluster Office: Wroclaw Technology Park S.A. Klecinska 125 54-413 Wroclaw Phone: +48 71 798 58 08 klaster@nutribiomed.pl www.nutribiomed.pl The cluster was created by 17 companies and 3 Wrocław universities (Wrocław University of Environmental and Life Sciences, Wrocław Medical University and University of Wrocław). Currently, the cluster gathers together 40 entities including 6 higher education schools, 3 business support institutions and 31 companies. The primary task of the cluster is to develop new dietary supplements, nutraceuticals and biomedical preparations based on native natural resources and on its own know-how. The following companies and institutions are among the cluster members: - University of Wrocław - Wrocław Technology Park S.A. - Wrocław Medical Science and Technology Park - Wrocław University of Environmental and Life Sciences - Poznań University of Life Sciences - Chem In - GALENA FSP - Algae Labs - Finepharm S.A. - Biochefa FZNP - BIOXEN Sp. z o.o. LifeScience Cluster Kraków Office: Bobrzynskiego 14 30-348 Krakow Phone: +48 12 297 46 05 klaster@lifescience.pl www.lifescience.pl The cluster was created at the initiative of the Jagiellonian University in Kraków in October 2006. Its primary aim is to support initiatives and innovations in the life science field and create conditions for effective commercialization of the results of research and development work. Administered by the Jagiellonian Centre of Innovation Sp. z o.o., the cluster embraces 32 institutions, including biotech companies and healthcare companies. The cluster members include: - Apipol-Farma Sp. z o.o. - Bio Byte - Biospekt Sp. z o.o. - Bio Te 21 Adam Master - Diagnostyka Sp. z o.o. - FARMINA Sp. z o.o. - BIOMED S.A. Instytut Biotechnologii Surowic i Szczepionek - Institute of Pharmacology of the Polish Academy of Sciences - Jagiellonian Center of Innovation Sp. z o.o. - JCI Venture - Krakow Cardiovascular Research Institute Sp. z o.o. - Laboratoria.net - Microbiolab - Oncogene Diagnostics Sp. z o.o. - Tadeusz Kościuszko Kraków University of Technology - Selvita S.A. - Trigendo Sp. z o.o. - Jagiellonian University - University of Agriculture in Kraków

Polish Technology Platform for Innovative Medicine (PPTIM) Polska Platforma Technologiczna Innowacyjnej Medycyny (PPTIM) Wolska 88 01-141 Warszawa Phone: +48 22 321 51 00 ekwapich@onboard.pl www.innowacyjnamedycyna.pl The Polish Technology Platform embraces companies conducting and funding research to develop new drugs, medical technologies, medical equipment modernization and the development of innovations in medicine. Its primary aim is to develop innovative pharmacy and increase the competitiveness of the Polish pharmaceutical industry. The following companies are the members of the Polish Technology Platform: - ADAMED GROUP - Biocentrum Sp. z o.o. - BioContract Sp. z o.o. - Biofarm Sp. z o.o. - Biomed Sp. z o.o. Wytwórnia Surowic i Szczepionek - Biowet Puławy Sp. z o.o. - Galena FSP - BIOMED S.A. Instytut Biotechnologii Surowic i Szczepionek - LABOFARM - Jelfa S.A. - Krzysztof Kucharczyk Electrophoretic Techniques Sp. z o.o. - Laboratory of Molecular Genetics - Novasome Sp. z o.o. - Read Gene S.A. - Selvita Sp. z o.o. - Synteza Sp. z o.o. - Vipharm S.A. - Wekz Med Sp. z o.o. - Polish National Contact Point for Research Programmes of the European Union - ZF Polpharma S.A. 3 BioTechMed Advanced Technology Centre Biuro Organizacyjno-Koordynacyjne CZT BioTechMed Politechnika Lodzka Stefanowskiego 1/15 90-924 Lodz Phone: +48 42 631 32 66 agata.kaczorowska@p.lodz.pl www.biotechmed.pl The BioTechMed Consortium conducts projects within the fields of: - medical biology, chemical biology, medical chemistry, virology - life sciences, biotechnology - materials science and materials engineering - pharmaceutical sciences, nonoperating clinical sciences, molecular and cell biology - techniques in medicine, biomedical engineering - chemical technology; chemistry, chemical sciences - crop and soil science The BioTechMed is a consortium of companies and scientific institutions from the region of Łódź, constituting the Advanced Technology Center together conducting research and development in the field of healthcare and protection of the natural environment, using the achievements of biotechnology, technology and medical sciences. The consortium has the following members: - Molecular and Macromolecular Research Center of the Polish Academy of Sciences - Institute for Medical Biology of the Polish Academy of Sciences - Nofer Institute of Occupational Medicine - Technical University of Łódź - University of Łódź - Medical University in Łódź - Polfarmex S.A. - IFOTAM Sp. z o.o. - BTL Sp. z o.o. Zakład Enzymów i Peptonów - Pharmena Sp. z o.o. - ICHEM Sp. z o.o. - Non-Public Health and Care Center Allergology Center - GASTRO Health and Care Center Consultative Clinic - International Institute of the Polish Academy of Sciences the European Regional Center on Ecohydrology under the auspices of UNESCO - Łódź Regional Park of Science and Technology Sp. z o.o.

3 Biocentrum Ochota Consortium Biocentrum Ochota Instytut Medycyny Doswiadczalnej i Klinicznej im. M. Mossakowskiego PAN Pawinskiego 5 02-106 Warszawa Phone: +48 22 668 52 50 sekretariat@cmdik.pan.pl www.biocentrumochota.gov.pl Biocentrum Ochota is a consortium of academic institutions of the Polish Academy of Sciences. It embraces: 1. Institute of Biochemistry and Biophysics of the Polish Academy of Sciences 2. Nałęcz Institute of Biocybernetics and Biomedical Engineering of the Polish Academy of Sciences 3. Nencki Institute of Experimental Biology of the Polish Academy of Sciences 4. Mossakowski Medical Research Center of the Polish Academy of Sciences 5. Institute of Fundamental Technological Research of the Polish Academy of Sciences 6. International Institute of Molecular and Cell Biology The consortium conducts research within the following fields: - molecular biology of molecular chaperones - biosensors and microsystems for multiparameter biochemical analysis - mitochondrial protein biogenesis - methods of visualization and analysis of processes in the living cells populations for diagnostics and therapy - structural studies of nucleus acid enzymes - hybrid systems for the production of biological factors - role of the cell cortex mechanics in cell mobility - reconstruction and regeneration of tissues for biomedical applications - molecular development mechanisms of dendritic arbor of neurons - crystallographic research on eukaryotic methylases - role of endocytosis in intracellular signal transduction - proteomic and genomic of neurogenerative diseases - analysis of enzymes responsible for post-transcriptional modification of RNA InnoBioBiz Cluster Łódź Coordinator: Mikołaj Gurdała Biuro Analiz i Strategii Uniwersytetu Medycznego w Lodzi Kosciuszki 4 90-419 Lodz mikolaj.gurdala@umed.lodz.pl The cluster was created by Łódź biotechnology companies and business support institutions in December 2011. The Medical University in Łódź and the University of Łódź are among the members of the cluster as well. The main goal of this cluster is to create conditions for the development and promotion of innovative biobusiness in the region, based mainly on the innovative biotech companies. The cluster gathers together the following companies and institutions: - Mabion S.A. - Celther Polska Sp. z o.o. - Proteon Pharmaceuticals S.A. - Flavopharma Sp. z o.o. - Bio-Tech Consulting Sp. z o.o. - Bio-Tech Invest Sp. z o.o. - Hot Gene - University of Łódź - Center for Technology Transfer of the University of Łódź - Medical University in Łódź

Organizations gathering Polish companies from the biotech and pharmacy sector POLFARMED Polish Chamber of Pharmaceutical and Medical Devices Industry Lucka 2/4/6 00-845 Warszawa Phone: +48 22 654 53 52 sekretariat@polfarmed.com.pl www.polfarmed.pl Established in 1993, it gathers together companies conducting business activities within the field of: - producing medical products and devices and introducing them to the market, - producing dietary supplements, special food products as well as materials and equipment used for producing medical products and devices and introducing them to the market, - services concerning the production of medical products and devices and introducing them to the market. Polish Employer Association of Pharmaceutical Industry Wisniowa 40b/4 02-520 Warszawa Phone: +48 22 542 40 80 biuro@producencilekow.pl www.pzppf.com.pl The organization was created in September 2002. It represents the producers of generic drugs and covers mainly large pharmaceutical companies. INFARMA Employers Union of Innovative Pharmaceutical Companies Pulawska 17 02-515 Warszawa Phone: +48 22 852 82 30 biuro@infarma.pl www.infarma.pl The union includes mainly branches of foreign pharmaceutical companies operating in Poland. 3 Polish Council for Supplements and Nutritional Foods Chlodna 64 00-872 Warszawa Phone: + 48 22 620 29 34 info@krsio.org.pl www.krsio.org.pl Established in 2004, the organization represents the interests of producers of dietary supplements and functional food.

Governmental organizations supporting the development of innovative pharmacy and biotech sector Polish Agency for Enterprise Development (PARP) Panska 81/83 00-834 Warszawa Phone: +48 22 432 80 80 biuro@parp.gov.pl www.parp.gov.pl A government agency using funds from the state budget and European Union funds to support enterprise development, innovativeness and development of human resources. Polish Information and Foreign Investment Agency S.A. (PAIIZ) Bagatela 12 00-585 Warszawa Phone: +48 22 334 98 00 invest@paiz.gov.pl www.paiz.gov.pl The agency helps foreign investors to enter the Polish market and invest in Poland. It provides comprehensive information concerning the legal environment of investments as well as help in finding proper partners and locations. 3 National Center for Research and Development (NCBR) Nowogrodzka 47a 00-695 Warszawa Phone: +48 22 24 42 858 sekretariat@ncbir.gov.pl www.ncbir.gov.pl The National Center for Research and Development is an executive agency of the Minister of Science and Higher Education. It conducts tasks within the field of science policy, science and technology policy and the innovation policy of the state. It performs the role of an intermediate body in three operational programmes: Human Capital, Innovative Economy and Infrastructure and Environment.

4. Technology parks operating for pharmaceutical and biotechnology companies Technology Park of the Jagiellonian Center of Innovation (JCI) LifeScience Park Bobrzynskiego 1 30-348 Krakow Phone: +48 12 297 46 00 jci@jci.pl www.jci.pl The Technology Park in Kraków has a complex of 3 buildings located at Bobrzyńskiego street 14. One of the buildings, with an area of 6,780 m 2, addresses the needs of small innovative biotech companies - biotech startup companies. The other two buildings perform the role of a technology park and offer space for commercial lease for domestic and foreign companies from the life science sector. The Technology Park is managed by the Jagiellonian Center of Innovation Sp. z o.o. (JCI), which is owned by the Jagiellonian University in Kraków. The company administers the activity of LifeScience Cluster as well. Within the framework of the JCI group there is also the JCI Venture Sp. z o.o. investment fund, which invests in biotech projects, including startup companies. The investment portfolio of the fund currently consists of 6 innovative companies from Life Science sector. Wrocław Research Center EIT+ (WRC EIT+) Wroclaw Research Center EIT+ Sp. z o.o. Stablowicka 147 54-066 Wroclaw Phone: +48 71 720 16 01 biuro@eitplus.pl www.eitplus.pl Wrocław Research Center EIT+ conducts activity exceeding the traditional formula of a technology park. Just as in the case of typical technology parks, it offers infrastructure to innovative companies, including biotech companies. WRC EIT+ creates and develops such biotechnology laboratories, as the following: - Laboratory for structural analysis - Laboratory for molecular modelling - Laboratory for immunochemistry, pathogens, molecular microbiology - Laboratory for syntheses of new materials - Laboratory for cellular imaging - Laboratory for bacteriological bases, culture fluids - Laboratory for bionanotechnology - Laboratory for target drug delivery - Laboratory for modulation of RNA catalytic activity - Laboratory for biomarkers - Laboratory for diagnostics of cancer diseases - Specialist biotechnological laboratory One important activity of the WRC EIT+ concerns research and development projects in the fields of: nanotechnologies, biotechnology and medicine, climate and energy, information and communication technology. Research conducted in the field of biotechnology and medicine aims to develop innovative anti-carcinogenic and anti-osteoporosis drugs, develop new methods for identifying hallucinogenic substances, methods for diagnostics and prevention of bacterial diseases, search for new biodegradable polymers such as drug carriers, obtain a new generation of vaccines and antibiotics based on new chemical compounds. Within the framework of the Accelerator EIT+ the WRC EIT+ creates innovative spin-off companies. Lipid System Sp. z o.o. can serve as an example of an innovative spin-off pharmaceutical company. In cooperation with the Medical University in Wrocław, the EIT+ is creating the Biobank in gathering biological material used for research, mainly blood samples, as well as DNA samples, tissues, and cell lines. 4

Wrocław Technology Park Wroclaw Technology Park Muchoborska 18 54-424 Wroclaw Phone: +48 71 798 58 00 wpt@technologpark.pl www.technologpark.pl The park offers lab space for lease for biotechnology companies. Creating innovative products based on the MIC-1 stem cells, Stem Cells Spin is one of the biotech companies whose research and production laboratory is located in the park. The Lower Silesian Academic Incubator for Entrepreneurship is one of the institutions operating within the framework of the park. Six years of the Incubator s activity resulted in 60 newly-established innovative companies created or co-created by Wrocław scientific circles. The park has its own laboratory rendering research services in the field of chemistry and biotechnology. Poznań Science and Technology Park Adam Mickiewicz University Foundation in Poznan - Poznan Science and Technology Park Rubiez 46 61-612 Poznan Phone: +48 61 82 79 700 ppnt@ppnt.poznan.pl www.ppnt.poznan.pl High Technology Incubators operating within the framework of the Poznań Science and Technology Park offer lab spaces tailored to the needs of biotech research and development projects. A microbiology service lab and a processing room with an area of 164 m 2, are created there as well. The following biotech companies are among the entities operating in the Poznań Science and Technology Park: CB DNA Sp. z o.o. - a company conducting molecular diagnostics and Future Synthesis - molecular probe synthesis, DNA/RNA synthesis. 4 Nickel Technology Park Poznań (NTPP) Nickel Technology Park Poznan Sp. z o.o. Krzemowa 1, Zlotniki 62-002 Suchy Las Phone: +48 61 65 85 499 biuro@ntpp.pl www.ntpp.pl The NTPP is a private technology park offering office, lab and storage spaces for innovative companies. Within the framework of the so-called Business Development Area, young companies and businessmen who are just starting up obtain preferential terms for the leasing office space. With the help of the Nickel Incubator which operates within the technology park, it is possible to obtain financial support for innovative business projects. The Nickel BioCentrum project, aimed at biotech companies, was launched in 2012. It is a modern building with lab spaces for biotechnology companies operating in the Bio/Med sector. The multi-faceted architecture of the lab space designated for lease allows a company to adapt it according to the needs arising from the current stage of its development. Gdańsk Science and Technology Park (GPN-T) Prof. Hilary Koprowski Gdansk Science and Technology Park Trzy Lipy 3 80-172 Gdansk Phone: +48 58 739 61 17 office@gpnt.pl www.gpnt.pl A technology incubator operating within the framework of the park supports the establishment and development of innovative startup companies. The park offers specialist laboratories, as well as infrastructure for launching modern processing rooms, including those for the production of biotech and pharmacy products. Well-known Polish pharmaceutical and biotech companies have their laboratories in the area of the park, including ZF Polpharma S.A., Blirt S.A., Biomax S.A., Lipopharm.PL

Pomeranian Science and Technology Park (PPNT) Pomorski Park Naukowo- Technologiczny (PPNT) Zwyciestwa 96/98 81-451 Gdynia Phone: +48 58 735 11 42 m.olczak@gci.gdynia.pl www.ppnt.pl The park is administered by the Gdynia Innovation Center. Biotechnology and pharmaceutical companies operating on the area of the park include A&A Biotechnology, Cerko PPHU s.c., Immunolab Sp. z o.o., Phage Consultants, Prochimia Surfaces Sp. z o.o., Spark-Lab s.c., TCI Laboratories. The park offers office and lab space fulfilling the requirements and expectations of biotech companies. Supporting the development of highly advanced technologies, including biotech companies, is one of the main tasks of the park. TechnoPark Lodz Lodz Regional Park of Science and Technology Sp. z o.o. Dubois 114/116 93-465 Lodz Phone: +48 42 684 44 44 biuro@technopark.lodz.pl www.technopark.lodz.pl The modern building of the TechnoPark offers office and laboratory spaces designed especially for the incubation of biotech startup companies. A research and implementation center for biotechnology and nanotechnology is being created. The park offers a wide range of lab and research services based on its own laboratories equipped with modern devices and scientific apparatus. The range of research offered covers: - biofuels - new biomaterials and biotechnologies - probiotics and prebiotics - wastewater treatment enzymes - technologies for microbial biodegradation of pollutants - preparations for microbial biodegradation of environmentally toxic substances - technologies of in-situ biogasification of lignite seams 4

5. Science and education for the development of the biotechnology and pharmacy industry There are over 8,000 biotechnology students attending 36 Polish higher education schools. There are over 8,000 biotechnology students attending 36 Polish higher education schools. The number of graduates (fig. 5.2) is much higher than the employment opportunities offered by Polish biotech and pharma companies. About 30,000 students graduate in life science in Poland every year. The subjects of biotechnology and pharmacy are being developed in almost all the larger academic centers in Poland (fig. 5.3). Leading centers are located in such academic cities as: Kraków, Wrocław, Poznań, Łódź, Warsaw and Gdańsk. Working at the universities and institutes of the Polish Academy of Sciences, over 2,800 scientists specializing in life and medical sciences constitute the scientific potential of biotechnology and pharmacy in Poland. Research and development projects of the biotech and pharma industry are conducted in over 100 scientific institutions. Most ongoing research and development projects in Poland (over 70% of all biotechnology R&D projects) concern the development of innovative products, which can be applied in health care. The subjects and percentage of particular types of R&D projects conducted in Poland are presented in fig. 5.1. Most ongoing research and development projects in Poland (over 70% of all biotechnology R&D projects) concern the development of innovative products, which can be applied in health care. 20% 5 9% 15% 18% 38% Fig. 5.1. Type of current biotechnology R&D projects in Poland. Drugs Medical materials Diagnostic kits Molecular biology tools Other 3000 2500 2000 1500 1004 1238 Graduates with Master of Science degree 1000 500 1229 1402 Graduates with Bachelor of Science degree 0 2010 2011 Fig. 5.2. Graduates in biotechnology (2010-2011).

Gdańsk, Gdynia Szczecin Bydgoszcz Olsztyn Poznań Warszawa Łódź Lublin Wrocław Katowice Kraków Rzeszów Fig. 5.3. The most important academic centres conducting research and development projects in the field of biotechnology and pharmacy. 5

6. Financial support from public funds for innovative projects in the biotech and pharmacy sector The Operational Programme Innovative Economy (OPIE) is one of the main financial sources for innovative research and development for investment projects in the pharmacy and biotech industry. The value of current projects conducted within the framework of the programme by Polish biotech and pharmaceutical companies exceeds 1.28 billion PLN (about 297.5 million EUR). Over 40% of the sum is covered by public funds within the framework of the Operational Programme Innovative Economy (fig. 6.1). 41% Costs incurred by companies (approx. 757.5 million PLN - 175.8 million EUR) 59% External funding for innovative projects covered by public means within the OPIE (approx. 523.9 million PLN - 121.6 million EUR) Figure 6.1. Expenditure (in PLN) for innovative projects conducted by Polish biotech and pharmaceutical companies. The value of ongoing innovative biotech and pharmaceutical R&D projects conducted by Polish scientific institutions is slightly higher than in the case of companies and exceeds 1.35 billion PLN (about 312.25 million EUR). The share of public funds (total sum amounts to about 1.27 billion PLN - 294.8 million EUR) in financing R&D projects conducted by scientific institutions is significantly higher than in the case of companies (fig. 6.2). As much as 85% of the total external funding is covered by the means (grants) from the European Union. The value of ongoing innovative biotech and pharmaceutical R&D projects conducted by the Polish scientific institutions is slightly higher than in the case of companies and exceeds 1.35 billion PLN (about 312.25 million EUR). 6 6% Costs incurred by research institutes (approx. 80 million PLN - 18.6 million EUR) Funding through public means (approx. 1.27 billion PLN - 294.8 million EUR) 94% Figure 6.2. Expenditures (in PLN) for innovative research and development projects conducted by Polish scientific institutions.

7. Selected innovative biotech and pharmaceutical projects conducted within the framework of the Operational Programme Innovative Economy (OPIE) 1. POIG. 01.04.00-00-002/08-04 Project title: 3CLA - biotechnology anticancer medicine Company: Adamed GROUP OPIE contribution: 26 363 858.77 PLN Description: This is a project from the field of medical biotechnology. The therapeutic molecule the project focuses on is an anticancer protein equipped in a special system which targets the tumor cells. The key task of the project is to develop an optimum form of active molecules, which will provide both maximum therapeutic activity and stability. Pilot-plant scale optimization of synthesis and purification is planned, which will be the next step before conducting the research necessary for the drug candidate to enter the clinical trial and, subsequently, undergo the trial. Innovativeness of the project consists mainly in using an original scientific concept as the basis for rational design of structures of the prospective drugs with desired physical, chemical and biological features. 2. POIG.01.04.00-22-064/09-02 Project title: Innovative compounds with highly selective toxicity as prospective drugs of crucial importance for the market of antifungal agents Company: Blirt S.A. OPIE contribution: 1 018 856.75 PLN Description: The project aims to develop a new biologically active compound with the features of a prospective innovative drug, which could be used in the treatment of systemic mycoses. A positive result from the project will be a breakthrough in the treatment of systemic mycoses. The implementation consists of developing the technology and obtaining the data necessary for increasing the scale of prospective drug production. The innovativeness of the project consists mainly in using an original scientific concept as the basis for the rational design of the structures of the prospective drugs with desired physical, chemical and biological features (innovative approach, especially in the case of antifungal drugs). 3. POIG.01.04.00-14-017/09-02 Project title: Innovative drug used in treating tumor diseases, impeding activity of STAT3 transcription factor Company: Celon Pharma Sp. z o.o. OPIE contribution: 2 904 917.50 PLN Description: The project aims to develop a new drug to be used in anticancer treatment. Currently, the drug is at the stage of pre-clinical development. For now, the research results have confirmed the effectiveness of the molecule. In the near future, animal testing starts, which will ultimately verify the therapeutical and pharmacological features of the drug. 7

4. POIG.01.01.02-00-007/08-04 Project title: Package of innovative biopharmaceuticals for human and animal therapy and prophylactics Scientific institution: Institute of Biotechnology and Antibiotics OPIE contribution: 76 278 233.34 PLN Description: The project consists of creating the Centre for Medicinal Product Biotechnology in a branch of the Institute of Biotechnology and Antibiotics in Macierzysz near Warsaw. The project falls in line with the Health research area presented in the National Framework Programme. The priority research directions in this field include 1.3 Molecular biology and biotechnology and their influence on improving the health and quality of life of society and 1.6 Innovative and generic drugs, materials and support equipment for diagnostics and medical therapy. 5. POIG.04.05.02-00-007/09-07 Project title: Establishing a research and development center for genetic research of cancer Company: READ-GENE S.A. OPIE contribution: 3 878 934.96 PLN Description: The direct aim of the project is to establish a research and development center, which will conduct genetic research and development work concerning cancer diagnostics and prevention. The strategic goal of the investment planned by the READ-GENE S.A. is the commercialization of methods for the detection, prevention and treatment of the most common types of cancer. As a result of research and development work conducted in the field of cancer genetics, new products will be introduced into the market genetic tests, dietary supplements and new drug formulas preventing the most popular forms of cancer, i.e. breast cancer, ovarian cancer, colorectal cancer and prostate cancer. 6. POIG.01.04.00-10-028/09-04 Project title: Peptaderm Development of a new drug based on truncated analog of cyclolinopeptide A (cyclic tetrapeptide) Company: Peptaderm Sp. z o.o. OPIE contribution: 2 040 789.52 PLN 7 Description: The aim of the project is to develop technology for obtaining medicinal means and introducing them into the market. The project is based on a molecule, which is an innovative chemical compound of immunosuppressive and antiphlogistic features to be used in dermatology. The first animal tests suggest the possibility of using the chemical compound in the production of topical drugs (cream, ointment) in allergic and seborrhoeic skin diseases, such as atopic dermatitis, psoriasis, different types of eczema, seborrhoeic dermatitis, skin T-cell lymphoma, photoallergic skin changes, skin drug reactions. Generally, it seems that the molecule, because of its strong antiphlogistic effects, can be used in all the cases where nowadays steroids are used, but without their side effects. Because of its low toxicity, the drug seems to be safe for children. Generally, it seems that the molecule, because of its strong antiphlogistic effects, can be used in all the cases which nowadays use steroids, but without their side effects.

7. POIG.04.05.02-00-017/09-03 Project title: Development of the research and development activity of the Biofana Center for Pharmaceutical Research and Clinical Trials Company: Biofana Sp. z o.o. OPIE contribution: 1 888 870.00 PLN Description: The aim of the project is to create the Center for Pharmaceutical Research and Clinical Trials in the Biofana Sp. z o.o. Pharmaceutical research and clinical trials verify the influence of a drug or medical product and determine its approval on the market. Tests proving the safety and effectiveness of a new medical substance have become a part of the activity of the Biofana Center for Pharmaceutical Research and Clinical Trials, which will develop its R&D work thanks to EU funding. The center is adapting a new area for laboratories and equipping them with new specialist devices for analytical laboratories and a formulation laboratory. The project will result in extending the company s offer: introducing new research methods into the market, e.g. analysis of the contamination level in medical substances and products with the use of liquid chromatography mass spectrometry. The company will also gain the possibility of checking the identity, purity and content of active ingredients in medical products. 8. POIG.01.04.00-10-020/10-01 Project title: Innovative biodegradable living bandage for chronic wounds and ulcerations Company: CELTHER POLSKA Sp. z o.o. OPIE contribution: 3 782 933.50 PLN Description: The project aims at developing a modern specialist biodegradable bandage and its commercial implementation. The bandage significantly accelerates the healing of wounds. 9. POIG.01.04.00-30-015/11-00 Project title: Development and implementation of innovative tests from the field of veterinary genetics of selected species Company: CB DNA Sp. z o.o. OPIE contribution: 3 149 998.00 PLN Description: The aim of the project is to develop and implement innovative comprehensive genetic tests for veterinary diagnostics within the scope of: - identification of relationship by selected farm animals - identification of gene mutations determining genetic diseases by selected farm animals. 10. POIG.01.04.00-10-051/09-02 Project title: Innovative technology for producing therapeutic monoclonal antibodies used in lymphoma treatment Company: MABION S.A. OPIE contribution: 16 719 542.50 PLN Description: The aim of the project is to implement an innovative system for producing therapeutic monoclonal antibodies used in the treatment of lymphoma. The system will use orbital shaker technology on an industrial scale. The technology planned for development is not a global standard for producing biotechnological products (recombinant proteins). Similar technology is used in research and laboratory work in the world, which is described in international specialized press, nevertheless, there are no known cases of the commercial production of medical products using this technology. The accomplishment of the project will introduce a new element to the production processes used currently by the company and will provide a new quality of technological processes and production capacity of biotechnological drugs. 7

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