Strongholds, key figures and facts about clinical trials in Denmark January 2014

Having clinical trials is important Clinical trials – investigator-driven as well as company initated – create the basis for a quick and correct introduction of modern therapy which benefit the patients. Engagement in clinical research improves scientific knowledge, practical skills and focus on structured patient treatment. Adds quality and efficiency to the healthcare sector and to the treatment of patients. Plays a key role in having a research-oriented, growing and exporting pharmaceutical industry.

Number of ongoing trials in Lif’s member companies Source: Survey – clinical trial activities 2012, Lif and Dansk Biotek,

The total number of clinical trial applications to Regulatory Authorities Source: Lif/Nordic Medicines Authorities

The number of clinical trial applications from commercial sponsors to Regulatory Authorities Source: Lif/Nordic Medicines Authorities

The number of clinical trial applications from academic sponsors to Regulatory Authorities Source: Lif/Nordic Medicines Authorities

Ongoing clinical trials 2007-2012 conducted by members of LMI, PIF, LIF Sweden and LIF DK Source: Lif DK, Lif SE, LMI and PIF

Number of clinical trials 2012 – Global Top 20 (All trials - industry and investigator initiated) Denmark is ranked 17 on a global Top 20 Source: www.clinicaltrials.gov (search and analysis made by Lif DK, October 2013)

Clinical trials per million capita i 2012 - Global Top 20 (All trials - industry and investigator initiated) Per capita, Denmark is the country in the world that conducts the most clinical trials Source: www.clinicaltrials.gov (search and analysis made by Lif DK, October 2013)

Number of new industry funded trials registered “first time” in clinicaltrials.gov (phase I-IV), 2008 - 2011 - comparison, selected countries Europe total (-8%): 2008: 6408 new trial registrations (summing up national figures), 2011: 5899 Source: www.clinicaltrials.gov (search and analysis made by Lif DK, February 26, 2013)

Number of new industry sponsored clinical trials taking into account the size of population Source: Danske regioner, Én indgang for industrien til kliniske forsøg i Danmark, April 2012

Distribution of the number of trials on therapeutic areas The listing is based on data extracted from www.clinicaltrials.gov

number of drug trials and number of trial subjects Distribution of the number of drug trials and number of trial subjects on therapeutic areas in 2012 Source: Danish Health and Medicines Authority, Annual Report 2012 – Clinical trials of medicines in humans

Danish strongholds Complex trials that require a lot of coordination Trials that require a lot of technical equipment – e.g. scanners Denmark has a very good infrastructure The Danish Healthcare sector is well-organised and of very high quality Efficient and very competent medicines authorities Very competent investigators (internationally recognised Key Opinion Leaders) Very competent and highly trained study staff Danish patients can easily be identified and followed by use of unique registries Danish patients are very willing to participate in clinical trails Danish patients are very compliant when participating in clinical trials

World-class patient registries, civil registries and biobanks create an unique foundation for clinical research In 2013 the Danish Government has initiated development of a National Strategy for Access to Healthcare Data. The aim is to improve access and use of data for research purposes.

Oncology Phase I Clinical Trials in Denmark - Fast start-up

Oncology Phase I Clinical Trials in Denmark - Fast start-up

A strong political ambition to make Danmark attractive for clinical trials Healthy Growth / Smart Health - Better Lives. A government initiative to increase health and wealth in Denmark. A series of nine initiatives launched november 2010 that aimed at improving the conditions for public-private partnerships in the area of health research and innovation. Single-point-of-entry for clinical trials in Denmark. In 2011, the Danish regions and Danish industry organisations established a joint project to create a simple and efficient portal for concluding agreements on clinical trials for the whole of Denmark. The “single-point-of-entry” (SPOE) system facilitates corporate access to preparing and planning clinical trials in Denmark and recruiting trial subjects. A new National Strategy for Clinical Research – to be launched spring 2014 A National Strategy for Access to Healthcare Data – to be launched in 2014 “Denmark as the preferred country for early clinical testing of new medicines” – one of five INNO+ projects to be initiated in 2014.

Danish strongholds in science

Private investments in R&D is a Danish/Nordic strength position Source: Forsknings- og Innovationsstyrelsen, 2010: Kortlægning af lægemiddelforskning,based on OECD R&D-statistics

Denmark ranks 1st when it comes to size of clinical pipeline Denmark ranks 1st when it comes to size of clinical pipeline* of new drugs in Europe measured by number of inhabitants DK * Clinical (phase I, II and III) Source: Ernst & Young, Beyond borders 2012

Denmark ranks top 3 when it comes to size of pipepline Denmark ranks top 3 when it comes to size of pipepline* of new drugs in Europe measured by number of inhabitants DK * Preclinical and Clinical (phase I, II and III) Source: Ernst & Young, Beyond borders, Biotechnology Industry Report 2013

High quality research in Denmark Publications per million inhabitants among OECD- and BRIC countries Citations per publication among OECD- and BRIC countries. Source: Ministeriet for Forskning, Innovation og Videregående Uddannelser – Forskningsbarometer 2012

Denmark ranks 3rd internationally by the number of articles (per inhabitants) in top scientific health journals Source: Ministeriet for Forskning, Innovation og Videregående Uddannelser – Forskningsbarometer 2012

High quality pharmaceutical research Second most scientific publications per inhabitant after Switzerland*. Second most quoted after Switzerland*. * Pharmaceutical research specifically Source: Rapport vedrørende bibliometrisk kortlægning af dansk lægemiddelforskning 2003-2008, Forsknings- og Innovationsstyrelsen 2010

Rapid assessment of clinical trials by Danish Health and Medicines Authority 30 working days (according to agreement with industry) 14 working days (Type A trials) 60 days (EU directive)

Medicon Valley

Medicon Valley – the primary location of the pharmaceutical industry Approx. 40.000 employees in the private life science sector Companies with R&D and/or production: Approx. 80 (red) biotech companies 20 pharma companies 100 medtech companies International companies with affiliates: More than 200 pharma companies Approx. 170 medtech companies

Public private research initiatives Funding partners: The Danish State Novo Foundation University Hospital, Rigshospitalet, DK Novo Nordisk A/S Uppsala University, SE When fully developed, the center will have approx. 100 researchers

Novo Nordisk Foundation Center for Protein Research Promote basic and applied discovery research on human proteins of medical relevance. Donation of 79 million EUR from the Novo Nordisk Foundation and through significant contributions from the University of Copenhagen for the renovation of the Center laboratories. Currently >130 employees have been recruited (out of an expected ~150, at complete staffing).

The Novo Nordisk Foundation Center for Basic Metabolic Research The center will be established at the Faculty of Health Sciences, University of Copenhagen and will employ between 150-200 scientists and technical staff. Donation of 117 million EUR from the Novo Nordisk Foundation. Research will work in close collaboration with research groups in the region as well as leading research groups from top ranking universities in the USA, Europe, China.

European Spallation Source (ESS) ESS will be located in Lund, Sweden, co-hosted by both Sweden and Denmark with the data management center in Copenhagen. ESS will be funded and operated by a partnership of 17 European countries (total investment of expected EUR 1.6 – 2.0 billion) ESS will be the brightest source of neutrons in the world for scientific research.

Danish National Biobank – Register research One of the worlds largest biobanks with more than 15 million samples. Scientists will have the possibility to link information about biological samples from individuals with the large amount of information contained in Danish administrative registries. The Danish National Biobank will become one of the world’s largest biobanks and a unique resource that will take Danish biomedical research another step forward.

Science City North Copenhagen 2011-2020 -> 1,3 billion EUR to be invested in new research facilities, buildings and hospital facilities. One of Europe’s largest concentration of education, basic research and applied research within health science, pharmaceutical science and natural science. 30.000 students and scientific personnel, science parks and facilities for companies that wants to be located close to and cooperate with public research.

The Danish pharmaceutical industry

The pharmaceutical industry’s key figures 130 companies 20.000 directly employed in the industry. 70.000 jobs in total including employment in subsupply branches. USD 2.78 billion annually – income tax and company tax to the Danish state USD 0.21 million – annual value added per employee per year (2.6 times industry average in Denmark). One out of three industries in Denmark that have a higher productivity growth than the same industries have in other countries. One of Denmark's largest export goods

Segmentation of industry Four different types of companies Companies that just sell drugs i.e. generic companies and parallel traders = 70 Sale of drugs + research i.e. affiliates of foreign R&D based companies with clinical research activities in Denmark = 46 (original producers) Sale of drugs + research + production i.e. national Danish companies with R&D HQ in Denmark and clinical research, production and sale of drugs in Denmark = 4 Just research i.e. small biotech companies with no production and sale = 80

Export of pharmaceutical products DKK 67 billion in 2012, 11% of total exports, Denmark’s largest export commodity

The largest Danish export commodities in 2012 (Euro, million) Medicinal And Pharmaceutical Products Petroleum, Petroleum Products And Related Materials General Industrial Machinery And Equipment Meat And Meat Preparations (11,76 billion USD)

Denmark is highly specialised in pharmaceuticals 2010 Export of pharmaceuticals per capita USD Pharmaceutical export’s share of total export Value added per employee in pharma-industry 1.000 USD (labour productivity) Denmark 1.621 9.4 % 216 Finland 242 1.9 % 213 Norway 146 0.4 % 204 Sweeden 967 5.8 % 151 Germany 794 5.2 % 172 France 530 6.7 % 145 Source: EFPIA and Eurostat

70% increase in the number of employees in the Danish pharmaceutical industry between 2000 and 2012

Read more here….. New Official Report Presents Opportunities in the Danish Life Science Industry

10 good reasons for choosing Denmark as the location for pharmaceutical research activities Unique framework conditions for the pharmaceutical industry Denmark ranks 3rd internationally by the number of articles (per inhabitants) in top scientific health journals and 2nd internationally by the number of publications based on clinical trials and pharmaceutical research Tradition for close public-private partnerships State investments in public-private research partnerships Highly qualified labour Heavy investment in new research infrastructure creates unique frameworks for pharmaceutical research in Denmark World-class patient registries, civil registries and biobanks The best clinical trial subjects Health service of high international standard Efficient public authorities