European Biotechnology News 10/2012 - Free Excerpt - Food or fuel? EU changes game

Nº 10 | Volume 11 | 2012 | 10.00 € | ISSN 1618-8276 | A 60711 |

European Biotechnology News Science & Industry

CENTRAL EUROPE

German RNA vaccine company CureVac lands record financing NORTHERN EUROPE

Food or fuel?

EU changes game

Swedish government boosts biotech with a320m investment WESTERN EUROPE

French GMO feeding study rattles EU researchers and policymakers Special

FR

T P R E C EE EX

Biocapital VC & new funds SOUTHERN EUROPE

Biospain 2012 grows despite economic crisis Eastern EUROPE

Bioprocessing specialist BIA Separations expands in India science & technology

Researchers identify cancer malignancy with MRI

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Nº 10 | Volume 11 | 2012

Intro

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Editorial

The importance of innovation in weak economies

Regina Revilla, Chair of ASEBIO and Emilio Muñoz, Chair of the ASEBIO Scientific Committee

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Regina Revilla Pedreira is the President of Asebio since July 2011. During her career, the Director of Policy and Communication at Merck, Sharp & Dohme (España)has been Pharmacy General Director in the Ministry of Health.

Emilio Muñoz is a member of the National Research Council of Spain (CSIC) and the President of ASEBIO’s Scientific Committee. He also has been the General Director for Science Policy in Spain and the General Secretary of the Spanish National Plan on R&D. He has been elected to the French Legion of Honour for his achievements.

ince the beginning of the year, there have been numerous government initiatives in the most advanced countries to implement and strengthen policies to support biotechnology. The UK launched a strategy early this year to promote the life sciences through a framework agreement between the pharmaceutical and biomedical industries, universities and the NHS that is aimed at making research more efficient. Sweden also implemented a national strategy to produce an economy based on biotechnology and sustainable development.

The US unveiled the ‘Fostering a Biobased Economy’ programme, while Europe is working on the ‘Innovating for Sustainable Growth: a Bioeconomy for Europe’, which focuses on applying innovation and biotechnology in such areas as agriculture and energy.

ASEBIO thinks that the Spanish Government should follow this lead. Biotechnology is a field of scientific endeavour in which Spain is already successful. That success is attributable to many factors: a long-established scientific community that has attained a very high standard in qualitative and quantitative terms; strategies and policies to foster biotechnology, promoting an appropriate linkage between science and business, which has made good – though insufficient – progress; appropriate cooperation between the public and private sectors (e.g. ASEBIO, SEBIOT, SEBBM); a successful move to internationalisation and competitiveness (e.g. BioSpain, Zeltia, Grifols, Oryzon, Progenika); and intelligent use of the diversity of niches that biotech offers.

Those factors make Spain a country to be reckoned with in working towards a sustainable bioeconomy, but the industry here needs regular funding, continuous support for links between the public and private sectors, and clear strategies towards internationalisation and competi-

tiveness. There are a number of success stories among Spanish companies, firms with a wholehearted commitment to R&D and innovation.

They want biotechnology to play a more prominent role in the transformation of society and the economic model, with a tax policy that fosters the development of biotech, more uniformity in autonomous region policies, and determined support from public and private funding. This will not only facilitate the creation of technology start-ups, but also finance proofsof-concept to enable companies to bring products to market.

The BioSpain 2012 event showcased our potential. It saw over 1,800 attendees (+20%), 762 companies (+9%), 217 exhibitors (+29%), an international presence amounting to 28% of the total, and a partnering section that hosted nearly 3,000 business development meetings (+29%).

The time has come for us to help Spain rise from the ashes of its beleaguered economy and expand, buoyed up by innovation. We have the flame, and the proposals to achieve it: promotion of public procurement of innovative technology, enhancing Spain’s presence in European projects, establishment of a stable framework and favourable tax treatment, determined support for entrepreneurs and innovative products, and encouragement for large industrial groups to get involved in this sector. We have the potential here and now to catalyse a recovery from the crisis. To that end, we offer our full support at any time to politicians and businessmen who are willing to listen, and who are receptive to a common project that can effectively produce growth.

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CIRCUL ATION

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European Biotechnology News is published in co-operation with the following organisations: European Biotechnology

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Net work

Europe: european-biotechnology.net

Blue: 100/15/0/35 Orange: 0/75/90/0

Germany: biodeutschland.org

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Council of European BioRegions

Europe: cebr.net

Europe: ebe-biopharma.org

Europe: europabio.org

Norway: biotekforum.no

Ireland: ibec.ie/ibia

Finland: finbio.net

Denmark: danskbiotek.dk

Sweden: swedenbio.com

The Netherlands: niaba.nl

Belgium: bio.be

Spain: asebio.com

France: france-biotech.org

Italy: assobiotec.it

Hungary: hungarianbiotech.org

EuroBiotechNews covers the biotechnology sector of the current 27 EU member states, Norway and Switzerland. If you would like to subscribe, please refer to Portugal: www.apbio.pt

www.eurobiotechnews.eu

N –º 10 | Volume 11 | 2012

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Euro|Biotech|News

contents

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Insight 10

Study: profitable orphan drugs

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EU biotech award; New CHMP head

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© Fotolia.de

Cover Story

Heard in Brussels; MEPs adopt new pharmacovigilance rules

Doctors attack clinical trials regulation; IP Flash 14 MEPs set to prohibit stem cell funding 16 Auditors say EFSA is independent

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Regulatory Affairs Breaking news from the EMA

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The European Commission backtracks on biofuels 6

Update on clinical trials

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Yet another steep rise in food prices worldwide is prompting a rethink among politicians about the EU’s sustainability policies, and a sector that once enjoyed cult status among proponents of renewable energy is coming under increasing fire. Biofuels produced from crops that can also be used for food have begun to suffer a serious image problem. Now a leaked report from the European Commission discussing plans to cap biofuel production from food-based feedstocks by 2020 has the industry up in arms.

Economic Focus on newsflow and dividends

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Stock markets

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Perspectives

Services

Special

Interview: Jose María Fernández Sousa-Faro, Zeltia S.A., Madrid

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EU funds GMO safety testing

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Regional News Northern Europe

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Central Europe

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Western Europe

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Southern Europe

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Eastern Europe

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Imprint

Capital & Markets Introduction: Europe’s biocapital – a mixed picture

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IPO: Adocia’s successful IPO in challenging times, Gérard Soula, CEO Adocia 40 Interview: “70 million euros are a good sign”, Rainer Strohmenger, Forbion Capital Partners, Munich 42

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Biopeople News from Silence Therapeutics, Hovione, TiGenix, Forbion Capital Partners, Mucosis and the European Association for the Study of Diabetes 36 Company index

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New products

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Events What’s on in October-November 2012 49 Encore

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INSIGHT EUROPE

Heard in Brussels M

When science makes you smile

Brussels – Hello readers! You know, when you view the biotechnology landscape from a Brussels perspective, you can very easily get stuck looking at the bad bits – meddling politicians, poor science reporting, insane funding decisions. Goodness knows I have had to solve the euro crisis already this year, and most months I have something or other to moan about.

But no more. I was recently reminded of all the joy that science can bring. In fact, I had a grin on my face afterward for the rest of the day. Certainly takes your mind off explaining to your mother that hand cream doesn’t make you go blind, and that GMOs probably won’t turn you into a zombie.

I am referring, of course, to the Ig® Nobel Awards (www.improbable.com) – a cele­ bration of ridiculous but excellent science, where the prizes are handed out by bemused Nobel laureates and where, if you outstay your welcome speech, a child shouts that you are boring. 2012 was no exception, as Europe demonstrated again that it leads the world in mad science. Not all of the winners were from biotech fields, but I want to share my favourites with you anyway because they will remind you of how much you love what you do. European researchers featured in most prizes, so we can be proud of the contribution we make to science that makes you smile.

When next in Paris, remember that leaning to the left can make the Eiffel Tower seem smaller. Scientists from the Erasmus University Rotterdam delivered this stunning revelation for the Psychology Prize. And how many tourists will be at an angle next time they visit?

My second favourite was the Neuroscience Prize, which demonstrated that, using complicated instruments and simple statistics, researchers can see meaningful brain activity anywhere – even in a dead salmon. How often have I thought

Claire Skentelbery, Secretary General of the European Biotechnology Network

that in a queue for train tickets, where the person holding it up at the front is clearly dead but exhibiting signs of life?

The forces that shape and move a pony­ tail was an awesome one for the Physics Prize – a joint effort from Unilever UK, the Cambridge University and the University of Warwick for that. Thanks boys!

The Anatomy Prize was also highly relevant, with research suggesting that chimpanzees can recognise each other from photos of their rear ends. Indeed, there are some distinctive backsides in Brussels, although I could not possibly comment on who they are.

Finally, French researchers played a blinder for the Medicine Prize, with work on minimising the chances of patients exploding during a colonoscopy. That was a weight off my mind – and my large intestine.

The point of the Ig Nobels is that science is fun, not boring, and everything is relevant. Europeans helped fuel technological development through scientific investigation. And if your kids ask more questions after hearing about these prizes, then we are still pursuing just the kind of research we need.

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European Parliament

Better oversight A Strasbourg – The European Parliament has approved revised proposals from the European Commission to improve the EU's system for drug safety and efficacy surveillance (pharmacovigilance). Two years ago, the Commission tabled new rules for the area after it became clear that Servier's appetite suppressant Mediator (benfluorex) was sold for 33 years in spite of having caused at least 1,300 deaths due to heart-valve insufficiency. Although the Italian Medicines Agency warned in 2000 that the drug might be dangerous, the EMA only completed its report in 2006.

In mid-September, a majority of MEPs adopted a bundle of measures – already approved by the EU Council – aimed at improving surveillance of drug safety and adverse drug effects. The new regulations clarify transparency obligations for both drugmakers and regulators.

Strict monitoring regime Starting in 2013, market authorisation holders who withdraw a drug from market must inform the EMA about their reasons (economic/safety) to help unmask hidden safety issues. Additionally, the European Medicines Agency (EMA) will set up a huge database and monitoring system to contain information on all adverse drug effects that doctors, patients, drugmakers and national regulators have reported to both national and European authorities.

Drugs monitored for safety reasons will contain a black box warning. Additionally, if a member state publishes a drug safety alert, all national authorities will be notified automatically. Drug­makers will be obliged to keep records on safety in electronic form that must be submitted regularly to the EMA (see p. 18).

The new rules do not directly apply for clinical trials. However, ”regulators will be able to ask for a post-marketing study, and until that is done, the drug will remain on the additional monitoring list,” according to British MEP Linda McAvan.

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Insight Europe

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nised drug pricing, which could impact the business model materially.” Increasing stratification of patient populations in oncology, for which 40% of all orphan drugs are developed, is a good example. Over its life cycle, Roche’s CD20 antibody drug rituximab is set to generate US$154bn, which would make it the second biggest box-office hit ever after Pfizer’s Lipitor. Along with other biologics (see table) such as Novartis’ ranibizumab, antibodies are among the other blockbusters for rare diseases.

Europe

Niche-busters set to capture market In times of reduced R&D productivity, pharma companies have refocused business models to include rare diseases or more stratified indications, especially in oncology. A new study from Thomson Reuters now demonstrates that drugs targeting small patient populations – when considered across their lifetime – seem to offer greater profitablility than drugs used for more common diseases. According to “The Economic Power of Orphan Drugs” report, niche drugs benefit from higher reimbursement, longer market exclusivity and lower attrition rates, and that combination makes them highly attractive to pharma companies.

The pharmaceutical industry’s blockbuster model lives on, but now has a different focus: orphan drugs. The more accurate differentiation of patient populations in the course of personalised medicine and the new identification of 250 rare diseases (orphan diseases) every year promise revenues as high as those for broader indications. Rare diseases, which affect fewer than 2-5 in 10,000 people, have much higher annual treatment costs than mainstream drugs (up to US$500m for Sensipar).

That’s why the proportion of blockbusters is remaining stable even with the increasing “orphanisation” of the pharmaceuticals market. At least, that’s the conclusion reached by a new market analysis provided by Thomson Reut­ers’ life sciences team.

Support for orphan drugs

According to the report, orphan drugs made more than US$50bn in 2011. Currently, this is just 6% of the total global pharma market (US$880bn). However, the orphan drug segment is growing faster (25.8% annually) than the non-orphan drug market (20.1%), and small patient populations don’t seem to be hampering business. Interestingly, orphan drugs currently generate the same percentage of blockbusters (29%) as non-orphan drugs do. “This data, combined with the increasing number of orphan drug authorisations, suggests that annual growth of launched niche drugs will outshine that of mainstream drugs over the next 30 years,” say the Thomson Reuters analysts.

According to them, a stratified approach in the market “could result in more scruti-

Sales over life cycle (US$bn)

Peak sales (US$bn)

Oncology

154

7

Ophthalmology

74

5

A Somatropin (off-patent)

Metabolism

62

3

A Imatinib mesylate (Novartis)

Oncology

42

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A F ilgrastim (off-patent)

Hematology

42

2

AR ec. Factor VIII/Octogog alfa

Hematology

28

1

A Bosentan (Actelion)

Cardiovascular

27

2

A Bortezomib (Janssen-Cilag)

Oncology

24

2

Generic Name (Company)

Therapy Area

A Rituximab (Roche) A Ranibizumab (Novartis)

© Thomson Reuters

Expected total sales (1999-2030) of current orphan blockbusters

Political incentives like the US and EU Orphan Drug Acts have generated a continued high interest in the industry to develop drugs in rare indications. Further support is provided by better chances for getting orphan drugs approved and reimbursed. The US-based company Alexion Pharmaceuticals, which developed Soliris to treat 6,000 patients that suffer from the blood disorder paroxysymal nocturnal hemoglobinuremia (PNH), recently received a premium price of US$409,000 per patient annually in the US. Besides reimbursement, a guaranteed market exclusivity of seven years, fewer hurdles to approval, lower marketing costs and faster uptake have led to the development of more orphan drugs in the past decade than ever before.

Analysts at Manning & Napier are extremely optimistic about the development of the orphan drug market. “We expect the business model of orphan diseases to sustain a competitive edge over the traditional primary care business model in the future,” says principal analyst Brian Lester. Thomson Reuters has calculated that based on current revenues, orphan drugs may offer a 15% higher market potential than current mainstream drugs over their entire life-cycle.

Another reason for the rapid uptake of orphan drugs and stratified medicines is provided by an analysis from KMR Group Inc., which shows that R&D productivity has fallen dramatically in the last five years.

From 2003-2007 it took about 12 new molecules to achieve a new market approval.

From 2007-2011 it took 30. Because orphan drugs have better chances of reaching the market, they could help companies save significant amounts of money.

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Company And Advertiser Inde x A

F/G

A&B Pharm Corporation srl (RO)………………… 35 Ablynx NV (B)… ………………………………… 21 Actelion AG (CH)… …………………………… 12, 42 ADC Therapeutics Sarl (CH)……………………… 39 Adocia S.A.S. (F)… …………………………… 39, 40 Advanced Accelerator Applications SA (F)… …… 20 Agendia B.V. (NL)… ……………………………… 39 Alexion Pharmaceuticals (USA)… ……………… 12 Algeta ASA (N)… ……………………………… 25, 39 Almirall S. A. (E)………………………………… 18, 33 Alphacore Pharma Ltd. (USA)… ………………… 18 Amgen Inc. (USA)………………………………… 36 AmsBio (UK)… …………………………………… 48 Apogenix GmbH (GER)…………………………… 39 Arch Chemicals Inc. (USA)… …………………… 21 AstraZeneca (GB/S)… ………………………… 30, 35

Falk Pharma GmbH (GER)… …………………… 32 Fermentas International UAB (LT)… …………… 35 Forbion Capital Partners (NL/GER)…………… 36, 42 Forest Laboratories Inc. (USA)…………………… 33 Galapagos NV (B)………………………………… 21 Galecto Biotech AB (DK)… ……………………… 39 Galen Ltd. (UK)…………………………………… 18 Gentium S.p.A. (I)………………………………… 33 Genzyme (USA)…………………………………… 35 GlaxoSmithKline Biologicals (B)… ……………… 36 Global Bioenergies SA (F)……………………… 13 Grifols Deutschland GmbH (GER)… …………… 18 Grifols SA (E)………………………………………… 3 Grünecker Patent- und Rechtsanwälte (GER)…… 14

B Baltymas (LT)……………………………………… 35 BASF Plant Science GmbH (GER)… …………… 45 Bayer Healthcare AG (GER)…………………… 18, 50 Berlin Partner GmbH (GER)……………………… 19 BIA Separations d.o.o. (SLO)… ………………… 34 BIOCOM AG (GER)… …………………………… 43 BIO.NRW (GER)…………………………………… 15 Biocrates Life Sciences AG (A)…………………… 17 Biogen Idec (USA)……………………………… 25, 28 BioM Biotech Cluster Development (GER)… …… 27 Biook lab (LT)……………………………………… 35 Bioquell Ltd. (UK)………………………………… 11 Biotie Therapies Corp. (FI)… ………………… 21, 24 Biovex (USA)……………………………………… 36 BioWin - The Health Cluster of Wallonia (B)… … 29 Boehringer Ingelheim (GER)… ………… 25, 26, 30

C Clavis Pharma ASA (N)…………………………… 39 Clinigen Group Ltd. (UK)… ……………………… 20 Clovis Oncology Ltd. (UK)……………………… 18 Cobra Biologics (UK)……………………………… 13 Cosmo Pharmaceuticals (I)… …………………… 32 Curevac GmbH (GER)… ……………………… 26, 39 Cytos AG (CH)… ………………………………… 39

D DASGIP GmbH (GER)… ………………………… 21 DBV Technologies (F)… ……………………… 39, 40 Definiens AG (GER)… …………………………… 50 Deutsche Gesellschaft für Proteomforschung …Suppl.

Devgen (B)……………………………………… 21, 27 Drug Abuse Science (F)… ……………………… 21

E EBD Group (GER)………………………………38, 50 Elan Corp. (IRL)…………………………………… 28 Epigenomics AG…………………………………… 26 Esteve S.A. (E)… ………………………………… 33 European Biotechnology Network… …………… 45 Evotec AG (GER)… ……………………………… 50 ExpreS2ion Biotechnologies (DK)… …………… 30

H/I/J H. Lundbeck A/S (DK)… ……………………… 21, 24 Hexal AG (GER)…………………………………… 39 High-Tech Gründerfonds GmbH (GER)… ……… 41 Hospira One 2 One Global Pharma (USA)…… CP 2 Hovione FarmaCiencia SA (PT)… ……………… 33 Hovione SA (PT)… ……………………………… 36 immatics biotechnologies GmbH (GER)………… 42 ImmunoGen Corp. (USA)………………………… 20 Ironwood Pharmaceuticals Inc. (USA)…………… 33 Janssen-Cilag (B)… ……………………………… 12 Johnson & Johnson (USA)… …………………… 28

K/L/M KMR Group (USA)………………………………… 12 Kyowa Hakko Kirin Co. Ltd. (JP)… ……………… 20 Life Technologies ……………………………… 9, 50 LISA Vienna Region, (A)… ………………… 27, CP 3 Lonza (CH)………………………………………… 21 Macrogenics Inc. (USA)…………………………… 30 Magnisense SA (F)… …………………………… 39 Manning & Napier (USA)… ……………………… 12 Medivir AB (S)… ………………………………… 20 Medtronic Inc. (USA)……………………………… 42 Merck KGaA (GER)… ………………………… 24, 33 Merck, Sharp & Dome (E)…………………………… 3 Monsanto (USA)… ……………………………… 45 mtm laboratories AG (GER)……………………… 42 Mucosis BV (NL)… ……………………………30, 36 Myriad Genetics (USA)…………………………… 14

N/O Neotope Bioscience (IRL)………………………… 28 Neuronova AB (S)………………………………… 33 New England Biolabs GmbH (GER)……………… 48 Newron Pharmaceuticals S.p.A. (I)……………… 33 Novartis AG (CH)… …………………………… 12, 35 Novavax Inc. (USA)… …………………………… 36 OrbiMed Advisors (USA)… ……………………… 35 Orexo AB (S)… …………………………………… 25 Oryzon Genetics S.A. (E)…………………………… 3

P Parexel (USA)……………………………………… 35 Pfizer (USA)… …………………………… 12, 28, 30 PharmaMar (E)… ……………………………… 18, 42

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Pharnext SAS (F)… ……………………………… 39 Pierrel Research SPA (I)… ……………………… 20 Probiodrug AG (GER)… ………………………… 39 Profarma UAB (LT)… …………………………… 35 Progenika Biopharma, S.A. (E)……………………… 3 Prometheus (USA)… …………………………… 14 ProStrakan Group plc UK)………………………… 20 ProtAffin Biotechnologie AG (A)… ……………… 13 Proteros Biostructures GmbH (GER)… ………… 39

Q/R Quartz Bio (CH)…………………………………… 21 Quintiles Limited (UK)… ………………………… 16 Regulus Therapeutics LLC (USA)………………… 30 Rhône-Poulenc (F)… …………………………… 40 Roche AG (CH)… ……………………………… 20, 26 Roche Diagnostics GmbH (GER)…………… 47, CP 4

S SALANS LLP (GER)… …………………………… 31 Sanofi (F)… ……………………………………… 26 Sanofi-Pasteur (F)………………………………… 20 SC Antibiotice SA (RO)…………………………… 35 SC Romsoft srl (RO)……………………………… 35 SEKAB E-Technology AB (S)……………………… 25 Servier (F)… ……………………………………… 30 Sicor Biotech UAB (LT)…………………………… 35 Silence Therapeutics (UK)… …………………… 36 Sinclair IS Pharma plc (UK)… …………………… 50 Stockholm-Uppsala Life Sciences (S)…………… 25 Swedish Orphan Biovitrum AB (S)… ………… 25, 39 Symphogen A/S (DK)… ……………………… 20, 24 Syngenta AG (CH)……………………………… 21, 27

T Takeda Pharmaceutical International (CH)……… 35 Tarix Pharmaceuticals Ltd. (USA)………………… 18 Telormedix SA (CH)… …………………………… 39 Teva Pharmaceutical Industries Ltd. (IL)………… 35 ThermoFisher Scientific (USA)…………………35, 48 Thomson Reuters (USA)… ……………………… 12 Thrombogenics (B)… …………………………… 39 TiGenix BV (B)… ………………………………… 36 Tissue Regenix (UK)……………………………… 39 TopoTarget A/S (DK)……………………………… 18

U/V UAB BiotechPharma (LT)………………………… 35 UCB S.A. (B)… …………………………………20, 30 Unilever (UK)……………………………………… 10 Uppsala BIO (S)…………………………………… 24 Valeant Pharmaceuticals Inc. (CDN)… ………… 50 Vernalis plc (UK)… …………………………… 30, 39 Vivia Biotech SL (E)… …………………………… 39

W/X/Z Wellington Partners (GER)… ………………… 39, 42 Wilex AG (GER)…………………………………… 39 Xcellerex Inc. (USA)… ……………………………… 7 Xenon Pharmaceuticals Inc.……………………… 36 ZAMBON Company S.p.A. (I)… ………………… 33 Zealand Pharmaceuticals A/S (DK)……………… 25 Zeltia (E)………………………………………… 3, 42

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