European Biotechnology News 4/2012 - Free Excerpt - It's finally spring for EU biotechs

Nº 5 | Volume 11 | 2012 | 10.00 € | ISSN 1618-8276 | A 60711 |

European Biotechnology News Science & Industry

CENTRAL EUROPE

Austrian efforts to implement a total national ban on GMOs NORTHERN EUROPE

Finland's UPM invests a150m in biodiesel refinery WESTERN EUROPE

AstraZeneca to take over US gout drug specialist Ardea SPECIAL

T P R E C EE EX

FR

It's finally spring for EU biotechs

Contract Research – Opportunities for outsourcing SOUTHERN EUROPE

Cancer start-up Vivia Biotech secures Series B financing EASTERN EUROPE

Gedeon Richter opens huge biologics manufacturing plant SCIENCE & TECHNOLOGY

Databases link cancer cell genomics to drug efficacy

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Editorial

Personalised medicine – the future for patients Marc de Garidel, President European Biopharmaceutical Enterprises, Brussels

I

Marc de Garidel is the President of European Biopharmaceutical Enterprises, as well as Group Chairman and CEo at Ipsen and a member of its strategic committee.

In the course of his career, he has also worked at Eli Lilly and Amgen, where he advanced to the post of VP for Southern Europe, MEA and Latin America. Marc de Garidel has also held teaching positions at the École Centrale de Paris and the ESSEC Business School since 2008, and has been named a «Chevalier de la Légion d’Honneur».

n the last 30 years, biotechnology has become a major source of innovation in combating untreated diseases and improving current treatments. A better understanding of the human genome rests at the heart of this incredible technological progress. With the dawn of personal medicine, we are also witnessing the dawn of a new era in medicine.

The aim of personalised medicine is to improve prevention, diagnosis and treatment of diseases by using patients’ individual characteristics to identify the most appropriate care.

The industry is using this knowledge to create medicines with more clearly defined molecular targets, and to profile these medicines more effectively during development and after market introduction using biomarker science. Personalised medicine promises to improve individual health. At the same time, it enables healthcare systems – especially here in Europe – to better allocate constrained healthcare budgets, thereby achieving savings in the delivery of medicines.

In the field of personalised medicine, diagnostic supporting technologies and devices are brought together with the disciplines underpinning medicinal product development.

Implement ing personalised medicine will therefore require a high degree of collaboration amongst the many stakeholders in the life science and medical sectors, to a point that has not been the norm in the past. These stakeholders include the research community, medicines and diagnostics manufacturers, regulators, health technology assessors, doctors and other health professionals (including health experts), and of course patient organisations and patients as a whole.

In this research area, sequencing the human genome has resulted in an avalanche of knowledge about the molecular biology of human

health and diseases, leading to the many new ‘omics’ disciplines: genomics, proteomics, epigenomics, transcriptomics, metabolomics and metagenomics, to name just a few. Translating ‘omics’ from basic to clinical research can yield more innovative approaches for the prediction, prevention, treatment and cure of diseases.

As new technologies emerge, there is a corresponding need for standardisation. The key challenge for the EU regulatory framework will be to allow as much flexibility as possible in order to ensure the rapid uptake of novel approaches and innovations, whilst at the same time ensuring the health and safety of the patient.

The introduction of personalised medicine to the point-of-care will affect the way healthcare is organised. One positive example: since its launch in May 2005, the French National Cancer Institute has been developing an increasing network of regional centres linked to healthcare institutions. These allow cancer patients to be rapidly diagnosed and identified for suitability to drug treatment, which has in turn lead to an overall reduction of costs of treatment.

Personalised medicine can bring significant benefits for patients, healthcare providers and healthcare authorities at the national level, but challenges across the innovation cycle – from basic research through to the uptake in the healthcare setting – still need to be overcome.

Because of their nature, these challenges will need to be addressed at European, national, regional and local levels.

Personalised medicine is a promising challenge for Europe’s biotechnology industry, and EBE is proud to contribute to this new medical era.

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CIRCUL ATION

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

CMYK

Net work

Europe: european-biotechnology.net

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

Germany: biodeutschland.org

Switzerland: swissbiotech.org

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 5 | Volume 11 | 2012

coNteNts

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INsIght 6

Heard in Brussels

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EU members boost green growth

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MEPs adopt strict health claims rules

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IP Flash; EU funds sponge biotech

12 © orpheusXl/fotolia.com

Cover Story

Study calls for better translation of EU biotech innovations

RegulatoRy affaIRs Update on clinical trials

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Breaking news from the EMA

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Has spring finally arrived for European biotech?

ecoNomIc Focus on newsflow and dividends

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Stock markets

18

PeRsPectIVes Interview: Erkki Leppävuori

Southern Europe Italy, Spain Eastern Europe Poland, Latvia, Hungary, Czech Republic

Industry experts have grown cautiously optimistic that venture capital might once again reach significant levels in the EU in 2012. A number of VC firms have closed new investment funds aimed specifically at Europe, and many are setting up branch offices here. With major investments in classic VC funds, Big Pharma is also getting involved in the VC game. This month we take a closer look at how these and other factors are providing the biotech sector with fresh growth after a long winter of abstinence.

seRVIces

SpeCial

Northern Europe Denmark, Norway, Sweden, Finland 20

Western Europe UK, France, Ireland, Belgium

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RegIoNal News

Central Europe Germany, Austria, Switzerland

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Contract Research Editorial: Stefano Marini, EUCROF, Rome

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Outsourcing – a growing market 36 Impact of globalisation on the CRO market

38

Cooperation models between CROs and drug developers

40

Harmonising EU clinical trials

41

Biosimilar properties that impact CRO work

42

Partners & Associations

4

Imprint

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Biopeople News from Cellectis, Isconova, Index Pharmaceuticals, Bicycle Therapeutics, the European Medicines Agency and the ALLEA 28 Events What’s on in May–June 2012

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Company index

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Encore

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Imprint European Biotechnology News is published monthly by: BIOCOM AG, Lützowstr. 33–36, D-10785 Berlin, Germany, Tel.: +49-30-264921-0, Fax: +49-30-264921-11, E-Mail: service@eurobiotechnews. eu; Internet: www.eurobiotechnews.eu, Publisher: Andreas Mietzsch, Editorial Team: Thomas Gabrielczyk (Managing Editor), Derrick Williams (Co-editor), Dr. Patrick Dieckhoff, Dr. Philipp Graf, Dr. Bernd Kaltwaßer, Dr. Martin Laqua; Advertising: Oliver Schnell, +49-30-2649-2145, Advertising USA: Avani Media, Inc. , Leslie Hallanan, Tel.: +1-415-331-2150 , Fax: +1-415-289-0402, E-Mail: leslie@avanimedia.com; Distribution: Angelika Werner, +49-30-2649-2140; Printed at: Druckhaus Humburg, Bremen; Graphic Design: Michaela Reblin. European Biotechnology Science & Industry News is only regularly available through subscription at BIOCOM AG. Annual subscription fees: € 100.00, Students € 50.00 (subject to proof of enrolment). Prices include VAT, postage & packaging. Ordered subscriptions can be cancelled within 2 weeks directly at BIOCOM AG. The subscription is initially valid for one year. Subscriptions will be renewed automatically for one more year, respectively, unless they are cancelled at least 6 weeks before the date of expiry. Failures of delivery which BIOCOM AG is not responsible for do not entitle the subscriber to delivery or reimbursement of pre-paid fees. Seat of court is Berlin, Germany. As regards contents: individually named articles are published within the sole responsibility of their respective authors. All material published is protected by copyright. No article or part thereof may be reproduced in any way or processed, copied and proliferated by electronic means without the prior written consent of the publisher. Cover Photo: © Fotolia.de ® BIOCOM is a registered trademark of BIOCOM AG, Berlin, Germany.

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INSIGHT EUROPE Study ReSultS

The EU’s fragmented regulatory backdrop Although things are finally looking up in Europe in terms of VC investment, the stormy seas of the financial crisis are still far from smooth. According to a report released by the European Associations for Bioindustries EuropaBio and consultant giant Ernst & Young, there is still a long way to go towards unlocking the EU's potential in the sector. “What Europe Has to Offer Biotechnology Companies: Unraveling the Tax, Financial and Regulatory Framework” is a sweeping document that examines the patchwork of taxes, regulations and development policies in 16 EU Member States. Its three areas of focus look closely at what establishing a company in different countries means, key tax considerations through the biotech life cycle, and the outlook for the industry in Europe. Although the EU has made progress in many areas, says the report, there is still much to be done in “bridging the gap between people with good ideas and the investment and opportunity to make them a reality.”

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state grants or financial support to startups at all, although they do provide significant R&D tax credits for the company (20.5%, 30% and 90%, respectively) as well investor incentives in the form of breaks on capital gains taxes (CGT). However, the broadest spectrum of programmes for aiding new biotech companies are in place in Belgium, Hungary, Ireland, Switzerland and the UK. Those countries all have regulations or incentives in place in at least four out of seven key areas (use of losses, R&D tax credits, patent/innovation box, IP regime, CGT, other incentives, grants/ finance support) defined by the report.

The study reveals that there are also dramatic differences between countries when it comes to tax rates, with Switzerland at the lower end of the scale (12%) and France hitting firms with a walloping 33% tax rate at the top end. But more and more national governments in the EU, it shows, are seeking to encourage innovation in spite of a stiff tax burden by introducing patent boxes. The UK is currently planning to implement a reduced tax rate (10%) on profits made from medicines and other products derived from certain kinds of IP. Belgium and Spain have similar programmes for seriously reducing the tax burden on innovative products, while the Netherlands has one in place that effectively lowers tax on income from qualifying IP to just 5%, according to the report.

Key considerations when taking your business abroad

Presentation of the report commissioned by EuropaBio in Brussels

Along with a regulatory overview of the current state of affairs in Europe, the report looked at start-up considerations on a country-by-country basis, comparing relative advantages and disadvantages in Austria, Belgium, Denmark, France, Germany, Hungary, Ireland, Italy, the Netherlands,

Norway, Poland, Portugal, Spain, Sweden, Switzerland, and the UK – “those Member States of the EU with the most established track records in commercialising biotechnology.” The comparison reveals for example that Belgium, France and Italy are the only three of those countries that offer no

The challenges facing European SMEs are many, and some of the biggest are customs and international trade considerations for carrying out clinical trials on a global basis, the report continues. Understanding regulatory frameworks, as well as identifying the right strategic partners and funding, is a complex task, and “What Europe Has to Offer Biotechnology Companies” therefore provides a road-map of the biggest pitfalls facing a young company trying to bring a drug to market, especially in the areas of intellectual property and taxes. A kind of primer for doing business abroad, especially in emerging markets, the second part of the report goes

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INSIGHT EUROPE into detail on how to avoid errors when moving beyond Europe's borders.

What Europe is doing right – and where it is going wrong ”Europe indeed has the potential to be a world leader in the field of biotechnology,” concludes the report, but it also warns that having the right tax and regulatory structures in place is no more than a first step, and that a major problem is still a ”threespeed Europe for the biotechnology industry, with each of the three applications – health care, agricultural and industrial – all operating under different regulatory and approval processes.”

In the area of industrial biotech, says the report, the European Commission’s new Horizon 2020 Strategic Framework for Research and Innovation and the EU's Bioeconomy Strategy (see EuroBiotechNews 3/2012) are both big steps in the right direction. But in the area of health care, it says, the ”Clinical Trials Directive”, which is expected to be updated in mid-2012, has to be simplified and made more efficient in order to make Europe a more attractive location for clinical research (see pages 38, 41). And things look bad for agribiotech in Europe, says the report. Competitiveness in the field is under ”serious threat”, largely due to an ongoing resistance to GM crops and associated technology. The EU could be left behind, i warns, if more isn’t done to speed up the approvals process at all levels.

And that sentiment could hold true for the biotechnology industry in Europe as a whole, at least according to “What Europe Has to Offer Biotechnology Companies: Unraveling the Tax, Financial and Regulatory Framework.” In spite of many incentives for operating in Europe and an excellent research base and skilled labourforce on the ground, it says, ”more needs to be done by industry and regulatory authorities alike.”

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Presentations from EuropaBio's ”Benefits of Biotechnology" Day and the study can be downloaded at: www.europabio.org/cross-sectors/news/ europabio-event-benefits-biotechnology-launcheuropabioernst-young-report.

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Heard in Brussels M

For real innovation, the pieces of the puzzle have to fit

Brussels – I co-chaired a session at the Commission’s ‘Innovation in Healthcare’ conference recently, and learned a very interesting lesson there that is overwhelmingly obvious, yet overlooked in our continuing mission to become one Europe.

The session looked at how business skills are developed in the EU – what we have, what we need and how we get it. I expected specific skills to be targeted as missing and needing to be developed.

Wrong. The overwhelming conclusion from our panel of EC, pharma, university and SME geniuses was that Europe pretty much has all the skills that it needs, but each expert is kept in his or her own little world, creating exceptional skills within a very narrow space.

The researcher pushed to publish, the SME that must meet the next milestone, the clinician locked into the healthcare system, the pharma guy stuck in an antique drug-discovery process … the list is long. For the last 25 years, training has been poured into a multitude of areas to ensure that the researcher becomes an entrepreneur, an SME CEO knows everything about FDA approval, and TTOs are gurus of industry development. It hasn’t really worked. Applying a thin layer of knowledge does not guarantee absorption. Why should a researcher, measured by publication success, also become an expert on commercial implications and plan research now for exploitation in 10 years time?

The blindingly obvious conclusion from the panel was not to train people a bit harder, but physically to get them into other worlds and bring other worlds to them. Entrepreneurs in residence at universities, academic researchers placed in SMEs and pharma, clinicians on the boards of companies, pharma people in universities and SMEs. It’s not going to happen on its own, and it hasn’t yet –

Claire Skentelbery, Secretary General of the European Biotechnology Network

so we need to make it happen. Horizon 2020 should make staff exchanges between partners in collaborative projects compulsory, up numbers of industryacademia research fellowships, increase pharma staff working in small company partners – there is loads we could do.

It’s not going to cost more money. The price is instead in the mindset. Europe talks the talk, but does it really walk the walk on direct integration of different worlds in the healthcare chain? People are so insulated in their own worlds, and the disruptive technology/attitudes of people from other worlds are not welcome. However, the evidence from the panel and audience confirmed direct integration as the most effective way to bring new skills and knowledge into each step of the chain.

So Europe – are you listening? Stop fretting about growing new skills through the age-old training and ‘have an MBA’ culture to create your vision of the perfect business mind, and start moving existing skills about between different bits of the healthcare sector. They don't bite, and it might prove the only effective way to help them integrate.

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CompaNy aNd adVertiser iNde x

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e/F

AB Science SA (F) ……………………………… 17 Abbott Diagnostics (USA) ……………………… 15 Ablynx N.V. (B) ………………………………… 17 Actelion AG (CH) …………………………… 17, 23 Active Biotech AB (S) ……………………… 17, 32 Addex Pharma S.A. (CH) ……………………… 23 Adocia S.A.S. (F) ……………………………… 17 Advanced Bio-Healing Inc (IRL/USA) ………… 24 Affimed Therapeutics AG (GER) ……………… 32 Agennix AG (GER/USA) …………………… 17, 30 Alcon Inc. (CH) ………………………………… 24 Algeta ASA (N) ………………………………… 17 Algiax Pharmaceuticals GmbH (GER) ………… 44 Allergan Inc. (USA)……………………………… 15 Altana AG (GER) ……………………………… 45 Amgen Inc. (USA) …………………………3, 24, 50 Amsterdam Molecular Therapeutics (NL) … 15, 16 Aptuit Verona Srl. (I) …………………………… 29 Ardea Biosciences Inc. (USA) ………………… 24 Astra Zeneca plc (GB/S) …………………… 21, 24 AudioCure Pharma GmbH (GER)……………… 44 Aventis Behring GmbH (GER) ………………… 32 Axxam S.p.A (I) ………………………………… 28 Ayoxxa Pte Ltd. (SG) …………………………… 44

e-Therapeutics plc (UK) ……………………… 15 Eli Lilly (USA) ……………………………………… 3 Ernst & Young (GER) …………………………… 13 European Biotechnology Network …………… 42 Evotec AG (GER) ……………………………… 45 F. Hoffmann - LA ROCHE AG (CH) …………… 16 FGK Clinical Research GmbH (GER) ………… 43 Fresenius Medical Care (GER) ………………… 16 Frost & Sullivan (UK) …………………………… 11

B

G/H

Galapagos N.V. (B)……………………………… 26 Gedeon Richter Syrt. (HUN) …………………… 31 Genentech Inc. (USA) ……………………… 15, 21 Genmab A/S (DK) ……………………………… 17 Genzyme Corp. (USA) ………………………… 24 GlaxoSmithKline plc (UK) …………………… 15, 26 Grünecker Patent- und Rechtsanwälte (GER) … 12 HBM Bioventures (CH) ………………………… 13 Hepatera LLC (RUS) …………………………… 23 Hexal AG (GER) ………………………………… 43 High Tech Gründerfonds (GER) ……………… 44 Hospira One 2 One Global Pharmac. (F) 43, CP2

i/J

ICON Clinical Research (IRL) ………………36, 40 Illumina Inc. (USA) ……………………………… 50 Imaxio S.A. (F) ………………………………… 26 Immunogen Inc. (USA) ………………………… 15 ImmuPharma France SA ……………………… 17 InDex Diagnostics AB (S) ……………………… 21 InDex Pharmaceuticals AB (S) ………………… 32 Index Ventures (CH) …………………………… 13 Isconova AB (S) ………………………………… 32 Janssen Italy …………………………………… 35

B.Braun Biotech International GmbH (GER) … 45 Baliopharm GmbH (GER) ……………………… 23 BASF SE (GER) ………………………………… 45 Bausch & Lomb (USA) ………………………… 17 Bayer Healthcare AG (GER) …………… 23, 32, 50 Beta-Cell N.V. (B) ……………………………… 32 Bicycle Therpeutics plc (UK) ………………… 32 BIO.NRW (GER) ………………………………… 37 Bioamber Inc. (USA) …………………………… 26 Bioanalitica Inversiones SL (E) ………………… 28 BIOCOM AG (GER) ………………………… 31, 34 BioInvent International AB (S) ……………… 17, 21 BioPartners GmbH (GER) ……………………… 43 BioTOP Berlin-Brandenburg (GER) …………… 11 BioWin - The Health Cluster of Wallonia (B) … 25 Boehringer Ingelheim GmbH (GER) ………… 26 Brane Discovery Srl (I) ………………………… 14

Karo Bio AB (S) ………………………………… 17 KINAXO Biotechnologies GmbH (GER) ……… 45 Kuros Biosurgery AG (CH) …………………… 23 KWS SAAT AG (GER) …………………………… 30 Laboratoires OncoTherapy Science (F) ……… 16 LG Life Science Ltd. (KR) ……………………… 43 Life Technologies Corp. (USA) ……………… 9, 50 Lingvitae AB (S/N)……………………………… 20 LISA Vienna Region, Clustermanagement (A)… CP3 Lonza AG (CH) ………………………………… 30

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m/N

Cancer Research UK ……………………………

Cellectis SA (F) …………………………………

Cellerix, S.A. (E) …………………………………

Celonic GmbH (GER) …………………………

Citeline (USA) …………………………………

Cobra Biologics (UK) ……………………………

Concept Heidelberg (GER) ……………………

Corimmun GmbH (GER) ………………………

Covance Laboratories GmbH (GER) ………… ct-Arzneimittel GmbH (GER) …………………

13 32 29 23 31 41 49 44 42 43

d DASGIP AG (GER) ……………………………… 17 DBV Technologies (F) ………………………… 17 DeciBio (USA) ………………………………… 50 Dimensione Ricera (I) ………………………… 35 Dr. Falk Pharma GmbH (GER) ………………… 45 DSM N.V. (NL) ……………………………… 29, 30 DuPont Tate & Lyle (USA) ……………………… 26

K/L

Maxwell Biotech Venture Fund (RUS) ………… 23 Medice Arzneimittel Pütter GmbH (GER) …… 43 Meiji Seika Pharma (JP) ……………………… 29 Merck KGaA (GER) …………………………… 50 Merck Sharp & Dohme Ltd (USA) …………… 16 Metsä Group (F) ……………………………… 48 Micromet AG (GER/USA) ……………………… 50 Mitsui Global Investment (JP) ………………… 26 Molecular Partners AG (CH) …………………… 15 Mologen AG (GER) …………………………… 15 Mondobiotech AG (CH) ……………………… 28 Monsanto (USA) ……………………………… 30 MYR GmbH (GER) ……………………………23, 44 NanotecMarin GmbH (GER) …………………… 12 Neste Oil Oyj (FIN) …………………………… 48 NeuroSearch A/S (DK) ……………………… 17, 21 Neurotune AG (CH) …………………………… 14 Newron Pharmaceuticals S.p.A. (I) ………… 14, 29 Nicox S.A. (F) …………………………………… 17 Nomura Code (UK) …………………………… 17 Norbitec GmbH (GER) ………………………… 43

Nova Institute GmbH (GER) …………………… 10 Novartis AG (CH) ……………………… 15, 24, 46 Novartis Europharm Ltd. (UK) ………………… 16

p

Pfizer Inc. (USA) ………………………………… 35 PharmaMar S.A. (E) …………………………29, 50 Pierrel S.p.A. (I) ………………………………… 28 Plarion Ltd. (UK) ……………………………… 20 pluriSelect GmbH (GER) ……………………… 44 Polygene AG (CH) ……………………………… 39 Pradeyrol Developpement (F) ………………… 26 Promethera plc (B) …………………………… 26 ProRetina Therapeutics S.L. (E) ……………… 16 Prosensa BV (NL) ……………………………… 16 Provecs Medical GmbH (GER) ………………… 44

Q/r

Qiagen NV (GER) ……………………………… 45 ratiopharm direct GmbH (GER) ……………… 43 RauCon EuroPLX (GER) ……………………… 49 Rautaruukki Group (F) ………………………… 48 Recardio GmbH (A) …………………………… 23 ReNeuron Group plc (UK) …………………… 17 Rentschler Biotechnologie GmbH (GER) …… 43 Reverdia (NL) …………………………………… 29 Riunite S.p.A. (I) ………………………………… 29 Roche AG (CH) ………………………… 13, 15, 50 Roche Diagnostics GmbH (GER) ……… 7, 46, CP4 Rodos BioTarget GmbH (GER) ………………… 44 Roquette Frères (F) …………………………… 29

s

Salans LLP (GER) ……………………………… 27 Sambrinvest (B) ………………………………… 26 Sandoz AG (CH) ……………………………… 43 Schering AG (GER) …………………………… 32 Seiratherm GmbH (GER) ……………………… 44 Serono SA (CH) ………………………………… 50 Shire plc (IRL)………………………………… 24, 26 SICOR Biotech UAB (LT) ……………………… 43 Sigma-tau HealthScience S.p.A. (I) …………… 29 SIX Swiss Exchange (CH) ……………………… 22 Solvo Biotechnology sro (HUN) ……………… 31 STADA Arzneimittel AG (GER) ………………… 43 Sunpine AB (S) ………………………………… 20 Synthes AG (CH) ……………………………… 23

t/U

Teva Pharmaceutical Industries Ltd. (IL) ……… 43 Thrombogenics N.V. (B) …………………… 17, 24 TiGenix B.V. (B) ………………………………… 29 UCB S.A. (B) …………………………………… 15 UPM-Kymmene Oyj (FI) ……………………20, 48

V

Vernalis plc (UK) ………………………………

Versant Ventures (USA)…………………………

Vitrolife AB (S) …………………………………

Vitrum Praha sro (CZ) …………………………

Vitrum Roznov sro (CZ)…………………………

Vivia Biotech Srl. (E) ……………………………

VWR International GmbH (GER) ………………

W/Z

Wellcome Trust Centre for Cell Biology (UK) …

Welsh Biotech Funds (UK) ……………………

Wilex AG (GER) …………………………………

ZAMBON Group S.p.A. (I)………………………

Zedira GmbH ……………………………………

Zeltia-Group (E) …………………………………

17 13 21 30 30 28 30 13 13 15 29 44 29

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