european biotechnology news 4/2012 - free excerpt - it's finally spring for eu biotechs

It's fi nally spring for EU biotechs

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

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

EuropeanBiotechnology

Science & Industry News

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

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Euro|Biotech|NewsN º– 5 | Volume 11 | 2012 3

INtro

In the last 30 years, biotechnology has be-come a major source of innovation in com-bating untreated diseases and improving

current treatments. A better understanding of the human genome rests at the heart of this in-credible 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 im-prove prevention, diagnosis and treatment of diseases by using patients’ individual charac-teristics 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 ef-fectively during development and after market introduction using biomarker science. Person-alised medicine promises to improve individu-al health. At the same time, it enables health-care systems – especially here in Europe – to better allocate constrained healthcare budg-ets, thereby achieving savings in the delivery of medicines.

In the field of personalised medicine, diag-nostic supporting technologies and devices are brought together with the disciplines un-derpinning medicinal product development. Implement ing personalised medicine will therefore require a high degree of collaboration amongst the many stakeholders in the life sci-ence and medical sectors, to a point that has not been the norm in the past. These stake-holders include the research community, med-icines and diagnostics manufacturers, regula-tors, health technology assessors, doctors and other health professionals (including health ex-perts), 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, epi-genomics, 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 cor-responding 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 Can-cer 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, re-gional and local levels.

Personalised medicine is a promising chal-lenge for Europe’s biotechnology industry, and EBE is proud to contribute to this new medi-cal era. B

Editorial

Personalised medicine – the future for patients

Marc de Garidel, President European Biopharmaceutical Enterprises, Brussels

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».

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4 Euro|Biotech|News N º– 5 | Volume 11 | 2012

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Has spring finally arrived for European biotech? 13

INsIght

Study calls for better translation of EU biotech innovations 6

Heard in Brussels 8

EU members boost green growth 10

MEPs adopt strict health claims rules 11

IP Flash; EU funds sponge biotech 12

RegulatoRy affaIRs

Update on clinical trials 15

Breaking news from the EMA 16

ecoNomIc

Focus on newsflow and dividends 17

Stock markets 18

PeRsPectIVes

Interview: Erkki Leppävuori 48

RegIoNal News

Northern Europe Denmark, Norway, Sweden, Finland 20

Central Europe Germany, Austria, Switzerland 24

Western Europe UK, France, Ireland, Belgium 26

Southern Europe Italy, Spain 28

Eastern Europe Poland, Latvia, Hungary, Czech Republic 30

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 in-vestment 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

Partners & Associations 4

Imprint 5

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 48

Company index 49

Encore 50

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.com

Cover Story

SpeCial

Contract ResearchEditorial: Stefano Marini, EUCROF, Rome 35

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

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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 Regu-latory Framework” is a sweeping document that examines the patchwork of taxes, regu-lations 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 considera-tions 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 opportu-nity to make them a reality.”

state grants or financial support to start-ups at all, although they do provide sig-nificant 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 aid-ing new biotech companies are in place in Belgium, Hungary, Ireland, Switzerland and the UK. Those countries all have reg-ulations 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 dra-matic 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 nation-al 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 im-plement 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 in-novative 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

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 ba-sis, the report continues. Understanding regulatory frameworks, as well as iden-tifying the right strategic partners and funding, is a complex task, and “What Europe Has to Offer Biotechnology Com-panies” therefore provides a road-map of the biggest pitfalls facing a young compa-ny trying to bring a drug to market, espe-cially in the areas of intellectual proper-ty and taxes. A kind of primer for doing business abroad, especially in emerging markets, the second part of the report goes

Presentation of the report commissioned by EuropaBio in Brussels

Along with a regulatory overview of the current state of affairs in Europe, the re-port looked at start-up considerations on a country-by-country basis, comparing rela-tive advantages and disadvantages in Aus-tria, 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 biotech-nology.” The comparison reveals for exam-ple that Belgium, France and Italy are the only three of those countries that offer no

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INSIGHT EUROPE

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 industry-academia 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 differ-ent worlds in the healthcare chain? Peo-ple are so insulated in their own worlds, and the disruptive technology/attitudes of people from other worlds are not wel-come. 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 per-fect business mind, and start moving ex-isting 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. B

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 struc-tures in place is no more than a first step, and that a major problem is still a ”three-speed Europe for the biotechnology indus-try, 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 Re-search and Innovation and the EU's Bio-economy Strategy (see EuroBiotechNews 3/2012) are both big steps in the right di-rection. 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. Competitive-ness 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 Eu-rope Has to Offer Biotechnology Compa-nies: Unraveling the Tax, Financial and Regulatory Framework.” In spite of many incentives for operating in Europe and an excellent research base and skilled labour-force on the ground, it says, ”more needs to be done by industry and regulatory au-thorities alike.” D

Presentations from EuropaBio's ”Benefits of Bio-technology" Day and the study can be download-ed at: www.europabio.org/cross-sectors/news/europabio-event-benefits-biotechnology-launch-europabioernst-young-report.

Heard in BrusselsM For real innovation, the pieces of the puzzle have to fit

Brussels – I co-chaired a session at the Commission’s ‘Innovation in Health-care’ conference recently, and learned a very interesting lesson there that is overwhelmingly obvious, yet over-looked in our continuing mission to be-come 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 pret-ty 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 an-tique drug-discovery process … the list is long. For the last 25 years, train-ing has been poured into a multitude of areas to ensure that the researcher be-comes an entrepreneur, an SME CEO knows everything about FDA approval, and TTOs are gurus of industry devel-opment. It hasn’t really worked. Apply-ing a thin layer of knowledge does not guarantee absorption. Why should a re-searcher, measured by publication suc-cess, also become an expert on commer-cial implications and plan research now for exploit ation 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 uni-versities, 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 –

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CompaNy aNd adVertiser iNdex

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

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

CCancer Research UK …………………………… 13Cellectis SA (F) ………………………………… 32Cellerix, S.A. (E) ………………………………… 29Celonic GmbH (GER) ………………………… 23Citeline (USA) ………………………………… 31Cobra Biologics (UK) …………………………… 41Concept Heidelberg (GER) …………………… 49Corimmun GmbH (GER) ……………………… 44Covance Laboratories GmbH (GER) ………… 42ct-Arzneimittel GmbH (GER) ………………… 43

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

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

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

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

K/LKaro Bio AB (S) ………………………………… 17KINAXO Biotechnologies GmbH (GER) ……… 45Kuros Biosurgery AG (CH) …………………… 23KWS SAAT AG (GER) …………………………… 30Laboratoires OncoTherapy Science (F) ……… 16LG Life Science Ltd. (KR) ……………………… 43Life Technologies Corp. (USA) ……………… 9, 50Lingvitae AB (S/N) ……………………………… 20LISA Vienna Region, Clustermanagement (A) … CP3Lonza AG (CH) ………………………………… 30

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

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

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

Q/rQiagen NV (GER) ……………………………… 45ratiopharm direct GmbH (GER) ……………… 43RauCon EuroPLX (GER) ……………………… 49Rautaruukki Group (F) ………………………… 48Recardio GmbH (A) …………………………… 23ReNeuron Group plc (UK) …………………… 17Rentschler Biotechnologie GmbH (GER) …… 43Reverdia (NL) …………………………………… 29Riunite S.p.A. (I) ………………………………… 29Roche AG (CH) ………………………… 13, 15, 50Roche Diagnostics GmbH (GER) ……… 7, 46, CP4Rodos BioTarget GmbH (GER) ………………… 44Roquette Frères (F) …………………………… 29

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

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

VVernalis plc (UK) ……………………………… 17Versant Ventures (USA)………………………… 13Vitrolife AB (S) ………………………………… 21Vitrum Praha sro (CZ) ………………………… 30Vitrum Roznov sro (CZ)………………………… 30Vivia Biotech Srl. (E) …………………………… 28VWR International GmbH (GER) ……………… 30

W/ZWellcome Trust Centre for Cell Biology (UK) … 13Welsh Biotech Funds (UK) …………………… 13Wilex AG (GER) ………………………………… 15ZAMBON Group S.p.A. (I) ……………………… 29Zedira GmbH …………………………………… 44Zeltia-Group (E) ………………………………… 29

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european biotechnology news 4/2012 - free excerpt - it's finally spring for eu biotechs

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