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Nº 4 | Volume 13 | 2014 | 10.00 € | ISSN 1618-8276 | A 60711 |

European Biotechnology News Science & Industry

CENTRAL EUROPE

AMD: Antitrust decision slams Roche and Novartis NORTHERN EUROPE

Denmark joins European life sciences data network

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Big Data & IP – Linking life sciences and IT WESTERN EUROPE

Ferring makes grab at cell therapy against Crohn’s disease SOUTHERN EUROPE

Novamont leads EU effort to scale up bio-based production

Europa attracts Clinical Trials

Eastern EUROPE

Polish researcher presents prediction tool for flu strains science & technology

Riboswitches can help improve control of viral vectors

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N –º 4 | Volume 13 | 2014

Euro|Biotech|News

Intro

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Editorial

Tech-transfer: time to send a wake-up call Pierre-Olivier Goineau, President, France Biotech, Paris

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here’s no question that Europe’s biotech sector produces high-quality science.

We have world- class research organisations and start-ups, as witnessed by the number of alliances with Big Pharma and the number of products being registered. And let’s not forget that the European biotech industry has more pipeline products than the Big Five pharma companies (Novartis, Roche, Pfizer, Sanofi and Merck ) put together! Nevertheless, the pathway from invention to innovation – from scientific and/or technological progress to a marketed product – remains stubbornly blocked in Europe. Why? The answer is simply that following an inPierre-Olivier Goineau is the itial idea and proof-of-concept, developing co-founder, Vice President and CEO of Erytech Pharma. Before and marketing an invention (whether biotech­ setting up the company, he was a nological or anything else) requires signifiSenior Consultant in Strategy and cant financial resources. European innovation Development at KPMG in Lyons in general is hamstrung by one fundamental (France) where he was in charge of the Health Division. Goineau problem: a lack of access to adequate funding. was chosen as the new President The recent financial crisis broke an upward of the biotechnology association trend in European equity investment in highFrance Biotech in February. He tech, and the continent’s capital risk sector now has a DEA (post-graduate degree) in Management Science and a needs rebuilding. In addition, the stock marMaster’s degree in Pharmaceutical kets have broken down (with the notable excepIndustry Management from the IAE (School of Business Management) tion of France, which has become the European leader in terms of IPOs). In some countries, in Lyons. the ecosystem of analysts/brokers/lawyers/auditors has simply disappeared.

Some efforts, on the other hand, are beginning to pay off, as witnessed by the emergence of a whole ecosystem of maturing life science companies. France Biotech is continuing to help its recently incorporated members to improve their practices and benefit from their elders’ experience. We are also intensifying efforts to bring members into contact with Big Pharma companies in Europe and worldwide, and promote sustainable funding in our sector.

But a lack of funding is our Achilles’ heel. Unlike otherwise similar North American companies in this field, that makes us easy prey. Unless a European biotech company tries to gain a foothold in North America to raise funds, it soon becomes vulnerable. Its know-how and intellectual property can be bought by third parties, who go on to develop the latter in-house.

Asia has also entered the game, but Europe does not always play by the same rules there.

Japan and South Korea use their regulatory agencies as tools for business competitiveness (in the field of cell therapy, for example). The same can hardly be said of the European Medicines Agency. China is investing massively in infrastructure and know-how, but we still have very few links with our Chinese counterparts.

Even countries like Singapore and Taiwan are showing themselves to be very dynamic. And there are plenty of other examples.

The European Union has (at last!) become aware of this situation. However, its initiatives are not scaled to meet the challenges we face! Our innovative, value-added industry deserves much better. Access to European Union funding programmes is still laborious, and restricts inter-company collaborations. The key success factor in our industry is speed. So are we moving fast enough?

As entrepreneurs and representatives of industry bodies, it is up to us to put these arguments on the table and gear up for June’s European elections. I call on you all to send out the same, shared message: “Wake up, Europe!” B

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N –º 4 | Volume 13 | 2014

Euro|Biotech|News

CIRCUL ATION

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

Europe: european-biotechnology.net

Germany: biodeutschland.org

Switzerland: swissbiotech.org

Belgium: edma-ivd.eu

Europe: eapb.org

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CouncilBlue: of European 100/15/0/35 BioRegions Orange: 0/75/90/0

Europe: europabio.org

Europe: cebr.net

Ireland: ibec.ie/ibia

Europe: ebe-biopharma.org

Denmark: danskbiotek.dk

Norway: biotekforum.no

The Netherlands: hollandbio.nl

Austria: lifescienceaustria.at

Sweden: swedenbio.com

Finland: finbio.net

Spain: asebio.com

France: france-biotech.org

Hungary: hungarianbiotech.org

Belgium: bio.be

EuroBiotechNews covers the biotechnology sector of the current 28 EU member states, Norway and Switzerland.

If you would like to subscribe, please refer to Portugal: www.apbio.pt

Italy: assobiotec.it

www.eurobiotechnews.eu

N –º 4 | Volume 13 | 2014

contents

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Insight EMA debates transparency policy; Junk-food tax; Heard in Brussels

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Euro|Biotech|News

Cover Story 10

Study revives debate on unique names for biosimilars 11 Investment flows back to Europe

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Agencies report on antibiotic resistance; DG Research update 13 Vote in favour of GM honey; Action against obesity; IP Flash

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Regulatory Affairs Update on clinical trials

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Europe’s new Clinical Trials Regulation

Breaking news from the EMA

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Although the EU’s citizens and companies have profited in countless ways from a borderless Europe, some areas of regulation have not kept up with the times. Now a longoverdue overhaul of legislation involving multinational drug studies has been adopted by the bloc. Its aim is to help finally reduce the amount of bureaucracy involved in filing for permission to carry out a multinational trial in the EU, to streamline the process as a whole – and to cut in half the amount of time it takes to acquire approval.

Economic Focus on newsflow and dividends

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Stock markets

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Perspectives Device identification for med-tech products

Services

Special 44

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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Partners & Associations

Big Data & IP Is Big the same as relevant?

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IP considerations in Companion Diagnostics

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Leveraging Big Data for new medicines

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Interview – Peter Langkafel, SAP

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Biopeople News from Prothena Corp. plc, Roche AG, Canbex Therapeutics Ltd., Nov­immune SA, Merck KGaA and the European Food Safety Authority 43 Company index

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Events What’s on in May-June 2014

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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, Uta Mommert, Dr. Martin Laqua, Benjamin Stolzenberg; Advertising: Oliver Schnell, +49-30-2649-2145, Christian Böhm, +49-30-2649-2149; Distribution: Marcus Laschke, +49-30-2649-2148; 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: Part of a historical banknote from 1948 ® BIOCOM is a registered trademark of BIOCOM AG, Berlin, Germany.

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N –º 4 | Volume 13 | 2014

Euro|Biotech|News

INSIGHT EUROPE

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EMA

Transparency takes time A London/Brussels – After delaying the finalisation of its new information poli­ cy on the publication of results from clini­ cal trials of approved medicines, the EMA announced in March it will complete ne­ gotiations in mid-June. Agency plans to proactively release clinical trial data faced stiff opposition from the pharmaceutical industry, which wants to keep trade se­ crets and distinct data under its control.

Originally, the EMA had been planning to present new rules governing how to grant researchers access to anonymised patientlevel data on 1 January 2014, but over 1,000 comments on its draft policy and litigation with Intermune and Abbvie have delayed publication of the hotly-debated rules. B

France/EU

Cola contribution A Paris/Brussels – A French proposal to put a tax on junk foods whose consumption is linked to cardiovascular disease has been added to next year’s EU Council agenda.

Senators Yves Daudigny (PS) and Cathe­ rine Deroche (UMP), who drafted the re­ port ”Taxation and public health: evalua­ tion of behavioural taxation”, are aiming specifically to slap a 20% tax on soft drinks in a legislative attempt to limit the risk of cardiovascular disease and cardiovascular events. The report concludes that the tax could partly help compensate for the public health costs that result from junk-food con­ sumption. According to recent research, se­ rious cardiac events can occur in genetical­ ly predisposed people who have consumed energy drinks. ”Our objective is to say that certain products are unhealthy,” says De­ roche, who will present the report to French Health Minister Marisol Touraine. EU min­ isters will discuss a health regulation in re­ sponse to the report next year.

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Heard in Brussels M

Throwing out the baby with the bathwater

Brussels – As we all know, the Europe­ an Commission is under intense pres­ sure to reduce costs and shed the image of being a gravy train. This is a favour­ ite topic at the national level in the on­ going fight against the reign of terror from Brussels.

The irony is that the era of eye­ watering salaries and mansions on leafy avenues actually ended some time ago.

While there are still plenty of Commis­ sion people who live very well ­– cour­ tesy of getting their feet under the ta­ ble back in the old days – many new staff face short contracts, lower wag­ es and substantially less sexy perks. I am all for the European Commission employing people on a realistic level (i.e. like the rest of us), but I am having problems with additional changes in structure that somebody thought was an ’efficiency’.

One cut too many?

The EC is a huge funding body, driving innovation and industrial development across Europe. To do that, it needs pas­ sionate and motivated staff who are in­ tegrated into the heart of the scientific process. Based on what I have seen my­ self and heard from plenty of others, the increased use of external agencies to ad­ minister project funding isn’t serving collaborative research well. Sure, the agencies come cheaper and let the EC talk about reducing costs, but the direct result is that you get people paid to ad­ minister – not to add value to – world­ class research collaborations.

Another irony is that there is a queue of people 10km long wanting to work for the Commission, and it includes talented scientists and project manag­ ers. So why make them just administer project reports? Managing collabora­ tive research is really hard, we all know

Claire Skentelbery, Secretary General of the European Biotechnology Network

that, so why not invest a bit more to en­ sure that it actually works? These guys would work on the same salaries as you pay external staff. In fact, I bet that those external staff would jump at the chance to stretch their brains beyond correctly completed personnel tables.

Investing in results The fact is that the European Commis­ sion will always take the heat for na­ tional issues. It is a useful whipping boy on any aspect of money because its budgets are so huge, and it always looks shifty because its answers are necessar­ ily complicated. The Commission is not going to win any debates at national lev­ el, regardless of how much it cuts budg­ ets, so it should stand up and say that it is proud to have skilled Project Officers working as partners with the projects that it funds. Then those projects have the maximum chance of delivering the results that they were funded to achieve, while the Directorates deliver­ ing the funding can also see the fruits of their labour and assess the effective­ ness of their policies.

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N –º 4 | Volume 13 | 2014 FREE EXCERPT

Euro|Biotech|News

INSIGHT EUROPE

DG Research update M

Mining for life sciences gold with European research

Brussels – This year’s slogan at the BIO International Convention (June 23-26, San Diego) “Connect, Partner, Innovate” perfectly fits to the European Commission’s (EC) goal to boost translation of research results into applications. In the 10th year of EC participation, DG Research[1] will increase visibility of a resource designed during FP6 and FP7 programmes to help projects and their results to flow in the exploitation pathway. The “Health Competence” database is more than an information resource on the outcomes and partners within the world’s largest research funding programme. It’s also a tool to drive innovation through the initiation of new cooperations and the synergy of public and private partners. A special panel session at BIO will provide insights on Health Competence as a tool for tech transfer and beyond.

All that glitters Exploiting projects funded by the taxpayer is a Holy Grail for governments, because it emphasises they are generating economic returns on the tax euro/

Torbjörn Ingemansson Principle Scientific Officer, DG Research and Innovation, European Commission [1] Short for: Directorate-General for Research and Innovation

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dollar, creating jobs, building sectors and meeting unmet needs. Project completion is not the end of this process, but the beginning, and in a global economic crisis they need to effectively deliver technologies to end-users and markets. The panel “Mining for gold – creating business opportunities from publicly funded collaborative research” brings together key tools and platforms that help technologies progress beyond the project.

This is not just technology transfer; this is technology maturation and delivery – involving an evo­lution of research results and research partners.

The Health Competence database is a multi-million euro tool created by the European Commission with a global perspective. It brings together more than 23,000 collaboration opportunities from EC-funded projects taking place all over the world. The tool to underpin future research collaborations, business development and clustering technologies will be presented by Torbjörn Ingemansson from the European Commission.

Health Competence brings a global perspective through its Advisory Board, which includes Bonny Harbinger, Deputy Director at the NIH’s Technology Transfer Office, who will emphasise the importance of global exploitation and practical access to technologies. Industry uptake and exploitation of EC-funded projects – particularly among SMEs – is crucial, and the CSO of Collaborative Drug Discovery Inc. Sean Ekins will explain how projects drive their commercial development. Finally – it is all about the people. Project exploitation comes through collaboration, and Claire Skentelbery from the European Biotechnology Network will be sharing techniques and platforms where effective partnerships are created for the exploitation of research. B

Antibiotic Resistance

A situation that could be worse A Paris/Brussels – Food-borne bacterial pathogens like Salmonella and Campylobacter are showing significant resistance to common antimicrobials, but levels of multi-drug resistant strains have remained low. That is the central conclusion reached by the European Union Summary Report on antimicrobial resistance in zoonotic and indicator bacteria from humans, animals and food. The report was published at the end of March by EU food watchdog EFSA and epidemiologists at the European Centre of Disease Control (ECDC). It shows that clinical resistance in humans to commonly used anti­ microbials in Salmon­ella isolates was frequently detected at the EU level, with almost half of the tested isolates resistant to at least one antimicrobial, and 28.9% of them multidrug-resistant. However, levels of clinical resistance and co-resistance in Salmonella spp. isolates to critically important antimicrobials were low – less than 0.2% co-resistance occurred across the 12 Member States that submitted data. The same picture emerged when EFSA and the ECDC searched for resistant Campylobacter strains in clinical isolates.

MDR bugs not yet a major problem And the same proved true in animals, especially in chickens, pigs and turkeys. Coresistance of Salmonella, Campylobacter and E. coli strains to critically important anti­microbials ciprofloxacin and cefotaxime was either not detected or reported at very low levels in the 12 Member States.

In 2014, the ECDC is launching the EU protocol for harmonised monitoring of anti­microbial resistance in human isolates of Salmonella and Campylobacter. “We expect to get more accurate data from countries and as a result better comparability of data,” said Johan Giesecke, Chief Scientist at the ECDC. B

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N –º 4 | Volume 13 | 2014

Euro|Biotech|News

Company And Advertiser Inde x A A1M Pharma AB (S)… …………………………… 23 AB Science SA (F)………………………………… 19 Ability Pharmaceuticals SL (E)…………………… 29 AC Immune SA (CH)……………………………… 12 Acteaventures GmbH (GER)……………………… 25 Activaero GmbH (GER)…………………………… 27 Active Biotech (S)………………………………… 19 Adaptimmune Ltd. (UK)… ……………………… 27 Adocia S.A.S. (F)… …………………………… 16, 19 Algeta AS (N)……………………………………… 23 Almirall S. A. (E)…………………………………… 50 Amgen Inc. (USA)………………………………… 11 Amirsehhi Intellectual Property Law (GER)…… 36, 41 Amneal Pharmaceuticals (USA)… ……………… 30 Anasyst (B)………………………………………… 42 Ark Therapeutics (UK)… ………………………… 12 AstraZeneca AB (S/UK)………………………… 43 Atopix (UK)………………………………………… 16

B Bayer AG (GER)…………………………………… 23 Bayer Healthcare AG (GER)……………………… 25 Betagenon AB (S)………………………………… 16 BioAlliance (F)… ………………………………… 19 Biocartis SA (CH)… ……………………………… 24 BIOCOM AG (GER)… …………………… 11, 19, 45 Biocrates Life Sciences AG (A)…………………… 24 BioInvent International AB (S)…………………… 19 Biotech Saniona AB (DK)………………………… 22 BioTOP Berlin-Brandenburg (GER)… …………… CP3 bluebird bio France … …………………………… 18 BOB - Best of BIOTECH (A)………………………… 9 Boehringer Ingelheim (GER)… ……………… 16, 18

C Caixa Capital Biomed (E)…………………………

Canbex Therapeutics Ltd. (UK)… ………………

Capital Markets (India) Private Ltd.………………

Cardio3 Biosciences (B)… ………………………

Cargill Dow LLC (USA)… …………………………

Celera Genomics (USA)… ………………………

Cell2B (PT)…………………………………………

Celltech Group plc (UK)… ………………………

Chiesi Farmaceutici S.p.A. (I)… …………………

Circassia Ltd. (UK)…………………………………

CMC Supply (DK)… ………………………………

Cobra Biologics (UK)………………………………

Codexis, Inc. (HUN)… ……………………………

Collaborative Drug Discovery Inc. (USA)…………

Crossject (F)… ……………………………………

Curevac GmbH (GER)… …………………………

28 43 26 12 29 43 28 43 17 12 23 15 30 13 12 25

D Danske Bank (DK)…………………………………

DBV Technologies (F)… …………………………

Debiopharm S.A. (CH)……………………………

Dell Inc. (USA)… …………………………………

Discuva Ltd. (UK)… ………………………………

21 19 24 33 25

E Elan Corp. (IRL)…………………………………… 43 Eli Lilly (USA)…………………………………… 16, 43

Elsa GmbH (GER)………………………………… 24 Endocyte Inc. (USA)… …………………………… 18 Eppendorf AG/Bioprocess Center Eur. (GER)…… CP2 Eppendorf AG (GER)……………………………… 47 Ernst & Young GmbH (GER)……………………… 12 Erytech Pharma (F)… ………………………… 3, 19 Esteve S.A. (E)… ………………………………… 28 Eurofins Scientific (F)… ………………………… 21 European Biotechnology Network (B)…………… 36 EY Farmindustria (I)… …………………………… 29

F/G Ferrer Group Int. SA (E)… ……………………… 28 Ferring International Center SA (CH)… ………… 27 Fort Knox F√∂rvaring AB (S)……………………… 17 Forum MedTech Pharma e.V. (GER)… ………… 37 Galapagos NV (B)………………………………… 17 Galmed Pharmaceuticals (IL)… ………………… 12 Genfit SA (F)… ………………………………… 19, 20 Genticel S.A. (F)… ……………………………… 12 Gilson International B.V. Deutschland…………… 47 GlaxoSmithKline (UK)… ………………… 16, 20, 26 Glycotope GmbH (GER)… ……………………… 24 GSK Pharmaceuticals Ltd. (IND)… ……………… 26

H/I Horizon Discovery Ltd. (UK)……………………… 12 Hospira (UK)… …………………………………… 11 Hospira One 2 One Global Pharmac. (USA)… … CP4 HSBC Trinkaus & Burkhardt KGaA (GER)………… 26 Human Genome Sciences Inc. (USA)…………… 33 IBM gmbH. (GER)……………………………… 33, 38 IMS Institute for Healthcare Informatics (I)……… 33 Index Pharmaceuticals AB (S)… ………………… 50 InHouse Patent Counsel LLC (USA)……………… 33 Innate Pharma SAS (F)…………………………… 19 Intrexon Corp. (USA)……………………………… 30

J Janssen-Cilag (B)… …………………………… 18, 22 Johnson & Johnson (USA)… …………………22, 30 Jossa Arznei GmbH (GER)… …………………… 24

K/L Karo Bio AB (S)…………………………………… 19 Kempen & Co (NL)… …………………………… 33 KPMG (GER)… ……………………………………… 3 Lee‘s Pharmaceutical Holdings Ltd. (HK)… …… 26 Life Technologies Corp. (USA)…………………… 25 Lombard Medical Techn. plc (UK)… …………… 12 Lubrizol Corp. (USA)……………………………… 29

M Mater-Biotech S.P.A. (I)…………………………… 29 Medivir AB (S)… ………………………………… 19 Merck KGaA (GER)… ………………………… 17, 43 Merck Serono (GER)……………………………… 43 Molecular Partners AG (CH)……………………… 12 Mologen AG (GER)… …………………………… 16 Morgan Stanley (DK)……………………………… 21 Myriad Genetics (USA)…………………………… 37

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N Neovacs SA (F)…………………………………… 17 NeuroSearch A/S (DK)…………………………… 22 NeuroVive Pharmaceutical AB (S)… ………… 19, 23 Nicox (F)…………………………………………… 19 NNIT A/S (DK)… ………………………………… 21 Novamont S.p.A. (I)… …………………………… 29 Novartis AG (CH)… ……………………………… 25 Novartis Europharm Ltd. (UK)…………………… 18 Novimmune SA (CH) … ……………………… 12, 43 Novo Nordisk A/S (DK)………………………… 21, 23 Novozymes A/S (DK)… ………………………… 22 Noxxon Pharma AG (GER)… …………………… 50

O Omegam Laboratoria BV (NL)……………………

OncoDNA SA (B)… ………………………………

Oncos Therapeutics Ltd. (FI)… …………………

Oragenics (USA)… ………………………………

Orexo AB (S)… ……………………………………

21 27 18 30 19

P Patentopolis Holding BV (NL)… …………………

Pharmium Securities (F)… ………………………

Piramal Imaging (GER)……………………………

Polyphor Ltd. (CH)…………………………………

Prionics AG (CH)… ………………………………

PromoCell GmbH (GER)… ………………………

Prosensa BV (NL)… ………………………………

Prothena Corp. plc (IRL)… ………………………

29 19 17 12 25 47 12 43

Q/R Qiagen NV (NL)………………………………… 34, 35 Regenx Biosciences LLC (USA)… ……………… 28 Renovo (UK)… …………………………………… 12 Roche AG (CH)… …………………… 16, 20, 25, 43

S Salans FMC SNR Denton Europe LLP… ………… 32 Sanofi SA (F)……………………………… 16, 26, 27 SAP AG (GER)… ………………………………… 40 Sartorius AG (GER)… …………………………… 18 Sillajen Inc. (KR)…………………………………… 26 South Korean SK Chemicals Co. (KR)…………… 27 Synthon (NL)……………………………………… 17

T/U Takeda Pharmaceuticals (JP)… ………………… 18 TAYLOR WESSING Germany………………………… 7 Thermo Fisher Scientific (USA)… ……………… 25 Transgene SA (F)… …………………………… 19, 26 TxCell S.A. (F)…………………………………… 27, 12 UCB Pharma SA (B)… …………………………… 26 uniQure BV (NL)… ……………………………… 17 UPM (FI)…………………………………………… 23

V/Y Valneva (F)……………………………………… 17, 20 Vectura Group plc (UK)…………………………… 27 Venter Pharma S.L. (E)…………………………… 28 Vernalis plc (UK)… ……………………………… 43 Voisin Consulting (F)……………………………… 18 Vontobel AG (CH)………………………………… 12 Ysios Capital Partners (E)………………………… 28

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