European Biotechnology News 1-2/2013 - Free Excerpt: IMI: Stem cells at centre-stage

N² 1-2 | Volume 12 | 2013 | 10.00 Ì | ISSN 1618-8276 | A 60711 |

European Biotechnology News Science & Industry

CENTRAL EUROPE

Intercell and Vivalis merge vaccine and antibody business NORTHERN EUROPE

BASF acquires new piece of omega-3 puzzle with Pronova

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WESTERN EUROPE

Wave of funding hits Britain’s biotech sector SPECIAL

Euro BioFairs Compass – the Life Sciences events guide SOUTHERN EUROPE

Pfizer grabs Philogen’s earlystage IBD antibody therapeutic EASTERN EUROPE

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Poland clashes with European Commission over GMO ban SCIENCE & TECHNOLOGY

Heat-inactivated HIV vaccine controls virus replication

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N –º 1-2 | Volume 12 | 2013

Euro|Biotech|News

INTRO

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EDITORIAL

Fostering collaboration and R&D quality in Europe Derrick Williams, European Biotechnology Network, Brussels

I

Derrick Williams is the head of communications at the European Biotechnology Network in Brussels. A biologist, the US native is a science correspondent and media professional who has worked in Europe since 1996. Williams is a journalist and PR professional in a variety of different formats, including both broadcast media and print.

His productions, TV reports and articles generally focus on helping the wider public better understand biotech and life sciences topics.

n an era when Member States are doing their utmost to limit national exposure in the EU budget, making the right choices has become more crucial than ever before to shaping Europe’s future. The problem with the current tenuous economic situation is that research-driven sectors like biotechnology need reliable support. Without it, they will be unable to deliver jobs and growth in the global markets of the future – among them biological production, personalized medicine and healthenhancing nutrition. To remain at the forefront of these fields and employ funds effectively, Europe has to foster even more collaboration, while at the same time putting frameworks in place to prevent research projects from being being carried out more than once.

Both Big Pharma and global agribiotech players have to fully implement biotechnological platform technologies in product development.

To improve their products, global industry leaders – like BASF in chemistry, for example, or Nestlé in nutrition – increasingly rely on biotechnologies invented by academic groups and perfected by life sciences SMEs. While this biologisation of industry is moving forward at a global scale, continuous support for collaboration is essential to ensure that innovations continue to flow steadily in both directions.

In the past, Europe has supported R&D collaboration with significant amounts of funding (Framework Programmes) as well as through the creation of European research infrastructures provided by the the European Strategy Forum on Research Infrastructures (ESFRI).

One example is the EU biobanking resource BBMRI, which is aimed at pooling data from local biobanks in Europe and harnessing it for drug target and biomarker discovery. This lays the foundation for personalised medicine and

therapies that target diseases where they need to be battled – at their roots. Better collaboration and data standardization are key to squeezing the greatest possible gain from pooled resources. That rule of thumb is also true for other collaborative EU projects that generate huge datasets for the research community. To ensure that public funds are invested well, one fairly simple step would be to make collaboration and standardization of research outcomes – i.e. by means of ring tests – a prerequisite for EU funding. This would help improve comparability in research results, and prevent duplication in research projects.

The only way to guarantee the high-quality results that future markets will demand is through collaboration and networking in the 27 Member States of the European Union, Switzerland and Norway. Only through collaboration among all the stakeholders in the value chain can we set the common standards necessary to take full advantage of vast projects, like searching cancer patient genomes for new targets and diagnostic biomarkers. Realizing European synergies can only happen, however, if potential partners are aware of one another. EU science, research and industry has yet to make really good use of the advantages provided by a common market, when these could be helping to drive even faster technology transfer and even more flexible labour. And at the end of the day, establishing a truly sustainable future through biologisation will never be achieved without even more political commitment.

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N –º 1-2 | Volume 12 | 2013

Euro|Biotech|News

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

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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 1-2 | Volume 12 | 2013

CONTENTS

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INSIGHT EU votes for unitary patent; Patents on genes; Heard in Brussels

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Euro|Biotech|News

COVER STORY 10

Commissioner willing to revive GMO talks; Printed cartilage; Sports vs. diabetes; QALYs invalid for HTA 12 IP-Flash; New rules for API importers; EFSA publishes GMO assessments 13 REGULATORY AFFAIRS Breaking news from the EMA

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Update on clinical trials

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ECONOMIC Focus on newsflow and dividends

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Stock markets

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PERSPECTIVES Interview: Federico Pollano

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Stem cells – the new stars of human disease models

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Big Pharma is for the first time directly addressing the need for better disease models than those available through animal experimentation. With a 50m EU project led by Hoffmann-La Roche and the University of Oxford, the Innovative Medicines Initiative’s StemBANCC project is using stem cells to establish 1,500 human cell lines to mimic disease processes in the bodies of the ill. One of the project’s goals is to lower the extremely high failure rate in screening and early clinical testing of drug candidates.

REGIONAL NEWS 20

Central Europe Germany, Austria, Switzerland

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Western Europe France, Belgium, Ireland, UK Southern Europe Italy, Spain, Greece Eastern Europe Poland, Hungary, Bulgaria, Estonia & the Czech Republic

SERVICES

SPECIAL

Northern Europe Denmark, Norway, Finland

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Euro BioFairs Compass BIO-Europe Spring

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Forum Life Science

36

Swiss Biotech Day

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7th International Meeting Stem Cell Network NRW

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European Lab Automation

42

Biomedica 2013

44

Partners & Associations

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Biopeople News from Bayer Healthcare/Novartis, Hoffmann-LaRoche, Merus, Hookipa Biotech, Novozymes and Aircraft Medical 47 Company index

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Events What’s on in February-March 2013

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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. 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: ©123rf.com ® BIOCOM is a registered trademark of BIOCOM AG, Berlin, Germany.

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INSIGHT EUROPE EU PATENT BREAKTHROUGH

Patent unification Strasbourg – Patenting across the EU is going to become cheaper and easier after the European Parliament greenlighted two EU Regulations establishing a unitary EU patent in December. After three decades of debate, it has been agreed that in future, patents must be only published in three languages (English, French and German). This will cut costs for Europe-wide patents by 80%, which is seen as an advantage, especially for small and medium-sized high-tech firms. Under the new Regulations, which are up for ratification by Member States beginning in February 2013, applications must be made in one of the languages above. Translation costs will be reimbursed for small players. Italy and Spain had delayed the adoption, since they demanded until the very end that their languages also be included. They will not vote on the language issue, however, so 13 ratifications from Member States will be sufficient for a majority. Another issue – the establishment of a central patent court – is dependent on ratification of the Regulations by a majority of Member States. Up to now, there have been four attempts to establish a unitary patent. Two of them (in 1975 and 1989) failed because too few Member States ratified the move. In 2000 and 2003, attempts fell through due to differing views in the language issue.

BIO-PATENTS

Explore genetics Brussels – The European Commission has selected a group to examine the development of biotech patents. The 15 industry, IP and policy experts will focus on the patentability of genes or parts of the human genome for diagnostic or other purposes, which has become easier since the establishment of next-generation sequencing. The group will advise the Commission on how to adapt ‘biotech patent’ Directive (98/44) with regard to recent developments.

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Heard in Brussels Patents dancing in the spring Brussels – All the hard work I invested in 2012 to rescue the Eurozone with biotechnology has reaped a new reward in 2013, as the European Parliament and Council finally approved the European patent in December. We can now look forward to a revolution in the commercialisation of innovation, as a unified Europe opens the doors to lower cost and wider impact patents.

Many accuse the EU of over-caution, like an old lady wrapped up warm on a summer’s day, but this is a glorious example of Europe going a bit mad and dancing naked in the street. Metaphorically, of course. It’s far too cold for that in reality right now.

New hope for Europe My friend Steven Zeman (see p. 13) can give you the formal overview of what the unified patent means for Europe (as he actually knows what he is talking about) so I will just relax and enjoy the feeling of freedom that the patent gives to technology in Europe.

I am intrigued to know how Europe will score on innovation rankings worldwide now, as universities can afford to protect more great science and SMEs don’t have to sell their grandmothers to bring their precious technology to an investable stage. We can expect to see far more patented innovations from collaborative research and people bold enough to take risks, as you have to do in biotechnology. We can also expect to see many technologies hitting the market at an earlier stage. Now you don’t have to hide it in your pocket for 10 years until you can finally afford that patent, or know for sure that it will do something.

Will this help to liberate Europe from its traditionally cautious approach to early-stage businesses? Let’s

Claire Skentelbery, Secretary General of the European Biotechnology Network

hope so. I would love to see European entrepreneurs seize the day and investors take early-stage opportunities more seriously. We yearn for the bold investments seen on the other side of the Atlantic. But money talks very quietly on this side of the pond, often because it is still muffled in the pockets of VCs who, in the face of early-stage companies, increasingly resemble me when my children describe the latest ‘must-have’ game or gadget, without which they will surely die.

Change of value creation?

This is not just about the point of purchasing patents. It’s also about the fact that it changes the whole value chain of innovation, and makes a serious statement from Europe as a whole. And that statement is that there might be a defragmentation of finance through the unfortunate situation of there being no money out there, but there has now also been a defragmentation of innovation because that is the right and glorious thing to do. Europe should be very proud of itself. Vive la revolution!

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Euro|Biotech|News

INSIGHT EUROPE

News Ink-jet cartilage Würzburg/Brussels – A consortium of eight research groups has nailed down 9.75m in EU funding over five years to construct implants with the resilience of natural cartilage. That’s not an easy task, according to coordinator Jürgen Groll from the University of Würzburg, because cartilage is by no means homogeneous. In fact, it contains functionally and structurally different zones. That‘s why tissue-engineered chondrocytes alone are not sufficient to treat the over 150 million patients worldwide who suffer from osteoarthritis. In contrast, the experts from the HydroZones project aim to mimic the natural structure of cartilage tissue by ‘printing’ it layer by layer. The spray nozzles used contain – depending on the layer being deposited – hydrogels of various densities, growth factors, hormones and chondrocytes rather than ink. The researchers envision automating the process.

Diabetes prevention Brussels/Copenhagen – The European Commission is sinking 9m into a project investigating how lifestyle factors affect the onset of type II diabetes, as well as which subgroups of prediabetics respond to sports and diet.

To identify relevant factors, the PREVIEW consortium will investigate a population of pre-diabetic overweight or obese individuals over five years.

Led by researchers from the University of Copenhagen, the 14 partners will conduct two studies: an interventional trial with 2,500 prediabetics on a special diet, and an epidemiological cohort with 170,000 participants. The latter will examine which combination of lifestyle and social factors contributes to disease onset.

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EU

Brussels seeks GMO breakthrough Brussels – European Health Commissioner Tonio Borg wants to revive talks with Member States about national GMO

EU Health Commissioner Tonio Borg

bans. His spokesman Frederic Vincent confirmed in January that the Commission is not going to push through the six pending GMO approvals for cultivation ”in the next weeks”. He also rejected previous reports by news agencies suggesting the Commission will freeze approvals for new GM crops until 2014. A Commission proposal from 2010 that would have allowed Member States to decide individually whether to grow GM crops or not was rebuffed by large EU members, including Germany, France and the UK. Vincent now says the Commission wants ”to discuss the issue with the three governments to see if we can reopen negotiations on the proposals.”

The six GMOs in question include the five maize varieties Bt11, Nk603, TC1507, GA21, and MON88017, along with the herbicide-tolerant Roundup Ready soybean (GTS 40-3-2). The EU food watchdog EFSA says that none of the strains pose a risk to either health or the environment.

BSE

HTAS

Relaxed testing

Invalid metric

Brussels – The European Commission will further loosen the current EU-wide BSE testing rules. Beginning on 1 April, Member States will no longer be required to test healthy animals at slaughter for the disease. The Commission added, however, that Member States could establish stricter rules on their own. The incidence of BSE has fallen so far in recent years that the Commission dropped the required testing age for healthy animals from 24 to 48 and finally 72 months of age. Testing dead cattle over 48 months will remain unchanged.

Member States like Germany had already announced plans to uphold obligatory testing, but only for healthy animals over 96 months of age. That reduces the number of tests and costs, but remains a source of data for animal monitoring.

Brussels/Paris – Health technology assessors (HTAs) should not use so-called ‘quality adjusted life years’ (QALYs) to decide if a medicine is cost-effective. That's the result of a EU-wide analysis of HTA bodies and their methods by the ECHOUTCOME consortium. At the end of January, the experts under Gerard Duru from the University of Lyon said QALYs are flawed because they make inappropriate assumptions in linking a reimbursement limit with a year of good health. Life years and quality of life can‘t be linked, people are not neutral about risk and the willingness to sacrifice life years is not constant over time, says Duru, which is why ”the QALY indicator is not a valid scientific scale.“ He recommends replacing QALYs with more flexible metrics like disease remission or relapse prevention.

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Euro|Biotech|News

COMPANY AND ADVERTISER INDE X 4-Antibody AG (CH) …………………………… 22

A AB-Biotics (E) …………………………………… 26 AbD Serotec (GER) …………………………… 22 Acambis plc (UK) ……………………………… 47 Aceto Corp. (USA) ……………………………… 26 Actelion AG (CH) ……………………………… 16 Advanced Accelerator Applications SA (F) …… 28 Agilent Technologies (USA) …………………… 21 Aircraft Medical (UK) …………………………… 47 Alexion Pharmaceuticals (USA) ……………… 46 Almirall S. A. (E) ………………………………… 26 Amgen Inc. (USA) ……………………………… 21 Anika Therapeutics Inc. (USA) ………………… 27 Apeiron Biologics (A)…………………………… 23 arGEN-X BV (NL/B) ………………………… 16, 25 Argenta Discovery Ltd (UK) ………………… 18, 25 Armstrong Laboratories (USA) ………………… 26 Arrowhead Research Group (USA) …………… 25 Astellas Pharma Europe B.V. (NL) ………… 14, 47 Astex Pharmaceuticals (IRL) …………………… 16

B BAC BV (NL) …………………………………… 25 BASF SE (GER) ……………………………… 20, 28 Bavarian Nordic A/S (DK) ……………………… 20 Baxter (USA) …………………………………… 19 Bayer Healthcare AG (GER) ………………… 16, 47 Bayern Innovativ GmbH (GER) ……………36, 37 Bio-Rad Laboratories GmbH (GER) …………… 22 BioFocus (UK) ………………………………… 25 BioInvent International AB (S) ………………… 16 Biolab Espanola de Analisis e Investigacion S.L. 26 BioRN Cluster Management GmbH (GER) …… 15 Biotie Therapies Corp. (FI) ………………… 16, 21 BioTOP Berlin-Brandenburg (GER) …………… 29 BlueSens gas sensor GmbH (GER) …………… 21 Boehringer Ingelheim (GER) ………………… 16 Bone Therapeutics (B) ………………………… 24 Bristol Myers Squibb Company (USA) ………… 21

C California Stem Cell Ltd. (USA)………………… 14 Cangenix Ltd. (UK) ………………………… 18, 25 Chemaxon Kft. (HUN) ………………………… 29 Chugai (JP) ……………………………………… 23 Cosmo Pharmaceuticals (I) …………………… 27 Cytos AG (CH) ………………………………… 22

D Dako Denmark A/S (DK) ……………………… 21 Debiopharm S.A. (CH) ………………………… 23 Deutsche Messe AG (GER) …………………… CP3 DLA Piper (UK) ………………………………… 47

E EBD Group (CH) …………………………… 34, 35 Edmond de Rothschild Investment Partner (F) 24 Eli Lilly & Co Ltd. (USA) ……………………… 16, 21 Enpharma Ltd. (UK) …………………………… 14

ethris GmbH (GER) …………………………… 25 Eurasanté (F) …………………………………… 25 European Biotech Network …………………… 45 Euroscreen S.A. (B) …………………………… 25

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Novartis Europharm Ltd. (UK) ……………… 14, 46 Novo Nordisk Foundation (DK) ……………… 21 Novozymes A/S (DK) ………………………… 20 Noxxon Pharma AG (GER) …………………… 16 Nycomed Danmark ApS ……………………… 46

F. Hoffmann - LA ROCHE AG (CH) …… 16, 23, 47 Ferrer Group Int. SA (E) ……………………… 27 Fidelta (HR) …………………………………… 25 Fidia Advanced Biopolymers srl (I) …………… 27

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Galapagos NV (B) …………………………… 18, 25 GANYMED Pharmaceuticals AG (GER) ……… 14 Genomica S.A.U. (ES) ………………………… 19 Genzyme Europe BV (B) ……………………… 14 GlaxoSmithKline (UK) ……………………… 19, 25

Paladin Labs Inc. (CDN) ……………………… 23

H H. Lundbeck A/S (DK) ……………………… 14, 21 HanAll BioPharma Co. Ltd. (KR) ……………… 26 High-Tech Gründerfonds Management (GER) 17 Hookipa Biotech AG (A) ……………………… 47 Hospira One 2 One (USA) …………………… CP4

I/J Incyte Corporation (USA) ……………………… 46 Inspiration Biopharmaceuticals (USA) ………… 19 Intercell AG (A) ……………………………… 14, 22 Iogen Corp. (CDN) …………………………… 20 Ipsen (F) ………………………………………… 19 Janssen-Cilag (B) ……………………………25, 46

K Kareus Therapeutics SA (CH) ………………… 16 KitoZyme S.A. (B) ……………………………… 25

L Laboratorios del Dr. Esteve, S.A. (E) ……… 14, 22 Laboratorios LETI, S.L. (E) ……………………… 26 Lead-Discovery Center GmbH (GER) ………… 23 Life Science Austria LISA (A)……………………… 9 Life Science Research Partners ……………… 24 Life Technologies Corp. (USA) ……………… 7, 25 LifeTecAachen-Jülich e.V. (GER) ……………… 44 Linklaters LLP (UK) …………………………… 47 Lonza AG (CH) ……………………………… 19, 47 Lophius Biosciences GmbH (GER) …………… 23

M Merck KGaA (GER) ……………………… 24, CP2 Merus B.V. (NL) ………………………………… 47 Mondobiotech AG (CH) ……………………… 23 Monsanto (USA) …………………………… 13, 28 MorphoSys AG (GER) ………………………… 22

N Nova Laboratories (UK) ……………………… 46 Novartis AG (CH) ……………………………… 47

OBN Ltd. (UK) ………………………………… 32 Onyx Pharmaceuticals Inc. (USA) …………… 16 Oxford Immunotec (UK) ……………………… 23

Pfizer Ltd. (USA)……………………………… 14, 26 Pharmaxis Pharma Ltd. (AUS) ………………… 46 Pharming Group N.V. (NL) …………………… 18 Philogen S.p.A. (I) ……………………………… 26 Pierrel Research SPA (I) ……………………… 23 Poxel SA (F) …………………………………… 24 Pronova Biopharma (N) …………………… 17, 20

R Recepta Biopharma SA (BR) …………………

Richardson Associates Regulatory Affairs (UK) Richter-Helm BioTec (GER) ……………………

Roche Registration Ltd. (UK) …………………

22 14 30 14

S SambrInvest (B) ………………………………… 24 Sanderling Ventures (USA) …………………… 19 Sandoz AG (CH) ……………………………… 47 Santarus Inc. (SA) ……………………………… 27 Santhera Pharmaceuticals (CH) ……………… 23 Santhera Pharmaceuticals (Deutschland) AG… 14 Seattle Genetics UK Ltd. ……………………… 46 Select Biosciences Ltd. (UK) ……………… 42, 43 Serono International SA (CH) ………………… 24 Shire plc (IRL)…………………………………… 25 Stem Cell Network NRW (GER) …………… 40, 41 Swiss Biotech Association (CH) ……… 11, 38, 39

T Telormedix SA (CH) …………………………… 16 Teva Pharmaceutical Industries Ltd. (IL) ……… 46 Thrombogenics (B) …………………………… 14

U/V uniQure BV (NL) ……………………………… 46 Versalis (I) ……………………………………… 27 Vertex Pharmaceuticals (Europe) Ltd. (UK) … 46 Vesalius Biocapital Partners S.a (L) …………… 25 Vivalis SA (F) …………………………………… 22 Vivia Biotech SL (E) …………………………… 27

Y/Z Yulex Corp. (USA) ……………………………… 27 Zeincro Hellas S.A. (GR) ……………………… 29 Zeltia-Group (E) ………………………………… 19

EUROPEAN BIOTECHNICA AWARD 2013 Nominations now being taken

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Register now: For the 10th EUROPEAN BIOTECHNICA AWARD, devoted to a European entity in the fields of biotechnology or life sciences with proven expertise and success in “Integration of Biotechnology into the industry” You may qualify, if your company or organization has successfully integrated biotechnology into daily business or converted conventional processes into biotechnology based ones The Award presentation will take place during BIOTECHNICA’s opening ceremony on Monday, 7 October 2013 at the Hannover exhibition grounds

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