European Biotechnology News 4/2012 - Free Excerpt - Can bioeconomy save the planet?

Nº 4 | Volume 11 | 2012 | 10.00 € | ISSN 1618-8276 | A 60711 |

European Biotechnology News Science & Industry

CENTRAL EUROPE

Swiss Biotech Report reveals more investment in sector NORTHERN EUROPE

Danes kick-off psychiatric genomics research hub WESTERN EUROPE

T P R E C EE EX

FR

Wellcome Trust to aid UK biotech with £200m in funding SPECiAL

Analytica 2012 in Munich Update on bioanalytics SOUTHERN EUROPE

Janus to commercialise inclusion body drug delivery system

Can bioeconomy save the planet?

EASTERN EUROPE

Mabion announces IPO on Warsaw Stock Exchange SCiENCE & TECHNOLOgy

Intratumour heterogeneity challenges biomarker approach

Parenteral Contract Manufacturing Service of Hospira

Our comfort zone is custom development and commercialization services One 2 One™ continually partners to guide your product from clinical trial materials to commercial product supply and distribution.

Start early to establish your custom comfort zone.

Site Selection Technical Transfer Process Development Clinical Manufacturing

Registration Batch Production Scale-up/ Validation CMC Preparation

Cold-chain Management Pre-Approval Inspection Final Package Development

Product to Market Production Efficiency Studies

Supply/ Distribution Drug Delivery Expansion

Discover your comfort zone at one2onecmo.com Get your custom report online or contact One 2 One. Call +1-224-212-2267 or +44 (0) 1926 835 554 or e-mail one2one@hospira.com

Your Parenteral Comfort Zone Parenteral Contract Manufacturing Service of Hospira

P11-3520A-Jan., 12

N –º 4 | Volume 11 | 2012

Euro|Biotech|News

INtro

FREE EXCERPT

Editorial

New framework for global research collaboration Prof. Dr. Kurt Zatloukal, Medical University of Graz, Austria

T

Kurt Zatloukal is Professor of Pathology at the Medical University of Graz, Austria. From 2008-2011 he coordinated the preparatory phase of the European research infrastructure for biobanking and biomolecular resources (BBMrI). Currently he is involved in several FP7 projects that focus on standardisation of molecular biosample analysis and is Director of the Christian Doppler Laboratory for biospecimen research and biobanking technologies.

he increase in lifestyle and ageingassociated diseases that has paralleled a rise in drug development costs – along with the financial constraints of the global economy – is putting enormous pressure on the sustainability of healthcare systems. These challenges can only be addressed by innovations for improved prevention and treatment of diseases that are based on scientific evidence.

Biobanks are a key resource for delivering such solutions, as they provide access to human biological samples linked with detailed information on diseases and lifestyle. These resources are essential for a more mechanism-based understanding of diseases as a prerequisite for the further development of personalised medicine.

After all, access to high-quality human samples is vital when it comes to supporting the development of molecular diagnostics, particularly companion diagnostics. Furthermore, to aid in better understanding gene-lifestyle interactions, large population-based cohort studies that contain information on lifestyle will help deliver a scientific basis for evidence-based disease prevention.

In order to address these needs, several European countries have made major investments in favour of biobanks. However, the challenges of providing sustainable healthcare are global rather than national issues. The need for action coordinated at the global scale is therefore obvious for many reasons. First, addressing the same problem in multiple non-coordinated approaches is neither efficient nor financially justified. Second, non-coordinated actions result in unnecessary duplication and – even worse – in non-compatible solutions that would undermine competitiveness in global biotech and the pharmaceutical industry.

The planning team of the European research infrastructure for biobanking and biomolecular resources (BBMRI) has developed the concept of a global network of expert centres to achieve global harmonisation in biobanking and biosample analysis. One rationale for the expert centres was to improve access to biobanks for industry and to avoid scenarios of sample commercialisation, which is illegal in Europe.

Expert centres could be established as publicprivate-partnerships that perform the analysis of biological samples using the latest technologies, and according to internationally harmonised procedures. Pre-competitive data generated in expert centres can be used by industry for product development, and will be made available to the public following procedures developed for the Innovative Medicines Initiative. Expert centres could also be established as public entities outside Europe to transform biological samples into high-quality data and information. This would avoid the need for transnational sample shipment in international research collaboration, thereby providing a new cooperation solution with countries that have legal restrictions on sample export.

In addition, sample analysis in the country of origin would exert a strong positive stimulus on generating local know-how and regional development. However, such a global network of expert centres can only work if pre-analytical and analytical procedures are thoroughly standardised, and if expert centres share common reference material and regularly participate in proficiency testing. The first voluntary activities for testing the feasibility of the concept, with a focus on genomics, metabolomics and molecular pathology technologies, are currently in development.

B

3

4

N –º 4 | Volume 11 | 2012

Euro|Biotech|News

CIRCUL ATION

FREE EXCERPT

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 4 | Volume 11 | 2012

5

Euro|Biotech|News

coNteNts

FREE EXCERPT

INsIght

Cover Story

OECD highlights need for bioeconomy 6 Heard in Brussels

8

IP Flash; Pharmaceuticals in our water 10

11 © fotolia.de/sergej Khackimullin

EUCLIDS project kicks off; IMI set to create EU drug-screening hub RegulatoRy affaIRs Update on clinical trials

12

Breaking news from the EMA

14

ecoNomIc Focus on newsflow and dividends

15

Stock markets

16

PeRsPectIVes Poland: update on GMO regulation

46

The consequences of (in)action

6

A sobering new OECD report predicts the planet’s projected nine billion inhabitants in the year 2050 will have to cope with serious health and environmental problems if we don’t begin fundamentally changing how we do things now. With the “Bioeconomy for Europe” strategy, the EU has taken the first steps towards change. Several Member States are also pursuing national agendas. In just a few years, sustainability programmes have gone from being prestige projects to vital investments in the future.

RegIoNal News Northern Europe Denmark, Norway, Sweden, Iceland 18 Central Europe Germany, Austria, Switzerland Western Europe UK, France, Netherlands, Belgium, Luxembourg Southern Europe Italy, Spain, Portugal Eastern Europe Poland, Hungary, Estonia, Slovenia, Czech Republic

20

22

24

26

seRVIces

SpeCial

Analytica 2012

Partners & Associations

4

Imprint

5

Analytica opens its gates

33

Bioanalytics drive innovation

34

Assay development: tracking the Schmallenberg virus

36

Interview: Peter Meldrum, CEO of Myriad Genetics

38

Next-gen sequencing: digging deeper into the tumour genome

Events What’s on in April-May 2012

48

40

Company index

49

Latest products

42

Encore

50

Biopeople News from Wilex, the EMBO, Hovione FarmaCiencia, Alkermes and the Innovative Medicines Iniative 28

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. Philipp Graf, 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.

6

N –º 4 | Volume 11 | 2012

Euro|Biotech|News

INsIght EuropE Bio-Economy

The consequences of (in)action the latest publication from the paris-based organization for Economic Cooperation and Development (oECD) is a sobering read. Most middle-class Europeans see only the tip of the iceberg when it comes to the unsustainable use of resources, and even that only when it affects them personally – for example, through yet another increase in the price of fuel. For a crash course in the details of why things look set to go horribly wrong, however, the 300 pages of the “oECD Environmental outlook to 2050: the Consequences of Inaction” are required reading. they highlight many of the uncomfortable yet unavoidable drawbacks of a rapidly industrialising world, and reveal that rising living standards in the coming decades could have a huge negative impact on practically everyone on the planet. the document focuses largely on four areas: climate change, biodiversity, freshwater and the health and environmental impacts of pollution. If things don’t change dramatically, it says, the expected socio-economic trends over the next forty years look grim. Europe has already reacted to the negative trends at both Eu and national levels by establishing bioeconomy strategies aimed at helping the continent play a leading role in preventing – or at least alleviating – the worst of the problems. But will it be enough?

The OECD report predicts that world energy demand in 2050 will be 80% higher than it is today, with most of the growth coming from emerging economies that will remain largely reliant on energy from fossil sources. If that goes unchanged, it will cause an increase in global greenhouse gas emissions of about 50% over those of today. As a result, it says, pollution in urban centres

in forty years could replace a lack of sanitation and clean water as the leading cause of mortality worldwide, with deaths caused by respiratory conditions doubling from “current levels to 3.6 million every year globally, with most occurring in China and India.”

And OECD countries won’t be spared. Ageing urban populations could “have one of the highest rates of premature death from

View into the heart of a biomass fermenter for the production of cellulosic bioethanol

FREE EXCERPT

ground-level ozone in 2050, second only to India.” Global diversity will also take a major hit, declining by 10% in the OECD forecast. And global water demand will rise sharply, largely due to manufacturing needs. As competition for fresh water increases, it will have a dramatic knock-on effect on the 40% of the global population living in river basins.

To mitigate the worst of the problems, the report recommends a wide range of policy solutions that include environmental taxes, emissions trading schemes, evaluating and pricing natural assets and ecosystem services, removing subsidies for fossil fuels and irrigation schemes that are wasteful, and encouraging green innovation by providing public support for basic R&D in sustainability-oriented technologies.

Europe trying to stave off disaster Europe has already taken action. In February, the European Commission announced it would invest a4.7bn from 2014-2020 “for developing the bioeconomy in Europe.” The strategy for green growth, which is aimed at establishing a sustainable “post-petroleum” industry production based on renewable resources, is based on three pillars: increasing R&D investment, boosting biomass production and its (biotechnological) conversion into value-added products, and communication of the benefits to consumers. According to Maive Rute, the Commission’s Director for Biotechnology, Agriculture and Food Research, it represents the best way “to promote research and innovation into sustainable production and exploitation of renewable raw materials, along with alternative energy and carbon sources.... (and it will help) pave the way to a more innovative and low-carbon society that reconciles food security with the sustainable use of renewable biological resources for industrial purposes, while simultaneously creating new job opportunities.” (see EuroBiotechNews 3/2012). In early March, the European Commission took the next step. It presented a so-called Innovation Partnership (EIP) for sustainable agriculture aimed at finding ways to sustainably produce more biomass to feed the world and secure biomass supply for industrial biotech applications. With-

8

N –º 4 | Volume 11 | 2012

Euro|Biotech|News

INsIght EuropE in the EIPs, which are constructed as public-private partnerships, researchers, SMEs and large firms will collaborate to cover the whole value chain.

some countries aren’t waiting Alongside the “Bioeconomy for Europe” strategy, national bioeconomy plans have been already established in five EU member states: Germany, Denmark, the Netherlands, Finland and Ireland. In November 2010, Germany’s government announced it would become the first country in the world to begin implementing a national bioeconomy strategy. Within the “National Research Strategy BioEconomy 2030” a2.4bn will be invested over six years: a1.1bn in the area of health-enhancing food, a511m in biomass exploitation for energy production, and a800m in industrial value creation. A a100m funding call for industrial biotech projects has already kicked-off.

The Danish “Agreement on green growth” will see a1.8bn (DKK13.5bn) in funding by 2015 – a 50% increase compared to previous initiatives. It’s aimed at securing environmental improvements through the largescale reduction of fertilizer and pesticide use, lowering the amount of greenhouse gasses emitted by the country’s agricultural sector, and improving protection for habitats. It will also revamp laws and streamline regulations in the agricultural sector, and encourage its contribution as a supplier of green energy.

The Dutch strategy (“Towards green chemistry and green materials”) focuses on a strong biochemicals industry, with plans to establish an algae production and research centre and to integrate biosynthesis and organic synthesis, while those in Ireland and Finland (wood biorefineries) are long-term, less concrete and focus on those countries’ strengths and resources.

Two major EU bioeconomy conferences, wrapped up in Copenhagen just after this edition went to press. One of them, the “Global Green Growth Forum”, presented six resource efficiency opportunities with a potential US$830bn in resource savings annually, along with the public-private avenues to seize them. Approaches like that will help define the next steps in a plan to prove the OECD forecasts wrong.

B

FREE EXCERPT

Heard in Brussels M

Do the clouds on the pharma horizon have a silver lining?

Brussels – If Jane Austen was writing in the early 21st century in Europe, she could well have begun one of her novels with: “It is a truth universally acknowledged, that a country in possession of a biotech sector, must be in want of a pharma company.“ Europe is experiencing a contraction in overall pharma presence as the sector on the whole continues to downsize. Entire industrial sites, all shiny and lovely, are emptying, with experienced pharma scientists and managers returned to the wild to forage for nuts and twigs.

Challenge or opportunity?

This is the horrible new reality for countries such as Sweden, which prides itself on a national environment of scientific innovation and big business. Site closures have been regularly making headlines across Europe, and every time they raise questions about the suitability of the countries concerned to retain such business.

But wait a minute…we’ve been here before, haven’t we? From my dim and distant youth in the Cambridge cluster, we watched large biotechs and pharma close doors as the first major funding crunch came. Biotech has taken quite a zigzag, crazy route to maturity, and the industry rarely repeats itself, but this is familiar and we should be learning from the past.

The notable outcome for the cluster as a whole was that scientists and managers turned to their own business enterprises, with IP and skills from big business being turned into new small business. That was really the making of the Cambridge cluster.

Through this flux of new enterprises, it managed to reach critical mass before the finances really got chilly and start-ups got harder.

Claire skentelbery, secretary general of the European Biotechnology Network

So the current round of closures needs to be channelling as quickly as possible to support more innovation and make use of the skills becoming available, before people retrain as lorry drivers or move to a commune in Peru. This time around, the big difference is that there is little or no start-up funding available privately, and this leads straight to the door of national governments.

political investment So governments, it’s time to put aside the handwringing and the vague statements about creating a leading scientific environment, and put your money where your mouth is. Seize the day for your healthcare sectors and invest for a political and financial return! If pharma moving out is inevitable, make good use of what it leaves behind in the next phase of biotech industry development. They have already made it cheap for you by building world-class sites and training top-notch scientists – what more do you want, the moon on a stick?

B

48

N –º 4 | Volume 11 | 2012

Euro|Biotech|News

CompaNy aNd adVertiser iNde x 454 Life Sciences (USA) ……………………… 25

a Abingworth LLP (UK) …………………………

Ablynx NV (B) …………………………………

Active Biotech (S) ………………………………

ADC Therapeutics Sarl (CH) ……………………

Agennix AG (GER/USA) ………………………

AiCuris GmbH & Co KG (GER) …………………

Aisling Capital (USA) ……………………………

Alan Boyd Consultants Ltd. (UK) ………………

Alcon Inc. (CH) …………………………………

Alkermes plc (IRL) ………………………………

Amgen Inc. (USA) ………………………………

AMS Biotechnology (Europe) Ltd………………

Analytik Jena (GER) ……………………………

Apeiron Biologics (A)……………………………

Araclon Biotech (E) ……………………………

Argenta Discovery Ltd (UK) ……………………

Astellas Pharma Europe B.V. (NL) ……………

Astra Zeneca (GB/S) ……………………………

Axel Semrau GmbH (GER) ……………………

16 23 18 50 23 12 16 14 20 28 16 42 34 12 24 18 14 18 34

B Basilea Pharmaceutica (CH) …………………… 12 Bausch & Lomb (USA) ………………………… 12 Bavarian Nordic A/S (DK) ……………………… 19 Bayer AG (GER) ………………………… 10, 12, 28 Berlin Partner GmbH (GER) …………………… 29 BIO.NRW (GER) ………………………………… 37 BIOCOM AG (GER) …………………………… 32 BioFocus (UK) ………………………………… 18 Biogenes GmbH (GER) ………………………… 47 Bioline Ltd. (UK) ……………………………… 34 Biometra GmbH (GER) ………………………… 42 BioWin – The Health Cluster of Wallonia (B) …… 7 Boehringer Ingelheim GmbH (GER) ………… 23 Bristol-Myers Squibb (USA) …………………… 27 BTG plc (UK) …………………………………… 12

C Cambridge Electrophoresis Ltd. (UK) …………… 9 Cell Therapeutics (UK) Ltd. …………………… 25 Celtic Therapeutics (USA) ……………………… 50 Cerebrus Ltd. (UK)……………………………… 28 Chiesi Farmaceutici S.p.A. (I) ………………… 14 Ciba-Geigy (CH) ……………………………… 28 Cobra Biologics (UK) ……………………………… 9 Cytos AG (CH) ………………………………… 16

Eli Lilly (USA) ………………………………… 11, 28 Elvido Medical Technology srl (I) ………………… 9 Emcools AG (A) …………………………………… 9 Enterome (F) …………………………………… 23 Eppendorf AG (GER) …………………………… 34 Era7Bioinformatics (E) ………………………… 25 European Biotechnology Network (B)………… 41

F Flowlabs Projectos de innovacion SL (E) ……… 9 Fornix Bioscience (NL) ………………………… 16 Forest Laboratories Inc. (USA) ………………… 27

G Galapagos NV (B) ……………………………… 18 Gedeon Richter (HUN) ………………………… 27 Genmab A/S (DK) ……………………………… 19 GlaxoSmithKline (UK) ……………………… 17, 22 Greiner Bio-one GmbH (GER) ………………… 34 Gri-Cel S.A. (E) ………………………………… 24 Grifols SA (E) …………………………………… 24 Grünecker Patent- und Rechtsanwälte (GER) … 10

H Halozyme Therapeutics Inc. (USA) …………… 20 High-Tech Gründerfonds GmbH (GER) ……… 11 Hospira One 2 One (F) ………………………… CP2 Hovione FarmaCiencia SA (PT) ……………… 28

i IDVet (F) ……………………………………… 33, 36 Illumina Inc. (USA) ……………………………… 20 Imperial Consultants (UK) …………………… 11 Index Ventures (CH) …………………………… 22 Intercell AG (A) ………………………………… 12 Ipsen (F) ………………………………………… 19

J Janssen Pharmaceutica N.V. (B) …………… 12, 19 Janus Development S.L. (E) …………………… 25 Johnson & Johnson (USA) …………… 17, 19, 22

L

16 22 12 24 22

e E. R. Squibb (USA) ……………………………… 28 ecoplus GmbH (A) …………………………… 35

Nicox S.A. (F) …………………………………… 12 Novartis AG (CH) …………………………… 10, 20 Novartis Vaccines and Diagnostics S.r.l. (I) …… 14 Novo Nordisk A/S (DK) ………………………… 14 Novuspharma (I) ……………………………… 25

o On-Q-ity (USA) …………………………………

Oncogene Science (USA) ………………………

Orexo AB (S) ……………………………………

OSI Pharmaceuticals (UK) Ltd. …………………

Oxford Gene Technology (UK) …………………

Oxford Instruments (UK) ………………………

Pfizer Inc. (USA) ………………………………… 12 PharmaMar (Grupo Zeltia) (E) …………………

Photocure ASA (N) ……………………………

Polymun Scientific (A) …………………………

Porvair (UK) ……………………………………

Q QuickCool AB (S) ………………………………… 9

r Radleys (UK) …………………………………… 43 Randox Ltd. (USA) ………………………………… 9 Roche AG (CH) ………………………………… 20 Roche Diagnostics GmbH (GER) ……………… CP4 Roche Spain (E) ………………………………… 25 Rowiak GmbH (GER)…………………………… 34

s SANOFI - Aventis (F) ………………………… 14, 24 Schering-Plough Ltd. (UK) …………………… 28 Seventure Partners (F) ………………………… 23 Shimadzu Deutschland GmbH (GER) ………… 34 Siemens Healthcare Diagnostics (GER) ……… 28 Stratec Biomedical Systems AG (GER) ……… 34 Suppremol GmbH (GER) ……………………… 20 Syngenta (CH) ………………………………… 20

t Telormedix SA (CH) ……………………………

Tengion Inc. (USA)………………………………

Teva Pharmaceutical Industries Ltd. (IL) ………

Thermo Fisher Scientific (USA) ………………

TTP Lab Tech Limited (UK) ……………………

m Mabion S.A. (PL) ……………………………… 27 Medivir AB (SE) ………………………………… 19 Merck & Co. (USA) ……………………………… 28 Messe München GmbH (GER) ……………… 33 Midronic (CH) ………………………………… 42 Möller Medical GmbH (GER) ………………… 34 MVM Life Science Partners LLP (UK) ………… 22 Myriad Genetics (USA) ……………………… 33, 38

13 19 12 43

PromoCell GmbH (GER) ……………………… 43 Proteome Sciences plc (UK) …………………… 9

Miniaturkomponenten (GER) ……………… 15, 27 LGC Genomics (GER) ………………………… 34 LifeSequencing S.L. (E) ………………………… 25 LISA Vienna Region, Clusterman. (A) …… CP3, 39 Lundbeckfond Ventures (DK) ………………… 23

28 28 17 28 11 22

p

LEE Hydraulische

d DBV Technologies (F) …………………………

Deltex Medical Group plc (UK) ………………

Dendreon Corporation (USA) …………………

Dompé Farmaceutici S.p.A. (I) …………………

DSM (NL) ………………………………………

FREE EXCERPT

20 28 18 44 44

U UCB S.A. (B) ………………………………… 23, 28

W Xvivo Perfusion AB (S) ………………………… 18

Z ZFUW – Universität Kaiserslautern (GER) …… 45 Zinsser Analytic GmbH (GER) ………………… 44

Size: Reduced. Fun: Amplified.

Get to know a completely new type of real-time PCR instrument at: www.lightcycler-nano.com

For life science research only.

Not for use in diagnostic procedures.

LIGHTCYCLER is a trademark of Roche.

Roche Diagnostics GmbH Sandhofer StraĂ&#x;e 116 68305 Mannheim, Germany Š 2012 Roche Diagnostics.

All rights reserved.