Can bioeconomy save the planet?

CENTRAL EUROPE

Swiss Biotech Report reveals more investment in sector

NORTHERN EUROPE

Danes kick-off psychiatric genomics research hub

WESTERN EUROPE

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

SPECiAL

Analytica 2012 in MunichUpdate on bioanalytics

SOUTHERN EUROPE

Janus to commercialise inclusion body drug delivery system

EASTERN EUROPE

Mabion announces IPO on Warsaw Stock Exchange

SCiENCE & TECHNOLOgy

Intratumour heterogeneity challenges biomarker approach

EuropeanBiotechnology

Science & Industry News

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

FREE EXCERPT

Start early to establish your custom comfort zone.

Site Selection

RegistrationBatch

Production

Scale-up/Validation

CMCPreparation

Pre-ApprovalInspection

Productto Market

ProductionEfficiency

Studies

Cold-chainManagement

Supply/Distribution

Drug DeliveryExpansion

Final PackageDevelopment

Technical Transfer

ProcessDevelopment

ClinicalManufacturing

One 2 One™ continually partners to guide your product from clinical trial materials to commercial product supply and distribution.

One 2 One Journal Ad - 8.25x10.875 (L. Science Leader)

Our comfort zone iscustom development and

commercialization services

Parenteral Contract Manufacturing Service of Hospira P11-3520A-Jan., 12

Parenteral Contract Manufacturing Service of Hospira

Your Parenteral Comfort Zone

Discover your comfort zone at one2onecmo.comGet 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

T he increase in lifestyle and ageing-associated 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 innova-tions 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 bio-logical samples linked with detailed information on diseases and lifestyle. These resources are essential for a more mechanism-based under-standing 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 devel-opment of molecular diagnostics, particularly companion diagnostics. Furthermore, to aid in better understanding gene-lifestyle interac-tions, 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 Eu-ropean 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 ac-tion coordinated at the global scale is therefore obvious for many reasons. First, addressing the same problem in multiple non-coordinated ap-proaches is neither efficient nor financially jus-tified. Second, non-coordinated actions result in unnecessary duplication and – even worse – in non-compatible solutions that would un-dermine competitiveness in global biotech and the pharmaceutical industry.

The planning team of the European research infrastructure for biobanking and biomolecu-lar resources (BBMRI) has developed the con-cept of a global network of expert centres to achieve global harmonisation in biobanking and bio sample analysis. One rationale for the ex-pert 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 public- private-partnerships that perform the analysis of biological samples using the latest technolo-gies, and according to internationally harmo-nised procedures. Pre-competitive data gener-ated in expert centres can be used by indus-try for product development, and will be made available to the public following procedures developed for the Innovative Medicines Initi-ative. 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 interna-tional research collaboration, thereby provid-ing 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-analyt-ical and analytical procedures are thoroughly standardised, and if expert centres share com-mon reference material and regularly partici-pate in proficiency testing. The first voluntary activities for testing the feasibility of the con-cept, with a focus on genomics, metabolomics and molecular pathology technologies, are cur-rently in development. B

Euro|Biotech|NewsN º– 4 | Volume 11 | 2012 3

INtro

Editorial

New framework for global research collaboration

Prof. Dr. Kurt Zatloukal, Medical University of Graz, Austria

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.

FREE EXCERPT

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

CIRCULATION

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

Europe: european-biotechnology.net Switzerland: swissbiotech.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

www.eurobiotechnews.eu

Europe: ebe-biopharma.org

The Netherlands: niaba.nl

Denmark: danskbiotek.dk

Spain: asebio.com France: france-biotech.org Italy: assobiotec.it

Portugal: www.apbio.pt

Europe: cebr.net

Hungary: hungarianbiotech.org

Belgium: bio.be

Germany: biodeutschland.org

Council of European BioRegions

Europe: europabio.org

FREE EXCERPT

CMYK

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

Sweden: swedenbio.com

EuropeanBiotechnology

Net work

Ireland: ibec.ie/ibia

Norway: biotekforum.no

Finland: finbio.net

Euro|Biotech|NewsN º– 4 | Volume 11 | 2012 5

coNteNts

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.

The consequences of (in)action 6

INsIght

OECD highlights need for bioeconomy 6

Heard in Brussels 8

IP Flash; Pharmaceuticals in our water 10

EUCLIDS project kicks off; IMI set to create EU drug-screening hub 11

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

RegIoNal News

Northern Europe Denmark, Norway, Sweden, Iceland 18

Central Europe Germany, Austria, Switzerland 20

Western Europe UK, France, Netherlands, Belgium, Luxembourg 22

Southern Europe Italy, Spain, Portugal 24

Eastern Europe Poland, Hungary, Estonia, Slovenia, Czech Republic 26

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 Mem-ber States are also pursuing national agendas. In just a few years, sustainability pro-grammes have gone from being prestige projects to vital investments in the future.

seRVIces

Partners & Associations 4

Imprint 5

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

Events What’s on in April-May 2012 48

Company index 49

Encore 50

© f

oto

lia.d

e/se

rgej

Kha

ckim

ulli

n

Cover Story

SpeCial

Analytica 2012Analytica 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 40

Latest products 42

FREE EXCERPT

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

INsIght EuropE

Bio-Economy

The consequences of (in)actionthe 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, how-ever, 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 bio-economy 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?

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 in-creases, it will have a dramatic knock-on ef-fect on the 40% of the global population liv-ing 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 serv-ices, removing subsidies for fossil fuels and irrigation schemes that are wasteful, and en-couraging green innovation by providing public support for basic R&D in sustaina-bility-oriented technologies.

Europe trying to stave off disaster

Europe has already taken action. In Febru-ary, the European Commission announced it would invest a4.7bn from 2014-2020 “for developing the bio economy in Europe.” The strategy for green growth, which is aimed at establishing a sustainable “post-petroleum” industry production based on renewable re-sources, is based on three pillars: increasing R&D investment, boosting biomass produc-tion and its (biotechnological) conversion into value-added products, and commu-nication of the benefits to consumers. Ac-cording 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 alter-native energy and carbon sources.... (and it will help) pave the way to a more innova-tive and low-carbon society that reconciles food security with the sustainable use of re-newable biological resources for industrial purposes, while simultaneously creating new job opportunities.” (see EuroBiotech-News 3/2012). In early March, the European Commission took the next step. It present-ed 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 sup-ply for industrial biotech applications. With-View into the heart of a biomass fermenter for the production of cellulosic bioethanol

The OECD report predicts that world ener-gy 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 sourc-es. If that goes unchanged, it will cause an increase in global greenhouse gas emis-sions of about 50% over those of today. As a result, it says, pollution in urban centres

in forty years could replace a lack of sanita-tion and clean water as the leading cause of mortality worldwide, with deaths caused by respiratory conditions doubling from “cur-rent levels to 3.6 million every year global-ly, with most occurring in China and India.” And OECD countries won’t be spared. Age-ing urban populations could “have one of the highest rates of premature death from

FREE EXCERPT

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

INsIght EuropE

Claire skentelbery, secretary general of the European Biotechnology Network

in the EIPs, which are constructed as pub-lic-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 mem-ber states: Germany, Denmark, the Neth-erlands, Finland and Ireland. In November 2010, Germany’s government announced it would become the first country in the world to begin implementing a national bio-economy strategy. Within the “National Re-search Strategy BioEconomy 2030” a2.4bn will be invested over six years: a1.1bn in the area of health-enhancing food, a511m in bio mass 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 previ-ous initiatives. It’s aimed at securing envi-ronmental improvements through the large-scale 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 or-ganic 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 “Glo-bal Green Growth Forum”, presented six resource efficiency opportunities with a potential US$830bn in resource savings annually, along with the public -private av-enues to seize them. Approaches like that will help define the next steps in a plan to prove the OECD forecasts wrong. B

Heard in BrusselsM 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 nov-els with: “It is a truth universally ac-knowledged, that a country in posses-sion 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. En-tire 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 coun-tries such as Sweden, which prides it-self on a national environment of scien-tific innovation and big business. Site closures have been regularly making headlines across Europe, and every time they raise questions about the suitabil-ity 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 clus-ter as a whole was that scientists and managers turned to their own busi-ness 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 be-fore the finances really got chilly and start-ups got harder.

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 lor-ry drivers or move to a commune in Peru. This time around, the big differ-ence 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 state-ments about creating a leading scien-tific environment, and put your mon-ey 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 de-velopment. 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

FREE EXCERPT

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

CompaNy aNd adVertiser iNdex

454 Life Sciences (USA) ……………………… 25

aAbingworth LLP (UK) ………………………… 16Ablynx NV (B) ………………………………… 23Active Biotech (S) ……………………………… 18ADC Therapeutics Sarl (CH) …………………… 50Agennix AG (GER/USA) ……………………… 23AiCuris GmbH & Co KG (GER) ………………… 12Aisling Capital (USA) …………………………… 16Alan Boyd Consultants Ltd. (UK) ……………… 14Alcon Inc. (CH) ………………………………… 20Alkermes plc (IRL) ……………………………… 28Amgen Inc. (USA) ……………………………… 16AMS Biotechnology (Europe) Ltd ……………… 42Analytik Jena (GER) …………………………… 34Apeiron Biologics (A) …………………………… 12Araclon Biotech (E) …………………………… 24Argenta Discovery Ltd (UK) …………………… 18Astellas Pharma Europe B.V. (NL) …………… 14Astra Zeneca (GB/S) …………………………… 18Axel Semrau GmbH (GER) …………………… 34

BBasilea Pharmaceutica (CH) …………………… 12Bausch & Lomb (USA) ………………………… 12Bavarian Nordic A/S (DK) ……………………… 19Bayer AG (GER) ………………………… 10, 12, 28

Berlin Partner GmbH (GER) …………………… 29

BIO.NRW (GER) ………………………………… 37

BIOCOM AG (GER) …………………………… 32BioFocus (UK) ………………………………… 18

Biogenes GmbH (GER) ………………………… 47Bioline Ltd. (UK) ……………………………… 34Biometra GmbH (GER) ………………………… 42

BioWin – The Health Cluster of Wallonia (B) …… 7Boehringer Ingelheim GmbH (GER) ………… 23Bristol-Myers Squibb (USA) …………………… 27BTG plc (UK) …………………………………… 12

CCambridge Electrophoresis Ltd. (UK) …………… 9Cell Therapeutics (UK) Ltd. …………………… 25Celtic Therapeutics (USA) ……………………… 50Cerebrus Ltd. (UK)……………………………… 28Chiesi Farmaceutici S.p.A. (I) ………………… 14Ciba-Geigy (CH) ……………………………… 28

Cobra Biologics (UK) ……………………………… 9Cytos AG (CH) ………………………………… 16

dDBV Technologies (F) ………………………… 16Deltex Medical Group plc (UK) ……………… 22Dendreon Corporation (USA) ………………… 12Dompé Farmaceutici S.p.A. (I) ………………… 24DSM (NL) ……………………………………… 22

eE. R. Squibb (USA) ……………………………… 28

ecoplus GmbH (A) …………………………… 35

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

oOn-Q-ity (USA) ………………………………… 28Oncogene Science (USA) ……………………… 28Orexo AB (S) …………………………………… 17OSI Pharmaceuticals (UK) Ltd. ………………… 28Oxford Gene Technology (UK) ………………… 11Oxford Instruments (UK) ……………………… 22

pPfizer Inc. (USA) ………………………………… 12

PharmaMar (Grupo Zeltia) (E) ………………… 13Photocure ASA (N) …………………………… 19Polymun Scientific (A) ………………………… 12Porvair (UK) …………………………………… 43

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

QQuickCool AB (S) ………………………………… 9

rRadleys (UK) …………………………………… 43Randox Ltd. (USA) ………………………………… 9Roche AG (CH) ………………………………… 20

Roche Diagnostics GmbH (GER) ……………… CP4Roche Spain (E) ………………………………… 25Rowiak GmbH (GER) …………………………… 34

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

tTelormedix SA (CH) …………………………… 20Tengion Inc. (USA) ……………………………… 28Teva Pharmaceutical Industries Ltd. (IL) ……… 18Thermo Fisher Scientific (USA) ……………… 44TTP Lab Tech Limited (UK) …………………… 44

UUCB S.A. (B) …………………………………23, 28

WXvivo Perfusion AB (S) ………………………… 18

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

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

European Biotechnology Network (B) ………… 41

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

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

HHalozyme Therapeutics Inc. (USA) …………… 20

High-Tech Gründerfonds GmbH (GER) ……… 11

Hospira One 2 One (F) ………………………… CP2Hovione FarmaCiencia SA (PT) ……………… 28

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

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

LLEE Hydraulische

Miniaturkomponenten (GER) ……………… 15, 27LGC Genomics (GER) ………………………… 34LifeSequencing S.L. (E) ………………………… 25

LISA Vienna Region, Clusterman. (A) …… CP3, 39Lundbeckfond Ventures (DK) ………………… 23

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

FREE EXCERPT

AWS-BOB_Anzeige_210x275_v1.indd 1 07.12.11 10:51

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

Size: Reduced. Fun: Amplified.

Roche Diagnostics GmbHSandhofer Straße 11668305 Mannheim, Germany

© 2012 Roche Diagnostics. All rights reserved.LIGHTCYCLER is a trademark of Roche.

For life science research only.Not for use in diagnostic procedures.

LC_Nano_Ad_Euro_Bio_Tech_210x275.indd 1 09.03.12 13:56