BASF Plant Science quits

Europe for the US

CENTRAL EUROPE

Roche makes hostile bid for US sequencing specialist Illumina

NORTHERN EUROPE

BioInvent International teams up with Servier in oncology

WESTERN EUROPE

French government boosts seed funding for biotech firms

SPECiAL

Euro BioFairs Compass 1/12:Guide to life sciences events

SOUTHERN EUROPE

Spanish Okairos delivers novel vaccine platform technology

EASTERN EUROPE

BIA Separations to cooperate with Japanese industrial giant

SCiENCE & TECHNOLOgy

Researchers model human body to predict drug response

EuropeanBiotechnology

Science & Industry News

Nº 1-2 | Volume 11 | 2012 | 10.00 € | ISSN 1618-8276 | A 60711 |

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Euro|Biotech|NewsNº 1-2 | Volume 11 | 2012 3

INtro

T he extensive coverage of the world wide financial crises has masked a looming crisis in healthcare. In addition to the

financial constraints affecting every part of society, healthcare also faces an innovation crisis. Innovation in the field is clearly ad­vancing faster than the ability of the system to adapt to the new innovations. Most experts acknowledge that the future of healthcare will involve sophisticated diagnostic and evalua­tive processes to dictate precise approaches for the treatment of disease or the maintenance of individual health. The evidence in favour of personalized healthcare is accumulating rapidly in some areas – for example, the molecular diag­nosis of cancer – but numerous barriers to rapid implementation remain. Because many of these new processes could save lives, we need to ask why rapidly expanding these new innovations to all patients is proving so difficult.

A recent meeting in Luxembourg entitled “Personalized Medicine in Europe: What will it take to succeed?” brought together leaders from healthcare, business and academia to dis­cuss the various aspects of implementation of personalized care. Unique and major challeng­es face each sector of the system. Patients are faced with a bewildering spectrum of options; device and pharmaceutical manufacturers are faced with shrinking markets for each inter­vention, making it difficult to create a profita­ble model. Physicians and health professionals face a big challenge in filtering patient data to find the best, individualized intervention. Final­ly, health policy experts are expressing concern about the cost of personalized medicine and the feasibility of introducing the new innovations without bankrupting the health system.

Most developed countries now spend from 8–12% of GDP on healthcare, and feel that if this increases substantially, it will seriously

affect other essential services and compromise overall quality of life. Thus, the radical changes required in healthcare systems to accommodate innovation must occur primarily by replacing old processes with new. This approach has failed in the past, as healthcare professionals are of­ten reluctant to give up traditional approaches for new ones without overwhelming evidence of improved outcome and efficiency.

Health policy experts know that introducing new processes from carefully controlled clinical trials into wide­spread clinical use almost nev­er achieves the same efficacy as that obtained in the clinical study. Many factors account for this discrepancy, and these factors lead to a reluc­tance to introduce expensive new processes that may not produce the expected benefits.

A lot of healthcare researchers now recognize that we need to create a new process for introduc­ing innovation into a healthcare system. Follow­ing confirmation in a clinical study, many new interventions should next be tested in an actual healthcare environment to determine whe ther or not the benefits of the new process can be easily achieved in a realistic healthcare setting. Such experiments in ‘real’ healthcare systems are dif­ficult to organize and manage, but several coun­tries are leading the way in testing innovations in a real­world setting before attempting to in­troduce the innovation in the entire system (the Maimonides Project). Such experiments in com­munity settings – involving only a few thousand people – can provide essential information on the feasibility of implementing the innovation in the entire system. The Maimonides group of countries has already achieved some document­ed successes in implementing cost­effective in­novations that improve health and well­being. Hopefully, more countries will adopt this inter­mediate method of testing innovation, and will share their experiences with others. B

Editorial

The Bumpy Road to Personalized Healthcare

robert A. Phillips, CEo of IBBL & rudi Balling, Director of LCSB, Luxembourg

robert A. Phillips, 1967–2010, professor, University of toronto: 1996–2010 Leadership positions: National Cancer Institute of Can-ada, ontario Cancer research Network, ontario Institute for Cancer research; 2010 CEo, In-tegrated Biobank of Luxembourg

rudi Balling, 1993-2001 Director, Institute of Mammalian Genetics, Helmholtz Centre Munich; 2001– 2009 Director, Helmholtz Centre for Infection research, Braun-schweig; 2009, Visiting Professor, Broad Institute, Boston; since 2010 Founding Director Luxem-bourg Centre for Systems Bio-medicine, University of Luxem-bourg

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coNteNts

Cover Story

A lack of acceptance for GM crops finally drives Europe’s biggest developer to relocate to the US 6

INsIght europe

Editorial Bob Phillips, CEO of IBB Luxembourg Rudi Balling, Director of LCSB 3

Heard in Brussels: A couple of outraged philosophical questions 8

The cost of GMO coexistence; EC to change food enzymes regulation 10

IP flash; EU animal test ban watered down 12

Interview: Hans Westerhoff Modelling virtual patients 29

regulatory affaIrs

Clinical trials 13

EMA news 14

ecoNomIc

Focus on newsflow and dividends 15

Stock markets 16

regIoNal News

Northern Europe Iceland, Denmark, Norway, Sweden 18

Central Europe Germany, Austria, Switzerland 20

Western Europe UK, France, Belgium, Netherlands 22

Southern Europe Italy, Spain, Portugal 24

Eastern Europe Latvia, Lithuania, Poland, Slovenia 26

SpeCial

Euro BioFairs CompassIntro 33

EuroPlx 34

BioEurope Spring, Amsterdam 36

Analytica 38

Biotech 2012 40

European Lab Automation 42

Achema 44

MedTechPharma 46

“BASF announced today that it is concentrating its plant biotechnology activities on the main markets in North and South America …” The press release began in-nocuously, and even sounded slightly upbeat, but biotech proponents are viewing the firm’s decision as a death knell for agribiotech development in Europe. After more than a decade of fighting stubborn politicians and a recalcitrant European public, the German chemical giant has thrown in the towel.

serVIces

Partners & Associations 4

Imprint 5

Biopeople News from Roche, Sobi, Algeta, Horizon Discovery, and the EMA 28

Company index 48

Events from February-March 2012 49

Encore 50

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, Christoph Mayerl, Dr. Philipp Graf, 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: D 100.00, Students D 50.00 (subject to proof of enrollment). 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: BASF; Supplements: Concept Heidelberg; DECHEMA. ® BIOCOM is a registered trademark of BIOCOM AG, Berlin, Germany.

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INSIGHT EUROPE

AGribiotech

A new low point for bioscience in the EU After years of strife, recriminations and boycotts surrounding the potential dangers and promise of GM crops, it should have come as no surprise. Even so, the BASF Plant Sci-ence announcement in mid-January that the company was moving its headquarters from Germany to the US dealt a possibly mortal blow to the future of innovative agri biotech in Europe. A week later, Monsanto announced that due to a lack of acceptance, it will not sell its genetically modified MON810 maize in France either in 2012 or in the near future – although the country's highest court overturned a three-year national ban on the plant last November. It appears that after more than a decade of refighting the same battles, the biggest participants in crop science in Europe are bowing to the inevitable and tak-ing European expertise in this future technology to greener pastures.

The world's largest chemical company BASF said that its subsidiary will retain just 11 staff positions – primarily regula­tory – at its the current headquarters site in Limburgerhof (Germany). 157 employ­ees currently work there in the area of bio­tech R&D. The company is also planning to close sites in Gatersleben (Germany) and Svalöv (Sweden). After a reshuffle involv­

ing BASF locations that are being retained in Berlin and Ghent (Belgium), the compa­ny says a total of around 140 positions will have been lost in Europe. BASF says it will try to offer the affected employees other positions within the BASF Group.

“We are convinced that plant biotech­nology is a key technology for the 21st cen­tury,” said Dr. Stefan Marcinowski, a mem­

ber of BASF's Board of Executive Directors . But the “lack of acceptance for this tech­nology in many parts of Europe (means) it doesn't make business sense to continue investing in products exclusively for culti­vation in this market.”

BASF’s research in Europe until now has focussed primarily on GM strains of pota­toes. The varieties Amadea, Modena and Amflora were engineered to provide large amounts of amylopectin starch for indus­trial applications, while the Fortuna varie­ty was tweaked to be resistant to the devas­tating potato blight caused by Phytophthora infestans. The company has also been devel­oping a GM strain of wheat that is resistant to fungus. The Amflora potato was finally granted approval for use in industrial ap­plications in 2010 – more than 13 years after the application was first submitted. How­ever, at least in part due to protests, BASF decided to plant just two hectares of the GM crop in Germany in 2011.

Public response in Germany, where the facility is closing, has been mixed. In an ar­ticle in the daily Frankfurter Allgemeine Zeitung one day after the BASF announce­ment, the Environment Minister in the Ger­man state of Rheinland­Pfalz – where Lim­burgerhof is located – cheered the decision, saying that “Genetic engineering in agricul­ture is not a future technology that is worth investing in.” Those sentiments were ech­oed by Greenpeace EU agriculture policy director Marco Contiero: “BASF admits that Europeans don’t want GM crops…(they) go hand in glove with factory farming, pesti­cide use, pest resistance and disappointing long­term yields.” Marcinowski's estimate of the current situation in Europe encapsu­lates the often vitriolic debate surrounding the topic in five succinct words: “It's schizo­phrenic, but it's reality.”

The domino effect

Faced with threats by the French govern­ment to renew a ban on MON810 in spite of a European Court of Justice (EJC) ruling in its favour late last fall, Monsanto has now pre­empted further confrontations by say­ing it will not attempt to sell the approved GM seeds in France in the near future (see p. 23). In an official statement, it added that

BASF's agriculture centre at Limburgerhof will be shutting down biotech R&D, but not plant protection activities.

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8 Euro|Biotech|News Nº 1-2 | Volume 11 | 2012

INSIGHT EUROPE

Claire Skentelbery, Secretary General of the European Biotechnology Network

Brussels – Europe likes to make life hard, creating situations where an idea must struggle mightily before it can achieve success, even when there is a more straightforward route (just look at the euro). Of course, in the world of bio­technology, this maxim can be applied pretty much everywhere (as we are mas­ochists in this trade), but the focus of my musings today are the topics of GMOs and embryonic stem cells. Both have re­ceived hundreds of millions of euros from the public purse, yet continue to de­liver a big fat zero to the European econ­omy due to sloth and indecision on the part of those that control their fates.

Throwing good money after bad

In the case of GMOs, it has long been ob­vious that Europe was never going to be an economic generator for its research. The question for Europe is – why did we continue to invest public money in GMO technologies targeted at the field if we were never going to get it back? Europe is now so far behind the rest of the world in food­crop GM technology that a euro spent is a euro wasted. We should have had the strength to either counteract anti­GMO claims immediately (too late now) or call the political bluff and say “stop the research funding for field­based GMOs.” But instead, Europe did what Europe always does, creeping down the mid­dle path, trying to offend nobody while building a sub­optimal R&D base with no exploitation. You might be asking yourself what has triggered this contemplation from some­body who usually supports biotech in all it's many forms. It was the closure of BASF Plant Science, at a German research base that has been open since 1914. This was no closure on an epic scale, just 140 jobs, but it tells you that the life has bled slow­ly from commercial research in Europe

until the company finally just called it a day and went off to live in America. So Europe – spend your money on building a biotech sector that delivers a benefit you can measure, don’t wait for it to die quietly while you fanny about appeasing politi­cians who are chasing re­election.

That brings me to the 2011 embryonic stem cell ruling – you must have heard me rolling my eyes from the other side of Brussels when that was announced. Well done Europe! Once again we have taken a technology where the EU had a leg up and killed its commercial potential. This time it wasn't even due to a public outcry. European citizens generally like the idea of stem cells – they can see the possible bene fits and understand in general what they do. But if the ruling isn’t overturned, you might as well cancel the funding. If Europe cannot benefit economically, then there is no point in funding the science. There isn't enough money to fund bio­tech where the door is closed to a return. The sector has spent decades persuading people to part with large sums of cash for high­risk technology, and it cannot justify its existence if the gate to clinic and mar­ket has been shut. B

Heard in BrusselsM A couple of outraged philosophical questions

“Monsanto considers that favourable condi­tions for the sale of the MON810 in France in 2012 and beyond are not in place”.

And it doesn’t look as though they will be any time soon. Two actions organised by GMO opponents were aimed at the compa­ny in France in January. Early in the month, dozens of beekeepers invaded a Monsan­to office with the aim of hindering sowing of MON810 this spring. Under yet another disputed ECJ ruling from last September (see EuroBiotechNews 9­10/2011), their honey could be taken from shelves if it is found to contain pollen from the transgenic maize. A second protest took place outside a Monsanto plant in southwestern France on 24 January, with activists claiming the company was planning to sell GMO seeds ahead of springtime sowing.

And the future of MON810 doesn't appear much brighter in the rest of Europe. Other nations in the EU – among them Germany, Greece, Austria, Luxembourg and Hunga­ry – continue to ban its cultivation, even though the GM maize has been approved as a safe agricultural product since 1998.

The wider picture

Monsanto’s cave­in and BASF's flight across the Atlantic are not equivalent indicators in predicting the long­term health of agri­biotech in Europe. Although Monsanto is invested heavily in Europe, it is fundamen­tally a North American company seeking to sell a product developed there on European markets. The US­based firm is also now pay­ing a price for failing dismally to convince Europeans of the future importance of GM crops back in the 1990s. BASF Plant Science, on the other hand, is a home­grown Europe­an firm that has invested well over a1bn in the groundbreaking science essential to con­verting to the much­desired ’bio­economy’. But both announcements reflect the relation­ship Europeans currently have with GMOs. It has now entered a critical phase – one that many experts in the sector feel is terminal. For reasons ranging from energy supply to reducing pollution, Europe has dedicated itself to building a greener future. Without the know­how of companies like BASF Plant Science, that will be impossible. It's schizo­phrenic, but it’s a reality. B

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CompaNy aNd adVertiser iNdex

aAbingworth LLP (GB) ………………………… 22

AB Science (F) ………………………………… 16

Actelion AG (CH) ……………………………… 15

Adocia S.A.S. (F) ……………………………… 23

Algeta ASA (N) ……………………………… 15, 28

Allos Therapeutics Inc. (USA) ………………… 14

Almirall-Prodesfarma, S.A. (E) ………………… 25

Amgen Inc. (USA) …………………………… 16, 19

Amsterdam Molecular Therapeutics (NL) …… 14

Antisense Pharma GmbH (GER) ……………… 13

Applied Biosystems Inc. (USA) ………………… 20

AstraZeneca (GB) ……………………………… 30

Athena Drug Delivery Solutions Pvt. Ltd. (IND) 18

austria wirtschaftsservice | erp-fonds (A) …… CP2

BBaltCap (LIT) …………………………………… 26

BASF AG (GER) …………………………………… 5

Basilea Pharmaceutica (CH) …………………… 21

Baxter Innovations GmbH (A) ………………… 14

Baxter Oncology GmbH (B) …………………… 18

Bayer Healthcare AG (GER) …………………… 28

Bayern Innovativ GmbH (GER) ……………… 46

Ben Venue Laboratories (USA) ……………… 18

BerGenBio AS (N) ……………………………… 19

BerlinPartner (GER) …………………………… CP3

Best of Biotech - BOB (A) ……………………… 39

BIA Separations d.o.o. (SI) …………………… 26

BIO.NRW (GER) ………………………………… 7

BIOCOM AG (GER) …………………………20, 47

BioFocus (GB) ………………………………… 25

Biogen Idec (USA) ……………………………… 23

BioInvent International AB (S) ………………… 18

BioPhausia AB (S) ……………………………… 15

Biotie Therapies Corp. (FI) …………………… 25

BioWin - The Health Cluster of Wallonia (B) … 11

Birk Venture (N) ………………………………… 19

Bloomberg New Energy Finance (USA) ……… 19

Braganza AS (N) ……………………………… 18

Bristol Laboratories Ltd. (GB) ………………… 25

CCellerix, S.A. (ES) ……………………………… 17

CEREP (F) ……………………………………… 15

Clavis Pharma (N) ……………………………… 18

Concept Heidelberg (GER) ……… 21, Supplement

dDako Denmark A/S (DK) ……………………… 19

DASGIP AG (GER) …………………………… 15, 21

Dechema e. V. (GER) ……………44, Supplement

deCode genetics (IS) ………………………… 19

eEBD-Group BEUS Amsterdam (USA) ………36, 37

Elan Corp. (IRL) ………………………………… 23

Envestia Ltd. (GB) ……………………………… 14

NNew Brunswick Scientific (F) ………………… 21New Enterprise Associates (USA) …………… 22Newron Pharmaceuticals S.p.A. (IT) ………… 25Norsk Innovasjonskapital (N) ………………… 19Novartis Europharm Ltd. (GB) ………………… 14Novozymes A/S (DK) ………………………… 19

oOctoplus (NL) ………………………………… 17Okairos Srl. (IT) ………………………………… 24Orexo (S) ……………………………………… 17Oxford Biomedica (GB) ……………………… 17

pPaion (GER) …………………………………… 17

Pharma Omnium SAS (F) ……………………… 22

Pharmatest Services Oy (FI) …………………… 18

Pharming Group N.V. (NL) …………………… 15

Plasmia Biotech S.L. (E) ……………………… 25

Poet LLC (USA) ………………………………… 23

Pronota N.V. (B) ………………………………… 23

Prosensa BV (NL) ……………………………… 22

ProStrakan (GB) ………………………………… 15

Q/rQiagen NV (GER) ……………………………… 15RauCon Business Development EuroPLX (GER) 34, 35RecipharmCobra (GB) ………………………… 25Reed Exhibitions (USA) ………………………… 40Roche Diagnostics GmbH (GER) ……………… CP4Roche Registration Ltd. (GB) ………………… 14Royal DSM (NL) ………………………………… 23

sSangamo Biosciences Inc. (USA) ……………… 28SAP AG (GER) ………………………………… 16Sarsia Development (N) ……………………… 19SEKAB E-Technology AB (S) …………………… 19Select Biosciences (GB) ……………………42, 43Sigma-Aldrich (USA) …………………………… 28Swedish Orphan Biovitrum (S)………………… 28Sygnis Pharma (GER) ………………………… 13Syntex Pharm AG (GER) ……………………… 28

tTigenix N.V. (B) ………………………………… 17

VValiRX plc (GB) ………………………………… 18Veloxis Pharmaceuticals A/S (S) ……………… 18

WWestLB AG (GER) ……………………………… 15Wilex AG (GER) ……………………………… 15, 16

ZZealand Pharmaceuticals A/S (DK) …………… 19Zeltia-Group (E) …………………………………… 9

Eppendorf AG (GER) …………………………… 21

EuroBioJobs.org (CH) ………………………… 29

European Biotechnology Network (B) ………… 32

FF. Hoffmann - La Roche AG (CH) ……… 13, 20, 28

Fresenius Medical Care (GER) ………………… 14

GGalapagos NV (B) ……………………………18, 25

Genentech Inc. (USA) ………………………… 20

Genzyme (USA) ………………………………… 28

GIMV (B) ………………………………………… 22

GlaxoSmithKline (GB) ………………………… 22

Gregory Fryer Associates Ltd. (GB) …………… 14

Grünecker Patent- und Rechtsanwälte (GER) … 12

HHellsinn Healthcare S.A. (CH) ……………… 13, 19

Horizon Discovery Ltd. (GB) …………………… 28

Hybrigenics S.A. (F) …………………………… 18

iIDInvest Partners (F) …………………………… 22

Illumina Inc. (USA) ……………………………… 20

ImmuPharma France SA ……………………… 22

Innate Pharma SAS (F) ………………………… 22

Intercell AG (A) ………………………………… 21

Invest in DK (DK) ……………………………… 27

Ipsogen SA (F) ………………………………… 15

JJanssen Biologics B.V. (NL) …………………… 14

Johnson & Johnson (USA) …………………… 21

JSR Corp. (JP) …………………………………… 26

KKölnmesse GmbH PerMediCon (GER) ……… 41

LLabochema Group (LIT) ……………………… 26

Les Laboratoires Servier S.A. (F) ……………… 18

Life Sciences Partners (NL) …………………… 22

Life Technologies Corp. (USA) ………………… 20

mM+W Process Industries (GER) ……………… 45

Magforce (GER) ………………………………… 17

MediGene AG (GER) …………………………… 15

Medivir (GB) Ltd. ……………………………… 15

MedSciences Capital BV (NL) ………………… 22

Meiji Seika Pharma (JP) ……………………… 25

Merck Serono (CH) …………………………… 25

Messe München GmbH, Analytica (GER) … 13, 38

Meteva GmbH (GER) ………………………… 19

Micromet AG (GER/USA) ……………………… 16

Monsanto (USA) ……………………………… 23

MorphoSys AG (GER) ………………………… 15

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