European Biotechnology News 6/2012 - Free Excerpt - Obama’s new biobased economy

Nº 6 | Volume 11 | 2012 | 10 € | ISSN 1618-8276 | A 60711 |

European Biotechnology News Science & Industry

CENTRAL EUROPE

GSK absorbs Cellzome; German biotech sector expanding NORTHERN EUROPE

Abbott buys kidney treatment from Action Pharma

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WESTERN EUROPE

DSM enters biomedicine with takeover of Kensey Nash SPECIAL

BiobasedWorld at Achema – The guide to the trade fair SOUTHERN EUROPE

Zeltia pockets Yondelis milestone from Johnson & Johnson

Obama’s new biobased economy

EASTERN EUROPE

Selvita stuffs its war-chest with shares, grants and awards SCIENCE & TECHNOLOGY

Pattern of DNA methylation determines genome stability

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N –º 6 | Volume 11 | 2012

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Editorial

Why Europe needs the Human Toxome Project François Busquet, Johns Hopkins University, Center for Alternatives to Animal testing, CAAt Europe Policy Coordinator, Brussels

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François Busquet studied Biotechnologies at the ENStBB in France. He graduated from the tU Dresden, completing his PhD at the MerckSerono group in Germany on the development of a new screening assay to detect proteratogenic compounds using zebrafish embryos. After his studies, he worked in ECVAM at the Joint research Centre (European Commission) in Italy on the coordination of the oECD validation study of the zebrafish embryo toxicity test.

Since 2012, Dr Busquet has been responsible for the CAAt-EU Policy Programme in Brussels.

hat is the Human Toxome Project?

It’s a wide-reaching programme aimed at helping us to reconsider how hazard/risk assessment has been performed over the last 50 years on marketed substances like chemicals, cosmetic products, pharmaceuticals, pesticides, biocides and feedstuffs.

It’s necessary because most of the scientific community now accepts that animal models for testing the safety of these products have more limitations than advantages. In basic terms, the loose genetic homology to humans is no match for modern cell-culture technology, which promises to be much more apt to correctly predict toxic effects in humans. These cell cultures can additionally be used in the high-throughput screening (HTS) necessary to test growing numbers of products. In the last 15 years, cell cultures have replaced acute/short-term in vivo tests. However, chronic/long-term tests are the real bottleneck for these models, which do not accurately represent the complexity of multiple mechanisms, and for which it is very difficult if not impossible to maintain integrity (e.g. for a month of exposure). More recently, new environmental and human health challenges have appeared along with the ubiquitous mix of chemicals in the environment, among them endocrine disruptors and nanoparticles, and no test can unequivocally determine the toxicity of – or absence of – these compounds.

In the US, the Toxic Substances Control Act Reauthorization – an equivalent of the REACH programme – might address more than 80,000 chemicals. In preparation, the ToxCast programme for predicting potential toxicity for pesticides or environmental pollutants has been started by the EPA based on HTS, and it has now been extended to nanomaterials, cosmetic ingredients and drugs that failed to make it to

market. How is the US dealing with these issues? 2007 was a cornerstone year for Tox-21c and the beginning of a paradigm shift in hazard/risk assessment. The NRC’s hallmark publication “Toxicity Testing in the 21st Century: A Vision and a Strategy” prompted a new, upbeat atmosphere. Its key proposal is to base regulatory toxicology on mechanisms and modes of action (preferably human-based models). The term “pathway of toxicity” (PoT) was coined to describe this concept. Then in 2010, the EPA assessed the safety of the chemical dispersants being used to treat the massive oil spill in the Gulf of Mexico by performing HTS. Analyses were concluded in about two weeks, instead of the six months it would have taken using traditional animal models.

Assuming that the mechanisms of toxicity are finite in number, the next step would be to map and annotate all of these PoT in humans to extrapolate the toxicological effects at the individual scale. To this end, it makes sense to create a public database of PoT – the Human Toxome. This could tackle animal welfare in laboratory experiments, speed up access to market for safer and better products and aid in the development of new analytical tools based on the knowledge gained. Pilot projects steered by CAAT and funded by the NIH and the FDA already exist. At the moment, they are focussed on endocrine disruptors and neurotoxicity pathways respectively. Discussions about a European branch have been initiated for the project, which is likely to be the size of the Human Genome Project – a task not for a single group, but for the international community.

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N –º 6 | Volume 11 | 2012

Euro|Biotech|News

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

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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

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coNteNts

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INsIght

Cover Story 8

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Heard in Brussels

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Euro|Biotech|News

European Commission to boost tech transfer in biotechnology; Study recommends eHealth boost; Loosening GMO thresholds in food imports 10 IP Flash; MEPs against IP on breeding 12 ecoNomIc Focus on newsflow and dividends

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Stock markets

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RegulatoRy affaIRs Breaking news from the EMA

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Update on clinical trials

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techNology Upstream and downstream processing in focus

Central Europe Germany, Austria, Switzerland

At the end of April, US President Barack Obama introduced a comprehensive new American bioeconomy strategy. The “National Bioeconomy Blueprint” is at least as ambitious as its European counterpart, with a focus on five strategic objectives and a flurry of new initiatives that are already up and running. Fearful of falling behind a potential juggernaut, the EU’s biotech experts are now clamouring for less talk and more action in implementing concrete bioeconomy measures in Europe.

seRVIces

SpeCial 36

ACHEMA 2012

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Chemistry, pharma and biotech go hand-in-hand

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BiobasedWorld at ACHEMA – future opportunities

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Western Europe UK, France, the Netherlands, Belgium

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Focal points: six routes that guide you through the ACHEMA s6

Southern Europe Italy, Spain

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Bioeconomy: where do we stand?

Eastern Europe Poland, Hungary, and the Czech Republic

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RegIoNal News Northern Europe Denmark, Sweden, Finland

The bioeconomy begins to go truly global

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Interview: Marcel Wubbolts, Chief Technology Officer, DSM NV s 14 44

Partners & Associations

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Imprint

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Biopeople News from Creabilis, EuropaBio, Nanobiotix, Antisense Pharma, Merck Millipore, and Population Genetics

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Company index

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Events What’s on in June-July 2012

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Encore

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INsIght EuropE Bioeconomy Blueprint

US hops on the bioeconomy train the White house has finally released its long-awaited “National Bioeconomy Blueprint”, a document that Barack obama’s administration is presenting as a water shed road-map for the country’s future. Like the Eu’s “Innovating for sustainable growth: a Bioeconomy for Europe“ strategy, the Blueprint is aimed at revolutionising how issues ranging from healthcare to energy supply to the environment are addressed. the report’s Executive summary kicks off with a quote from obama: “the world is shifting to an innovation economy, and nobody does innovation better than America.” self-congratulatory statements like these are not unexpected in an election year, but how much of the document is smoke and how much is substance? And more importantly for Europe’s biotech sector – what does it say about serious competition for future products and services?

NatureWorks plant in Nebraska

Published in late April, Blueprint is based on five strategic objectives aimed at helping generate economic growth and address societal needs in the US. These are: – Support R&D investments to provide a basis for the future bioeconomy – Facilitate the transition of bioinventions from research lab to market – Develop and reform regulations to reduce barriers, increase the speed and predictability of regulatory processes,

and reduce costs while protecting human and environmental health – Update training programs and align academic institution incentives with student training – Identify and support opportunities for development of PPPs and precompetitive collaborations.

Those strategic objectives are very broad indeed. The New York Times quickly complained that the Blueprint contains

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“a list of government programs that are already under way. So it is not clear what concrete changes, if any, will result.”

Even a broad statement of support, however, was welcome to those in the US sector who have complained that Obama has in the past spent too much time and energy pushing non-biotech future technologies like solar energy and electronics, to the detriment of the US biotech industry. At the BIO “World Congress on Industrial Biotechnology and Bioprocessing” in early May, a plenary session headed by the US biotech organisation’s President and CEO Jim Greenwood was positive but cautious. The initiative is a great step forward, he said, but there are other steps the government still has to take to help foster more innovation – specifically in the areas of energy, continued investment in the production of biofuels, and tax policy.

Europeans happy us is on board – but nervous about the future The Blueprint is proving to be something of a rude wake-up call for European biotech. Although bioeconomy legislation at both EU and national levels has played a trailblazing role in the world so far, a massive, well-planned new initiative on the other side of the Atlantic could quickly cut Europe’s leads in specific fields. In areas like synthetic biology and GMOs, the Americans are already well out in front.

On the day the Blueprint was announced, Dr. Christian Patermann – generally considered the mastermind behind the EU’s bioeconomy strategies – said at a conference in northern Germany that the “US initiative has changed the character of the bioeconomy dramatically.”

Up until now, bioeconomy activities have been “concentrated in northern Europe, Germany and the Benelux countries,” he commented,”but now....it has become a global initiative.” It’s now time to bring the lengthy planning period to a close, he continued, and begin implementing concrete measures.

Joanna Dupont-Inglis, Director Industrial Biotechnology at the European biotechnology association EuropaBio, said

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INsIght EuropE that “on the face of it, the US (even) seems to have some clear advantages in terms of support from the Department of Agriculture. On the other hand,” she continued, “the EU still retains significant industry technological excellence in this field and has the support of a dynamic Research and Innovation Directorate within the EU Commission. Success for the EU may now hinge on how well its member states can pull together and adopt the ‘all hands on deck’ approach advocated by President Obama.” European Bioplastics Policy Affairs Manager Roland Scharathow agrees.

He believes the US strategy highlights a lack of “specific proposals for supportive measures” in Europe’s bioeconomy strategy, and complains that the bioplastics market is still missing “desperately-needed concrete measures.”

More than just pretty words Fears of being left behind are not without a basis. The five strategic objectives in the report are certainly vague, but the US has also already begin to move forward with some concrete measures of its own.

On the day the “National Bio economy Blueprint” was released, a number of different US departments and agencies announced no less than ten new initiatives aimed at helping to achieve the objectives.

The US Department of Agriculture, for example, will be expanding its biobased products purchasing programme to help promote rural development. The Food & Drug Administration (FDA) clinical trials archives will be integrated with patient data to help accelerate the development of new personalised treatments, while the National Institutes of Health (NIH) has launched a new Center for Regenerative Medicine to advance research in the key area of induced pluripotent stem (iPS) cells.

Some of the fire and smoke surrounding the Blueprint can therefore be put down to US election-year posturing, but there’s also substance. Certainly enough that the EU will have a fight on its hands to prove Obama wrong, and show that Europe can do innovation every bit as well as America – or even better.

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Heard in Brussels M

solving the debt with biotech

Brussels – Good news! After some thinking, I’ve solved the eurocrisis and saved national investment in biotechnology!

As with most people who champion a single Europe, what is going to happen in the eurozone weighs heavily on my mind.

Not just because of the surreal and seemingly uncontrollable debt crisis, but also because investment in growth in most European countries has stalled. Governments are only going to invest again when there’s a market for the products that such investment will deliver.

And governments aren’t investing in biotech, as it doesn’t produce large-scale employment or big shiny things, and it usually doesn’t deliver within an electoral cycle. A nagging voice at the back of my mind has been saying: ‘and why would they?’ If I were a regional government looking to rescue the economy, biotech wouldn’t be high on my list unless there was already significant commercial presence.

You have no idea how guilty writing that just made me feel. But fear not, dear reader, that was just a dark turn of the soul, and now the relentless optimism that drives all people who love biotech has already returned. Here’s the deal. People aren’t buying things from shops, so governments aren’t investing in growth there. But what DO they always need to buy? Easy – medicine, food and energy.

And this is why governments should be investing in biotech – it delivers all of these things and there will always be a market for it, even if people are not buying anything else.

– In medicine, the rush to manage diseases more effectively has huge market pull, and companies literally cannot get products through the pipeline fast enough.

– In energy, Europe has the capacity to lead the world in sustainable, intelligent power generation at local and national

Claire skentelbery, secretary general of the European Biotechnology Network

levels. Any country leading on this has a global market at their fingertips.

– In food, the easiest sell of all, there are demonstrable returns within an electoral cycle. The role of biotechnology in all steps of the food production chain is a winner, and oddly enough, the global demand for things to eat has not been damaged by the crisis.

So this is the message for national and regional investors in biotechnology: you should be investing each year at a local level to deliver products to a constant global market that gets hungrier as the cost of medicine, food and energy increases. By doing so, you will also establish your country as an intellectual driver behind these key sectors. Healthcare is already well-advanced, but in energy and food technologies, the leads are there for the taking. Significant money advancing biotech delivery – translational centres of excellence, global partnerships with big business and placement of the sectors on the national policy agenda. It can’t fail. Phew – glad we got that sorted. The eurozone will be saved by biotechnology, and I’ll have something to write about next time. See you then! B

European Biotechnology Net work

Join the European Biotechnology Network!

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European Biotechnology Foundation Rue d‘Egmont 15 B-1000 Bruxelles, Belgique Tel: +32 2 50 08 531 Fax +32 2 64 92 989 info@european-biotechnology.org www.european-biotechnology.net

N –º 6 | Volume 11 | 2012

COMPANY AND ADVERTISER INDE X Abbott Laboratories (USA) …………………… 36 Abcodia Ltd. (UK) ……………………………… 42 Actelion AG (CH) …………………………… 14, 18 Action Pharma A/S (DK) ……………………… 36 Admescope Ltd. (FIN) ………………………… 37 Adocia S.A.S. (F) ……………………………… 18 AiCuris GmbH & Co KG (GER) ………………… 16 Alcon Corp. (USA) ……………………………… 13 Alfa Laval (GER) ………………………………… 6/S Allos Therapeutics Inc. (USA) ………………… 16 AMProtein Inc. (USA) ………………………… 46 Antisense Pharma GmbH (GER) ……………… 35 Apeptico GmbH (A) …………………………… 39 Applikon Biotechnology (NL) ………………… 46 Ardea Biosciences Inc. (USA) ……………… 13, 15 ASEBIO (E) ……………………………………… 17 AstraZeneca AB (SE) ……………… 13, 15, 16, 35 ATMI LifeSciences (B) ……………………… 41, 46 Automatik Plastic Machinery (GER) … 6/S, 7/S, 9/S BASF SE (GER) ………………………………… 44 Bayer Technology Services GmbH (GER) …… 46 BB Biotech (CH) ……………………………… 14 Belimed Deutschland GmbH (GER) ………… 9/S Beta Renawables S.p.A. (I) ……… U3/S, 7/S, 11/S Bilfinger Berger Ind. Serv. (GER) … U4/S, 7/S, 11/S BIO.NRW (GER) ………………………………… CP3 BIOCOM AG (GER) …………………………… 41 Biogen Idec (USA) ……………………………… 38 Bioncotech Therapeutics S.L. (E) ……………… 16 BioPlan Associates, Inc. (USA) ………………… 44 BIOQUELL UK Limited ………………………… 6/S BiotecArea Krems/Ecoplus (A)………………… 41 Biouniversa S.r.l. (I) …………………………… 42 bluebird bio France …………………………… 16 BlueSens gas sensor GmbH (GER) …………… 7/S BMBF/BMELV (GER) ………………………… 10/S Boehringer Ingelheim GmbH (GER) ……… 37, 41 Bristol-Myers Squibb (USA) …………………… 16 c-LEcta GmbH (GER) ……………………… 11/S Caisson Biotech LLC (USA) …………………… 36 Cambridge Cell Networks (UK) ……………… 50 Cellectis SA (F) ………………………………… 50 Cellexus Biosystems (UK)……………………… 46 Cellzome Inc. (UK) …………………………38, 50 Danone (F) ……………………………………… 44 DASGIP GmbH (GER) …………………… 6/S, 13 Dornier-LTF GmbH (GER) ……………………… 8/S DSM Biologics BV (NL) ……………………… 14/S DuPont Tate & Lyle (USA) ……………………… 44 Enzymicals AG (GER) ………………………… 7/S Eppendorf AG (GER) ……………………… 9/S, 46 European Biotechnology Network (B)………… 48 Evestra (USA) …………………………………… 39 Fondazione Telethon (I) ……………………… 16 Fumapharm AG (CH) ………………………… 38 GE Healtcare (UK) ………………………… 6/S, 4/6 GEA Process Engineering (GER) ……………… 6/S Genentech Inc. (USA) ………………………… 13 Genzyme (USA) ………………………………… 13 GlaxoSmithKline (UK) ………………… 35, 38, 50 Gregory Fryer Associates Ltd. (UK) …………… 16 Greiner Bio-One GmbH (GER)………………… 9/S Grünecker Patent- und Rechtsanwälte (GER) … 12 HEINKEL Process Technology GmbH (GER) … 45 Heparinex LLC (USA)…………………………… 36 Hermo Pharma (FIN) ………………………… 37 Hill + Knowlton (B) …………………………… 35 Hospira One 2 One Gl. Pharmaceutical (USA) CP2 ICI Pharmaceuticals (UK) ……………………… 35 IKA - Werke GmbH & Co. KG ………………… 6/S Intercell AG (A) ………………………………… 14

Invensys Systems (UK) …………………… 7/S, 8/S Janssen Pharmaceuticals (USA) ……………… 42 Johnson & Johnson (USA) …………………… 42 Kensey Nash (USA) …………………………… 40 Kreab Gavin Anderson (B) …………………… 35 LEWA - Herbert Ott GmbH (GER) …………… 7/S LISA Vienna Region, Clustermanagement (A) 47 Lonza AG (CH) ………………………………… 46 M+W Process Industries GmbH (GER) ……… 7/S m2p-labs GmbH ……………………………… 46 Maag Pump Systems AG (CH) ……………… 10/S Meda AB (N) …………………………………… 37 Merck KGaA (GER) ……………… 13, 35, 39, 46 Michell Instruments GmbH (GER) …………… 8/S Millipore S.A.S. (F) ……………………………… 46 Mitsui Global Investment (JP) ………………… 41 Moberg Derma AB (S) ………………………… 18 Monsanto (USA) ……………………………… 44 Mucosis BV (NL) ……………………………… 18 Nanobiotix S.A. (F) …………………………… 35 NDA Regulatory Science Ltd. (UK) …………… 16 Nestle S.A. (CH) ……………………………44, 46 Novartis AG (CH) ……………………… 13, 18, 35 Novo Nordisk A/S (DK) ………………………… 36 Novozymes A/S (DK) ………………………… 37 Nuevolutin A/S (DK) …………………………… 37 Okawara MFG Co. Ltd. (JP) …………………… 9/S Organobalance GmbH (GER) ……………… 11/S Oxford Nanopore Technologies Ltd. (UK) …… 40 Pall Corporation (USA) ………………………… 46 PBS Biotech Inc (USA) ………………………… 46 Pfizer Inc. (USA) ………………………………… 40 Pharma Executive Consulting Ltd. (UK) ……… 16 PharmaMar (Grupo Zeltia) (E) ……………… 9, 42 PIERRE GUERIN SAS (F) ………… 6/S, 8/S, 10/S Plexpress (FIN) ………………………………… 37 Population Genetics Technologies Ltd. (UK) … 35 Process Systems Enterprise (UK)……… 7/S, 11/S Promethera (B) ………………………………… 41 RBC Capital Markets (CDN) …………………… 38 Rentschler Biotechnologie GmbH (GER) …… 46 Roche AG (CH) ………………… 13, 18, 35, 40, 41 Roche Diagnostics GmbH (GER) ……………… CP4 Royal DSM (NL) ………………………………… 40 Royalty Pharma (USA) ………………………… 38 Salans LLP (GER) ……………………………… 11 SambrInvest (B) ………………………………… 41 SANOFI (F) ……………………………………… 13 Sartorius Stedim Biotech GmbH ……………… 46 SBW International BV (FIN) …………………… 37 Selvita S.A. (PL) ………………………………… 44 Serono SA (CH) ………………………………… 13 Shengquan Group (VRC) ……………………… 37 Shire plc (IRL)…………………………………… 41 Süd-Chemie AG (GER) …………… U2/S, 7/S, 11/S Syngenta (CH) ………………………………… 44 Takeda Pharmaceuticals (JP) ………………… 16 Thermo Fisher Scientific (Schweiz) AG ……… 46 UCB S.A. (B) …………………………………… 15 Uhde High Pressure Technologies 7S (GER) … 7/S Unilever (CH) …………………………………… 44 VBU (GER) …………………………………… 11/S Vernalis plc (UK) ……………………………… 18 Werum Software & Systems AG (GER) ……… 9/S Wilex AG (GER) ………………………………… 35 WILHELM WERNER GmbH (GER) …………… 9/S WYATT TECHNOLOGY Europe GmbH (GER) … 9/S Xcellerex (USA) …………………………………… 7 Xylem Water solutions GmbH (GER) … 7/S, 11/S ZAB Brandenburg Economic Dev. Board (GER) 43 Zealand Pharmaceuticals A/S (DK) …………… 36

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