European Biotechnology Science & Industry News N 11 | Volume 11 | 2012 | 10.00 | ISSN 1618-8276 | A 60711 | CENTRAL EUROPE German Chancellor Angela Merkel opens 53m biorefinery NORTHERN EUROPE Norway’s Aqua Gen maps salmon genome to improve aquaculture WESTERN EUROPE French consortium builds first EU cell therapeutics facility SPECIAL Bio-Europe in Hamburg Partnering & Deals SOUTHERN EUROPE New Italian framework for pushing clinical trails in biotech EASTERN EUROPE GENNET and BGI Europe team up to foster genomic screening SCIENCE & TECHNOLOGY Targeting stathmin prevents neurodegeneration in ALS FREE EXCERPT
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European Biotechnology News 11/2012 - Free Excerpt - Chemical giants inch into the post-petrol era
CENTRAL EUROPE German Chancellor Angela Merkel opens 53m biorefinery +++ NORTHERN EUROPE Norway’s Aqua Gen maps salmon genome to improve aquacultur +++ WESTERN EUROPE French consortium builds first EU cell therapeutics facility +++ SPECIAL Bio-Europe in Hamburg Partnering & Deals +++ SOUTHERN EUROPE New Italian framework for pushing clinical trails in biotech +++ EASTERN EUROPE GENNET and BGI Europe team up to foster genomic screening +++ SCIENCE & TECHNOLOGY Targeting stathmin prevents neurodegeneration in ALS
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EuropeanBiotechnology
Science & Industry News
N 11 | Volume 11 | 2012 | 10.00 | ISSN 1618-8276 | A 60711 |
CENTRAL EUROPEGerman Chancellor Angela Merkel opens 53m biorefinery
NORTHERN EUROPE
Norway’s Aqua Gen maps salmon genome to improve aquaculture
WESTERN EUROPE
French consortium builds first EU cell therapeutics facility
SPECIAL
Bio-Europe in HamburgPartnering & Deals
SOUTHERN EUROPE
New Italian framework for pushing clinical trails in biotech
EASTERN EUROPE
GENNET and BGI Europe team up to foster genomic screening
SCIENCE & TECHNOLOGY
Targeting stathmin prevents neurodegeneration in ALS
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P artnering and even open innovation is becoming increasingly important for our industry in a world where health sys-
tems are undergoing profound transformations. As the global population has grown above seven billion, emerging markets have become major markets. Mature markets around the world are aging. These factors and others are giving rise to greater medical need at a time when many health systems are reaching their !nancial lim-its. One key to addressing these challenges is innovation – both internal and external.
In this context, partnering plays an impor-tant role. At Bayer HealthCare, we are commit-ted to research & development in areas with high medical needs like oncology, cardiology, gyne-cological therapies, hematology and ophthal-mology. Our partnering activities are also ad-dressing both regional and local business needs, and we are constantly looking for new collabo-rations with academia, pharma and companies in the biotechnology !eld across all phases of the value chain to combine the innovative sci-ence of our partners with our drug discovery activities, our development experience and our marketing expertise worldwide.
Today, we are well-positioned, with a strong portfolio of innovative products and an out-standing pipeline of new developments. How-ever, to add more value for physicians and pa-tients, our company is seeking to think beyond the scope of individual products and increas-ingly develop healthcare solutions. In the car-diovascular area, for example, such solutions could start with prevention, encompass diagno-sis and treatment where disease does occur, and also protect against recurrence – a truly com-prehensive approach to heart health. Following the idea of developing innovative solutions, as well as individual products, our business deve- lopment organisation brings together colleagues
from Pharmaceuticals, Consumer Care, Medi-cal Care, and Animal Health divisions.
One of the unexpected bene!ts of the tight !nancing environment over the last few years is that companies are forced to collaborate ear-ly on in the drug-discovery and development process. This may allow the next generation of molecules to bene!t from ‘collaborative advan-tages’ – bringing together the science and ex-perience of organizations for mutual bene!t, and ultimately increasing the chance of devel-oping new therapies that will have an impact. These days, more than 80% of Bayer Health-Care meetings at partnering conferences deal with pre-clinical opportunities.
Our company is open to all types of collabo-rations, but prefers structures that allow both partners a seat at the table and real input to ensure the best decisions are made for the pro-grams. We want to work with strong partners that thrive independently, and ideally will bring multiple opportunities to the table. We also recognize the need to meet the needs of in-vestors who will need successful exits if they are to have con!dence to reinvest in healthcare innovation.
The growing importance of collaborations in our industry is also nicely re"ected by the de-mand for, and increasing number of, partner-ing events worldwide. Events like the upcom-ing Bio-Europe offer excellent opportunities, both to catch up with companies we already know and to meet new companies or academ-ic institutions at an early stage of their deve- lopment.
EDITORIAL
Partnering for innovative healthcare solutions
Nigel Sheail, Head of Global Business Development & Licensing, Bayer HealthCare, Leverkusen
Nigel Sheail, has been a member of the Bayer HealthCare Executive Committee and Head of Global Business Development & Licensing since November of 2011. The biologist (BSc, University of Edinburgh) began his professional career in the pharmaceuticals industry in 1990 at GlaxoSmithKline, before transferring to F.Hoffmann-La Roche Ltd. in 1993. There he held a variety of positions with increasing responsibility in both the firm’s finance and research organisations. Prior to joining Bayer HealthCare, Sheail was Head of Corporate Mergers & Acquisitions and Head of Global Pharma Licensing at F.Hoffmann-La Roche Ltd. in Basel.
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4 Euro|Biotech|News N º– 11 | Volume 11 | 2012
CIRCULATION
European Biotechnology News is published in co-operation with the following organisations:
EuroBiotechNews covers the biotechnology sector of the current 27 EU member states, Norway and Switzerland. If you would like to subscribe, please refer to
Replacing petrochemicals with biobased alternatives 6
INSIGHT
Heard in Brussels; EU agencies don’t adequately manage con!icts of interest 10
Study compares 19 biotech clusters 12
EMA says small biotechs resist asking for advice; Market for mAbs growing strong; IP Flash 14
REGULATORY AFFAIRS
Breaking news from the EMA 15
Update on clinical trials 16
ECONOMIC
Focus on news!ow and dividends 17
Stock markets 18
PERSPECTIVES
Reverse merger – Gentrix marries X-Pol Biotech with Sygnis 44
REGIONAL NEWS
Northern Europe Denmark, Norway, Sweden, Finland 20
Central Europe Germany, Austria, Switzerland 22
Western Europe UK, France, the Netherlands, Belgium 24
Southern Europe Italy, Spain 26
Eastern Europe Poland, Hungary, Slovenia, Slovakia, and the Czech Republic 28
Spurred by opportunities in the booming market for sustainable chemicals, major industry players are closing deal after deal to build new production facilities across the globe. After years of planning and testing, bio fermenters able to produce thou-sands of tonnes of key chemical building blocks annually are gearing up to go online. A "rst biobased key substance to be produced en masse is succinic acid, a precursor compound that can be used to make a wide range of other materials.
SERVICES
Partners & Associations 4
Imprint 5
Biopeople News from Epigenomics, Heptares Therapeutics, Boehringer Ingelheim, Anagnostics, Cytos Biotechnology, and the European Parliament 46
Company index 48
Events What’s on in Nov.-Dec. 2012 49
Encore 50
COVER STORY
SPECIAL
BIO-Europe 2012Partnering at its best 31
Partnering is still key to success 32
Real cooperation at an early stage 34
The world is on our doorstep 36
Contract manufacturing – Tailored production 40
Handling intellectual property in high-tech start-ups 42
Focus on T cell therapies 47
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10 Euro|Biotech|News N º– 11 | Volume 11 | 2012
INSIGHT EUROPE
Claire Skentelbery, Secretary General of the European Biotechnology Network
Heard in Brussels When scientists have to strike at their own
ECA
Cleaning house Luxembourg – The European Agencies
responsible for drug approval (EMA), food safety (EFSA), safety of chemicals (ECHA) and aviation (EASA) are not adequately managing con!ict of interest situations, says a new report tabled by the European Court of Auditors (ECA). The study, re-leased in Oct ober, appears to con"rm con-cerns expressed by MEPs who commis-sioned it in 2011. Last spring, they post-poned approval of the 2010 accounts from the EMA and the EFSA due to doubts over the independence of staff there (see E#$%-B&%'()*N(+, 6/2012). The ECA, howev-er, also stressed that of the four agencies, the EMA and the EFSA ”have developed the most advanced policies and procedures for declaring, assessing and managing the con!ict of interest.” Igors Ludbor-s, who headed the assessment, said that “after ex-amining the situation at the agencies, we (the ECA) have drawn up a list of general and speci"c recommendations which – if properly implemented – might bring sig-ni"cant improvements in the management of con!ict of interest situations, not only in the selected agencies, but in all EU in-stitutions and decentralised bodies.” The ECA inter alia recommends:– establishing clear and objective criteria
for the assessment of declaration of in-terests and applying them,
– introducing gifts and invitation policies (EMA, EASA, ECHA),
– developing clear, transparent and con-sistent breach of trust policies, and
– screening candidates for con!ict of in-terest before their appointment (EMA, EASA, ECHA).
”We will continue to rigorously imple-ment our new policy on independence and scienti"c decision-making processes,and the related implementing rules, which came into force in July,” said EFSA head Catherine Geslain-Lanéelle. The EMA said it's already addressed most of the recom-mendations. At the end of October, the European Parliament con"rmed its 2010 accounts.
Brussels – We all read with dismay – but not a huge amount of surprise – the Oct-ober paper from French researchers led by Gilles-Eric Séralini on the two-year rat-feeding study looking at the effects of glyphosate-treated GM maize. It‘s al-most boring these days when new head-lines emerge saying we're all going to DIE HORRIBLY from eating GM food. This is despite a conspicuous lack of people DYING HORRIBLY from any thing oth-er than the usual human-inspired causes, which are not worthy of comment or ac-tion because they are 100% ‘natural’.
In the bad old days, scientists, com-panies and politicians would have been looking the other way when the report was published, and before long the headline would have been accepted as fact. Any response would have been far too late and far too weak to look like anything other than an evil corpo-rate cover-up.
This time, however, I was pleasant-ly surprised. As they raced to hit dead-lines, I heard journalists adding that an awful lot of people disagreed with the results, and that the science was actu-ally a bit suspect – not enough animals, dodgy design, cancer-prone rats and less maths than my budget planning for shoes. They also added, in pensive tones, that the researcher was a long-time opponent of GM crops, and this might mean he isn‘t exactly unbiased.
Even more refreshing was the rap-id response from researchers and pol-iticians. The latter got it badly wrong when the GM farce "rst hit the head-lines. But then the French research com-munity itself bit back quickly. The coun-try‘s national academies of agriculture, medicine, pharmacy, sciences, technology and veterinary studies signed a statement that not only are the conclusions unsup-ported by the presented data, but that the paper spreads fear in the public.
This was rapidly backed up by the Euro-pean Food Safety Authority, which pub-lished a statement pointing out that the author had been invited to supply the ev-idence missing from the paper, but had obviously ”forgotten” to post it before their deadline. The full review from the EFSA contained the damning phrase “the study has unclear objectives and is inade-quately reported in the publication, with many key details of the design, conduct and analysis being omitted. Without such details it is impossible to give weight to the results.” Dark words for any scientist to hear, and I’ll bet the peer review proc-ess in F%%. /0. C*(1&)/2 T%3&)%2%45 is now undergoing an overhaul.
Bravo, I say. The scienti"c community needs to manage its scientists better. It has been too easy for too long to grab head-lines with poor but sensationalist science, and the price is paid by everybody.
When science is bad, it should be the scientists who point it out and remind their own community and the rest of the world that to be science, it has to be sci-enti"c – you don’t start from the result, and you always show the maths. Obvi-ously, that doesn’t apply to shoes.
Basel – A brand-new study conducted by the market research institute BAK Basel Economics AG has taken a look at the role the life sciences play in 19 selected metro-politan or regional clusters in Europe, the US and Asia. The difference between the “Life Sciences Report 2011/2012” and oth-er analyses is that its focus is less on abso-lute employment numbers, patents or R&D expenditure created by the clusters than on their relative contributions to their respec-tive economies. Viewing the !eld from this special angle, the study !nds that nowhere is the life science industry as important to the local economy as it is to the Basel region and its 470,000 inhabitants.
There, the densely-clustered agrochemi-cal, pharmaceutical and medtech industry shares of gross domestic product (GDP) hit about 18% between 2000 and 2010. With the exception of Singapore (around 5%), contri-butions from the life sciences industries to GDP in most areas is generally in the 1-3% range, even in other cheek-and-jowl clus-ters like Boston, the San Francisco Bay Area, Shanghai, London and New York. A simi-lar picture emerges when it comes to life sciences contributions to total employment. While Shanghai, New Jersey, New York, and Southern California lead the pack in abso-lute numbers, Basel (7.8%) outperforms
Key figures of metropolitan life sciences areas:1 patents in agrochemicals, pharmaceuticals and medtech as of 2009, 2average 2000-2010 (rounded), 3as of 2010
Cluster Staff (Share of Employment)
Patents1 per inhabitant
Share of Life Sciences in GDP2
Share of expendi-ture in GDP3
Shanghai 91,700 (0.8%) N.A. 1.5% N.A.
New Jersey 79,500 (2.0%) 80 3.5% 5.4%
New York 55,700 (0.7%) 30 3% 1.5%
Southern California 51,900 (0.7%) 50 1% 4.8%
Paris 36,600 (0.7%) 40 1% 3%
Milan 33,600 (1.6%) 30 0.5% 1.1%
SF Bay Area 30,000 (1.4%) 180 2% 4.8%
Basel Region 27,600 (7.8%) 280 18% 9.8%
Boston 23,400 (0.8%) 190 1.5% 8.9%
Singapore 22,000 (0.7%) N.A. 5% N.A.
News Inconclusive GMO study
Parma/Paris – Europe’s food watch-dog EFSA has said a long-term rat-feeding study published by Séralini et al. has “inadequate design, analysis and reporting for safety assessment”. The study (see E"#$B%$&'()N'*+ 10/2012), which was accompanied by the release of a GM-sceptic book and !lm by the authors, claimed GM maize NK603 has a negative impact on health. Without access to the raw data, those conclusions can’t be veri!ed or interpreted. Séralini, however, has re-jected requests to release that data to the scienti!c community (see p. 10). At the end of Oct ober, the French nation-al academies of agriculture, medicine, pharmacy, sciences, technology and veterinary studies jointly dismissed the study as “a scienti!c non-event” and ,awed science. “Given the numerous gaps in methods and interpretation, the data presented in this article cannot challenge previous studies, which have concluded that NK603 corn is harmless from the health point of view,“ stressed the researchers. Some days before, the French Haut conseil des biotechnolo-gies (HCB) said the data presented by Séralini didn’t demonstrate any nega-tive effects caused by NK603 or the her-bicide glyphosate.
Dalli steps down
Brussels – EU Health Commissioner John Dalli resigned from his post in October after an anti-fraud investiga-tion connected him to an attempt to in,uence EU tobacco legislation. Al-though the report didn’t !nd any con-clusive evidence of the Commission-er’s direct participation in the scandal, Dalli decided to step down. VP Maros Sefcovic will take over his post on an interim basis.
them in relative terms (see table), and tops the chart when it comes to share of R&D ex-penditure in GDP (1. Basel: 9.8%, 2. Boston: 8.9%, 3. Cambridge/UK: 8.1%).
The study’s aim was not only to ana-lyse established clusters, but also to iden-tify emerging ones. A comparision of an-nual growth rates (“gross value added”, GVA) from 1995-2000 and from 2000-2010 revealed that Shanghai (GVA: 14%), Cam-bridge (13%) and the Geneva Region (12%) currently perform better than they did be-fore the turn of the millennium. Basel is growing constantly at about 10% annually. The large US clusters and Singapore built critical mass with peak growth rates of 15%-20% in the 1990s, and have only averaged annual growth rates of about 7% during the last decade. Milan, Paris and Munich are currently showing a decrease in GVA, ac-cording to the analysis.
When it comes to analysing productivity, the study remains somewhat vague. In order to correct for the size of a region, it looks at the number of life sciences patents !led in that region in relation to its total population. A more informative number would have been to compare it to the number of life sci-ence researchers who work there.This may be a contributing factor to its claim that Ba-sel is outperforming top US clusters.
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48 Euro|Biotech|News N º– 11 | Volume 11 | 2012
COMPANY INDEX
Euro BioTech News ?What are you planning to examine in the clinical trial, and what’s your timeline?
REINKE: !Our Treg approach will be tested in two stud-ies. First, by a EU consortium within the “One Study“ progamme (www.onestudy.org), which is set to start patient enrolment next autumn. 16 transplant recipients each in Berlin, Regensburg and Oxford respective-ly will receive a kidney from living donors who have no standard suppression. Oxford and Regensburg will use similar expansion protocols. Second, a trial sponsored by t-cell Europe will be conducted with recipients of kidneys from deceased donors. The dose -escalation study is designed to demonstrate safety and indirect (biomarker-based) ef!ca-cy, and will include initial T-cell depletion. Starting next autumn, we will recruit 16 pa-tients over a year who will have a one-year follow-up. Here we will recheck some of the results we got from preclinical testing. For
instance, we found that FoxP3+-Tregs can be given under calc i neurin inhibition, which contrasts with the established idea that pa-tients need IL-2 for survival. Second, we will have to recheck whether our Tregs are still functional – as they were in preclinical tests – after 2-3 weeks of expansion from one mil-lion to 100 million cells. t-cell Europe’s focus in this trial is on deceased donors, because 70% of available kidneys are allocated by Eurotransplant. We expect the results from both studies in 2015.
Euro BioTech News ?What market potential do you see for your approach in kidney transplantation?
VOLK: !We are not so starry-eyed as to believe we could fully substitute immuno suppressive therapy, which costs directly and indirectly
30,000 annually per patient. But even if it reduces the need for immuno suppressives by only 50%, our approach would pay for
itself after just two years. We are already in talks over both an adequate reimbursement price and on quality-of-life parameters with healthcare insurance companies to create acceptance for our approach. That may be a plus if it comes to licensing.
ULBRICH: !Conservative estimates say that calculat-ing at 40,000 per treatment, the !eld has a 300m annual potential …
REINKE: !We have to progress step-by-step – to see if patients bene!t from our treatment in the clinic. Only then will we switch to the all-ogenic setting, because it is more practical and cost-effective. We believe regulatory authorities are changing their minds about biological mixtures like mAbs or cell thera-pies if they do the job. More and more phy-sicians accept that complex biological proc-esses can’t be addressed with one drug af-fecting one pathway.
4SC AG (GER) ………………………………………… 17Ablynx NV (B) …………………………………… 16, 25Actelion Ltd (CH) ……………………………………… 16Active Biotech (S) ……………………………………… 21Adenovir Pharma AB (S) ……………………………… 16Affimed Therapeutics AG (GER) ……………………… 22Agennix AG (GER/USA) ……………………………… 31AiCuris GmbH & Co KG (GER) ………………………… 22Altona Diagnostic Technologies GmbH (GER) ……… 36Amakem NV (B) ……………………………………… 16Anagnostics Bioanalysis GmbH (A) …………………… 46APIM Therapeutics AS (N) …………………………… 20Aqua Gen AS (N) ……………………………………… 21BAK Basel Economics AG (CH) ……………………… 12BASF SE (GER) ………………………………………… 6Bayer Healthcare AG (GER) ………………………… 3, 19Berlin Partner GmbH (GER) …………………………… 25BGI Europe (DK) ……………………………………… 28BIO.NRW (GER) ………………………………………… 11Bioamber Inc. (USA) …………………………………… 8BIOCOM AG …………………………………………… 30Biom’Up (F) …………………………………………… 25Bionamics GmbH (GER) ……………………………… 38Biotest AG (GER) ……………………………………… 38Biotie Therapies Corp. (FIN) …………………………… 46BioWin - The Health Cluster of Wallonia (B) ………… 23Boehringer Ingelheim (GER) …………………… 25, 46Burrill & Company (USA) ………………………… 31, 32BWG Holding (S) ……………………………………… 16Caixa Capital Biomed (E) ……………………………… 26Caja Navarra (E)………………………………………… 26Campbell Alliance (USA) ……………………………… 32Cedrus Therapeutics Inc. (USA) ……………………… 38Celogos (F) …………………………………………… 24Chemotargets S.L. (E) ………………………………… 26Clean Cells SA (F) ……………………………………… 24 Cobra Biologics (GB) …………………………………… 43Cresces GmbH (GER) ………………………………… 36Curacyte AG (GER) …………………………………… 31Cytos AG (CH) ………………………………………… 46DASGIP GmbH (GER) ………………………………… 17Devgen (B) ……………………………………………… 17