Nº 4 | Volume 12 | 2013 | 10.00 € | ISSN 1618-8276 | A 60711 |
European Biotechnology News Science & Industry
CENTRAL EUROPE
T P R E C EE EX
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Roche expands manufacture of immunodiagnostics NORTHERN EUROPE
Orion Pharma drug arrests Alzheimer's disease SPECIAL
Diagnostics and Genomic Therapy WESTERN EUROPE
k c o r s r e y a l Big p t e k r a m s bioplastic
Shire grabs neonatology specialist Premacure SOUTHERN EUROPE
Grifols absorbs biomarker firm Progenika EASTERN EUROPE
Mabion raises a9.3m on Warsaw Stock Exchange SCIENCE & TECHNOLOGY
GIANT consortium study links new gene loci to body traits
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N –º 4 | Volume 12 | 2013
Euro|Biotech|News
Intro
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Editorial
Time is of the essence for the “father of healthcare” Jesús Rueda Rodríguez, Regulatory Affairs Director, European Diagnostic Manufacturers Association, Brussels
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Jesús Rueda Rodriguez heads the regulatory team of EDMA and ensures the association’s active participation in the regulatory debates that affect IVDs in the EU. He is also involved in work at the international level, acting as the EDMA representative to the WHO and ISO, as well as a liaison to other associations on regulatory matters.
h e proposal for an in vitro diagnostics (IVD) regulation currently under discussion in the European Parliament and Council of the European Union will chart the future of the regulatory system for IVDs in Europe. Dubbed the “father of healthcare” by rapporteur of IVD Regulation Peter Liese, the various rounds of discussions are beginning to underscore the importance that IVDs have in healthcare as a pathway for guiding patient management decisions. And with this recognition, an important and more detailed look at the proposal is also starting to take place. It’s clear that IVD manufacturers will be controlled more strictly under the new regulations, and that notified bodies will also be more deeply involved. With the new classification system, they will have levels of oversight in about 90% of all IVD applications. However, the involvement of reference labs – which will provide a pool of scientific expertise to authorities and notified bodies, and test samples collected through unannounced visits – will mean dealing with new operators in the future. Specific device types are currently being highlighted, and special care is being taken to ensure that they are safe and effective. This is the case for companion diagnostics, where there is a need to ensure that both IVD authorities and medicinal products authorities are satisfied that personalised medicine is delivering on the promise it holds. The same holds true for nearpatient testing systems, which are growing in importance as a means for ensuring that testing results actually reach patients and have an impact in managing their health. Finally, it is important to underline that the specific requirements for IVD software will enable a better in-
tegration of the information that is transferred from IVDs to information systems. The regulation takes a balanced approach between pre-market and post-market controls. In the pre-market setting, the use of Common Technical Specifications (CTS) for the highest risk IVDs continues to provide a very stringent requirement that has to be met before a diagnostic reaches the market. In addition, all IVDs will now have to be supported by clinical evidence. This is to include not just their analytical performance, but also clinical performance and scientific validity – in other words, knowing how the information that is generated by the IVD benefits the patient. A lot of the questions that have been raised by the regulation will be addressed through the way in which it is implemented. In this, it is essential that implementation be driven by the need to ensure the safety and effectiveness of IVDs, while at the same time retaining relatively rapid access to the market for them. Only this combination will result in direct benefits to both the patients and the users of these devices. Industry will have time to adapt, but that time must be used wisely. Collecting clinical evidence must begin as soon as the details are finalised. Those companies that begin an early programme of implementation will be in the best position to benefit from the advantages of the new system, which will include greater international convergence, as well as an increased confidence in a more stringent – but possibly still supple – system for regulating IVDs. B
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N –º 4 | Volume 12 | 2013
Euro|Biotech|News
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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
www.eurobiotechnews.eu
N –º 4 | Volume 12 | 2013
contents
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Insight GMO opponents sue EFSA; Further horsemeat tests; Heard in Brussels
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Euro|Biotech|News
Cover Story 10
GMOs could break US-EU free trade agreement; MEPs vote for clinical trials transparency; Forced feeding 12 Animal testing ban for cosmetics
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Ban for endocrine disruptors , IP Flash 14 Regulatory Affairs Update on clinical trials
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Breaking news from the EMA
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A major boost to the market for bioploymers
Economic Focus on newsflow and dividends
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Stock markets
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Perspectives Interview: Wolf Wieland, EAPB
A comprehensive new study shows that biobased precursor compounds used in plastics are finally beginning to come into their own. With support from some of the planet’s biggest manufacturers, production worldwide is expected to triple within the next seven years. Much of the new production capacity will be created in Asia and South America, where cheap sugar feedstocks are easier to come by than in Europe or the US. The steadily expanding bioplastics pie, however, looks big enough for all.
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Regional News
Services
Special
Northern Europe Denmark, Sweden, Norway, Finland 22
Genomics & Diagnostics
Central Europe Germany, Switzerland, Austria
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Diagnostics – the basis for genomic medicine
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Western Europe France, UK, Netherlands, Belgium
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EAPB experts discuss the future of personalised medicine
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Southern Europe Italy, Spain, Greece Eastern Europe Poland, Hungary, Czech Republic
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Biosensors extend diagnostic range
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OncoNetwork: characterising lung and colon cancer
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Partners & Associations
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Biopeople News from Curetis AG, Eyevensys plc, Phagenesis, Vitrolife AB, Poxel S.A, and Rentschler Biotechnologie GmbH
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Company index
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Events What’s on in April-May 2013
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Encore
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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. 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: Marcus Laschke, +49-30-2649-2148; 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: © Coca-Cola Company ® BIOCOM is a registered trademark of BIOCOM AG, Berlin, Germany.
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N –º 4 | Volume 12 | 2013
Euro|Biotech|News
INSIGHT EUROPE agri-Biotech
GMO maneuver
Heard in Brussels M
A Brussels/Parma – GMO opponents have filed a lawsuit at the European Court of Justice against the EU import of Monsanto's GM soybean MON 87701 x MON 9788. The NGO Testbiotech and five other GMOsceptic organisations announced at the end of March that they believed EU food watchdog EFSA had failed to carry out legally required risk assessments for the insect-resistant and herbicide-tolerant soybean, questioning the authority's conclusion that the strain is equivalent to conventional soybeans. The plaintiffs also claim that no investigations of the combined effects of the genetic modifications had been carried out, that the assessment of possible allergenic effects was flawed, and that there was no obligation yet for monitoring the product's health effects at the stage of consumption. In June of 2012, the Commission greenlighted food and feed uses for the soybeans, which are mainly imported from Brazil. After speaking with EFSA experts, the Commission quickly answered the critics in a letter, saying that the authority “considers that there are no scientific arguments that would invalidate the conclusions of the GMO Panel on soybean MON 87701 x MON 89788 published in February 2012.” According to figures from the WWF, 80% of all soy imports to the EU are currently used for animal feed. B
EMA/EFSA
Drug Trojans A Brussels/London/Parma – The European Medicines Agency (EMA) and food experts at the EFSA are to assess the health impacts of phenylbutazone in horse meat. At the beginning of March, the European Commisson asked the Agencies to do so after horse meat was found to be illegally contaminated with Novartis’ anti-inflammatory drug. The experts are expected to present their first results in mid-April. B
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The Innovation Scoreboard – plotting a pathway for the future
Brussels – March saw the publication of the latest innovation scoreboard. ‘More stats!’ I hear you groan, but this is important reading for researchers, businesses and governments in biotech. It tells you where the innovation leaders and followers are, as well as informing you about changes in performance over time. Unsurprisingly, the innovation leaders are Denmark, Sweden, Germany and Finland – countries that have long looked far ahead when planning strategy, and that have a strong national innovation focus. They don’t leave it to market forces to stimulate growth. Instead, they continue to innovate strongly in research and business, and the rankings are similar to previous reports. The innovation followers are Europe’s mid-table performers: the UK, France, Belgium, etc. Estonia and Slovenia signal a newer EU27 presence. These countries have varying strategies, as well as very different sizes and histories. They’re doing just fine in mid-table, with strengths and weaknesses in different parts of the economy. Moderate innovators include Europe’s old school countries such as Spain, Portugal, and many of the newer EU27 members (Hungary and the Czech Republic jump out at you), as well as a ‘plummeting’ Greece (their words not mine). Modest (such a polite term) innovators bring in the final few stragglers, among them Romania, Bulgaria and Poland. So why is this important? You could probably guess without this report where countries score on innovation in research and business. It’s the figures behind the headlines that make for interesting reading. A key comment was that declining innovation investment was linked to shortterm decision making. Positive growth was linked to decisions made and stuck to. This is a key earning point for governments planning their life sciences strategy. Aim high, and stick to it. You give confi-
Claire Skentelbery, Secretary General of the European Biotechnology Network
dence to investors, researchers and companies when you plan 20 years ahead, and that’s repaid with skilled personnel, entrepreneurial SMEs and stable investment. In a sector like life sciences, only governments can create stable, long-term infrastructure for high-risk activities to take place and business to grow. The headlines also hide the fact that innovation convergence between countries has pretty much stopped, which is a worry for the European project. After all, we are supposed to work together to bring everybody to the same level. There is a lot of pressure on national budgets, and those countries suffering the most are radically cutting their ability to innovate – and thus their ability to grow – over the long term. This means that you need to think beyond borders in supporting innovation. Disabling innovation elsewhere will also impact on you. So in the innovation race, there are two key lessons to learn for the life sciences: think big and plan long-term for innovation – while remembering that we have to innovate to survive. Help your neighbours in Europe to enable, not disable, their innovation systems. B
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N –º 4 | Volume 12 | 2013
Euro|Biotech|News
INSIGHT EUROPE
News Black label substances
Brussels – Pharmaceuticals that are undergoing additional monitoring will be labeled with an inverted black triangle, according to a decision of the European Commission announced in midMarch. Obligatory from September 2013, the label – which will be printed on product information brochures – is intended to encourage reporting of unexpected adverse reactions. According to EU Health Commissioner Tonio Borg, a ”stronger involvement of patients in the reporting on side effects is an integral part of Europe’s pharmaco vigilance system.” Since 2011, all approved (bio)pharmaceuticals with new active substances are subject to permanent safety monitoring.
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GMO Research
Agri-biotech
Clean GM plates Dealbreaker? A Brussels – A new decision made by EU member states stipulates that new applications for EU GMO market authorisation must contain data on three-month feeding studies performed on rodents. Up to now, about 70 % of the agribiotech companies involved provided that data on their own. Now their dossiers must include data on feeding studies with rodents. The EFSA published guidelines on how to conduct such studies in 2011. Animal welfare organisations are not pleased. According to the German Animal Welfare Association, the rules contradict the EU Animal Testing Directive (2010/63/EU). D
Diabetics at cancer risk
London – The European Medicines Agency has taken action after US researchers reported in mid-March that certain type II diabetes drugs (incretins) significantly boost the proliferation and risk for neuroendocrine tumours (Diabetes J., doi: 10.2337/db121686). The Agency announced it will investigate the impact of GLP-1-analogs and DDP-4 inhibitors on the risk for developing pancreatitis and precancerous cellular changes. Independent pharmacovigilance centres across the EU are already checking evidence for drug-induced pancreatitis by GLP1 analogons within the SAFEGUARD study. The market for incretins is a large one. It includes producers of GLP-1 analogons exenatide (Lilly et al.) and liraglutide (Novo Nordisk), the GLP-1 agonist lixisenatide (Sanofi) and DDP4 blockers sitagliptin (MSD Sharp & Dohme), saxagliptin (BMS), linagliptin (Boehringer Ingelheim) and vildagliptin (Novartis).
© mgkuijpers – Fotolia.com
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A Brussels – Differing views about genetically modified organisms (GMOs) could scuttle negotiations between the US and the EU over the world’s largest free trade agreement. “If one of the areas where we’ve got the greatest comparative advantage is cordoned off from an overall trade deal, it’s very hard to get something going,” said US President Barack Obama after EU leaders indicated they want to keep discussions on the EU’s GMO rules out of the talks. Friction surfaced after European Commission head José Manuel Barroso stressed that “we will not negotiate changes that we do not want of the basic rules on either side, be it on hormones or GMOs.” US Trade Representative Ron Kirk replied that everything was on the table, “including all across the agricultural sector, whether it is GMOs or other issues.” Backing US farmers, Obama said it’s hard to imagine an agreement that doesn’t address issues of this nature. “Any free trade agreement that doesn’t cover agriculture is in trouble,” confirmed Cathleen Enright, an Executive VP at the US Biotechnology Industry Organisation. However, EU Trade Commissioner Karel De Gucht appeared to rule out a compromise: “A future deal will not change the existing legislation. Let me repeat: no change.” B
Clinical trials Regulations
The different faces of transparency A Brussels – Members of the European Parliament have backed calls to open up access on clinical trial data once a drug has been approved. However, a broad spectrum of different solutions were proposed at a meeting of the EP’s ENVI Committee when it came to specifying the right balance between commercial interests among pharma companies (see p. 18) and those that want to review the data. As ENVI rapporteur Glenis Willmott (UK) has received more than 700 amendments to the Commission’s
draft regulation on clinical trials, it seems probable that the Parliament’s vote scheduled for the end of April will be postponed. In contrast to the Commission’s draft, Willmott wants to push publication of the full datasets generated during a clinical trial. Swiss-based giant Roche instead proposed opening up access to an edited set of data for individual investigators after an expert committee had reviewed the request. GSK argued for a similar gate-keeping mechanism to ”prevent misinterpretation”. B
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N –º 4 | Volume 12 | 2013
Euro|Biotech|News
Company And Advertiser Inde x A
Abbott Laboratories (USA)… ………………… 18, 44 AbbVie Inc. (USA)… ……………………………… 18 Ablynx (B)… ……………………………………… 19 Acorda Therapeutics, Inc. (USA)… ……………… 16 Activaris Biotech GmbH (A)……………………… 25 Active Biotech (S)………………………………… 22 Almirall S.A. (E)…………………………………… 29 Amadix S.L. (E)… ………………………………… 29 Amgen Inc. (USA)………………………………… 44 Analytik Jena AG (GER)………………………… 21, 47 Apeiron Biologics (A)……………………………… 17 ARIAD Pharmaceuticals, Inc. (USA)……………… 18 Ariana Pharma (F/USA)…………………………… 26 AstraZeneca AB (S/UK)………………………26, 50
B
BASF SE (GER)… …………………………………… 8 Baxter International (USA)… …………………… 18 Bayer AG (GER)………………………………… 16, 34 Beckman Coulter (UK)…………………………… 48 Beiersdorf AG (GER)……………………………… 13 BIOCOM AG (GER)… …………………… 32, 41, 42 Bioferon GmbH (GER)… ………………………… 43 Biofortis (F)… …………………………………… 26 Biogen Idec Inc. (USA)…………………………… 18 BioInvent International AB (S)…………………… 20 Biolamina AB (S)… ……………………………… 25 Biotica Technology Ltd. (UK)… ………………… 23 BioTOP Berlin-Brandenburg (GER)… …………… CP3 Bloomberg New Energy Finance (USA)… ……… 19 BlueSens gas sensor GmbH (GER)…………… 25, 43 Boehringer Ingelheim (GER)… ………… 12, 18, 44 Braskem SA (BR)… ………………………………… 8 Bristol-Myers Squibb (USA)……………………… 50 BST Bio Sensor Technology GmbH (GER)……… 36
C
Calypso Biotech S.A. (CH)… …………………… 24 Capio Diagnostik AB (S)… ……………………… 44 Cargill Dow LLC (USA)… ……………………… 8, 25 CellSeed Europe Ltd.……………………………… 18 Celtic Pharmaceutical Holdings LLP (UK)… …… 27 Chemaxon Kft. (HUN)… ………………………… 30 Clavis Pharma (N)………………………………… 22 Clinigen Group Ltd. (UK)… ……………………… 24 Clovis Oncology (USA)…………………………… 22 Coca-Cola (USA)… ………………………………… 6 CTI-BIOTECH (F)… ……………………………… 26 Curetis AG (GER)… ……………………………… 44 Cytos Biotechnology AG (CH)…………………… 16
D
Deutsche Messe AG (GER)… …………………… 19 Devgen NV (B)… ………………………………… 27 Diagnostik Net | BB (GER)… ………………… 9, 36 Dow Chemical Company (USA)… ………………… 8 Dr. Reddy‚Äôs Laboratories Ltd. (IND)…………… 21 DSM (NL)… ………………………………………… 8 DuPont (USA)… …………………………………… 8
E
East Bay AB (S)…………………………………… 22 Eisai Europe Ltd. (UK)… ………………………… 18 Eli Lilly (USA)……………………………………… 44 Eppendorf AG (GER)…………………………… 7, 47 Essential Inventions Inc. (GR)… ………………… 29 Evolva A/S (CH)…………………………………… 25 Eyevensys SA (F)… ……………………………… 44
F
Five Prime Therapeutics Inc. (USA)……………… 26 Ford Motor Company (USA)………………………… 6 Frost & Sullivan (GER)… ……………………… 36, 42
G Galapagos NV (B)………………………………… 27 GenSight Biologics (GER)………………………… 50 Gentium S.p.A. (I)………………………………… 18 Genzyme Europe BV (B)… ……………………… 18 Gilead Sciences Limited (USA)……………… 17, 18 Grifols SA (E)……………………………………… 28 Grünecker Patent- und Rechtsanwälte (GER)…… 14 GSK Biologicals (UK)……………………………… 12
H
Henkel AG & Co. KGaA (GER)… ………………… 13 High-Tech Gründerfonds GmbH (GER)… ……… 13 Hospira One 2 One Global Pharma (USA)……… CP4 Hyglos GmbH (GER)……………………………… 25
I/J
Illumina Inc. (USA)………………………………… 48 Innovia Films Ltd. (UK)……………………………… 8 InterMune Inc. (USA)…………………………… 18 InternA Technologies B.V. (NL)…………………… 27 Ipsen (F)…………………………………………22, 26 IRe Chemical Ltd. (KR)……………………………… 8 Joanneum Research (A)… ……………………… 24 Johnson & Johnson (USA)… ………………… 13, 27
K/L
KBC Securities (B)………………………………… 19 Kverva AS (N)…………………………………… 23 L‘Or√©al (F)… …………………………………… 13 Laboratoires SMB S.A. (F)………………………… 18 Lee Products (UK)………………………………… 48 Leica Biosystems GmbH (GER)… ……………… 16 Life Science Austria LISA (A)……………………… 15 Life Technologies GmbH (GER)… ………… 35, 38 LMC SA (ARG)… ………………………………… 30 Lonza AG (CH)… ………………………………… 25 Lundbeck A/S (DK)… …………………………… 23
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Mabion S.A. (PL)… ……………………………… 30 Marinomed Biotechnologie GmbH (A)… ……… 16 Medivir (UK) Ltd… ……………………………… 17 Medtronic Inc. (USA)……………………………… 44 Merck KGaA (GER)… ……………………… CP2, 24 Merck Serono (CH)… …………………………… 44 Mercurius DM (PL)… …………………………… 30 MGA Holding AB (S)……………………………… 22 Moberg Derma AB (S)… ………………………… 16 Mölnlycke Health Care (S)… …………………… 44 Monsanto (USA)… ……………………………… 10 MSD Sharp & Dohme GmbH (USA)… ………… 12
N NeuroSearch A/S (DK)…………………………… 22 NeuroVive Pharmaceutical AB (S)… …………… 23 Nike Inc. (USA)… …………………………………… 6 Nobel Biocare (S)………………………………… 44 Nordstjernan AB (S)… …………………………… 22 nova-Institut GmbH (GER)… ……………………… 6 Novamont S.p.A. (I)… ……………………………… 8 Novartis AG (CH)… ……………… 10, 12, 19, 24, 34 Novo Nordisk A/S (DK)………………………… 12, 16
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Octoplus N.V. (NL)………………………………… Oncodesign SA (F)… …………………………… Oncomedics (F)…………………………………… Orion Pharma (FIN)… …………………………… Orkla ASA (N)…………………………………… Otsuka (JP)………………………………………… Oxford Biomedica (UK)… ………………………
21 26 26 23 23 23 17
P
Paion (GER)… …………………………………… 16 Permira (UK)……………………………………… 23 Phagenesis plc (UK)……………………………… 44 Pharmaq AS (N)………………………………… 23 Pierre Fabre Oncology Laboratories (F)… ……… 26 Polytherics Limited (UK)… ……………………… 27 Poxel SA (F)… ………………………………… 16, 44 PPM Oost (NL)… ………………………………… 27 Premacure AB (S)………………………………… 27 ProBioGen AG (GER)……………………………… 43 Procter & Gamble (UK)………………………… 6, 13 Progenika Biopharma, S.A. (E)…………………… 28 PROvendis GmbH (GER)… ……………………… 34
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Randox Life Sciences (USA)…………………… 17, 37 Reed Exhibitions Japan Ltd. (JP)… ……………… 41 Regeneron Pharmaceuticals Inc. (USA)… ……… 16 Rentschler Biotechnologie GmbH (GER)… …43, 44 Roche AG (CH)… …………12, 16, 24, 25, 27, 44, 50 Roche Registration Ltd. (GB)… ………………… 18
S
SALANS FMC SNR Denton Europe LLP (GER)… 11 Sanofi SA (F)… ……………… 12, 18, 20, 26, 44, 45 Santhera Pharmaceuticals (CH)… ……………… 50 Sartorius Stedim Biotech GmbH (GER)… ……… 48 Servier (F)… ……………………………………… 26 Shire plc (IRL)……………………………………… 27 Siemens Healthcare (GER)… …………………… 25 SOLVAY SA (B)… …………………………………… 8 Sony DADC (A)… ………………………………… 47 Sotio a.s. (CR)… ………………………………… 30 Sylent S.A. (E)… ………………………………… 29 Syngenta AG (CH)………………………………… 27 Synthon Biopharmaceuticals (UK)… …………… 16
T
Teva Pharmaceutical Industries Ltd. (IL)………22, 44 Theradiag SA (F)… ……………………………… 50 Thrombogenics (B)… …………………………… 19 Transbiomed S.L. (E)……………………………… 29 Transgene SA (F)… …………………………… 20, 26 Trophos SA (F)… ………………………………… 16
U
UCB S.A. (B)… ……………………… 18, 19, 26, 44 Unfors RaySafe (S)… …………………………… 44 Unilever (UK)……………………………………… 13 UVP Group (USA)… ……………………………… 21
V/Z Vanda Pharmaceuticals Ltd. (USA)… …………… Vitrolife AB (S)… ………………………………… Voisin Consulting (F)……………………………… Vossius und Partner (GER) … …………………… Zeltia Group (E)……………………………………
18 44 18 39 29
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