European Biotechnology News 3/2012 - FreeExcerpt - Are released GM mosquitoes safe?

Nº 3 | Volume 11 | 2012 | 10.00 € | ISSN 1618-8276 | A 60711 |

European Biotechnology News Science & Industry

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CENTRAL EUROPE

Novartis poised to enter HCV market with Enanta compound NORTHERN EUROPE

Norway to use sequencing data in the country’s healthcare system WESTERN EUROPE

Oxford Nanopore shakes up Next-Gen sequencing market SPECiAL

BIO-Europe Spring: Antibodies – Unlocking new markets SOUTHERN EUROPE

Are released GM mosquitoes safe?

Spain leads EU project for iPSCs in cell replacement therapies EASTERN EUROPE

Bioton joins forces with Actavis to develop biosimilar insulins SCiENCE & TECHNOLOgy

European Commission presents 2020 roadmap to bioeconomy

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Editorial

Your role in establishing the real bioceconomy Maive rute; Director Biotechnology, Agriculture & Food, DG rtD, Brussels

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Maive rute was nominated Director for SME policy in the European Commission in 2005. the creation of the Small Business Act for Europe and the launch of the pan-European Enterprise Europe Network are considered the two main highlights of her term. During this period, she also led the Commission’s Lisbon team for Estonia. In 2009, rute took on the responsibilities of Director for Biotechnology, Agriculture and Food research in DG rtD, which also includes fisheries and forestry research.

he societal and economic challenges facing Europe and the world are complex and interconnected. The Bioeconomy Strategy and Action Plan “Innovating for Sustainable Growth: a Bioeconomy for Europe”, which was adopted by the European Commission on 13 February 2012, offers a unique approach to addressing these challenges in a comprehensive way.

In order to reduce heavy economic dependency on fossil resources and focus on mitigating climate change, Europe needs to move towards a post-petroleum society. The Bioeconomy Strategy will contribute to this transition by promoting research and innovation into sustainable production and exploitation of renewable raw materials, along with alternative energy and carbon sources. It will pave the way to a more innovative and low-carbon society that reconciles food security with the sustainable use of renewable biological resources for industrial purposes, while simultaneously creating new job opportunities. Biotechnology as an enabling technology will play a crucial role in enhancing sustainability and competitiveness in the EU’s primary production and processing industries.

It will also significantly contribute to reducing EU industry dependence on fossil resources, and improve the resource efficiency of production processes through the use of renewable raw materials (including wastes) and more environmentally-friendly bio-based processes.

The Bioeconomy Strategy is based on three complementary pillars. The first is aimed at increasing investment in research, innovation and skills. Under the European Framework “Horizon 2020” (2014-2020) Programme for Research and Innovation, €4.7bn of funding has been earmarked for bioeconomy research and innovation under the societal challenge “Food security, sustainable agriculture, marine and

maritime research, and the bioeconomy” and for biotechnology as an enabling technology.

It is estimated that this funding could generate about 130,000 new jobs and €45bn in value added in bioeconomy sectors by 2025, not taking into account other direct and indirect public and private investments into bioeconomy sectors. A Public Private Partnership for bio-based industries is under consideration.

The second pillar aims to improve synergies and coherence between priorities of European research and innovation policy and other policies relevant to the bioeconomy. It will provide different platforms to enhance interactions between researchers, policymakers, industries and society, as well as supporting similar initiatives in the EU Member States and Regions. The Strategy will also further develop international cooperation in the area of the bioeconomy.

In its third pillar, the Strategy provides support to new markets and the expansion of existing ones; for example, by promoting the development of standards, sustainability assessments and labels for bio-based products that will help facilitate their uptake in consumer markets and by green procurement. This promotes both the establishment of networks of integrated and diversified biorefineries, and demonstration and pilot plants across Europe. Finally, the Strategy promotes the development of science-based approaches that can better inform consumers about product properties (like environmental sustainability) and aid in the promotion of a healthy and sustainable lifestyle.

Five Commissioners have demonstrated their strong commitment to the bioeconomy by cosigning the Bioeconomy Strategy. However, its success will very much depend on the commitment of member states, regions, stakeholders in the research and innovation community and citizens – like you.

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coNteNts

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INsIght 6

Heard in Brussels

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© ctRd/istockphoto.com

cover Story

Release of GM mosquitos spurs debate on GM safety issues

EU adopts bioeconomy priorities

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GMO acreage grows all over the globe 12 RegulatoRy affaIRs Update on clinical trials

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Breaking news from the EMA

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ecoNomIc Focus on newsflow and dividends

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Stock markets

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PeRsPectIVes Portugal: life after the recession

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Release of transgenic mosquitoes in large-scale studies spurs European debate on safety issues

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The latest high-profile debate between environmental groups and bioengineers continues to heat up. Over the last three years, British firm Oxitec’s release of millions of genetically modified mosquitoes on Grand Cayman island has decimated populations of the disease-carrying insects there, but that success has come at a price.

Eager to avoid a media disaster like the one that occurred with GM crops, many EU scientists are now also calling for clear standards and guidelines.

Of mAbs and new immunotherapies 49

Northern Europe Denmark, Norway, Sweden

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Central Europe Germany, Austria, Switzerland

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Western Europe UK, France, Ireland, Netherlands

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Southern Europe Italy, Spain, Portugal Eastern Europe Poland, Hungary, Czech Republic

seRVIces

Special

RegIoNal News

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Antibodies & markets Editorial: Domenico Alexakis

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Intro: Antibodies & Partnering

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Enhancing ADCC

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Manufacturing of bispecific mABs 36 Antibodies against Alzheimer’s

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Upscaling bioprocesses

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Companion diagnostics for mAbs 42 Armed cancer antibodies

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Partners & Associations

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Imprint

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Biopeople News from Tecan, Prosonix, Ablynx, Silence Therapeutics, Biotie, and the Swedish Royal Academy of Sciences 28 Company index

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Events What’s on in March-April 2012

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Encore

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INsIght EuropE Genetically modified orGanisms

Trust, transparency & transgenic insects the human race is at war with another species, and has been for thousands of years.

Each of us in Europe swats dead dozens of the enemy every summer, and in the tropics they kill thousands of people with infectious diseases hidden within their bodies. As in all wars, the battle for public opinion plays a key role in hostilities, along with the latest high-tech weaponry. the newest front in our battle with bloodsucking insects is now a matter of public debate. Innovative and powerful bioengineering technologies are providing Homo sapiens with a potential game-changer in the war against disease-carrying mosquitos. unfortunately, at some point the weapons have to be tested out in the field. Exactly how careful and transparent do researchers have to be in large-scale studies involving transgenic animals?

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the supplement, however, these die before reaching maturity. The release of successive waves of transgenic adult male mosquitoes, so the theory, can help decimate populations of the dangerous disease-carriers.

And in fact, the first results from the Caribbean look positive. “We monitored the mosquito population very thoroughly for several months after the pilot study was conducted, and found an initial reduction in the population of around 80%,” said Bill Petrie, the Director of Cayman’s Mosquito Research & Control Unit. He also told the country’s news service in January that “these data refute any allegation that the released mosquitoes persisted in the environment.” Fears in the general public might revolve around being bitten by GM mosquitoes, but for experts, the persistence of the implanted genes in the wild population would be a worrying indicator that everything was not going according to plan.

A grave lack of transparency

Luminescence is just one trait bioengineers can now build into an insect’s DNA.

Since 2009, Oxford-based biotech company Oxitec Ltd has released millions of genetically altered Aedes mosquitoes – which transmit both yellow fever and dengue fever – in a field test on the island of Grand Cayman. In 2010 and 2011, the British bioengineers also began large-scale experiments in both Brazil and Malaysia. A long list of other countries where the diseases pose a major health concern are lining up to host field tests of their own. Strikingly, it took more than a year for the littlepublicised studies to begin making head-

lines. But when they did, the ensuing uproar was loud, and many scientists have sided with environmental groups in voicing concerns about inadequate oversight in the emerging field.

The mosquitoes used in the Grand Cayman study were altered using Oxitec’s RIDL® technology, which produces insects that can only survive if as larvae they are also fed a particular supplement. Larvae born of matings between RIDL and wildtype mosquitoes live for awhile, competing with ‘healthy’ offspring. Without access to

Although the experiment has apparently gone well, Oxitec was widely condemned

by NGOs and environmental organisations for not being more forthcoming about the study, even though it was approved by the Caymans government. Scientists are also concerned about gray areas and a lack of standards. In a paper published at the end of January in the open-access journal PLoS – Neglected Tropical Diseases, researchers from the Max Planck Institute for Evolutionary Biology took a close look at how different countries cope with oversight and public access to information on large-scale field tests with GM mosquitoes – and found them seriously lacking. In “Scientific standards and the regulation of genetically modified insects”, their assessment of the regulatory apparatus found that in field experiments performed with transgenic insects in the US so far, little was done to inform the public in advance that the tests were taking place, and there was no real public debate on the issue. There was also no estimate of possible hazards prior to the releases in the Caymans, Brazil or Malaysia.

“We noted that public access to scientific information is highly restricted throughout the world, particularly information made

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INsIght EuropE available before releases start,” said Guy Reeves, the paper’s lead author, who also pursues fundamental research in how to combat disease-carrying insects effectively with the help of bioengineering techniques.

“We argue for transparency – not for transparency’s sake – but for clearly articulated strategic reasons that promote acceptance of the value of evaluating this promising technology,” he says.

trying not to repeat mistakes According to the WHO, up to 100 million people are infected with dengue fever every year. Around half a million of them, mostly children, end up in hospital. Up to 30,000 people die of the disease annually. Yellow fever kills around the same number. While there is an effective vaccine available for yellow fever, the only way to fight dengue at the moment is through vector control.

Scientists in the field agree that bioengineered insects could prove an effective weapon in controlling that host vector, but are divided on the best ways to move forward with the research. Oxitec has defended its quiet pursuit of large-scale testing by pointing out that government agencies in the affected countries approved the trials well in advance. And the company’s initial success has paid off in more than scientific terms. In February, Oxitec received £8m in fresh cash from investment fund Oxford Capital, and has also increased staff numbers.

But many other scientists and companies are desperate to avoid a media debacle like that surrounding GM crops in Europe. By ignoring public concerns in the early days of that technology, firms like Monsanto drove European consumers firmly into the anti-GMO camp, where they have remained to this day. Researchers active in the field of transgenic insects don’t want to see those mistakes repeated.

“While it may appear naïve to argue for pre-release access to accurate scientific information and a high quality multi-disciplinary approach,” concludes the MPI researchers’ paper on standards, “it is in our opinion even more naïve to expect that the development of GM insect technologies will progress far in its absence.”

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Heard in Brussels M

Keeping it local – be afraid of the CJEu

Brussels – In February, I heard of a slightly mad and very worrying trend in decisions handed down by the Court of Justice of the European Union (CJEU) with regard to IP issues handed up from the national level for clarification. IP is not very exciting to start with, but the more you understand about the situation developing, the more you see Europe backing itself into a corner about something that could have major ramifications for commercialisation of technologies.

It all started with IP for antibodies. As everyone in the industry knows, antibodies are incredibly complicated items in terms of IP – with a product that cannot be pinned to the wall accurately, and with post-translation modification and environmental factors influencing structure, activity and effect. This leads to long development times in groundbreaking regulatory and IP arenas. The supplementary protection certificate (SPC) in theory gives 5.5 years of extension beyond the original patent duration, and this has been used by a number of organisations to enable effective biological products to be protected to market. Of course, this is a very challenging area of IP, which was not designed to include biological entities, and which refers strongly to the regulations of the original patent. Increasingly, national patent offices are referring tricky cases to the CJEU for clarification, and this is where the wheels are coming off – with very serious consequences for the European commercial environment.

Instead of casting light into the darkness, aside from a few notable decisions, the CJEU has instead returned slow, lengthy and impenetrable decisions that make it nearly impossible to make a national decision to grant an SPC. Clarification has been requested but actively avoided by the court, a great example being reference to ‘non-European rules governing patents’ but without actually saying which

Claire skentelbery, secretary general of the European Biotechnology Network

ones, even when asked a straight question on the matter.

National authorities are unable to interpret the legal way forward. “I am bound to say that I find this reasoning difficult to follow,” says Lord Justice Arnold, and “not only has the Court not answered the question referred, but also the guidance it has provided is not sufficiently clear to enable future disputes to be resolved”.

Translation: it would seem that Europe has knitted itself a time-bomb for extending protection of biological products. The CJEU, through either a profound lack of understanding of the issues or through wilful incompetence, is preventing the successful exploitation of next-generation therapeutics, and can’t be touched.

The price will be paid by European companies trying to develop products, by researchers who have dedicated years to the innovation behind biologicals and of course by the patients, who may wait much longer for a groundbreaking therapy. Those products will one day be developed elsewhere and imported into Europe – exactly the opposite of the EC’s drive to create a knowledge-driven economy … and a mess of Europe’s own making. B

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CompaNy aNd adVertiser iNde x

4SC AG (GER) ……………………………… 15, 17

a Abbott Laboratories (USA) ………………… 14, 23 Ablynx NV (B) ………………………………… 28 Accenture plc (IRL) …………………………… 28 Actavis Group (IS) ……………………………… 26 Actelion AG (CH) …………………………… 17, 50 Adocia S.A.S. (F) ……………………………… 16 Alfama (PT) …………………………………… 47 Algeta ASA (N) ……………………………… 13, 50 Altana AG (GER) ……………………………… 17 Amgen Inc. (USA) ……………………… 15, 32, 49 Amsterdam Molecular Therapeutics (NL) …… 22 Angiochem (CDN) ……………………………22, 50 Apeiron Biologics (A)…………………………… 21 Astra Zeneca (GB/S) …………………………… 50

B BASF Plant Science GmbH (GER) ……………

Bayer Schering Pharma AG (GER) ……………

Bayern Innovativ GmbH (GER) ………………

Berlin Partner GmbH (GER) ……………………

BIO.NRW (GER) …………………………………

BioAlvo (PT) ……………………………………

Biocant (PT) ……………………………………

Biocodex (PT) …………………………………

BIOCOM AG (GER) ……………………………

Biofrontera (GER) ………………………………

BioGaia AB (S) …………………………………

Biogen Idec (USA) ………………………………

Biogenes GmbH (GER) …………………………

Biomode (PT) …………………………………

Bionor Pharma ASA (N) ………………………

Biopartners (CH) ………………………………

Biopremier (PT) …………………………………

Biosurfit (PT) ……………………………………

Biotecnol (PT) …………………………………

Biotie Therapies Corp. (FI) ……………………

Bioton S.A. (PL) …………………………………

Biotrend (PT) ……………………………………

BioWin - The Health Cluster of Wallonia (B) …

Boehringer Ingelheim GmbH (GER) …………

Braskem SA (BR) ………………………………

Bridge Plus AG (CH) ……………………………

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

Bristol Myers Squibb Company (USA) …………

BTG plc (GB) ……………………………………

50 43 25 37 41 47 47 47 49 21 18 49 49 47 19 26 47 47 47 28 26 47 11 28 10 31 20 32 50

C Caixa Capital Biomed (E) ………………………

Caixa Capital Risc (E) …………………………

Celgene Europe Ltd. (GB)………………………

Cell2B (PT) ………………………………………

CellArtis AB (S) …………………………………

CEV (PT) …………………………………………

ClamiTec (PT) …………………………………

CLC bio (DK) ……………………………………

Cobra Biologics (GB) ……………………………

CTI Life Sciencs Ltd. (GB) ………………………

Cytos AG (CH) …………………………………

25 25 32 47 24 47 47 24 23 14 21

d DASGIP AG (GER) ……………………………… 40 Desitin Arzneimittel GmbH (GER) …………… 21

DIESSE Ricerche S.r.l. (IT) ……………………… 25 Dr. Regenold GmbH (Regulanet) (GER) ……… 42

e/F EBD Group (GER) ……………………………… 33 ECBio (PT) ……………………………………… 47 Elektrobit Corp. (USA) ………………………… 28 Eli Lilly (USA) ………………………………… 16, 26 Enanta Pharmaceutical Inc. (USA) …………… 20 Equigerminal (PT) ……………………………… 47 EuroBioJobs.org (CH) ………………………… 15 European Biotechnology Network (B)………… 30 Forest Laboratories Inc. (USA) ………………… 27

G Galapagos NV (B) ……………………………… 15 Gedeon Richter Ltd. (HUN) …………………… 27 Gene PreDiT (PT) ……………………………… 47 GeneBox (PT) ………………………………… 47 Genetest (PT) ………………………………… 47 Genfit SA (F) …………………………………… 13 GenIBET (PT) …………………………………… 47 Genmab A/S (DK) …………………………… 19, 40 Genticel S.A. (F) ……………………………… 13 Genzyme Corp. (USA) ………………………… 28 Geron Corp. (USA) …………………………… 22 Gilead Ltd. (USA) ……………………………… 20 GlaxoSmithKline (GB) ………………… 21, 24, 50 Grünecker Patent- und Rechtsanwälte (GER) … 12

H H. Lundbeck A/S (DK) ………………………… 19 Hanwha Chemical Corp. (KR) ………………… 32 HBM Partners AG (CH) ………………………… 16 Horizon Discovery Ltd. (GB) …………………… 24 Hospira One 2 One (F) ………………………… CP2

i IDA Ireland ……………………………………… 23 Illumina Inc. (USA) ……………………………22, 50 ImunoStar (PT) ………………………………… 47 InfoGene (PT) ………………………………… 47 Inspiration Biopharmaceuticals (USA) ………… 25 Integromics S.L. (E) …………………………… 24 Intradigm Corp. (USA) ………………………… 28 Isconova AB (S) ………………………………… 19

J/K Janssen Pharmaceutica N.V. (B) ………………

Karo Bio AB (S) …………………………………

Kempen & Co (NL) ……………………………

Kiecana Clinical Research (PL) …………………

KPMG (GER) ……………………………………

19 19 15 27 28

L/m Leica Microsystems (Schweiz) AG …………… 28 LISA Vienna Region (A) ………………………… 35 Luzitin (PT) ……………………………………… 47 Mabion S.A. (PL) ……………………………… 27 Matera (PT) …………………………………… 47 Merck & Co. (USA) …………………………… 32, 50 Merck KGaA (GER) ………………………… 21, 28 Messe München GmbH (GER) ……………… 13 Micromet AG (GER/USA) …………………… 15, 49 Monsanto (USA) …………………………… 12, 23

N Nestle S.A. (CH) ……………………………… 18 Neurimmune AG (CH) ………………………… 38 nLife Therapeutics S.L. (E) …………………… 25 Nomura Code (GB) …………………………… 50 Novartis AG (CH) …………………………… 20, 28 Novartis Europharm Ltd. (GB) ………………… 14 Novonordisk A/S ……………………………… 26 Novozymes A/S (DK) ……………………… 10, 19 Nycomed GmbH (GER) ……………………… 17

o Ordesa Laboratories (E) ………………………

Orexo AB (S) ……………………………………

Oryzon Genetics S.A. (E) ………………………

Oxford Nanopore Technologies Ltd. (GB) ……

24 19 24 22

p PAREXEL International GmbH (GER) ………… 32 Particular GmbH (GER) ………………………… 27x PharmaMar Zeltia Group (E)……………………… 9 Pharmasset (USA) ……………………………… 20 Philochem AG (CH) …………………………… 44 Polymun Scientific (A) ………………………… 21 PregLem SA (CH) ……………………………… 27 Preqin (USA) …………………………………… 16 ProBioGen AG (GER)………………………… 34, 39 Prosonix plc (GB) ……………………………… 28 ProStrakan (GB) ………………………………… 14

r Reed Exhibitions Japan Ltd (JP) ……………… CP3 Roche AG (CH) …………………… 13, 32, 36, 50 Roche Diagnostics GmbH (GER) ……………… CP4

s Samsung (KR) …………………………………

Sandoz AG (CH) ………………………………

SANOFI - Aventis (F) ……………………………

Schering AG (GER) ……………………………

Sea6 Energy (IND) ……………………………

Shing Poong Pharmaceutical Co. Ltd. (KR) ……

SilicoLife (PT) ……………………………………

Stemmatters (PT) ………………………………

Syngenta (CH) …………………………………

32 20 26 28 19 14 47 47 23

t Tecan (CH) ………………………………………

Technophage (PT) ………………………………

Thelial (PT) ………………………………………

Theshold Pharmaceuticals Inc. (USA) …………

Toscana Biomarkers Srl (IT) ……………………

TreatU (PT) ………………………………………

28 47 47 21 25 47

U UMN Pharma Inc. (J) …………………………… 18 uniQure BV (NL) ……………………………… 22 UPM (FI) ………………………………………… 19 Uppsala Bio (S) …………………………………… 7

V/W Vectron Biosolutions AS (F) ……………………

VetBioChem (RU) ………………………………

Vossius & Partner (GER) ………………………

Watson Pharmaceuticals (USA) ………………

18 19 49 32

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