European Biotechnology News 8/2013 – Free Excerpt: Bridge to the bioeconomy future

Nº 8 | Volume 12 | 2013 | 10.00 € | ISSN 1618-8276 | A 60711 |

European Biotechnology News Science & Industry

CENTRAL EUROPE

Lonza and Teva terminate biosimilar joint venture

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NORTHERN EUROPE

AstraZeneca seals cardiovascular pact with Karolinska Institute Special

The Euro BioFairs Compass guide to life sciences events WESTERN EUROPE

Perrigo bags Irish Elan in US$8.6bn takeover SOUTHERN EUROPE

Vivacell advances cannabinoid compounds with US partner Eastern EUROPE

Hungary razes and burns illegal GM maize science & technology

The iKnife – a scalpel that can smell cancer cells

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Intro

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Editorial

Learning to regulate powerful new diagnostics

Dr. Peter Liese, Rapporteur at the European Parliament’s ENVI on IVDs, Strasbourg

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Peter Liese was elected as a Member of the European Parliament in 1994. He is Chairman of the EPP Working Group on Bioethics in the European Parliament and a member of the Committee on Environment, Public Health and Food Safety (ENVI), as well as a substitute member of the Committee on Foreign Affairs and member of the delegation for relations with the countries of Central America. During this legislative term, Peter Liese became a co-coordinator for the EPP Group in the ENVI committee. Before going into politics, he worked as a doctor in a pediatrics hospital in Paderborn (Germany), and spent six months in Central America working in a state-owned hospital and on foreign aid projects. Liese received his medical degree from the University of Bonn’s Institute of Human Genetics in 1992.

n September of last year, the European Commission presented a proposal concerning a revision of the in vitro diagnostics medical devices (IVD) Directive. The European Parliament and Council will negotiate the concrete wording of the regulation in the coming months, which means it will probably enter into force within the next three to five years.

Many people consider the IVD medical devices regulation the “little sister” of the Medical Devices Regulation, which will be discussed in parallel in European institutions. In my opinion, however, IVD medical devices are less the “little sister” than they are the “parents” of medical devices. Indeed, in some ways they are the progenitors of all therapies, including pharmaceutical products and surgery. Without a proper diagnostic, there can be no proper treatment or prevention of diseases. Unfortunately, the current directive from 1998 has not stopped lowquality IVD medical devices from reaching the market. In the past, there have been cases where low-quality HIV tests were placed on the European market with a CE-label. In one particular instance, a scientific institute had determined even before the notified bodies approved the CElabel that a test delivered many more false negative results than other available HIV tests. In other words, it sometimes said there was no virus present when in fact a subject had contracted the disease. Patients in the EU were given this test for years. When it comes to patient safety, we have to strengthen our system. Similar cases have been reported with hepatitis C, which is still a life-threatening disease that cannot be treated properly.

Another report highlights a different facet of the diagnostics problem. Francis Collins – who headed the Human Genome Project – once sent samples of his own DNA to three different laboratories and received three different results pre-

dicting his risk for contracting certain genetic conditions. That’s why I also believe it is indispensable to include some basic criteria at a European level for the application of genetic tests.

The Commission proposal focuses very much on the quality of a product. But experts and many international organisations – including the Council of Europe, the OECD and the European Society for Human Genetics – have articulated again and again that in many cases, the framework in which the product is applied is even more important than the quality of the product itself. When it comes to DNA testing in particular, it is very important to respect the principle of informed consent. The European Parliament has requested this several times. A legal opinion concludes that it is possible and appropriate to introduce respective wording in the proposal. Therefore, I have proposed respective amendments together with colleagues from all political groups and different countries on this issue. There is a consensus that it should not be the intention of the European Union to limit patient access to DNA tests, but that appro­priate genetic counselling should be offered in cases of predictive and prenatal diagnostics in order to inform patients properly about possible results before a test is performed.

To respect the principle of subsidiary, it should be left to Member States to regulate details, and individual Member States need to have the option to go further than regulations require. One could even argue that it should be mandatory to include informed consent in the proposal, because it is a crucial element of the Charter of Fundamental Rights (Article 3) – a legally binding document for the European Union in those areas where it acts.

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N –º 8 | Volume 12 | 2013

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Euro|Biotech|News

contents

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Insight

Cover Story

European Parliament sets biofuels cap; Heard in Brussels 10 Monsanto switches tracks on GMO marketing strategy in Europe

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EMA greenlights diabetes medicines; EU establishes HTA network; IP Flash 14 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 EMA recommends first two biosimilar antibody drugs 44 CO2 – a sustainable raw material; Technology update

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Leachables in lab plastics

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Regional News

Bridge-building in the bioeconomy

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Biobased processes hold the key to the future in fields from energy supply to plastics production to climate change mitigation. Until now, attempts to link up the wide range of fields and stakeholders involved in creating new value chains have suffered from the lack of a comprehensive road plan that would satisfy both politicians and industry.

Now the European Commission and an industry consortium have proposed a sevenyear a3.8bn public private partnership to do what the EU does best – build bridges.

Services

Special

Euro BioFairs Compass New partners & technologies

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XI International Pharma Licensing Symposium

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Biotechnica 2013

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Northern Europe

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Central Europe

24

Western Europe

26

Bioinnovation & ScanBalt Forum 38

Southern Europe

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BIO-Europe 2013 in Vienna

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Eastern Europe

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BioLatam in Bogotà

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Partners & Associations

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Biopeople News from Abcam, Roche Diagnostics, the BIA, Imperial Innovations Group, Lombard Medical Technologies and Prosonix 47 Company index

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Events What’s on in August-September 2013 49 Encore

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N –º 8 | Volume 12 | 2013

Euro|Biotech|News

INSIGHT EUROPE Biofuels

Technology shift

Heard in Brussels M

A Strasbourg – Europe is making progress in replacing traditional biofuels made with food crops with those made from ligno­ cellulosic waste feedstocks. In mid-July, the European Parliament’s influential ENVI committee voted to set a cap for fuels made from food crops at 5.5% of transport fuel use by 2020. To accelerate the switchover, the body also defined a target value of 2% for socalled ”advanced biofuels”. Additionally, the 43-21 majority proposed including what’s known as an ”indirect land use change” fac­ tor when evaluating the sustainability of bi­ ofuels in the Renewable Energy and the Fuel Quality Directive. The factor seeks to reflect how the clearing of forests, wetlands, or grasslands for biofuel crop production also affects greenhouse gas emissions.

Changing gears in a sensible way The ENVI vote was welcomed by the Lead­ ers of Sustainable Biofuels, a lobby group composed of the CEOs from Clariant, Brit­ ish Airways, BTG, Chemrec, Chemtex, Dong Energy, Forest BtL Oy, St1 Biofuels Oy and UPM – firms pushing the uptake of second­ generation biofuels. ”There is huge poten­ tial for lignocellulosic biofuels in Europe,” said Andre Koltermann, Head of Clari­ ant’s Bio­tech & Renewables Center. ”Stud­ ies prognose they could replace up to 62% of gasoline in Europe until 2020. Thus is is important to redirect investements in more sustainable biofuels by setting a cap that protects investments already been made by first-generation biofuel producers.” He welcomed the move to push for the adop­ tion of advanced biofuels by setting a target, but asked for more. ”Today, the industry has the technology to produce advanced biofu­ els at a competitive price. Companies need a long-term commitment with even high­ er targets beyond 2020.” To exclude fraud it is also crucial, according to Koltermann, to closely look at which feedstocks qualify as advanced. ”It is important to include all lignocellulosic feedstocks that do not grow on arable farmland in that list,” he said. B

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A Bioeconomy PPP – the next generation in collaboration

Brussels – As Horizon 2020 takes shape, I was keen to read about the new public private initiative that will target the bioeconomy (see p. 6-8). Pub­ lic private partnerships mark a signif­ icant change in how collaborative re­ search is undertaken in Europe, and they are a logical progression from the requirement to work across nation­ al borders. The need to work more ef­ fectively through the value chain is an unsolved challenge, and PPPs can help break down borders.

Learning from experience The groundwork for partnerships between the public and private sectors has been in put in place over the last few years within the life sciences, while a healthcare equivalent – the Innovative Medicines Initiative (IMI) – has provid­ ed interesting insights that could help teach us how to optimise a new gener­ ation of PPPs. One of the curious ele­ ments in the IMI is the fact that the ’pri­ vate’ side of the equation only includes large pharma companies, which col­ laborate with SMEs and academic re­ searchers on the ’public’ side. There was a noticeable gap in the company chain between SMEs and Big Pharma firms, as non-SMEs are not eligible for fund­ ing. This has always been odd, as many non-SME companies play a key role in the healthcare value chain, and also be­ cause you can’t expect a smooth transi­ tion from the advanced technologies in academia and early-stage risk of SMEs into the close-to-market activities and structures demanded by companies at the other end of the chain.

A broader bioeconomy The Biobased Industries Consortium (BIC) is behind the Bridge 2020 Public

Claire Skentelbery, Secretary General of the European Biotechnology Network

Private Partnership that aims to trans­ form bioeconomy research and exploit­ ation in Europe. Almost fifty compa­ nies – both large and small – have com­ mitted to the programme, giving it a budget of a2.8bn from the private sec­ tor boosted by a1bn from European Commission coffers. That’s great news, as we know how fragmented life sci­ ence value chains are. The bio­economy, which is trying to move cutting-edge tech into traditional and highly diverse sectors, poses a particular challenge.

For a collaborative effort to truly de­ liver bioeconomy technologies to the market, you need to engage players at every stage of the chain. A clear mar­ ket pathway that is defined by compa­ nies throughout the chain is going to be more effective than one defined by com­ panies perched at the far end (and un­ dergoing their own personal crises).

I have high hopes for this Public Pri­ vate Partnership. Europe is often slow and complex, but it is the only region in the world that makes a huge effort to cross difficult boundaries, and the rewards will come. Go bioeconomy – we’re behind you all the way!

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INSIGHT EUROPE

News M

Light on the Horizon

Brussels – Members of the COREPER Committee have laid the foundations for the coming votes in the European Council and Parliament on the upcoming EU innovation programme Horizon 2020. In mid-July, Member State representatives tabled a package of laws to establish the seven-year programme. Although the final budget is still subject to negotiations, it will amount to some a70bn – a10bn less than initially proposed by the European Commission. About 4% is earmarked for SMEs, while a22bn will be assigned to five Joint Technology Initiatives in promising technology fields, two of which are driven by the life sciences. The Innovative Medicines Initiative, which focuses on pre­ competitive pharma research, will receive a1.725bn from the Horizon 2020 budget and the same amount from Big Pharma companies. The new bioeconomy public-private partnership JTIBBI will be funded with a1bn in EU money, with industry kicking in another a2.8bn (see p. 6).

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IMI 2.0 on the way

Brussels – Big Pharma members of the European industry association EFPIA have welcomed a European Commission decision to continue funding the Innovative Medicines Initiative (IMI).

The Commission expects to launch IMI2 next January with a budget of about a3.5bn through 2024, of which the EU will contribute a1.7bn. According to EFPIA, IMI2 will aim to advance trends in personalised medicine. IMI1 was launched in 2008 with a a2bn budget and the goal of speeding up the development of safer and more effective medicines through a publicprivate partnership.

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EUropean union

Series of GM-hostile actions triggers change in Monsanto’s EU strategy A Brussels – Following a series of drawbacks for GM foods, feed, and seeds, US agribio­tech giant Monsanto has pulled the plug on its European GM seed business. The company, which has never stopped lobbying for biotech crops in the bloc, announced in mid-July that it will withdraw all pending applications to grow new GMOs in Europe due to a lack of commercial prospects for cultivation there. Instead, it said, it would focus on other parts of the world, where interest in GM crops is growing.

In the EU, Monsanto currently has five pending requests to plant GM maize varieties, one GM soy crop, and another for transgenic sugar beet. “We will be withdrawing the applications in the coming months,” said Jose Manuel Madero, Monsanto’s President and Managing Director for Europe. Greenpeace lobbyists celebrated the withdrawal as a success, although it appears to be little more than a refocus in marketing strategy.

According to Madero, the St. Louis-based provider of insect-resistant and herbicidetolerant GM crops will actually expand its EU business with conventional seeds, which traditionally make up the majority of its EU franchise. What’s more, Monsanto isn’t giving up planting its EU-approved GM maize Mon810 in markets – such as Spain – where acceptance for the product is high. In a press

release, Monsanto stressed: “We’ll focus on enabling imports of biotech crops into the EU and expanding our current business, particularly in Eastern Europe.”

Governments against GM crops Although some EU Member States have repeatedly banned EU-approved GMOs at a national level in the past, this summer a new series of anti-GM sentiments surfaced.

Hungary ordered more than 1,000 acres of “illegally sown” GM maize to be burned and ploughed under (see p. 30). France phased out its last remaining field trial with transgenic poplars (see p. 27). And like France and Poland before it, Italy signed a decree in mid-July banning the cultivation of Mon810 maize. The country’s Ministry of Agriculture justified the 18-month-ban with a statement that the crop would have a ”negative impact on biodiversity”.

The European Commission, said it had “noted” the Monsanto decision. GM proponents spoke of a “black hour for Europe” after the announcement. However, Monsonto’s strategy to produce outside Europe and import GM crops into the EU is apparently working. In mid-July, the EU Council failed to vote against the firm’s SmartStax maize. The Commission will likely clear the crop for import in a timely fashion. 

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Euro|Biotech|News

Company And Advertiser Inde x 3i Group (UK)… ………………………………… 47 454 Life Sciences (USA)… ……………………… 47 4SC AG (GER)… ………………………………… 17

A Abbott Healthcare Products Ltd. (NL)…………… 18 AbbVie Inc. (USA)… ……………………………… 18 Abcam (UK)… …………………………………… 47 Abingworth LLP (UK)… ……………………… 21, 27 Ablynx (B)… ……………………………………… 16 Acro Associates Europe (NL)… ………………… 11 Actavis (CH)… …………………………………… 19 Activaris Biotech GmbH (A)……………………… 17 Advanced In Vitro Cell (ES)… …………………… 29 Advancell SA (ES)… ……………………………… 29 Aeris Capital AG (CH)… ………………………… 25 Affimed Therapeutics AG (GER)… ……………… 25 Algeta (N)… ……………………………………… 16 Alize Pharma SAS (F)… ………………………… 16 ALK-Abello A/S (DK)……………………………… 22 Allergan Inc. (USA)… …………………………… 26 Almirall SA (ES)…………………………………… 29 Amgen Europe B.V. (NL)… ……………………… 26 Amgen Inc. (USA)………………………………… 44 Amphivena Therapeutics Inc. (USA)… ………… 25 Aphios Corp. (USA)… …………………………… 28 Apotex Europe BV (NL)…………………………… 18 AstraZeneca AB (SE)……………………………… 22

B Bain & Company (USA)…………………………… 47 Bayer AG (GER)………………………………… 16, 18 BerGenBio AS (N)………………………………… 16 Berlin Partner GmbH (GER)……………………… 35 Biogen Idec (USA)………………………………… 16 Bioinnovation & Scanbalt Forum 2013… ……… 39 BioInvent International AB (SE)… ……………… 23 BioLife Solutions (UK)… ………………………… 47 Biotica Technology Ltd. (UK)… ………………… 47 Boehringer Ingelheim GmbH (GER)… … 18, 25, 44 British Airways (UK)… …………………………… 10 BTG (NL)…………………………………………… 10

C Celltrion (KR)……………………………………… 44 Celltrion Healthcare Hungary Kft. (HU)… ……… 18 Chemrec (SE)…………………………………… 10 Chemtex (USA)…………………………………… 10 Chiesi Farmaceutici S.p.A. (I)… ………………… 26 Clariant (GER)… ………………………………… 10 Coller Capital (UK)………………………………… 26 Concept Heidelberg (GER)… ………… Supplement CSL Behring GmbH (GER)… …………………… 17 Curetis AG (GER)… ……………………………… 17

D/E Dendreon Corporation (USA)… ………………… 18 Deutsche Messe AG (GER)… ………… 19, 36, CP3 Dong Energy (DK)………………………………… 10 DuPont (USA)… ………………………………… 38

EBD Group (GER)……………………………… 40, 41 ecoplus. Niederösterr. Wirtschaftsagentur (A)…… 37 Elan Corp. (IRL)………………………………… 19, 27 Eli Lilly (USA)……………………………………… 25 Eppendorf AG (GER)………………………………… 7 European Biotechnology Network (B)…………… 32 Evotec AG (GER)… ……………………………… 25

F/G Faulding Pharmaceutical Co. (AUS)……………… 47 FIT Biotech Oyi Plc (FI)…………………………… 23 Forest BtL Oy (FI)… ……………………………… 10 Forest Laboratories Inc. (USA)…………………… 27 Galapagos NV (B)………………………………… 17 Gdansk Economic Dev. Agency Ltd. (PL)… …… 38 Gentium S.p.A. (I)………………………………… 29 Genzyme Europe BV (B)… ……………………… 18 GIMV (B)…………………………………………… 21 GlaxoSmithKline (UK)… ……………………… 18, 21

H H. Lundbeck A/S (DK)… ………………………… 16 Helsinn Healthcare S.A. (CH)… ………………… 29 Heptares Therapeutics (UK)……………………… 27 Hercules Technology Growth Capital (USA)… … 26 Hospira One 2 One (USA)… ………… 18, 44, CP4

I/J immatics biotechnologies GmbH (GER)………… 25 Imperial Innovations Group plc (UK)… ………… 47 InterMune Inc. (USA)…………………………… 18 Invesco Ltd. (USA)………………………………… 27 Ipsen (F)…………………………………………… 26 Ironwood Pharmaceuticals (USA)… …………… 29 IVAX Pharmaceuticals s.r.o. (CZ)… ……………… 47 Janssen Research & Dev. (B)… ………………… 25 JenaValve Technology GmbH (GER)… ………… 47 Johnson & Johnson (USA)… ………………… 16, 25

K/L Kreatech Biotechnology B.V. (NL)… …………… 25 Leica Biosystems GmbH (GER)… ……………… 25 Life Science Austria LISA (A)……………………… 15 Life Sciences Partners (NL)… …………………… 27 Lombard Medical Techn. plc (UK)… …………… 47 LoneStar Heart Inc. (USA)………………………… 47 Lonza AG (CH)… ………………………………23, 44 LSP (Life Sciences Partners) (GER)……………… 21

M MedSciences Capital BV (NL)… ………………… 21 Menarini Biotech S.r.l. (I)… ……………………… 29 Merck & Co. (USA)………………………………… 44 MLM Medical Labs GmbH (GER)…………………… 9 Molmed Spa (I)…………………………………… 28 Mondobiotech AG (CH)… ……………………… 20 Monsanto (USA)… …………………………… 12, 30 MPM Capital GmbH (GER)… …………………… 25 Myriad Genetics (USA)…………………………… 14

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N/O NEA (USA)………………………………………… 21 nova-Institut GmbH (GER)… …………………… 13 Novartis AG (CH)… ……………………………… 16 Novartis Europharm Ltd. (UK)…………………… 18 Novo Nordisk A/S (DK)…………………………25, 38 Olink AB (SE)……………………………………… 38 Omrix biopharmaceuticals S.A. (F)……………… 18 Orphan Biovitrum (SE)…………………………… 16 Otsuka Pharmaceutical Co. Ltd. (JP)… ………… 16

P Perrigo (IL)……………………………………… 19, 27 Pfizer (USA)… …………………………… 16, 18, 44 Pharming Group N.V. (NL)… …………………… 27 Phlogo ApS (N)…………………………………… 22 Pierrel Research SPA (I)… ……………………… 20 Polyphor Ltd. (CH)………………………………… 25 Porvair (UK)… …………………………………… 46 Pro-Science Poland Ltd.… ……………………… 38 Prosensa BV (NL)… ……………………………… 21 Prosonix plc (UK)… ……………………………… 47

R/S ReNeuron Group plc (UK)… …………………… 27 Roche AG (CH)… ……………………………… 16, 47 Royce Motors (UK)… …………………………… 47 Salans FMC SNR Denton (USA/GER)… ………… CP2 Sandoz AG (CH)… ……………………………… 44 Sanofi SA (F)……………………………………… 25 Santhera Pharmaceuticals (CH)… ……………… 28 Sartorius Stedim Biotech GmbH (GER)… ……… 43 Scottish Equity Partners… ……………………… 47 Sequenom (USA)… ……………………………… 38 Serodus ASA (N)… ……………………………… 22 Shanghai Inst. of Pharmaceutical Industry (PRC)… 27 SkyePharma PLC (UK)… ………………………… 47 Spectrum Pharmaceuticals Inc. (USA)…………… 47 St1 Biofuels Oy (FI)… …………………………… 10 Syncona Partners LLP (UK)… …………………… 47 Syncroness (USA)………………………………… 47 Syntaxin Ltd (UK)… ……………………………… 26

T/U Teva Pharmaceutical Industries Ltd. (IL)……… 24, 44 Therametrics Holding AG (CH)… ……………… 20 TiGenix BV (B)… ………………………………… 20 TRM Leipzig (GER)………………………………… 17 uniQure BV (NL)… ……………………………… 26 UPM (FI)…………………………………………… 10

V/W/Y Vernalis (UK)………………………………………

Vessics Vascular Inc. (USA)… ……………………

Vivacell Biotechnology Espana S.L.………………

Vivus Inc. (USA)……………………………………

Wales Life Sciences Investing Fund (UK)… ……

Yakult Honsha (JP)…………………………………

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EUROPEAN BIOTECHNICA AWARD 2013

: Save the date 3 7 October 201 Winner of the EUROPEAN BIOTECHNICA AWARD 2011: Unitectra AG

Don’t miss this year’s award presentation: 10th EUROPEAN BIOTECHNICA AWARD, given in recognition of a European biotech or life sciences organization with proven expertise and success in achieving “Integration of Biotechnology into the Industry” One of Europe’s most important biotechnology prizes, awarded by an international jury Monday, 7 October 2013, on the occasion of the BIOTECHNICA Opening Ceremony at the Hannover Exhibition Center (Hannover, Germany)

For detailed information simply go to: www.biotechnica.de/en/award

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