European Biotechnology News 9/2013 - freeexcerpt

Nº 9 | Volume 12 | 2013 | 10.00 € | ISSN 1618-8276 | A 60711 |

European Biotechnology News Science & Industry

CENTRAL EUROPE

Haplogen presents antibody vaccine against multiple viruses NORTHERN EUROPE

AstraZeneca expands its footprint in cancer immune therapy

T P R E XC

E E E R F

SPECIAL

Biotechnica 2013 – from tools to platforms WESTERN EUROPE

Electroceuticals energize the market

British BIA lobbies against new drug pricing system SOUTHERN EUROPE

Chiesi enters orphan drugs with Zymenex take-over EASTERN EUROPE

Polish report on biosimilars predicts major growth SCIENCE & TECHNOLOGY

Haploid human cell line set to accelerate drug discovery

Research is still your favorite?

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N –º 9 | Volume 12 | 2013

Euro|Biotech|News

Intro

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Editorial

In biosimilars, don’t do ‘more’ – just get it right

Carsten Thiel, PhD, Vice President Amgen Europe, Zug, Switzerland

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Carsten Thiel is the Vice President and Regional General Manager of Amgen Europe. He joined the European oncology franchise in 2002, and held the post of General Manager for Amgen’s Central and Eastern European operations from 2006-2007 before taking up duties as General Manager in Germany from 20072010. He moved to his current post in 2011.

iosimilar products are not generic medicines, nor are they identical to their reference product or each other. Instead, they are similar versions of well-established recombinant proteins with well-characterised structures and pharmacology. All biologics (biosimilars and reference products) have complicated safety and immunogenicity profiles.

So far only three classes of bio­similar have been approved for use in the EU (somatropins, epoetins and GCSFs), but a second generation of biosimilars is on the way that focuses on more complicated molecules – such as monoclonal antibodies and fusion proteins – to help patients fight diseases like RA and cancer. This has been made possible by the EU’s science-led regulatory framework, which has established confidence in the quality of existing biosimilars. Various biosimilars are currently in different stages of clinical development and regulatory approval in the EU, and biosimilar regulatory pathways are also in place in countries like Canada, the US and Australia.

Biosimilars have been providing alternative therapeutic choices for European patients and physicians since 2006. The European Commission recently completed an exhaustive study on the introduction of biosimilars into European medical practice, and determined that their availability is helping increase market competition.

Although the available commercial data says other­wise, some claim biosimilars have had a disappointing introduction, and that regulators and politicians need to do ‘more’ to spur their uptake. As a representative for a company developing several biosimilar medicines, I tend to disagree. It’s important to let the market decide, and ensuring patient safety should be the foremost concern for both governments and the biosimilars industry.

There have been significant advances in our ability to use analytics to better understand the biology of both reference product and bio­ similar. However, we haven’t yet (and may never) reach a stage where biosimilars should not be absolutely required to exhibit fidelity to their reference products and be rigorously evaluated in analytical, non-clinical and clinical comparisons.

The industry has an obligation to take proactive steps to be accountable to providers and patients for product quality. For example, all stakeholders, manufacturers, regulators and healthcare professionals should embrace pharmaco­vigilance and naming systems that allow all biologics to be properly identified and traced in cases of adverse events. The EU’s pharmaco­vigilance legislation addresses this, and will help instill further confidence in the field.

It’s evident that high-quality, reliably supplied biosimilars can offer additional choices to patients and other key stakeholders, although development and supply of these complex medicines is scientifically challenging and capitalintensive. We now know manufacturers need significant expertise, infrastructure and capital to successfully develop these molecules.

The healthcare community, industry and regulators have a key opportunity – to work as partners to ensure appropriate standards for these products are maintained. As we at Amgen move forward with developing our own port­folio, we know our experience is critical in a field where patient safety and reliability of supply are paramount concerns.

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N –º 9 | Volume 12 | 2013

Euro|Biotech|News

CIRCUL ATION

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European Biotechnology News is published in co-operation with the following organisations: European Biotechnology Net work

Europe: european-biotechnology.net

Germany: biodeutschland.org

Switzerland: swissbiotech.org

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CouncilBlue: of European 100/15/0/35 BioRegions Orange: 0/75/90/0

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Ireland: ibec.ie/ibia

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Denmark: danskbiotek.dk

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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

Italy: assobiotec.it

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N –º 9 | Volume 12 | 2013

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Euro|Biotech|News

contents

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Insight

Cover Story

Campaigners protest release of GM insects in Europe

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Australia challenges Europe’s biosimilars rules; EC paves way to unified patent court; EMA begins reorganisation

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EC checks unlawful state aid for pharma firms; ERC grants; IP Flash

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Regulatory Affairs Update on clinical trials

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Breaking news from the EMA

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Could electroceuticals replace many drugs?

Economic Focus on newsflow and dividends

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Stock markets

20

Perspectives New IVD regulations: The key to getting the transition right, Jesús Rueda Rodríguez, EDMA

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PharmaLab 2013 preview

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Regional News

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Current treatments for metabolic and immune diseases are molecule-based, with available therapies all involving medicines that have been approved for specific conditions.

But what if physicians could instead use targeted electrical current to keep the immune system of a patient who suffers from asthma or diabetes on track? As pacemakers and deep brain stimulation show, electricity can heal. Now big investments on the part of Big Pharma are taking pioneering bioelectronic therapies to the next level.

Services

Special

Partners & Associations

Biotechnica Biotechnica

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Northern Europe

22

Interview: Harald Sobek, Roche Diagnostics

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Central Europe

24

Biotech in Switzerland

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Western Europe

26

Companion Diagnostics: Medical and regulatory considerations 39

Southern Europe

28

Eastern Europe

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Interview: David Spaight, CEO WIL Research

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Biopeople News from the European Food Safety Authority, Skyepharma plc, Sanofi, Algeta ASA, Horizon Discovery and Genzyme 47 Company index

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Events What’s on in September-October 2013 49 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: ©Feraru Nicolae/fotolia.com ® BIOCOM is a registered trademark of BIOCOM AG, Berlin, Germany.

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INSIGHT EUROPE Genetic Engineering

Fly fracas

Heard in Brussels M

A Strasbourg – GM opponents from Testbio­tech have begun campaigning to stop field experiments – applied for by British company Oxitec – aimed at reducing the economic impact of olive flies. In a press release, the NGO predicted dire consequences if trials with genetically modified insects are allowed in Italy and Spain (see p. 28). Oxi­tec has used its RIDL technology to insert a lethality gene into the insects that causes female offspring to die before reaching adulthood.

Testbiotech said the tests would pose unpredictable risks for olive farmers. “If the genetically engineered flies escape, the harvest in the regions concerned would become non-marketable,” said the organisation’s head Christoph Then, since any GM larvae in the olives would not be approved for food consumption in the EU. Oxitec’s male olive fly RIDL strain (OX3097D), which has been subject to extensive testing, could help dramatically reduce the huge amounts of olive­-penetrating insecticides currently used to fight the pests.

Oxitec has already carried out field trials in Brazil and Malaysia in another area, reducing populations of a mosquito species that acts as a vector for dengue fever.

Oxitec says its method of pest control is safe and effective. “This application is to request the ability to carry out a very limited field trial, under nets to preserve the integrity of the trial, as a first step to demonstrate the potential of this method to control the olive fly – a huge threat to European olive production and to small communities dependent on the olive,” Oxitec CEO Hadyn Parry told EuroBiotechNews.“Spain already uses sterile insects in citrus, and our approach we believe expands the potential of a tried and tested methodology. We have seen a very positive response to our approach around the world, where we have primarily focused on mosquitoes that spread dengue fever. All releases we have made in all countries are carried out with the approval of regulators,” Parry added.

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FREE EXCERPT

Is getting specialised smart? Europe is going to find out

Brussels – Europe has a wealth of talent and skills embedded in its regions, skills which are highly diverse and usually associated with a long history of trade and culture. The latest regional development policy – one that will underpin future structural fund spending – is “Smart Specialisation” – and it is coming to a region near you soon.What does that have to do with me?” I hear you cry. “I’m a scientist and wouldn’t know a regional policy if it bit me!” However, this is likely to impact everyone in the sector, particularly if you are an SME and rely on regional funds as part of your income. In a nutshell, 'smart specialisation' is a strategy for building commercial strength through an integrated approach to regional development that draws on a region’s strengths.

Regions have to submit a 'smart specialisation' plan to the EC, and you can bet your bottom dollar (or euro) that you are going to see changes to regional investment based on this.

Making the smartest move Smart specialisation is intended to foster entrepreneurship and innovation around a topic important to the region. It's a winner for those who find their business close to the smart specialisation strategy, since regional investment and funding should become more accessible. In biotech, however, Europe has always struggled with regional specialisation. Instead, universities usually create clusters around diverse research output, and I can’t think of a single cluster with a technology or application that creates critical mass.

This is where the problem may lie for biotechnology development. If your region creates a smart specialisation strategy that doesn’t benefit you, regional investment could dry up rapidly. Regional funding for environmental technologies or ICT won’t fund an oncology start-up.

Claire Skentelbery, Secretary General of the European Biotechnology Network

Bioeconomy is the obvious winner in smart specialisation – especially areas like food production, which encompasses high-tech to low-tech industries and impacts directly on local landscape and production chains. This makes sense for European regions, most of which have local specialities and significant employment around food production. It also ticks the boxes for regional politicians, as you can see results quickly and locally.

But what of healthcare biotech? It doesn’t tend to employ high numbers over a wide spectrum. Results are felt globally, and local public awareness is often limited to a headline in the regional paper rather than a new factory or locally recognised product. I suspect that where there are no existing commercial activities in healthcare, it won’t feature in specialisation strategies. That will impact on tech transfer in the region’s universities, as most start-ups fall close to the tree.

As regions publish smart specialisation strategies, serious money will follow. Will Europe be able to build on regional strengths without stifling innovation in other sectors? We just have to wait and see.

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INSIGHT EUROPE

FREE EXCERPT

News Court delay

Brussels – Just before the summer break, the European Commision paved the way for the Unified Patent Court (UPC) to solve disputes in one instance and avoid multiple litigation cases in up to 28 different national courts. At the end of July, the Commission tabled amendments to the so-called Brussels I Regulation, which will allow the court to operate across borders. The UPC can get down to work after being adopted and greenlighted by the European Parliament and Council. It’s hoped the new legal body will accelerate decisions on the validity of patents and cut costs significantly. The original time-line, however – which originally called for the UPC to open sometime in early 2014 – has been delayed because at least 13 Member States have to ratify the agreement to establish the court.

Experts now say it will take at least a further four months for the UPC to go into operation. Officially, the new kickoff date is at some point in 2015, but many legal experts say they don’t expect it to take up work before 2016.

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EMA reloaded

London – The European Medicines Agency’s CHMP has begun the process of internal reorganisation. Its current two divisions ”Human Medicines Development and Evaluation” and ”Patient Health Protection” are to be replaced by four new branches: support for industry’s R&D phase; medicine evaluation and lifecycle management; procedure management and business data; and inspections and pharmacovigilance. The agency hopes to establish the new structure by next year. Further details will be published in September.

© ursule – Fotolia.com

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EMA/TGA

The biosimilar quagmire goes global A London/Symonston – For some time, Australia has simply adopted the European Medicines Agency’s (EMA) rules for demonstrating comparability of biosimilars to their originators. But that changed in August, and this latest regulatory move could prove both a model for other countries, and a real threat to marketing bio­ similars. In contrast to current practice at the EMA, Australia’s Therapeutic Goods Administration (TGA) published guidelines requiring special provisions when it comes to naming biosimilars – giving one its so-called International Nonproprietary Name (INN). According to the TGA, any individual biosimilar ”must be assumed to be different to any other bio­similar, as no direct comparability study has been conducted.” Because only small differences can cause different clinical behaviour, particularly regarding immunogenicity, ”certain additional nomenclature differences are necessary to ensure that it is possible to distinguish beween biosimilars and clearly identify the reference product,” the TGA ruled. The agency wants to implement suggestions made last February by the World Health Organisation’s INN Committee, which grants generic names. It proposes tagging a generic biosimilar name with an identifier and an additional three-letter code specific only to that product to help prevent confusion among prescribers. The TGA shares the view that a combination

of generic name plus company name may suggest that biosimilars are generics. According to the TGA, however, studies can currently only provide data on comparability, and not bioequivalence.

Manufacturers less than happy Australia’s Generic Medicines Industry Association (GMiA) stressed that not all of its member companies would agree with the naming convention. They view the INN solely as a measure to classify pharmacological classes, but not to identify a drug product or as a means of tracking drug safety.

Under EMA rules, a biosimilar shares the same INN as its reference substance. Each biosimilar has a unique brand name coupled with the company name but a generic name identical to that of the originator.

According to the European Generics Association (EGA), the automatic substitution of a brand drug for its biosimilar is regulated by each EU Member State individually. But de facto a physician’s prescription decision is usually based on the INN. As a consequence, difficulities may arise in recognising a biosimilar just from the combination of brand and company name. According to the US Generic Pharmaceutical Association ”bio­similar competition is expected to be the most important opportunity to hold down the cost of biologic medicines.” 

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Company And Advertiser Inde x

has largely been true of laboratory equipment fairs. For visitors and exhibitors with a focus on pharma, these were often too large and not specific enough. Events like these can rapidly translate into many visitors but little professional exchange for specialised exhibitors. A new series of conferences aims to fill that gap.

PharmaLab (13-14 November, Swissôtel Düsseldorf, www.pharmalab-congress.

com) will kick off in 2013. The goal of the new laboratory congress is to provide lab staff in the pharmaceuticals industry with up-to-date information on new developments, applications and validation in analytics, bio­analytics and microbiology. It also aims to facilitate the exchange of information and experience pertaining to GMP compliance in labs. In six conferences, 40 speakers from the industry, from both contract laboratories and authorities, will report on hands-on experience in the lab, regulatory changes and method implementation and validation.

The major exhibition that will be held in parallel. Located centrally between the conference rooms, is also aimed at streamlining information exchange. Nearly 40 specialised providers will be on hand there to present the latest systems, methods and services, allowing visitors to contrast and compare the most cutting-edge laboratory equipment.

B schroeder@concept-heidelberg.de

Abbott Laboratories (USA)… ………………………… 47 Ablynx (B)… …………………………………………… 47 Actelion Pharmaceuticals Ltd. (CH)……………… 25, 38 Alexion Europe SAS (F)………………………………… 18 Algeta ASA (N)… ……………………………………… 47 Almirall S.A. (E)………………………………………… 16 Amgen Europe (CH)…………………………………… 3 Amplimmune Inc. (USA)… …………………………… 22 Analytik Jena AG (GER)………………………………… 35 Arthurian Life Science Group (UK)…………………… 26 ASEBIO/Invest in Bogota (E)… ……………………… 15 AstraZeneca AB (S)… ………………………………… 22 Axis-Shield plc (UK)… ………………………………… 47

Forest Laboratories Inc. (USA)………………………… 16 Fraunhofer IZI (GER)…………………………………… 27 Fresenius Kabi Deutschland GmbH…………………… 18

Orphan Biovitrum (S)… ……………………………… 22 Oxford Biomedica (UK)… …………………………… 21 Oxitec Ltd. (UK)…………………………………… 10, 28

GANYMED Pharmaceuticals AG (GER)… …………… 18 Genfit SA (F)… ………………………………………… 21 Genzyme Corp. (USA)… ……………………………… 47 GlaxoSmithKline (UK)… ……………………… 16, 47, 50 GlycART Biotechnology AG (GER)… ………………… 34 Grünecker Patent- und Rechtsanwälte (GER)………… 14

Patcore (JP)… ………………………………………… 30 Peptisyntha S.A. (B)… ………………………………… 27 Pfizer (USA)… ………………………………… 16, 21, 22 Pharming Group N.V. (NL)… ………………………… 21 PMR (PL)… …………………………………………… 30 Promethera Biosciences (B)………………………… 18

Haplogen GmbH (A)…………………………………… 24 Hospira One 2 One (USA)… ………………………… 7 Humabs Biomed SA (CH)… ………………………… 24

QOL Therapeutics EU Ltd. (UK)… …………………… 18

Bayer Healthcare AG (GER)……………………………

BIOCOM AG (GER)… …………………………………

Bioinnovation & ScanBalt Forum 2013… ……………

Biomerieux (F)… ………………………………………

Biopta Ltd. (UK)…………………………………………

Biosurfit (PT)……………………………………………

BlueSens gas sensor GmbH (GER)……………………

Boehringer Ingelheim (GER)… ………………………

Bone Therapeutics (B)…………………………………

Borders Technology Manag. (UK)… …………………

50 6 13 26 24 47 23 23 18 18

Immco Diagnostics (USA)… ………………………… 26 Invista S.a.r.l. (PT)……………………………………… 28 iReg Medical AB (S)… ………………………………… 18

Centaur Pharmaceuticals (IND)… ……………………

Ceptaris Therapeutics (CH)……………………………

Chemaxon Kft. (HUN)… ………………………………

Chiesi Farmaceutici S.p.A. (I)… ………………………

Clariant (GER)… ………………………………………

Close Brothers Seydler AG (GER)… …………………

Cobra Biologics (UK)……………………………………

Corden Pharma GmbH (GER)…………………………

CRO-PharmaNet Services GmbH (GER)………………

Cytotools AG (GER)… …………………………………

16 25 30 28 33 19 39 27 18 16

Dermatools Biotech GmbH (GER)… …………………

Deutsche Messe AG (GER)… …………………………

Dr. Regenold GmbH (GER)… ………………………… ecoplus GmbH (A)… …………………………………

Eli Lilly (USA)……………………………………………

Eppendorf AG – Bioprocess Center Europe (GER)…

European Biotechnology Network (B)… ……………

16 38 39 11 23 9 43

Conference

A Düsseldorf – As regulatory authorities devote more and more attention to quality management and laboratory compliance in pharmaceutical development and manufacturing, informed staff in the lab have become an absolute prerequisite to establishing GMP compliance. Employees must focus increasingly on the establishment of GLP and GMP standards in deployed systems and methods. Analysing and processing a multitude of accumulated results and data in compliance with GMP standards – and ensuring the validity of systems like LIMS – pose additional challenges.

Staying on top of the latest developments has proven no easy task for lab staff. Most courses or conferences are only able to convey knowledge and current trends to a very limited extent. The same

© Concept Heidelberg

Meet the pros at PharmaLab 2013

Janssen-Cilag International NV (B)… …………… 18, 38 KaloBios Ltd. (USA)… ………………………………… 18 Larode Ltd. (UK)… …………………………………… 18 Life Science Austria LISA (A)… ……………………… 32 Meda AB (N)…………………………………………… 50 MediGene AG (GER)…………………………………… 20 Medimmune Ltd (UK)… ………………………… 22, 24 Merck KGaA (GER)… ……………………………… CP2 Merz Pharma Group (GER)… ………………………… 25 Messe München (GER)………………………………… 19 Midatech Biogune S.L. (E)… ………………………… 24 Molecular Profiles (UK)………………………………… 24 MorphoSys (GER)………………………………… 17, 50 Multiplicom NV (B)… ………………………………… 47 Neocutis SA (CH)… …………………………………… 25 Novartis AG (CH)… ……………………… 16, 17, 38, 50 Novartis Animal Health (CH)… ……………………… 26 Novo Nordisk A/S (DK)………………………………… 50 Novozymes A/S (DK)… ……………………………… 33 Noxxon Pharma AG (GER)… ………………………… 17 Okapi Sciences NV (B)………………………………… 26 Oncopeptides AB (S)… ……………………………… 17

Randox Life Sciences (UK)… …………………… 17, 37 ReNeuron Group plc (UK)… ………………………… 26 Ricerca Biosciences (USA)… ………………………… 42 Roche Diagnostics GmbH (GER)…………………34, CP3 Roche Group (CH)… …………………………… 25, 38 Sanofi SA (F)……………………………………23, 47, 50 Scancell Holding plc. (UK)… ………………………… 20 Schering AG (GER)… ………………………………… 47 SilicoLife (PT)…………………………………………… 28 SIRION BIOTECH GmbH (GER)… …………………… 41 SkyePharma PLC (UK)… ……………………………… 47 Solvay Group (B)… …………………………………… 27 STADA Arzneimittel AG (GER)………………………… 25 Stora Enso Ventures Oy (FIN)… ……………………… 23 Swiss Biotech Association (CH)… …………………… 45 Telormedix SA (CH)… …………………………………

Teva Pharmaceutical Industries Ltd. (IL)………………

Thornton & Ross (UK)… ………………………………

Trinity Biotech plc (IRL)…………………………………

Trophos SA (F)… ………………………………………

24 50 25 26 16

UCB (B)… ……………………………………………… 50 WIL Research (USA)… …………………………… 42, CP4 Wilex AG (GER)………………………………………… 16 Yorkville Advisors LLC (USA)… ……………………… 21 ZAB Brandenburg Ec. Dev. Board (GER)……………… 29 Zealand Pharmaceuticals A/S (DK)…………………… 23 Zymenex A/S (DK)… ………………………………… 28

Confidence. Inspired by Results.

Alan Alfano Cancer Researcher, University of Maryland School of Medicine, Baltimore, MD

“In cancer research, achieving uniform results with transfection is often a big hurdle. X-tremeGENE is by far the best transfection reagent I’ve ever used. It’s nice to know that with all the potential issues I might encounter in my research, transfection isn’t one of them.”

X-tremeGENE Reagents. Transfect with confidence.

See more of Alan‘s story at www.x-tremegene.roche.com

For life science research only.

Not for use in diagnostic procedures.

X-TREMEGENE is a trademark of Roche.

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