2013 12 ebsin freeexcerpt

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

European Biotechnology News Science & Industry

CENTRAL EUROPE

Bayer bids to take over partner Algeta for D1.6bn NORTHERN EUROPE

Danes appoint panel to improve national bioeconomy Special

T P R E E EXC

FRE

Products of the year – stunning tech innovations WESTERN EUROPE

Shire acquires orphan disease specialist ViroPharma SOUTHERN EUROPE

Grifols set to buy Novartis blood transfusion diagnostics arm

Horizon 2020 – the future begins

Eastern EUROPE

Gedeon Richter’s antipsychotic fails to convince FDA science & technology

Engineered yeast could solve tank-or-table biofuel dilemma

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.”

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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.

Roche Diagnostics Corporation Roche Applied Science Indianapolis, Indiana © 2013 Roche Diagnostics.

All rights reserved.

N –º 12 | Volume 12 | 2013

Euro|Biotech|News

Intro

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Editorial

Striking a balance in greater clinical trials data sharing Richard Bergström, Director General EFPIA, Brussels

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n the past year, the debate surrounding increased transparency of clinical trials has seen a great deal of progress. From an industry perspective, we have engaged more openly with a greater diversity of stake­ holders on the topic – a positive development, as an intelligent exchange of ideas is needed to determine the best path forward. Opinions on how to best increase openness around clinical trials data are varied, but as the conversation has progressed, one thing has become clear: It will be necessary to strike a certain balance if we are to develop data-sharing measures that will best serve public health interests.

Greater transparency around clinical tri­ Richard Bergström was appointed als data is needed – but it must be a responsi­ Director General of the European Federation of Pharmaceutical ble transparency. This means protecting not Industries and Associations only patients by ensuring their private data (EFPIA) in April 2011. Over the is appropriately protected, but also protect­ past 20 years, he has worked ing the information contained in clinical tri­ for Roche, Novartis and with the Swedish pharmaceutical industry als data that is potentially commercially sen­ association (LIF). A pharmacist sitive. This is a must if we are to safeguard in­ by training, he received his novation, the tool that the pharmaceutical in­ MScPharm degree from the University of Uppsala (Sweden) in dustry relies on to develop treatments for im­ 1988. Since 2006, Bergström has proved patient outcomes. Publishing Clinical been an advisor to the WHO on Study Reports (CSRs) in their entirety, as they Good Governance in Medicine. are written now, does not strike this balance.

Making patient-level data available to all does not strike this balance. Allowing indetermi­ nate access to full data sets – again, does not strike this balance.

A responsible transparency is one that safe­ guards patients and their privacy, respects regulatory systems at all levels and protects research incentives. These are the premises underlying the EFPIA-PhRMA Principles for Responsible Clinical Trial Data Sharing, which EFPIA and PhRMA member compa­ nies have agreed to implement from January 1, 2014. These commitments enhance patient and public access to clinical study information

by providing synopses of clinical study reports, which give the public information it needs while protecting sensitive patient information. More detailed patient-level and study-level data can be made available on request to those who can do good with it, including qualified researchers who will further science.

In a recent NEJM article (doi: 10.1056/ NEJMp1310771), the EMA’s Hans-Georg Eich­ ler, Guido Rasi and other authors argue that access to patient-level trial data could help drug developers in how they conduct clinical trials – something that could potentially improve healthcare outcomes. Drugmakers have already recognised the value of sharing data with quali­ fied researchers. We are increasingly seeing cas­ es of open innovation and companies that were once competitors joining forces to tackle areas of unmet need. The Innovative Medicines Ini­ tiative, the public-private partnership between EFPIA and the European Commission, is fos­ tering open innovation and encouraging collab­ oration, with companies sharing data and pool­ ing resources. There are undeniable benefits to increasing openness around clinical trials data – but only if it is shared in the right way, with the right people.

Knowledge is power, and this is especially true when it comes to healthcare. The science of medicine has allowed for amazing progress in improving treatment for a variety of illnesses, from HIV to cancer. Medical and scientific in­ novation is one of the most powerful tools we have for improving patients’ lives. Responsi­ ble data-sharing is about recognising this and striking the right balance – one that protects both patients and innovation.

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N –º 12 | 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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EuroBiotechNews covers the biotechnology sector of the current 28 EU member states, Norway and Switzerland.

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Italy: assobiotec.it

www.eurobiotechnews.eu

N –º 12 | Volume 12 | 2013

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Euro|Biotech|News

contents

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Insight

Cover Story

EMA delays draft; Heard in Brussels 10 Money for flu vaccines and antibiotics 12 Call for ban on iLUC factors

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EU targets healthy ageing; IP Flash

14

Regulatory Affairs Update on clinical trials

16

Breaking news from the EMA

18

Economic Focus on newsflow and dividends

19

Stock markets

20

Perspectives Merck relies on Israeli know-how

38

Getting grads ready for industry

42

BioEurope: Full house in Vienna

43

Managing risks in strategic alliances 44

Horizon 2020 ushers in a new era in biotech

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The European Parliament has paved the way for the launch of the largest innovation programme in the world. After it was formally approved by the Council of the European Union in December, Horizon 2020 is heading to the starting line this coming January with a seven-year budget of nearly D80bn and a brief to tackle grand scientific and social challenges. In the programme, biotech is a cornerstone technology for the development and establishment of better drugs and more sustainable products.

Services

Special

FDA drafts new validation guidance 46

Product of the Year

Regional News

New technologies are high on the agenda

Partners & Associations

33

Northern Europe

22

Central Europe

24

Hamamatsu Photonics Deutschland, Eppendorf Bioprocess Centre Europe, Dornier-LTF, Li-cor Biosciences 34

Western Europe

26

Promocell, Phenom-World

Southern Europe

28

Metrohm, Photometrics, Genaxxon biosciences, Switch

Eastern Europe

30

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Biopeople News from Deinove SA, Thrombogenics NV, TxCell SA, Groupe Novasep, EuropaBio and the International Diabetes Federation 47 Company index

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Events What’s on in Dec. 2013 - Jan. 2014

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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, Benjamin Stolzenberg; Advertising: Oliver Schnell, +49-30-2649-2145, Christian Böhm, +49-30-2649-2149; 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.

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N –º 12 | Volume 12 | 2013

Euro|Biotech|News

INSIGHT EUROPE Clinical Trial Transparency

EMA postpones publication rules

© Fotolia.com

A Brussels/London – The implementation of more liberal rules on access to clinical trial data linked to new market-approved medicines will be delayed, according to the European Medicines Agency. In midNovember, the agency announced that it won’t be able to finalise its draft policy on public access to clinical raw data taken from clinical study reports as planned.

Originally, the EMA wanted to implement the new publication rules beginning January 1st. But analysing more than 1,000 comments by 150 stakeholders on its draft policy will take more time than expected, the Agency said in a press release.

Before the announcement, members of the AllTrials initiative, including the British Medical Journal and PLoS, had lobbied intensively to extend the scope of the EMA policy, which seeks to publish the original results submitted to the agency by drug developers in a controlled fashion.

Industry representatives said, however, that they were concerned about losing control over publication of sensitive data.

The EMA now says it will provide an update on timelines by December 12th at the latest. In its press release, the agency stressed that it is convinced the release of data is about establishing trust and confidence in the system: “The Agency is also firmly of the opinion that availability of data broadens the scientific knowledge base, fosters innovation, encourages investment in the development of medicines and ultimately benefits public health.” 

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Heard in Brussels M

Don’t mess with nature – just ride the waves

Brussels – Welcome to December, and a rather nautical analogy this month. I don’t mean the title of this piece literally of course – messing with nature is what biotech is supposed to do (in a well thought-out and good way, of course) and I stand up to be counted with all those people who mess about with what nature and evolution have so kindly provided.

I’m referring instead to politicians who are seeking, with the best of intentions, to support the biotech sector and impose their own rather rosy view of what companies should look like. Trying to say what a biotech company should be is like trying to get a straight answer from a 10 year old to the question: “Why the hell did you do that?” You’ll get a different response every time, and it’ll be influenced by the least predictable of factors.

Navigating stormy seas I have seen a number of politicians confuse high-risk, early-stage biotechs with 100-year-old engineering firms that have a Bentley parked outside. The mission of a biotech company is not to develop a firm with hundreds of employees (although that would be a nice side effect) but to deliver the firm’s technology to its destination. A company is a vessel for the precious technology that it holds.

A firm is not the deliverable, but rather the small and leaky boat that must navigate a stormy sea. The current destination may not even be the final one. The goal might for example be a transfer to a larger boat, and a captain with a more luxuriant beard.

Too many politicians view a company’s size and age as the deliverable – but why would this be the case? You might keep your company afloat for 20 years, but if you delivered your product to its destination 10 years ago and you are now just bobbing about, then why does

Claire Skentelbery, Secretary General of the European Biotechnology Network

it still exist? If your technology is a platform rather than a product, that is a different question, of course – in that case, the technology is the very fabric of the company. But you can only continue to sail your boat if she is watertight, you have a good set of charts and there is a fair wind in your sails.

An eye on the Horizon And this is where the politicians have to wise up. Don’t throw grant money at a company with your mission to attend its 20th Christmas party. Instead, give it to the company with a mission to celebrate the successful delivery of its cargo to its destination. And don’t worry about what happens to empty boats lost at sea. There are ZERO examples of successful entrepreneurs retiring and doing nothing. Most just end up building new boats, growing bigger beards and heading off on the next voyage.

So target the cargo, not the boat and those sunny shores of Europe’s biotechdreams won’t be far away. Leave the safety of the harbour and see where your voyage takes you.

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N –º 12 | Volume 12 | 2013

Euro|Biotech|News

Insight Europe

News M

Let the patients decide

London – Senior staff from the European Medicines Agency (EMA) have concluded that the agency’s decisions on market approvals are often too riskaverse. In Nature Reviews Drug Discovery (doi: 10-1038/nrd4129) the group headed by EMA director Guido Rasi writes that “good drug regulation” is about “maximising gains in public health” and not just minimising risk. The authors therefore propose that regulatory agencies should include patient perspectives on levels of acceptable risk in the drug review process.

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EU Funding

Investing in influenza vaccines A Brussels – Two European funding programmes launched in November are seeking to improve flu vaccines. Together with academic partners and biotechs, pharma giants Novartis, Sanofi-Pasteur, GlaxoSmithKline, Abbott, Crucell (J&J) and Med­ Immune (Astra­Zeneca) will try to establish standardised bio­marker assays able to predict vaccine efficacy. The a12.2m project is funded by the Innovative Medicines Initiative (IMI). About a4.5m have been earmarked by the European Commission for the EDUFLUVAC consortium, which is aiming to develop a universal flu vaccine that targets multiple variable virus epitopes,

© Fotolia.com

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thus eliminating the need for seasonal vaccines. In the meantime, the Commission is also working on a “Joint Procurement Agreement” for guaranteeing equal access to flu vaccines for all EU Member States. B

Antibiotics M

EU-China collaboration

Brussels – The EU and China are to tighten collaboration in agri-food and biotech research. At the end of November, a number of EU Commissioners and China’s Vice-Minister of Agriculture signed a Letter of Intent laying the groundwork for an ambitious strategic partnership. It’s aimed at implementing joint research programmes that address challenges of sustainable global food supply, and also at delivering new sources of biomass for industrial use within the bioeconomy.

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Bioequivalence guidance

London – The EMA has for the first time released product-specific guidance on how to demonstrate bioequivalence of a generic to its reference drug.

The 16 drugs covered in the guidelines include Xeloda, Sprycel, Tarceva, Nexavar, Gleevec, Truvada, Tamiflu and Namenda. The move is aimed at promoting a consistent approach, supported by bioequivalence data, to the process of assessing applications.

EMA takes the fight to MDR bugs A Brussels – Citing poor returns on investment and high development risks, almost every Big Pharma company spun-out its antibio­tics business decades ago. This November, the EMA published a new market authorisation approach that looks set to bring pharma giants back into the field by markedly reducing risk and development costs. As with the American “FDA breakthrough status”, the European agency says it will now accept limited clinical data from non-inferiority trials if the “new” antibiotic targets only deadly, hard-to-treat multidrug-resistant (MDR) pathogens. According to the EMA draft, which is almost identical to an FDA guidance document published last summer, for these substances sponsors will only have to provide detailed data on in vitro activity, preclinical ADMET and efficacy, as well as human pharmacokinetics data. Pivotal trials could be conducted in small patient subpopulations that carry the target pathogen.

The EMA guidance comes on the heels of the “Antibiotic Resistance Action Plan” launched by the European Commission in 2011 and the Innovative Medicines Initia-

tive’s a224m “New Drugs for Bad Bugs” programme set up in 2012. Although anti­ biotic resistance is currently limited to a very small patient population, bug­-specific antibiotics have entered political agendas in important pharma markets. For the companies, the new authorisation path promises significantly higher incomes than with cheap broad-band counterparts, as well as new options for getting drugs approved.

Big Pharma’s commitment to the new approach began to take shape this autumn.

Roche, which spun out its antibiotics business into Basilea in 1999, returned to it with the acquisition of Polyphor (see p. 25) in November. Spokesmen for the Swiss giant say that purchase will be only the first in a series. The firm has been restructuring the pipeline of its pRED business, and is now focussing on infectious diseases as well as oncology and CNS/ophthalmology/orphan diseases. According to the company, its pRED arm has developed several narrow-band antibiotics in the last 18 months, and the first candidates from programmes focused on Gram-negative bacteria will enter the clinic next year.

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N –º 12 | Volume 12 | 2013 FREE EXCERPT

Euro|Biotech|News

biopeople

TxCell

EuropaBio

Phase II dealmaker

Award-winner

A French biotech Tx­ Cell SA appointed Damian Marron as Chief Executive Of­ ficer at the begin­ ning of November to push the develop­ ment of its Phase II antigen specific Treg cell immuno­therapy Damian Marron Ovasave. The new CEO, who brings in extensive experience in licensing deals, comes from Cytheris SA, a specialist for IL-7-based immunotherapies.

From 2008-2012 Marron served as CEO of Trophos SA. Prior to that he was Executive Vice President Corporate Development at NicOx SA. In the past, he has held business development and operational roles at 3M Pharmaceuticals, Orphan Europe, RhonePoulenc-Rorer and GlaxoSmithKline. B

Novasep

Market expander A Novasep SA has named N a d e ge Laborde President of its Industrial Bio­ tech Business Unit.

The new member of the executive com­ mittee is expected to expand Novasep’s market reach into Nadege Laborde new geo­g raphical territories. Laborde joined Novasep in 2000 after qualifying as an engineer from the École Centrale (Paris). Starting as a project manager, she rapidly expanded her respon­ sibilities, quickly taking on roles as engi­ neering manager in the US and Asia, and later becoming head of the system engineer­ ing and construction department.

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A EuropaBio’s Secre­ tary General Natha­ lie Moll has been given the ”2013 Women Innovation” prize at the Wo­men & Technologies con­ ference in Milan for raising awareness about the role of bio­ technology in in­ Nathalie Moll creasing sustainability for future gen­ erations. The biochemist, who has been with EuropaBio for over 10 years, has also worked in the biotech and food policy area for the European Crop Protection Associa­ tion, as well as for the Italian national bio­ tech association Assobiotec.

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Thrombogenics

Pharma pioneer A ThromboGenics’ founder Désiré Col­ len was given the Scrip Lifetime Achieve­ ment Award at the end of November in London for his outstanding contributions to the pharmaceutical/biotech industry.

Collen played a key role in the develop­ ment of both tissue plasminogen activator (tPA) for acute myocardial infarction and ischemic stroke, and ocriplasmin for the treatment of symptomatic vitreomacular adhesion/vitreomacular traction. A treat­ ment for acute myocardial infarctions, tPA was a key product in Genentech’s success in the late 1980s and 1990s.

Ocriplasmin, a pro­ teoly t ic en z y me indicated for the treatment of symp­ t o m at i c v it r e o ­ macular adhesion, was launched in 2 013 u n d e r t h e trade name Jetrea, Désiré Collen

and licensed by Alcon in March 2012 in a a375m deal. Collen has co-authored more than 650 scientific publications, and is list­ ed as co-inventor on 20 patents and patent applications.

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IDF

Diabetes leader A The International Diabetes Federa­ tion (IDF) has appointed Petra Wilson as its Chief Executive Officer. She joins IDF from Cisco, where she was Senior Direc­ tor of its European Health and Care Busi­ ness Solutions team. Wilson has previous­ ly held posts as Di­ rector of the Europe­ an Health Manage­ ment Association and as a science of­ ficer for the Europe­ an Commission. She is also a former sen­ ior lecturer in law at the University of Petra Wilson Nottingham.

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Deinove

Chemistry pro A Jacqueline Le ­ courtier has joined industrial biotech specialist Deinove S.A. (Paris) as the new President of the firm's Scientif­ ic Advisory Board.

Lecourtier comes in from the French Jacqueline Lecourtier National Research Agency, where she was General Manag­ er from 2006-2012. Prior to that ,she was Scientific Director at the French Institute of Petroleum (IFP) for 15 years. Lecourti­ er is an engineer from the École Nationale Supérieure des Industries Chimiques, and she also holds a doctorate in physics.

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