LifeSciences Insight no 4 - 2012

LifeSciences Insight - No 4 - 2012

No 4 - 2012

The Magazine about Life and Science in Medicon Valley

Quality Research Deserves Quality Logistics – Quality Research Deserves Quality Logistics – Please Let Us Help You Succeed Quality Research Deserves Quality Quality Research Deserves Quality Logistics Logistics –– Please Let Us Help You Succeed Please Please Let Let Us Us Help Help You You Succeed Succeed 2010 World Courier is the first specialty courier to offer fully

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became the deal of the year

22: Are the Chinese moving in?

We ask Peter Halkjær-Knudsen

36: Neurosearch – from golden child to fallen titan

Contents

LifeSciences Insight no. 4 - 2012 LifeSciences Insight is distributed in Denmark and Sweden to: • Named decision-makers in the life science industry • Investors • Science parks • Hospitals • Universities • Life science media • Relevant MPs in Scandinavia • Medicon Valley Alliance’s members and • collaboration partners In addition, the magazine is available at relevant exhibitions and fairs in Europe, North America and Asia.

Feature: In search of a new business model

3

Fredrik Hedlund on the need to make personalized medicine profitable.

Highlights from Medicon Valley

4

The best deals and the flops, new knowledge on antibiotic resistance and much more.

It photographs your invisible disease

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Now the air you exhale can be photographed for trace substances from asthma or lung cancer

Connecting with California bioclusters

14

A new long-term strategic collaboration brings Medicon Valley closer to one of the biggest global hotspots for biotech.

Publisher: RASK Media ApS Frydendalsvej 3 DK-1809 Frederiksberg C Denmark +45 3326 9520 ce@raskmedia.com www.raskmedia.com

The turning point

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In 2009 Action Pharma was on the verge of collapse.

Today their drug candidate has been sold in one of the year’s largest up-front deals. Get the story.

Interview: Peter Halkjær-Knudsen

Partners: Medicon Valley Alliance www.mva.org

22

Executive Director of Chinese biotech giant ChemPartner’s European division is working to bridge the cultural gap between Chinese research units and European companies.

EBD GROUP www.ebdgroup.com

Theme: Spotlight on medicines for children

Editor in chief: Malene Aadal Bo Editors: Lone Frank, Carsten Elgstrøm

The vast majority of registered drugs are indicated for use in adults or adolescents only. But the demand for developing and testing medicines for and on children is growing.

Advertising: +45 2887 0770 sales@raskmedia.com

What happened to Neurosearch

28 36

The Danish biotech patriarch stands on the brink of divesting the company’s very existence. What happened to the glorious flagship?

Cover photo: Jeppe Carlsen

Guide: How to draw up good licensing agreements

Layout and print: artegrafix and PE Offset A/S

40

Technology licensing is one of the key ways of commercialising intellectual property. Learn how to do it right.

Next issue: February 2013 ISSN: 1904-4755

More funding for Swedish innovation

42

Swedish science parks are improving the financial picture for innovation by establishing a dozen new venture funds.

Major Norwegian bank sets sights on Medicon Valley XXX-XXX Printed matter

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Norwegian heavyweight DNB was hosting an event with MVA on how to attract investors.

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In search of a business model for personalized medicine?

By Fredrik Hedlund For some time now I’ve been hearing a lot said about personalized medicine.

On the face of it, the idea is as simple as it is smart. The latest blockbuster drugs have low efficacy, and on average work only in half the people who take them. Personalized medicine is about putting the latest research results to work by only giving drugs to those patients who will really benefit from them. The result is a better therapeutic effect and fewer adverse drug reactions.

A bright idea, but unfortunately one that clashes with the prevailing business model in the pharma industry, which might be described as the one-size-fits-all blockbuster concept. This is the one where quantity is what counts: the more people taking a drug, the more its maker earns.

No surprise then that the concept of personalized medicine has gone down like a lead balloon in the average boardroom. Since, after all, it means deliberately giving the drugs to fewer people than necessary, that is, only those who will actually benefit from them. And nobody pays for patients who aren’t on the meds.

This is why personalized medicine is so slow to catch on. In fact, by and large it’s confined to cancer treatment. The latest basic research in cell and tumour biology has made it possible to identify certain genetic defects in cancer cells that make them susceptible so they can be targeted for destruction.

Probably the best-known personalized medicines are Herceptin for treating HER2-positive breast cancer and Gleevec/Glivec for conditions such as bcr-abl-dependent chronic myeloid leukaemia (CML).

These cancer drugs and a few more besides are big enough to cut it in the blockbuster model, but many others fail.

A great many life science companies are battling on with research in various types of receptor blockers or monoclonal antibodies to arrest certain types of cancer in certain types of patients. According to PhRMA, America’s leading association of pharma industry research and biotech companies, there are some 1,000 substances for cancer alone in the industry’s pipelines. But many of them will never make it onto the market. The research costs are as high as for the blockbuster drugs, but the patient base is considerably smaller and current payers are not prepared to buy a new therapy at any price, not even if it saves lives.

As a result, viable drug candidates are consigned to oblivion by corporate number-crunchers because they don’t see them as profitable under the prevailing (un) willingness to pay. This in turn means that cancer sufferers die in spite of the fact that therapies exist which can help them, but which they don’t have access to because the drugs are not profitable.

What we need to do Does this chime with a democratic world anno 2012? I don’t think so.

As I see it, the world’s policymakers in medicines spending – primarily governments and insurers – and drug manufacturers should put their heads together and agree on a new business model that favours personalized medicine. And they should do so now.

I’m not under the delusion that I can fix the problem in any way. The business model has been a problem ever since personalized medicine was first introduced 15 years ago. But the basic premise for a new model would have to be that it champions the benefits of personalized medicine. Meaning that it pays for a good effect in those who take the medicine, but also pays for avoidance

Fredrik Hedlund is a medical journalist with qualifications as both a pharmacist from Uppsala University and as a journalist from Stockholm University.

After having been editor-in-chief of the journal Läkemedelsvärlden and medical reporter for Sweden’s leading daily, Dagens Nyheter, he is now a freelance based in Malmö. He contributes regularly to journals such as Läkartidningen, Tandläkartidningen, Medicinsk Vetenskap, Läkemedelsvärlden and Life Science Insight.

of adverse drug reactions, as in the side effects that otherwise cost huge sums for health services to deal with.

So, it’s going to mean some thinking outside the box, and may even mean paying for patients who are kept off the meds.

The price of drugs in any society is obviously an important issue with both an economic and an ethical dimension. And if the world’s policymakers fail to come up with a new business model for personalized medicine, then, as both a society and as individuals, we will end up paying the highest price payable – since human lives will be lost in spite of the fact that they could have been saved, all for want of a different business model.  Translation: CLS Communication A/S

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Highlights from Medicon Valley

By Malene Aadal Bo

Immune defence protein could explain inflammation Now there is a clear target for the treatment of acute pancreatitis. This is the opinion of researchers at Lund University who have discovered that a well-known protein plays a crucial role in the development of the disease.

However, current research shows that calcium-sensitive proteins found in our bodies, such as calcineurin, encourage inflammation; however it is unclear precisely how. Henrik Thorlacius and Maria Gomez at the university’s Department

of Clinical Sciences in Malmö have researched this issue in more detail. The spotlight has fallen on the NFAT family of proteins related to calcineurin. Their role in connection with acute pancreatitis has never previously been investigated. And it seems the protein plays an extremely prominent role in the development of inflammation of the pancreas. In mice trials, researchers found that NFAT can be linked to acute pancreatitis in several ways. This knowledge opens up new opportunities for research in treatment and medicines, both for acute pancreatitis and for other acute inflammatory diseases. For example, this could be the case for blood poisoning and diseases of the intestines, according to Thorlacius.

MVA Ambassador Program expands to the US West Coast and China Companies and organisations in Medicon Valley now get their own matchmaker on the US West Coast and in China.

This is a fact after Region Skåne and the Capital Region of Denmark have dedicated DKK 14.4 million to expanding the Medicon Valley Alliance (MVA) Ambassador Program between 2013 and 2017.

The MVA Ambassador Programme was initiated in the beginning of 2008 with the positioning of an MVA Ambassador in Japan. The program builds and facilitates international relations between organisations and companies in Medicon Valley and organisations located in the world’s most innovative and prosperous life science clusters. Currently, the program includes ambassadors covering three countries: Japan, South Korea and the US (Boston).

“We wish to further develop the program by positioning one ambassador in San Diego, California, in 2013, and one in China in 2014. It is an enormous strength for companies and organizations in Medicon Valley to have people on

location in the U.S., Japan, China and South Korea. A smaller organisation in Medicon Valley is not able to simply pick up the phone and ask for a meeting with, say, a large Japanese pharmaceutical group. But with the help of the ambassadors’ network, they can establish such contacts,” says Charlotte Ahlgren Moritz, Vice President of MVA and the manager responsible for the MVA Ambassador Program.

A couple of months ago the Boston-based ambassador’s work led to a new partnership agreement between the US State of Massachusetts and the Capital Region of Denmark, Region Zealand and Region Skåne.

Potential benefits of the agreement include enhanced research partnerships, exchanges of researchers and students between Medicon Valley and Massachusetts, easier access to US research funding and enhanced business development in the Øresund Region.

Charlotte Ahlgren Moritz, Vice President of MVA and Head of the MVA Ambassador Program: “The US is a gigantic market for life science, which we want to be a part of. We are therefore expanding our presence in the US by placing an ambassador in San Diego”.

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Danish biotech sales in top ten When Enobia Pharma received USD 610 million for its drug candidate ENB-0040, it was the largest up-front deal since 2007 according to a list compiled by Action Pharma.

The list shows the largest sales of individual products in the global biotech and pharmaceutical industry from 2007 until May 2012 measured in up-front payments in million dollars within phase II and III products.

The most lucrative deal was achieved by Enobia Pharma when Alexion Pharmaceutical paid USD 610 million for Enobia’s product for treatment of hypophosphotasia, a rare bone disease.

However, perhaps surprisingly a grand total of two Danish companies are also among the top ten: In eighth place is Zymenex, which in 2008 received USD 135 million for the rights to its drug against a disease caused by enzyme defects – also called metachromatic leukodystrophy. And in tenth place is the sale of Action Pharma’s drug candidate AP214 against kidney failure, which was sold for USD 110 million.

Overview of top 10 sales of individual products in the life science sector measured according to size of upfront payment (globally, since 1 January 2007) Company (seller)

Coun- Buyer try

Enobia Pharma

USA

Alexion Pharma- 12/2011 ceuticals

Ilypsa

USA

Amgen

06/2007 ILY101

NovaCardia

USA

Merck

07/2007

Isis Pharmaceuticals

USA

Genzyme

Hypnion

Product

Indication

Clinical status

ENB0040

Hypophosphotasia

Phase 2 610

Global

Hypophosphatemia (hereditary disease)

Phase 2 400

Global

Phase 3 366

Global

01/2008 Mipomersen

Familial hyper- Phase 3 325 cholesterolemia

Global

USA

Insomnia

KW-3902 Acute deteriorated chronic heart failure

Upfront payment (USD mill)

Rights

Lilly

03/2007 HY10275

Phase 2 315

Global

Bristol-Myers USA Squibb

Pfizer

04/2007 Apixaban Deep vein thrombosis (prevention)

Phase 3 250

Global

Targacept

USA

AstraZeneca

12/2009 TC-5214

Severe depression

Phase 2 200

Global

Zymenex

Denmark

Shire Pharmaceuticals

04/2008 Metazym Meta leukodystrophy

Phase 2 135

Global

Renovo

UK

Shire Pharmaceuticals

06/2007 Juvista

Scarring after surgery

Phase 2 125

Global,

Action Pharma

Denmark

Abbott

05/2012 AP214

Acute kidney failure

Phase 2 110

Global

And then there were the flops...

Even in phase III, a third of all drug candidates fail. Biotech expert John Carroll from FierceBiotech has considered the drug candidates that failed in 2012 and believes these five are the biggest flops.

• BMS-094 from Bristol-Myers Squibb against hepatitis C - Only 7 months after Bristol-Myers Squibb paid USD 2.5 billion for the candidate, the investment went up in smoke after a patient sickened and then died of heart failure.

• Bapineuzumab from Pfizer, Johnson & Johnson against Alzheimer’s - Just about every analyst in the business had given this virtually no chance of success and they were right.

The drug tried to tackle the illness at the wrong stage.

Recruiting patients whose brains had already been damaged left little chance that their therapy could work.

• Solanezumab from Eli Lilly against Alzheimer’s - Eli Lilly reported that solanezumab had failed both primary endpoints in a large phase III study. Only days later Lilly scuttled its late-stage schizophrenia programme for pomaglumetad methionil. In a matter of weeks, Lilly wrote off five late-stage drugs.

• The cholesterol medicine Dalcetrapib from Roche - Roche, normally quite sedate in buttoned-down Swiss fashion when it talks about pipeline programmes, tended to loosen its tie and get downright giddy about the mega-blockbuster potential of this treatment. But at the end of the day there was nothing here at all.

• The antidepressant TC-5214 from AstraZeneca Antidepressants are notoriously difficult to develop. In AstraZeneca’s case, four late-stage studies of TC-5214 partnered with Targacept produced four flops.

Source: Medwatch.dk and fiercebiotech.com

Date

excl. EU

Notes and sources - Phase 2 or 3 individual products, projects or companies - Transactions where information exists on all transaction terms, including payments and geographical rights - M&A, purchase of rights and products, as well as inlicensing of individual products for all therapeutic areas - Not transactions concerning equipment, diagnostics and generica - Source: Recap IQ

New nanomedicine centre at DTU DTU has just opened a Center for Nanomedicine and Theranostics, a new, multi-disciplinary centre focusing on using nanomedicine to develop new technologies for diagnosing and treating serious diseases such as cancer.

The pharmaceuticals industry is constantly on the lookout for new drug candidates in the hope of producing new medicines.

The new centre’s vision is to support the development of future generations of medicine that are far more specific than those we can produce today.

The centre will develop advanced biomaterial technology for ‘personalised disease management’, and the therapeutic advantages for the individual patient can be assessed both before and during the treatment – in other words, the therapy and diagnosis are integrated, giving the concept of theranostics. Nanomedicine offers many new opportunities for developing personalised treatment methods.

Nanomedicine is a relatively new area predicted to develop rapidly in the years ahead. Professor Omid Farokhzad, M.D., from Harvard Medical School in the US agrees.

“There are vast academic and industrial interests in nanoparticle technology. The effect of developing nanoparticles that can hit several targets at once will be enormous.”

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New knowledge about antibiotic resistance

The Danish Council of Ethics questions the value of genome testing

New research from the University of Copenhagen shows that bacteria can produce toxins like antibiotics to obtain food in an environment lacking in nutrients.

Previously, it was thought that this aggressive behaviour between bacterial strains was the result of competition to outnumber bacteria of the same kind. However, the new research shows that the bacteria use the bacteriocins to combat hunger.

“When a population grows, a shortage of nutrients quickly results. By producing toxins, the bacteria limit the number of competitors while the bacteria that are killed are broken down into nutrients which are useful for the survivors. So we think the bacteria that produce antibiotics or bacteriocins in that way have an evolutionary advantage,” says Jørgen Leisner. The mapped mechanism can influence our understanding of antibiotic resistance: “We know that antibiotic resistance occurs naturally in some species of bacteria without exposure to medication or growth promoters in the form of antibiotics. According to our hypothesis, resistant bacteria can act as a kind of ‘cheat’ that simply profits from the nutrients released in the war of the bacteria,” according to Jørgen Leisner.

Source: www.nyheder.ku.dk

The scope for decoding and interpreting human genetic material provides better prevention and treatment options for people who know in advance that they are at risk of having a Det Etiske Råds udtalelse hereditary disease. But the om genom-undersøgelser question remains whether healthy people can improve their quality of life by using genome testing to reveal diseases that may be lurking in their future. Not according to a report and recommendation by the Danish Council of Ethics.

The Council believes that in many cases, genome testing of healthy people would be worthless from a health perspective or at worst could have distinctly negative consequences for both individuals and society: “For healthy people, genome testing can trigger a false alarm or false sense of security and thereby increase the risk that people will make bad health choices. And as a society, we will face a challenge if the public health service is flooded by people seeking advice and more tests because they have had a genome test at their own initiative,” says professor Gunna Christiansen, former Chairman of the Danish Council of Ethics’ working group on the topic.

See the Council’s recommendations and the complete report in Danish at www.etiskraad.dk Etiske dilemmaer i diagnostik, i forskning og direkte til forbrugeren

Beacon Initiative is identifying potential strongholds The Beacon Initiative is part of the three-year EU Interreg-funded collaboration project between Medicon Valley Alliance and Invest in Skåne called “Medicon Valley – a world-class life science cluster”.

The aim is to implement a common strategy for enhanced attractiveness and growth in Medicon Valley, building on existing regional strongholds and meeting future challenges of retaining growth and labour

Potential Beacon areas emerging: Technology Imaging Large-scale protein production System biology Structual biology/chemistry Nanotechnology Epidemiology Enzymes Peptides

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Therapeutic Areas Cancer Diabetes Onology Neuroscience Infection Immune regulation Hematology Chronic dieases Reproduction therapy

opportunities in Medicon Valley. The project is now identifying potential strongholds – cross-discipline combinations that meet future trends and create worldclass innovative scientific environments.

The vision is that three to five Beacons will have been established in 2020 and will have reached international recognition as world-class centres of excellence with innovative and productive research and cross-disciplinary collaborations between academia, industry and public organisations.

This will contribute Other to an overall global Healthy ageing attractiveness for Independant living quality registers/biobanks talents and investors, and Affordable drugs ensuring a sustainable Perzonalized medicine growth in Medicon Early clinical trials Valley – a world class life Mobile health science region.

Functional foods Companion diagnostics Rrphan drugs

For further information please visit: www.mva.org

Astrazeneca resurrects failed drugs The British Medical Research Council (MRC) has given GBP 7 million to no fewer than 15 research projects established to discover new applications for a number of the products and components that Astrazeneca has

developed over the years – but has shelved for various reasons.

The pharmaceuticals industry is used to drugs ending up being used for diseases that are very different to their original purposes, and that is being attempted by making a total of 22 chemical compounds available freeof-charge to scientists who were encouraged to apply for MRC funding to use them in medical research with the ultimate aim of benefiting patients.

Scientists will use the compounds to study a wide range of conditions from common diseases like Alzheimer’s, cancer and lung disease to rarer conditions such as motor neurone disease and muscular dystrophy.

Eight of the projects will involve clinical (human) trials of potential new therapies, and seven will focus on earlier work in laboratory and animal models. All the projects will increase our understanding of human disease and accelerate the search for innovative treatments.

One of the body’s satiety hormones, neurotensin, can increase the risk of women succumbing to the three major endemic diseases: diabetes, heart attack and breast cancer. Satiety hormones are also associated with premature death in women, particularly due to cardiovascular disease.

The result is presented in a study by Lund University published in the Journal of the American Medical Association (JAMA).

“The link with the risk of type 2 diabetes and cardiovascular disease as well as breast cancer was surprisingly clear. Obesity is a common risk factor for the three diseases, but the link with neurotensin cannot be explained through obesity or other known factors,” says Olle Melander, professor at the Department of Clinical Sciences in Malmö, Lund University and consultant at Skåne University Hospital.

This is the first time a satiety hormone has been linked to these three common diseases in women, and this therefore also opens up new avenues for further research into risk assessment and prevention.

The strong link also facilitates the use of neurotensin as a clinical risk marker for the diseases according to researchers. This provides new opportunities for the

early identification of women who are likely to develop cardiovascular diseases, which cannot be predicted through current known risk factors.

Source: Lund University  Translation: CLS Communication A/S

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Satiety hormone linked to premature death in women

CLS Communication A/S DK-1160 Copenhagen K | T +45 3332 3452 | info-dk@cls-communication.com | www.cls-communication.com |

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It photographs your invisible disease Now the air you exhale can be photographed for trace substances from asthma or lung cancer, thanks to a new ‘camera lens’ from DTU Fotonik which renders invisible light visible.

By Kristian Sjøgren

Most chemical substances have a unique chemical signature – like a fingerprint – in the mid-infrared radiation spectrum, in other words with a wavelength from 2.85 to 5 micrometres. This signature is attracting great interest in many branches of science, as analysing it can quickly and easily map the precise chemistry of a given substance – whether solid, liquid or gas.

Now researchers at DTU Fotonik have developed a laser system that converts light from precisely this midinfrared radiation spectrum into visible light. The system can be connected to a camera like an active lens and images can then be taken of something that is otherwise invisible.

Back in the 1970s, other researchers explored similar techniques but gave up as it was impossible to convert more than one out of five million photons, which is insufficient for a proper analysis. As the researchers from DTU have now improved the quantum efficiency by a

Facts The invention is the brainchild of Jeppe Seidelin Dam, researcher at DTU Fotonik, Peter Tidemand-Lichtenberg, Associate Professor at DTU Fotonik, and Christian Pedersen, Head of Programme at DTU Fotonik.

Read more at www.nature.com/nphoton/journal/ vaop/ncurrent/full/nphoton.2012.231.html

multiple of one million, the new invention converts one in five photons, which gives a razor-sharp snapshot of the chemistry behind what is being photographed. The new lens means images can be taken of exhaled air, for example, or other gases, capturing the unique mid-infrared signature from a wealth of chemical substances and compounds.

The system works like a digital camera lens. Here, the mid-infrared light is converted into visible light that can be recorded on the camera’s image sensor.

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Illustration: DTU Fotonik

What?

photons and can therefore be deducted to form a picture of the original mid-infrared signature. A datalogical analysis of the image of the mid-infrared signature reveals which substances are present in the image.

What next?

Photo: DTU Fotonik

The new invention has not been fully developed and must first be fine-tuned to suit specific applications. Future applications will depend largely on who wishes to invest more in the product and blaze a trail for future research.

The DTU researchers are pursuing: The food industry. The lens could be used to analyse the bacteria content of a packet of minced beef – without even penetrating the packaging.

The pharmaceuticals industry. The lens can be used to analyse exhaled air for trace substances from lung diseases or to look for signs of cell changes in the skin.

Gas analysis. The researchers have already joined forces with Haldor Topsøe regarding spectral analysis relating to measuring gases.

Analyses of atmospheric air for the content of various greenhouse gases.  Translation: CLS Communication A/S The new invention is very compact and handy to transport to wherever rapid analysis of mid-infrared radiation is required.

Spectral analysis of the converted light can be used to reveal the chemical composition of exhaust gases, the presence of disease-related trace substances in exhaled air, or even whether a birthmark contains chemical traces produced by cell changes.

If the invention can be developed to make precise analyses of exhaled air, doctors will be looking for ethane, 1-butanol and 3-hydroxy-2-butanone, in particular. The presence of these three substances indicates that the patient has either asthma (ethane) or lung cancer (1-butanol and 3-hydroxy-2-butanone).

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How? The lens works by reflecting a 1,064 nanometre laser beam back and forth between two mirrors through a lithium niobate crystal. ‘The lens’ is built up so that a germanium window filters out the visible and near infrared at the entrance to the lens. Then only the mid-infrared light has access to the lithium niobate crystal and the detector for visible light.

When the light photon in the mid-infrared spectrum enters the lens and passes through the crystal, energy is transferred from a laser photon to the mid-infrared photon. The surplus energy makes the light frequency higher and the wavelength shorter, which changes the light from invisible mid-infrared to visible at a wavelength of between 400 and 780 nanometres.

The converted light then continues through the lens and can be captured by a normal camera. The image of the mid-infrared light can be subsequently analysed directly as the energy added to each photon is always the same for all

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9

Business Profile

Turning viral vectors into useful biomedical tools Sirion Biotech is providing pre-clinical gene expression platforms based on viral vectors to the pharmaceutical and biotech industry. “Bad guys” are being turned into unique tools enabling improved drug target screening and validation.

By Charlotte Strøm, MD, PhD Journalist Viral vectors platforms and sophisticated cell modeling enable highly improved target identification and compound screening in the biopharmaceutical, cosmetics, and food industries. Sirion Biotech was founded in 2005 based on the scientific expertise on viral vectors. Since then the know-how and experience of the company has grown considerably from running more than 300 projects with global partners in pharma, biotech, and academia.

Headquartered in Munich and with affiliates in Tokyo and New Hampshire, Sirion Biotech aims at meeting its customers globally as well as locally.

Unique tools for gene expression – or suppression “Our core competences are the biotechnologies evolving from viral vectors. Our tools enable biopharmaceutical customers to perform customized testing of gene expression or gene suppression,” says Dr. Christian Thirion, Chief Technology Officer at and Founder of Sirion Biotech.

The company currently has four viral vectors to offer: adenovirus, adeno-associated virus, lenti virus, and herpes virus, whereby Sirion Biotech developed own patented

Facts about Sirion Biotech • Provides sophisticated and patented cell modeling and viral vector platforms for gene expression of gene suppression, yes • Delivers a range of biotechnology services as a CRO, including cell model generation for assay development and customized viral vectors for preclinical research • Was founded 2005 • Is located in Munich, Tokyo, and New Hampshire, yes • Employs 14 scientists, mostly molecular biologists For more information: www.sirion-biotech.com/company

adenovirus virus vectors with applications in gene therapy and vaccination.

Christian Thirion continues, “From the lenti virus platform e.g. we can generate sophisticated cell model that holds an inducible gene expression or suppression system. With combining the lenti virus system with our RNAiONE technology we have demonstrated that we are able to silence a gene at 98%.”

The tools have readily found use in a number of preclinical drug development projects.

“The viral vectors from Sirion Biotech have been very reliable tools. We have made excellent use of them for our in vitro gene knockdown experiments,” says Michael Detmar, M.D., Professor of Pharmacogenomics, Swiss Federal Institute of Technology, ETH Zurich.

Acting as a CRO Besides providing the viral vectors used in pre-clinical drug development to the customers, Sirion Biotech can also deliver development services as a contract research organization.

“We have the in-house expertise and the laboratory facilities to provide a range of services. This is a key benefit of our service for many pharma companies with outsourcing needs, small pharma companies or small to

10

Business Profile

midsize biotechs with only limited development capacities,” says Christian Thirion.

B.R.A.I.N Aktiengesellschaft in Zwingenberg, Germany, has been working with Sirion Biotech on the development of a nutritional product: ”B.R.A.I.N was searching for a competent partner with profound expertise in primary cell isolation and virusbased engineering technologies. In close collaboration we managed to establish immortalized human sensory cell lines from biopsy samples, which were implemented in our technology programme. We look forward to continuing this successful partnership with Sirion Biotech as part of our long-term industry innovation alliance NatLifE 2020,” says PhD Dr. Andreas Hochheimer, Programme Manager System Technologies Taste at B.R.A.I.N. The in depth development work as a CRO and production of viral vectors for ongoing development activities go hand in hand. ”As a customer of Sirion-Biotech I would like to express my very positive impression about the quality of

the material obtained for research, about the service of Sirion-Biotech and the very cooperative attitude of people involved in organizing, handling, and shipping of the adeno-associated viral vector constructs,» says Professor Christa Büchler, Department of Internal Medicine, University of Regensburg.

Christian Thirion explains about the role of Sirion Biotech a CRO: “As a CRO we typically take part in setting up the technology platforms, and assist until the end of preclinical development. Subsequently we transfer the technology allowing the pharma or biotech company to carry on further clinical development while we continuously provide the material,” he ends.

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Business Profile

Get an international outlook and expand the talent to recruit from Workindenmark focuses on bringing Danish employers and international candidates together.

By Charlotte Strøm, MD, PhD, Journalist In some ways, recruiting employees from abroad differs from recruiting employees in Denmark. At Workindenmark Danish employers can get advice and assistance in recruiting employees from abroad. “One of our main goals is to make jobs in Danish companies visible to international specialists. This happens by publishing job advertisements at www. workindenmark.dk but also through the participation at job fairs and career events,â€? says Marianne Hansen, Director at Workindenmark East.

Traditionally, many life science companies recruit a large portion of international candidates for vacancies.

During 2012 Workindenmark East presented about 1000 international candidates for different Danish companies.

About 300 were candidates for life science.

Job fairs with life science focus With a special focus on the life science opportunities in Denmark, Workindenmark participates each year on different job fairs all over Europe, from career fairs

Business Profile

at universities to job fairs for experienced life science specialists.

“It can be quite difficult to reach the whole world with a job add, and even more so for the smaller companies the task of recruiting talented employees internationally can be difficult to overcome. At the job fairs we bring vacancies in Danish companies with us and present them to international candidates in addition to informing them about job opportunities in Denmark and the Øresund Region in general,” Marianne Hansen explains.

Job fairs are an effective tool for locating new employees. Employers have the opportunity to participate in the job fairs where they can meet applicants from other countries. It is also possible to present open positions and to conduct job interviews.

“If employers are not able to participate personally,

Facts about Workindenmark • Workindenmark.dk is the official website of Denmark for international recruitment and job seeking • Workindenmark has offices in three major cities in Denmark: Copenhagen, Aarhus, and Odense • As an employer you can create job vacancies, search for foreign manpower in the CV-database and you can find relevant information about recruiting and retaining employees from abroad • The services of Workindenmark is free of charge for the employer as well as for the employee • Danish Life Science companies interested in participating at European job fairs or making their vacancies visible at relevant fairs can contact the Bio&Pharma team at Workindenmark East for further information.

Please contact Eva Op De Beeck edb@workindenmark.dk and Dawid Andersen, dsa@workindenmark.dk.

Workindenmark can present their vacant job positions at the fair,” Marianne Hansen says.

This year Workindenmark has participated at Bio&Pharma Days in Milan, Employment Fair at Technical University of Valencia, Oxford University Science, Engineering, and Technology Fair, Engineering job fairs in Lisbon and Basel, and Naturejobs Career Expo in London.

The Naturejobs Career Expo is the largest career fair and conference for the scientific community in the UK. Over 1200 experienced English and European scientists in physics, chemistry, the life sciences, and medical sciences, attended this year. More than 45% of them had a PhD. Workindenmark participated together with Copenhagen University and DTU, the Technical University of Denmark, and shared an exhibition stand at the fair.

Jesper Berg from DTU thinks the trip to London was definitely worthwhile: “It was a busy day. We had lots of interested scientists popping by and asking questions about concrete academic positions and simultaneously looking for more general information about working and living in Denmark.

And we have specifically seen an increasing numbers of subscribers to our job agent,” says Jesper Berg, International Recruitment Specialist at DTU. The collaboration between the universities and Workindenmark appears to be a valuable setup.

“Our common goal is to attract talented foreign scientists to Denmark – and by doing so we create value for the universities, the industry – and for Denmark,” Jesper Berg says.

International Citizen Service - an One-stop-shop for authority contact Once the right candidate has been found a lot of practicalities have to fall into place. In order to ease the process Workindenmark cooperates with the Immigration Services, the regional State Administration, the Danish tax authorities, and the local municipality in International Citizen Services. You find the International Citizen Services in Copenhagen, Aarhus, Aalborg and Odense, where all practicalities are handled at the same time. The service has so far been successful and Workindenmark receives very positive feedback from the users.

“Employers, foreigners, their families, and relocation agencies are unanimously excited about the possibility of getting all the paperwork done in one go. It saves time and in some cases also frustration,” Marianne Hansen from Workindenmark ends. 

Medicon Valley connects with California A new long-term strategic collaboration brings Medicon Valley closer to two of the most innovative and entrepreneurial hubs for biotech in Northern and Southern California, USA: the Bay Area biocluster and the San Diego biocluster.

By Claus Clausen Companies and universities in Medicon Valley are now getting a unique beachhead in California, USA – one of the biggest global hotspots for biotech. California is known for its world-leading concentration of R&D activities within life sciences and an entrepreneurial spirit that permeates scientists and entrepreneurs.

Under the auspices of the Ambassador Program, Medicon Valley Alliance (MVA) has entered into agreements with the two biocluster organisations BayBio and BIOCOM in order to build closer relations between Medicon Valley and California at all levels.

“With the MVA Ambassador Program we continue to develop international partnerships and this agreement is a cornerstone in our US strategy. We already have an MVA Ambassador based in Boston, Massachusetts,

creating value for the life science community in Medicon Valley, and now we want to expand our efforts to the Western US bioclusters as well; not least we plan to post a new MVA Ambassador in San Diego from spring 2013,” says Charlotte Ahlgren Moritz, Executive Vice President of MVA. The new agreements with BIOCOM and BayBio will focus on collaboration between various stakeholders: business-to-business, university-to-university and hospital-to-hospital.

The purpose of the agreements is to define and execute complementary research and educational programmes. Interdisciplinary initiatives combining the skills and competencies of the private life science sector, the universities and the healthcare sector are

Jennifer Landress, Sr. VP & COO, BIOCOM, has high expectations for the cooperation with Medicon Valley: - There is a benefit, especially for researchers and life science businesses, in exchanging information and combining complementary strengths and resources to tackle difficult drug and device development challenges.

Gail Maderis, President & CEO, BayBio: - The San Francisco Bay Area is a leading hub of innovation and is at the forefront of regenerative medicine, personalised medicine, digital health and biofuels. As the custodian for our region’s long-term innovation, BayBio works with international organisations to share the secrets of the Bay Area’s entrepreneurial spirit.

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also important parts of the agreement. The same is promotion of opportunities for private VC investments.

BIOCOM: Tremendous potential BIOCOM, located in the San Diego biocluster in Southern California, is the largest regional life science association in the world, representing more than 550 member companies in Southern California. Jennifer Landress, Sr. VP & COO, has high expectations for the cooperation with Medicon Valley: “There is a tremendous amount of potential for the development of collaborations between members of the Southern California life science cluster and those in the Medicon Valley region. There is a benefit, especially for researchers and life science businesses, in exchanging information and combining complementary strengths and resources to tackle difficult drug and device development challenges.

Biomedical researchers in one region might be able to collaborate with or advise businesses in the other region and provide valuable scientific guidance for drug development.”

BayBio: We’ll share the secrets of entrepreneurial spirit BayBio, which is located in the Bay Area of Northern

California and has the support of more than 450 member organisations, is also very much looking forward to their new collaboration in Medicon Valley.

“The San Francisco Bay Area is a leading hub of innovation and is at the forefront of regenerative medicine, personalised medicine, digital health and biofuels. As such, collaboration has been a cornerstone to our community’s success.

As the custodian for our region’s long-term innovation, BayBio works with international organisations to share the secrets of the Bay Area’s entrepreneurial spirit. We regularly put together meetings between international pharma partners and our start-ups. We also provide tours and introductions

“

There is a tremendous amount of potential for the development of collaborations.

Jennifer Landress

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When funding sources dried up, we brought new and traditional sources of capital back into the market.

Gail Maderis

to global leaders seeking to access the Bay Area community,” says Gail Maderis, President & CEO, BayBio. Lack of venture capital is a big issue in both Europe and the USA. Gail Maderis points to the fact that BayBio has a lot of activities focusing on both innovation and venture capital.

“When funding sources dried up, we brought new and traditional sources of capital back into the market. We introduced disease foundations, corporate venture arms, interested pharma companies and sovereign wealth funds as attendees at our annual conference and at the Entrepreneur and Investor Roundtables.

International attendees were able to hold one-onone meetings and discuss potential collaboration opportunities.

With more Pharmas investing and licensing

technologies, European companies can find innovation in the Bay Area,” says Gail Maderis.

In the past year, BayBio has held four Pharma Partnering Days, hosting among others BMS, Shire and Bayer Healthcare. A Novo Nordisk Partnering Day was held at 4 December and at these events BayBio identifies companies – both in the Bay Area and internationally – that are good candidates to meet up with for the pharma partner of the day. 

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New strategic collaboration with japan A new collaboration agreement between Medicon Valley Alliance (MVA) and the Japan Bioindustry Association creates new opportunities for DanishSwedish life science in Japan and is expected to strengthen Japan’s already substantial interest in Medicon Valley.

With the new collaboration agreement, MVA and the Japan Bioindustry Association will aim to establish partnerships between the industry and universities in Medicon Valley and Japan. The agreement includes all aspects of research, development and production as well as commercialisation.

The collaboration is being established at a time when several large Japanese pharmaceutical

companies are already showing interest in life science in the Øresund region.

“The Japanese pharmaceutical companies have been focusing on the region’s biotech and medical equipment companies for quite a while. We are also experiencing keen interest in innovation at an early stage at the universities in Medicon Valley,” says Thomas Jonsson, who has spent the last five years as MVA’s Ambassador in Japan.

Japanese companies such as Astellas, DaiichiSankyo, Terumo, Yakult, MitsubishiTanabe, Shionogi, Ono, Panasonic, Eisai and Olympus have shown great interest in Medicon Valley and as a result, MVA’s Ambassador Program has arranged several Japanese visits to the region.

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The turning point…

In June 2009, one of Action Pharma’s drug candidates began displaying inexplicable effects and had to be put on hold. To compound the problem, a couple of investor agreements folded and an otherwise promising company found itself on the verge of collapse.

But Action Pharma got back in the saddle and drug candidate AP214 has just been sold in one of the year’s largest up-front deals. See what happened.

Photo: Lars Kruse, AU kommunikation

By Malene Aadal Bo

It was the right thing to do – none of us doubted that.

It was tough but necessary,” says Søren Nielsen about the changes that was made to turn Action Pharma into a success.

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110 million. Dollars. Up front. That’s what it said in the sales contract that Sten Verland signed at home on his dining table late one night last April. As Chairman of the Board and a partner at Action Pharma’s largest investor, Sunstone Capital, he had been deeply involved in the month-long negotiations with US pharma giant Abbott. The negotiations culminated in Abbott agreeing to pay more than DKK 600 million to buy Action Pharma’s golden egg – a substance with the decidedly unflashy name of AP214.

“The price and the deal structure met our ambitions.

It was the right buyer and a fair price,” says Sten Verland. In an overview Action Pharma has compiled of deals measured in up-front value between 2007 and 2012, in global terms, AP214 reaped the tenth-largest up-front payment, and as almost DKK 290 million has been invested in the company during Action Pharma’s entire 11-year lifetime, that leaves the investors with a handsome profit.

“From the word go, I thought Action Pharma was a very exciting company. With my background in research, I was intrigued by the potential of the new pharmacological target that Action Pharma was working on. And as an investor, I was pleased both that there was a medical need we could address – patients and doctors who wanted the product – while doing good business for

“

We had two options. Either pull the plug and close the company down on the premise that you shouldn’t throw good money after bad. Or go all in.

Sten Verland

the funds Sunstone manages,” says Sten Verland, who has been personally involved with the company since 2007.

By then, seven years had already passed since the research results Dr Søren Nielsen had achieved at Aarhus University had been so promising that he joined forces with three colleagues to establish the company.

They gathered a team of researchers who focused on three projects in particular: AP1030 – a drug against obesity and diabetes type 2; AP 1189 and AP405 against inflammatory diseases and AP214 against organ damage – especially kidney damage.

“We were always convinced that the technology would hold water and make a difference. And we were driven by the dream of creating a company and a product – applying basic research,” explains Søren Nielsen, whose initial plan was to lead the company through to a stock exchange listing and thereby raise sufficient capital to further develop the company and not least take several of the products to late phase clinical development.

Photo: Sunstone Capital

The ultimate low

As Chairman of the Board and partner in Action Pharma’s largest investor, Sunstone Capital, Sten Verland took part in both the ups and downs in what would eventually become a great danish biotech success.

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Getting investors on board was relatively easy during the first few years, and the projects sailed along happily.

But in 2008 the financial crisis sank our plans for a stock exchange listing and it became much more difficult to raise capital for the company to continue operating.

According to Søren Nielsen, the ultimate low was reached in the summer of 2009. A number of funding options crumbled and one of the company’s leading drug candidates encountered problems in phase I. The diabetes drug displayed mild but inexplicable side effects and there was neither the time nor the money to investigate this in more detail.

Action Pharma was in the midst of a crisis and the investors risked losing their investment, which by then was over DKK 200 million. The Board convened to determine the company’s future.

“In our view, we had two options. Either pull the plug and close the company down on the premise that you shouldn’t throw good money after bad. Or go all in with enough money so that at least one of the other products could show its worth,” says Sten Verland.

The management team and employees were on tenterhooks while the investors thought things over.

“We knew that the investors were tired. Several were

short of cash themselves and the entire venture market was suffering from fatigue,” says Søren Nielsen.

Yet he never really believed that the investors would pull out. It would be very unwise to throw in the towel when we also had promising phase II clinical trials under way with our lead candidate,” he explains.

And the investor group ultimately agreed with Søren Nielsen. They chose to believe that AP214 – the drug against acute kidney damage in connection with heart disease – would do well in phase 2 and bring a good return on their investment. This decision became the first important step towards the success that Action Pharma would ultimately become.

“

It was the right thing to do – none of us doubted that. But it meant stopping some very excitingprojects and saying goodbye to some very highlyskilled employees.

Søren Nielsen

The price of success The funding the investors pumped into Action Pharma had a price, however. It was conditional on important changes and a brand new corporate strategy. A strategy that required focusing solely on AP214, and grinding all other development projects to a halt.

It also involved reducing the company down to Søren Nielsen as chief operational officer and a new CEO – Ingelise Saunders – who was called in to prepare the company for sale.

“It was the right thing to do – none of us doubted that. But it meant stopping some very exciting projects and saying goodbye to some very highly-skilled employees who had worked their fingers to the bone to make the company a success. Streamlining the management team also meant losing people who had helped found the company but could no longer see an upside. It was tough but necessary,” says Søren Nielsen.

Luckily, the cure had the desired effect. In summer 2010 the results of the 2A trial with AP214 were ready and with them in hand the company was pitching to potential buyers by the end of the year.

“There was plenty of interest but the study was relatively small and the data was not strong enough to tempt anyone to put money on the table. However, several said they’d be happy to talk to us again if we did a phase 2b study,” says Sten Verland.

Once again, the investors had a decision to make: whether to stop or conjure up the necessary cash.

“It was slightly easier this time because we had a clear feeling from the industry feedback that we had a very

interesting product. We just had to shoulder the risk a little longer,” says Sten Verland.

The investors dug up even more millions and paid for a larger phase 2 study. The results achieved in 2011 were once again strong. And once again we hit the road with our sales pitch – this time with a significantly better response. In fact the Board could choose the buyer they preferred.

Very satisfied The US pharmaceuticals giant Abbott was chosen for its willingness not only to pay the right price but also to invest the resources needed to continue the product’s clinical development.

“We had always believed in the project and had a dream that patients would benefit. It was therefore important to sell to someone who can make that happen,” says Søren Nielsen, who describes himself as “very satisfied”. He is still closely following AP214’s development, and has also picked up where he left off with developing one of Action Pharma’s other projects.

This is being accomplished in a new company that he has established together with former colleagues from Action Pharma.

Sten Verland is also happy with the course of events and sums up: “We have developed a drug candidate that can make a difference to patients, and have done so in a way that is commercially rewarding for us as investors and for the pharma industry. It doesn’t get better than that,” he concludes.  Translation: CLS Communication A/S

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Photo: Jeppe Clausen

The bridge builder He compares his work to that of a cultural ambassador, and for Peter Halkjær-Knudsen, 60-year-old Executive Director of the Chinese biotech giant ChemPartner’s European division, the whole world is his workplace. His task is to bridge the cultural differences between Chinese research units and European companies.

Photo: Jeppe Carlsen

By Jannie Schjødt Kold

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When ChemPartner, one of Asia’s leading biotech companies, began looking for an executive director for the planned European division in 2009, they consulted their own network. Did anyone know of anyone? Three or four names came up, including a Dane called Peter Halkjær-Knudsen.

At that time he was based in Stockholm as Vice President of the pharmaceuticals company iNovacia, a job he really enjoyed, but the thrill of a Chinese adventure was tempting nevertheless. Peter Halkjær-Knudsen therefore travelled to Shanghai, where he stayed for about a week.

It was a week-long meeting along typical Chinese lines involving several interviews and tests. A thoroughness that makes sense if you ask Peter Halkjær-Knudsen: “It is symptomatic of Chinese business practices that

“

From 2002 to 2012 the Chinese have managed to reach the same standard as the US and Europe in many areas and that deserves respect,

they are extremely careful in their deliberations from the outset,” he says today.

“This thoroughness means they can take action fast once the necessary trust has been established.”

And it certainly was fast. When Peter HalkjærKnudsen was called up and offered a job just one week after his trip to China, events took off.

“When we had agreed on the terms and I had accepted the position, it surprised them that I was still on the phone and not already setting the wheels in motion,” recalls Peter Halkjær-Knudsen, believing that this is a core aspect of Chinese business practices.

“Once the relationship has become personal, events move fast,” he explains, adding that the day after the telephone call, capital was transferred so that the company could be set up.

In other words, there was no time to waste and no reason to dally. In just a few days, the new Executive Director had set up an ApS and hired the services of a lawyer, Corporate Banking, accountant and bookkeeper.

He found offices at the science park in Hørsholm, north of Copenhagen, which was an extremely popular decision on the home front.

“I had travelled extensively until that point, but now I could walk to work,” explains Peter Halkjær-Knudsen, whose daughter is studying at university and son is attending upper secondary school.

Cultural ambassador in China

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Since Peter Halkjær-Knudsen began his career with Hewlett Packard, he has seen a lot of the world. First as a chemist and later in an increasingly business and managerial capacity, he has sat at desks in practically all four corners of the world and 20 years of his working life counts as international experience.

“I have had a Japanese boss, a Chinese boss, and American, Swiss, Norwegian and Danish bosses,” he reels off, listing his jobs: “And I have worked in places as diverse as San Diego, Basel, Paris, Stockholm and New Jersey, so I’ve been a bit of a nomad,” he explains.

This extensive international experience is useful to Peter Halkjær-Knudsen today, acting as he does as the link between the highly-educated researchers in China and business partners in Europe. He compares his job with that of a cultural ambassador’s.

“I tell the European companies how things work in China and vice versa,” says the Executive Director, who also holds speeches on this subject for Chinese companies wanting to enter the European market.

In fact a third of his salary should be covered by the EU and the Chinese government, he believes.

“My job is to build bridges and forge contacts,” he says. “When a personal relationship and cooperation has been established, I take more of a back seat.”

As one of Asia’s leading contract research companies, ChemPartner works on medical research in potentially fatal diseases involving cancer, the metabolism and central nervous system.

“Our tasks are extremely varied. We can advise a

customer for two days or we can allocate 90 men to a research project for several years,” says Peter HalkjærKnudsen, elaborating: “As soon as a product or a medicine enters a human body, we withdraw from the process and just supply the active drugs or proteins required for the clinical research. Sometimes it’s hard to leave a project that you feel emotionally attached to.”

On the other hand, he enjoys being involved in so many projects. “It’s incredibly rewarding being in close contact with about 200 pharma and biotech companies in Asia and the West and feeling that as an advisor and sparring partner you are helping to build something,” he says.

Over-the-top decisions in a growth industry Curiosity about other nations and the desire to work in other countries have numbered among Peter Halkjær-

What is the West’s greatest misconception about China?

“One of the greatest misconceptions between Europeans and the Chinese is that often Europeans are unaware of the scope of the internal differences within China. No one answer covers the whole of China.

We must be careful not to generalise. That is evident in the Danish media. If there is a train crash somewhere in China, the headline is simply ‘Train crash in China’. But China covers an area larger than the US and if we were a bit more familiar with its geography the headline would have read ‘Train crash in the Hunan province’. We don’t combine events in Morocco with those in Northern Norway though the distance is shorter between them than the distance across China. On the other hand, it is also hard for the Chinese to understand that though Europe is so small, there are major differences in culture and business traditions – after all, we all look the same!”

Knudsen’s interests since his childhood. He regards it as a continuation of the course his parents chose for him at an early age.

“My father worked for the UN and we accompanied him everywhere. I could find my way around Nicosia on Cyprus at the age of 12 and give directions in Jerusalem,” he smiles, adding that he is very grateful that this international mindset was imprinted on him as a matter of course.

“My father showed me that you can work in all kinds of places on the planet and cooperate with everyone, and I value that lesson to this very day,” he says.

He has enjoyed his career, which has revolved around development. When asked if he would do anything differently, he says he would have become familiar with the Chinese growth industry earlier on.

“The decisions you can make when the Chinese

Four short facts on China

What advice would you give to those facing the prospect of working with building up a partnership with a Chinese company?

“Be clear in your minds about why you want to enter the Chinese market.

The Chinese will expect your project to be carefully thought out. It may sound very basic but you need to be very clear on two points: What you have to offer and what you want to take home with you.”

Is it true that the Chinese are wiser, more highly skilled and more diligent than us - and are also cheaper labour?

“Employees in China are becoming better and better due to the major investments in education.

They have slightly longer workdays and shorter holidays and somewhat lower wages and taxes than is the case in Denmark.

Ultimately, the price for a highly scientific project is about half the cost of what it would be in Denmark.”

Does it take the Chinese twice as long to complete an engineering project compared to, say, Denmark?

“That may have been the case at one time. But today they focus so much on all the parameters and costs that it wouldn’t be the case. However, I would think that we have a “surplus consumption” of staff hours of 10-15% in relation to the same project being carried out by a German research company. That is something we frequently benchmark.”

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economy is blooming are so overthe-top,” he says, describing a protein project as an example, which in just 12 months grew from having just three employees to over a hundred, and has now delivered its first project to GLPTox with plenty more in the pipeline.

“We would never see such a willingness to provide venture capital in a European context, where we often struggle with fixed headcounts,” he explains.

In a Chinese growth industry, the flow of resources is turned up and down quickly. They are also generally better at thinking out of the box though naturally sometimes their high-flying innovative ideas ultimately fall short,” explains Peter Halkjær-Knudsen.

Photo: Jeppe Carlsen

A brilliant idea

Peter Halkjær-Knudsen Peter Halkjær-Knudsen, born in 1952, Master of Science in biology from the University of Copenhagen. He has worked in the biotech industry for 20 years for companies such as iNovacia, Discovery Partners International and Nanogen. He lives with his family in Hørsholm, north of Copenhagen.

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“I can remember at one point we had the smart idea of launching a greener form of biotech,” recalls Peter Halkjær-Knudsen.

The idea was to use fewer raw materials and advise companies on greener chemicals and reducing the use of pollutants and harmful substances. Two days after the idea was conceived, two men were appointed to work on the project and six months later, 48. Unfortunately, none of ChemPartner’s customers were exactly queuing up to convert to sustainable biotech.

“Everyone thought it was a brilliant idea, but after one year we could see that our sales efforts vastly outweighed the projects we were attracting. So we closed down the project and absorbed the employees in the department through normal growth,” explains Halkjær-Knudsen, who thrives on short decision processes and the thorough legwork that are always features of the initial process in China.

The question is, what is the biggest difference between Chinese and Western biotech?

“Naturally, there is a base of experience that, for better or worse, you still won’t find in China.

But it is quickly being generated!

The Chinese government is supporting the universities with

huge amounts of funding to pump out graduates with master’s degrees,” explains Halkjær-Knudsen.

In addition, China is implementing a very active policy to attract highly educated people to settle in China, and according to Peter Halkjær-Knudsen, the talent pool is rapidly growing as experience pours in.

“China is also working purposefully to protect its intellectual property, and this is what has given them a strong role to play in the biotech market in a short space of time,” says Peter Halkjær-Knudsen.

China level with the West Not long ago, research was conducted in China but designed and managed from the West. Today, China is a leading light and even stronger player in the biotech market.

“From 2002 to 2012 the Chinese have managed to reach the same standard as the US and Europe in many areas and that deserves respect,” explains HalkjærKnudsen.

Chinese research is level with Danish research but whereas in Denmark we are cutting back, China is investing intensively in pharma, medicine and engineering science.

“This support may be managed, but in size alone it is unheard of in our part of the world,” says Peter HalkjærKnudsen, who commands 350 managers and middle managers, each with at least a PhD.

Overall, close to 2,000 of ChemPartner’s employees work at a scientific level.

“We have a core of employees who are educated at the best universities in the US and Europe and who have at least ten years of experience from Western companies. These people act as mentors for the Chinese academics, which supports the ability to grow very rapidly,” he explains enthusiastically.

As a bridge builder, Peter Halkjær-Knudsen spends his time explaining this and other aspects, and in one sense at least as a “cultural ambassador” he has achieved his childhood dreams.

“I wanted to be a civil engineer and was fascinated by bridges,” he explains.

Not that there were many bridges in North Zealand where he spent most of his childhood, but when they did drive over bridges, the young boy on the back seat was transfixed.

“I think bridges are beautiful in a Meccano-type way,” laughs Peter Halkjær-Knudsen.

Today, he still stops at bridges like the Brooklyn Bridge on his travels round the world, but has a more multi-faceted view of their aesthetic appeal.

“I also like what bridges symbolise, and without sounding too pompous, you could say that sums up my function today.”  Translation: CLS Communication A/S

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Photo: Jeppe Carlsen

Clinical dilemma:

Bedside empirical treatment The vast majority of registered drugs are indicated for use in adults or adolescents only. Few drugs have been investigated for use in younger children aged 5+ years. However, clinical evidence is scarce to non-existing when it comes to toddlers and infants, leaving clinicians with a significant clinical dilemma.

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By Charlotte Strøm, MD, PhD, Journalist Every day around the world children are prescribed medicines that are indicated for use in adults only.

“It is a considerable clinical issue that paediatricians face on a daily basis. It is a slippery slope to take because we typically start using medicines we know have an effect in adults, and perhaps adolescents. Sometimes we are lucky enough to have clinical data on efficacy and safety in children as young as five years of age. But we rarely have solid documentation to justify our clinical choices for medical interventions in young children and even less in infants or premature infants,” says Lone Graff Stensballe, specialist in paediatrics.

Lone Graff Stensballe encourages the national or international health authorities to drive studies that will enlighten paediatricians scientifically.

Widespread off-label use She points to the ethical dilemma.

“We want to improve our patients’ lives and better yet cure them, but due to the limited clinical data we end up making clinical decisions that are far from being evidence based.”

This applies to the indications as well as dosing.

“Even with drugs we have acquired a large amount of empirical experience on over the years, dosing remains a constant issue. We discuss it, try to document it in local guidelines, but we all know that it is totally inadequate from a scientific and ethical point of view. I think all paediatricians recognise the frustration of not knowing the proper dosing for young children.”

The obvious concerns are potentially impaired or different patterns of metabolism in the immature livers and kidneys, particularly in premature infants, but also in toddlers and mature infants.

She points to the controversy of the widespread off-label drug use within paediatrics as manufacturers basically have no motivation to do proper clinical trials in children. The new drugs will be marketed with an improved level of clinical information about paediatric use, however manufacturers of currently registered drugs may feel less encouraged to run clinical trials in children, unless they are looking to extend the label or change the formulation.

“As a clinician it is not an option to do nothing, when you are facing a seriously ill and potentially dying infant and his or her family in your ward. You have to do something. And that’s why we often end up in off-label prescriptions,” Lone Graff Stensballe says.

She encourages the national or international health authorities to drive studies that will enlighten paediatricians scientifically: “Sure we may have to change clinical practice from these studies, but the issue is that we currently make

far too many clinical decisions that are not properly and scientifically documented.”

Observational studies on long-term effects She stresses that not all documentation has to be prospectively collected.

“It would make an immense difference even if only observational studies were performed, especially to investigate the long-term effects of the use of medicines in children. It is obvious that the use of e.g. immunosuppressive drugs, antibiotics or chemotherapeutics in growing organisms may have an impact that is not yet known.”

Lone Graff Stensballe has acted as an investigator in observational and interventional paediatric trials a number of times and is currently the sponsor and research team leader of a large-scale prospective controlled clinical trial.

The study aims at investigating the effects of BCG (Bacille Calmette Guerin) vaccine on infants’ morbidity based on the hypothesis is that BCG modulates the immune system in newborn babies. The study has planned to enrol 4,300 infants (EudraCT Number: 2010-021979-85).

Hurdles in clinical research As a sponsor, Lone Graff Stensballe argues that a major bureaucratic hurdle to get started on clinical research.

“Sure, the application procedures in Denmark have been somewhat improved, but still the combination of doing clinical work and clinical research is extremely difficult.

Unfortunately there are no real incentives or at least fast tracks to clinical research, only bureaucracy and long hours, and this is why so many clinicians simply refrain from doing it, even if they know it is desperately needed,” she concludes.

FACTS: • N= 1,322 is the total number of registered clinical trials in children in the EudraCT, the EU Clinical Trial System • In 2011, 19 studies in children and adolescents under the age of 18 were registered in the database • The ongoing number of paediatric clinical trials this year is seven (search conducted at end of October 2012) • The EudraCT database is hosted by the European Medicines Agency (EMA) For more information about the BCG vaccination trial: www.cviva.dk

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European paediatric regulation:

Improved knowledge about medicines for children The Paediatric Committee (PDCO) of the European Medicines Agency (EMA) concludes in the five-year status report that the paediatric regulation has been successful. Even though the regulation is more whip than carrot, the pharmaceutical industry generally acknowledges the need for it.

By Charlotte Strøm, MD, PhD, Journalist By 26 January 2007, the paediatric regulation came into action in Europe and forced pharmaceutical companies to document the use of new substances in children (article 7 application) and in readily registered drugs when a new formulation or extension of the label is planned for (article 8 application). Based solely on the number of Paediatric

FACTS: About PIP waivers • Some diseases do not affect children (for example Parkinson’s disease). The development of medicines for this and similar diseases should not be performed in children. In these cases, a PIP is not required and it will be waived by PDCO. For more information on the classes of diseases subject to waivers, see class waivers.

About Regulation (EC) No. 1901/2006 • Regulation (EC) No. 1901/2006 of the European Parliament and of the Council on medicinal products for paediatric use (also referred to as ‘the Paediatric Regulation’) was published in the Official Journal of the European Communities on 27 December 2006 and entered into force on 26 January 2007.

• The Paediatric Committee (PDCO) reports annually to the European Commission • The 2011 status report is available at: http:// ec.europa.eu/health/files/paediatrics/2012-07_ paediatric_regulations.pdf • The five-year draft evaluation of PDCO’s work was published in July of this year and is open for comments and replies until 28 November 2012 For more information: http://ec.europa.eu/health/humanuse/paediatric-medicines/developments/index_en.htm

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Investigational Plans (PIPs) the regulation has been a success. The evaluation of PIPs was completed for 682 medicines up to the end of 2011. Among the opinions adopted, 476 were on the agreement of a PIP (70%) and 30 per cent of a full waiver. Waivers indicate that the use of the medicine in the targeted condition was not of paediatric relevance or interest, or likely to be unsafe. Around 75 per cent of PIPs were for medicines that were not yet authorised at the time of evaluation.

Member of the committee, Marianne Orholm, MD and specialist in infectious diseases, confirms that the first years at PDCO have been rather busy.

“The number of PIPs submitted until 2010 was high – and higher than expected,” she says.

During the first years the number of PIP applications in medicines that were already registered for use in adults and were looking to extend the label or change the formulation was relatively high compared to PIPs in new drug substances.

“I believe we have seen the peak now – and the majority of the PIPs we will evaluate in the years to come will represent new drug substances that are developed for use in both adults and children. The difference compared to the time before the regulation is that the paediatric development is planned simultaneously with the adult programme and it is no longer an option to omit paediatric development,” she says.

Only when it comes to diseases that do not occur in children, the medicines need not undergo paediatric development and is waived by PDCO.

Paradigm shift Philippe Auby, Regional Medical Director at Lundbeck, thinks the European initiative reflects a more or less global change of mindset when it comes to clinical trials in children.

“We used to believe in protecting children from clinical trials, nowadays we tend to believe in protecting paediatric populations with clinical trials. This is truly a paradigm shift that has occurred over the past five to ten years in regulators, ethics committees, clinicians and in parents,” Philippe Auby says.

Photo: Jeppe Carlsen

Marianne Orholm is convinced that the regulation will provide consumers and patients access to improved care and better drugs.

“This is the right way to gain more and improved knowledge about medicines in children,” she says, continuing: “Obviously it will take time for the law to be fully implemented, which explains why it has not resulted in a large number of new registrations of drugs for paediatric use. Clinical trials take time – and this is also the case when it comes to children.”

Amendments and changes Many of the PIPs that the committee has evaluated during the first years have later on been amended or changed.

“Sometimes the request for changes relates to updated knowledge, new findings that fundamentally change the original scope of the PIP. However, the most common reason for changes is as trivial as an extension of timelines, because it is often difficult for sponsors to find children to enrol in the trials.”

Philippe Auby argues that the level of detail required in the PIPs is too comprehensive.

“The PIP is submitted at a very early stage during the specific drug development programme, not only with respect to children but also for adults, i.e. at the end of phase I or the beginning of phase II. I acknowledge the need for PIPs, but it causes a significant amount of extra paperwork and documentation not only for the drug developers but also for PDCO, which is basically caused

by the fact that at the time of submission we know only a fraction of what we know just a few years down the road in the clinical development programme.”

Global trend As the trend is global, one would expect clinical data to be valid on more than one continent.

“For the benefit of everyone, the children, their parents and the drug developers, it makes sense that data obtained in children on one continent is valid and applicable on another continent. In about 80 per cent of cases this is so, but for the remaining 20 per cent, studies will have to be conducted all over again,” Philippe Auby says and encourages the international regulatory authorities to take action for improved collaboration.

There is currently no formal collaboration between the international regulatory authorities on this specific point in order to optimise the development process for innovative, effective and safe medicines for children.

Few drug developers – if any – dispute the need for improved medicines and higher standards of clinical data in paediatric populations. But is it always a good business case?

“I believe it is too soon to answer that question. We have a strong late-stage pipeline at Lundbeck, but we are just beginning to implement and execute the PIPs now. So it remains to be seen. However, the need for innovative drug development for use in children – I believe – now goes without saying,” Philippe Auby ends.

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Working with the Paediatric Regulation Lillan Rejkjær, at IWA Consulting, has hands-on experience with Regulation (EC) No 1901/2006, the formal name of the regulation on medicines in children.

By Charlotte Strøm, MD, PhD, Journalist As an external consultant, Lillan Rejkjær, Vice President Regulatory & Medical Development at IWA Consulting, has assisted a number of pharmaceutical companies with their challenges when it comes to the Paediatric Regulation.

Personally, she is encouraged by the positive impact the regulation can have.

“There is no doubt in my mind that the regulation will facilitate improved medicines for children. In principle – as a community – we will all benefit from this. Moreover, the regulation changes the scope of drug development in general, as it is no longer an option to defer from documenting proper safety and efficacy in children,” she says.

Greater commitment and stricter timelines The Committee for Medicinal Products for Human Use (CHMP) evaluates marketing authorisation applications

FACTS: • For more information about PDCO and the application procedure: www.ec.europa.eu/ health/human-use/paediatric-medicines/index_ en.htm#geninf • Data protection in adults: For a new drug that is approved by CHMP with a PIP, the marketing authorisation holder will receive an additional sixmonths of data protection in the adult indication • Data protection in children: Paediatric-use marketing authorisations (PUMAs) is a marketing authorisation following a PIP as agreed with PDCO • Companies can request PUMAs for medicines that are already authorised, are no longer covered by intellectual property rights (patents or supplementary protection certificates) or are to be exclusively developed for use in children • This type of marketing authorisation covers the indication and appropriate formulation for the paediatric population • A PUMA will benefit from 10 years of market protection as a reward for the development in children

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(MAA) for drugs. The Paediatric Committee’s (PDCO) role is to assess data generated in accordance with agreed PIPs, and to adopt opinions on the quality, safety or efficacy of a medicine for use in the paediatric population, at the request of CHMP. A Scientific Advice may be requested with EMA for a medicine developed for paediatric use. This advice is free of charge, even though Scientific Advice with EMA usually is not. When it comes to decisions and opinions on Paediatric Investigational Plans, PDCO provides the opinions, which may contradict previously applicable national authority scientific advice or EMA advice.

“This is one of the things that has puzzled the industry,” Lillan Rejkjær says.

In her experience the pharmaceutical industry in general was quite well prepared to meet the new requirements back in 2008. It was the level of detail and the strict timelines that came as a surprise to many companies.

“The timelines are very strict in the Paediatric Regulation, and this is where I see pharma companies most often running into problems.”

She points to the difficulties with recruiting subjects for clinical trials as a major obstacle when it comes to meeting the deadlines within the PIPs. This is especially a problem when the execution of the paediatric clinical trials is not deferred after the approval of the MAA.

USA versus EU Based on her work with pharma companies and their PIPs and MAAs, Lillan Rejkjær has observed specific differences between the way paediatric drug development is handled in the USA compared to Europe. Typically, the timing of paediatric trials is not an obstacle for the filing of the New Drug Application (NDA) in the USA and it is acceptable if the paediatric clinical development takes place at a later stage.

“Very few US-based companies keep in mind how strict the regulations for paediatric clinical development are in Europe. I in some cases the PIP ends up having a suspensive effect on the European MAA process, if companies only start thinking about it when the phase III trials in adults are drawing to an end,” Lillan Rejkjær concludes.

Her advice is to have the PIP ready for submission, or at least to be prepared to initiate the dialogue with PDCO, by the end of phase I.

Guide:

Children may be a challenge – also for drug developers As a CRO consultant, Kate Westergaard works with clinical trials in both adults and children. She points to some of the fundamental differences in the two populations.

By Charlotte Strøm, MD, PhD, Journalist When it comes to clinical trials, children are a challenge that requires special attention to overcome.

“Conducting trials with children as participants involves different aspects. First of all, the parents play an active role, but they also present an extra intermediary, for better and for worse,” says Kate Westergaard.

She works as an independent consultant and has more than 20 years of experience in clinical research and clinical operations.

Trial design specifically for children Kate Westergaard stresses the importance of making the children’s rights, safety and well-being the highest priority when developing the protocol and the protocol procedures.

“The sooner the investigators and the clinical staff at the site get involved the better. Pharma companies have protocol standards, and from an operational point of view this is a good thing. However, it is often necessary to be more flexible when it comes to paediatric trials – and the best way to address this is to discuss the protocol or, better yet, to develop the protocol in collaboration with the staff at site,” Kate Westergaard explains.

A number of things may be designed specifically to suit trials in children, the amount of blood samples or the amount of blood that is needed to sample at each visit, the formulation may possibly be improved for paediatric use, and potential medical devices used in drug delivery should specifically aim at being user friendly for children.

It takes time In Kate Westergaard’s experience the need to allocate sufficient time with the study participants and their parents is crucial.

“You cannot speed things up around a child for the purpose of your trial. In many ways the same thing goes with the parents, because they are the ones who will play an active role and ensure compliance,” she says, and stresses how informed consents with all parties, children and parents, take extra time and require age-adapted communication platforms, besides the standard information for adults.

“It all takes time, and it takes time for families to consider the trial participation,” Kate Westergaard says.

“Having said that I generally meet a great deal of openmindedness with parents,” she says, explaining, as an example, how she has set up a protocol that required study participants – and one or two parents – to travel from Denmark to Sweden and stay overnight for each study visit.

“I have been impressed with this positive mind set – and how willing parents are to contribute and spend time and energy to see the trial through and support their child,” she concludes.

DO’s For sponsors • Always consider the subjects’ rights , safety and well-being in the development of the protocol and the protocol procedures • Involve the study site staff at an early stage of the protocol development • Ensure qualified study staff is allocated to the trial for all protocol assessments • Investigate the possibilities of adapting blood samples or other tests to children, i.e. smaller amounts, shorter test duration, fewer X-rays etc.

• Develop age-specific patient information with cartoons or photos that illustrate all protocolspecific procedures • Consider children-friendly instructions, gadgets or accessories for diaries or for transportation of medicines For trial site staff • Discuss in detail with the parents the importance of correct handling of the investigational drug in order to ensure compliance and safe treatment • Ensure an open dialogue about the importance of adverse events reporting that may be sourced from parents or the child • Allow sufficient time for protocol visits and the involvement of both parents. Children may require more time in the clinic than adults • In particular, allow sufficient time for the informed consent process. Leave time for questions, reflection and review of written information. This part often proves essential for successful trial participation and completion

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Innovative drug formulation:

Optimising drug formulations for paediatric use The quest for intelligent formulations applicable in children is a challenge that all drug manufacturers and pharmaceutical companies currently have to face. However, innovative formulations designed for paediatric use may be the solution to personalised drug administration in the future rather than a hurdle in the present.

By Charlotte Strøm, MD, PhD, Journalist

Photo: Jeppe Carlsen

Since 2007 the European Medicines Agency has required the submission and validation of Paediatric Investigational Plans (PIPs) prior to the submission of a marketing authorisation application for all new medicinal products, including age-specific formulations. Additionally, applications for new indications or new formulations of readily marketed products also require validated PIPs. Hence the need for drug development designed specifically for paediatric use seems overt. Does this mean we will

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be seeing innovation within drug formulation targeted at children? So far the mainstay of drug formulation development for paediatric use is the rather old-fashioned attempt to disguise the taste of the medicinal product using sugary syrups.

Oral drug administration Oral drug administration remains the preferred formulation, in children as well as adults. With this in mind, Daniel Bar-Shalom, a drug formulation specialist and associate professor at the Faculty of Pharmaceutical Sciences, University of Copenhagen and Bioneer: FARMA, explains why the current thinking regarding paediatric drug formulations is outdated.

“Contrary to the belief of the pharmaceutical industry, children are not fond of syrups. Children do not like novelty in food; in fact, they are reticent to try new flavours and consistencies,” Daniel Bar-Shalom says.

He explains why this behavioural pattern is strong in a child: “Drugs are per se poisons. They taste like poison and evolution has equipped us with the means to detect and avoid them in time, via the senses of taste and smell.”

A Danish study, conducted by Pottegård and Hallas and published in 2010, confirms this assertion. The authors investigated children’s preference with respect to narrow and broad spectrum antibiotics and extracted data on all penicillin prescriptions issued to children in the Region of Southern Denmark in 2009. The rate of early switch from narrow to broad spectrum antibiotics was calculated and defined by redeeming a new penicillin prescription within three days. Such a switch was believed to reflect tasterelated therapeutic failure because a treatment effect or failure cannot be determined clinically within three days.

Narrow spectrum penicillin, however, has a distinctive and characteristic taste while broad spectrum antibiotics do not.

Daniel Bar-Shalom understands why this occurs.

“Adult humans differ from other animals in their ability

to make the conscious decision to override the warnings by reasoning that, in the long term, swallowing the bitter pill is for their own good,” he explains.

Daniel Bar-Shalom’s point is that it takes years for a child to acquire this ability.

Children are not small adults Although children generally are healthier than adults, they still need to take medicines occasionally and for a small group chronically. Mostly medicine is taken orally, leaving a huge unmet need for drug formulation development.

Daniel Bar-Shalom stresses that it is a fundamental misunderstanding simply to dose adjust medicines indicated for use in adults.

“Children are not small adults in whom you can simply adjust the dose of the active pharmaceutical ingredient.

Due to an immature metabolism this method may, at best, be useless and, at worst, downright fatal,” Daniel BarShalom says.

He sees the new requirements for drug development in children as a golden opportunity for the pharmaceutical industry to think out of the box and reflect more on how to develop drug formulations that are particularly well accepted by children.

“The question and its answer are simple. What type of food is generally accepted globally not only by children but by everyone: a semi-solid formulation that is pale in colour, mild in flavour, and soft in texture, namely porridge, pudding or similar,” Daniel Bar-Shalom says.

The science of food perception Daniel Bar-Shalom explains that the introduction of food perception, organoleptics, together with rheology (the study of the flow of matter, e.g. liquids or soft solids) and tribology (the science and engineering of interacting surfaces in relative motion) will revolutionise drug formulation as we traditionally know it. The development of semi-solid formulations is, however, trivial matter. It involves choice of polymers, investigation and characterisation of stability, agglomeration and shearthinning.

“Furthermore, the issue of taste must be addressed, particularly as we are looking to develop drugs for use in children,” Daniel Bar-Shalom says.

Methods to hide the taste that have readily been developed by Professor Bar-Shalom comprise microencapsulation, coating materials and methods for controlling particle size and dose.

New visions in drug formulation for children – and adults Microencapsulation solves the problem of how to disguise the taste in drug formulations. However, it is also the cornerstone of a new vision, according to Daniel BarShalom.

“What if it were possible to administer all drugs, at an individualised dose, in the same dosage unit?” asks Daniel Bar-Shalom.

He believes this is possible.

“We have all the components to make this vision a reality. Gelling granulate we can handle. We are able to do microencapsulation which will allow two or more drugs to be

dispensed in the same dose. We have automated dispensing machines. We are able to perform packaging of individual doses. Finally, I feel confident that software to go with it will be developed soon enough.”

Individualised drug formulation To Daniel Bar-Shalom this paves the way for what he believes will be the future of drug development and formulation.

“The pharmaceutical industry has largely neglected the paediatric segment. Today the industry is forced to make the move into paediatric formulations and this is expensive with a potentially low return on investment,” Daniel BarShalom says.

“However, the re-thinking of how drug formulations can be done not only to meet the needs of young children, but to meet the needs of anyone who has to take medication orally, will allow improved and individualised treatment with better compliance and better patient outcomes. This sounds like a pretty good investment to me,” he concludes. 

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The crash of the titan For many years, NeuroSearch pioneered Danish biotech as the glorified flagship for the entire industry. But in the wake of the financial crisis and some unfortunate decisions, time has run out for the Danish biotech patriarch now standing on the brink of divesting the company’s property, patents and very existence.

By Kristian Sjøgren

Photo: NeuroSearch

The name NeuroSearch still inspires a feeling of enthusiasm that lingers on from its heyday when champagne glasses were raised less than five years ago. But the major headlines and great expectations are a thing of the past. The only headline needed now is for the obituary of the pioneer and patriarch who sparked the Danish biotech adventure 23 years ago.

It all began even further back in the R&D department of the pharmaceutical company Ferrosan when Jørgen Buus Lassen was promoted to head of research in 1980. He was later to become NeuroSearch’s CEO. Throughout the 80s, he had struggled – and managed – to create a department that generated a profit.

However, due to a conflict of interests between the shareholders, Jørgen Buus Lassen’s department was sold to Novo Nordisk in 1986. This meant a change in strategy in 1988 when several employees regrettably found the research becoming more streamlined and goal oriented.

“My more creative research colleagues, in particular, felt their hands were less free to explore new avenues of research.

It wasn’t that we didn’t have faith in Novo Nordisk – it has since had an extremely good track record – but my colleagues and I just wanted something else,” explains Jørgen Buus Lassen, who has agreed to take us on a trip back in time to trace the company’s history.

In 2007 investors were falling over themselves to invest in Neurosearch. Only few years later the company is but a shadow of itself.

36

Hit the ground running In the shadow of Novo Nordisk’s strategy,

Jørgen Buus Lassen and five of his colleagues chose to resign and start a new biotech company with leading financial light Asger Aamund. It was destined to focus on research into drugs against diseases of the central nervous system linked to ion channels. NeuroSearch was launched with CEO Jørgen Buus Lassen at the helm.

The new adventure got off to a flying start. Just nine months later, NeuroSearch signed its first cooperation agreement and over the years developed new projects with business partners including GSK, Lily and Abbot laboratories.

In 1996, NeuroSearch was listed as the first Danish biotech company ever and thereby creating the platform for the investor frenzy that characterised the biotech industry for the next 10 years. More biotech investments followed in the wake of NeuroSearch’s pioneering work, which in turn resulted in more stock exchange listings.

In record time, Denmark had established itself as one of Europe’s leading biotech nations.

Back at the bridge, Jørgen Buus Lassen continued steering the NeuroSearch flagship on its appointed course.

“For many years, there were both good times and bad.

Sometimes our clinical trials went well and shares rose.

Sometimes the results of clinical trials were less positive and the shares declined. But our whole concept was based on proceeding quickly with project work and finding business partners with the experience and organisation

NeuroSearch was established in 1989

by Jørgen Buus Lassen, Asger Aamund, Frank Wätjen, Leif Helth Jensen, Henrik K. Moltke, Peter Wulff and Jørgen Drejer.

The most promising products in the corporate portfolio were once Huntexil, Tesofensine and NS2359. NeuroSearch also has some products in early clinical phases.

When NeuroSearch was riding high in 2008, one share cost more than DKK 300, and the company was valued to be worth several billion. Today, one share costs about DKK 3, and NeuroSearch’s total value is about DKK 100 million.

At one point NeuroSearch had 230 employees but in 2011 it announced that the staff would be cut to just 35 by mid-2013.

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to complete the clinical trials so we wouldn’t have to invest so intensively in the development phase,” he says.

The business strategy was clear-cut and for 17 years under Jørgen Buus Lassen, NeuroSearch blossomed with more than 200 employees and earned between DKK 1.5 and 2 billion during that period. Meanwhile the press cheered enthusiastically from the sidelines.

Those happy days In 2006, after 17 years at the helm, Jørgen Buus Lassen left the company at the top of the Danish biotech industry.

Neurosearch was valued at DKK 4 million then with a share price of over 300, and the company had bought Carlsson Research and by doing so had gained the patent for Huntexil. The addition of Carlsson Research bolstered the

“

Every biotech company dreams of taking a product from development to market singlehandedly. But something went wrong

Photo: NeuroSearch

Frank Hørning Andersen

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project portfolio, which now featured three strong drug candidates: Huntexil for treating Huntington’s Disease, Tesofensine for treating obesity and NS2359 against depression.

In 2007, NeuroSearch was nominated as one of Europe’s top 10 biotech companies and investors with venture capital were still falling over themselves to invest.

These happy days were numbered, however – for both the global economy and NeuroSearch. As the depression worsened, purse strings tightened, venture capital dried up and NeuroSearch’s project portfolio collapsed. In 2009, NS2359 fell off the bandwagon when clinical phase II tests failed to show that the drug had an effect on depression. One of NeuroSearch’s three legs was cut away and the company became less stable.

Then Tesofensine hit a rough patch. FDA guidelines require long-term clinical outcome studies for drugs that increase the heart rate even slightly. These costintensive studies deterred interested pharmaceutical companies from cooperating on Tesofensine. The second leg was kicked from under NeuroSearch, and the former biotech giant now had to hold itself upright using only Huntexil – a drug for a rare disease.

Something went wrong With a weakened project portfolio of promising drug

“

Now the remains of what was once the flagship of Danish biotech were to be cut up and sold off before the final curtain.

candidates, NeuroSearch decided drastic action was required and did something never done before during its 20-year history. The decision was made to attempt to take Huntexil to market by completing the remaining clinical tests single-handedly. This was a last ditch effort for NeuroSearch.

However the decision was understandable enough, according to Jyske Bank’s senior analyst and biotech specialist Frank Hørning Andersen: “Naturally, every biotech company dreams of taking a product from development to market single-handedly.

The concept itself is sound enough but something went wrong,” he explains.

In the clinical trials, NeuroSearch didn’t meet its primary endpoints, and Huntexil was forced to complete another round of clinical phase III trials. This was the final straw, according to Frank Hørning Andersen.

“NeuroSearch found itself having to decide how

to proceed with Huntexil. Potential partners can see the writing on the wall and can lean back and wait for NeuroSearch to go under and then pick over the spoils.

The market isn’t ready for investments to the tune of DKK 400-450 million that Neurosearch would have to raise to carry out the clinical trials. That leaves just one option. Sell the rights to Huntexil,” says Frank Hørning Andersen.

In July 2012, CFO Rene Schneider Patrick Dahlen stepped into Patrick Dahlen’s shoes as CEO of NeuroSearch. The signal was clear. Its days as a biotech company were over. Now the remains of what was once the flagship of Danish biotech were to be cut up and sold off before the final curtain.

Huntexil was sold to Teva in September 2012 for the modest sum of DKK 149 million and with it went the last of the promising projects in NeuroSearch’s portfolio.

Today, the future looks bleak. The share price has fallen from over 300 to less than 3 in five years and the company is ready to bow out.

“We must now assume that the company is in liquidation. Its offices in North Zealand are up for sale, and having sold Huntexil, NeuroSearch must invest in a new product if it wants to stay in business. Instead it will probably end up with an extraordinary dividend for the shareholders,” says Frank Hørning Andersen.  Translation: CLS Communication A/S

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Guide

How to...

Maximise the income stream from technology license agreements Technology licensing is one of the key ways of commercialising intellectual property in the life science industry; however licensing agreements are complex.

See how to do it.

By : Thomas Bjørn, Solicitor, Miller Rosenfalck LLP, London

The purpose of a licence agreement is usually to transfer the right to exploit intellectual property (IP) from a licensor to a licensee against a consideration in money. The parties will have opposing interests in a number of areas and the licensor will often – but not always – be a smaller company with limited legal resources. Here are some important points which a licensor in the life sciences industry should have in mind when out-licensing intellectual property rights.

•

Where the license agreement includes “Licensed Know-How”, it must be clearly defined and (for the EU block exemption rules to apply) be “secret, substantial and identified in any appropriate form” and set out in the agreement itself or in a separate document.

•

The definition of “Licensed Products” should be wide and include any product of which the manufacture, use or sale would infringe one or more claims of the patent rights if it had not been for the licence granted under the agreement or which are manufactured using a “Licensed Process”. Where know-how is involved, the definition should include products which are developed or manufactured using the know-how or the use of which practices the know-how.

•

The “Field of Use” may be limited to one or more technical fields of use, or one or more product market may be limited to one or more technical fields of use, or one or more product market may be limited to a specific technical field or a specific product market and the “Territory” to specified countries. Both are important instruments to ensure that a licence is limited to the technical and geographical areas where the licensee has sufficient expertise and capability to commercialise the technology effectively and may act as ways of

1: Have clear and specific definitions The defined terms are important because they describe the licensed technology and any restrictions or limitations in the licensee’s use of it, and provide the important links between the duration of the agreement and the royalty stream. The licensee should, in particular, ensure clear definitions in the following areas: •

The “Patent Rights” is a key definition which should include not only the patents and patent applications listed in the agreement but also any continuations, continuations in part, extensions, reissues and divisions and any patents, supplementary protection certificates or similar extensions which are based on or derive priority from the patents.

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Guide

2: Maximise the royalty stream Royalty is typically calculated as a percentage of the arm’s length sale price of the licensed product and with special calculation methods for sale of combination products. The percentage varies with royalties in the pharmaceutical industry being towards the higher end. In order to ensure that the licensee is active and efficient in commercialising the technology, the agreement should also include an obligation to use best or all reasonable efforts to sell the licensed product together with a provision for a reasonable minimum royalty.

In addition to getting the highest possible royalty in per cent, the licensor should also consider ways of extending the duration of the royalty period: •

The agreement should, where relevant, provide for any extensions of the patent term such as supplementary protection certificates (in the EU) or extensions under the Hatch-Waxman Act (in the USA).

•

It should be considered whether it is possible to extend the duration through reference to any data exclusivity period.

•

Where the licensed technology includes know-how as well as patents (a hybrid license), the know-how is, in theory, capable of remaining secret indefinitely.

Normally the royalty period will be restricted to the later of (a) the expiration or abandonment of all patents or patent applications or (b) the 10 th or 15th anniversary of the first commercial sale of the licensed product, but longer periods could be considered.

3: Secure milestone and other non-royalty payments A license agreement will often provide for a downpayment at the signing of the agreement. For an exclusive licence in an ideal world, this should, at least, reflect the level of investment that the licensor has made in the patent, such as professional and official fees.

A number of milestone payments may also be agreed when important milestones are achieved, such as the completion of clinical trials and the grant of marketing authorisations.

In some cases, additional future payments to the licensor may also be generated through provision of technical or research-related assistance to the licensee.

The licensee should ensure that all such payments (together with all other amounts which are not calculated as a percentage of net sale and including any fixed minimum royalties) are increased on a regular basis in accordance with a relevant price index.

The World Intellectual Property Organisation (WIPO) has issued a useful and comprehensive manual covering

the negotiation of technology licensing agreements, which is available at www.wipo.int/sme/en/documents/ pdf/technology_licensing.pdf. Although it will not replace specialist legal advice, it will serve well as a reminder of the many aspects which need to be taken into consideration when drafting licensing agreements in the field of life sciences. 

Photo: Miller Rosenfalck

carving out areas in which the licensor may wish to grant licensing rights to other potential licensees.

About the author Thomas Bjørn is a solicitor with Miller Rosenfalck LLP in London.

Thomas Bjørn has a law degree from the University of Copenhagen and has worked in private legal practice and the pharmaceutical and biotech industries in England, Switzerland and Denmark.

His areas of expertise include the protection and commercialisation of intellectual property, regulatory affairs and sale of goods and services to the NHS. Miller Rosenfalck LLP is an international law firm with offices in London and Copenhagen, specialising in commercial law and with a strong focus on the life science industries.

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More funding for Swedish innovation Swedish science parks are improving the financial picture for the country’s innovation environments. By next year, five new venture funds will see the light of day.

By Kristian Sjøgren

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The financial crisis is hitting hard across the board. In the world of research, innovation in particular is being suffocated as investors are reluctant to loosen their purse strings.

This has prompted the Swedish Incubators and Science Parks (SISP) organisation to establish a dozen new venture funds. SISP also wants to strengthen the structure and relationship with investors in existing funds. Generally speaking, the improved scope for fresh capital will give new companies a much needed boost in the early start-up phase.

“Today, fewer private individuals have the opportunity to act as ‘business angels’ and invest in new companies.

The shortage of private investors fuels a need for more structured funding options that give new companies easier access to start capital. We have therefore started up between 10 and 12 venture funds to work with some of Sweden’s 40 or so incubators and give new projects a push in the right direction,” explains Hans Möller, CEO of IDEON and chairman of SISP. The role model for the new venture funds is the Stockholm-based incubator Sting, which has raised DKK 200 million for innovation projects since 2005.

Five funds ready in 2013 According to the plan, the project to strengthen the venture funds will span from 2012 to 2014, with the first five new venture funds already up and running next year.

This will require raising between SEK 10-50 million for each venture fund, which is to partly from private investors and partly from public-sector sources.

The funds will then be divided up, with approximately one million being invested in each new company.

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Hans Möller is CEO of IDEON and chairman of SISP. His hope is that the new venture funds will give new projects a push in the right direction.

29.6.2012 10.57

“New companies must have an opportunity to raise funds for the early investments in their projects.

That’s why these kinds of funds are essential. The venture funds give investors a perfect window on the research environments’ incubators and the new projects under way here,” says Hans Möller, who thinks a larger structure in the venture funds will make them more attractive to the necessary investors.

Christian Bjerre Bojsen, investment director for Innovation Midtvest, envies the Swedish initiative. He would like to see a similar initiative in Denmark.

“These days, new companies are having a lot of trouble finding venture capital. So an initiative like that would also be grist for our mill. The venture opportunities available in Denmark are harder to drum up and so companies never get their projects off the ground. By giving companies easier access to venture capital you can bring the companies up to a level where investors can appreciate their potential and begin investing in them,” says Christian Bjerre Bojsen.

Similar initiatives have been attempted in Denmark before with some of the pension funds being brought into play. However ultimately the initiative had the same high demands for security for the investments as those set by the Vækstfonden and venture funds with capital to spare. For obvious reasons, new companies often have trouble meeting such demands.  Translation: CLS Communication A/S

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Major Norwegian bank sets its sights on Medicon Valley Norwegian DNB is an international heavyweight when it comes to providing loans for the life science sector. The bank is now turning its sights on Medicon Valley and will be hosting an event on how to attract investors and industry partners at a time when fresh capital is drying up.

By Claus Clausen It is generally known that in the present climate, raising capital is a challenging task for the life science industry.

However, there are both capital and investors in the market. And in week 11, 2013 (exact date will be announced

at www.mva.org), DNB and Medicon Valley Alliance will be holding a Boost Seminar under the heading “Attracting investors and industry partners for life science companies�, where life science companies in Medicon Valley will find useful advice on pursuing new funds.

Companies will hear what Bristol-Myers Squibb

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values most when signing new cooperation agreements.

HealthCap will explain about its focus when investing in venture-stage companies and DNB will describe how it can add value as a bank in the pre-commercial development stage. The participating companies will also be able to hold one-to-one meetings with the speakers.

The meeting reflects DNB’s efforts to intensify its focus on the life science sector in Medicon Valley. The only Nordic bank with a global focus on Healthcare, DNB has a large portfolio of European and US Pharma and Medtech clients who look to DNB for insight into future partnering/ acquisition opportunities in the Nordic countries. Øyvind W. Brekke, Senior Advisor, Section International Healthcare, DNB, explains: “Many of our customers are international companies within pharma, medtech and diagnostics. The common denominator is their reliance on external partners for fulfilling their growth ambitions. At the same time, the Nordic market is often considered slightly off the beaten track for people looking for new technologies and companies. However, through our proximity to the Nordic environment, we can draw attention to and showcase the most promising projects in the Nordic region. We are therefore looking for the best companies in areas where our customers operate,” says Øyvind W. Brekke.

Photo: DNB

Intensified focus on Medicon Valley

Øyvind W. Brekke, Senior Advisor, Section International Healthcare, DNB : We are also finding that our customers are gradually becoming more aware of the innovations being created in the Nordic region, and Medicon Valley is an important centre of gravity in this respect.

10th largest bank in the US last year Last year, DNB was the 10th largest bank for new healthcare loans in the US market and currently has about DKK 20 billion loaned out to healthcare companies. One third of the loans are in the US and two thirds in Europe.

“We still have capital and are ready to work with new customers who match our portfolio risk profile. We are also finding that our customers are gradually becoming

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more aware of the innovations being created in the Nordic region, and Medicon Valley is an important centre of gravity in this respect,” says Øyvind W. Brekke.

He underlines, now more than ever, the importance of companies considering partnerships/licensing as an alternative means of financing development.

“Try to find other projects in the same situation and see if you can work together to get through the rough times.

I also think companies should try to find international partners even if it means giving away some of their project upsides. If your small company receives an offer from a larger business or equity investor, accept it unless you know you can finance your own development,” says Øyvind W. Brekke.

He acknowledges that the traditional pursuit of capital has become difficult.

“Some Nordic venture funds have fresh capital, but there are fewer than before, they enter the picture at a later stage of development and have a stronger negotiating position. I believe that all the Nordic countries need greater public-sector funding in the seed phase if we are to see new companies blossoming in the years ahead.”

Read more about the event in week 11, 2013, at www.mva. org under “Upcoming events”. 

Expand your network:

Latest members of Medicon Valley Alliance

DanPet: DanPET AB develops future PET-ligands in areas where there is an unmet need for biomarkers and diagnostics, in collaboration with world-leading academic partners. The most advanced products in development are the best-in-class nicotinic alpha-7 PET ligands: 11C-NS14492 and 18F-NS10743 which have the potential for guiding diagnosis and treatment of Alzheimer’s Disease. DanPET owns a broad IP portfolio with major focus on the EU and US markets.

Dan Peters has more than 20 years of experience in pharmaceutical discovery and development as a key scientific and management leader at NeuroSearch A/S.

Norway – still a ‘little brother’ of Nordic life science For many years, DNB has had exposure to the Healthcare sector in Norway and Sweden; partly because of the growth indicators in the demography and partly due to the life science companies’ important role in society.

In 2007, DNB decided to expand its focus on Healthcare to include the international arena.

Today, Norwegian life science companies do not account for as much of the bank’s total commitment, but it still has a handful of Norwegian companies in its portfolio, according to Øyvind W. Brekke, Senior Advisor, Section International Healthcare, DNB. “A number of successful Norwegian life science companies have been acquired by foreign players.

One of the most recent examples is Japanese Takedas’ purchase of the originally Norwegian Nycomed for EUR 9.6 billion.

In a Nordic context, Norway is labelled ‘little brother’ due to the size of its life science sector – measured on value creation and number of employees. Yet over the years a series of our companies have made a positive impression; including listed companies such as Algeta, Clavis Pharma, Photocure and PCI Biotech.”

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New members & Upcoming Events Events by Medicon Valley Alliance

Wonderful Copenhagen Wonderful Copenhagen is the official convention, event and tourism organisation for the Capital Region of Denmark. Together with close collaboration with local corporate, cultural and governmental communities, Wonderful Copenhagen is dedicated to bidding to host international meetings and congresses, especially within Copenhagen’s positions of strength as an international city of knowledge.

Denmark has become a strong internationally renowned science centre with a high density of universities, hospitals, knowledge institutions as well as research and development based organisations, primarily within the fields of life science, IT and cleantech. Wonderful Copenhagen focuses on raising awareness for responsible and sustainable practices and supports initiatives for green meetings and congresses.

Onyx Scientific Onyx Scientific is a CRO/CMO that helps pharmaceutical and biotech companies accelerate candidates from discovery to manufacturing.

A preferred partner of many top global pharma firms, it operates from MHRA and FDA-licensed sites in the UK and India, supporting clients from medchem and preclinical through phase I-III, scaling-up to largescale commercial API production.

Its UK-based labs deal with complex chemistry and deliver early-stage programmes involving custom synthesis, lead optimisation, process development, solid-state chemistry and GMP API synthesis. It is then able to scale-up, internally tech transfer and provide increased efficiency for clients from its commercial sites in India.

22 January 2013 Are the Conditions of Outsourcing Changing?

By bringing the industry together to discuss the future of outsourcing, the MVA’s Outsourcing Workshop seeks solutions and best practice sharing on how to act in the future. Discussion topics will include: vendor selection and evaluation; optimal project resource allocation vs. securing the “A Team”; consequences and challenges with regards to sponsor oversight.

Venue: Arne Jacobsens Allé 15-17, 2300 Copenhagen S, Denmark Time: 09.00-18:00 www.mva.org/medicon-valley-outsourcingworkshop-2013

24 January 2013 Big Data and HPC in the Cloud As the size and complexity of large scientific datasets increases, Life Sciences teams from industry and academia are using cloud computing to deliver results more quickly, on a larger scale and more cost-effectively.

Medicon Valley Alliance and Amazon Web Services invite you to a morning of lively discussion, technical talks and deep dives focused on getting the most from elastic, utility computing.

Venue: Arne Jacobsens Allé 15-17, 2300 Copenhagen S, Denmark Time: 08.00-10:00 www.mva.org/big-data-and-hpc-cloud

Week 11, 2013 (Exact date to be announced on www.mva.org) Attracting Investors and Industry Partners Medicon Valley Alliance in cooperation with DNB invites you to participate in a network meeting on how to attract investors and industry partners to a life science company.

At the meeting you will also have the opportunity to present your technology / business plan to any of the cooperating partners in a 1-1 setting. Hear Lubor Gaal describe how BMS looks at licensing, Eugen Steiner from HealthCap shed light on the venture capitalists’ point of view, and ex-entrepreneur Øyvind W. Brekke discuss how DNB as a bank can play a role even for early-stage companies.

Venue: Arne Jacobsens Allé 15-17, 2300 Copenhagen S, Denmark Time: To be announced on www.mva.org

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