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Features

MAM04 Supplements to benefit malnourished childrenThe twelve food supplements providing malnutrition relief have been developed via collaborative research within the TreatFOOD research project. The research aspect of the project investigated the specific needs of those children suffering from moderate acute malnutrition (MAM)

MEDICON VALLEY06 Predicting the Future for Medicon Valley A new global biotechnology scorecard, by Scientific American, gives the Nordic countries high marks in growth indicators. Denmark earns the number two spot thanks to government support, plenty of patents, and lots of employees in public biotechnology companies

METABOLIC RESEARCH10 Revealing the risk of obesity and type 2 diabetesHaving a particular set of bacteria in your gut places you in the high-risk group for developing metabolic disorders such as obesity, type 2 diabetes and cardiovascular disease. These findings offer the prospect of developing new prevention and treatment strategies

DIABETES & OBESITY12 Amino acid with promising anti-diabetic effects New experiments conducted by researchers from the University of Copenhagen and the University of Cincinnati, show that the amino acid arginine – found in a wide variety of foods such as salmon, eggs and nuts – greatly improves the body’s ability to metabolise glucose

TRYPANOSOMIASIS16 African sleeping sickness parasites strike backAccording to the WHO, some 60 million people are threatened by the deadly African sleeping sickness which infects the brain. The disease spreads through bites of the tsetse fly, which leaves parasites in the body. Up to 500,000 people are believed to be infected by the disease

NEW CHEMISTRY18 Gentle chemistry for better and safer drugsA new and kinder chemistry promises cleaner and subsequently safer pharmaceuticals with fewer side-effects The ground-breaking method, developed by a chemistry research group at the University of Copenhagen, is published in the journal, Chemical Communications

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Thirty-three million children world-wide suffer from moderate acute malnutrition. It affects human develop-ment and generally, increases suscepti-bility to illness. Unfortunately, the nutritional supplements and aid that these children may receive today is based upon dated standards developed for adults or otherwise intended for children with severe acute nutrition. A collaborative venture between the University of Copenhagen (UCPH) and the Danish chapter of Doctors Without Borders is countering this decades old mismatch with the development of 12 supplementary foods geared specifi-cally for children with moderate acute malnutrition. Now, researchers, PhD-students and relief workers from a host of African and other nations have gathered for a course during which leading international experts will discuss the most current knowledge and science concerning the treatment of childhood malnutrition

The twelve food supplements providing malnutrition relief have been developed via collaborative research within the TreatFOOD research project. The research aspect of the project investigated the specific needs of those children suffering from moderate acute malnutrition (MAM).Thus far, the project has produced an otherwise absent body of knowledge on the subject. Current food supplements for children with MAM are either inadequate or too costly, making them unavailable for the

Effective supplements to benefit malnourished children worldwide

By Katherina Killander

(Photo: Christian Fabiansen, Médecins Sans Frontières)

millions of kids worldwide who need them.- Until now, food supplement assistance was either based on dated knowledge of adult needs or based upon the requirements for children with severe acute malnourishment. However, the dietary needs of moderately malnourished children are different. They are typically not in any immediate danger of dying, but their physical development, activity levels and immune systems are hit hard. So hard in fact, that 3.5 million children die annually due to illnesses such as pneumonia, simply because they are physically weakened, says Henrik Friis, an international nutrition and health professor at UCPH’s Department of Nutrition, Exercise and Sports.

To be tested in large-scale field study

The testing and comparison of the 12 MAM food supplements will begin two weeks from now in Burkina Faso. The study’s 1600 participants, children aged 6 months – 3-years-old, represent a critical age group during which moderate malnutrition can manifest itself in permanent damage to organ and mental development. Researchers will monitor how the supplements are absorbed by the children and how they affect their physical development and overall well-being. Additionally, researchers will meet with each of the children after three months and make a follow-up assessment of their individual well-being.- The large-scale field study about to take place in Burkina Faso is unprecedented in that we are evaluating the effects of 12 different products in the field. Far from just measuring weight gain, we will also be measuring so-called ‘lean body mass’ with the help of stable isotopes that provide a much more accurate reflection of a child’s condition and overall development. It is also unique in that we won’t be conducting the study at a university or in a hospital, but within the framework of a nutritional programme run by the NGO, Alima, says Kim F. Michelsen, a professor of pediatric nutrition at UCPH’s Department of Nutrition, Exercise and Sports and head of TreatFOOD.Price is a key parameter. Indeed, aid packages should be as cheap as possible, to benefit as many children as possible. For this reason, TreatFOOD has ensured that the nutritional supplement recipes are not bound by any patent and are available for all to make use of.

Results may alter current practice

While a couple years will pass before the field study’s results are clear, the WHO and World Food Programme await them with excitement:- If results are positive, the WHO and World

Food Programme will use the findings to develop effective new types of nutritional aid. This would meet the needs of the millions of children who currently suffer from malnutrition, states Professor Michaelsen.And that could save countless lives.- We know that children with severe acute malnutrition face a high mortality risk. However, we also know that with the appropri-ate treatment, they can recover and once again live as robustly as other children. We expect that the same results can be achieved with moderately acute malnourished children, who today, are often not treated or receive the wrong type of treatment, says Vibeke Brix, a Rigshospitalet (national hospital) pediatrician, also of Doctors Without Borders.

Research combined with treatment

Another key aspect of TreatFOOD is capacity-building among those who treat malnourished children. This includes NGO’s, doctors, PhD students and other aid workers:- Part of our funding will be directed towards capacity-building within the treatment aspect of child malnutrition in Africa. We primarily provide instruction for African PhD students who are members of TreatFOOD Training Teams. However, we also reach out to other key individuals within the field who seek to expand their knowledge, and thus grow their opportunity to make an even greater difference, continues Vibeke Brix.This week, TreatFOOD is assembling the most renown international experts for a course being held at the University of Copenhagen during which the experts will provide instruction for 31 PhD students in the field’s most up-to-date research. Participants originate from 19 countries including: Uganda, Ghana, Ethiopia, Kenya, Mozam-bique, Mali, India, Nepal, Bangladesh, Cambodia, Tajikistan and Jamaica.This expansive, collaborative effort is about to put Denmark on the map within the field of malnourishment:- I don’t think there’s anywhere else in the world where one experiences this type of collective focus on malnourishment. Our exceptional partnership with Doctors Without Borders makes it possible to combine research with treatment that benefits children. In the meantime, we have built strong research-ties with some of the planet’s leading actors in the field of malnutrition, summarizes Professor Henrik Friis.

Publishing company: BJ Media, Tingaardsvej 4 - Valore, DK-4130 Viby Sj, DenmarkPhone: +45 8230 7500E-mail: [email protected]: www.medicon-valley.dkEditor: Knud Meldgaard, editor-in-chiefJournalists: Viggo Mortensen, Sussie Munk and Chris Tachibana Production coordinator: Simon Busk VestergaardLayout and reproduction: SvendborgTrykCover photo: Novo Nordisk A/SPrinting: SvendborgTryk A/SDistribution: PostDanmarkISSN: 1603-4880

The Medicon Valley Magazine undertakes no responsibility for unsolicited texts, the use of which we deem reasonable, unless otherwise expressly stated. Nor does the Medicon Valley Magazine undertake any responsibility for errors or omissions, which might occur in text and/or advertisements. Commercial reproduction, photographing, copying, etc. of pages in this magazine may not take place without the magazine’s prior written consent. PROFILE is a term used to indicate, that the text is prepared and approved in coop-eration with the respective company or organization.

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Predicting the Future for Medicon Valley By Chris Tachibana

A new global biotechnology scorecard gives the Nordic countries high marks in growth indicators. Denmark earns the number two spot thanks to government support, plenty of patents, and lots of employees in public biotechnology com-panies

The United States, Denmark, and Switzerland are the top three countries for biotechnology, according to the 2013 Scientific American World-view Scorecard. The scorecard is an annual meta-analysis by Scientific American, a US-based science maga-zine. Since the first scorecard in 2009, Denmark has always been in the top five. In general, the Nordic countries do well against the competition, which is countries in North America, South Africa, Europe, and Asia. In 2013, all Scandina-vian countries were in the top 25, with Finland and Sweden at numbers 4 and 5, Norway at 19, and Iceland at 23. Iceland led in a measure of education and workforce, and for the third year in a row, Denmark won the competition for intensity.Intensity and Education/Workforce were two of six categories used to rank 54 countries in the Scientific American report. The other categories were intellectual property (IP), Enterprise Support, Foundations, and Policy and Stability. The scoring was based on data and indexes from sources such as the Organisa-tion for Economic Co-operation and Development (OECD), the World Bank, and academic reports. According to the scorecard:- Scandinavia also runs away with our “entre-preneurship and opportunity” component, with Denmark leading the way, followed by Sweden, Finland and Norway, in order. This metric indi-cates, among other things, the odds of creating spin-offs from universities or companies. Con-sequently, a strong score in this component could indicate extremely strong growth in bio-technology ahead.

How to be intense

Denmark’s consistent high ranking is because of stellar scores in intensity. Danish people do not have a reputation for being intense, but this category measures general energy in the bio-technology field. To score intensity, Scientific American analysts used five measures including public biotechnology company employees per capita, and public company revenues – with Denmark scoring highest for both factors. Oth-er contributors to the score were added value and business expenditures on biotechnology R&D, for which the United States earned top scores. Denmark won in the fifth factor: bio-technology patents.Steen Wadskov-Hansen is a European Patent Attorney and chief operating officer of Budde

Schou, a Scandinavian IP attorney firm. He has a PhD in biotechnology from the Technical University of Denmark and has worked as a research fellow at Chr Hansen. He says, - I’m not surprised that Medicon Valley scores well. The area around Copenhagen and Southern Sweden has strengths measured by numerous parameters: the number of patent applications, the number of of startup companies, and the value extracted from IP filed from universities, says Steen Wadskov-Hansen.In fact, Denmark and Finland were two of eight countries in second place, after the United States, in the IP category. The Scientific American editors conclude that this category is crucial for biotechnology success and that leaders in this field have successfully addressed IP protec-tion. However, the Medicon Valley countries vary in their IP policies about basic research discoveries. Researchers can immediately develop their findings in Sweden, but in Denmark, universities usually get to decide if they will commercialize discoveries – a policy that is under debate in Denmark, says Steen Wadskov-Hansen. Still, Denmark does submit a high number of technology-focused patent applica-tions.- Denmark has a history of being good at patents in biotechnology and green energy such as wind, wave and solar power. Also, the country does not have many patents in traditional areas like car manufacturing, so the number of biotechnology patents compared to all patents is high, explains Steen Wadskov-Hansen.Nordic countries also scored high in Policy and

Stability, with Finland on top and Denmark second. This category reflects political stabil-ity and government effectiveness, so violence and terrorism are obvious negative factors and regulatory quality and rule of law are positives. Years of government support for biotechnol-ogy in policies, funding, and infrastructure development have creating an environment in Scandinavia that attracts established companies and startups. The region also did well in the Foundations category, which contains four components measuring R&D business expen-ditures, government support, infrastructure quality, and innovation and entrepreneurship opportunity. These factors create a synergistic effect in Medicon Valley, say the scorecard editors:- For anyone interested in the concept of clus-tering, this area offers a great example.

Room for improvement

With highly educated workers who tend to stay in their home country, the Nordic countries scored well in Education/Workforce. However, the United States still attracts the largest num-ber of international students who want to stay and work in the country, giving the US a brain-gain advantage. Education is an area where Medicon Valley could improve to maintain its edge, says Steen Wadskov-Hansen:- We need to educate people going through universities with courses on IP and how to set up a business and be entrepreneurs. Our students need to learn about the sys-tem and to heighten their awareness about

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IP and IP protection.According to the scorecard, another area where the Nordic countries could improve is capital availability and market opportunities. These factors were measured in the scorecard’s Enterprise Support category, with no Nordic countries in the top ten. In fact, biotechnology invest-ment analysts have long noted that although public support of biotech-nology is excellent in the Nordic countries, their investors tend to be quite risk averse.

The future looks bright

Investment in biotechnology is improving in general, however, at least in the United States. The California-based investment firm Burrill & Company found that 2013 already has greater investments than 2012 in companies developing new therapeutics, diagnostics, and tools such as genomics and data analysis.Steen Wadskov-Hansen is also positive that biotechnology will con-tinue to be strong in Medicon Valley:- Our universities have a well-founded tradition of biotechnology development and they tend to develop and commercialize their bio-technology inventions. If biotechnology becomes old-fashioned then this will be a weakness, but I see no signs of that happening.

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Shire and Santaris extend their strategic alliance

Edit. by Viggo Mortensen

To discover and develop LNA-drugs in the rare genetic disease field

Santaris Pharma A/S, a clinical-stage biopharmaceutical company focused on the discovery and development of RNA-targeted therapies, has announced that its long term partner, Shire has extended the existing partnership in the rare genetic disease space.Under the terms of the extended agreement, Shire will have the right to nominate additional collaboration targets for drug discovery and development. Santaris will receive an upfront payment and, consistent with the initial agreement, is eligible for research support, pre-clinical, clinical and sales milestones and royalties on each product emerging from the collaboration.- Our collaboration with Shire is very important to us so we are very pleased with

the decision to extend the agreement and allow for more drug discovery and develop-ment programs. We believe the LNA drug platform offers a unique opportunity to develop drugs against the rapidly expanding number of disease targets in the rare genetic disorder space, stated Henrik Stage, President & CEO at Santaris Pharma A/S.- We are delighted with our partnership with Santaris, whose expertise and capabilities in LNA antisense therapy complement Shire’s drug discovery and development strengths. Our hope is that the partnership will eventually translate into novel drugs that will help patients suffering from debilitating rare diseases lead better lives, said Albert Seymour, VP, Discovery Research, Shire.

Locked Nucleic Acid (LNA) Drug Platform

The LNA Drug Platform and Drug Discovery Engine developed by Santaris Pharma A/S combines the company’s proprietary LNA chemistry with its highly specialized and targeted drug development capabilities to rapidly deliver LNA-based drug candidates against RNA targets, both mRNA and microRNA, for a range of diseases including cardiometabolic disorders, infectious and inflammatory diseases, cancer and rare genetic disorders. LNA is also sometimes referred to as BNA (Bicyclic or Bridged

Nucleic Acid). LNA-based drugs are a promising new class of therapeutics that are enabling scientists to develop drug candida-tes to work through previously inaccessible clinical pathways. The LNA Drug Platform overcomes the limitations of earlier antisense and siRNA technologies to deliver potent single-stranded LNA-based drug candidates across a multitude of disease states. The unique combination of small size and very high affinity allows this new class of drugs candidates to potently and specifically inhibit RNA targets in many different tissues without the need for complex delivery vehicles. The most important features of LNA-based drugs include excellent specificity providing optimal targeting; increased affinity to targets providing improved potency; and favorable pharmacokinetic and tissue-penetrating properties that allow systemic delivery of these drugs without complex and potentially troublesome delivery vehicles.

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European Medicines Agency reveals new structure


An agency reshaped for the future

The European Medicines Agency (EMA) has announced details of its new organisational structure. The changes fundamentally reorganise the Agency’s operations to support better its public and animal health mission, and its role as part of the European medicines regulatory system. The new structure reflects a renewed focus on three key elements:- How to better support the scientific work of the of the EMA committees;- How to better share the knowledge and information the Agency holds throughout the EU medicines regulatory network;- How to better meet the need of the Agency’s stakeholders and partners.- The changes announced today will reshape the EMA so that it is ready to handle future challenges and seize opportunities, said Professor Guido Rasi, EMA Executive Director.- My aim is to give our scientific committees the best possible support, alongside the

expertise from the national agencies, to help them keep delivering high-quality, consistent opinions. These changes will enable us to use our resources more efficiently and effectively and ensures that the Agency is better prepared for future legislative and policy challenges.

Continuity of operations

The changes announced are the beginning of a transition period as the Agency revises its operating processes, expected to be com-pleted in 2014. While work continues to further refine the organisational structure, the Agency will ensure continuity of operati-ons. This means that applicants, marketing authorisation holders and other stakeholders should continue to work with their current EMA liaison staff and product team leaders unless informed otherwise.The new structure has at its core four new Divisions with responsibilities right through the lifecycle of a medicine for human use from development to use in patients. Those are:- Human Medicines Research and Develop-ment Support Division,- Human Medicines Evaluation Division,- Procedure Management and Business Support Division,- Inspections and Human Medicines Pharma-covigilance Division.

Reinforces the robustness and quality

The reorganisation introduces a new operating model for how medicines are

managed through their entire lifecycle at the Agency, with separation of the scientific and procedure management. With the increasing number and complexity of applications being handled by the Agency’s committees, this is intended to reinforce the robustness and quality of the Agency’s output and allow development of greater specialities able to respond and support the work of the committees.Veterinary medicines are managed through a single Division that has been re-focused to deal solely with veterinary medicines and animal health. Information technology and administration continue to be managed through separate Divisions.A new Division for Stakeholders and Communication is created to provide improved coordination of the Agency’s relations with stakeholders, in particular patients and healthcare professionals, support for small and medium-sized enterpri-ses, and a dedicated communication service.The new organisational structure is underpin-ned by advisory functions, which provide advice to the Executive Director and the Agency on operational and scientific issues in their fields of expertise. In addition to the existing functions of Senior Medical Officer, International Affairs, Audit and the Legal Department, this also includes the newly created roles of Chief Policy Adviser and Head of Programme Design Board.More information on the work of the European Medicines Agency can be found on: www.ema.europa.eu.

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Gut microbial communities reveal risk of obesity and type 2 diabetes

By Iben Julie Schmidt

Having a particular set of bacteria in your gut places you in the high-risk group for developing metabolic disor-ders such as obesity, type 2 diabetes and cardiovascular disease. These findings – recently published in Nature – offer the prospect of developing new prevention and treatment strategies

The number of overweight and obese people is currently increasing by several per cent per annum in many of the industrialized countries. This is why there is now talk of an outright obesity epidemic that represents a ticking time bomb under the healthcare systems of the West. Obesity, however, is not an unequivocal diagnosis. For some people, obesity does not pose a serious health risk–while for others obesity results in dire consequences in the form of metabolic illnesses and increased mortality.

Few species is bad

It is therefore seen as a potential break-through that researchers from DTU and

Centre for Basic Metabolic Research at the University of Copenhagen - together with a large international research team - have now succeeded in identifying people with an increased risk of developing obesity-related diseases such as type 2 diabetes and cardiovascular disease. Common to this group is the fact that they have certain species of bacteria in their gut that can be used as markers. Generally, they also all have a low richness of bacterial species in their intestinal flora - while healthy people have a high richness of bacterial species and therefore also a high number of microbial genes in the gut. And this is important knowledge, explains DTU researcher Henrik Bjørn Nielsen from Centre for Biological Sequence Analysis, DTU Systems Biology: - For a long time we have known - from twin studies among others - that obesity and related metabolic diseases aren’t just about lifestyle but also involve an important hereditary component. But proving this has

been extremely difficult using particular genes in the human genome. The task is simply too complex. If we look at our metagenome, however - i.e. the quantity of genes from the microorganisms (chiefly bacteria) living in our gut - we have now succeeded in proving a clear link between the presence of certain bacteria and the incidence of metabolic diseases. This gives researchers renewed hope of developing techniques to prevent and treat these diseases.

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Researcher Henrik Bjørn Nielsen from Centre for Biological Sequence Analysis, DTU Systems Biology

Many or few genes

The new results are based on the mapping of 292 Danes’ microbiome (composition of microorganisms in the intestinal system). As most of the bacteria in our gut cannot be cultivated, they have to be studied indi-rectly by examining which genes are present - and the results show that the vast majority of the study group fell into two categories: Those with less than 480,000 different genes and those with more than 600,000 genes.

Metabolic disorder markers

Thanks to the generally explosive develop-ment in DNA sequencing and metagenomics - combined with entirely new methods developed in connection with this research project - it was also possible to demonstrate not only which genes but also which types of bacteria each individual had in his/her gut flora right down to species level. When the researchers then compared the number of bacteria species in the gut with the individu-als’ general state of health, the group with a small number of bacterial species had a higher BMI and was more metabolically stressed with diabetes and cardiovascular problems, for example. It also became clear that by screening for a few particular bacterial species it was possible to identify those individuals at high risk of developing metabolic disorders. These findings pave the

way for crucial new metabolism research, which is why these new techniques and results are now being published in the distinguished science magazine, Nature. - In the course of this project we have developed a technique enabling us to identify even unknown bacterial species using gene profiles. Previously, reference genomes of known cultivatable bacteria were used for identification purposes, but now there are sufficient data for us to say with a high degree of certainty that this is a new species by examining which genes they always co occur with (so-called Coabun-dance). And this is actually a quantum leap for metagenomics research, explains Henrik Bjørn Nielsen.

Early days

Despite the grounds for optimism, Henrik Bjørn Nielsen believes that this type of research is at a very early stage - as there is a great deal researchers still do not know. One of the big questions is why they are seeing a particular pattern in the microbiome of individuals with metabolic disorders.- What we are hoping is that it is the microorganisms in the intestine which in some way provoke the metabolic disturbanc-es - because that makes it easier to develop new intervention strategies - but it could just as easily be the opposite, that it is the inflammation associated with type 2 diabetes

that results in a lower richness of bacterial species in the gut.

Changes over time

The next thing researchers want to study therefore is how the bacterial composition changes over time.- In principle, this study represents a frozen moment in an individual’s life. The next step will be to carry out time studies to map bacterial composition over longer periods to determine how static or dynamic our microbiome actually is and how it is affected during illness. The more we understand about the development of the microbiome in relation to the onset of illnesses such as obesity and type 2 diabetes, the better our chances of intervention and prevention, concludes Henrik Bjørn Nielsen. The new knowledge is the result of an extensive international research project financed by the European Commission under the major EU Metahit project, which officially ended in 2012. DTU is one of several Danish and European collaborative partners that also includes The Novo Nordisk Foundation Centre for Basic Metabolic Research at the University of Copenhagen.

Chatelier et al. Richness of human gut microbial communities correlates with metabolic markers, 29. Aug 2013 Nature, doi:10.1038/nature12506.

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Amino acid with promising anti-diabetic effects

By Stine Rasmussen

New experiments conducted by researchers from the University of Copenhagen show that the amino acid arginine – found in a wide variety of foods such as salmon, eggs and nuts – greatly improves the body’s ability to metabolise glucose. Arginine stimulates a hormone linked to the treatment of type 2 diabetes, and works just as well as several established drugs on the market. The research findings have just been published in the scientific journal Endocrinology

More than 371 million people worldwide suffer from diabetes, of whom 90% are affected by lifestyle-related diabetes mellitus type 2 (type 2 diabetes). In new experiments, researchers from the University of Copenhagen working in collaboration with a research group at the University of Cincinnati, USA, have demonstrated that the amino acid arginine improves glucose metabolism significantly in both lean (insulin-sensitive) and obese (insulin-resistant) mice.- In fact, the amino acid is just as effective as several well-established drugs for type 2 diabetics, says postdoc Christoffer Clemmensen. He has conducted the new experiments based at Faculty of Health and Medical Sciences, University of Copenhagen. He is currently conducting research at the Institute for Diabetes and Obesity at Helmholtz Zentrum München, the German Research Centre for Environmental Health in Munich.To test the effect of the amino acid arginine, researchers subjected lean and obese animal models to a so-called glucose tolerance test, which

measures the body’s ability to remove glucose from the blood over time.- We have demonstrated that both lean and fat laboratory mice benefit considerably from arginine supplements. In fact, we improved glucose metabolism by as much as 40% in both groups. We can also see that arginine increases the body’s production of glucagon-like peptide-1 (GLP-1), an intestinal hormone which plays an important role in regulating appetite and glucose metabolism, and which is therefore used in numerous drugs for treating type 2 diabetes, says Christoffer Clemmensen, and continues:- You cannot, of course, cure diabetes by eating unlimited quantities of arginine-rich almonds and hazelnuts. However, our findings indicate that diet-based interventions with arginine-containing foods can have a positive effect on how the body processes the food we eat.The research findings were recently published in the American scientific journal Endocrinology under the heading Oral l-arginine Stimulates GLP-1 Secretion to Improve Glucose Tolerance in Male Mice.

Hormone plays key roleResearchers have known for many years that the amino acid arginine is important for the body’s ability to secrete insulin. However, the latest findings show that it is an indirect process. The process is actually controlled by arginine’s ability to secrete the intestinal hormone GLP-1, which subsequently affects insulin secretion.- Mice without GLP-1 receptors are not affected to the same extent by arginine. There is no perceptible improvement in glucose metabolism or insulin secretion, confirming our hypothesis of a close biological connection between GLP-1 and arginine, says Christoffer Clemmensen, who conducted the biological experiments in the USA using a special animal model where the receptor for GLP-1 is genetically inactivated.The new findings provide optimism for better and more targeted drugs for treating type 2 diabetes; the outlook is long-term, but promising.- This exciting result has raised several new questions which we want to investigate. Can other amino acids do what arginine does? Which intestinal mechanisms ‘measure’ arginine and lead to the release of GLP-1? Finally, there is the more long-term perspective – the question of whether the findings can be transferred from mice to humans and be used to design drugs that will benefit diabetes patients, says Professor Hans Bräuner-Osborne , who is continuing work on the project in the research group at the Department of Drug Design and Pharmacology at the University of Copenhagen.

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The International Biotechnology Leadership Camp


Novartis holds annual healthcare entrepreneur competition to generate insight into healthcare and innovation of tomorrow

Novartis has invited 60 selected students from leading international universities in 21 countries to its headquarters in Switzerland for the International Biotechnology Leaders-hip Camp (BioCamp). Over the course of three days, students will gain first-hand experience of starting a biotechnology company as well as developing and launching an innovative healthcare product. This year’s BioCamp focuses on the Company’s innova-tion efforts in new business approaches to the healthcare industry.- With the aging population and increases in chronic disease around the world, demand for healthcare will continue to grow, well into the future. This will require innovative solutions as more healthcare systems focus on improving patient outcomes, comments Joseph Jimenez, CEO of Novartis.- As Novartis innovates in healthcare, BioCamp

underscores our commitment to creating a unique learning environment for young entrepreneurs. This program enables us to forge ties between the healthcare industry and young talent from top universities. We believe this fosters the fresh thinking required to develop truly differentiated products and services with real-world outcomes.

Understanding trends and challengesSome of the Company’s leading outcome-based business models include collaborations with payors on pricing arrangements, patient compliance programs as well as online support and education. For example, the Company looks at innovative business models that go beyond traditional philanthropic and commercial efforts to reach patients today and those of future generations. The Novartis Arogya Parivar (“Healthy Family”) project is one such social healthcare business model involving a deep-rooted outreach program that trains local health educators and offers medicines in smaller, affordable packaging. Through this program, Novartis has reached 42 million people in 33,000 villages in India.BioCamp is part of the Novartis commitment to supporting the exchange of ideas and thoughts between young talents in science and business and the Company. Top students will meet with leading scientists and members of top management at Novartis including, among others, Rolf M. Zinkernagel, M.D., a

Nobel Laureate and member of the Novartis AG Board of Directors, and Prof. Susan Gasser, Director of the Friedrich Miescher Institute for Biomedical Research.BioCamp students also interact with Novartis scientists and executives who lead the Company’s approach to drug development and learn about new breakthrough medicines to address patients’ unmet medical needs. The program is designed to help students understand trends and challenges in the biotechnology and life science sectors as well as gain first-hand experience about starting and running a biotech company. BioCamp has helped forge ties with local communities and build connections to aid future innovative collaborations in research and clinical development.

First started nine years ago in Taiwan, BioCamp has developed into an international forum for science and business students from around the world to learn, exchange ideas and work together in a highly competitive business environment. Previously hosted in Tokyo, Hong Kong and Cambridge, Massachusetts, today’s seminar marks the fourth time International BioCamp is hosted at the state-of-the-art Novartis global headquarters in Basel, Switzerland. For more information, please visit: www.novartis.com.

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Zealand appoints new Chief Scientific Officer

Dr Torsten Hoffmann joins from Roche, where he held the position of Head of Discovery Chemistry, Pharma Research in Basel, Switzerland

Zealand Pharma has announced the appoint-ment of Dr Torsten Hoffmann as Executive Vice President and the company’s new Chief Scientific Officer. Torsten joins Zealand with effect from 1 October 2013 from F. Hoffmann-La Roche Ltd where he served as Head of Discovery Chemistry in the Pharma Research division at the company’s headquarters in Basel, Switzerland.In his role at Zealand, Torsten will have the overall responsibility for the company’s research and development activities. His focus will be on driving innovation and strengthening Zealand’s pipeline of peptide drug candidates by enhancing the research engine and ensuring a strong scientific base for partnering activities. Torsten will join Zealand’s Executive Management team and will be based in Copenhagen.

Extremely valuable

- We are extremely fortunate to have attracted Torsten to Zealand. Torsten is known for being a strong and collaborative leader and his impressive and impactful scientific record plus wealth of sector experience and innovative ideas will be extremely valuable to our company. I am confident that under his leadership, we can drive Zealand’s R&D activities further towards tomorrow’s breakthrough peptide therapeutics. As we leverage our capabilities with greater innovation and collaboration, as exemplified by our recent agreement with Lilly, I have no doubt that Torsten will play a pivotal role in the growth of Zealand, comments David Solomon, Chief Executive Officer of Zealand.At Roche, where he worked since 1997, Dr Torsten Hoffmann was responsible for the identification of many new drug candidates, more than 25 of which entered clinical development.- I am very excited about the opportunity to lead such a talented R&D team to help fulfill Zealand’s mission to deliver innovative peptide medicines that improve patients’ lives.These are exciting times for the company following the launch of its first discovered medicine lixisenatide (Lyxumia®). By strengthening the company’s excellent scientific base, I am convinced we can further broaden its research capabilities and accelerate the development of innovative Zealand peptide treatments for the benefit of human health and patient wellbeing, said Dr Torsten Hoffmann.

Collaboration on cellulosic ethanolNovozymes has announced that it has entered into a collaboration agreement with Brazil’s largest sugarcane crusher, Raízen Energia S/A

As part of the agreement, Novozymes will supply enzyme technology to Raízen’s first commercial-scale cellulosic ethanol plant in Brazil, scheduled to be operational by end 2014. The plant will be a bolt-on facility to Raízen’s Costa Pinto sugarcane mill in the state of São Paulo and will have the capacity to produce 40 million liters of cellulosic ethanol a year from sugarcane bagasse and straw. The agreement also provides for Novozymes to supply enzyme technology to Raízen’s second cellulosic ethanol plant, should such a plant be constructed.

An important step

To support Raízen in its efforts to advance cellulosic ethanol, Novozymes will develop enzyme technology optimized for Raízen’s process. Furthermore, Novozymes intends to establish new enzyme-manufacturing capacity in Brazil. The exact size, location and invest-ment budget for this enzyme-manufacturing facility are not yet determined and will depend on the level of estimated demand for enzyme technology in Brazil.- This first plant developed by one of the world’s largest sugarcane ethanol producers marks an important step in the commerciali-zation of cellulosic ethanol in Brazil, says Thomas Videbæk, Novozymes’ Executive Vice President of Business Development. - We look forward to sharing the journey with Raízen and enabling this exciting develop-ment for Brazil through the delivery of world-leading enzyme technology.The agreement does not have any impact on Novozymes’ financial guidance for 2013.

The world’s largest

Raízen is the world’s largest sugarcane crusher and one of the leading sugar and ethanol producers in Brazil. Raízen was established in 2011 as a joint venture between global oil major Royal Dutch Shell plc and Brazilian energy and infrastructure conglomerate Cosan. Currently, the company produces 2 billion liters of ethanol from sugarcane per year from a network of 24 sugarcane mills in Brazil. Read more at www.raizen.com.br/en.

Alternative target for breast cancer drugsScientists have identified higher levels of a receptor protein found on the surface of human breast tumour cells that may serve as a new drug target for the treatment of breast cancer. The results, which are published in EMBO Molecular Medicine, show that elevated levels of the protein Ret, which is short for “Rearranged during transfection”, are associated with a lower likelihood of survival for breast cancer patients in the years following surgery to remove tumours and cancerous tissue

- Our findings suggest that Ret kinase might be an attractive and novel alternative therapeutic target in selected groups of breast cancer patients, remarked Nancy Hynes, Professor at the Friedrich Miescher Institute for Biomedical Research and the University of Basel, Switzerland.- Initial experiments in mice that serve as model organisms for the study of breast cancer have revealed that specific inhibitors significantly block the spread of cancer and decrease the number of metastatic tumours found in the lungs.The scientists examined tumour tissue microarrays of more than 100 breast cancer patients who had undergone surgery to remove their tumours. Antibodies were used to detect the levels of Ret in the samples. In other experiments, four different cancer cell lines were used and injected into mice to study the effects of Ret inhibitors on the progress and spread of the cancer.- Our findings demonstrate that blocking Ret kinase not only decreases the growth of tumours but also impacts the potential of the cancer to spread throughout the body, Hynes said.

Essential to discover additional inhibitors

Targeting receptor tyrosine kinase enzymes with antibodies or small molecular inhibitors is a clinically validated approach for cancer therapy. However, only a subset of patients are eligible for these types of treatments which makes it essential to discover additional inhibitors that could be useful in breast cancer therapy.Dr. Albana Gattelli was supported by grant KG101234 from Susan G. Komen for the Cure®Ret inhibition decreases growth and metastatic potential of estrogen receptor positive breast cancer cells - Albana Gattelli, Ivan Nalvarte, Anne Boulay, Tim C. Roloff, Martin Schreiber, Neil Carragher, Kenneth K. Macleod, Michaela Schlederer, Susanne Lienhard, Lukas Kenner, Maria I. Torres-Arzayus and Nancy E. HynesFurther information on EMBO Molecular Medicine is available at www.embomolmed.org.

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African sleep-ing sickness parasites strike back

By Mette Louise Ohana

Assisted by Danish researchers, Belgian researchers have discovered how parasites in African tsetse flies cheat an otherwise intelligent immune mechanism in humans to cause the deadly sleeping sickness (trypanosomiasis). The discovery provides more knowledge about how to combat the disease which constitutes a major problem in Africa

According to the WHO, some 60 million people are threatened by the deadly African sleeping sickness which infects the brain. The disease spreads through bites of the tsetse fly, which leaves parasites in the body. Up to 500,000 people are believed to be infected by the disease. Hopes were therefore raised when Danish and Belgian researchers a couple of years ago discovered a new mechanism in the human immune system which fights some types of the disease.

However, new research from almost the same research team now reveals that the most dangerous type of sleeping sickness parasites can cheat this immune mechanism. Just published in the international journal Nature, the result will contribute to re-evaluate the options for developing an effective treatment.

Parasite adapts to survive

The response from the parasites is the result of millions of years of evolution.- The sleeping sickness parasite needs parts of our haemoglobin, which carries oxygen and other gases in our blood. We first discovered that the body has developed a mechanism that releases a haemoglobin-binding protein – the so-called haptoglobin-related protein – which brings another substance into the parasite, where it becomes deadly toxic to the parasite. In this way, the body cheats the parasite, which explains why people are resistant to some types of sleeping sickness parasites, for example those causing Nagana, the widespread and serious sleeping sickness in cattle. However, the new research findings now also show that the most dangerous sleep-ing sickness parasite, which infects humans, has developed its counter move. It absorbs less toxin and may even inactivate the toxin to bypass our otherwise sophisticated immune mechanism and carry on with its undesirable job, says Professor Søren Moestrup from Aarhus University.

No vaccine on the horizon

The researchers have no new therapy in the immediate pipeline, but the new discoveries are an important step in the development of a new medicine to circumvent the parasite’s defences, adds Søren Moestrup. Despite the new findings, it may be long into the future before an actual drug can be offered to the Africans.- We also have to face the fact that it is extremely difficult to get the pharmaceutical industry to invest money in Third World diseases, says Søren Moestrup.Denmark has only seen very few cases of sleeping sickness. Tourists travelling in the affected areas in Africa do, however, risk being infected by the disease. Until a vaccine is available, the most effective preventive measure is to avoid tsetse fly bites.Read the scientific article ”Mechanism of Trypanosoma brucei gambiense resistance to human serum” at: www.nature.com/nature/journal/vaop/ncurrent/full/nature12516.html

The African tsetse fly is not as innocent as it looks. A bite from the fly can cause the fatal disease sleeping sickness

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Broad insight into drug discovery


Professor Dr. Jutta Heim has joined Nuevolution as Director and Senior Scientific Advisor to the Board of Directors

Dr. Heim worked for more than 20 years at Ciba-Geigy/Novartis (CH and US). At Novartis, she was involved in the successful development and launch of anti-thrombotic and fibrinolytic products. She established Novartis’ molecular genetics department in oncology, became Novartis’ Senior Scientific Expert in Molecular Biology and a member of the Research Management Board. Dr. Heim completed her career at Novartis heading the Novartis Lead Discovery Center with worldwide responsibility. From 2004 to 2009, Dr. Heim served as CSO at Basilea Pharmaceutica Ltd., a Swiss biopharmaceutical company focusing on anti-infectives, inflammation and oncology. From 2009 to 2013, she served as CTO and CSO at Evolva SA, where she led Evolva’s discovery activities and strengthened the development of its technology platform. She received a PhD from the University of Tübingen in 1981 and holds a professorship in Biotechnology at the Biocenter of the University of Basel. Prof. Dr. Heim is a member of the advisory board of ”Stiftung für Wissenschaftliche Forschung Universität Zürich” and a board member of Evolva SA.

Adds significant value

- Jutta’s significant expertise and input has already been well appre-ciated by management and our board, said Alex Gouliaev, CEO of Nuevolution A/S.

- We are certain that her experience from the Industry, broad insight into general drug discovery and in particular within oncology will add significant value to the company. We are very pleased that Jutta accepted our invitation to join our Board of Directors.- Given that Nuevolution A/S has developed its Chemetics® technology to a very advanced level, and is in the middle of the build-up of an own product pipeline, we are eager to add complementary know-how and skills to the organization, including the Board. Jutta represents an important and valuable contribution in this regard, ads Stig Løkke Pedersen, Chairman of Nuevolution A/S.

Expanding the platform

Proof-of-concept studies have been initiated for several of the internal programs that have emerged from current screening efforts. Going forward, the company will seek joint venture partnerships and out-licensing of these programs. In parallel with this, Nuevolution will continue to form partnerships around its platform technology.- We have a major focus on the progress of our internal programs and invest significantly in the establishing of our internal pipeline within oncology and inflammation. However, we also believe it is imperative to continue to expand our platform including the production of additional high-complexity compound libraries that address tough-to-drug targets, said Thomas Franch, CSO of Nuevolution.Nuevolution has also initiated a scientific collaboration where Professor Dr. Robert J. Lefkowitz, a Duke Faculty member and HHMI employee and Nobel Laureate in Chemistry 2012 will act as principal investigator in the investigation of the biological mechanism of action of a specified GPCR drug target using Nuevolutions Chemetics® platform. This collaboration is by and between Duke University, Howard Hughes Medical Institute, Lexicon Pharmaceuticals and Nuevolution.

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Gentle chemistry for better and safer drugs

By Jes Andersen

A new and kinder chemistry promises cleaner and subsequently safer pharmaceuticals with fewer side-effects

The ground-breaking method, developed by a chemistry research group at the University of Copenhagen, is now published in the internationally renowned journal, Chemical Communications, as “Site-selective three component reaction for dual functionalization of peptides”.Knud J. Jensen, the group’s leader, is convinced that the method will become pivotal in the development of new pharmaceuticals.- This method opens a new chest of tools. I believe, it will be applied to pharmaceutical research right away, ensures Professor Jensen.

Exacting work becomes easier

Knud J. Jensen is a Chemical Biology and Nanobioscience professor at the University of Copenhagen’s Department of Chemistry. For the past five years, he and UCPH colleague, Associate Professor Jørn B. Christen-sen, have been researching methods for altering proteins and peptides, the chemical structures that run everything in the human body. Jensen asserts that protein drugs are the most rapidly growing group of pharmaceuticals.- Protein drugs are used to combat serious illnesses such as sclerosis, leukaemia, diabetes and cancer. However, because their chemical architecture so nearly resembles the body’s own structures, they are tough to work with. Or, rather – they were, says Professor Jensen.

Delicate substances require a gentle touch

Helpful new substances are traditionally concocted using rather rough methods. The contents of a test tube are typically fed a dash of powerful solvent before being boiled, under high pressure, together with some metal additives to speed along the reaction. Natural compounds like protein based drugs can’t tolerate this, explains Jakob Ewald Rasmussen, a Post Doc in the research group.- Proteins are larger, more intricate and fragile. And, they have evolved over millions of years to function in water that is: ph-neutral, 37 degrees celcius and often without reactive metals, explains Rasmussen.- It is under these delicate circumstances that the group has managed to develop new chemistry.

Two pivotal innovations

In addition to the delicate approach, the breakthrough method offers two distinct advantages. Firstly, it’s a “one-pot” synthesis method. That means that the reactions occur in a single procedure. However, the method also makes it possible to attach two so-called functional groups to an individual protein. The latter sets the groups research apart and makes the method truly novel.

Two halves better than a whole

- A functional group can be a coupled molecule, such as polyethylene glycol (PEG). PEG is a compound used in pharmaceuticals to extend the life of a particular drug. But it has a weakness. The compound is a long molecular chain with hard to control contents. If, however, the PEG is divided and then attached to two sites on a protein, the risk of side effects is lowered, explains Knud Jensen. - Shorter PEG chains can be made cleaner and more uniform. This means that their medicinal effect can be made more predictable and easier to control.But the possibility of attaching two functional groups on a single protein also opens the door for entirely new applications.

Three...Two...One...

The new chemistry trick makes it possible to synthesise proteins with, not just two, but three functions, because the protein itself can serve a function. This means that proteins can be produced, for example, to target and stick to cancer cells. The two functional groups on a protein can then be used as a contrasting agent, so as to help discern whether a cancer is present through imaging, as well as a luminescent substance, to help guide the surgeon to a tumour’s location when the patient is open and ready to be operated upon, fantasizes Jakob E. Rasmussen. - With three functions possible in a single drug, imagination is just about the only limit, summarizes the protein postdoc.

Rapidly burgeoning line of business

Hundreds of biopharmaceutical drugs are already on the market and a peek at the number of biopharm patents reflects huge growth in the area. In 1978, 30 patents were taken out for protein based pharmaceuticals. That number jumped to 15,600 in 1995 and shot up to 34,527 patent applications in 2001.Copenhagen www.hoiberg.comAarhus Denmark

Got the idea?

- This method opens a new chest of tools. I believe, it will be applied to pharmaceutical research right away, ensures Professor Knud J. Jensen, Chemical Biology and Nanobioscience, Department of Chemistry University of Copenhagen

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New EVP for the Health & Nutrition DivisionChr. Hansen has appointe Christian Barker new Executive Vice President

- We are ready for the next step for this division and we look for different manage-ment competencies to take us there. We will enforce our strategic focus and look at new opportunities for future growth. I am happy that Christian Barker has accepted to head up this challenge. Christian has substantial experience with identifying and developing growth opportunities and I look forward to expanding our collaboration, says Cees de Jong, CEO. Christian Barker joined Chr. Hansen on May 2, 2012, as head of Corporate Strategic Development. Prior to this, Christian Barker was a partner at McKinsey & Company, where he spent 15 years serving global clients on a range of topics including growth strategy, M&A, business building, and restructuring. Christian Barker joined McKinsey in Copenhagen in 1996, worked for McKinsey in London and Buenos Aires, and from 1999 to 2010 he was based in New York/New Jersey before returning to Copenhagen. No decisions regarding his succession have been made at this point.

A considerable contribution

Christian Barker will replace Henrik Dalboege, who stopped at Chr. Hansen the 30. September 2013. Henrik Dalboege has been with the company since 2006 and from 2007 as part of the executive management.- Henrik has a solid background within human health and industrial biotechnology and under his leadership the Health & Nutrition Division has developed from a business unit to an independent division with strong growth. Henrik has professionalized our activities in Health and Nutrition, and developed a sound platform for probiotics for dietary supplements and infant health. I would like to thank Henrik for his considerable contribution and dedication to Chr. Hansen, says Cees de Jong, CEO. As of today, Chr. Hansen’s Executive Board consists of Cees de Jong, Klaus Pedersen, Knud Vindfeldt, Carsten Bennike and Jesper Allentoft.

Pancreatic stem cells isolated from miceScientists have succeeded in growing stem cells that have the ability to develop into two different types of cells that make up a healthy pancreas

The research team led by Dr. Hans Clevers of the Hubrecht Institute, The Netherlands, have isolated and grown stem cells from the pancreases of mice using a 3-D culture system previously developed by the scientists. The results, which are reported in The EMBO Journal, could eventually lead to ways to repair damaged insulin-producing beta cells or pancreatic duct cells.Cell signalling molecules known as Wnts and a protein called Lgr5 are essential to produce adult stem cells that can be coaxed to grow and divide rapidly. However, these signaling pathways and molecules are inactive in the adult pancreas.- We have found a way to activate the Wnt pathway to produce an unlimited expansion of pancreatic stem cells isolated from mice. By changing the growth conditions we can select two different fates for the stem cells and generate large numbers of either hormone-producing beta cells or pancreatic duct cells.This work is still at a very early stage and further experiments are needed before we can use such an approach for the culture of human cells but the results are a promising proof-of-concept, said Dr. Hans Clevers. Unlimited supply of pancreatic stem cells

In the study, the pancreases of mice were altered in a way that makes duct cells proliferate and differentiate. Some cells in this new population were stem cells that were capable of self-renewal. The scientists were able to culture these cells to give rise to large numbers of pancreatic cells or tiny clumps of tissue referred to as organoids.Therapeutic strategies for pancreatic disease have been hampered by a lack of cell culture systems that allow scientists to grow replacement tissue in a test tube or on a dish. Alternative approaches such as tissue transplantation are limited by the scarcity of donors and the possibility of tissue rejection. The new work offers access to an unlimited supply of pancreatic stem cells that would be beneficial for the development of new therapeutic interventions for pancreatic diseases like diabetes.The next steps for the scientists will include further refinement of the cell culture methods developed in this study and investigation of ways to extend the approach to human pancreatic cells.Read the EMBO Journal article at: www.nature.com/emboj.

Europe to invest €3.8 billion in the biobased economy48 Companies join forces with the European Commission to set up a Public-Private Partnership and accelerate the deployment of biobased products in Europe

Today, the European Commission proposed a €3.8 billion Public Private Partnership (PPP) on Biobased Industries, in order to accelerate the commercialization of biobased products in Europe. The European Commission will invest €1 billion and industry €2.8 billion, from 2014 to 2020, to boost market uptake of new biobased products that are “made in Europe”.The partnership promotes the use of various sources of sustainable biomass and waste to produce everyday products such as food, feed, chemicals and fuels. The use of local biomass and waste will generate growth and jobs in rural areas across European regions, while reducing the EU’s reliance on fossil fuels, thereby offering sustainable alternatives to oil-based products and enhancing energy and food security.Novozymes is part of this initiative alongside 47 leading European companies in the biotech, chemical, energy, agro-food and pulp and paper sectors.

From research labs to market

- The Biobased Industries PPP is essential for Europe to remain competitive in the global race for the development of a biobased economy, says Novozymes CEO Peder Holk Nielsen.- It is an opportunity for reindustrialization and for reversing the investment trend currently going to other regions of the world because of more attractive policy frameworks.The PPP will capitalize on Europe’s innovation and technological leadership to bring biobased solutions from research labs to the market. Various sectors will be brought together to optimize and create new value chains, such as connecting farmers and foresters directly to consumers.The PPP is part of the European Commission’s Innovation Investment Package that was released today. The PPP is expected to start its activities in early 2014 following approval from EU Member States. For more information please visit: www.bridge2020.eu/

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