Copenhagen Life Science no 1 - 2013

NO. 1

OCTOBER/NOVEMBER 2013

“It was like competing in Paris-Dakar.”

Nuevolution CEO Alex Haahr Gouliaev after recieving DKK 80 million from investors.

The Patent Cliff

As the blockbuster patents expire a brand new world is opening.

We take a closer look.

Peter Gøtzsche’s utopia He has published a harsh critique of the pharmaceutical industry.

But what does he want instead?

No. 1 – 2013

Contents The Column:

PUBLISHER:

Update RASK Media ApS Frydendalsvej 3 DK-1809 Frederiksberg C Denmark +45 3326 9520 www.raskmedia.com rask@raskmedia.com Editor in Chief: Malene Aadal Bo Editors; Lone Frank, Carsten Elgstrøm and Charlotte Strøm

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Fredrik Hedlun on “Cancer Mystery Solved”

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News in brief about business, science and technology

The Picture

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Photographer Stephen Freiheit followed 30 kilo of medicine to a remote village in Nepal

Talkin’ About

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Eske Willerslev is an expert on viruses and cancer.

But what are the big talking points for him these days?

MEDIAPARTNERSHIPS WITH:

The Turning Point

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Nuevolution CEO Alex Haahr Gouliaev had a dream.

Read the story about the day the dream became reality. www.ibceuroforum.dk

Theme - The Patent Cliff www.scanlab.dk

What are the challenges and opportunities in a world with blockbuster patents expiring?

ADVERTISING:

Interview - Peter Gøtzsche

Thomas Rosendal Phone: +45 2360 3940 thomas@media-partners.dk

Guide - The Unitary Patent

Hanne Kjærgaard Phone: +45 2967 1436 hanne@media-partners.dk Marianne Lander Phone: +45 2967 1446 marianne@media-partners.dk

Cover Photo: Jeppe Carlsen Layout and print: artegrafix and PE Offset A/S ISSN: 1904-4755

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The professor introduces his vision for the pharmaceutical industry.

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Solicitor Thomas Bjørn on how the new patent will work.

Calendar Selected meetings and seminars on Life Science.

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The column

Cancer mystery solved* Translation: CLS Communication A/S

and will certainly see them again – headlines like the one above announcing medical news and breakthroughs in research that pay no regard to the underlying scientific nuances. Dig a little deeper and you will find the headline is rarely founded in the actual research it seeks to report.

still being more accessible than the scientific journals. The goal is to independently examine and monitor developments within biotech and life science, especially in the important Øresund region.

That is where the action is.

Denmark and Sweden are

today’s editors to handle medical news reporting. News desks have seen cutbacks in editorial staff and nearly all specialist journalists have disappeared, especially in the field of medicine, which is often viewed as something of a luxury area on par with sport and finance. At the same time, the requirement for speed has increased significantly in the last ten years as the Internet has made constant news updates possible. Thus, it’s not so strange for something to be printed quickly and incorrectly in the daily news today.

global leaders when it comes to biotech innovation. On Scientific American’s annual list of the world’s most prominent biotech countries, these two Nordic nations have continually ranked among the top ten countries since the journal first started the ranking in 2009.

This year, Denmark solidifies its position as the second-best biotech country in the world for the third year running, surpassed only by the USA – again. Admittedly, Sweden has fallen slightly in the ranking, but still comes in at a very respectable 6th place. Meanwhile, Finland has earned a spot among the top five countries, ranking third.

This is one of the reasons why I

In other words, the Nordic region

am so delighted to see the arrival of this new publication, or perhaps I should say its return. Copenhagen Life Science has arisen from the remains of the journal Life Sciences Insight, previously published in collaboration with Medicon Valley Alliance. Like its predecessor, the journalistic ambition of Copenhagen Life Science is to be informed and analytical, and to dig much deeper than the daily news while

continues to be the most innovative region in the world when it comes to biotech and life science. And with so many exciting things happening here, I for one intend to watch it very closely. Perhaps a discovery might even be made right here in the cold North that will inspire the headline “Cancer mystery solved” – and it would actually be correct. I spoke with some researchers recently who

However, it is not always easy for

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Photo: PR

You have seen them before

Fredrik Hedlund is a medical journalist with qualifications as 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 Copenhagen Life Science.

believe this strongly. And the publication you hold in your hands right now is an excellent source of insightful news on developments in the world of life science in the Nordic region. * Just joking – this time.

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Intellectual Property Rights

Excellence in patent examinations matches international demand The Danish Patent and Trademark Office provides highly qualified patent searches on behalf of life science companies, nationally and internationally.

By Charlotte Strøm, MD, PhD, Journalist The trick is to know what exactly to look for. The examiners at the Danish Patent and Trademark Office (DKPTO), who investigate intellectual property related to life science, all have a background in life science.

“Our examiners are used to working with life science patent applications; hence they know exactly what elements to look for when performing searches for new chemical entities, DNA or protein sequences,” says Tecnical advisor Rikke Louise Vinther, MSc Biochemestry at the DKPTO. She continues: “Furthermore, as an authority we are privileged to have access to the European Patent Office’s search engines, enabling us to deliver searches that are much wider and more thorough than what is easily accessible elsewhere in the market.”

The DKPTO provides all types of patent searches, including searches aiming at disclosing potential areas of “freedom to operate”, i.e. areas where potential patent infringements are unlikely.

“Our clients typically have patent experts of their own, who are able to use the results of our searches as a basis for building business strategies,” Rikke Louise Vinther says.

She describes how customised searches may be ap-

Tecnical advisor Rikke Louise Vinther, MSc Biochemestry at the DKPTO. Painting: Uffe Christophersen 1988

Facts about the Danish Patent and Trademark Office (DKPTO) • DKPTO is a national Searching and Examination Authority • DKPTO conducts international search and examinations through the PCT authority NPI (Nordic Patent Institute) under the PCT system for residents of the contracting states as well as international type searches in connection with national patent applications • DKPTO also conducts searches for other patent authorities and private clients • DKPTO issues Patent and Design Rights and registers Trademarks • DKPTO has a dedicated workforce of approximately 200 employees, including life science and legal experts For more information: www.dkpto.org

plicable in particular cases and this is brought into action in close dialogue with the clients’ own experts.

“So-called landscape searches are highly complex and often require special insight and expertise to perform.

These searches typically investigate information surrounding a known chemical entity, manufacturing, combinations with other chemical entities, therapeutic indications, administration, formulation etc.,” she says.

International demand The DKPTO provides its services globally, and in recent years has seen increasing interest in and demand for highly qualified searches from international clients, counting, among others, several US-based large life science companies.

“Considering that there are a number of strong commercial US-based players carrying out patent searches, we feel encouraged that the standard of our products makes it worthwhile for our international clients to purchase our services from across the Atlantic,” concludes Rikke Louise Vinther.

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UPDATE - BUSINESS

Update

Business By medwatch.dk · Translation: CLS Communication A/S

Pension fund focus on life science

A number of Danish life science companies have just visited New York to present their most exciting projects to more than 25 potential US venture investors. This new concept is the brain child of the Danish Consulate General in New York and the Medicon Valley Alliance and will be an annual event. The Danish companies are given advice on general legislation, IP rules and the opportunity to find partners and funding. They then met more than 25 venture capitalists.

Eurovision brings Scanlab and Rehab together The Health & Rehab Scandi­ navia trade fair has been moved as it overlapped with the Eurovision Song Contest, which is expected to monopolise most of Copenhagen’s hotel capacity. The change has opened for collaboration with another major conference, Scanlab. Both

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events will take place on 9-11 September 2014 at Bella Center.

“There are many synergies between the two, and we can now look forward to an event with twice the visitor potential,” says Per Buus from the Danish Rehabilitation Group.

EU approves the first biosimilar antibody For the first time ever, the EU authorities have approved a biological copy of a monoclonal antibody for marketing in Europe. Hospira is behind the biological copycat medicine sold under the name of Inflectra. The product is a biological copy of the popular Remicade from Johnson & Johnson. The artificial monoclonal antibody has been approved for a number of inflammatory diseases such as rheumatoid arthritis, psoriasis and Crohn’s disease.

Photo: Bjarne Bergius Hermansen, DR

Closer to US investors

An animal study sponsored by “Alzheimer’s Society” suggests that Novo Nordisk’s blockbuster diabetes medicine Victoza (GLP-1-analogue with the active ingredient liraglutid) may have a positive effect on Alzheimer’s disease. The study, based on mice, shows significant improvement in the cognitive skills and a reduction in the formation of harmful plaque in the brain. A new study will now show the effect on humans and could pave the way for a new avenue of opportunity for Novo.

Photo:Ccreative commons

Photo: Francisco Diez

Novo: Alzheimer’s next in line?

Photo: ScanStockPhoto

Nine out of PensionDanmark’s 25 most valuable investments in listed shares are related to life science. In fact, the pension fund has invested in just about all of the world’s largest life science companies. However investments in Danish companies are thin. With the exception of Novo Nordisk, there are only modest investments. ATP is investing more in Denmark and has funds in Genmab, Ambu and William Demant among others.

Universities are no longer considering research-based knowledge and techniques as a profitable source of revenue. The expectations the liberal-conservative (VK) government presented in 2001, are unrealistic, concludes a new report from the DEA think tank.

University research is of considerable value but not in terms of maximising profit. Companies are unwilling to pay large amounts for an invention they must spend years developing before it is ready for market, according to DEA.

Tax havens for medgiants

Lundbeck get EU recommendation

USD 300 billion. This is how much American healthcare industry have stashed away in tax havens according to a report from the US federation of nonprofit Public Interest Research Groups. Pfizer tops the list of life science companies with money in subsidiaries in tax havens. It has allegedly USD 73 billion distributed throughout 174 subsidiaries.

Merck has over USD 53 billion in 151 subsidiaries while Johnson & Johnson has almost USD 50 billion spread among 55 subsidiaries.

The FDA recently approved Lundbeck and its partner Otsuka’s medicine Abilify Maintena for treating schizophrenia. Now the medicine, which is estimated to harvest sales of up to DKK 2.5 billion, is taking step towards approval in the EU even though doctors are reluctant to use it.

CHMP, the EMA’s advisory committee, has given a positive recommendation for the long-acting injection-based sustained release medicine.

Yet another Genmab breakthrough For the second time, US authorities have awarded Genmab the special breakthrough status. First it was daratumumab, and now ofatumumab, which is Genmab and GSK’s medicine marketed under the commercial name of Arzerra. This status has been given for the indication of previously untreated chronic lymphatic leukaemia. The breakthrough status is intended to accelerate the clinical development of medicines for treating serious or life-threatening conditions.

Photo: Bavarian Nordic

Huge order bound for Bavaria Bavarian Nordic could be about to receive yet another order from the US authorities for the smallpox vaccine Imvamune, now that funding for the order is said to be in hand. The funding required for the new smallpox vaccines for the US military appears to have been found under the framework agreement with Bavarian Nordic, writes Bloomberg News. This could mean a new order for about USD 100 million may be heading in the direction of the Danish company.

Photo: KU

Research is no cash cow

The father of GLP-1 awarded Professor Jens Juul Holst at the University of Copenhagen identified the human intestinal hormones GLP-1, which determine the development of obesity and diabetes. This achievement is now being rewarded as he is to receive the Anders Jahre Senior Medical Prize, known as “the little Nobel Prize”, and NOK 1 million. In 1987, he was the first to show that GLP-1 influences insulin secretion.

This discovery has since provided the platform for e.g. Novo Nordisk’s blockbuster Victoza.

Biotech boosts R&D Biotech companies are pumping money into research and development. BDO, an US consulting firm, has discovered that the average R&D costs in the Nasdaq companies have risen from USD 48 million in 2010, to USD 54 million in 2012. “Unlike the major pharmaceutical companies, biotech companies are continuing to demonstrate willingness to increase R&D costs,” explains Ryan Starkes from BDO. This counts in partular for biotech companies with a turnover of less than USD 50 million.

This page was compiled in collaboration with Medwatch.

Read more news at www.medwatch.dk

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UPDATE - SCIENCE AND TECHNOLGY

Update

Science and technology

By Videnskab.dk

Breakthrough in our understanding of bacteria Scientists have developed a method that will revolutionise genome sequencing of bacteria. PhD student Mads Albertsen from Aalborg University cut the genomes from two samples with different relative amounts of the same bacteria into tiny DNA sequences of between 150 and 250 base pairs. DNA pieces with the same frequency were grouped and indicated which DNA pieces belonged together originally, and thus belonged to the same bacterial species. The researchers assembled the grouped DNA sequences into the whole genome of the individual bacteria. The new method allows insight into the thousands of unknown bacteria from which it has hitherto been impossible to extract genetic data because they cannot be grown in a laboratory.

Photo: ScanStockPhoto

New cancer drug looks promising G202, has exhibited positive effects in combating liver cancer in initial human trials. The drug managed to significantly delay the development of new tumours in patients who had not responded positively to other treatment. The findings have

been published by American biotech company GenSpera, which has teamed up with researchers from the University of Copenhagen and Johns Hopkins University in the USA. The new drug is developed from the natural substance

thapsigargin, a cell poison which kills all the cells in the body.

By coupling thapsigargin to a larger molecule, the researchers obtained a compound which the body’s cells could not absorb. It is this coupling that makes the new drug unique.

Cancer is currently being treated based on the assumption that the enzymes should be prevented from cleaving the next substance in a chain. This is done to prevent a chain reaction which would trigger the cancer to spread. But by studying two enzymes: matriptase and prostasin, researcher Stine Friis, from the University of Copenhagen, discovered that the enzymes are smarter than we thought as they

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can activate one another in more ways than one. “So far we’ve only been putting a sock in the mouth of the enzyme, leaving it incapable to ‘biting’ the next substance in the chain. But if we want to block the entire signalling pathway, it appears that we also need to tie down its arms,” says Friis.

Published in Journal of Biological Chemistry.

Photo: PR

Cancer enzymes are smart

data. The Global Microbial Identifier (GMI) project aims to improve the treatment and diagnosis of patients all over the world.

Photo: Suzanne Rindom

Biologists across the world are discussing the possibility of establishing a global database of bacteria, viruses and other biological

“This is a revolutionary step forward, and we already have the necessary technology. We collect biological data through sequencing machines in laboratories all over the world. Why not make this data available across national borders?” says Professor Frank Aarestrup, the research manager of the project.

The aim is to be able to diagnose patients within a single day, regardless of where in the world they may be. Read more www. globalmicrobialidentifier.org

Anxiety could be linked to a protein People differ immensely in their vulnerability toward developing chronic problems with anxiety. Professor Magnus Ingelman-Sundberg from Karolinska Institutet, found that mice which had been genetically manipulated to carry a particular protein became stressed and anxious. There are indications that the same may apply to humans. The active human gene − CYP2C19 – controls an enzyme that can break down substances which affect our central nervous system. Mutations of the gene that makes CYP2C19 can change our quantities of this protein. A study of 1,750 pairs of twins carried out by the same team of researchers indicates that higher amounts of the protein may link to depression.

Paper strips allow rapid diagnoses

Key mechanism in essential enzyme uncovered

Acreo Swedish ICT have succeeded in printing biosensors directly on paper. The sensors contain components that react to biological material, such as blood or urine, and make measurements according to what needs monitoring. The results would then be delivered as a digital signal on a special display.

“The biosensor will eventually be very useful for detecting and controlling kidney ailments, cardiovascular disease and cancer,” says Professor Anthony Turner, Linköping University, who has been involved in the development of the sensor.

Acreo Swedish are now looking for a commercial partner to take the sensor to market.

Scientists know that when certain steroids bind to the so called sodium pump, it can both kill and cure. Now, for the first time, scientists from the Department of Biomedicine and the PUMPkin centre of excellence at Aarhus University have described in atomic detail how the cardiotonic steroids work by binding to an essential enzyme in the body. This enzyme is known as the Na+/ K+-ATPase.

This page has been compiled in collaboration with Videnskab.dk and ScienceNordic.com.

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Photo: ScanStockPhoto

Global disease network

THE PICTURE

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By Malene Aadal Bo 路 Photo: Stephen Freiheit

It sometimes seems a long way from the world of high technology, where medicines are developed and manufactured, to the real world in which they are used.

From Kathmandu in Nepal, it took the Malaysian physician, Doctor Way, nine days travelling along narrow paths to reach the village of Samagaun. He had with him 30 kilograms of drugs lashed to the back of a yak.

The penicillin, which he is shown here giving to a small boy, is the first medicine seen in the village for many months.

Translation: CLS Communication A/S

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TALKIN’ ABOUT

The Search

for the unknown Two years ago, internationally recognised researcher Eske Willerslev and his colleagues received DKK 86 million – the highest grant ever – from the Danish National Advanced Technology Foundation to dig into the world of viruses and cancer. We asked the professor what the big talking points are these days.

By Mia Riise Hansen

What’s the big talking point in your world these days?

to limit ourselves in the search for a correlation between viruses and cancer. Rather, we prefer to start out wide and narrow the field as we go.

Also, we have established a set of methods to detect viruses, bacteria and fungi in the cancer tissue DNA. The DNA sequencing is performed using so-called next generation sequencing – a method to sequence

Photo: Mikal Schlosser

I just came home from a research seminar where my colleagues and I discussed the status of our cancer DNA sequencing project. After one and a half years’ work, we

have finished collecting samples from approximately 200 cancer patients. The samples are biopsies from tumours, abdominal cavity liquid as well as tissue samples from approximately 20 different cancers.

We have chosen to sequence DNA from different types of cancer patients and from different types of samples because we don’t want

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“It’s a high risk project, but I believe we will discover something ground-breaking.” potential for collaboration because of my work on sequencing the first ancient human nuclear genome in 2010. In addition to the Centre for GeoGenetics, a handful of other partners are involved in the project: Statens Serum Institut, Technical University of Denmark, Herlev Hospital, Aalborg University, Beijing Genomics Europe and Bavarian Nordic.

Why is this such a hot topic?

Because it’s a high-risk/high-gain project. On the one hand, we risk finding nothing, but on the other hand, we could potentially discover previously unknown correlations between new viruses and cancer diseases, which would really be ground-breaking. The DNA sequencing methods we have developed can find all kinds of

viruses in the cancer tissue samples either in the form of DNA, RNA, double-stranded, single-stranded viruses etc. Previously, researchers have looked for known viruses, but we can find new and unknown viruses which could potentially be linked to the development of cancer.

In fact, we have compared our method to already established detection methods, such as shotgun sequencing, and demonstrated an even higher degree of sensitivity.

Photo: Mikal Schlosser

huge amounts of DNA very quickly and cheaply. We have nearly completed the sequencing and are about to start analysing the results.

My involvement in the project started when I was contacted by Lars Peter Nielsen, chief physician at Statens Serum Institut. He saw a

What do you think about all this?

I am so excited!

We have asked ourselves: Can we find even more cancer types which are caused by viruses or bacteria?

Today, there are several known correlations between cancer and viruses, bacteria and, in some cases, fungi. Examples of viruses known to cause human cancers include some genotypes of human papilloma virus, hepatitis B virus and EpsteinBarr virus. And according to the WHO International Agency for Research on Cancer, in 2002, 17.8 per cent of human cancers were caused by infection.

So we are very confident that we will succeed in finding new correlations between viruses and cancer. I know that it’s a high risk project, but personally, I believe that we will discover something groundbreaking.

What’s next?

Today, we have completed the sequencing of several of the cancer tissue samples, and the detective work can begin. Ultimately, the correlations between viruses and cancer could lead to new cancer vaccines. I believe we will be much wiser within a year.

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READ MORE about Eske Willerslev’s work at (article in Danish): http://hoejteknologifonden.dk/projektgalleri/projektgalleri/kraeftvaccine_ og_kortlaegning_af_danskernes_arvemasse/

Eske Willerslev, DSc, is Director of the Centre of Excellence in GeoGenetics and the National CryoBank and Sequencing Facility at the National History Museum of Denmark. In his PhD thesis, Willerslev established the first ancient DNA facility in Denmark, which, despite its small size, rapidly became internationally recognised.

After completing his PhD fellowship and spending time at MD Anderson Cancer Centre in Texas in the USA, Willerslev was granted a prestigious Wellcome Trust Fellowship to join the University of Oxford, UK. At the age of 33, Willerslev was called back to the University of Copenhagen to take a position as Full Professor – the youngest in Denmark at the time.

Willerslev is an internationally recognised researcher in the fields of ancient DNA, ancient genomics, DNA degradation and evolutionary biology.

He has 25 publications in the renowned journals Science and Nature and 159 publications in other high-profile peer review journals.

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THE TURNING POINT

“It’s a long, exhausting test of endurance and many drop out along the way.

Photo: Jeppe Carlsen

You only cross the finish line if you stay focused on the road ahead, keep your hands on the wheel and listen to your co-driver.”

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A significant capital injection from investors makes a pipeline dream come true for the small biotech company Nuevolution that once played second fiddle to Goliath pharmaceutical companies.

By Gitte Willumsen · Photos: Jeppe Carlsen · Translation: CLS Communication A/S

L

ate at night on Thursday 14 June 2012 – hours after signing the formal contract with investors – Alex Haahr Gouliaev, Chief Executive Officer of Nuevolution, finally grasped the scale of the milestone his company had achieved.

Those signatures meant that DKK 80 million was coming to the small biotech company.

Now Nuevolution could adopt a revolutionary new business strategy that had been on the drawing board since 2008. Rather than simply playing second fiddle to the giants of the pharmaceuticals industry, now Nuevolution could begin producing its own drug candidates.

The dream came true on a lovely summer day. The sun was shining with not a cloud in the sky and the canteen at Nuevolution in Østerbro in Copenhagen was buzzing with activity. All the shareholders were there, gathered around dining tables piled high with documents that had to be kept in strict order and signed – copy after copy.

Then the reality hit him Despite whirlwind months of hard work when the momentous day finally dawned there was little room for being emotional.

“The process was cut and dried with everyone focusing singlemindedly on making sure that all the relevant documents were properly signed and the procedures followed to the letter. Right up until the very last minute, commas

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were still being corrected and appendices produced and copied.

There were stacks of papers to be signed. Some were printed and prepared for signing while others were sent from our lawyer and arrived in big boxes. It was pretty hectic,” explains Gouliaev.

When everything was in order, checked and double-checked, Alex Alex Haahr Gouliaev said goodbye to the Swedish investors and new co-owners, who had to return home that night. Then as a sense of calm began to descend, the CEO collected the documents and locked them securely in the office safe. It was late by the time he got home and could relax on the couch with his feet up. And only then did the reality of the situation truly hit him.

Hectic spring Several months of intense

“We just jumped in at the deep end, really.”

activity had passed. Nuevolution had completed a due diligence process involving patent experts, accountants and lawyers inspecting every nook and cranny of the company. Gouliaev and his staff were constantly kept on their toes answering questions.

“By that point in the process, there was little time for ironing out any wrinkles the experts might find.

It all happens in top gear,” says the CEO, “like being a rally driver speeding through the desert.”

“I was so focused on navigating the car through complicated terrain at top speed that there was only time to think about anything else.

Like competing in the Paris-Dakar rally. It’s a long, exhausting test of endurance and many drop out along the way. You only cross the finish line if you stay focused on the road ahead, keep your hands on the wheel and listen to your co-driver.”

Just in time Alex Haahr Gouliaev co-founded Nuevolution in 2001 together with Henrik Pedersen and Mads Nørregaard-Madsen, who had been colleagues at Novo Nordisk.

Gouliaev led the department of medicinal chemistry at NeuroSearch.

“We just jumped in at the deep end, really. We had some seed capital from Vækstfonden and

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THE TURNING POINT

Nordic Biotec, a basic idea and plenty of pioneering spirit, but at that point no laboratory trials to document that the project was feasible,” says Gouliaev.

Dramatic change in core concept

• Potential future revenue from existing partnerships: up to >1.5 billion Danish kroner

The original idea was to produce large collections of artificial drugs comprising polymer molecules using biomolecular methods with the ultimate aim of accumulating large pharmaceutical-related screening libraries. That core concept would change dramatically during the time of development.

It took the researchers until 2004 to find the method that would support their whole livelihood.

A technique that combined wet chemistry with DNA technology to expand the number of compounds and now small molecules in the libraries to exceed a collection of over 100 million. Nuevolution patented the method under the name Chemetics.

“With conventional methods, you can test only 20-50 targets a year at the most. A major company typically spends 3-4 weeks screening its library of up to three million compounds. With our technology, one person can test a target against hundreds of millions of small molecules and potential drug candidates – in one week.”

• Employees: 41

They still had the faith

NUEVOLUTION • Founded: 2001 • Technology: Patented method for rapid and efficient screening of biological targets using millions to billions of more small molecules • Develops: Own medicines within oncology and inflammation as well as medicines for various indications in cooperation with partners • Total revenue realised from partnerships, as per Sep. 2013: DKK 150 million

• Funding: Venture capital (Main shareholders: SEB Venture Capital, Sunstone Capital and Industrifonden) • Business partners: Merck & Co., Novartis, Boehringer Ingelheim, Lexicon Pharmaceuticals and GSK

And they managed to get the investors on board. Nuevolution was established in the slipstream of the great biotech wave that hit the market in the 90s, before the majority of investors lost their last vestige of faith in early biotechnology’s ability to turn a profit.

“We just managed to get on the bandwagon in time,” says Gouliaev.

Working for nothing encouraged partnerships Nuevolution supplied major

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pharmaceutical companies, including Novartis, with the technology and employees free of charge. The medical companies supplied interesting biological targets and Nuevolution screened their libraries. Only if the screening identified interesting molecules did the subject of money arise.

“I wake up happy every day know­ing that we have this opportunity.”

By 2008, the researchers had mastered their methods to the point that they began charging upfront payments for their services.

And now that Industrifonden, SEB Venture Capital and Sunstone Capital have injected DKK 80 million into Nuevolution, the company can establish an internal pipeline focusing on oncology and inflammation. Nuevolution hopes to drive projects to the lead phase, and then plans to sell some and continue developing others.

“I wake up happy every day knowing that we have this opportunity and that the agreement with the investors worked out well.”

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Highly specialized recruiting of executives for starts-ups and SME Best Talent has specialized in recruiting executives for start-up businesses, small and mid-size enterprises. And it does in fact take special expertise to match the demands of the clients with candidates with the right competences and extensive experience – and moreover the right personality, and attitude.

By Charlotte Strøm, MD PhD Journalist As preferred partner in executive search for Coloplast and Lundbeck, Best Talent knows that it takes diligence and thoroughness to find the right man or woman for an executive position, but sometimes it is an even greater challenge to recruit talented people in start-up or SME within life science.

Where the brand alone in larger companies is likely to attract a number of candidates to choose from, recruiting budgets are typically much smaller in SME. However, smaller budgets do not imply lower expectations.

Managing Director at Best Talent, Helle Jørnung, explains why it is difficult to recruit for SME: “The demands in SME and start-ups are typically higher at a lower pay. Additionally, most of the candidates at the executive level may be very well accustomed already to working at a strategic level, but in SME and start-ups this is required on top of skills in taking decisions to an operational level as well.”

She exemplifies this by illustrating how people quickly tend to get used to service functions in larger companies such as IT-support, having assistants etc.

“You will not find the same level of service in a start-up company, but for those with the right personality, the ability to influence matters and move the company forward, is rewarding even without the service,” Helle Jørnung says.

Assessing the expectations of all stakeholders The recruiting model Helle Jørnung and her colleagues at Best Talent including their global network operate from is based on much more than reviewing CV’s.

“Unfortunately recruiting is often primarily based on competences and experience. However, we believe it takes more, namely matching the candidate’s personality to the culture of the business,” she says, carrying on, “To put it in a nut shell, your CV is what may in many cases give you a job, but a mismatch of your personality to the culture of the enterprise is what will get you fired.”

A thorough analysis of the expectations within the company is done prior to the global search among candidates, and this is considered essential in order to succeed in finding and matching the right candidate for the job.

Helle Jørnung continues, “Start-ups and SME may be characterized by having many different stakeholders, i.e. the inventor, the investors, the development team, perhaps an academic partner etc. At Best Talent we interview all the stakeholdHelle Jørnung, ers and have them define Managing Director and moreover align internally, precisely what the expectations and demands for the vacant role as e.g. Chief Executive Officer are.”

The ideal profile – and the ideal candidate Based on this, Best Talent operates not only with competences, experience, and IQ. The emotional intelligence, the EQ, is considered equally important: “Once we have done the initial analysis on the start-up or SME, the role, and the culture, we search and test the candidates thoroughly in order for us to assess and find the best possible and ideal candidate for the job.”

On a running basis the processes used by Best Talent undergo evaluation and quality assessment.

FACTS about Best Talent Best Talent performs Executive Search in Scandinavia and is represented globally with an Executive Life Science network of headhunters represented in more than 30 countries As a Scandinavian executive search company with a global network Best Talent acquires top talent for key organizational positions For more information, please visit: www.besttalent.dk

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THEME: PATENTS

The patent cliff is here In these years, many of big pharma’s blockbuster medicines face patent expiration. This opens up for a brand new world within the life science industry. What are the challenges and opportunities and for whom?

This is the focal point of this issue’s theme.

By Frederik Rementorp · Illustrations: Bob Katzenelson

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“There is a willingness to accept a steep price for a limited period of time until a patent expires to ensure that the pharmaceutical companies keep developing new drugs.”

Jes Søgaard

Lower costs and biosimilars But while big pharmaceutical companies are challenged and loose large shares of the market when exposed to generic competition from companies living solely on producing generics, this also opens up new and previously patent-protected

markets for these exact same generic companies.

“Generic companies can set their prices very differently because they don’t have to consider the R&D costs in the same way,” says Thomas Klit Christensen, senior consultant at the Danish Association of the Pharmaceutical Industr y (LIF), responsible for International Property Rights (IPC). He continues: “It costs somewhere in the order of DKK 8-10 billion to develop a new drug, and pharmaceutical companies have a relatively short timeframe within which to earn back their investment.”

Also, the introduction of biosimilars has further changed the market. Although biosimilars are not as cheap as generics, due to the development costs, they are still cheaper than the patent-protected blockbuster drugs and will have an impact on the market.

Cheaper medicines for patients and society The patent expirations affect more than just the industry, however.

They also affect the patients for whom the drugs are intended.

“When a patent expires it will almost always benefit patients as the price of the drug will decline – maybe not overnight – but often quite quickly, and patients will ultimately pay less for their prescription drugs,” says Jes Søgaard.

From a macro perspective, patent expirations ease the public expenditures on healthcare as well. The Danish Regions, the

governing body of the hospital sector in Denmark, has placed much emphasis on getting the most value for money by establishing central organs, such as the Coordinating Council for Commissioning of New Hospital Medicine (KRIS), the Council for Use of Expensive Hospital Medicine (RADS) and the Regions Pharmaceutical

Blockbuster patent expirations Zyprexa (olanzapin), antipsychotic – October 2011.

Eli Lilly. Sales in Denmark in 2010: DKK 265 million Seroquel (quetiapin), antipsychotic – March 2012.

AstraZeneca. Sales in Denmark in 2011: DKK 172.5 million Zarator (atorvastatin), cholesterol-lowering – May 2012. Pfizer. Sales in Denmark in 2011: DKK 97.3 million Viagra (sildenafil), erectile dysfunction – June 2013. Pfizer.

Sales in Denmark in 2012: DKK 88 million Cymbalta (duloxetin), antidepressive – December 2013. Eli Lilly. Sales in Denmark in 2012: DKK 54.3 million Evista (raloxifen), osteoporosis – March 2014. Eli Lilly. Sales in Denmark in 2012: DKK 35 million

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Source: Medstat.dk

S

ince the patent expiration of Viagra on 24 June of this year, the price has fallen by 97% from DKK 121 per pill to less than DKK 3 (source: medicinpriser. dk). This clearly illustrates the huge impact the patent expiration dates on blockbuster medicines have on the market.

In recent years, the patents on a large number of big pharma’s blockbusters have expired and there are more to come. The losses linked to these patent expirations are not pennies, even for the established pharmaceutical companies (see fact box). The sheer number of patents affected and the money involved has inspired the term “patent cliff”. And the effects of the patent cliff are already very real, manifesting themselves in massive lay-offs within big pharma and huge investments in and takeovers of companies with promising candidates to fill the gaps.

“The expiration of a blockbuster patent can be very critical for pharmaceutical companies. They therefore try to plan around it by having a new drug or drug extension ready on the date of expiration,” says Jes Søgaard, professor of health economics at the Department of Public Health, Aarhus University.

THEME: PATENTS

Organization (AMGROS). KRIS decides whether medicines gain market entry in Denmark or not, while RADS develops treatment guidelines that specify which drugs are to be used across the country and when. Finally AMGROS draws up tenders on behalf of all the hospitals to ensure the lowest prices possible. However, there are several factors for public authorities to consider regarding new drugs.

The trade-off game “There is always a trade-off between price and innovation when the Danish authorities make a healtheconomic analysis regarding a new patented drug. In Denmark, there is a willingness to accept a steep price for a limited period of time until a patent expires to ensure that the pharmaceutical companies

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What is generic substitution?

Generic medicines are different medicinal products containing the same active substances.

Generic substitution has existed in Denmark since 1991. The Danish Health and Medicines Authority decide which generic medicines are suitable for substitution. Pharmacies must then dispense the least expensive products to the patient, unless the doctor and/or the patient prefer another product.

Due to competition between the manufacturers of original medicines and generics, the prices of the generics often vary greatly. Reimbursement from the Danish National Health Service takes the substitution rules into account. This means that the National Health Service only pays reimbursement for the price of the least expensive product.

keep developing new drugs for the benefit of patients in the future,” Jes Søgaard explains and continues: “A very different approach has been initiated in the UK where the National Institute for Health and Care Excellence (NICE) has begun

rejecting new and expensive drugs that are considered cost-inefficient.

However, with such behaviour there is a risk of missing out on the innovation needed.”

•

The history of Danish drug patents For some months, discussions have focused on whether Denmark should endorse the European Patent Court and the Unitary Patent, enabling pharmaceutical companies to file a single drug patent application spanning Europe rather than following current practice and applying in every country where they market the drug. In retrospect, two dates in particular stand out in the history of Danish drug patents:

1979

1992

Until 1979, companies selling knock-off medicines enjoyed free rein. In Denmark, unlike in many other countries, patents, also called process patents, covered how a drug was produced and not the active ingredient present in the drug.

Companies could easily sidestep patents and copy products simply by changing the manufacturing process. However when Denmark signed the International Patent Cooperation Treaty in 1979, product patents also provided protection for active ingredients in individual drugs. This effectively stopped the knock-off drug companies in their tracks.

In 1992, it became possible to apply for supplementary protection certificates covering drugs for up to five years. These certificates acknowledge the lengthy journey from laboratory to patient and the relatively brief window of opportunity during which pharmaceutical companies can obtain a return on their investment.

Sources: • Danish Executive Order of the Patent Cooperation Treaty no. 3 of 16 January 1979 • The Official Journal of the European Union no. L 182 of 2 July 1992

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THEME: PATENTS

More than just generics companies Patent expirations present a golden opportunity for the generic industry.

Teva Scandinavia and Actavis each perceive this opportunity differently.

While Teva considers the upcoming patent expirations to be business as usual, Actavis finds that the change will, for the most part, have a positive impact for customers.

By Louise Bruce

ACTAVIS:

Going forward

What kind of challenges does the generics industry face at the moment?

“There are several challenges: The number of patent expirations will decline quickly after 2015-16. The price level of the existing portfolio is falling and the products up for patent expiration are increasingly more complex.”

How do you address these challenges at Actavis?

“We are moving away from being ‘only’ a generics company to being a leading specialty pharmaceutical company going forward, building a pipeline of more complex products as well as investing more in our OTC business and other niche areas.”

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A lot of the major patents are expiring.

Does this represent an opportunity for you?

“It is correct that major patents have/will expire in near future. This will definitely have a positive impact for customers and on price setting in Denmark, because from the perspective of Actavis, we expect to see huge competition and continued price erosion.”

How do you choose the products in your pipeline?

“Market size, in terms of both volume and value, is of course the main criterion for choosing products for our pipeline. However, we may also consider any capabilities our

company possesses, for instance in certain therapy areas and/or formulation techniques.”

If two products have the same indication and mode of action and their patent expires more or less at the same time, how do you select which generic to develop?

“The therapy area or type of disease is seldom a criterion for selecting a product for development unless Actavis suspects that the generic penetration is extremely low for a particular treatment.”

•

Photo: ScanStockPhoto

By Louise Bruce

TEVA:

Business as usual

Although a lot of the bestselling pharmaceutical patents have expired or will expire over the next few years, the generics company Teva considers the situation to be business as usual.

“We don’t develop and manufacture a product if there is no medical need. There has to be a market for our product, which is not necessarily the case every time a patent expires. For example, if a new and much better product compared to the old one is on the market or likely to enter the market within a short period of time after patent expiry, we would not consider developing a generic of that specific product,” Søren Rasmussen explains.

Another factor that might discourage companies from developing copies of medicines is if the development process is too complex. Simple molecule structures are easier to copy, whereas molecules with a complex structure and drug delivery system could prove very difficult or almost impossible to copy.

New holistic approach Previously, the pharmaceutical industry was divided into the “innovative” companies and the generics companies. Today it is no longer a given that generics companies only produce generics, and the makers of original pharmaceuticals only produce

original products. The trend seems to be that both types of companies are moving towards a more holistic approach to the market.

“The global market is changing and pharmaceutical companies – generic as well as original – must act accordingly,” concludes Søren Rasmussen.

Companies need to differentiate their business in order to meet the needs of the new market situation where there the demand for generics is growing in the developing countries while the market in the industrialised countries still demands original products despite budget cuts and tightened rules and regulations.

•

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THEME: PATENTS

If you can’t beat them – get your piece of the pie When generics first came along, the original producers tried to fight them, arguing that patients could not be sure the generics were actually identical to the original products. Today, many original producers launch their own generic versions in an attempt to get a piece of the pie. One such company is Pfizer.

I

n the days before the expiry of the Viagra patent in June of this year, Pfizer Denmark issued a press release with the heading “Viagra patent expiration means cheaper potency pills for Danish men”.

The press release announced that Pfizer would be the first to launch a generic version of Viagra – a white diamond-shaped pill with exactly the same content as the original product at a lower price.

“A few years ago, Pfizer decided to launch generic versions of our

22 June 2013, the day before the expiry of Pfizer’s Viagra patent, the price for one Viagra tablet was DKK 121. The next day, patients could buy generic versions of Viagra for about DKK 21, and less than three months later, in September, the price had fallen to less than DKK 3 per pill.

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own products. The generics market is growing rapidly. We continue to invest in developing new medicines, and this is still our primary focus area. But we have realised that there are sales potentials in the generics market as well,” says Managing Director of Pfizer Denmark Jens Holmstrup, adding that Pfizer invests some of the profit from its generic products in the development of new original medicines.

According to Reuters, Pfizer generics had global sales of nearly DKK 57 billion last year, representing 17% of Pfizer’s total global sales.

Photo: Pfizer

By Karina Kvisgaard · Illustration: Bob Katzenelson

Never Big Business

“We have realised that there are sales potentials in the generics market as well,” says Managing Director of Pfizer Denmark Jens Holmstrup.

By adding a generic version of their products to their product line, the original producers get their piece of the generics market while continuing to sell their original product at a higher price to those consumers who prefer the original.

With far lower profit margins, the generics market will never be as profitable as the original producers’ core business, the original products, according to Hans Henrik Raith.

But that does not mean it is a bad idea for them to launch their own generic versions once their blockbusters’ patents expire: “This strategy can be profitable, despite low profit margins in the generics market, because they already have the production facilities, distribution etc. in place,” says Hans Henrik Raith, co-founder

“There are a few very strong brands or very special therapeutic areas where patients may be willing to pay more to get “the original copy.”

and former member of the board of directors of the Danish Generic Medicines Industry Association (IGL).

“Sales volumes are bigger. And by taking part in the initial price battle, the original producers may scare off some of the competitors and, subsequently, be able to increase prices.”

Viagra – the exception to the rule Once a patent expires and generics enter the market via generic substitution, price will be the only competitive parameter, and normally the original producers’ generic versions will have no competitive advantages, claims Hans Henrik Raith.

However, he does see a few exceptions to this rule: “There are a few very strong brands or very special therapeutic areas where patients may be willing to pay more to get ‘the original copy’ produced by the original producer,

“With ‘the white diamond’, Pfizer wants to indicate to the end-user that it’s the ‘original copy’ from Pfizer,” says Managing Director of Pfizer Denmark Jens Holmstrup.

such as Pfizer’s blockbuster Viagra,” he says.

Jens Holmstrup agrees that price is generally the primary criterion when dispensing medicine at the pharmacy in Denmark, and that the Danish substitution rules enhance price-consciousness among consumers and doctors. However, he argues that other factors, such as consistency of supply, quality, packaging etc., can also influence prescriptions and dispensing.

“Viagra is one of the strongest brands in the world. We believe that consumers as well as healthcare personnel see a value in either Viagra or a Pfizer-produced generic version. Our production of generics complies with the same standards as our patent-protected medicines, and, therefore, it can be difficult to compete on price. A slightly higher price on our generic version of Viagra compared to the cheapest

competitor will probably not scare off consumers, if in return we deliver quality products. But significantly higher prices would not meet the requirements of the Danish substitution model,” Jens Holmstrup explains.

Blue diamonds in white “With ‘the white diamond’, Pfizer wants to indicate to the end-user that it’s the ‘original copy’ from Pfizer, and at the same time make sure that the patients who wish to stick to Viagra can be sure they have bought the original medicine, ‘the blue diamond’,” explains Jens Holmstrup.

“By applying this proactive strategy, Pfizer seeks to gain bigger shares of the generic Viagra market.

It will be interesting to see how this battle for market shares plays out,” concludes Hans Henrik Raith.

•

27

THEME: PATENTS

Don’t develop generics Do not be tempted by the many upcoming blockbuster patent expirations. Developing generics is not a worthwhile undertaking. This is the cold hard truth, according to Hans Henrik Raith, founder of one of the first generics companies in Denmark.

Instead, he sees several other potentially good business opportunities in generics.

By Maria Alstrup

The transition of sales from the original medicine to generic drugs is exceptionally fast in Denmark, which has some of the lowest generics prices in Europe.

The price drops are enormous – often with savings of more than 90% at the first day of patent expiry.

This is why Hans Henrik Raith argues that there is no money nor are there new markets in developing generics from a Danish perspective.

“Generics are subject to extreme price competition where price alone

Hans Henrik Raith is the founder of United Nordic Pharma A/S, one of the first generic drug companies in Denmark, established in 1990.

He is also co-founder of the Generic Medicines Industry Association and served as chairman from 2002 to 2005.

Furthermore he has held a top position at Actavis, responsible for corporate business development. Today, he is key driver at FarmaDirect, which aims to significantly change the price picture of drug distribution in Denmark.

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controls whether you sell or not.

A new price period begins every second week, and if you are not the cheapest you will be shelved with your product.

Therefore, you need to constantly lower the price; otherwise you could end up scrapping your product. This price adjustment is, of course, to the benefit of public health costs – but it also means that the profitability, if you can even call it that, of generics in Denmark is very low.

In short it is all about volume – and in it is nature Denmark is a small market compared to most other markets,” he explains.

Still business potential Consequently Raith believes that only the big players in the market can still profit from developing generics – despite price competition.

However, this does not mean that there is no Danish business potential at all for generics. You just have to approach the matter differently.

“There are still potentially good business strategies when it comes to generics in Denmark. One being specialising in niches and developing generics for old substances that don’t have the same interest as the big blockbusters when patents expire.

Another option is to parallel import generics. Although Denmark

has very low prices for generics, it is still possible to buy generics on the spot market, parallel import them to Denmark and make a profit that way. However, both approaches require important know-how.”

“Generics are exposed to extreme price competition, making profitability minimal from a Danish perspective.”

Raith elaborates that parallel import of generics has the advantage of not requiring a large stock, which is a necessity if you wish to develop and sell generics.

Instead, you can parallel import the required amount for the next 14-day price period, thus avoiding being stuck with stocked products you cannot sell. So why bother with developing generics? Raith asks.

•

Biosimilars are here to stay Although more complex and costly than generics: biosimilars are here to stay – Professor Steffen Thirstrup has no doubt. And with upcoming patent expirations of biological pharmaceuticals, development and imitation will gain momentum over the next few years. Hospira, producer of the newly approved biosimilar of Remicade, agrees.

By Maria Alstrup · Illustration: Bob Katzenelson

When small molecule generics were introduced more than 20 years ago, they were met with scepticism.

“How can the same medicine be as good, safe and effective when it only costs a fraction of the original?”

Today generics are a natural extension of patent expirations, resulting in substantial savings for the publicly financed healthcare system. At the same time, generics have been a motivator for the pharmaceutical companies to be innovative and continuously develop new and even better products.

ent and far more complicated compared to generics, not least because of the manufacturing process.

Generics are chemical products that must be exact copies of the originals – that is 100% identical to the molecule. Biosimilars on the other hand, are based on a biological system consisting of cells. When you use cells to make proteins, as these drugs are, the cells will automatically become a product of the cells in question and thus there may be variants that are different than the ones we make in the human body.

Consequently, you can’t make an

The history of biosimilars • The development of biosimilars started in 1996.

• In 2005, a revised EU pharmaceutical legislation came into force, and in 2006 the first biosimilars obtained approval from the EMA. • 18 applications were evaluated the first year, and 14 products were approved.

The products fell into three categories: growth hormone, EPO (epotein alfa or zeta) and fligrastim (G-CSF).

Understanding biosimilars

• Between 2010 and June 2013, the EMA has not received any applications for approval of biosimilars.

Photo: PR

Now the same process has begun with the more complex biological pharmaceuticals.

However, there is a big difference between manufacturing generics and manufacturing biosimilars, according to Professor Steffen Thirstrup.

He is a medical advisor at Europe’s leading regulatory affairs consultancy, NDA Group, and former head of drug licensing at the Danish Health and Medicines Authority. He was also closely involved in the debate on biosimilars during his time on the European Medicines Agency’s key scientific committee, CHMP. “Developing biosimilars is differ-

“Developing biosimilars is different and far more complicated compared to generics,” says Steffen Thirstrup, medical advisor at the regulatory affairs consultancy NDA Group.

• The largest producers of biosimilars are: Sandoz, Teva Pharmaceuticals, Hospira, Stada Arzneimittel, Medice Arzneimittel Pütter and JCR Pharmaceuticals.

Source: www.visiongain.com/ Report/1114/Pharma- LeaderSeries-Top-25-Biosimilar- DrugManufacturers-2013-2023

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THEME: PATENTS

exact copy of biological pharmaceuticals. Instead you aim to make an imitation. That is why we don’t talk about biological copies or “biogenerics”, but instead about biological imitations, hence the term biosimilars,” Steffen Thirstrup says.

Heavy documentation requirements As a result of the complex manufacturing process, the making of biosimilars is a comprehensive international business that requires more documentation than generics before obtaining approval.

“When developing generics you have to carry out a bio equivalence study to prove that the substance is added in the same amount and speed as the original drug. The process is the same when developing biosimilars, but in addition you have to document efficacy, safety and the quality of the manufacturing – just like when developing an original product. And lastly, you must demonstrate that it is comparable to the original product.”

It is important to explain these special documentation requirements for biosimilars to prescribers to help them understand that they can feel comfortable using biosimilars as well.

Thirstrup believes that the key is dialogue. The industry needs to help specialists understand how biosimilars are developed and the requirements they are subject to.

Marketing Director Lena Storm, from Hospira, one of the leading producers of generic medications, agrees that it is a challenge to make prescribers feel secure about biosimilars.

They recently received European approval for Inflectra, the biosimilar of Remicade for rheumatoid arthritis.

“Although EMA’s guidelines include a very extensive process to obtain approval, it is as if biosimilars are seen as a kind of discount product – a lot like when generics entered the market. I think it is essential that specialists understand the complex and comprehensive process surrounding the development of biosimilars. Then, hopefully, they

will approve biosimilars as a highquality, effective and safe imitation of a biological product,” Lena Storm argues.

Attractive market A consequence of the more comprehensive manufacturing process for biosimilars is the price – initially for the producer, but ultimately also for the public healthcare system. How-

Inflectra – first EU-approved biosimilar for the treatment of rheumatoid arthritis • Inflectra is the first biosimilar monoclonal antibody to be approved in Europe.

• It is a biological copy of Remicade.

• Inflectra and Remicade are both approved for the treatment of rheumatoid arthritis, inflammatory bowel disease and plaque psoriasis.

• Inflectra has been approved on the basis of a phase III trial which showed that Inflectra has the same quality, safety and efficacy as Remicade.

• Hospira has the marketing authorisation for Inflectra in Europe, whereas Remicade has been launched by MSD. • The development of generics usually starts 5-6 years prior to patent expiration. Developing a biosimilar takes considerably longer, and Hospira already acquired the marketing authorisation rights for Inflectra in 2009.

• Inflectra is expected to be released on the Danish and Swedish markets in 2015.

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ever, Thirstrup still believes that the market is attractive for all parties.

“The more complex manufacturing process will consequently mean that we won’t see the same enormous price drops when the patents for biologicals expire as we have with generics. However, Europe is a pioneer in developing biosimilars, because we believe that increased competition will help keep the health costs down – also when it comes to biological pharmaceuticals.

The development costs of biosimilars will still be lower than of the originals, so we will experience price reductions. I look forward to seeing what will happen in the next few years, as we face several major patent expirations, especially in the cancer field. This alone should give rise to an expansion of biosimilars,” Steffen Thirstrup explains.

AMGROS emphasises the

potential market for biosimilars with the new statistics on the ten most widely used drugs in 2012 – which are all biological. So it should make sense to develop biosimilars – for the producer as well as for the healthcare system.

History repeats itself Steffen Thirstrup stresses that an additional benefit of biosimilars – as with generics – is that a more competitive market for biologics benefits innovation.

“The increased competition forces pharmaceutical companies to develop new and even better medicines faster. While we may not save as much on public expenses – we will be able to spend the money on even better drugs. So I am certain that both patients and the healthcare system will win with more biosimilars in the market.”

5 biosimilars on the market • Inflectra by Hospira. Indication: Rheumatoid arthritis, inflammatory bowel disease and plaque psoriasis • Filgrastim Hexal by Hexal. Indication: Cancer, neutropenia and hematopoietic stem cell transplantation • Silapo by Stada. Indication: Anaemia, blood transfusions, cancer and chronic kidney failure • Tevagrastim by Teva. Indication: Neutropenia, hematopoietic stem cell transplantation and cancer • Omnitrope by Sandoz. Indication: Dwarfism, Prader-Willi Syndrome and Turner Syndrome

•

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LOREM IPSUM DOT NOS ET ADVERT

Business partner and scientific collaborator The network at Bioneer comprises many biotech companies, small and large, as well as academic collaborators. Being right in the centre of biotech innovation is what Bioneer is all about.

By Charlotte Strøm, MD, PhD, Journalist

At Bioneer 40 people, predominantly biomedical scientists and technicians, play a rather unique role as partners in both academia and the biopharmaceutical industry.

Bioneer is a research-based biomedical and biotechnological service provider located in Scion DTU Science Park in Hørsholm, Denmark. Bioneer’s mission is to facilitate biomedical development by providing a wide range of services to small and middle sized enterprises (SME) in Denmark.

Bjørn, one of Bioneers scientists investigates the expression of a recombinant protein in E. coli.

International collaboration Scientific collaboration in biomedicine is, however, typically international, and Bioneer’s network therefore extends far beyond the Danish borders. Most recently, Bioneer entered into a scientific collaboration with Amphidex (DK), Orla Protein Technology (UK). The research project, called SURFStem, is aimed at developing intelligent biosurfaces, i.e. coatings and enclosure of proteins for use in stem cell growth. The collaboration was granted DKK 8 million from the Eurostars programme under the European Union and is the fourth of its kind with Bioneer as a partner.

“We have managed to position Bioneer as a competent and qualified partner in a number of high-profile scientific collaborations. But in the end it comes down to our ability to use our specific know-how and experience with highly specialised biotechnology platforms, such as stem cell technology, to create value for biotech companies,” says Christian Clausen, MSc, MD and Head of Department at Bioneer, who will be heading the SURFStem project over the next two years.

Dedicated to facilitating innovation in life science Bioneer operates in the crossroads of biotech, academic researchers and pharmaceutical companies, providing a range of different competences as well as insight into preclinical drug development.

“We facilitate the process of bringing biotech ideas into

32

the world and enable their commercialisation,” says Niels Skjærbæk, Business Development Manager at Bioneer.

He continues: “Moreover, we wish to help existing biotech companies to expand into new business areas or explore new product opportunities as exemplified by the small Danish company Bifodan.”

Bifodan is a biotech company that manufactures innovative and scientifically based probiotic strains for use in a range of areas, such as women’s health and digestive, oral and immune health.

“Our collaboration with Bioneer is driven by our desire to continuously reinforce our specialist technological platform and know-how within probiotics. We focus on innovative and sustainable probiotic product solutions that are safe, well proven and cost effective,” says Erik Brandsborg, Chief Scientific Officer at Bifodan.

According to Erik Brandsborg the possibility of strengthening Bifodan’s business with scientific data regarding product functionality is a key driver for the collaboration.

“At Bioneer, we can evaluate the effect of our probiotic strains on the immune system in unique human cell models and, thus, provide relevant documentation of our products to our clients as well as to the regulatory authorities,” explains Erik Brandsborg.

This is the essence of the wide range of services provided by Bioneer:

“Only a handful of small biotech companies and academic research groups have the set-up to carry out optimisation of the production of a new therapeutic candidate protein or to test their novel therapeutic compounds for immunomodulating effects including immunotoxicity,” Niels Skjærbæk says, referring to Bioneer’s bacterial and mammalian cell production technology and the wide range of in vitro immunologic models developed by Bioneer.

Drug formulation services Bioneer provides services within drug formulation as well, and since January of this year, Bioneer:FARMA (a business unit of Bioneer located at the University of Copenhagen) also offers comprehensive and highly specialised drug formulation testing to the pharmaceutical and food-related industries using the Dynamic Gastric Model (DGM). The DGM is a breakthrough as it accurately simulates the human gastric compartment by fully replicating the complex biochemical conditions as well as the array of gastric forces crucial for the prediction of the bio-performance of active pharmaceutical ingredients (APIs) and pharmaceutical dosage forms.

DGM Executive Manager Hiep Huatan, PhD Pharm, explains how the DGM is gaining traction in the evaluation of generic substances.

“The DGM is an excellent tool for assessing the likelihood of clinical bioequivalence and as such very useful for preempting the risk of clinical failure,” says Hiep Huatan.

Another important area where the DGM is proving useful is the evaluation of gastro-retentive formulations.

“24-hour profiling of slow-release formulations in vivo is laborious, whereas the DGM allows testing of several different simulated meal conditions in a single run,” he says.

Hiep Huatan also points to significant new applications for the DGM as a result of changing regulatory demands for modified drug formulations. Testing of alcohol interaction,

About Bioneer Bioneer is an independent, research-based service company within biomedicine, biomedical technology and biotechnology Bioneer carries out industry-sponsored research and develops new product and process opportunities by cross-linking ideas from the world of science with those of the market Bioneer is a fully-owned subsidiary of the Technical University of Denmark (DTU) and is located in ScionDTU research park in Hørsholm www.bioneer.dk

risk of dose dumping etc. is now required under various release patterns: “In vivo testing of alcohol is hardly considered to be ethical, but the DGM has proven to be a very useful tool for these analyses.”

Bioneer’s DGM activities are currently located in Norwich, UK, but will be transferred to Bioneer:FARMA in Copenhagen during 2014.

Scouting for the right partners Bioneer participates in a number of biotechnology conferences globally in order to identify partners for projects with Danish biotech companies and projects of their own.

“It’s an ongoing process for us to continuously expand our network and bring SMEs from all over the world, and especially from Europe, together in scientific collaborations,” concludes Niels Skjærbæk.

For more information on where to meet Bioneer visit www.bioneer.dk.

Bioneers fermentation technicians prepare for a new round of protein manufacturing

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PORTRAIT

How to develop pharmaceuticals in an ideal world A world without the pharmaceutical industry: after reading Professor Peter C. Gøtzsche’s latest book Deadly Medicines and Organised Crime, you cannot help thinking that this is Gøtzsche’s utopia.

By Louise Bruce

As the title of Gøtzsche’s new book indicates, he finds an urgent need for a system change as the pharmaceutical industry is comparable to the mafia, although “the mafia kills far less people than the pharmaceutical industry,” as he writes.

Among other things, he accuses the industry of being corrupt, bribing whoever they can, withholding and altering clinical trial results, only publishing beneficial results and concealing adverse effects whenever possible.

However, according to Gøtzsche it is possible to limit the crimes of the pharmaceutical industry through tightened rules and regulations.

Phase III trials are a public matter One of the corner stones in Gøtzsche’s solution to the current issues is making phase III trials a public matter.

Financed by the industry,

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universities and other independent research organisations should take over all clinical trials, at least in phase III, to ensure academic leadership of all trials. This means that the universities and the independent organisations will be responsible for the entire process of producing the trials from design through analysis to presentation of the findings.

“All pharmaceutical trials should be a public matter. The industry can pay for the trials, but should not have anything to do with them, as it is very well documented that very often the industry embellish results, when they have to evaluate themselves and their own pharmaceuticals, and that inconvenient research results are withheld, which damages the patient’s health and survival,” says Gøtzsche.

According to Gøtzsche, public clinical trials would benefit the patients as well as the industry

The issue in brief Professor Peter C. Gøtzsche’s book Deadly Medicines and Organised Crime: How big pharma has corrupted healthcare was published on 19 September 2013.

The book is a harsh critique of the entire pharmaceutical industry and everyone associated with it. Response to the book has been mixed, but the majority criticise him for blowing things out of proportion.

Gøtzsche is known for his criticism of the industry and one of his previous books started an intense debate on mammography.

Photo: Katrine Emilie Andersen, Scanpix

“All pharmaceutical trials should be a public matter.

The industry can pay for the trials, but should not have anything to do with them.�

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Photo: PR

PORTRAIT

Peter C. Gøtzsche, Professor and Director of the Nordic Cochrane Centre, graduated as a master of science in biology and chemistry in 1974 and as a physician 1984.

He is a specialist in internal medicine; worked with clinical trials and regulatory affairs in the drug industry from 1975 to 1983, and at hospitals in Copenhagen from 1984 to 1995.

He co-founded The Cochrane Collaboration in 1993 and established the Nordic Cochrane Centre the same year. In 2010, he became professor of Clinical Research Design and Analysis at the University of Copenhagen.

Peter Gøtzsche has published more than 50 papers in “the big five” (BMJ, Lancet, JAMA, Ann Intern Med and N Engl J Med) and his scientific works have been cited over 10,000 times.

He is author of the books: Rational Diagnosis and Treatment. Evidence-Based Clinical Decision-Making (2007), Mammography Screening: Truth, Lies and Controversy (2012) and Deadly Medicines and Organised Crime: How big pharma has corrupted healthcare (2013).

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as this setup ensures that only pharmaceuticals that are actual breakthroughs would be prescribed.

At the same time, the setup would make it much cheaper for the industry.

Independent trials would also make it more likely that new products would be compared to old and cheap ones in a fair way, where the old product is not administered in a dose that is too high or too low.

Gøtzsche also points out that this setup makes it possible to compare pharmaceutical interventions with non-pharmaceutical interventions, a practice which, in his opinion, takes place too rarely as it does not present any value to the industry.

Finally, the grounds for all proposed trials should be based on recent, stringent review of all previous trials with similar pharmaceuticals. This could potentially contribute with information that would disallow the trial as the pharmaceutical in question already has proven beneficial or harmful.

Open access to clinical data Once all clinical trials are under academic leadership, as a matter of course all trial data would be made accessible to the public. It is a grave misunderstanding that individual companies can own clinical data.

Thus, Gøtzsche criticizes the industry for withholding research data and only publishing that which benefits their pharmaceutical sales.

“We need laws that demand that the companies forward all knowledge regarding their pharmaceuticals and research data, and which do not only provide an opportunity, but demand that the medicines agencies disclose all they know. At the moment the companies can keep everything a secret, even when they know their product is harmful,” he argues.

In the meantime, the regulatory authorities should take action and

sanction the companies until all data is available and non-disclosure agreements are removed. Deciding not to recommend or buy the product in question could be one way to sanction the companies.

While we wait for a system change Gøtzsche recognises that the comprehensive system change he proposes is not going to happen overnight.

He suggests a model for a transition system where each country finds its own way of financing independent supplementary trials before it is decided to use or reimburse a specific pharmaceutical.

Financing of the independent trials could be subject to various charges. For instance, a 2% tax on prescriptions charged to the companies would quickly create a large foundation that could be allocated to this kind of research.

Even the governments and the hospitals could allocate funds, as independent trials could easily become a source of income instead of an expense.

However, establishing independent supplementary trials is not sufficient to make a relevant

“At the moment the companies can keep everything a secret, even when they know their product is harmful.”

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PORTRAIT

transition system. According to Gøtzsche, the misconducts he accuses some doctors of committing disqualify them from conducting clinical trials.

As a consequence, he proposes that the regulatory authorities select those who are permitted to conduct clinical trials, ensuring that only doctors with no financial connections to the industry will be able to conduct trials.

The end of me-too With the implementation of the new system, it would no longer be profitable to develop me-too products, and the industry would be forced to carry out more innovative research instead of devoting all their money to marketing.

Me-too products are new products that are similar to older products, but are often believed to

present minor benefits compared to the old one. So far, these types of pharmaceuticals have been largely approved and reimbursed by the authorities. But this is a misunderstanding, according to Gøtzsche: “It is a misunderstanding that small improvements are made all the time. It only seems so, because the industry manipulates with the trials and avoids publishing unfavourable research results. The real improvements are very, very far apart,” he explains.

“In 2009 the prestigious independent French medical journal Prescrire analysed 109 new pharmaceuticals or indications: three were considered minor therapeutic breakthroughs, 76 did not add anything new, while 19 were regarded a possible risks to the public health,” he continues.

GØTZSCHE’S SUGGESTIONS Actions • All phase III trials should be under public academic leadership • Public access to all research data should be ensured • In a transitional period, independent supplementary trials should be conducted

Consequences • Developing me-too products would become unprofitable • A need for more “real” innovation would develop • Patients would only be given effective medicine

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poster or some other form of visualization produced. You have probably also found it challenging to communicate your research to the graphics staff and ensure that you end up with a scientifically accurate product.

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Room for more innovation With me-too products out of the picture, companies would be forced to be more innovative and develop real breakthroughs. One could wonder whether the companies would be more likely to decrease their research effort, but Gøtzsche believes this to be unlikely.

“The opposite will happen.

Innovation has dried out, as it is it is more lucrative for the industry to develop me-too products that do not represent any kind of therapeutic advance instead of doing innovative research,” he states.

The demand for more innovation would present an opportunity to smaller businesses, and the industry as a whole, locally and internationally, would benefit from a more innovative approach where “real” innovation is paramount.

S T O C K H O L M

“The pharmaceutical industry is one of the most profitable industries in the world and has been so for decades.”

Huge profits anyway Without me-too products one might think that the incentive for investing in pharmaceutical companies would decrease. However, Gøtzsche

O S L O

is convinced this would not be the case. He claims that with the current profit margins, the companies could easily survive without the me-too products.

“The pharmaceutical industry is one of the most profitable industries in the world and has been so for decades. The profit per sold unit has always been much higher in the pharmaceutical industry than in other industries, e.g. 11% in 1960 compared with 6% in all Fortune 500 companies (big pharma included).

But in the 1980s when marketing executives took over the companies, the industry’s profit exploded and became 19% in 2011. In 2002, the combined profit for the ten pharmaceutical companies in Fortune 500 exceeded the profit of all other 490 companies combined,” claims Gøtzsche.

C O P E N H A G E N

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GUIDE

The unitary patent takes effect As of 1 January 2014 or the date of entry into force of the Agreement on a Unified Patent Court (UPC Agreement), inventors will be able to apply for a Unitary Patent. The single European patent is a huge step forward. But how does this new patent actually work?

By Thomas Bjørn

For several decades, the Member States of the European Union have been negotiating the creation of a European patent with unitary effect and a unified European patent court.

On 17 December 2012, the Council of the European Union approved two regulations that create a European Patent with unitary effect (Unitary Patent). A Unitary Patent, once granted by the European Patent Office (EPO), will provide uniform protection with equal effect in all of the participating countries.

This will ensure uniform protection for an invention across 25 Member States on a one-stop shop basis. At the moment, all countries in the European Union are covered with the exception of Spain and Italy, although they may join at a later date.

Any disputes relating to the infringement or validity of a Unitary Patent will apply across the whole of the territory of the patent. Unitary Patents will be subject to the payment of a single set of renewal fees to the EPO, which will manage the scheme centrally.

How this new system will work Under the new system, any inventor will be able to apply to the EPO for a Unitary Patent, which will, on registration, be immediately effective and enforceable in the new UPC, with decisions on validity and infringement being directly binding throughout the participating Member States.

How can an applicant apply for a Unitary Patent?

Unitary Patents will be obtained using the existing European patent application procedure. The decision about which route to take will not have to be made until

40

the European patent is granted. Within a maximum of one month from the date on which the grant of the European patent has become effective, the patentee can request the EPO to register the Unitary Patent in the European Patent Register. Should such a request be made after the grant, the patent will take effect retroactively in the 25 participating Member States without any additional validation requirement. Renewal fees will then be payable to the EPO on an annual basis.

KEY FACTS • The Unitary Patent will cover a territory of 25 countries, including Europe’s biggest economies.

• The Unified Patent Court will replace the domestic courts of 26 countries (Italy has acceded to the UPC but not the Unitary Patent).

• The UPC will have its central division in Paris, with branches in London and Munich.

• Litigation can be managed by a single European lawyer or by a patent attorney with a litigation certificate.

• A final decision by the UPC will be binding in the 26 participating Member States.

• The system will provide an efficient one-stop shop, effectively reducing the costs of patent registration and litigation.

Costs There will be a transitional period of up to 12 years before the new fee regime is fully implemented.

During the transitional period, the cost will be about EUR 6,500, which includes the cost of the additional translation of the patent claims required during this period (see below).

After the transitional period, it is anticipated that the cost of obtaining a Unitary Patent will fall to around EUR 5,000. This covers the procedural fees of the EPO as well as the cost of the translation of the claims to two of the other procedural languages of the EPO (English, French or German).

Today, a “traditional” European patent costs about EUR 36,000. By comparison, in the USA a patent cost about EUR 2,000 and in China about EUR 600. Renewal fees are likely to be set at a price point equivalent to an “average” European patent.

rather than better for the majority of patent owners, and this seems to be the view of the majority of EU patent professionals.

Concerns The advantages of the Unitary Patent and the UPC are many and evident, but there has also been significant public debate about the possible weaknesses. The Max Planck Institute in Germany has raised reasons for concern, warning that the system adds to the complexity and may lead to the fragmentation of patent protection in the EU. They criticise it for being unbalanced and lacking in legal certainty. The future will show whether the possible disadvantages will be outweighed by the benefits of lower registration and litigation costs and more uniform court decisions across the European Union.

•

Photo: PR

Translations Applications for Unitary Patents can be filed in any language; however applicants must provide a translation of the application in English, French or German. For the transitional period, European patents with unitary effect that were granted in French or German will need to be translated into English and any granted in English will need to be translated into either French or German.

The Unified Patent Court The UPC Agreement establishes a specialised patent court (UPC) with exclusive jurisdiction for litigation relating to European patents and European patents with unitary effect and so the UPC is expected to lead to more uniform legal decisions across the EU and to reduce the costs of patent litigation significantly.

The UPC will comprise a Court of First Instance (to be seated in Paris), a Court of Appeal (located in Luxembourg) and a Registry (also in Luxembourg).

Transitional provisions and coming into force of the regulations There will be a seven-year period during which actions relating to European patents (as opposed to Unitary Patents) can still be brought in national courts.

The UPC Agreement will come into force on the first day of the fourth month after thirteen states, including the three states that had the highest number of European patents in effect (Germany, UK and France), have ratified the Agreement, or on 1 January 2014, whichever is the later. This is because there is still uncertainty about this agreement. The UK Parliament, for instance, has been sceptical about whether this system will make European patent litigation worse

ABOUT THE AUTHOR Thomas Bjørn works as a solicitor with Royds LLP in London.

Thomas Bjørn holds a law degree from the University of Copenhagen and has worked in private legal practice and in the pharmaceutical and biotech industries in the UK, Switzerland and Denmark. His areas of expertise include the protection and commercialisation of intellectual property, regulatory affairs and the sale of goods and services to the NHS. Royds LLP is a London City based law firm providing legal services to the international business community. The firm specialises in commercial law and has a strong focus on intellectual property and the life science industries.

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CALENDAR

Translation: CLS Communication A/S

OCTOBER ÖRESUNDSTING 2013 24 October 13 – 18 CPH Conference in DGI-byen Copenhagen Registration at: www.oresundskomiteen.org/ oresundsting2013/

In olden times, a meeting at which shared issues and disputes were discussed was called a “ting”. Our aim is for Öresundsting 2013 to be that place – an opportunity for stakeholders to sit down together to draw up general guidelines for the Öresund region of the future. A meeting place with a focus on collaboration across the Öresund region – stakeholders – who want to and who can drive change,

both in politics, the media, business, research and the ideas-driven sector.

BIO-Europe® 2013

Pharmacovigilance 2013

4–6 November 2013 Vienna, Austria Registration at: senglhart@ebdgroup.com Read more at: www.ebdgroup.com

14–15 November 2013 Radisson Blu Falconer Hotel & Conference Center Copenhagen Registration at: www.ibceuroforum.dk

Speakers include: Henrik Sass Larsen, the Danish Minister for Business and Growth Tine Horwitz, CEO of Consortium for Global Talent Morten Christiansen, CEO of “3” in Denmark Ursula Hultkvist Bengtsson, Executive Vice President at Medicon Village

NOVEMBER Advanced Business Development Course 2013 1–3 November 2013 Hilton Vienna Danube Vienna, Austria Registration at: www.ebdgroup.com The Advanced Business Development Course is designed for business development professionals interested in bringing their skills in valuation, due diligence, negotiation and contracts to the next level. During this intensive, three-day session attendees will receive advanced hands-on training from veteran business development professionals and legal advisers using real-world case studies.

This course has been organised for life science business development professionals by the Biotechnology Industry Organization in collaboration with EBD Group.

Key topics are: Valuation skills, Intellectual property, Due diligence, Negotiation and influence strategies and Contracts in depth.

The 19th annual BIO-Europe® is Europe’s largest partnering conference serving the global biotechnology industry. Delegates from all parts of the biotechnology value chain come to BIO-Europe to quickly identify, engage and enter into strategic relationships that drive their businesses successfully forward. Investment and collaboration opportunities developed at prior BIO-Europe conferences have produced many highly successful business partnerships. This year’s BIO-Europe partnering event will again draw upwards of 3,000 industry attendees from over 40 countries, representing close to 1,800 companies for three days of high-level networking.

Nordic QA FORUM

3 November 2013 Vienna, Austria Read more at: www.ebdgroup.com

13 November 2013 Crowne Plaza Copenhagen Towers Copenhagen Registration at: www.kompetensinstitutet.se/qaforum

Now in its fourth year, China Forum 2013 will be a full-day event bringing together China-based life science executives and their counterparts from Europe and the rest of the world. The event will provide insights into recent developments in the rapidly changing life science industry in China.

Executives from China and the West will discuss partnering opportunities and attendees will gain essential knowledge on how to step into new marketplaces.

The EMA GDP guidelines have been updated, and the Nordic QA Forum will give you insights into how the Danish and Swedish authorities are going to interpret these changes, while business cases, such as AstraZeneca, Novo Nordisk and MSD, will share best practices. Key topics are: Implementation of the new EU GDP, How to proceed and become compliant, Key best practices from AstraZeneca, Novo Nordisk and MSD and Transport Validation: a step-by-step guide.

China Forum 2013

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Update on Legislation & Practical Implications Key Topics: • EU Pharmacovigilance Legislation – new GVP modules & practical implications • Pharmacovigilance Inspections – trends from UK & DK authorities • Risk Minimisation Measures – new guideline & practical experiences • Periodic Benefit-Risk Evaluation Reports (PBRER) – changes & practical experiences • Additional Monitoring – new guidelines • PASS & PAES – randomised pragmatic trials • Signal Detection – new methods and processes • Safety Data Handling & Data Privacy in Market Research & Patient Support Programmes

DECEMBER ICI Meeting 2013 - Innnovation in Cardiovascular Interventions 1–3 December 2014 Tel-Aviv, Israel Registration at: www.icimeeting.com The ICI meeting 2013 is the best place to present your new technologies. ICI began as a scientific meeting for interventional cardiologist and has grown throughout the years into a prestigious event targeting medical Unmet Needs.

From a cardiologist’s conference, ICI has developed into a premier event challenging the industry for better innovative solutions related to all blood vessels complications. ICI provides an extensive platform for startup companies presenting their latest technologies.

JANUARY CLINICAL TRIALS 2013

Biotech Showcase™ 2014

4–5 December 2014 Radisson Blu Falconer Hotel & Conference Center, Copenhagen Registration at: www.ibceuroforum.dk

13–15 January 2014, San Francisco Registration at: www.ebdgroup.com/bts

This conference is an excellent forum for anyone working with clinical trials and testing who wants to keep up-to-date on legislation, procedures and practice in the field.

Key topics among others: • New framework conditions for clinical research and public/private partnerships • Clinical testing of medical equip­ ment – new legislation & practice • Clinical trials in practice – hospitals & GPs

Biotech Showcase™ is an investor and partnering conference devoted to providing private and public-sector biotechnology and life science companies an opportunity to present to and meet with investors and pharmaceutical executives in one place during one of the industry’s largest annual healthcare investor conferences. Investors and biopharmaceutical executives from around the world gather in San Francisco during this critical week, which is widely viewed as setting the tone for the coming year.

Surveillance of the safety and benefit risk balance - how to meet the increasing PV regulatory requirements?

Pharmacovigilance is becoming more business critical than ever – who wants a Roche scandal? At the same time the increasing amount of drug safety legislation leaves the pharmaceutical industry with lots of unanswered questions as to how to comply. How to deal with this?

No doubt the practical implications of the new EU Pharmacovigilance Legislation – the GVP Modules of 2012 as well as the remaining ones – are many. Pharmacovigilance 2013 is a conference in December which provide the pharmaceutical industry with both an important overview of the most relevant issues and at the same time with a unique insight into the experiences of leading industry experts from Denmark, UK and Germany. To ensure the quality of the conference you will meet only the most respected European advisors and experts.

Selected subjects of the conference are the new GVP modules, PV inspection trends, risk minimisation measures, Periodic Benefit-Risk Evaluation Reports, additional monitoring, randomised pragmatic trials and new methods on signal detection.

New regulatory framework – how will it strengthen clinical research & public private partnerships?

The question of how to strengthen the framework for clinical research and public private partnerships has been debated strongly in recent years – new ways are definitely needed if the Danish health research level is to keep its

prominent position internationally. Since 2009 the question has been dealt with in the Danish “Nationale Samarbejdsforum for Sundhedsforskning”(NSS) and the result is a national action plan which is currently underway.

At the conference Kliniske forsøg 2013 in December the chairman of the “Nationale Samarbejdsforum for Sundhedsforskning”, dr. med. Poul Jaszczak, will introduce the delegating clinical trial professionals to the action plan – what is new and how can it support clinical research?

Further, some of the already implemented initiatives will be presented by the Danish Health and Medicines Authority, sundhed.dk and the Capital Region of Denmark.

The conference also goes into more practical aspects of clinical trials with drugs and medical devices, e.g. new ways of recruiting patients, legal limits of cooperation with health professionals, clinical trials at hospitals and GPs.

For further information: IBC Euroforum, Senior Contract Manager Rikke Ryge Casper, rc@ibceuroforum.dk, +45 41 95 14 29,

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A strong Team

MALENE AADAL Bo

LoNE fRANk

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Copenhagen Life Science is a high-quality magazine that weights validity and thoroughness highly. Therefore we have joined forces with a strong team. As previously life science journalists Lone Frank (DK) and Fredrik Hedlund (SE) will take turns writing a column for the magazine, and editor in Chief is Malene Aadal Bo. The exclusive and close cooperation with our partners ensures that Copenhagen Life Science constantly has an in-depth knowledge of the life sciences industry, the latest trends and conditions in the market.

Distribution In addition to interesting and updated articles about the conditions of the industry, Copenhagen Life Science gives companies in the region a unique opportunity to brand themselves both nationally and internationally. With its thoroughly selected distribution network, Copenhagen Life Science is the ultimate and optimum opportunity to present your company to customers and business partners.

Copenhagen Life Science is distributed in Denmark, Sweeden and Norway to: • • • • • •

Named decision-makers in the life sciences industry Investors Science parks Hospitals Universities Life science media

• Relevant MPs in Scandinavia • Medicon Valley Alliance’s members and collaboration partners • Relevant national and international trade fairs, conferences and exhibitions in Europe, North America and Asia

Copenhagen Life Science gives its readers a thorough knowledge of and an updated insight into the industry and the conditions the industry is facing right now.

Would you like to know more? Please contact: Thomas Rosendal, phone: +45 2360 3940 thomas@media-partners.dk Hanne kjærgaard, phone: +45 2967 1436 hanne@media-partners.dk Marianne Lander, phone: +45 2967 1446 marianne@media-partners.dk

RASk Media ApS frydendalsvej 3, dk-1809 frederiksberg C, denmark Phone: +45 3326 9520 rask@raskmedia.com www.raskmedia.com