Novo Nordisk (NN) has celebrated 90 years of manufacturing and selling insulin for the treatment of diabetes.

The Danish company was the first to develop human insulin and the insulin pen for fixed dose injection.

It now produces half of the world’s insulin – a drug vital to all people with type 1 diabetes and many with type 2.

NN was founded by medical researchers August and Marie Krogh. August was a Nobel Prize winning zoologist and Marie was a doctor and diabetes patient.

In 1922, the couple went to Canada to meet Professor Macleod, the leader of the team who had discovered insulin. They gained permission to commercialise the drug in Scandinavia, and launched the company in early 1923.

Treatment innovations developed by NN include ‘modern’ insulins (genetically engineered insulin analogues with enhanced properties) and GLP-1, a type 2 diabetes drug than enhances the production and absorption of the body’s insulin.

In 2002, NN started the World Diabetes Foundation, an international funding agency supporting diabetes prevention and treatment in the developing world.

The company also manufactures biopharmaceuticals to treat haemophilia and growth disorders, and established the Novo Nordisk Haemophilia Foundation in 2005 to support patient care and treatment.

“Our 90 year anniversary is a significant milestone for Novo Nordisk. Our commitment to changing the lives of people with diabetes is unparalleled both globally and here in the UK, where we have been operating for over 25 years,” said Peter Meeus, NN’s UK Managing Director.

“Our researchers have discovered many breakthroughs in diabetes treatments for patients and our dedication to the training and support of NHS doctors and nurses has helped thousands to share expertise between primary and specialist care.”

Based in West Sussex, Novo Nordisk UK employs about 400 people.

AbbVie’s Humira (adalimumab) is now available in the UK for treatment of paediatric Crohn’s disease (CD), a painful bowel disorder that can inhibit children’s growth.

The drug is licensed for treatment of patients aged six to 17 years with severe active CD who do not respond well to conventional therapies.

This new indication for a drug already used to treat arthritis and psoriasis offers the first new biological therapy for paediatric CD to gain EU approval in five years.

It also represents AbbVie’s first UK drug launch since its split from Abbott to form a stand-alone research-based biopharmaceutical company.

CD, which affects 90,000 people in the UK, is an inflammatory bowel disorder that causes severe pain and diarrhoea. In young patients, it can inhibit growth and the onset of puberty.

Conventional treatments include hospital-based injection of corticosteroids and immunomodulator drugs. Humira can be injected by children and their families outside the hospital, allowing for more flexible treatment with less disruption.

“Paediatric Crohn’s disease is a chronic bowel disease that may have a significant impact on a child or young person,” said Dr Richard Russell, Consultant Paediatric Gastroenterologist, Royal Hospital for Sick Children, Glasgow. “For patients who do not respond to standard therapies, this new treatment option addresses a significant unmet need.”

Richard Driscoll, Chief Executive of the charity Crohn’s and Colitis UK, commented: “Paediatric Crohn’s disease is known to be increasing in frequency among children and young adults of all ages. We welcome this new treatment that is being made available in the UK, as the symptoms can be very severe and have a significant debilitating effect on the child and their family.”

AbbVie separated from Abbott in early January as a manufacturer of research-based biological medicines.

Partnership is the new black. Lonely-hearted blogger Maxine Vaccine raises the flag for life science collaboration – as long as the goal is truly mutual and not just a one-molecule stand.

Spare a thought for the pharmaceutical industry’s logo designers. A few years ago they were creating new logos like there was no tomorrow, as each merger or acquisition led to a new company name. The redesigning of wall plaques and letterheads rivalled R&D as a running cost for the industry.

Now, all the offices have white patches on the walls where the corporate logo used to be. There’s nothing there, because a biotech company has been invited to come and work with the team – and after Easter, it will be another company sitting in the same chairs and drinking coffee from the same mugs. Another month, another molecule.

We’ve gone from the harem model – one master and many brides all under the same roof – to the rapid turnover of the speed dating model. Why merge when you can partner on a contract basis, share resources for the duration of a single project, and not argue about who does the washing-up?

Is this just commitment phobia on the part of big pharma? Are those CEOs worried that raising investment will be too difficult if there isn’t a bright new partner every time? Well, yes – but it’s not that simple. It’s about the way biologics work – which is, of course, the way life works.

The role of biotechnology in drug discovery is one of the two great principles of healthcare in the 21^st century. As healthcare becomes more personalised, drugs map more closely onto the patient’s genetic and physiological make-up, and the relationship between biological processes and the drugs that protect or modify them becomes more and more that of a lock and key.

Biologics have a great history. Vaccination gained proof of concept in 1796, when Edward Jenner showed that fluid from cowpox sores could be used to inoculate people against smallpox. The first artificial vaccine (against rabies) was developed by Louis Pasteur in 1885. The first injection of an extracted human hormone, insulin, was achieved by Frederick Banting and Charles Best in 1923 – we are told that its effect on a ward of children dying from type 1 diabetes was greeted as a miracle. The first antibiotic, penicillin, was discovered by Alexander Fleming in 1928 – another medical miracle, until...

Until the overuse of broad-spectrum antibiotics in modern medicine led to the growing problem of antibiotic-resistant strains of bacteria, and a need for new and more closely targeted antibiotics. Recently, GSK’s Andrew Witty drew attention to the need for better industry collaboration to address this crucial danger. At the moment, he said, new antibiotics cannot command a huge market. But by the time there is a major unmet need, it may be too late. The solution lies in collaboration, so that the costs, risks and rewards are shared across a spectrum of life science industry stakeholders.

“We are trying to get ahead of the disaster,” said Witty. “Everybody has a concern that, one day, there might be a bug for which we don't have a drug. We don’t want that day to happen, and we need to re-double our energies, and the way to do that is to acknowledge that the market has failed.”

And there’s the second great principle of healthcare in the 21^st century.

Maxine’s views are not necessarily those of Pharmaceutical Field.

Patent applications for biologics by leading pharmaceutical companies are surging further ahead of applications for small-molecule drugs, according to a new report.

Another report notes that the next few years will offer major opportunities for pharma companies to develop biosimilars.

Both of these findings reflect the increasing importance of biotechnology in drug development.

Research by patent law specialist Withers & Rogers shows that while the number of patent applications for biologics has exceeded that for small-molecule drugs for 15 years, the gap has widened rapidly since 2007.

The legal firm’s analysis of the top 10 global pharma companies reveals that the gap between the numbers of patents filed for biologics and for small molecules grew by 14.5% between 2007 and 2009.

By 2009, 60% of the drug patents filed by these companies were for biologics.

Novartis made the greatest number of patent applications for biologics in 2009, followed by Johnson & Johnson and Merck & Co.

Nicholas Jones, patent attorney at Withers & Rogers, said that despite the impact of “economic uncertainty and cost pressures facing big pharma as blockbuster drugs hit the patent cliff, R&D interest in biologics has remained strong.”

He noted although “it is considerably easier to develop and manufacture small-molecule drugs”, major drug companies may be “increasingly willing to compete with major generics producers for a share of the follow-on biologics market”.

Growth partnership company Frost & Sullivan (F&S) reached the same conclusion in a report on the growing opportunity for biosimilars in the European drug market, where numerous blockbuster biologics are nearing the patent cliff.

However, the report noted, the cost of developing and manufacturing biosimilars makes them financially a more high-risk option than conventional generics.

Srinivas Sashidhar, Research Analyst at F&S, said: “$100 billion worth biologics are expected to go off patent by 2020, as a result of which the market is likely to hold significant potential.”

Before this potential can be exploited, he commented, “Improvements concerning the manufacturing and the clinical development processes of biosimilars have to take place.”

The report predicted the European biosimilars market will grow from $172m in 2010 to $3,987 in 2017, at a CAGR of 56.7%.

To overcome the challenges in the way of access to the growing biosimilars market, Sashidhar said, “Collaborations among large pharmaceutical companies with financial capabilities and specialty biotech companies with technical expertise are expected. The strong integration of marketing and research and development skills is the key to success in the biosimilars market.”

F&S expects the growing biosimilars market to drive growth in such therapy areas as diabetes and oncology, where biologics are having the greatest impact.

European pharmaceutical group Mundipharma has appointed Paul Medeiros as Head of Corporate and Business Development.

Medeiros, who joins the group from AVI BioPharma, will join the executive leadership team and be responsible for extending and expanding areas for growth.

Based in the UK, Mundipharma is a network of companies across 32 European countries, including Napp in the UK.

Medeiros was previously Senior VP and Chief Business Officer at AVI BioPharma, a specialist in RNA-based drugs for rare diseases.

Over 19 years in the biopharmaceutical industry, Medeiros has also been VP of Global Licensing and Strategic Alliances for Schering-Plough and held several roles in sales and marketing at Merck & Co.

His experience includes licensing and strategic partnering initiatives in specialist therapy areas.

Antony Mattessich, Regional Director, Mundipharma Europe, said: “Paul’s deep experience and network in the pharma industry, combined with his entrepreneurial mind-set and nuanced understanding of the business, will be essential for Mundipharma’s continued growth.”

Boehringer Ingelheim plans to invest €17 million in its biopharmaceutical drug development and manufacturing capabilities in Europe.

The expansion of its facilities in Biberach, Germany, and Vienna, Austria, will reinforce Boehringer’s position as the industry’s leading contract manufacturer.

By investing in cell culture and microbial technologies for drug development, Boehringer will also strengthen its relationship with the biotech sector.

The new investment follows years of building the company’s capacity for contract manufacture of biopharmaceuticals through its cell culture facilities in Biberach and its microbial fermentation facility in Vienna.

The money will cover cell line and microbial strain development, as well as process development in contract drug manufacturing, and will be used to expand Boehringer’s Good Manufacturing Practice capabilities in these areas.

At the Biberach site, the investment will support the company’s ‘Lean to Clinic’ programme for monoclonal antibody projects, aiming to deliver drug candidates ready for clinical testing within 13 months.

At the Vienna site, it will advance Boehringer’s proprietary technologies, including its plasmid DNA manufacturing platform and its biotech collaborations with Pfenex and VTU Technology.

“The expansion has been tailor-suited to fully meet our customer demands in cell culture and microbial process science, especially for our rapidly expanding preclinical project portfolio with biotech companies,” said Dr Dorothee Ambrosius, Boehringer’s Senior VP for Biopharmaceuticals Global Process Science.

“This is another milestone within our contract manufacturing strategy, securing technology leadership and towards increased flexibility and customer orientation.”

Boehringer accounts for 23% of contract manufacturing capacity in the global biopharmaceuticals sector.

Bioscience holds out the prospect of medical breakthroughs that can transform our lives – but it has to contend with traditional fears about ‘interfering with nature’. Maxine Vaccine asks whether fear itself might not be the greatest danger.

Everybody’s talking about biotechnology and its implications for medicine. Even the UK Government, hardly the brightest light on the Christmas tree, recently identified stratified medicine as a crucial area for medical innovation. The idea that drugs can be tailored to the specific genetic characteristics of a patient group is powerful and opens up a new vision of ‘personalised medicine’.

But with that comes the familiar fear among doctors and patients that the new therapies are ‘interfering with nature’. It’s a fear that runs through the history of medicine. Before the invention of the microscope, some doctors who argued that diseases could be spread by ‘germs’ were hounded out of their profession. Body fluids are ‘natural’ – how could they possibly pose a danger? The argument ‘it’s not natural’ has been used against hygiene, antiseptics, antibiotics, vaccines, transplants, transfusions, hormonal treatments...

But that’s all long in the past, you might say. These days we’re enlightened, we have evidence, we don’t listen to superstition. Well... maybe. Back in 1998 a doctor fabricated evidence that the MMR vaccine caused autism. He has now been convicted of fraud, but thousands of doctors believed him. Only this year, a critical analysis of the Million Woman Study by scientists who are not clinicians concluded that it had failed to prove a causal link between hormone replacement therapy (HRT) and increased risk of breast cancer – a causal link that had been broadly accepted by the medical profession across Europe and the USA, despite the persistent voices of a sceptical minority.

Is it just possible that where biopharmaceuticals are concerned, a significant proportion of clinicians are primed to believe scare stories because, at a deep level, they suspect that such therapies are ‘against nature’? Where HRT was concerned, after all, many thousands of women had been enabled to continue successful midlife careers without being nudged by the menopause and its traumatic sequels into early retirement. How could that be right?

Many people – and doctors are not only not immune to this, they may be more prone to it than patients – are driven by an uncritical reverence for ‘nature’s way’ to fear and resist the changes we can make to our own lives as our scientific knowledge develops. The recent decision of a European court to deny patents to medical therapies developed from stem cell research shows that the power of fear is still sometimes greater than the will to heal.

Of course there are valid fears about potential harm arising from science and technology. But the danger lies in the abuse of scientific knowledge for purposes of exploitation and social control. Where valid questions need to be asked about the ethics of medical science, those are not questions about the dangers of scientific knowledge. They are questions about us.

The CHMP has recommended Astellas Pharma and Optimer Pharmaceuticals’ Dificlir (fidaxomicin) to treat adults with colon disease.

The drug specifically targets the bacteria causing the infection in the colon whilst avoiding ‘friendly’ bacteria in the gut of patients with the disease, which is also known as Clostridium difficile-associated diarrhoea (CDAD).

Ken Jones, President and CEO of Astellas Pharma Europe, said: “European patients with this potentially fatal disease can take encouragement from the positive CHMP opinion for Dificlir that a new medication for clostridium difficile infection may soon be available.”

Dificlir’s active substance is fidaxomicin, which belongs to the macrocyclic class of antibacterials and inhibits RNA synthesis by bacterial RNA polymerase.

Dr Xavier Luria, Head of Safety and Efficacy at the EMA, said: “This is a promising step forward in the Agency's drive for addressing patients' needs in infectious diseases.”

The positive opinion is based on Phase III clinical research data comparing fidaxomicin with oral vancomycin on patients in the US and Canada. Results of the studies showed that clinical cure was achieved at the end of ten days of treatment with both treatments. Furthermore, fidaxomicin had a significantly lower rate of recurrence of CDI compared to vancomycin.

Dificlir, known as Dificid in the US, was approved by the FDA in May for the treatment of CDAD in adults.

The European Commission will deliver its final decision within three months.

CDI is a serious illness resulting from infection of the internal lining of the colon by C. difficile bacteria. The bacteria produce toxins that cause inflammation of the colon, diarrhoea and, in some cases, death.

UK-based Astellas Pharma Europe manufactures and distributes pharmaceuticals globally with the intention to improve lives through the introduction of innovative and reliable pharmaceutical products.

Optimer Pharmaceuticals, is a biopharmaceutical company focused on developing and commercialising hospital specialty products to treat serious infections and address unmet medical needs.

Ipsen has filled all the positions in the Group’s Executive Committee after making two new appointments.

Nathalie Joannes has been appointed Executive Vice President, General Counsel, and Susheel Surpal has joined as Executive Vice President, Chief Financial Officer.

Mr Surpal had been a member of the Executive Committee and Financial Director of LABCO since 2009 and will commence his new role in the coming weeks. Nathalie Joannes joins from Genzyme where she served as Senior Vice President and Chief European Counsel for the past three years. She will begin her role on 1st October 2011.

The company has also entered into a strategic partnership agreement with Inspiration Biopharmaceuticals to launch Inspiration’s haemophilia product portfolio in Europe.

Inspiration aims to file a Marketing Authorisation Application with the EMA for its intravenous recombinant factor IX, IB1001, for the treatment and prevention of bleeding in individuals with haemophilia B by the end of this year.

AstraZeneca’s cardiovascular-friendly drug, Axanum, has been approved for use in 23 EU countries and Norway.

The once-daily medicine is a combination of low-dose ASA (aspirin) and esomeprazole, indicated for prevention of cardiovascular (CV) events in high-risk patients who are likely to develop gastric ulcers.

Tony Zook, Executive Vice President of AstraZeneca’s Global Commercial Organisation says the company is pleased the drug has joined the “significant regulatory approvals” the company has had recently.

Unlike generic aspirin medicines, Axanum can protect patients against gastric ulcers. Esomeprazole is an active ingredient which reduces the risk of peptic ulcer development and is the only proton pump inhibitor (PPI) approved to reduce the risk of re-bleeding in peptic ulcer bleed patients.

AstraZeneca is a global biopharmaceutical company which develops and commercialises prescription medicines for gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious diseases.