Steve Turley, Managing Director of Lundbeck, has been re-elected Chair of the European Medicines Group (EMG), the UK voice of pharmaceutical companies based in continental Europe.

Robin Bhattacherjee, General Manager of Actelion, was re-elected vice-Chair of the EMG; and Mike Sumpter, CEO of Servier Laboratories, was elected Treasurer.

Issues highlighted at the EMG’s twelfth AGM included the impact of NHS reform on European-based companies and European perceptions of the UK as a pharmaceutical market and research base.

The EMG’s 15 member companies are Actelion, Almirall, Bayer, Boehringer Ingelheim, Ferring, Lundbeck, Menarini, Merck Serono, Norgine, Novartis, Novo Nordisk, Roche, Sanofi, Servier and UCB.

Steve Turley (pictured) commented: “We have members ranging from the UK’s biggest pharmaceutical companies, through biotechnology specialists to emerging organisations. Yet we all share common challenges and can benefit from being able to view these through a European-focused lens.”

“How the implementation of the NHS reforms affects European-based companies is a key issue this year,” noted Robin Bhattacherjee.

“Upwards of 60% of the medicines our members have introduced in the last decade have not been subject to a NICE health technology appraisal, so... local decision making in the CCGs about the use of these remains a major focus for EMG.”

Mike Sumpter noted: “Globally the UK is viewed as a tough market where innovative new medicines aren’t adopted as readily as similar economies.

“We want to work closely with our NHS stakeholder partners to demonstrate that the UK and the NHS is worth investing in.”

Lundbeck is based in Denmark, Actelion in Switzerland and Servier in France; all three companies have major UK operations.

Novo Nordisk, the world’s leading supplier of medicines for diabetes care, has joined the ABPI for the first time.

The decision reflects the Danish company’s growing involvement in the UK health market, where the importance of diabetes care is growing rapidly.

It also reflects the increased profile of the ABPI in negotiations affecting the UK pharmaceutical industry, including the adoption of value-based pricing for drugs.

Novo Nordisk recently launched a new basal insulin, Tresiba, in the UK and celebrated 90 years in the diabetes care market.

Peter Meeus, UK General Manager of Novo Nordisk, commented: “As a growing player in the UK pharmaceutical market, we felt the time was right to join the ABPI. The ABPI has undergone real transformation in recent years and we are confident that as our business continues to grow in the UK, ABPI engagement will complement what we are doing to ensure we are better positioned to face the challenges and the opportunities in an increasingly dynamic business setting.”

“Novo Nordisk is a very welcome and important addition to our membership and will further strengthen the ABPI as the voice of the pharmaceutical industry,” said Stephen Whitehead, ABPI Chief Executive.

“We will be looking to support them and our wider membership to ensure that once a medicine has been approved for use in the UK, the NHS is able to adopt it and patients can fully realise its benefits.”

Novo Nordisk has launched Tresiba (insulin degludec), a new basal insulin for adults with type 1 or type 2 diabetes, in the UK.

Tresiba controls HbA1c levels as effectively as the standard basal insulin Lantus (insulin glargine) while posing less risk of nocturnal hypoglycaemic episodes.

It is also the first basal insulin to allow flexibility in injection time, as it has a 42-hour action, requiring only a minimum of 8 hours between injections.

Compared to Sanofi’s Lantus, Tresiba has been shown to reduce the incidence of nocturnal hypoglycaemia in patients with type 1 diabetes by 25%, and in insulin-naive patients with type 2 diabetes by 36%.

The overall rate of hypoglycaemia was similar for both types of insulin – but nocturnal episodes are particularly dangerous because they are harder to treat. Severe hypoglycaemic episodes are estimated to be responsible for 6% of deaths in people with diabetes under the age of 40, and half of such episodes take place at night.

Professor Melanie J Davies, Professor of Diabetes Medicine, University of Leicester, said: “Many of my patients have difficulty taking their insulin at exactly the same time each day, for reasons which we can all sympathise with and understand. For example, picking children up from school or working irregular shifts at work.

“It is thus very useful that there is now an insulin which, because of its longer duration of action, is able to offer patients a bit more flexibility in terms of timing of their dose without compromising either their glycaemic control or risk of hypoglycaemia.”

Tresiba is available in two FlexTouch pens: FlexTouch U100 (1–80 units per dose) and FlexTouch U200 (2–160 units per dose).

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.

As the incidence of diabetes in the UK soars, the austerity NHS is increasingly unable to meet the needs of patients with this complex and lethal disease. How can the pharmaceutical industry help the situation?

Blindness. Foot and leg amputation. Kidney failure. These are among the complications of diabetes, a complex metabolic disorder that is now the leading health challenge facing western society.
In diabetes the absorption of glucose (sugar) from the blood fails, causing it to accumulate in the circulatory system. This occurs either because the pancreas stops producing the hormone insulin (type 1 diabetes) or because insulin production is inadequate or the body’s response to it is poor (type 2 diabetes).
Both types of diabetes have genetic risk factors, but type 2 or ‘mature onset’ diabetes has other risk factors such as age, obesity and lack of exercise. Type 1 or ‘juvenile onset’ diabetes is fatal unless the missing insulin is replaced by injection. In type 2 diabetes, a range of medications such as metformin can be used to improve glucose uptake.

The number of people diagnosed with diabetes in the UK has increased from 1.4 million in 1996 to 2.9 million in 2012, and continues to rise, with type 1 diabetes now accounting for only 10% of the total. The prevalence of type 2 diabetes has risen sharply, due to the ageing population and the trend towards obesity.

There is no cure for diabetes. A range of medications exist to treat it, but establishing the correct dosage levels is not easy: only an estimated 6% of diabetes patients get the balance right. Since no medication can make diabetes go away, the condition demands constant monitoring and medication adjustment, as well as checks for complications.

And at a time of deepening austerity in NHS funding, that level of attention to patient needs is getting harder to afford. All the signs are that people with diabetes (especially the more high-maintenance type 1) in the UK are at increasing risk of disabling or fatal complications. Sugar is killing more of us all the time.

High and dry
In November 2012, the Public Accounts Committee observed that diabetes care in England was “depressingly poor”, with 24,000 preventable deaths from the disease happening each year. The report pointed to a lack of clinical leadership and a ‘postcode lottery’ in diabetes care.

Barabara Young, Chief Executive of charity Diabetes UK, commented: “Given all the increasingly strong evidence of inadequate care, we simply cannot understand why the NHS has sleepwalked into this situation.”

During 2012, Diabetes UK drew attention to the need for better access to diagnostics, more referrals to specialist care, and wider awareness of the role of healthy lifestyle in preventing and controlling diabetes.
In April 2012, Young noted that 80% of NHS spending on diabetes care went on treating preventable complications. In May 2012, Diabetes UK stated that diabetes care in England was in a “state of crisis” with fewer than half of patients receiving adequate care.

Yet the medicines and diagnostics exist to reduce the incidence of diabetes, manage the condition and avoid complications. It’s not rocket science. What has gone wrong – and what is the solution?

A preventable crisis
Tracy Kelly, Head of Care at Diabetes UK, spoke to Pf about the problems of diabetes care. For the patient, she said, “Optimal diabetes control requires dedication and motivation from the individual to test, inject or take medication, adjust their dietary intake, potentially make lifestyle changes, monitor their condition and ensure they are receiving their health checks.”

This puts the patient under intense pressure, especially if they have other chronic conditions. How can the pharmaceutical industry help? In three ways, Kelly said: “Better provision of information and education for people with diabetes and for the healthcare professionals; commitment to research into new and improved treatments and monitoring approaches; and bridging the gap in healthcare services by supporting specialist nurses and dieticians in hospitals, for example with pump training and starting on insulin.”
Importantly, Kelly noted, the agendas of drug treatment and lifestyle change are not opposed: “There should always be a dual approach.” In treating both types of diabetes, clinicians need to look for the optimum blend of medication and lifestyle factors for each patient. The NHS needs to deliver programmes of risk assessment and early diagnosis; offer effective education in self-care for all patients; and ensure that they receive the nine regular checks recommended by NICE.

Working together
Successful diabetes care depends on integrating primary and specialist care, Kelly emphasised. “Effective diabetes care can only be achieved through integration. There must be clear referral plans in place and transparency about who does what and where specialist diabetes care is required. Specialist teams also have a key role to play in educating and supporting primary care.”

Cutting down on GP referrals is a growing NHS trend, praised by David Nicholson in his 2012 NHS review and promised in many CCG commissioning plans. Does this pose a threat to diabetes care? Kelly’s response was clear: “Cutting down referrals to specialist care may increase the risk of complications and could result in increasing costs to the health system. Diabetes is complex and any blanket rules to cut referrals could put lives at risk over the long term.”

For patients with type 1 diabetes, in particular, referral management is a recipe for trouble: “We know it is important for people with type 1 to have access to a team of specialists such as a dietician, podiatrist and counsellor. But often their access to this kind of support only comes once complications have developed.”
In short, drug manufacturers and healthcare providers can work together to support patients in avoiding complications – but clumsy cost-driven applications of QIPP are tending to disable care.

The hidden disease
As Louis MacNeice said, the North begins inside. Danish pharmaceutical company Novo Nordisk has specialised in diabetes care since its launch in 1923. Its insulin products (used by many type 2 as well as type 1 patients) are the standard of care in the UK. The company’s CEO, Lars Sorensen, recently observed: “What we are good at, all of a sudden becomes the biggest public health problem we have ever seen.”
Peter Meeus, Vice President, Novo Nordisk UK and Ireland, spoke to Pf about the company’s role in meeting the diabetes challenge. He noted that according to the National Diabetes Audit, only half of diagnosed patients in the UK are achieving treatment targets, while fewer than half of all people with diabetes receive all nine recommended healthcare checks.

Too often, Meeus noted, diabetes is only detected when secondary complications arise such as retinopathy and foot ulcers. Insulin can be the most effective treatment, but fear of injecting is sometimes a barrier to its adoption. As a result, “many patients start on insulin too late and are therefore at risk for developing serious late complications”. This is unfortunate, as the needles used today are much thinner and less painful.

Shot in the dark
According to Meeus, the pharmaceutical industry can help the NHS meet the challenge of diabetes by helping to identify the high proportion of diabetes patients who are poorly controlled, and to ensure these patients achieve control within the national guidelines.

He added: “Novo Nordisk is working with the DH and local health economies, together with physicians, to deliver agreed diabetes health outcomes at both national and local level, using appropriate innovative medicinal interventions as well as service design and support.” Specifically, the company provides Diabetes Education Nurse Facilitators to primary and secondary care organisations where needed, and its local Diabetes Outcomes Directors work to assist the redesign of diabetes services.

The company may owe its current growth in part to the growing incidence of diabetes, Meeus said, but its depth of experience in this therapy area has enabled it to take advantage of the opportunities: “Innovation and science have always been at the core of Novo Nordisk’s business, and as a result we today have the broadest portfolio of R&D diabetes projects. At a time when others in the pharmaceutical industry are cutting R&D budgets, we’re increasing our investment.”

“The challenge going forward,” he concluded, “is the fact that diabetes today is the biggest problem for healthcare systems, but at the same time the healthcare budgets are under increased pressure.” Diabetes UK and millions of patients would agree. But where there’s a will, there’s (sometimes) a way.

Novo Nordisk has partnered with sporting organisations to launch a global sports team with more than 100 cyclists and athletes, all of whom have diabetes.

Team Novo Nordisk will compete in more than 500 sporting events worldwide in 2013, promoting effective diabetes control as a road to health and success.

The global team comprises cyclists, runners and triathletes, including the world’s first all-diabetic professional men’s cycling team.

The cyclists will compete in the USA Pro Cycling Challenge, the Tour of Britain and the Paris-Tours, with the goal of qualifying for the Tour de France.

“We stand for what life with diabetes can be like,” said Phil Southerland, founder of Team Novo Nordisk. “Exercise is that billion-dollar drug that nobody ever gets prescribed, and in my experience is the best of them all.”

Jakob Riis, Novo Nordisk’s Senior Vice President, Global Marketing and Global Medical Affairs, commented: “As part of our long-standing Changing Diabetes programme, this partnership provides a tremendous opportunity to raise awareness, and educate, empower and inspire people with diabetes.”

Changing Diabetes is Novo Nordisk’s global advocacy and partner platform, working to promote the prevention and early diagnosis of diabetes, as well as more effective treatment and care.

The Danish company has specialised in the treatment of diabetes for nearly 90 years, but only in the last decade has it seen the disease area become the developed world’s leading health issue.

Major pharma companies are paying multi-million dollar fines for alleged bribery in emerging markets, but these markets remain highly profitable.

Recent payments by Pfizer ($60m) and Johnson & Johnson ($70m) to settle charges under the Foreign Corrupt Practices Act (FCPA) represent only a small fraction of their revenue from the countries where the alleged offences took place.

However, steep increases in FCPA fines have been threatened if evidence suggests that pharma corporations regard them as a manageable cost.

Comparable European legislation, such as the Bribery Act in the UK, is tightening the net around overseas sales operations that pander to a culture of ‘goodwill’ gifts and other inducements.

Pfizer’s income from emerging markets is predicted to reach $10bn, while J&J has reported $6.5bn sales in Brazil, Russia, India and China.

Global Data analyst Michael Leibfried said: “The $60 million fine for Pfizer to a lay person sounds like quite a bit of money, but in perspective it took less than two days of Lipitor sales during its peak. It’s really just chump change for them.”

However, according to Kara Brockmeyer, chief of FCPA investigations within the Securities and Exchange Commission, no FCPA prosecution has so far needed to be repeated.

“I would hate to think the companies view enforcement actions as the cost of doing business,” she commented. “If we find that out, it will certainly increase the size of the penalty.”

In relation to the Pfizer settlement, she noted that a number of the company’s overseas subsidiaries “had bribery entwined in their sales culture”. Pfizer has since introduced an anti-corruption audit programme.

Novo Nordisk and Teva have also undergone FCPA investigations, with Latin American markets being a particular focus.

CSO solutions and specialist recruitment service provider CHASE has added two new members of staff to its senior management team.

The experienced Graham Hawthorn (pictured right) has been appointed alongside Simon Couldstone (pictured left) – who joined at the turn of the year from The MSI Consultancy.

Both have a number of years’ experience working within the pharmaceutical industry.

Simon, who initially joined the industry on a contract with CHASE in 2001, has worked at Novo Nordisk and Bristol-Myers Squibb obtaining extensive sales and marketing experience.

Graham Hawthorn also boasts more than 15 years of experience within a variety of operational and business development positions at companies including IHS and Quintiles/Royce.

Major pharmaceutical companies are in discussion with European authorities to develop an emergency plan to maintain medicine supplies to Greece.

The country’s potential exit from the euro threatens the continuity of drug reimbursement and supply to patients.

An agreed solution may involve delays in payment for critical medicines to ensure short-term supplies during a phase of greater economic disruption.

Greece imports all of its medicines, relying heavily on branded products from European companies including AstraZeneca, GSK, Novartis and Roche.

Drug suppliers are already owed €1.21bn by Greek state hospitals, and their approaches to the crisis vary: Novo Nordisk is demanding immediate payment, but GSK is not; Roche is supplying only to pharmacies, not to public hospitals.

Shortage of drug supplies is already affecting many Greek patients.

The industry’s strategy may have wider implications as the economic crisis spreads across the EU, with Spain, Ireland and other countries facing similar breakdowns in drug import trade.

Pfizer’s Robert Clarke will leave his role as US regulatory strategy head to join Novo Nordisk in a similar position.

Mr Clarke will join Novo on 14 May to lead the Danish-based pharma company’s US regulatory team.

Anne Philips, Corporate Vice President of Clinical Development, Medical and Regulatory Affairs at Novo Nordisk, said the new recruit’s “know-how” is required by the diabetes specialist.

He will be tasked with maintaining relationships with key stakeholders and agencies that play a specific role in the FDA’s review and approval process.

“Bob is bringing 27 years of experience and knowledge of the global and US regulatory environment, and it’s that know-how we require for an increasingly complex pharmaceutical marketplace,” said Anne Philips.

“Novo Nordisk has one of the most promising diabetes pipelines in the industry, and having a respected leader known to regulatory authorities will help us achieve our ongoing mission to bring new therapies to patients.”