The first and only C1 inhibitor approved for use in adults and adolescents in the UK with the rare and life threatening genetic disorder, hereditary angioedema (HAE), has been launched.

ViroPharma’s Cinryze (C1 inhibitor [human]) is a new treatment option which has demonstrated in Phase III pivotal trials to significantly reduce the duration and frequency of HAE attacks.

Dr Hilary Longhurst, Consultant Immunologist and Clinical Lead at Bart’s and the London Children’s Hospital, says the availability of Cinryze provides “another important therapeutic option”.

HAE is a rare, debilitating and potentially life-threatening genetic disorder affecting around 10,000 people across Europe. It’s estimated there are around 1,850 cases in the UK.

People living with the disorder suffer from recurrent and disabling attacks of swelling that may affect the larynx, abdomen, face, extremities and urogenital tract.

Cinryze is the first and only C1 inhibitor approved for use in the UK for the prevention of angioedema attacks in patients with severe and reoccurring HAE who are intolerant to or insufficiently protected by oral treatments, or in patients who are inadequately managed with repeat acute treatment.

Eligible patients are able to self-administer the treatment, giving doctors and patients convenience and the ability to better manage the condition.

“We are excited to offer the only C1 inhibitor approved in the UK with a label that includes routine prevention of attacks, in addition to treating the attacks as they occur,” said Matt Mason, ViroPharma’s General Manager, UK and Ireland. “We will be working closely with physicians to help and support patients through prevention and treatment of their HAE attacks.”

Eli Lilly has launched a new global innovation initiative to help increase the speed of delivery of new medicines to patients.

Innovation Starts Here will see scientists from the Lilly Research Awards Program and the Lilly Innovation Fellowship Awards collaborate with researchers to aid the advancement of its pipeline.

Dr Jan Lundberg, Executive Vice President, Science and Technology, and President, Lilly Research Laboratories, says the initiative is “contributing to a global collaborative culture for idea generation and innovation”.

Lilly’s new innovation awards scheme will foster post-doctoral career development through specifically selected research proposals. The programme has been created to broaden the company’s scientists’ training experience in preparation for a range of future careers.

The research awards programme aims to bring together specialists in an effort to further advance research in important therapeutic areas such as neuroscience, cancer, diabetes, immune system disorders and others. The scheme was established towards the end of 2011 to complement collaborations between Lilly scientists and global external academics.

“Collaboration is a key component to discovering innovative medicines and improving outcomes for patients,” said Dr Lundberg. “Finding innovative medicines that have clear, demonstrable value for those diseases where the unmet need is great – like diabetes and Alzheimer's disease – is not only a scientific imperative, it’s an economic one as well.”

Lilly hopes the important programmes will also further its own R&D in Europe, as well as the US.

Last year, the company’s global investments in R&D totalled more than $5 billion. It has also doubled its R&D investments in Europe over the past decade. Recent initiatives in Europe include multiple clinical trials, involvement in the Innovative Medicines Initiative, the creation of Cognitive Neuroscience and plans to open a new building at its Erl Wood Research Centre in the UK.

The chair of Tower Hamlets Clinical Commissioning Group, Sam Everington, has written to David Cameron calling for him to withdraw the controversial Health and Social Care Bill.

Mr Everington claims that local commissioning decisions already take place within his area and “an act of Parliament is not needed to make this happen” throughout the country.

In the letter posted on the internet, he said his CCG shares the concerns of the Royal College of General Practitioners and the British Medical Association in opposing the Bill.

“The Board of NHS Tower Hamlets Clinical Commissioning Group ask you to reflect and to withdraw the Health and Social Care Bill,” he said.

“Supporting improvements in the quality of patient care is our passion and focus. We support a strong role for clinical involvement in commissioning decisions that lead to better health outcomes for our patients. We do this already in Tower Hamlets.

“Tower Hamlets primary care team has a long tradition and reputation for innovation and commitment to partnership working with patients and managers. We make the best of any challenges that come our way. Innovations include real improvements in the health of our patients with chronic illnesses like diabetes, the highest childhood vaccination rates in London, and an exemplary local out of hours service, delivered by our GPs and highly valued by patients.”

Mr Everington added that his CCG already works in partnership with the local community and health services “to improve and integrate services for the benefit of our patients”. The GP said that it was “against this background that we represent the views of our local GPs in asking you to withdraw the Bill”.

“Clinicians, patients and managers in Tower Hamlets are determined to improve health and well-being, but your rolling restructuring of the NHS compromises our ability to focus on what really counts – improving quality of services for patients, and ensuring value for money during a period of financial restraint,” he said.

“We care deeply about the patients that we see every day and we believe the improvements we all want to see in the NHS can be achieved without the bureaucracy generated by the Bill.”

The discovery of fake vials of cancer drug Avastin in the US has prompted a call by The Lancet for stronger international laws against counterfeiting.

The counterfeit vials of the Roche drug, distributed in the US medical system, contained various laboratory chemicals but no pharmaceuticals.

The case has revealed a complex supply chain involving wholesalers in the UK, Denmark and Switzerland, with a possible source in Egypt or Turkey.

According to the International Journal of Clinical Practice, such global supply chains have resulted in worldwide sales of counterfeit medications doubling between 2005 and 2010 to $75bn.

The Lancet has called for “a binding, international standard for criminalising the manufacture and distribution” of counterfeit drugs to be launched by the WHO and backed up with stronger regulatory oversight and control.

The MHRA, which is participating in the investigation, commented that the counterfeit vials had “incorrect expiry dates and fake batch numbers”.

The manufacture of the fake Avastin was not sophisticated: several organic chemicals were included, but no active pharmaceutical ingredients.

The opportunity for concealment lay in the existing global supply chain. MHRA has stated that the vials were supplied to the US market via a UK wholesaler, buying from a Danish wholesaler, buying from a Swiss wholesaler.

Beyond that, it has been claimed, there may have been an Egyptian supplier and possibly a Turkish source of the vials.

The case reflects the growing risk of counterfeiting to high-cost injectable drugs as well as to oral medications.

Three NHS Centres of Excellence for the diagnosis and treatment of Behçet’s Disease (BD), a rare immune disorder, will be commissioned in April 2012.

The centres, located at Bart’s and the London Hospital, Birmingham City Hospital and Aintree University Hospital in Liverpool, will centralise drug budgets and co-ordinate treatment for the condition nationwide.

While fewer than 1,000 people in the UK suffer from BD, the new centres will provide a model for the treatment of rare diseases through multi-drug therapy.

The contract follows a successful bid by the Behçet’s Syndrome Society together with multi-disciplinary clinical teams from each hospital.

Behçet’s (pronounced Betjets) Disease is a chronic condition caused by disturbances in the immune system. Common symptoms include headaches, mouth and genital ulcers, eye inflammation and arthritis.

Symptomatic BD-related therapies include analgesics, topical steroids, NSAIDs and beta-blockers. Systemic therapies include immunosuppressants and cytotoxic drugs, as well as new biologic agents.

The centralisation of the drug budget for BD patients will ensure timely access to high-cost drugs. The centres will also provide a platform for research into new therapies for the condition.

Professor Robert J. Moots, who will lead the Liverpool centre, commented: “As cure is currently not possible, the strategy for treating BD today is to suppress disease activity as much as possible without the patients paying the price of unacceptable side-effects. This means the doctor choosing from a wide armamentarium of drugs, to tailor therapy at the right time to the right person.

“It is essential that such treatment is led by a specialist with expertise not only in BD, but also in the delivery of such medications – and often, the best care is provided by a team of specialists who are each able to bring their particular expertise with the patient at the centre.”

Pf Editor, Chris Ross, asks who pharma’s customers really are as the NHS reforms continue to progress.

The journey towards NHS reform was always likely to be a long and painful one for the coalition government – but, as opposition to the Health & Social Care Bill grows stronger by the day, it’s becoming increasingly difficult to predict where the journey will end. At present, Royal Assent seems many miles away.

But despite the fierce political and ideological objections to the proposals, in many parts of the country the NHS has already ventured some way along the roadmap to reorganisation. Embryonic Clinical Commissioning Groups are steadily establishing themselves across England, and the transfer of powers from PCTs to the new commissioning organisations is well underway. It is likely to prove costly for NHS productivity and patient care if the journey to reform finds itself at a dead end and the Kill the Bill movement finally succeeds.

Whatever happens in the coming weeks and months, the ramifications for the pharmaceutical industry have already been significant. Since the introduction of PCOs, PCGs, PCTs and, of course, NICE in the early 2000s, UK pharma companies have spent the best part of a decade trying to establish exactly who their customers are and realigning their sales and marketing efforts accordingly. During that time, it’s become increasingly clear that a one-size-fits-all solution to customer segmentation will not work, and that the identity of so-called ‘key accounts’ will vary from region to region, and disease area to disease area. In such a dynamic and fast-moving environment, the work of field-based medical sales professionals becomes ever more important. The role of the rep may have been redefined in the past ten years, but while numbers on the ground have dropped significantly, their value to UK pharma in a changing marketplace has only increased.

Chris Ross, Editor.

UK pharma companies are not doing enough to help medical sales professionals succeed in the modern environment, new qualitative research has shown.

The study, designed to understand the real world challenges of field-based executives, indicates that the working practices of UK pharma sales executives have changed dramatically in the past three years.

The combination of a maturing KAM model, the emergence of joint working and an increasing reliance on iPad technology, is driving a radical shift in the NHS/pharma relationship – and is forcing medical representatives to develop new skills to thrive in the new environment.

But many sales professionals claim that they have been given inadequate support to help them prosper in an evolving marketplace, and that some employers remain reliant upon traditional training methodologies to see them through, despite rhetoric to the contrary.

The findings are the result of the first phase of an ongoing research exercise by Pharmaceutical Field, and follow a series of one-to-one interviews and roundtable discussions with existing sales professionals in the first two months of 2012. “Early indications, from what will be a sustained research programme throughout 2012, are that, across the board, the role of the medical sales professional has evolved considerably,” says Chris Ross, Editor of Pharmaceutical Field. “In 2008, when we conducted a similar exercise, whilst the term Key Account Management was beginning to gain traction, the concept of joint working with the NHS barely merited a mention. But it would seem that both aspects are now playing a central role in the day-to-day work of the medical representative. The problem is, too many argue that the training they are given to manage relationships with their local health economies – and indeed the metrics upon which they are judged – mirrors that of the traditional drugs rep. And when it comes to joint working, the majority of respondents are describing confusion on both sides of the NHS/pharma equation. The industry clearly has work to do in this regard.”

The 2010 launch of the iPad, along with the subsequent introduction of similar mobile devices, has revolutionised customer communications for many industries – and it would appear that pharma is also beginning to enjoy the benefits of digital technologies, albeit slowly. It is estimated that around 25% of UK medical sales professionals are now using iPad or equivalent to detail their products to customers – and this is very much in line with Pf’s research. A fifth of those canvassed have been issued with mobile devices and are using them with customers. Feedback suggests that HCPs find multimedia presentations more engaging and memorable. One regional account manager, from a medium-sized UK pharma company, said: “Gaining time with customers remains one of our biggest challenges, and it’s not unusual to be given just a few minutes in a corridor or a hospital canteen. Making the most of that time is imperative. We’re finding that detailing our products via the iPad has a much greater impact than printed leave-pieces, and the customer experience is significantly improved.”

Despite this, representatives from some of the smaller pharmaceutical companies that have taken part in the study still appear to be using traditional detail aids – and believe that it will take some time before the use of tablet devices in the field reaches a critical mass.

The Pf study also indicated an increasing number of medical sales professionals are choosing to work on contract, rather than on headcount at mainstream pharmaceutical companies – with job security cited as one of the key factors.