DuoCap, manufactured by Encap Drug Delivery, is an oral unit that consists of a capsule inside another capsule which offers various therapeutic applications.

The capsules may contain the same active drug offering a multiple release unit or combine different actives that are incompatible.

Already used by GSK and AstraZeneca, it’s said to have ‘huge potential’ for pharmaceutical active agents requiring controlled release.

The inner capsule can contain liquid, semi-solid, powder or pellet formations. The outer shell can also house liquid or semi-solid formulations.

Further options are also available in the capsule’s lining. It can be coated either with enteric systems or with Encap’s colonic delivery system, ENCODE.

Protection for clients interested in the line-extension formulations for drugs coming to the end of their patent is also provided by DuoCap. The opportunity to license a patent-protected technology on a product-by-product basis is also available.

Sales & Marketing Director Dr Robbie Stewart welcomed the patent and highlighted its future capabilities.

“Encap is able to manufacture DuoCap for clinical or proof-of-concept studies right through to full-scale commercial volumes,” he said.

The Committee for Medicinal Products for Human Use (CHMP) has given the green light for an expanded license.

GlaxoSmithKline said it was “very glad” and welcomed the decision by the EMA.

The application was based around results from the CALISTO study, which GSK claims shows the first clinical effect with an anticoagulant versus placebo.

“SVT is a condition that can lead to serious and even life-threatening complications,” said Dr. Tony Hoos, Senior Vice President for European Medical Affairs at GSK. “We expect that fondaparinux will be an important option for the treatment of SVT.”

Fondaprinux is already indicated in the EU for the prevention of venous thromboembolic events (VTE), initial treatment of acute deep vein thrombosis (DVT) and pulmonary embolism (PE) treatment of unstable angina or non-ST segment elevation myocardial infarction (UA/NSTEMI), and for the treatment of ST segment elevation myocardial infarction (STEMI).

Sir Paul takes over at a time when the UKCMRI will have a “key role”, he said, in tackling the most significant diseases that affect people.

“I am honoured to have the opportunity to head UKCMRI as it takes shape as one of the foremost biomedical research institutes in the world,” he added. “This is a time of extraordinary opportunity in our quest to understand the causes of health and disease.”

The UKCMRI is a collaboration between four of the UK’s largest and most successful scientific and academic institutions: the Medical Research Council, Cancer Research UK, University College London and the Wellcome Trust.

The former Cancer Research UK chief executive will take over the role on 1^st January 2011.

A report by the Pacific Research Institute has suggested that American patients would benefit if the FDA did not have a monopoly on regulations, as the EU agency approves more medicines and has faster approval times.

The US think tank argues that “allowing American patients to access medicines that have already been approved in Europe would increase regulatory competition, enable patient choice and potentially save the lives of those suffering life-threatening illnesses and who currently have no treatment options.”

The report shows that, of 39 medicines approved by the EMA and FDA in 2008 and 2009, 11 were only approved by the EMA. The EMA’s average approval time was 97 days faster than the FDA’s for medicines approved by both regulators.

“Clearly, Congress’ grant of a regulatory monopoly to the FDA is creating a significant obstacle to Americans’ timely access to new medicines,” the Institute argues.

The report recommends that the Food, Drug and Cosmetic Act is amended to require the FDA to approve a new drug if it has been accepted by a ‘comparable foreign jurisdiction’, such as the EMA.

However, social media (SM) experts have criticised the new offering, claiming that as it does not allow interaction it cannot be termed ‘social’.

The Pfizer channel has been launched on the SlideShare site, which has around 30 million unique visitors per month, and will provide public access to corporate presentations and documents.

“This channel offers an integrated social media experience, delivering a variety of content – presentations, video, blog posts – via the largest online resource for sharing presentations,” commented Ray Kerins, Pfizer’s Vice President of External Affairs. “We’re pleased to be the first company in a regulated industry to create a custom channel on SlideShare.”

Various criticisms have been raised against the channel, however, including the fact that it does not allow comments and accusations that it is simply a way for Pfizer to boost its profile. Experts have questioned whether the new venture can be called ‘social media’ when it simply provides one-way information.

It is currently under debate whether the pharmaceutical industry can legitimately engage through social media due to the strict regulations that govern its interactions with the public.

The FDA and pharmaceutical companies in the US are working towards establishing some ground rules to guide the industry’s online interactions, and these are likely to have an impact internationally.

Responding to critics on social media platform Twitter, Ray Kerins likened the current situation for pharma companies seeking to use social media to “assembling a child’s toy without the instructions”, adding: “SlideShare is part of our multi-year strategic digital/SM plan and we are happy with the progress.”

London-based healthcare communications agency Aurora has defended the use of SM amongst UK pharma in its blog. The company’s Neil Crump wrote that “as pharma companies venture into this uncharted territory, our early champions must be encouraged, must be championed, must be nurtured. Otherwise we will lose them and we will be back to square one, and that would be a terrible shame.”

Pfizer has stated its intention to continue exploring various SM platforms as ways to share information about the company.

Are you a pharma company successfully navigating the social media maze? Send your success story to diana.spencer@healthpublishing.co.uk.

If the regulators’ concerns are proven accurate, Servier could face a fine of up to 1% of its annual turnover.

The Commission has sent Servier a statement of objections. A spokesperson said: “The Commission’s provisional view is that it has evidence that Servier has provided misleading and incorrect information in a request of information in the context of the pharmaceutical competition sector inquiry.”

The inquiry concluded last year that pharmaceutical companies were blocking the launch of generic versions of its drugs to protect profits.

Servier has said that it is cooperating fully with the investigation. The company stated: “In the context of the European Commission pharmaceutical competition sector inquiry, Servier today received a statement of objections from the European Commission relating to a procedural issue. The receipt of such a statement does not prejudge the final outcome of the investigation.”

International law firm Eversheds has warned that if the suspicions are borne out Servier can expect a significant fine. Partner Stephen Rose commented: “The Commission found enough evidence to open ‘abuse of dominance’ proceedings against Servier, and these latest proceedings will come as a further blow to the company. The Commission will want to send an unequivocal message that companies must comply with sector inquiries or face the consequences.”

The company has a broad portfolio of GI treatments with Resolor (prucalopride), a treatment for chronic constipation, its lead product.

Movetis now aims to undertake further research with prucalopride in areas outside its current indication and advance its pipeline of GI treatments.

General Manager of Movetis (UK) David Trevor said the expansion into the UK was an exciting time for the company.

“As a specialist GI pharmaceutical company we are able to focus our efforts and concentrate on ensuring new treatment options are made available for the management of gastrointestinal disease,” he said. “The introduction of Resolor is an exciting new era for Movetis.”

Resolor has received EU approval and was launched in the UK in March 2010.

Research from Cardiff University showed nearly 7% of the overall NHS budget is spent tackling the disease.

The health service spent £700 million on drugs to control blood sugar levels in 2008. The study suggests that this was due to more expensive drugs being prescribed and pricey treatments being aggressively marketed by drug companies.

Critics argued national guidelines were not being followed, but GPs insisted they were only helping patients and were saving money over time.

Between 2000 and 2008 the number of prescriptions for glucose-lowering drugs had risen by 50%. In England alone, the annual figure spent increased from £290m to £591m during the study period.

But the rise in sufferers of type 2 diabetes does not account for the price increase, the report said. Newer drugs such as rosiglitazone, as well as the increased use of insulin, saw costs soar by 104% in that time.

The study did show a dramatic rise in the generic metformin as a first-line treatment.

Researcher Dr Chris Currie said GPs should follow national guidelines more closely in an attempt to reduce costs. NICE currently recommends lifestyle changes for initially controlling type 2 diabetes followed by basic treatments.

“The drugs bill is extremely high,” said Dr Currie.

“Somebody has got to take a lead in managing the way we treat people with diabetes and making sure doctors adhere to the recommendations.

“This is going to continue to rise and part of the issue is people don’t realise how big the problem is.”

Dr Niti Pall, a GP in Birmingham and spokesperson for Diabetes UK, disagreed with the report and questioned the effectiveness of cheaper alternatives.

“They have not looked at the health economics,” she claimed. “We are saving the NHS money in the long run.

“We need to do whatever it takes to get blood sugar down and some of the cheaper drugs don’t do the job."

Following on from last year’s review into the matter, MPs have identified ten new terms of reference.

These include clinical engagement in commissioning, accountability for commissioning decisions and transitional arrangements.

Focus will also be placed on the government’s commitment to NHS growth and the impact of the £20bn planned efficiency cuts.

The new inquiry has been driven by the recent White Paper proposals on commissioning. A Health Committee statement said: “The coalition has made it clear that, like its predecessor, it regards more empowered and more effective commissioning as the key to successful delivery of its objectives for the NHS.

“The new health committee has therefore decided to follow up the work of its predecessor by holding an inquiry into how the new government intends to resolve the issues which have undermined the effectiveness of commissioning in the NHS.”

An invitation to submit written evidence for the new inquiry, which is likely to be published in November, has been issued by the committee.

The review aims to contribute to the proposed White Paper reforms.

A report published by the DH yesterday entitled Extent and Causes of International Variation in Drug Usage demonstrated that the UK lags behind its European counterparts in providing access to medicines, particularly new cancer drugs.

For the uptake of cancer medicines fewer than five years old, the UK’s average ranking was 12 out of 14 countries worldwide. This places the UK above only Canada and New Zealand and at the lowest ranking amongst comparable European countries.

Alison Clough, ABPI Director of Commercial and Communications, commented: “Clearly patients, such as those suffering from cancer, are not benefiting as they should. We welcome the new Government’s recognition of the need to improve access to innovative medicines and the launch of an interim fund for cancer medicines.”

The report showed that the UK lags well behind comparator countries in the provision of medicines for atypical antipsychotics, dementia, hepatitis C, multiple sclerosis and rheumatoid arthritis, as well as cancer; but it does well in the provision of medicines for acute myocardial infarction (heart attacks) and stroke.

“It is really important that continued steps are taken to tackle the causes of variation, not just for cancer but for other conditions as well,” Alison Clough added. “We have a strong heritage in medicines research and development and yet patients are not always seeing the benefits quickly enough. Sustaining the rapid adoption of new medicines is important to promote continued research and development. Steps to ensure patients receive appropriate medicines need to be part of the implementation of the reforms in the NHS.”

The publication of the report coincided with the launch of a new £50 million cancer drugs fund, to stand in as an emergency fund until the Government’s promised £200 million fund is available in April 2011.

The appraisal into whether Prolia is a suitable treatment for therapy-induced bone loss in patients with non-metastatic prostate cancer was terminated after manufacturer Amgen declined to provide any clinical or cost effectiveness data.

Dr Carole Longson, Health Technology Evaluation Centre Director at NICE, said: “When an appraisal is terminated, we issue advice to the NHS stating that ‘NICE is unable to recommend the use of the technology’. This advice sets out an explanation provided by the manufacturer as to why they did not submit evidence and will offer advice on what to do next. NHS organisations should take into account the reasons why no evidence of denosumab’s clinical and cost-effectiveness was submitted when considering their local use of the drug.”

“Of course, if the manufacturer decides to submit the evidence in the future, NICE will then take the opportunity to review our advice to the NHS,” she added.

Another NICE appraisal of Prolia, evaluating the drug as a treatment for therapy-induced bone loss in non-metastatic breast cancer, has been removed from the Institute’s work programme, because the drug has not received a separate marketing authorisation for this indication.

NICE issued draft guidance last month recommending Prolia as a treatment for the prevention of osteoporotic fractures in post-menopausal women, and is also currently assessing the drug for bone metastases treatment in cancer.

MabThera (rituximab) will now be available in combination with chemotherapy drugs fludarabine and cyclophosphamide for the treatment of relapsed or refractory chronic lymphocytic leukaemia.

Following an appeal earlier this year, MabThera can also be used by patients who have previously used the drug during a clinical trial, or in combination with other chemotherapy drugs in trials, at a lower dose.

Despite the recommendation, NICE confirmed it will continue to research MabThera.

“We want to ensure rituximab is routinely available in the NHS for those patients who may benefit most from it, including those who had already been treated with the drug during a clinical trial but at a lower dose than usual or in combination with other chemotherapy regimens,” said Clinical and Public Health Director at NICE Professor Peter Littlejohns.

“Where rituximab has been recommended in the context of research, this is because of a lack of evidence relating to the treatment’s efficacy in those instances. Hopefully, there will be more research in these areas to help NICE develop firmer recommendations when this guidance is updated.”

Approximately 2,400 people are diagnosed with chronic lymphocytic leukaemia in the UK each year.

Roche’s Xeloda (Capecitabine) has been recommended in combination with a platinum-based regimen for the first-line treatment of inoperable advanced gastric cancer. Iressa (gefitinib) has also been given the go-ahead for first-line treatment of locally advanced or metastatic non-small-cell lung cancer.

NICE said that Iressa, which has been proposed as a patient access scheme by AstraZeneca, offers patients added convenience in its oral form. It also noted the Xeloda tablet would allow patients less time in hospitals connected to infusion pumps.

Health Technology Evaluation Centre Director Dr. Carole Longson hoped the new treatments would help the thousands of people suffering from the conditions in the UK each year.

“Non-small-cell lung cancer and gastric cancer can both be devastating conditions, with gastric cancer affecting approximately 8,200 people in the UK every year and non-small-cell lung cancer approximately 38,000,” she said. “We are very pleased to be able to recommend both capecitabine and gefitinib for use on the NHS.”

This fund, due from October, precedes the promised Cancer Drugs Fund due to commence in April next year. Doctors will be put in charge of deciding how the funding is spent based on the advice of cancer specialists.

The announcement coincides with the publication of a report by National Cancer Director Professor Sir Mike Richards, which shows the UK’s uptake of new drugs falls behind other European countries.

Minister for Universities and Science David Willetts said: “The UK is a world leader in researching and developing innovative medicines to improve health and save lives. The swift uptake of new treatments within the NHS is vital so patients can benefit, and I welcome Professor Richards’ recommendation that we need to do more to achieve this.

“Sustaining the rapid adoption of new advances is also important to promote research and development by the life sciences industry. Through the Office for Life Sciences, my department is committed to working with the Department of Health to ensure that the changes we are making to the NHS deliver both health and economic benefits.”

While the research showed good provision of drugs such as statins in the UK, the country had a low ranking for access to drugs for dementia, multiple sclerosis and newer cancer drugs. However, many of these cancer drugs have not been approved by NICE.

Andrew Dillon, Chief Executive of NICE, told the BBC: “There will always be exceptions to our recommendations which are justified on clinical grounds. A national fund to meet the cost of these exceptional cases, administered in a consistent way, complements NICE guidance and we are happy to work with the new arrangements.”

Patient groups have also welcomed the new fund. Nick Turkentine, Chief Operating Officer for the James Whale Fund for Kidney Cancer, said: “For the past four years we have been pleading in front of juries of PCT administrators to allow patients to have proven, innovative cancer drugs that clinicians want to prescribe. Today’s accelerated plans to pay for an emergency drug fund could save hundreds of lives as long as these clinically led regional panels do not hold up proceedings.”

The decision has come following months of campaigning on the part of MDS charities and patient groups.

The NICE appeal panel has requested that the appraisal committee reconsider the guidance it originally issued on azacitidine, taking account of low-dose chemotherapy as well as best supportive care as comparisons for cost-effectiveness. The committee will also examine data on quality of life provided by the MDS UK Patient Support Group.

David Hall, Chairman of the MDS UK Patient Support Group, said: “We welcome this decision by NICE to re-appraise azacitidine and believe it has been brought about by the weight of patient, expert and clinical opinion behind the arguments put to the appeal panel. We only wish that the appraisal committee had considered these points in its initial appraisal and made this life-extending therapy available to patients from early this year. Instead patients are still waiting to see if they will be thrown a lifeline.”

NICE recommended that azacitidine should not be provided through the NHS on cost-effectiveness grounds in March 2010, but said that it recognised the drug was clinically effective and that it should be seen as a life-extending end-of-life treatment. In June the decision was appealed by eight organisations, including three patient groups and four healthcare professional bodies.

MDS which can lead to complications such as recurrent or life-threatening infections or bleeding and can progress to acute myelogenous leukemia (AML), which has an average survival period of a few months only.

Azacitidine is the only licensed medicine proven to prolong survival for people with higher risk MDS and has been shown to improve patients’ quality of life substantially, reduce dependence on blood transfusions and is less toxic than chemotherapy.

The NICE announcement coincided with the launch of a Government cancer treatments fund of £50 million to be available to patients until the full promised £200 million fund comes into effect from April 2011.

The company is implementing a compensation system that will rely on the customer service provided by the sales professional, as well as adherence to the company’s values of transparency, integrity, respect and patient-focus.

It is part of a wider effort on the part of GSK to better target its sales staff based on the changing needs of healthcare professionals (HCPs).

“The US healthcare marketplace is changing significantly in response to demand by patients, healthcare providers and payers for higher quality care, lower costs and better health outcomes,” said Deirdre Connelly, President of North America Pharmaceuticals at GSK.

“Physicians have been telling us they want to see fewer sales professionals, and those they do see need to provide greater value in helping improve patient health. In response, we are changing the way we sell our medicines and vaccines in order to deliver the value our customers demand, in a transparent way, with integrity and respect for the patient,” she added.

GSK is hoping to align its sales efforts with the needs of US HCPs working in large health systems or integrated delivery networks where decisions on purchasing are made from a central office.

“We’ve spent a good deal of time listening to our customers, and they are asking us for more information about reimbursement, disease education and support for improving patient health,” Deirdre Connelly concluded.

Deals to share the costs of expensive treatments with the NHS are now commonplace. But lengthy required procedures often see deadlines and repayments missed.

A study of 31 PCTs in England showed more than 50% of the costs had not been recovered on two of the first four PASs – bortezomib and sunitinib.

The DH insisted it was aiming to make repayments as easy as possible. But study leader Steve Williamson said the complex procedures within the NHS were making the PASs unmanageable.

The consultant pharmacist at Northumbria Healthcare NHS Foundation Trust said: “We’re delighted to have these schemes because they allow patients access to drugs but they have not been executed very well.”

He added that deadlines needed to be more flexible and that the NHS should introduce a basic template for reimbursement instead of individual company paperwork.

“For example with bortezomib, in principle this is a very good scheme because if it doesn’t work you get the money back, but if for some reason you miss making one claim within the timeframe allowed it costs £12,000,” he said.

The report went on to conclude that NHS staff time is spent on tracking patients and filling in the correct forms and that “PASs can be difficult to manage within current NHS financial arrangements”.

With seven-out-of-ten respondents admitting they did not have the capacity to begin more schemes, the report also suggested the NHS may refuse future PASs. However, the DH insisted it will continue with PASs but said PCTs should create their own system for managing the rebates.

“We have – through the National Institute for health and Clinical Excellence (NICE) – now set up an expert advisory panel with strong NHS representation which is consulted when schemes are proposed and which provides advice to the department on their implementability,” a spokesperson said.

“Primary care trusts and hospital trusts need to agree locally between them how any rebates paid by drug companies are dealt with.”

The review by the CHMP was initiated due to a number of safety concerns relating to psychiatric disorders, skin and subcutaneous tissue reactions, as well as significant off-label use and potential for abuse.

As a result, the committee said modafinil should no longer be considered as a treatment for idiopathic hypersomnia, excessive sleepiness associated with obstructive sleep apnoea and chronic shift work sleep disorder.

The CHMP’s recommendation has been forwarded to the EC for the adoption of a binding decision.

The committee reported the risk of the development of serious skin and hypersensitivity adverse reactions appeared to be higher in children than adults and concluded the product information should carry a recommendation saying it should not be prescribed to youngsters.

Particular cardiovascular risks with modafinil were also identified with the CHMP recommending its use be contraindicated in patients with uncontrolled moderate to severe hypertension, and in patients with cardiac arrhythmias.

Modafinil is manufactured by US biopharmaceutical company Cephalon, Inc.

Novartis has agreed to pay $152.5 million to 5,600 female executives and Sanofi-Aventis a tenth of that amount to 5,200 reps.

As a result, both will be required to overhaul internal policies of pay and promotions for female sales force members. The settlement also requires Sanofi to increase females’ salaries if gender disparities are found.

The Novartis settlement, which followed a jury ordering the company’s US unit Novartis Pharmaceuticals Corp to pay $250 million in punitive damages in May, was described by lawyers as the largest gender discrimination case to go to trial in the US.

The Sanofi deal will be heard on August 3^rd with the Novartis settlement scheduled for November 19^th.

Under the new system proposed by the health secretary, doctors will be responsible for commissioning all care for local communities. The reform aims to bring together the management of care with the management of resources to ensure patients’ wishes and needs are met.

A poll by networking site Doctors.net.uk revealed 83% of doctors do not feel adequately equipped to make the outlined changes to commissioning, with that figure rising to 93% amongst GPs who are at the forefront of implementing the reform.

Doctors.net.uk Medical Adviser, Dr James Quekett (left), said: “Naturally there is a lot of excitement about the white paper but also much uncertainty about the new plans for GP commissioning. With allocation of time, resource and funding still to be resolved, GPs are expressing concern about how the reform will work in practice, and are pointing out that for this to work all doctors need to be engaged and involved– not just GPs.”

In response, Doctors.net.uk has launched an online micro site dedicated to commissioning. It is designed to provide clear information about the planned reforms and to provide a trusted forum for doctors across general practice, public health and hospital-based services to collaborate online with ideas and examples of best practice.

The content of the site will include a concise summary of the key points made in the white paper and responses posted by key organisations including the BMA and King’s Fund, in addition to providing direct access to the white paper and relevant news articles, presentations and interviews.

“We can’t predict what the future outcome for GP commissioning will turn out to be but we can at least ensure that doctors are informed and involved throughout this intense period of change to give it the best chance of success,” added Dr Quekett.

Specialised cancer teams are to be set up in accordance with recent Institute guidelines, which aim to help the NHS provide effective and tailored care for patients with cancer of unknown primary (CUP).

This is part of a set of measures being recommended by NICE to tackle the current inequality in care these patients often receive compared with people who have a site-specific type of cancer such as breast, lung or prostate.

The National Cancer Peer Review Programme in England is to decide a number of ‘quality measures’ that hospitals will be required to follow and assessed against.

Professor Peter Littlejohns (left), NICE Clinical and Public Health Director, said: “We are pleased that the National Cancer Peer Review Programme in England is taking note of our guideline and looking to use it to improve services.

“It is important that patients with this form of cancer receive the same level of care that other cancer patients experience. This guideline seeks to provide a consistent, national approach to the diagnosis and management of this condition.”

Central to the guidelines is that all hospitals with a cancer centre or unit will be required to establish specialist CUP teams. These teams will be responsible for guiding patients’ care until they are referred to a consultant with expertise in a particular type of cancer, referred for palliative care alone, or are finally diagnosed with confirmed CUP.

Dr Andrew Fowell, Guideline Development Group (GDG) Chair and a Macmillan Consultant in Palliative Medicine at Eryri Hospital, North Wales, said: “We expect some oncologists to become CUP specialists, alongside their more conventional site-specific activities. They will be supported by CUP Nurse Specialists, Palliative Care physicians, and other core diagnostic staff. These teams should be supported by their hospitals to ensure they are given sufficient time in their job plans for this specialist role and any training that may be needed.”

Regarding treatment and diagnosis, the recommendations include:

• taking account of prognostic factors when making decisions about further diagnostic tests and treatment
• explaining to patients and carers if further investigations will not alter treatment options and providing appropriate emotional and psychological support
• offering patients with CUP the opportunity to enter clinical trials.

If chemotherapy is given outside clinical trials, clinicians must take into account the characteristics of the tumour, the toxicity profile of the drugs, their ease of administration and response rate when choosing a treatment.

NICE has produced a podcast to help explain the guideline’s key recommendations, along with various other tools, available on the NICE website.

But despite the high appraisal rate, the ABPI dismissed the high percentage insisting NICE can do more to offer medicines ‘doctors wished to prescribe’.

The new online summary of all technology appraisals reveals that NICE has issued 378 individual recommendations on drugs and treatments since its inception, plus 49 single and 141 multiple technology appraisals. Of that total, 67 per cent were recommended in line with its licensed indication, and a further 16 per cent for ‘optimised use’ under specific conditions.

Only 11% of treatments were rejected due to lack of evidence for its clinical effectiveness or for cost-effective use of NHS resources. The final six per cent of recommendations were approved for ‘research only’.

NICE Chief Executive Sir Andrew Dillon insists they’ll continue to provide ‘authoritative evidence based information’ from both ‘clinical and cost standpoints’ to ensure patients can benefit from cost effective treatments.

“Over 80 per cent of the recommendations that NICE has made on new treatments since it started work in 1999 have been positive,” he said. “So patients with a range of conditions have benefitted from treatments that are clinically effective as well as a good use of limited NHS resources. Following our guidance is the best possible way for organisations to deliver quality care for patients, and we will continue to produce robust advice to improve the health of the nation.”

The ABPI however said the UK is still behind other European countries where ‘new and innovative’ treatments are concerned.

“We would challenge the statement issued by NICE because "yes" does not always mean yes for every patient in the UK,” a statement said. “There are some very clear examples where a medicine has been "optimised" where access has been either denied or restricted to a sub-group of patients for whom the medicine is licensed.”

NICE is asked by the Department of Health to carry out technology appraisals to decide whether or not a drug or treatment should be made available on the NHS. The figures were released to show details of each recommendation issued and the decision behind it.

The DH’s latest consultation paper – Liberating the NHS: commissioning for patients – says trusts must work closely with the new consortia to ensure “appropriate skills and knowledge are retained.”

The paper proposes consortia should shadow PCTs during 2010–11 before a comprehensive shadow system is in place by 2011–12. It also recommends that PCTs work alongside shadow consortia “to forge relationships with patient and public groups and with the range of external partners.”

A number of “practical steps” have also been identified to ensure a smooth transition during the early stages of the handover. These include “identifying the likely future shape of consortia and enabling them to start taking increasing responsibility for making commissioning decisions on behalf of PCTs”.

The new structural proposals have been backed by the NHS Confederation. Deputy director of policy, Jo Webber, said the plans would improve patient confidence and encouraged the consortia to embrace the PCTs’ assistance.

"It will be a real challenge for GPs to take on the role of commissioning so many of the services provided by the health service at a time when there is already a need for the NHS to find around £20bn of efficiency savings,” she said.

“As the document on commissioning makes clear, they will need the support of skilled managers both during the period of transition and afterwards as well, if this new vision for health is to be made to work.”

GP consortia are to be fully operational by 2013–14.

CEOs fear the austerity measures being introduced by governments across the region are likely to lead to increased pressure for lower-priced medicines.

Andrew Witty, GSK CEO, expects price pressure to accelerate through the second half of the year and become a ‘2011 phenomenon’.

Europe accounted for 30.6 per cent of global drug sales in 2009, according to IMS Health. But industry bosses are concerned about the future of the market, with some of the leading players predicting a downturn.

Johnson & Johnson has said that cost containment efforts in Europe could have $200 million impact on its business in 2010, while Novartis claims that drug price cuts have already driven a 3% decline in its sales during the first half of the year.

GSK’s Witty anticipates a similar decline. “We see Europe as being roughly a minus 3 (per cent annually) type of marketplace on an ongoing basis. It is likely that over the next 18 months we will see something a little more than 3. Whether it is going to be a lot more than 3 is still a little premature to call,” he said.

Dominic Caruso, CFO at J&J, says that although pricing pressures are not unusual, they are having a growing impact on the European market: “We have experienced pricing pressure year-over-year (in Europe) in any event, so it is not an unusual phenomenon, but there is now incremental pricing pressure,” he said. “I would say that the incremental pricing pressure on an annual basis looks like it is in the mid-single digits impact to the European businesses."

Boehringer Ingelheim’s Twynsta (telmisartan/amlodipine) for the treatment of essential hypertension was the only product to come away with a positive decision.

The generics recommended for approval were Teva’s Plavix generics Clopidogrel Teva Pharma B.V., Clopidogrel HCS and Clopidogrel Teva Generics B.V., as well as Myclausen (mycophenolate mofetil) from Herbert J. Passauer, a generic of Cellcept.

Positive opinions for extensions of indication were adopted for GSK’s Arixtra (fondaparinux sodium) to include treatment of acute symptomatic spontaneous superficial vein thrombosis of the lower limbs, Sanofi Pasteur MSD’s measles, mumps and rubella vaccine to include children from nine months of age under special circumstances, and Gilead’s Viread (tenofovir disoproxil) to include treatment of chronic hepatitis B in adults with decompensated liver disease.

A new paediatric indication was also granted for Xalatan eye drops from Pfizer, recommending the license be extended to include reduction of elevated intraocular pressure in the treatment of paediatric patients with elevated intraocular pressure and paediatric glaucoma.

These recommendations will now be referred to the European Commission to make a final decision whether marketing authorisations should be granted.

These are part of the Government’s plans for how local healthcare should be managed, revealed today in two public consultations Commissioning for Patients and Local Democratic Legitimacy in Health.

These publications expand on the recent White Paper Equity and excellence: Liberating the NHS.

The Government intends for patients, locally elected councillors, local authorities, public health experts and others to work with GP consortia to make health services meet the needs of local areas and improve health outcomes.

The Health Secretary and Communities Secretary hope these proposals will mean “services become more responsive and developed in ways that fit around the people who use them”.

As part of the plans, local health improvement funds will be held by local authorities. A new patient group, local HealthWatch – “a ‘citizen’s advice bureau’ for health and social care” – has also been suggested.

Secretary of State for Health, Andrew Lansley, said: “Power has to be devolved to local people so that decisions about their health are made by them, or by people that best understand their needs.

“Whitehall can’t prescribe all of this, and the health service shouldn’t wait for a rule book from Government. Everyone should have their say in these consultations so we can get on with building strong local partnerships and improve people’s health.”

In a consultation running until 11 October 2010, the Government is asking for feedback on:

• How GP consortia and the NHS Commissioning Board can best involve patients in improving the quality of health services.
• How GP consortia can work closely with secondary care, community partners and other health and care professionals to design joined-up services that are responsive to patients and the public.
• How the NHS Commissioning Board and GP consortia can best work together ensure a national framework that supports consortia in making effective and efficient commissioning decisions
• How the NHS Commissioning Board can best support consortia and hold them to account for the outcomes they achieve and their stewardship of NHS resources.

The AIDS Treatment for Life International Survey (ATLIS 2010), a multi-country survey of more than 2,000 people living with HIV/AIDS, has revealed that the UK has the highest level of complete treatment adherence in Europe at 65%.

This is compared to just 34% adherence in France and 44% in Germany. However, the UK lagged behind countries such as Brazil, which reported the highest levels of adherence to treatment at 89%. And a third of UK respondents admitted to missing a dose of their medication in the last month.

The results of the survey, which was spearheaded by the International Association of Physicians in AIDS Care (IAPAC) and sponsored by MSD, were presented this week at the XVIII International AIDS Conference in Vienna, Austria.

Nearly nine out of 10 UK respondents (87%) reported being very or extremely satisfied with their healthcare professional (HCP), driven by respondents feeling comfortable talking to their HCP about their HIV or AIDS (96%), the perception that their HCP is very understanding (90%) and complete trust in their HCP’s recommendations (85%).

A further 69% of respondents added that they would like to be more involved in decisions about their healthcare in future. While one-third (34%) said that their HCP is not always very forthcoming about potential side effects or health conditions caused by HIV medications and 27% said that their HCP does not suggest ways to help them remember to take their medication.

A £1.7 billion fund is to be allocated for the redundancy deals for the 30,000 administrators who are expected to lose their jobs.

Chief executives of the 10 SHAs qualify for an average payout of £340,000 – if they cannot be redeployed – with the majority of the 152 PCT bosses entitled to deals of more than £200,000.

However, with most NHS chiefs expected to be rehired by the new GP consortia, critics have voiced concerns.

“The NHS risks making too many skilled and experienced managers redundant, and rehiring them, via GP consortia or private-sector consultancy, probably at higher rates,” said Jon Restell, chief executive of Managers in Partnership, the trade union for NHS managers. “With public finances as they are, it would be a stupid waste of money to repeat past mistakes.”

Despite Health Secretary Andrew Lansley trying to slash bureaucracy and transfer more power to GPs, the Patients Association insists the huge redundancy packages are another example of the ‘gravy-train’ continuing in the health sector.

Growth is expected to be driven by the emergence of nine new therapies, including the potential blockbuster, Provenge.

Analysts predict the new products will account for 57% of global sales in what will become a ‘crowded and highly competitive’ market.

The forecasts form part of a Pharmacor 2010 study into prostate cancer by US research analysts Decision Resources.

Sales expectations are on the basis the agents can improve the overall survival in the castrate-resistant metastatic setting. Currently, only Provenge and sanofi-aventis’s Jevtana and Taxotere can make this claim after several other agents failed.

“Among the emerging therapies, Provenge – which gained approval in the US earlier this year for asymptomatic or minimally symptomatic metastatic castrate-resistant prostate cancer – will have the most significant market impact,” said Decision Resources’ Andrew Merron.

“However, several other agents will earn sales in excess of $500 million.”

Other prostate cancer products in development include AstraZeneca’s zibotentan, Johnson & Johnson’s abiraterone, Amgen/GlaxoSmithKline/Daiichi Sankyo’s Prolia, Medivation/Astellas Pharma’s MDV-3100, Algeta/Bayer Schering Pharma’s Alpharadin, Bristol-Myers Squibb’s Sprycel and Celgene’s Revlimid.

The suspension follows reports of adverse events in osteoarthritis patients taking tanezumab. Trials into the drug in osteoarthritis were stopped in June, but the agency is concerned that there may be negative reactions in other patient populations.

Pfizer has said that it will continue to work with the FDA to reach “a common understanding about the appropriate scope of continued clinical investigation of tanezumab”.

Tanezumab is an infused biologic which is designed to block pain by inhibiting nerve growth factor. If approved, it would be the first biotech therapy approved for pain.

Pfizer added that it will continue to investigate the compound in other areas of high unmet medical need, including cancer pain.

HIV/AIDS patients will now be able to access its whole portfolio of antiretroviral medicines produced by generic companies. This will include all least developed countries, all low-income countries and all of sub-Saharan Africa – covering 80% of all people currently living with HIV.

Voluntary licences are granted by patent holders to allow a generic company to manufacture and sell versions of their products. These will now be available to generic companies for all of ViiV’s current portfolio, including newer innovative products.

The patents for these drugs will also be made available in these countries for all future pipeline developments.

“At present the numbers of people in the least developed countries moving onto second line therapy is very low compared to the developed world. However as more people have access to treatment, there is an increased need for second and third line treatment options once initial treatment failure occurs,” said Dr Dominique Limet, CEO of ViiV Healthcare.

“This is why we have taken steps to make our entire portfolio and our pipeline available through our royalty-free voluntary licensing and not-for-profit initiatives.”

ViiV Healthcare has acknowledged the contribution of Shire Pharmaceuticals Group and Shionogi, companies with which it has co-development agreements and that have also agreed to waive rights to royalty payments in order to improve access to these products.

ViiV Healthcare is a global specialist HIV company established by GlaxoSmithKline and Pfizer to deliver advances in treatment and care for people living with HIV.

Research from GfK HealthCare will canvass key decision makers with payer responsibility in Spain, Germany, Italy, Sweden and the Netherlands.

GfK says the study will help the industry better understand NICE’s impact outside the UK, which it describes as ‘significant’.

Andreas Guhl, MD, Director of GfK HealthCare’s Market Access Centre, said: “According to what we’ve heard from U.S. payers, the absence of positive NICE guidance on a given drug is seen as a significant barrier to the drug’s success in other markets. We want to see if this statement is true for other countries.”Understanding how NICE’s decisions affect product uptake and revenue and their actions have on reimbursement decisions is critically important to pharmaceutical manufacturers to develop successful HTA submissions and grasp payers’ perception and behaviour outside the UK.

The study will also address questions such as: Is NICE viewed as a benchmark for payers outside the UK? Are parts of the NICE appraisal process seen as benchmarks? And is NICE’s new flexibility, especially in regard to patient access programs, a potential model for other payers?

The funding will see nine independent research projects set up across the UK to look into issues such as economic modeling, quality of life measurements and preventative healthcare.

“Ensuring we have the best tools for evaluating treatments and the effects they have on patients’ lives is a crucial part of bringing medical research to impact on patient care as quickly as possible,” said Professor Tim Peters, Chair of the MRC/NIHR Methodology Research Programme Panel.

NICE currently uses a range of academic tools and methodologies to decide whether a treatment should be recommended for NHS use. The new projects will focus on enhancing existing methodologies with the aim of maintaining the UK’s high standards of clinical excellence.

The MRC funding follows an independent study in 2008 to identify NICE’s methodological research priorities.

Professor Peter Littlejohns, NICE’s Clinical and Public Health Director, welcomed the announcement. “Over the last 10 years NICE has built an outstanding international reputation for the rigour of its decision-making methods and processes,” he said. “We are continually pushing the boundaries of the existing methodology and we are committed to ensuring the methods remain up-to-date and fit for purpose. The new tools and methodologies developed by these MRC-funded research projects should do just that.”

Speers takes over from Nigel Brooksby (sanofi-aventis) and will be supported by the new vice-chair, Lundbeck Managing Director Steve Turley.

Formed in 2001 by 16 research-driven pharmaceutical companies who develop and supply prescription medicines to the NHS, the EMG focuses on access to medicines.

On his appointment, Matthew Spears said: “Despite the tremendous advances in research and development we continue to face considerable market access challenges in the UK with uptake of innovative medicines still lagging significantly behind Europe.

“I am delighted to have been elected to lead the EMG and to continue the work we have undertaken to ensure that all UK citizens have timely access to appropriate, innovative medicines taking other countries in Europe as our benchmark.”

Working alongside the government, the NHS and ABPI, EMG aims to increase the awareness of patients, carers and policy-makers of the European pharma industry’s contribution to the health and wealth of the UK.

“The European perspective is an important one, as European healthcare systems tend to be founded on social values that are closely aligned with those of the NHS,” added Steve Turley.

“We will continue to hold the mirror up to Europe and work together with government, clinicians and patients to improve the health and quality of life of people in the UK.”

A new treatment to reduce mortality rates in patients with atrial fibrillation (AF) has been recommended by NICE, despite it being less effective in preventing the condition than existing options.

But Sanofi-Aventis’ dronedarone can only be considered as a treatment option for patients who have additional cardiovascular risk factors such as diabetes or high blood pressure.

The decision to recommend the limited use of dronedarone follows positive comments from patients and clinical experts during the NICE consultation process.

The reduced number of side effects was found to be a major positive with sufferers – although long-term use of all current antiarrhythmic treatments will have a significant impact on patients’ quality of life.

“The independent Appraisal Committee concluded that although dronedarone reduced atrial fibrillation recurrence compared with placebo, it appeared to be less effective for atrial fibrillation recurrence than other antiarrhythmic drugs,” said NICE Chief Executive, Sir Andrew Dillion. “However, it noted comments from patients and clinical experts received during consultation on a previous draft that all current antiarrhythmic drugs have side effects that have a significant impact on quality of life with long-term use. It heard from patient experts that some people with atrial fibrillation might prefer to take dronedarone because it has fewer side effects, despite it being less effective in preventing recurrence of atrial fibrillation.”

NICE opted to restrict the use of dronedarone to patients with additional cardiovascular risk factors as the cost-effectiveness estimates for the drug were largely based on a single clinical trial, which included people who had a higher risk of a major cardiovascular event.

Other treatments use to control AF, one of the most common heart rhythm disturbance conditions, include beta-blockers and miodarone. Final guidance is expected to be published in August 2010.

Critics claim the proposals, which will see the abolition of PCTs and SHAs and the emergence of commissioning led by GP consortia, represent a significant U-turn from a coalition Government who only weeks ago promised there would be no top-down reorganisations of the NHS.

But NHS Chief Executive, Sir David Nicholson, said the document – Liberating the NHS – set out a ‘compelling vision’ for an NHS configured to deliver increasing quality of services.

“The ambition is high and the proposed timetable is rapid,” he said. “The vision needs to be realised through a period in which the NHS needs to achieve £15-20 billion of efficiency savings to reinvest in improving quality and outcomes. This represents a significant delivery challenge.”

Shadow Health Secretary Andy Burnham labelled the changes a political experiment. “It is a huge gamble with an NHS that is working well for patients,” he said.

Under the new proposals, GPs will be handed around £80 billion of the NHS budget to commission patient care, with vast swathes of NHS management positions being cut away. Tens of thousands of jobs in PCTs and SHAs will be shed in the next four years. SHAs will be “abolished as statutory bodies during 2012/13” and PCTs “from April 2013”.

The reforms will once again redraw the pharmaceutical industry’s customer-base. It will undoubtedly impact the industry’s sales methodology – and may well facilitate a move back towards primary care field forces, albeit on a much smaller scale.

Andy Lee, Commissioning and NHS Partnerships Director at WG Consulting said: “The White Paper promises significant reform and a renewed focus on quality and patient outcomes. However, it appears to offer equal measures of increased opportunity and exposure to risk. The devil will be in the details and the negotiations to follow.”

The King’s Fund described the programme as being unlike “anything we have seen since the inception of the NHS in 1948”. It said the plans were “not without risk” and that some GPs would not have the skills to manage the budget. Sir David Nicholson agreed, saying that the scale of change being proposed was “unprecedented and affects all parts of the service”.

“The lesson of past reorganisations was that there is a ‘significant risk’ during this transition, of a loss of focus on quality, financial and performance disciplines as organisations and individuals go through change,” he said.

Nicholson had appeared to question the Government’s plans, in particular the proposed speed of change. Speaking at last month’s NHS Confederation conference, he said he doubted the reforms would be anywhere near completion for full implementation by the date set by the Health Secretary, and that the transfer of NHS commissioning to GPs by 2012 was ambitious. “It’s dangerous to put a date of that nature on it,” he said. Nicholson outlined his views on the size of the challenge ahead, saying that on a scale of one to ten, even the best GP practice based commissioners were “only about a three in terms of the quality of their commissioning”.

A report by independent Think Tank, Civitas, claims that evidence suggesting GPs will be more effective than health trusts at commissioning is ‘weak.’ The report says: “There is no evidence to draw on to support GPs across the country taking on commissioning as consortia.”

But Dr Amit Bhargava, from the Clinical Commissioning Federation, said: “Clinicians – who spend 80% of the health resource, who have great influence on flows of patients, have organisation memory and have the intellectual capacity and capability – are in exactly the right place now to deliver the paradigm shift that will improve the well-being of the health service that is so critically needed.”

The NHS Alliance welcomed the proposals, saying it supports a phased approach to clinical commissioning, with a clear and agreed road map. Dr Michael Dixon, Chairman of the NHS Alliance, said: “This is a unique opportunity for frontline GPs and the managers and other clinicians who work with them to make a real difference to the health of their patients, the services they receive and make the best out of limited resources.”

Dr Tim Riley, Chief Executive, NHS Tameside and Glossop, said: “The NHS faces difficult funding decisions but we can, and should, use local clinical know-how to get the best for less. The mechanics of commissioning need to be unleashed from bureaucracy. A remaining challenge will be for the new Regional Divisions of the Independent Commissioning Board to embrace the new agenda and not reinvent themselves as SHAs or ultra large PCTs. The NHS top down approach can then be replaced with GPs leading from the grass roots up.”

David Cameron and Andrew Lansley speak with a group of nurses during a visit to The Royal Marsden Hospital in London, on the same day that the White Paper was launched.

The regions covered in the Global Pharma-Biotech Alliance Analysis include Brazil, Russia, India, and China.

However, despite these markets offering advantages such as intellectual talent pool, cheap land and labour and investor-friendly governments, the market conditions can be problematic for companies.

“With companies focusing on emerging markets, they would need to address the varying medical requirements of each of these markets,” said Frost & Sullivan Research Analyst Swetha Shantikumar. “Therefore, there will be an overall shift in the pharmaceutical industry from a very Western centric model to a global one.”

The research revealed that vaccines, biologics, over the counter (OTC) candidates and generics are the principal revenue generators in the emerging markets. But weak intellectual property (IP) laws, escalating drug costs and low reimbursement rates for drugs can plague these countries.

Shantikumar added: “For instance, one of the main drawbacks of the Indian pharmaceutical industry is weak IP laws and policies. The new Indian patent code has addressed that and several other issues, yet there remains a clause that disallows patents for treatments that are not more efficacious than those already available.”

“These companies need to re-evaluate their priorities and develop customised strategies that are suitable for the emerging markets.”

Global Pharma-Biotech Alliance Analysis is part of Frost & Sullivan’s Pharmaceuticals & Biotechnology Growth Partnership Services programme.

The company will soon be listed on the ABPI website and will receive updates of new developments within the pharmaceutical industry.

“This is a great feather in our cap and further demonstrates our commitment to being one of the world’s leading agencies for the pharmaceutical and healthcare industries,” said Matthew Wall, VP Strategic Communications EMEA. “Being this closely affiliated with the ABPI means we will always have the most up-to-date knowledge of compliance issues and can advise our clients accordingly.”

As part of its expansion plans in Europe, BCD M&I has also appointed John Lauri as Managing Director EMEA.

Lauri spent six years with Rosenbluth International Business Travel, where he held a variety of roles including overseeing pan-European EMEA account management, multi-national implementation and general management of offices in the both the Nordics and the Middle East.

“I’m thrilled to be joining the team at BCD M&I,” said Lauri. “This is an incredibly exciting time for the company, and I am looking forward to helping take the business from strength to strength. We’re already seeing an acceleration in our acquisition of SMM accounts, and as companies resume their MICE activity our services are more and more in demand. I see opportunity all around and believe that BCD M&I is uniquely positioned to win new clients at both an event and an enterprise level.”

Clinical evidence was submitted that Avastin could slow tumour growth for five and a half months longer when added to paclitaxel. However, there was no improvement to overall survival rates, the drug only extending patients’ lives by around an extra seven weeks (1.7 months).

NICE also pointed out that Roche did not compare Avastin with docetaxel – a ‘gold standard’ breast cancer treatment – despite research data being available.

The Appraisal Committee concluded that the cost of bevacizumab is too high for the limited and uncertain benefit it may offer patients. Roche acknowledged that its own calculations on cost-effectiveness were ‘optimistic’.

Sir Andrew Dillon, NICE Chief Executive, said: “The Committee did hear evidence from a clinical expert and patient representative that the amount of time a drug can slow the growth and spread of the cancer is highly valued by patients but evidence of the length of time bevacizumab could keep the cancer under control was not robust.

“It is important to remember that current breast cancer treatments like paclitaxel and docetaxel are very effective in helping to extend the lives of patients with metastatic breast cancer. For example, the study comparing bevacizumab plus paclitaxel with paclitaxel monotherapy highlighted that paclitaxel could prolong lives by just over two years, on average.”

The preliminary guidance is now available for public consultation until 30 July 2010.

The European Commission has approved the boosted form of Bristol-Myers Squibbs’ drug to treat HIV-1 infection in paediatric patients aged six to eighteen years and greater than 15 kg, as part of combination HIV therapy.

“Globally, more than two million children under 15 years of age are living with HIV, and between 1,000 and 1,500 become newly infected with HIV every day,” said Dr Gareth Tudor-Williams, Consultant in Paediatric Infectious Diseases, St. Mary’s Hospital. “Despite the availability of treatment options, there are still many unmet needs in this patient population. The European Commission approval of Reyataz is a milestone in addressing these challenges for children with HIV. We look forward to Reyataz capsules being available for our paediatrics patients across the European Union.”

In 2004, Reyataz was the first once-daily protease inhibitor to be launched in the EU for pre-treated HIV patients, while the use of the boosted form in combination with other antiretrovirals was approved for treatment-naïve patients in June 2008. 

Professor Nick Barber was also elected as Vice President and John Gentle was re-elected as a Treasurer in the recent Council meeting.

In accepting his re-election, the President highlighted the achievements of the Society and reaffirmed his vision for the establishment of a professional body in which members could take pride and for the safe transfer of the regulatory responsibilities from the Society to the General Pharmaceutical Council (GPhC).

Steve Churton said: “I am as proud to be a member of this profession now, as I was on the first day that I registered over 30 years ago. I can only hope that I have been able to make a difference, and played my part in securing a sustainable and influential future for our profession.

During my time as President I have felt both honoured and proud that individual members of the profession and the fantastic people who work so hard on our behalf, have seen fit to place their trust in me.

I remain very grateful to those colleagues here today who continue to demonstrate their loyalty and support for me, and for what I am trying to achieve, by electing me once again. It means a great deal personally, and I will not let you or the profession down.”

A world expert in the social determinants of health, Sir Marmot chaired the WHO Commission which produced its report in 2008 entitled Closing the gap in a generation: health equity through action on social determinants of health.

Sir Marmot recently conducted a review of health inequalities in Britain, which published its report Fair Society, Healthy Lives in February 2010. He has now been invited by the Regional Director of World Health Organisation Euro to conduct a European review of health inequalities. Sir Marmot said: “I am delighted and honoured to have been appointed President of the BMA for the coming year. The theme I have chosen for my year as President is health inequalities and I hope to assist the BMA with their work in this area.”

“Despite living in one of the richest and most developed countries in the world, many individuals in the UK have a poor start in life simply because they are born on the wrong side of the tracks. The poorest people will die earlier and they will also spend a greater proportion of those shorter lives unwell.

“Doctors are in a unique position to speak out for their patients and to call for more resources to be spent on preventing disease. I hope as President of the BMA I will be able to help the Association with this task.”

NICE has ruled that it is unable to recommend the drug due to a lack of evidence that it significantly increases the overall survival of patients compared to current treatments. This is despite Takeda’s proposal to make the drug free of charge for a patient’s first seven doses.

Around 150 new cases of osteosarcoma are diagnosed each year in the UK, with most cases in children, teenagers and young adults. Current treatment involves chemotherapy and surgery to remove the part of the bone or limb affected, and some patients will need an amputation.

Michael Francis, Chairman of the Bone Cancer Research Trust, said: “The Trust is astonished by the decision taken by NICE. We really thought that NICE would recognise that Mepact offers the first real opportunity to help these young people. Of course we do not begrudge funding for treatment for other cancers, but it seems perverse that we are prepared to let those young people die for the sake of £2.5 million – a sum which would dramatically allow more young people to survive.”

Sarcoma UK’s Director, Roger Wilson, added: “If we take the decision down to its essentials, this means that NICE is prepared to sacrifice children on its self-justified altar of cost-effectiveness. I believe that our society has higher moral principles and will not allow an academic process, which has already been shown to be flawed, to take this unprincipled route.”

Sir Andrew Dillon, NICE Chief Executive, has defended the decision, however. He said: “We understand a diagnosis of cancer is very distressing, and especially so when children and young adults are affected. With this in mind, we are disappointed that the evidence for mifamurtide is not stronger. It is important to remember, though, that other, effective treatments are available in the NHS for treating this condition.”

The preliminary guidance is now available for public consultation until 2 August 2010.

A similar judgment was made in a case in relation to Schering-Plough representatives the same day, while Abbott Labs and Boehringer Ingelheim have also lost related cases.

Industry analysts have questioned whether the verdict could actually hasten the “death of the salesman” by making sales representatives more expensive.

The decision overturned a previous ruling that sales representatives fell under exceptions to the Fair Labour Standards Act, which rules that workers have to be paid time and a half for any work over 40 hours a week.

Around 2,500 current and former Novartis sales people employed between 23 March 2000 and 7 April 2007 will be affected by the decision. One lawyer estimated that damages could reach a total of $100 million.

This is the second employment law case that Novartis has lost in recent months in the US, following a sex discrimination case that resulted in employee payouts of up to $250 million.

In 2009 Southern District Judge Paul Crotty found that representatives did not qualify under the Act as they were working remotely. However, in the appeals court the plaintiffs won their case by arguing that their work is “repetitive and trivial”.

Commenting on the case in a blog on BNET Pharma, US journalist Jim Edwards said: “Ironically, the reps’ success in obtaining overtime will likely hasten the death of the salesman. Companies already regard them as too expensive and have laid off tens of thousands over the recession. This ruling will likely make them more expensive still.”

There is no similar Act in the UK regarding overtime pay, so it is up to companies to agree fair policies with their employees.

It represents the first new class of treatment for COPD in more than a decade.

Daxas is indicated for the maintenance treatment of patients with a history of frequent exacerbations as an add-on to bronchodilator treatment.

Nycomed plans to launch the treatment across Europe soon, starting with Germany and the UK.

Guido Oelkers, Executive Vice President Commercial Operations at Nycomed, said: “Nycomed is very excited about the marketing authorisation for Daxas in the European Union. It is an important milestone for the company and very good news for people suffering from this life-threatening disease. The approval of Daxas offers clinicians and patients a much-needed new treatment option alongside existing inhaled therapies.”

Encouraging data from four clinical studies into Orencia were published in The Lancet in August 2009 and were presented at the annual European Respiratory Society (ERS) Congress in Vienna, Austria, in September 2009.

Neil Barnes, Professor of Respiratory Medicine at Barts and the London Hospital, said: “We have a large number of patients who remain symptomatic and have frequent exacerbations despite existing treatments, and for that more severe end of the spectrum we need new therapeutic options. For patients with COPD associated with chronic bronchitis and a history of flare-ups, Daxas can make a real contribution.”

Nycomed and Merck & Co. have an agreement to co-promote Daxas in France, Germany, Italy, Spain, Portugal and Canada, as well as to commercialise Daxas in the UK.

The European Commission has approved the drug, in combination with methotrexate (MTX), for the treatment of adult patients who have not responded to previous therapy with one or more DMARDs including MTX or a TNF-alpha inhibitor.

“This is a very welcome decision from the European Commission and one which will potentially have a positive impact on treatment outcomes for RA patients who have already experienced inadequate response to a first DMARD,” said Dr Manuela Le Bars, European Medical Lead for Immunoscience, Bristol-Myers Squibb.

“There is a growing body of evidence to show that earlier use of Orencia may have significant benefits for patients – for both short-term and long-term efficacy. This new indication means patients have the potential to benefit sooner from incremental improvements in function and quality of life provided by Orencia.”

The approval was supported by trial data which indicate that Orencia may provide improved outcomes in short-term efficacy, as well as durable and sustained long-term efficacy (up to seven years) when used with MTX at an earlier stage in RA treatment. A sustained reduction in the rate of progression of structural damage by up to five years was also demonstrated.

Orencia was first approved for adult RA in May 2007 by the European Commission. It is also indicated, in combination with MTX, for the treatment of moderate to severe active polyarticular juvenile idiopathic arthritis.

The number of ‘anticompetitive’ agreements fell to 10% of total patent settlements in the sector in the period July 2008 to December 2009, compared with 22% in the period covered in last year’s inquiry into the pharmaceutical sector (January 2000–June 2008).

These findings, part of a Commission report on the monitoring of patent settlements, could show that pharma companies are becoming increasingly aware of the potential concerns caused by their deals with the generics industry.

The amount of money involved in the settlements also appears to have decreased from more than €200 million recorded in the sector inquiry period to less than €1 million in the more recent period.

“Patent settlements are an effective means to end patent-related disputes and litigation. Nobody disputes this,” said Joaquín Almunia, Commission Vice President in charge of Competition Policy. “However, some of them may be anticompetitive. Our report appears to show the sector’s increased awareness of the potential competition concerns, but the Commission will remain attentive to ensure that the sale of safe, affordable medicines is not delayed by unfair practices. This is all the more important in times of crisis and of serious budgetary constraints.”

The settlements that are judged problematic are those that limit generic entry and include a value transfer, in the form of direct payment or other commercial advantages, from an originator to a generic company.

Last week the US House of Representatives passed legislation banning deals that delay the market entry of generic products – the bill will now go to the Senate for review.

However, several NHS organisations recognise the value of working with industry and are in talks to set up more formal joint working arrangements, HSJ has reported.

Senior health figures warned that education provided by pharma may lead to a bias in clinical decisions, following an investigation into practice nurse training by Nursing Times.

The research found that out of the 52 PCTs who responded to the survey, only 15 had a dedicated practice nurse education scheme, but more than half said they were happy for the industry to provide funding for training.

Despite these warnings, many SHAs are now working to establish formal arrangements with the industry on patient care, training and education. Indeed, NHS Liverpool is in formal talks with companies over possible ways of providing practice nurse training.

NHS North West Chief Executive Mike Farrar told HSJ: “This isn’t about doing something cheap and nasty, it’s about trying to recognise that the two sectors can get mutual benefit from working together better. There are potential risks and I don’t think we should rely on the pharmaceutical industry for what should be mainstream education budgets.”

The Committee also recommends that for patients receiving a dose of Fabrazyme less than 1 mg/kg every other week, physicians should consider switching to an alternative treatment, such as Replagal.

This change to the previous recommendations has come due to warnings from the manufacturer Genzyme that the current supply of Fabrazyme will not meet the needs of the nearly 600 patients receiving Fabrazyme in Europe today.

However, the EMA has emphasised that these recommendations are temporary and do not change the currently approved product information for Fabrazyme.

The supply shortage of Fabrazyme began in June 2009 and was caused by manufacturing problems at the US production site in Allston Landing. Genzyme has cautioned that the supply of the drug will not return to normal before the end of the year as current productivity is still lower than expected.

Fabrazyme is used to treat the rare, inherited enzyme-deficiency disorder Fabry disease.

The CHMP has said that it is “concerned” about the continued shortages of Genzyme’s medicines. It is currently assessing the company’s proposals for improvement measures to prevent similar manufacturing and quality problems in the future, and is closely monitoring the implementation of these measures.

In preliminary draft guidance, NICE says it is “unable” to recommend Herceptin in combination with cisplatin and capecitabine or 5 fluorouracil for the treatment of people with HER2-positive metastatic gastric cancer.

Gastric cancer affects approximately 8,200 people in the UK every year – of whom just 500 would be eligible for treatment with trastuzumab.

Andrew Dillon, Chief Executive of NICE, said: “Although clinical trials suggest that trastuzumab can extend life for patients with HER2-positive metastatic gastric cancer, there is considerable uncertainty about the data on how long this extension would be.

“The manufacturer and other consultees now have an opportunity to help the independent Appraisal Committee resolve this uncertainty, to the extent that they can. All comments received will be fully considered by the Committee at their next meeting.”

NICE is also appraising capecitabine for gastric cancer and has recommended it as a treatment option in draft guidance.

Pfizer could receive a further six months’ patent protection on Lipitor as a result of securing this paediatric indication.

Both the current tablet form and the new chewable formulation have been approved to treat children with high levels of LDL cholesterol and high triglycerides due to the inherited disorder familial hypercholesterolaemia and other primary causes.

The EC’s decision is based on the results of a paediatric investigation plan (PIP) filed by Pfizer with the EMA.

Investigations into paediatric use are now required by European regulations, but the EU has created incentives to encourage trials in children, including supplementary protection certificates – a six-month extension to an existing patent extension.

Pfizer will apply for the additional six months of patent protection in European countries where it has an SPC, though this will involve a country-by-country process.

Lipitor has been approved for use in children (aged 10 to 17 years) with heterozygous familial hypercholesterolaemia in the US since 2002.

All European mediscience companies in the healthcare, medical, pharmaceutical, biotechnology and life sciences sectors are eligible for the European Mediscience Awards.

Angus Russell, Chief Executive Officer of Shire, said: “We’re delighted to have been voted Company of the Year at the Mediscience Awards. This award recognises the success of our strategy and the hard work of everyone at Shire who are so dedicated to meeting the needs of the patients and their families that rely on Shire medicines.”

The award scheme recognises the importance of the capital markets to fund growth and innovation in the biopharmaceutical marketplace. Companies need to have a well-defined strategy and demonstrate the ability to deliver key financial, ethical and social ambitions to qualify for the Company of the Year award.

On behalf of the voting panel, Kate Silverton, BBC personality and Awards presenter, said: “Shire has enjoyed a spectacular year, successfully making an excellent transition from a focus on attention deficit hyperactivity disorders to a genetic disease and specialist biopharmaceutical company. In financial terms its 25% increase in 2009 in core product sales underlines its potential in 2010 and beyond.”

GlaxoSmithKline’s Votrient (pazopanib) is now available for the first-line treatment of patients with advanced RCC and for patients who have previously received cytokine therapy for advanced disease.

The conditional approval was based on results from a phase III trial, which showed that Votrient reduced the risk of progression in these patients by 54% compared with placebo, providing up to five extra months’ progression-free survival (PFS).

Votrient is a selective tyrosine kinase inhibitor (TKI) that has a specific kinase affinity profile.

Professor Robert Hawkins, Consultant Medical Oncologist at The Christie, Manchester, has welcomed the new licence: “The introduction of targeted therapies such as TKIs has greatly improved outcomes for many patients with renal cancer.

“Currently used TKIs can produce ongoing side effects as such mucositis and stomatitis which have a profound effect on how patients are able to function day to day. Votrient provides clinicians with a welcome alternative option that may not present the same adverse event burden.”

Advanced RCC is one of the most treatment resistant cancers – around nine out of ten patients die within five years.

New medications likely to be hit hardest under tough pricing regulation include antibiotics, as well as treatments for cardiovascular disease and immune system disorders such as multiple sclerosis and chronic meningitis, the research has shown.

The study on ‘Pharmaceutical Innovation and Pricing Regulation’ modelled and quantified the direct link between strict regulation and low innovation.

Many countries use either External Price Benchmarking (EPB) or Internal Reference Pricing (IRP) to control drug costs. EPB caused a 5.7% drop in the optimal pharma portfolio value of a representative company under the ESMT CA simulation, whereas IRP caused an 11.7% drop.

All forms of pricing regulation, when compared to market-based pricing, were found likely to reduce the value of projects and the resources available for R&D activities.

The research also demonstrated the need to support both ‘first in class’ and ‘best in class’ products, rather than drawing a regulatory distinction between ‘breakthrough’ drugs and later products that may add further benefits.

“Our study shows the consequences that pricing and reimbursement regulation can have on pharmaceutical innovation. It also shows that, incorrectly applied, regulation can reduce the value of pharmaceutical projects and curtail the resources available to carry them out,” said Dr Hans W. Friederiszick of ESMT CA.

“Rational investors will naturally look for the most profitable investment choices, which is why regulation has a direct impact on the number and characteristics of the medications developed.”

The study, which was commissioned by Novartis, was based on a simulation of a representative pharmaceutical firm’s decision-making process. Conclusions were drawn from the simulated actions of the pharmaceutical company, taking account of parameters including the costs of developing products, the probability of failure during clinical trials, and the probability of a final product not being approved by regulators.

Lilly will acquire Alnara’s lead product liprotamase, a non-porcine pancreatic enzyme replacement therapy (PERT) that is currently under review by the FDA for the treatment of exocrine pancreatic insufficiency (EPI).

“The acquisition of Alnara provides Lilly with a promising entry into enzyme replacement therapy – an area with unmet medical needs as well as opportunities for novel compounds that give patients additional treatment options,” said Bryce Carmine, Executive Vice President of Lilly and President of Lilly BioMedicines.

“Alnara has been very successful in the development of liprotamase – as indicated by its recent submission to the FDA – and we look forward to partnering with Alnara’s experts during the regulatory review process.”

Alexey Margolin, Chief Executive Officer of Alnara, added: “Lilly’s deep expertise in the US pharmaceutical business, including regulatory affairs and the development of innovative compounds that address unmet medical needs, created a natural fit and could allow for opportunities in markets beyond cystic fibrosis. We look forward to finalising the transaction and working together on next steps to bring liprotamase to patients.”

EPI is often associated with cystic fibrosis, which affects nearly 100,000 people worldwide. Approximately 90% of cystic fibrosis patients receive PERT to improve nutritional status and bowel-related symptoms related to pancreatic insufficiency.

Financial terms of the agreement have not been disclosed.

In draft guidance, the Institute has not recommended the drug for NHS funding for the second line treatment of advanced renal cell carcinoma.

Expressing their anger at the guidance, patient groups have looked to the coalition Government’s promised Cancer Drugs Fund to bring hope to patients.

Sir Andrew Dillon, Chief Executive at NICE, said: “A diagnosis of renal cancer is devastating for patients and those who care for them and we are disappointed not to be able to recommend everolimus as a second line treatment option. However, we to have ensure that the money available to the NHS is used to best effect, particularly when NHS funds, like the rest of the public sector, are under considerable financial pressure.”

The James Whale Fund for Kidney Cancer has described the ruling as “another disappointing blow” for kidney cancer patients, as the decision leaves clinicians with the choice of only one NHS drug (sunitinib, Sutent) with which to treat terminally ill patients.

Nick Turkentine, Chief Operating Officer of the Fund, said: “As a country, our health care system is falling behind that of the majority of European countries, because we are only able to offer sub-optimal treatment to those patients who need it the most. That said, there is some hope for cancer patients in the form of the Cancer Drugs Fund; we are delighted that the new coalition Government has promised to set up this £200 million fund to help cancer patients access the new drugs through the NHS.”

The Fund has also urged for NICE procedures, which it argues are “out-moded and unsuitable” and have been “shown to be unfair to many cancer patient groups”, to be reviewed.

Rose Woodward, Head of Patient Support for the Fund, said: “I find it incomprehensible that NICE are fully aware that the mood of the Government and the general public is that terminally ill cancer patients should not be denied effective cancer treatment. Again NICE will restrict an effective cancer drug to a small group of rich, privately insured patients and the rest of us, who rely on the NHS, feel totally abandoned.”

Speaking at the NHS Confederation annual conference at the end of June, Andrew Lansley told delegates he wishes to empower NHS practitioners to have greater freedom from targets and top-down policies by making doctors responsible for commissioning.

“I want to provide freedom, responsibility and accountability so that clinicians don’t have to wait for permission to move from the thing that is targeted to something better,” he said.

He encouraged the NHS to start preparing for the changes ahead of the publication of the new White Paper, which will provide more details on timescales. “PCTs can start accelerating their efforts with practice-based commissioning consortia,” he said. “Trusts that aren’t yet foundation trusts must now be pushing themselves to achieve FT status… and everyone can ready themselves for these changes, focusing more on outcomes, safety and shared decision-making with patients.”

Also speaking at the conference, NHS Chief Executive Sir David Nicholson provided more details on the proposed changes, but encouraged delegates: “We have done great things before and we can do so again.”

He went on to say that NHS leaders need to take up the challenge of reform by supporting their staff, and promised a greater say for employees throughout the transition. He added, however: “With the necessary management cost savings, some people are going to lose their jobs and we shouldn’t give people false hope.”

He also stated that QIPP will continue to play an important role and that NHS services will need to increase their scope to include social services clients who are also patients.

Earlier draft guidance published in March 2010 was minded not to recommend the use of the drug, and the committee asked for additional information from manufacturer Roche.

The latest final draft recommendations state that RoActemra, in combination with methotrexate, is recommended for the treatment of moderate to severe active rheumatoid arthritis in people whose rheumatoid arthritis has responded inadequately to one or more TNF-α inhibitors and rituximab.

Dr Carole Longson, Director of the Centre for Health Technology  at NICE, said: “The use of tocilizumab after rituximab was raised as a potentially important place for this drug in the treatment pathway during consultation on previous draft guidance. The additional information provided by the manufacturer on use in these circumstances has enabled the appraisal committee to now produce positive recommendations – which we hope will be good news for people with rheumatoid arthritis.”

RoActemra is a modern biologic and is used to reduce inflammation in the joints, to help prevent long-term damage.

Roche also recently presented data at the European League Against Rheumatism (EULAR), which showed that the drug is effective in the treatment of Juvenile Idiopathic Arthritis.

The European Commission said that AZ had breached EU rules by blocking or delaying market access for generic versions of its ulcer pill Losec (omeprazole) from 1993 to 2000.

The original fine of 60 million euros was reduced to 52.5 million, however, following AZ’s appeal to the General Court, the EU’s second-highest court.

“The General Court essentially upholds the decision of the Commission which found that the AstraZeneca Group abused its dominant position by preventing the marketing of generic products replicating Losec,” the court said in a statement.

The fine was reduced as the Commission had not proved that the deregistration of marketing authorisations for the drug in Denmark and Norway affected parallel imports. But the court did back the Commission’s finding that the company had provided misleading information to patent offices in Belgium, Denmark, Germany, the Netherlands, Norway and Britain.

“We were disappointed that the court hasn’t confirmed our position. We will be reviewing it in detail and decide on any next step once we have a chance to go through it in more detail,” said AstraZeneca spokeswoman Sarah Lindgreen.

The British Generic Manufacturers Association (BGMA) has applauded the ruling. BGMA Director Warwick Smith said that the findings “are consistent with those of the European Commission’s inquiry into the pharmaceutical sector and our own experience that the research-based pharmaceutical industry uses a toolkit of devices to prevent generic launch when the patents on its drugs expire. This costs the NHS many millions of pounds and diverts the research-based industry from its true task of developing new medicines that patients need.”

AZ has two months to appeal against the ruling at the Court of Justice, the EU’s top court.

The study COPD Uncovered, from leading charity Education for Health, shows that lost productivity due to early retirement of patients with COPD aged from 45–64 years is £728 million per year. The research was supported by an educational grant from Novartis Pharma.

The findings highlight an urgent need to keep individuals with COPD active and contributing to society for the benefit of all. The authors also warn that an increase to the retirement age will add to the economic impact.

In association with health economists, industry specialists and Education for Health, the COPD economic model was developed to provide the first step of uncovering the size of the economic impact of COPD amongst the working age population.

The figure of £1.2 billion includes direct healthcare costs, as well as lost income tax, payment of state benefits and productivity loss due to COPD.

Speaking at COPD7, an International Conference on Chronic Obstructive Pulmonary Disease, Education for Health’s Chief Executive, Monica Fletcher, said: “Studies have already shown that COPD has a devastating impact on quality of life; however, we now have a tool to enable us to determine the financial implications of this debilitating disease.

“These figures further demonstrate that early diagnosis and management of COPD may enable patients to maintain active and productive lives for longer, thereby helping to reduce the economic burden of the condition and improve patient quality of life.”

NICE updated its COPD guidelines this month as part of a wider DH national strategy to improve care for people with COPD. Changes to the guidelines included guidance on the availability of pulmonary rehabilitation and encouraging greater awareness of possible side-effects from inhaled corticosteroids.

Education for Health is the largest international charity that undertakes research which contributes to the evidence base for health professional education as a health improvement intervention.