The NHS Commissioning Board (NCB) has appointed four PCT and SHA bosses as new regional directors.

They will form part of the senior leadership team of the Operations Directorate and will provide guidance for the NCB across their selected regions.

The appointments are as follows:

• North of England – Richard Barker, currently the Chief Operating Officer, NHS North of England and a former Director of Commissioning Development for the North East SHA
• Midlands and the East – Dr Paul Watson, currently Chief Executive, NHS Suffolk, and a former Director of Commissioning at the East of England SHA
• London – Dr Anne Rainsberry, current Chief Executive, NHS North West London and Deputy Chief Executive, NHS London
• South of England – Andrea Young, presently the Chief Operating Officer / Deputy Chief Executive, NHS South of England, and formerly Chief Executive of Oxfordshire PCT.

Ian Dalton, Chief Operating Officer of the NHS Commissioning Board Authority, said he was delighted to have four “highly skilled” directors “each with a strong track record of achievements”.

“This equips us with outstanding leadership to work with clinical commissioning groups and partners to ensure we have a strong and innovative commissioning system that improves outcomes for patients,” he said. “It also enables us to finalise the design of the regional and local presence of the NHS Commissioning Board.”

Their first tasks will be to work with PCTs, SHAs and other stakeholders to design plans for the final model of the Board’s network of local teams.

The appointments follow last week’s NCB announcement of the first wave of applications for CCG authorisation.

The first wave of applications for CCG authorisation to be confirmed by the NHS Commissioning Board Authority comprises 35 organisations across England.

The applications will take place in four waves up to January 2013.

Decisions on the first wave of applications will be made by the Board Authority by October, with all applications to be assessed by January 2013.

Health Secretary Andrew Lansley has said that by April 2013, when the NHS Commissioning Board takes on full statutory powers, as many CCGs as possible should be authorised without conditions.

The time between January and April 2013 is intended to allow for any conditions of authorisation to be met.

Dame Barbara Hakin, National Director of Commissioning Development at the NHS Commissioning Board Authority, said: “All the emerging clinical commissioning groups have made fantastic progress to prepare themselves for authorisation. We expect confirmation of which CCGs will be assessed in waves 2, 3 and 4 shortly.

“We will continue to work with all emerging CCGs over the coming months to guide and support them on their journey to establishment to ensure they are in a strong position to take on their full responsibilities.”

The wave 1 applicants are:

Bassetlaw

Blackpool

Bedfordshire

Calderdale

Cumbria

Dudley

East & North Herts

East Leicestershire & Rutland

East Riding

Gloucestershire

Great Yarmouth & Waveney

Islington

Kernow (Cornwall)

Kingston

Leicester City

Liverpool

Newbury & District

North & West Reading

North East Lincolnshire

North Staffordshire

Oldham

Oxfordshire

Portsmouth

Rotherham

Sandwell & West Birmingham

Shropshire

Somerset

South Reading

Stoke on Trent

Wakefield

Wandsworth

Warrington

West Cheshire

West Leicestershire

Wokingham

Revenue from the European biosimilars market will reach nearly $4 billion by 2017, analysts have predicted.

The market is estimated to grow at an annual rate of 56.7% in the next five years with the expirations of key patents and intellectual property providing opportunities for manufacturers.

Srinivas Sashidhar, Research Analyst at Frost & Sullivan, said upcoming opportunities will see various biosimilars enter the market and increase industry competition.

Frost & Sullivan estimates that the European biosimilars market earned revenue of around $172 million in 2010. It recognises that the industry is at a “nascent stage”, but will experience significant growth within the next decade.

But while the market offers lucrative growth prospects, smaller firms may struggle with the sizeable investments needed to exploit these opportunities.

Complex production processes, expensive biological and chemical materials and rigorous clinical trials will require significant investment and may require small and medium sized firms to merge or partner with pharmaceutical companies.

“Price reduction strategies will ensure increased adoption among physicians and patients alike, spurring market advancement,” said Srinivas Sashidhar.

“The need for considerable financial outlays will hinder the entry of small biotech firms in particular. On the other hand, specialty pharmaceutical companies with biotech expertise and financial capabilities are well positioned to venture into the biosimilars market.”

However, despite the expected growth, Frost & Sullivan warn there are still persistent uncertainties and risks for biosimilars manufacturers. Companies will need to have strong integrated R&D, production and sales and marketing divisions to ensure market access and success. Effective sales communication coupled with continuous promotional activities and constant interaction will also be key to realising potential growth, Srinivas Sashidhar added.

The ABPI and the NHS Confederation are to partner with Communiqué to share best practice in healthcare communications.

The new Communiqué Awards workshops will share experience and expertise for the benefit of industry and the NHS.

The agreement reflects recent steps by both organisations to develop closer industry-NHS partnership in order to promote the uptake of innovative therapies.

At its recent conference, the ABPI launched a new team to promote regional collaboration with the NHS through the sharing of best practice.

The NHS Confederation has since appointed Sir Keith Pearson as Chair of Health Education England, which will lead healthcare education and training from June 2012.

The new initiative takes its lead from the DH report Innovation Health and Wealth: Accelerating Adoption and Diffusion in the NHS, which said: “We need to get the brightest and best innovators to share their knowledge, learning and expertise with the NHS.”

GSK has appointed the experienced James Shannon as its new Chief Medical Officer (CMO).

Mr Shannon will succeed Ellen Strahlman in the role and have responsibility for patient safety, medical governance, ethics and integrity and medical information.

The new CMO said joining the company was an easy decision as GKS’ “values so closely match my own”.

He spent nearly 14 years at Novartis as their head of global pharmaceutical development until 2008. Since then, Mr Shannon has served on the boards of several companies and as the president and CEO of San Francisco-based biopharmaceutical company Cerimon.

“I am delighted to welcome James to GSK,” said Moncef Slaoui, GSK R&D Chairman. “Our chief medical officer is vital to the success of this organisation. As the ‘voice of the patient’ within GSK, James will ensure the interests of the patient are placed at the centre of research, development and commercialisation of our medicines.

“James’ medical leadership, combined with his extensive experience of successful drug development, makes him a valuable addition to GSK.”

Teva UK has launched a generic atorvastatin tablet on the day after the expiry of UK patent protection on Pfizer’s cholesterol-lowering drug Lipitor.

According to the British Generic Manufacturers Association (BGMA), buying generic alternatives to Lipitor could save the NHS up to £350m per year.

Pfizer could lose 85% of its UK revenue from Lipitor by the end of this year.

Atorvastatin is the most widely prescribed statin, used in millions of patients worldwide to help prevent cardiovascular disease.

Kim Innes, Commercial Director at Teva, commented: “Millions of prescriptions are written each year in the UK for atorvastatin, and the availability of the generic will save the NHS millions of pounds each year.”

“The expiration of Pfizer’s patent exclusivity on Lipitor is hugely significant for the NHS and a demonstration of the valuable role generic drugs play in patient care in the UK,” said Warwick Smith, Director General of the BGMA.

Responding to recent claims that generics harm innovation, he argued: “It is generic competition that sustains innovation. Without competition from generic products, originators could continue to make their money out of established products and the patent system would simply not work effectively.”

Roche has cancelled its dal-OUTCOMES Phase III trial after its cholesterol drug dalcetrapib failed to show any clinically meaningful efficacy.

The independent Data and Safety Monitoring Board recommended stopping the study after dalcetrapib failed to show efficacy when added to standard options of care.

Hal Barron, Chief Medical Officer and Head of Global Product Development, said Roche was “disappointed” the drug didn’t “provide benefit to patients”.

The dal-OUTCOMES trial was part of the dal-HEART global programme involving six studies. More than 35,000 patients were involved in the trials – which have also been scrapped.

Patients in the dal-OUTCOMES trial were evaluated with the use of dalcetrapib when added to existing treatment options in those with stable coronary heart disease following an acute coronary syndrome.

There were no issues regarding the safety of the drug, but the outcome comes as a setback to Roche. The Swiss-based company had hoped dalcetrapib would reach ‘blockbuster’ status and saw its share price drop by 3.5% after the trial’s closure.

“We continue to be fully committed to the development of innovative medicines for people with cardiovascular disease,” said Hal Barron. “Our pipeline remains robust with 23 positive late-stage clinical trials reporting over the past 16 months and a significant increase in New Molecular Entities in late-stage development.”

Abbott Laboratories has agreed to pay a total of $1.6bn to settle federal and state charges of off-label marketing regarding its anti-seizure drug Depakote.

The company admitted actively promoting the unlicensed use of Depakote in nursing homes to sedate dementia patients from 1998 to 2006.

The US Government alleges that Abbott exploited a loophole in the legislation protecting elderly patients from inappropriate medication.

Abbott will pay $800m to settle civil allegations, a $700m federal criminal fine and $100m in state level consumer protection fines.

Depakote is licensed by the FDA as a treatment for epilepsy, migraine and manic episodes.

Abbott has pleaded guilty to ‘misbranding’ the drug as a treatment to control agitation and aggression in elderly dementia patients.

From 1998, the company trained a special sales force to promote the off-label use of Depakote to nursing homes.

This promotion continued despite a 1999 clinical trial that showed the drug caused drowsiness, dehydration and anorexia in elderly patients.

Abbott’s marketing highlighted the fact that Depakote was not included in a list of medications banned in nursing homes under by a 1987 law.

Representing one of four ‘whistleblower’ Abbott sales representatives, attorney Reuben Guttman said: “Abbott directed its sales force to get Depakote widely used in nursing homes, principally to neutralise older patients as a substitute for proper staffing.”

Deputy US Attorney General James Cole commented: “We are resolute in stopping this type of activity and today’s settlement sends a strong message to other companies.”

NICE has issued draft public health guidance to tackle the ever-increasing problem of obesity in England using a community-wide approach.

Draft recommendations advise that activities should be integrated within wider strategies, communities be involved to gather thoughts on obesity, and that private healthcare providers be used to implement local programmes.

Professor Mike Kelly, Director of the Centre for Public Health Excellence at NICE, said the recommendations “emphasise the importance” of working with local people to tackle obesity.

The health regulator estimates that the long term consequences of obesity cost the NHS around £5.1 billion each year.

Obesity increases the risk of diabetes, heart disease and certain cancers. Currently, more than a quarter of adult population are classed as obese.

Levels of obesity are rising in England and up to 60% of men, half of women and a quarter of children could be classed as obese by 2050.

NICE aims to tackle the problem by using an integrated community approach where local government and regional bodies and networks partner to plan and implement local strategies.

The new guidance is now open for consultation with NICE welcoming comments until 6 June.