NICE has appointed two new directors to join its Senior Management Team after the departure of Professor Peter Littlejohns and the retirement of Dr Fergus Macbeth.

Professor Mark Baker (pictured) has been appointed Director of the Centre for Clinical Practice and Alexia Tonnel will join as Director of Evidence Resources.

Sir Andrew Dillon, NICE Chief Executive, says the two have “a wealth of experience in their respective fields”.

Professor Mark Baker has previously worked as Chief Executive of Bradford Teaching Hospitals, Director of Research and Development for the Yorkshire Region and Director of the Yorkshire Cancer Network.

He has worked at NICE for almost a decade on the Guidelines Programme and has chaired two clinical guideline development groups. Since 2009, Professor Baker has also worked as a consultant advisor to the Institute.

“I am truly delighted and honoured to be able to lead the guidelines and prescribing centre work and to join the Senior Management Team in taking forward the challenging work programme for NICE in the coming years,” commented Professor Baker.

New Director of Evidence Resources Alexia Tonnel also has previous experience of working with NICE. For the past two years she has worked as a Programme Director redesigning and managing the processes for the provision of content into NHS Evidence and leading the development of new products.

She commented: “I am very pleased to be asked to lead the Evidence Resources directorate and honoured to be managing this highly talented and dedicated team. I look forward to working with the Senior Management Team of NICE to prepare for and implement the continued transition of the organisation and its products into a new digital era.”

Alexia Tonnel will begin her role 12 March and Professor Baker start his position on 2 April 2012.

Ranbaxy has launched its generic version of Pfizer’s Lipitor in four major EU markets with temporary exclusivity.

The Indian company’s generic atorvastatin has been launched in Germany, Italy, Sweden and the Netherlands ahead of its EU patent expiry in May.

The launch follows a 2008 agreement with Pfizer that Ranbaxy could launch its generic atorvastatin exclusively while Lipitor was still protected, in return for dropping a patent challenge.

Ranbaxy launched its generic version of the cholesterol-lowering drug in the US in November 2011, with a 180-day exclusivity period that is now ending. The generic caused fourth-quarter US sales of Lipitor to fall by 42% relative to the same quarter in 2010.

The market for statins remains highly lucrative despite concerns over their potential side-effects, including an increased risk of type 2 diabetes. Lipitor is the highest-selling drug in Italy, with annual sales of $377m.

Ranbaxy will sell its generic atorvastatin in Germany through its subsidiary Basics GmbH, with marketing assistance from Daiichi Sankyo.

From the end of May, other companies will be able to launch generic versions of Lipitor in the EU.

The Greek parliament has made prescribing of branded (as opposed to generic) drugs by state healthcare providers a criminal offence.

Further legislation rushed through under the EU bailout agreement will force drug suppliers to pay back any overspending on the reduced drugs budget.

Overall spending on medication by Greece’s social insurance funds has been capped at €2.88bn for this year.

From April 1, clinicians may only prescribe generic drugs in the 10 leading therapeutic classes; from June 1 this will apply to all reimbursed medications.

The Greek health service will reimburse only for the cheapest product in each class. Prescribing anything other than the cheapest generic product, except on a private basis, will now be a criminal offence.

Greek Health Minister Andreas Loverdos has said he aims to cut €1bn from the nation’s drug spending in 2012.

The new legislation was demanded by the economic ‘troika’ of the EU, the European Central Bank and the IMF in return for Greece’s €130bn bailout.

The troika and the Greek health authorities are also reported to be planning a ban on the introduction of new medicines into Greece until they have been accepted for reimbursement by 8–10 other EU countries.

The implications for Greek pharmaceutical companies, and for multinational companies investing in Greece, are serious. These companies are currently owed major sums by the Greek public hospitals, while the government bonds that have been used to pay some international debts are now worth very little.

The medical debt crisis is also spreading across Portugal, Italy and Spain, with unpaid debts by EU health systems to pharma companies now standing at €12–15bn. About half of this is currently owed by Spain’s regional governments.

Richard Bergstrom, Director General of EFPIA, commented: “Things are getting rapidly worse.”

A drug to treat alcoholism has been shown in phase III trials to reduce alcohol consumption by an average of 66% in six months.

Selincro (nalmefene), made by specialist Biotie in partnership with Lundbeck, is claimed to be a breakthrough in the treatment of alcohol dependence.

However, the effect of placebo – reducing alcohol consumption by 50% – in the same trials has weakened the impact of the results.

Selincro is an opioid system modulator that inhibits the reward pathway in the brain, reducing the craving for alcohol and other addictive substances.

Alcohol dependence affects an estimated 14 million people in the EU, but only 13% of these receive any treatment.

The first medicine aimed at reducing alcohol consumption, Selincro is currently being appraised by the EMA.

Lundbeck presented results from three phase III studies, ESENSE 1, ESENSE 2 and SENSE, with almost 2,000 patients – all of whom were given medical advice and support in reducing their alcohol intake. The drug was taken when the patients perceived themselves to be at high risk of drinking.

In ESENSE 1, patients taking Selincro showed a decline in heavy drinking days per month from 19 to 7 and in alcohol consumption from 84g to 30g per day; patients on placebo showed a drop from 20 days to 10 and 85g to 45g per day.

In ESENSE 2, the Selincro arm showed a drop from 20 to 7 days and from 93g to 30g; the placebo arm showed a drop from 18 to 7 and from 89g to 33g.

In SENSE, the results were: for Selincro, a drop from 15 to 5 days after six months and to 3 days after one year, and from 75g to 22g after six months and 16g after one year; for placebo, a drop from 15 to 6 days and from 75g to 27g after six months, with no further change after one year.

While the differences in outcomes between Selincro and placebo are statistically significant, they are much smaller than the impact of patient guidance and support.

However, Timo Veromaa, CEO of Biotie, commented: “Selincro has the potential to transform the way alcohol dependence is managed by both physicians and patients and we look forward to working with our partner Lundbeck and the regulators to make this important new treatment option available in Europe.”

Biotie has licensed global rights to the product to Lundbeck for an upfront payment of €12m total and a potential further €72m in milestone payments and royalties on sales. Lundbeck will be responsible for manufacturing and seeking regulatory approval for Selincro.

Based in Finland, Biotie specialises in developing treatments to address major unmet needs in neurological, psychiatric and inflammatory diseases. It partners with pharmaceutical companies (including Lundbeck, Roche and UCB) for late-stage development and commercialisation.

The Selincro trial results will fuel debate about the value of placebo-controlled trials relative to head-to-head drug trials.

The Government has again made amendments to its Health and Social Care Bill as it attempts to address Liberal Democrat concerns.

Further safeguards have been added over private patient income and to clarify and extend the compliance powers of Monitor over foundation trusts.

Health Minister Earl Howe hopes the amendments will provide “ongoing reassurance that the NHS will always operate in the interests of patients”.

However, the series of amendments which have been added to the Bill during its passage through Lords are still not enough for certain Liberal Democrats. Activists are aiming to hold a vote to axe the reforms at the party’s spring conference later this week.

The amendments to the powers of Monitor will now see it able to direct foundation trusts to change their boards when there are concerns it “will fail to comply with the conditions of its licence”, said Earl Howe.

Although it will not maintain its existing compliance regime over trusts, it will mean the regulator continues its extensive powers over foundation trusts until the health secretary makes a parliamentary order.

Changes have also been made on the issue of trusts benefiting from income from private patients. The amendments will now mean trusts will have to declare annual plans to increase non-NHS income. If these plans aim to increase income by five percentage points of overall income, the Department of Health would then have to agree to the proposals.

“The principles of our modernisation plans – doctors and nurses making decisions, patients being at the heart of the health system, and less bureaucracy – have always been at the core of the Bill,” said Earl Howe.

“These principles are widely accepted according to the independent NHS Future Forum. We will continue to work with peers to provide the reassurance and clarity necessary as the Health Bill progresses through Parliament.”

The controversial Health Bill returns to the Lords this afternoon.

Merck KGaA saw record-breaking levels of revenue in 2011 as sales topped €10 billion for the first time.

Revenue was up 10.6% to €10.2 billion following the 2010 acquisition of the Millipore Corporation and growth in the Group’s four divisions – Merck Serono, Merck Millipore, Consumer Healthcare and Performance Materials.

Karl-Ludwig Kley, Chairman of Merck’s Executive Board, said the Group delivered a “good operational result in a challenging year” but confirmed that despite topping €10bn in revenue job cuts would still be made.

The company revealed last month it plans to cut jobs across all businesses and regions under new efficiency plans it aims will reduce costs and exploit new growth opportunities. (Read here)

Mr Kley says that the efficiency plans recognise the “competitive and market pressures” Merck faces in the future.

Despite the record breaking levels of revenue, overall operating result was down 11.5% to €985 million and net profits decreased 2.3% to 617 million Euros.

Sales increased by 17% to €2.78 billion and gross margin rose by 8.4% to €7.4bn. However, marketing and selling expenses were up 7.1% to €2.39bn and royalty, licence and commissioning expenses increased after increased sales of Rebif and Erbitux. R&D costs also jumped to €1.5bn after expensive late-stage clinical trials by Merck Serono.

Total revenues of Merck Serono increased 2.9% to €5.92bn compared to €5.75bn in 2010, which was described as a “solid performance” by the Group. Global sales of Rebif topped €1.69bn after increased demand in the US. Targeted cancer treatment Erbitux recorded sales of €855 million due to strong growth in emerging markets.

In Merck’s other divisions, Merck Millipore almost increased sales by half (48%) to €2.39 billion after growth in North America, Latin America and Asia. Its consumer health care arm saw revenue increase 5.1% to €484 million in 2011, and its Performance Materials division increased revenue slightly by 1% to €1.46bn.

The Group’s Executive Board now expects total revenues to increase slightly in 2012 and 2013.