For the first time a randomised trial has demonstrated improved overall survival in the most common type of leukaemia.

New landmark data indicates that adding MabThera (rituximab) to chemotherapy could extend life and double remission rates.

The data, presented at the American Society of Hematology (ASH) annual meeting, demonstrate that the addition of MabThera to chemotherapy in previously untreated patients with chronic lymphocytic leukaemia (CLL) significantly improves chances of survival.

The same trial showed that the addition of rituximab to chemotherapy doubles the number of patients achieving complete remission and lengthens the period of time before the disease returns by more than 1.6 years, compared to chemotherapy alone.

Professor Peter Hillmen, Consultant Haematologist, Leeds Teaching Hospitals NHS Trust, commented: “Never before have we seen proof that any treatment has led directly to improved overall survival in CLL. The combination of rituximab and fludarabine-based chemotherapy has proven to be a formidable partnership, sending more patients into remission, extending the period before their leukaemia returns and now increasing the length of time people survive overall. This is certainly one of the most significant steps forward we have seen in this area for a long time.”

In the CLL8 clinical trial, the number of people still living after an average observation time of 36 months was 87.2% in the rituximab plus fludarabine cyclophosphamide (R-FC) arm, versus 82.5% in the FC arm.

In a separate UK-only study, also presented at ASH, rituximab was trialled in combination with chlorambucil chemotherapy in previously untreated CLL patients. Chlorambucil is the first-line treatment option for patients who cannot tolerate a more intensive treatment regimen.

The interim results from this study indicate that adding rituximab improves the overall response rate by 17.3% compared to historical data from patients in another UK study (CLL4) who received chlorambucil alone.

Professor Hillmen, lead investigator for the CLL208 trial, explained: “The interim results are very encouraging, showing a significant increase in the overall response rate. With further analysis this could potentially offer this patient group – up to half of all CLL patients – the chance to benefit from the increased efficacy rituximab has shown with other chemotherapy combinations.”

Rituximab is licensed to treat all patients with CLL who require chemotherapy combination treatment. It has received positive recommendations from NICE and the Scottish Medicines Consortium (SMC) for first-line use in combination with FC chemotherapy and is currently undergoing appraisal with both institutions for its extended licence in relapsed and refractory CLL patients.

Jane Barnard, Chair of the CLL Support Association, commented: “This year has been exceptional in terms of advances in treatment for people with CLL. The fact that we are now at a stage where we can see improved overall survival is incredible and this news offers real hope to the many thousands of people living with this condition in the UK.”

The UK has dropped to the bottom of the official league table comparing the prices of medicines across Europe, a Government report has revealed.

For the first time, the UK lags behind Austria, Belgium, Finland, France, Germany, Ireland, Italy, Netherlands, Spain and Sweden.

The figures were published in an annual report to Parliament from the Department of Health, which sets the price paid for medicines by the NHS. The report compares the 2008 prices of the leading 150 branded medicines in 11 European countries, the USA and Australia.

The UK ranks 12 out of 13, behind the USA and all of its counterparts in Europe, with only Australia, a new addition to the list in 2007, coming out lower.

Since 2008, prices have dropped further relative to Europe as there was a cut in January 2009 and Sterling has fallen against the Euro.

Recent analysis by the ABPI puts the UK behind even Australia in the second quarter of 2009. David Fisher, Commercial Director of the ABPI, said: “What we are talking about here is the breakthrough medicines which make huge differences to people’s lives. Prices in the UK are less than in any other comparative European country, yet the UK Government, via NICE, continues to tell patients we can’t afford new medicines.

“I think patients, many of whom have paid into the healthcare pot for many years, should be asking hard questions about why they are not being allowed to get their investment back.”

Additional research by the ABPI shows that the UK spends 1% of GDP on medicines, less than half that of Greece (2.32%) and Portugal (2.17%), half that of France (2%) and two-thirds of the average of 15 European countries (1.54%).

David Fisher added: “Spending by GDP provides an indication of what is affordable. No matter what measure you use, the UK is the poor man of Europe. Patients in the UK deserve better.”

The report to Parliament also highlights the important contribution the pharmaceutical industry makes to the UK economy, with a positive trade balance of £6.2bn in 2008.

The National Institute for Health and Clinical Excellence (NICE) has decided against RoActemra (tocilizumab) for patients with rheumatoid arthritis (RA) for the second time.

The Institute has issued new preliminary guidance which recommends that RoActemra is not used in patients who do not respond to DMARDs (disease modifying anti-rheumatic drugs), and has issued a ‘minded not to recommend’ decision for RoActemra’s use in patients who cannot tolerate anti-TNF treatments.

Medical professionals and patient groups have expressed concern that this decision could leave rheumatoid arthritis patients in the UK with only two classes of biologic treatment: anti-TNFs, the first of which launched over a decade ago, and rituximab.

RoActemra is already reimbursed in Germany, Denmark, Luxembourg, France, Norway, Switzerland, Greece, Ireland, Spain, Belgium, Austria, Finland, Sweden, Bulgaria and Slovakia, leading to fears that the UK is once again trailing behind Europe in delivering new, innovative medicines.

“This is devastating news for patients suffering from a disabling, lifelong disease,” said rheumatologist Professor John Isaacs, Institute of Cellular Medicine, Newcastle University. “Tocilizumab works in a completely different way to the existing drugs and could help those who are not responding to other treatments. However if NICE remains firm, our hands are tied, reducing quality of life and function for many of our patients.”

Ailsa Bosworth, Chief Executive of the National Rheumatoid Arthritis Society, added: “We are very disappointed by NICE’s decision. This is another step backwards for patients with rheumatoid arthritis instead of the step forwards that a new class of treatment heralds. We strongly urge NICE to rethink its current stance and give patients who face a life of pain and potential disability another chance of overcoming their disease.”

Roche and Chugai have announced that they will respond to the ACD with further data to support the treatment’s cost effectiveness in both indications.

John Melville, General Manager of Roche in the UK, commented: “The unacceptable divide between UK and European healthcare continues to grow, with rheumatoid arthritis patients paying the ultimate penalty. Patients deserve to have access to these new, innovative medicines, and not just to be left with decade-old treatment classes.

“With the wealth of clinical and cost effectiveness evidence for RoActemra, we will be working hard to overturn NICE’s decision so that patients can benefit from this new treatment.”

England’s Chief Medical Officer, Sir Liam Donaldson, has decided to step down in May 2010 after 12 years of service.

Appointed in 1998, Sir Liam is the longest-serving Chief Medical Officer of modern times.

During his time in the role, he has been at the forefront of reforms to the NHS and major improvements to the country’s public health. His work and policy recommendations in the role led to many reforms including smoke-free public places, the creation of the Health Protection Agency and the introduction of clinical governance in the NHS.

Most recently, Sir Liam has been central to the UK’s response to the swine flu pandemic. As chair of the Pandemic Influenza Programme Board, he oversaw the development of the National Flu Pandemic Framework in 2007.

Although he originally planned to leave his post when he turned 60 in mid-2009, Sir Liam agreed to stay in his role as Chief Medical Officer to supervise the response to the swine flu pandemic.

Since taking up the post of Chief Medical Officer, Sir Liam has also been involved in responding to high-profile issues of public concern, including the retention and storage of children’s organs at Alder Hey Children’s Hospital and the clinical audit of the practice of Dr Harold Shipman.

Health Secretary Andy Burnham said: “Sir Liam has fulfilled his duties in this important public office with great distinction, wisdom and good humour. He has brought courage and foresight to the role of improving the nation’s health. His bold and once-controversial proposal to turn public places smoke-free shows the difference he has made.

“I am sure I speak for all my predecessors in saying it has been a privilege to work with him. I am personally indebted to him for his clear and calm advice on dealing with the swine flu pandemic. His leadership and reassurance have taken the NHS and the country through a challenging year, and his preparations for this moment over many years put us in the best position to deal with it.

“Liam is one of those rare people who combines great intellect with warmth and humanity. He will, I am sure, go down as one of the great CMOs.”

Bayer Schering Pharma’s Visanne has been cleared for market launch in Europe as a new treatment option for endometriosis.

Visanne is a once-daily oral tablet containing dienogest 2mg, developed specifically for the treatment of endometriosis.

A dedicated clinical study programme has proven that Visanne relieves endometriosis pain with high efficacy, reduces endometriosis lesions and demonstrates a favourable safety and tolerability profile. Market launch of the product is planned from the second quarter 2010 onwards.

“With Visanne, we will be able to offer women a new treatment option which can reduce the substantial burden of endometriosis,” said Phil Smits, Head of Bayer Schering Pharma’s Business Unit Women’s Healthcare. “Surgical treatment of endometriosis is associated with high relapse rates, and many currently available medical therapy options have side effects which do not allow for long-term use.

“Patients often need to use different combinations of the available treatment options and even undergo repeat surgical procedures. There is therefore a high medical need for new treatment options.”

The current standard therapy, GnRH analogue, can only be used for the short-term relief of symptoms, as safety concerns such as decreased bone mineral density and side effects such as hot flushes limit its long-term use.

Visanne has been shown to be as effective as GnRH analogue. Pain relief is sustained over time (shown in a clinical study lasting 15 months) and includes dysmenorrhoea-like pain, pre-menstrual pain, diffuse pelvic pain and dyspareunia (painful sexual intercourse).

Endometriosis is a chronic gynaecological disease defined by the presence of endometrium-like tissue outside the uterus, which induces a chronic inflammatory reaction. Its prevalence is estimated to be around 5–10% in women of childbearing age.

The National Institute for Health and Clinical Excellence has launched a new guide illustrating the support available from NICE and benefits of using NICE guidance.

Launched at NICE’s annual Conference in Manchester, How to use NICE guidance to commission high quality services explains how NICE guidance supports the commissioning of high quality services and describes how the guidance can be used throughout the commissioning cycle.

The guide is aimed at everyone involved in commissioning health and social care services, as well as public health programmes within the NHS and partner organisations in England. 

It seeks to support commissioners in developing systems and processes that entrench NICE guidance into commissioning, and also highlights sources of further information and practical help.

Val Moore, Implementation Director, said: “NICE guidance is world-renowned for setting the standard in effective and high quality healthcare services. This guide will help commissioners across England to provide the best healthcare services that meet the needs of their local populations. In such financially challenging times for the NHS, this guide will be important in helping commissioners deliver the best with their limited resources. 

“We are grateful for the support of many PCTs in the development of this guide – some of these are featured as case studies, and show how NICE guidance is being used throughout the country to deliver clinically and cost-effective healthcare.”

Gary Belfield, Acting Director General for Commissioning and System Management, Department of Health, added: “It’s a must read for all those involved in commissioning services across health and social care, and will prove a really valuable resource for board members too.”

Women with an aggressive form of breast cancer could live longer if treated with a combination of Tyverb (lapatinib) plus Herceptin (trastuzumab), recent trial data suggests.

The median survival time for those taking the investigational combination treatment was 14 months, compared to 9.5 months on monotherapy lapatinib.

The results of the Phase III study were presented during the 32nd Annual CTRC-AACR San Antonio Breast Cancer Symposium, held in Texas, USA.

The study included 296 women with ErbB2-positive breast cancer, which is characterised by an overexpression of the ErbB2 protein in the cancer cells. Patients enrolled in the study had experienced recurrence of breast cancer despite a median of three prior trastuzumab-based therapies.

The data presented at the San Antonio congress showed that patients overcame resistance to trastuzumab with the introduction of the lapatinib-trastuzumab combination.

“The clinical benefits brought forth by the lapatinib and trastuzumab combination are quite compelling and lead me to believe the agents may be acting together to form a sort of ‘dual blockade’ to obstruct the ErbB2 pathway necessary for the tumour to thrive,” said primary investigator Kimberly Blackwell, MD, Duke University Medical Center.

Patients in the study received either single-agent lapatinib or a combination of lapatinib and trastuzumab, though patients in the first group were able to switch to combination therapy if their disease progressed after four weeks. Women treated with monotherapy lapatinib experienced a median overall survival time of 9.5 months compared with 14 months when treated with the combination.

“It’s possible that, by lapatinib working inside the cell and trastuzumab working outside the cell, the combination of agents is able to provide a more complete anti-tumour attack,” said Blackwell. “To achieve a survival advantage of greater than one year for this aggressive form of breast cancer is very encouraging.”

The pharmaceutical industry (ABPI) has welcomed the proposal for a ‘patent box’ outlined by Chancellor Alastair Darling in his Pre-Budget Report.

The patent box is being introduced to encourage research and development within the UK from the pharmaceutical and biotech industries. In his speech, Mr Darling said he would bring in a 10% corporation tax rate on income that stems from patents in the UK.

The move was one of the measures outlined in the Office for Life Sciences ‘Life Sciences Blueprint’, published in July.

Dr Richard Barker, Director-General of the ABPI, said: “The ABPI commends Government for taking a step that will bring advanced pharmaceutical manufacturing investment back to Britain. It is one of the most important outcomes of the work we have been doing with Government through the Office for Life Sciences, and we look forward to working with Government to finalise the design to maximise its impact on companies’ investment decisions.”

In response to the patent box announcement, GSK has already drawn up detailed implementation plans for its first state-of-the-art UK-based biopharmaceutical manufacturing plant, which the company hopes will make the UK the future home of the latest generation of biological medicines.

GSK has also committed to manufacture the next generation of respiratory medicines at its facility in Ware, Hertfordshire.

Andrew Witty, CEO of GSK, said: “The patent box is exactly the sort of active, long-term and creative support that we need from the Government to ensure that the UK remains an attractive place for highly skilled sectors such as pharmaceuticals. For GSK, assuming the new regime will apply to patents currently under development, it will have the immediate impact of making the UK a priority area for future investments, particularly in manufacturing.”

Prime Minister Gordon Brown has appointed six new Business Ambassadors – business and academic leaders chosen to support the Government in promoting the UK’s excellence internationally.

The new Business Ambassadors include Chris Brinsmead, Chairman of AstraZeneca UK, and Lord Ara Darzi, Professor at Imperial College and former Health Minister, representing the UK life sciences industry.

The UK represents 3% of the global pharmaceutical market, but attracts 10% of all R&D. Five of the world’s top 20 medicines were discovered in the UK – and in 2007, the UK exported pharmaceuticals worth £14.6 billion, creating a £3.4 billion surplus for the UK economy.

The Business Ambassadors Network was created in October 2008, with a particular focus on helping small and medium-sized enterprises (SMEs), which sometimes face greater barriers to accessing global markets than larger businesses.

The new additions bring the number of UK Business Ambassadors to 24, enabling them to reach more audiences overseas and to provide expert coverage across a wider range of sectors.

Prime Minister Gordon Brown said: “Since the UK Business Ambassadors network was set up just over a year ago, its members have carried out over 70 international engagements in some 25 different markets, promoting British trade across the globe and playing an important role in championing UK business.

“I am delighted that a further six leaders from business and academia will be joining the team, promoting our businesses and working with them to develop opportunities worldwide and boost growth.”

The other new Business Ambassadors are: Larry Hirst, Chairman of IBM Europe, Middle East and North Africa; Lady Barbara Judge, Chairman of UK Atomic Energy Authority; Professor Julia King, Vice-Chancellor of Aston University and author of the King Review of low carbon transport; and Sir John Sorrell, Chairman of the London Design Festival and co-Chair of the Sorrell Foundation.

GSK and Intercell have formed a strategic alliance to develop and commercialise innovative needle-free patch-based vaccines.

The agreement will include Intercell’s candidate vaccine for travelers’ diarrhoea (TD) and an investigational single-application pandemic influenza vaccine, as well as the use of the patch technology for other vaccines in GSK’s portfolio.

Under the terms of the agreement, GSK will make an upfront cash contribution of EUR 33.6 million, in addition to an equity investment of up to EUR 84 million through a staggered shareholding purchase option of up to 5% in Intercell.

Gerd Zettlmeissl, Chief Executive Officer of Intercell, said: “This new partnership is combining the forces of Intercell’s innovative needle-free vaccination program and technologies with a vaccine leader’s strength in development and commercialisation.

“In addition, we can pursue our business strategy of creating significant shareholder value as an independent company whilst continuing to develop one of the most innovative product pipelines in the industry.”

The patch technology opens up a new method of vaccine delivery that could make the vaccines easier to administer and faster to deliver, and can result in lower or fewer doses.

The Vaccine Patch is a needle-free delivery technology that can be used to enhance the effect of injected vaccines, and to develop new vaccines that require transcutaneous administration because the antigen cannot be delivered safely through other routes.

“This novel technology has real potential to change the way vaccines are delivered in the future. GSK has an extensive portfolio of vaccines and we believe needle-free vaccination could offer benefits such as simplified administration and increased compliance,” said Jean Stephenne, President of GSK Biologicals.

“This agreement demonstrates how, as an integral part of our R&D program, we not only look at new vaccines but also at alternative approaches to oral and intramuscular administration.”