The company said that the European Commission’s decision came after a positive recommendation from the CHMP.

Viramune’s SmPC has been updated to show that clinical studies have indicated the treatment is linked to an increase in HDL cholesterol, as well as an overall improvement in the total proportion of HDL cholesterol within the body.

Dr Manfred Haehl, Senior Vice President of Medicine at Boehringer Ingelheim, stated that the firm is “very satisfied” with the Commission’s decision.

“Physicians treating patients with HIV need to have a range of treatment options available so they can tailor the therapy to the individual patient’s need and response,” he added.

Cancer Research UK figures have revealed that the mortality rates for breast, bowel and male lung cancer are at their lowest since 1971.

Harpal Kumar, Chief Executive of Cancer Research UK, said: "Years of research are behind the dramatic progress being made in the fight against Britain’s common cancers.

"Survival rates have doubled in the last thirty years and the work of Cancer Research UK has been at the heart of that progress.”

The figures show that breast cancer deaths peaked in 1989, when 15,625 women died from the disease. The latest figures (from 2007) showed the figure having dropped to 11,990.

For bowel cancer the mortality rate peaked in 1992 at 19,598 deaths, but was down by 31% in 2007.

The number of men dying from lung cancer was down by 53% in 2007 from the number in 1979.

The Blueprint aims to transform the UK environment for life sciences companies and ensure faster patient access to cutting-edge medicines and technologies.

NICE has supported the new Blueprint and announced changes to its own interactions with the pharmaceutical industry to create a better working relationship.

As part of the new agreement, the Government and NICE will introduce an ‘Innovation Pass’, a three-year initiative that will make selected innovative medicines available on the NHS for a time-limited period. The Pass will be piloted in 2010/2011, with a budget of £25 million.

Lord Darzi, Health Minister for Quality and Innovation, said: “Establishing a culture of innovation is essential for the NHS to meet any current economic challenges, and the Life Sciences Blueprint will help us continue to support this country’s knowledge industries and ensure that we benefit from the competitive edge which they provide.”

In welcoming the Blueprint, NICE emphasised the importance of the life sciences industry both to patients and to the UK’s economy. Chief Executive Andrew Dillon went on to explain how NICE will be changing how it works with companies to increase confidence in its product evaluations.

“Later this year, we will begin asking pharmaceutical and other life sciences companies whose products we are evaluating to make technical staff available to engage with our advisory Appraisal Committees,” he said. “They will be able to respond to requests from committee chairs to clarify the data they have submitted and to point out any error of fact in the presentation of their data.”

Other features of the Blueprint include a review of system incentives to accelerate the uptake of medical technologies, a greater emphasis on research and clinical trials in the next NHS Operating Framework, the formation of a UK Life Sciences Super Cluster to co-ordinate work across industry, Higher Education and the NHS, and the investment of an extra £1 million to promote the UK and NHS brands at flagship life sciences events.

In addition, the Technology Strategy Board will launch an £18 million ‘RegenMed’ programme of investment to support commercial R&D with additional funding from the Medical Research Council, the Engineering and Physical Sciences Research Council, and the Biotechnology and Biological Sciences Research Council.

Glucocorticoids are widely used to treat inflammatory conditions such as asthma and rheumatoid arthritis, but also cause bone loss and can increase the risk of fracture in up to 50% of patients on long-term glucocorticoid therapy.

This approval in glucocorticoid-induced osteoporosis (GIO) represents a fifth indication for Aclasta, which is already approved to treat osteoporosis in men and postmenopausal women, including those who have experienced a low-trauma hip fracture.

The new indication is based on study data published in the Lancet, which showed that Aclasta, given once a year as a 15-minute infusion, is more effective at treating bone loss than daily oral risedronate, a currently established therapy.

"Oral bisphosphonates have been used for many years for the treatment of GIO, but they are associated with poor compliance as patients frequently fail to take them as prescribed," said Professor David Reid, Head of the Division of Applied Medicine at the University of Aberdeen. "Available data show that patients who remember to take their medicines only half of the time receive little or no protection."

He added: "The approval of Aclasta is a significant step forward, as it is more effective and faster-acting than a current established therapy for the treatment of GIO and has the advantage of year-long compliance and sustained osteoprotection."

Aclasta is the only bisphosphonate approved in the EU and US to reduce the risk of fractures at all key osteoporotic fracture sites. It is also approved to treat Paget’s disease of the bone.

"This European approval marks another important achievement for Aclasta by adding to the broad spectrum of patients who can now be treated with this therapy," said Trevor Mundel, MD, Global Head of Development at Novartis Pharma AG. "Since its launch in 2007, Aclasta has been used in more than 500,000 patients, demonstrating that an annual infusion has become a valuable treatment option."

The decision followed a positive opinion from the new Committee for Advanced Therapies (CAT) and the Committee for Medicinal Products for Human Use (CHMP).

ChondroCelect, from TiGenix NV, is a cell-based medicine that is used to repair defects in the cartilage of the femoral condyle (the end of the thighbone) in the knee.

The treatment consists of chondrocytes (cartilage-forming cells) that are taken from a healthy region of the patient’s cartilage, grown outside the body, and then re-implanted during surgery.

ChondroCelect is the first product to benefit from the new legal and regulatory framework for advanced therapy medicinal products, which was designed to ensure these treatments gain access to the EU market and to encourage competitiveness between pharma companies in the field.

The CAT assessed the scientific data provided to support the marketing authorisation application for ChondroCelect. On the basis of their positive opinion, the CHMP also recommended the therapy be granted marketing authorisation.

As part of the application, the company has been asked to submit a risk management plan with a series of measures, including further studies to ensure that the medicine’s efficacy and safety are followed up in a robust manner once it is on the market.

The research team, led by Professor Clive Robinson, has identified novel, drug-like chemical compounds that combat asthma and allergic diseases of the nose, eyes and skin.

Asthma and allergic conditions such as rhinitis, conjunctivitis and dermatitis are an escalating problem expected to affect more than 100 million people globally by 2011.

In the UK, 5.2 million adults and 1.1 million children currently receive treatment for asthma, creating a significant social and healthcare burden for the NHS.

The Allergen Delivery Inhibitors being developed by Professor Robinson and his team target allergens excreted by dust mites, tiny creatures that live in the carpets and soft furnishings of homes, offices, trains, planes and cars.

The team at St George’s will work with pharmaceutical research and development contractors worldwide to develop a drug for clinical trials in the next few years.

This latest award comes from the Seeding Drug Discovery initiative, and follows more than £1 million of Wellcome Trust support for the programme since 2005.

The recommendation is for the product in powder and solvent solution, intended for the suppression of chronic pulmonary infection due to Pseudomonas aeruginosa in patients with cystic fibrosis (CF) aged 18 years and older.

Cayston, when given as a 28-day three times daily course of treatment, is shown to improve pulmonary function in adult CF patients suffering from chronic pulmonary infection due to Pseudomonas aeruginosa.

A conditional marketing authorisation is granted to a product that fulfils an unmet medical need when the benefit to public health of immediate availability outweighs the risk inherent in the fact that additional data are still required.

It is likely that Gilead will be required to provide comprehensive clinical data at a later stage.

The active substance of Cayston is aztreonam, an antibacterial medicinal product for inhalation use only. Aztreonam binds to penicillin-binding proteins of susceptible bacteria, including P. aeruginosa, which leads to inhibition of bacterial cell wall synthesis, followed by cell lysis.

The Bournemouth-based company has become a partner in the Peter Jones Foundation, which aims to train a new generation of business leaders through the National Enterprise Academy (NEA).

The NEA, a brainchild of Peter Jones, will offer the UK’s first full-time accredited courses in Enterprise and Entrepreneurship, providing 16–19 year olds with an opportunity to develop the skills and knowledge necessary to succeed in the modern business world.

Ceuta will contribute a three-year package of support worth up to £300,000: mentoring and coaching, lecturing on various topics, training through its New Life training division, and offering work placements.

Edwin Bessant, CEO of Ceuta Healthcare, said: “We are living through difficult economic times at the moment, and this country needs strong, skilled and confident entrepreneurs coming through to help maximise recovery when it comes. There is a wealth of undiscovered talent in young people in this country, and whatever can be done to unearth that I am very proud to play a part in.”

The CHMP recommended the approval of EU marketing authorisations for the following:

· UCB’s Cimzia (certolizumab pegol) for rheumatoid arthritis

· Pierre Fabre’s Javlor (vinflunine ditartrate) for carcinoma of urothelial tract

· Bristol-Myers Squibb and AstraZeneca’s Onglyza (saxagliptin) for type 2 diabetes mellitus.

· Centocor’s Simponi (golimumab) for rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.

Positive opinions were also adopted for the following generic medicines:

· Viagra generic Vizarsin (sildenafil), from Krka, d.d., Novo mesto

· Topotecan Teva (topotecan hydrochloride), a generic of Hycamtin, to treat ovary carcinoma, small cell lung cancer and carcinoma of the cervix

A total of 13 clopidogrel-containing medicines were also given positive opinions – these are all generics of Plavix and are intended for the prevention of atherothrombotic events.

The Committee reversed its previous negative opinion on Gilead’s Cayston (aztreonam lysine) for the suppressive therapy of chronic pulmonary infection caused by Pseudomonas aeruginosa bacteria in adults with cystic fibrosis.

Several extensions of indication were also approved:

· Roche’s Avastin (bevacizumab) – adding combination therapy with docetaxel chemotherapy to the first-line treatment of metastatic breast cancer

· Merck Sharpe and Dohme’s Januvia (sitagliptin), Tesavel (sitagliptin) and Xelevia (sitagliptin) – allowing the use of sitagliptin as monotherapy

· Novartis’ Xolair (omalizumab) – extending the existing indication to paediatric patients from 6 to less than 12 years of age.

In June this year, NICE announced that the guidance remains unchanged despite recognising significant errors within their model. Eisai and Pfizer have decided not to appeal the decision, however, on the basis that NICE has promised to review the existing guidelines.

Nick Burgin, Managing Director of Eisai, commented: "While we shared the disappointment of many on hearing NICE’s decision, we have decided not to appeal. The fundamental reason for this is that on June 11th, Andrew Dillon, NICE Chief Executive, committed to commence a review of the existing guidance ‘as soon as possible’, as long as no appeals were received.

“It is therefore right that Eisai and Pfizer do all we can to allow NICE to honour its stated commitment and to take into account new data that have become available as well as advances in economic modelling techniques."

Eisai and Pfizer have stated that they are committed to working with NICE and call upon the Institute to provide a timeline for the review as a matter of urgency.

Since its inauguration in 1995, the Agency has worked continuously to improve the transparency of its operations, often extending the levels of transparency beyond the existing legal requirements.

The new policy brings all these initiatives together and describes, for the first time in one comprehensive document, the Agency’s vision on its level of transparency towards its stakeholders.

The policy proposes to focus on three main objectives for achieving a robust and consistent approach towards transparency in all areas of its activity.

The first of these is to make the daily operations of the Agency more transparent. This will include a re-assessment of the balance between transparency and the protection of commercially confidential information. It also aims to be more proactive in disclosing details about the scientific evaluation of medicines.

The second is to strengthen the Agency’s interaction with its stakeholders, in particular patients and healthcare professionals. The eventual aim is for patients and HCPs to be consulted on the evaluation of drugs at the same level as the Agency’s scientific committees.

The third objective is to work with authorities in the member states to promote a harmonised approach to transparency across the EU, including consistent implementation across Europe.

The EMEA is inviting comments on its draft transparency policy until 25 September 2009. The publication of the final document is currently planned for the end of 2009.

The next three years had been earmarked as a cliff edge for many pharmaceutical companies with a number of the world’s drug blockbusters, such as Pfizer’s Lipitor and Eli Lilly’s Zyprexa, due to see their patents expire, but national patent and trademark firm Mathys & Squire is more optimistic.

Following the EPO’s decision, the company expect that pharmaceutical and biotech patent claims directed at new administration regimens, for example a change to dosage recommendations for an existing drug, will be considered more favourably in Europe, giving the sector a new focus.

Martin MacLean, partner at Mathys & Squire, commented: “Historically, the EPO has generally refused to grant dosage regimen claims on the basis that any underlying technical effect constitutes a method step that a physician would typically perform. Such method steps fall within a statutory exclusion and are therefore unpatentable.

“This approach has had a negative impact on the industry as patents have been refused without the need for thorough assessment of their respective merits under the more conventional metrics of novelty and inventive step.”

The shortfalls of this approach were first acknowledged in October 2004, when the EPO granted a patent for a new dosage regimen based on the cyclical administration of Insulin-like Growth Factor (IGF-1). Since this landmark case, there have been signs of a more favourable approach by the EPO to this type of patent claim category, which has separately found support by the UK Court of Appeal in a case involving Actavis and Merck.

Martin MacLean added: “If the Enlarged Board affirms the Genentech approach, it will pave the way for second-generation patent claims and provide potential patent protection for key commercial products long after the first generation ‘master’ patents have expired. This, in turn, is likely to have a dramatic impact on the sector and its ongoing revenue.”

During the opening session of the Pacific Health Summit, Chief Executive of the company Christopher Viehbacher said the whole industry has a “collective responsibility to assist patients across the globe during the current pandemic”.

He added that the company’s flexible donation of preventative medication is to help the body address the needs of the most vulnerable populations.

Once production begins, 10% of the A(H1N1) vaccines will be put to one side to go to communities in developing locations.

Mr Viehbacher asserted that the future of the sector is linked to healthcare solutions that can be found for emerging countries. "By pooling our collective strengths, as well as our dedication and our motivation, we can save millions of lives," he added.

ABPI Director General Richard Barker described the move as an important first step towards putting life sciences at the forefront of the UK’s economy.

He said: “The economy and NHS patients need our country to lead in life sciences. Many great discoveries begin in small companies, many of which face an urgent funding crisis. Meeting this need is an important signal of Government’s intent and a first step towards delivering against an ambitious strategy to put UK life sciences at the forefront of our country’s economic and health future.”

The UK Innovation Fund (UKIF) will be made up of £150 million cornerstone investment from the Government which will leverage significant investment from VCs, institutional investors and large pharmaceutical companies.

The UKIF will hope to raise £1 billion to invest over a ten year life span and will invest in life sciences, clean technology, advanced manufacturing and digital Britain.

Clive Dix, Chairman of the BioIndustry Association (BIA), commented: “The Government’s plan for an Innovation Fund will make a significant contribution to securing the long-term health of the life science sector in the UK, providing much needed follow-on investment to early-stage companies developing innovative technologies for the patients that need them.

“This is an excellent first step towards delivering an integrated strategy for life sciences and we look forward to the announcement of a full package of measures from the Office for Life Sciences expected in July.”

The CHMP recommendation states that the new prolonged-release formulation is indicated for treatment of the signs and symptoms of idiopathic Parkinson’s disease, alone or in combination with levodopa.

"This effective new treatment option combines the trusted clinical benefits of Mirapexin with the convenience of a single daily dose,” commented Dr. Manfred Haehl, Boehringer Ingelheim’s MD and Senior Vice-President, Medicine.

“In addition to benefiting from the high therapeutic value of Mirapexin, the reduced pill burden will mean added convenience for patients and their carers. It is important for physicians to have effective and flexible treatment regimens to choose from so that they can offer individualised treatments in line with the patient’s needs," Haehl added.

Pramipexole was first approved in 1997 for the treatment of the signs and symptoms of idiopathic Parkinson’s disease, as monotherapy or in combination with levodopa. It was also was approved in 2006 to treat the symptoms of moderate to severe idiopathic Restless Legs Syndrome (RLS).

A study funded by the Trust published this year shows that the survival of children and young adults with bone cancer in the UK has not improved for 20 years.

More research is urgently needed to find new treatments, says the Trust. It also urges that when new treatments are developed, they are introduced without delay to avoid any more young people dying of this disease.

On average, a young person cured of the disease would have another 60 years of life.

One new treatment for osteosarcoma that improves survival is currently being considered for funding by NICE. The BCRT has asked that this drug be made available as quickly as possible.

Michael Francis, Chairman of the BCRT, said: “Too many of the children and young people with bone cancer still die from their disease. We need to make bone cancer a priority and we urgently need more research to identify effective new treatments. The Government needs to play its part and streamline the process for introducing new treatments into the UK.”

An awareness week was held during June 2009, focusing on the need to improve survival for young people with this disease, and demanding greater priority, more research and new treatments. The week finished with a conference for patients and their supporters, which covered recent research and gave patients the opportunity to question experts in bone cancer.

Twenty-eight year-old Hannah Millington from Bromsgrove, who has been treated for osteosarcoma, said: "’Awareness Week and the Patients’ and Supporters’ Conference are key events for patients. They are an opportunity to raise awareness about this awful disease and to meet other people who are affected. Bone cancer is quite rare and it is easy for young people with the illness to feel extremely isolated."

The Awareness Week was supported by, the Teenage Cancer Trust, Sarcoma UK, Cancer 52 and the Rarer Cancers Forum.

The decision was based on data from a comprehensive clinical development programme involving 4,148 patients that assessed the safety and efficacy of saxagliptin as a once-daily therapy.

Saxagliptin belongs to the class of dipeptidyl peptidase-4 (DPP-4) inhibitors. These are designed to enhance the body’s ability to decrease blood sugar (glucose) when it is elevated by acting on the natural hormones, incretins, thereby increasing insulin production, and by reducing the liver’s production of glucose.

The recommended indication is as an add-on therapy in combination with metformin,

Sulphonylurea or a thiazolidinedione, when these treatments alone do not provide adequate glycaemic control.

Manufacturers Bristol-Myers Squibb and AstraZeneca expect the European Commission to issue its decision on a marketing authorisation for this investigational drug in the coming months.

The company says its decision does not alter its commitment to working within the Code of Practice and, to reiterate this, has recently strengthened its internal compliance procedures.

Roche was suspended from the Association in 2008 after making payments to clinics that prescribed its obesity drug Xenical.

In a statement, Roche said: “Our time away from the ABPI has enabled us to reflect upon the nature of this relationship and consideration of mutual needs for the future. We have concluded that this is something we need to review further and for that reason, we have decided not to re-join the ABPI for the time being.”

The ABPI receives a six-figure annual subscription from Roche and it is rumoured that the Association is disputing the company’s right to leave. President Chris Brinsmead told the Financial Times: “Roche is thinking through the situation. There is an ongoing dialogue. Technically it is still a member. The ABPI doesn’t want to see any member walk away. A unified front makes sense.”

Roche has also announced plans to drop its membership of the Pharmaceutical Research and Manufacturers Association (PhRMA) in the US. Following its acquisition of biotech company Genentech, it has suggested that membership of the Biotech Industry Organisation (BIO) is a more logical choice.

US spokesperson Darian Wilson said: “Genentech and Roche believe BIO’s purpose is closely aligned with the direction of the new company and can therefore represent the company’s interest in Weshington.”

The Global Fertility Academy has been developed for physicians active in treating infertility and aims to improve their knowledge of clinical standards in fertility and maximise the success rates of treatment by providing valuable educational tools and sharing best practices.

The newly launched website, www.GlobalFertilityAcademy.org, provides an online learning platform, covering topics ranging from the diagnosis of infertility to the business management of fertility clinics.

After the participants have passed a mandatory e-learning module test, they can register for one of five different practice sessions proposed by over 20 selected leading in vitro fertilization (IVF) centers in Europe, North and Latin America, Asia and Australia and last for one week.

"The goal of the Global Fertility Academy is to share the experience of practicing fertility specialists to train physicians, researchers and fertility center staff in the theory, application and implementation of state-of-the art methods in the treatment of infertility," said Dr. Antonio Pellicer, a Professor of Obstetrics and Gynaecology and one of the Academy’s faculty members.

"This will be a valuable tool to provide the next generation of fertility professionals with the skills and excellence required to meet the needs of our patients."

As part of the agreement between the two companies, Johnson & Johnson will invest $1 billion in Elan in exchange for 18.4% of Elan’s outstanding ordinary shares.

The AIP Program, in collaboration with Wyeth, aims to develop and commercialise selective products for the treatment and/or prevention of neurodegenerative conditions, including Alzheimer’s disease.

Johnson & Johnson’s affiliate company will continue Elan’s activities with Wyeth under the AIP Program. The company will also initially commit up to $500 million to continue the development and launch of bapineuzumab, a potential first-in-class treatment for slowing the progression of Alzheimer’s disease, as well as other compounds.

For the transfer of these assets, Elan will receive a 49.9% equity interest in the newly formed affiliate company, as well as a 49.9% share of the profits and certain royalty payments upon the launch of any products.

The AIP Program includes multiple compounds being evaluated for slowing the progression of Alzheimer’s disease. The lead compound (bapineuzumab) is currently in Phase 3 clinical trials and a subcutaneous formulation is currently in Phase 2 trials. A vaccine for Alzheimer’s disease (ACC-001) is also under development.

Dale Schenk, Chief Scientific Officer for Elan, commented: “It is our responsibility to ensure that this therapy, upon further clinical and regulatory progress, may be made available to the broadest range of patients globally. The capabilities of Johnson & Johnson will help in achieving that goal."

Husseini Manji, head of neuroscience at Johnson & Johnson, added: "We expect to focus our resources on bringing the AIP Program to fruition as quickly as possible because of its potential to slow the progression of Alzheimer’s disease."

This is the company’s second subsidiary in Europe as it expands its operational presence beyond its French headquarters to support the launch of its next generation emergency contraceptive, ellaOne.

HRA Pharma UK will handle local marketing, sales and distribution of ellaOne, as well as that of its product Lysodren, indicated for the symptomatic treatment of advanced adrenal cortical carcinoma.

Tony Fraser has been named HRA Pharma UK’s General Manager. Mr Fraser has over 15 years of experience in the pharmaceutical industry, most recently as business unit director at Schering-Plough for the company’s UK-based substance misuse and virology division.

“Since the UK is Europe’s largest market for emergency contraception, we felt it was imperative to create a local entity with skilled management to support ellaOne’s upcoming launch,” said Dr Erin Gainer, CEO of HRA Pharma. “As a company who, for over a decade, has been committed to providing social programs, education and solutions to improve reproductive health as a part of our mission, we look forward to bringing ellaOne to the UK as a complementary tool in this important public health endeavour.”

HRA Pharma is a privately-held European pharmaceutical company that designs products, devices and supporting services in reproductive health and endocrinology.

HRA Pharma established its first European subsidiary in Germany in late 2008. Now with teams on the ground in three European countries, the company plans to pursue other key European markets in the months to come to support ellaOne, as well as to handle the local distribution of other products.

A team of dermatologists in Portsmouth found that since 2000, summer referrals are on average 41% higher than during the preceding winter months.

The largest increase was in summer 2008, when referrals were 64% higher than the preceding winter and 41% higher than summer 2007. This correlated to increased media coverage of skin cancer at the time.

The researchers examined data about referrals to their hospital dermatology department for suspected skin cancers, as well as the number of confirmed cases. They then looked at press reports from the same time periods and surveyed local GPs.

Local cancer network data from 2007 and 2008 showed a similar rise across the region, excluding the possibility that this particular department was seeing a higher number of referrals than other clinics.

It was not just referrals that increased but also actual diagnoses of skin cancers. Pathology data comparing the year 2006/7 to 2007/08 confirms an increase of 47% for melanomas and 15% for squamous cell carcinomas diagnosed by the dermatology department.

In addition, the team identified a marked increase in local and national media reports on skin cancer in 2008 compared to 2007.

A survey of local GPs revealed that 93% felt they were seeing more patients concerned about skin cancer than five years ago, with just over half (53%) noticing a specific increase in 2008.

Nina Goad of the British Association of Dermatologists said: “IIn 2008, the national Sun Awareness campaign received its highest level of media coverage to date, and it is so encouraging to think this might be making a difference and contributing to a 47% increase in melanoma diagnoses. Early diagnosis is crucial with melanoma, and this proves how helpful the media have been to our campaign.”

The approval makes Tracleer the only PAH therapy with an approved pediatric formulation for treating children from two years of age.

The therapy has also recently been proven to be a cost-effective treatment for adult PAH patients.

PAH is a severe condition in children with an estimated median survival of 10 months after diagnosis if left untreated. The new dispersible tablet formulation of bosentan allows a more flexible dosing regimen according to low body weight.

Professor Maurice Beghetti, Head of the Pediatric Cardiology Unit at Hôpital des Enfants, Geneva, commented: "Ensuring correct dosing for children is a challenge we face across all diseases but particularly in orphan diseases that affect children. This pediatric formulation for Tracleer is a large step in the right direction towards developing treatment with the needs of children specifically in mind."

Tracleer is currently approved in Europe for the treatment of PAH; in WHO Functional Class III to improve exercise capacity and symptoms and in WHO Functional Class II where some improvements have also been shown.

Recent research using a cost utility model has suggested that Tracleer is a cost effective first-line treatment option for patients classified as WHO functional class III.

The research was published online in Value in Health, the journal of the International Society for Pharmacoeconomics and Outcomes Research, and simulated the treatment of 10,000 hypothetical patients in two treatment groups: Tracleer plus palliative care and palliative care only.

Dr Matt Stevenson, lead researcher, University of Sheffield, commented: “Long-term follow-up data from randomised controlled trials show that bosentan significantly delays progression to more severe states compared with no active intervention. This results in both potential cost-savings due to a reduction in the duration of relatively expensive epoprostenol treatment and in an improvement in the quality of life of patients.”

MabThera was recommended in combination with fludarabine and cyclophosphamide (FC) chemotherapy for previously untreated patients with the UK’s most common form of leukaemia, chronic lymphocytic leukaemia (CLL).

When added to FC chemotherapy, research shows that rituximab more than doubles the number of CLL patients achieving complete remission and halts the progression of the disease for almost a year longer than chemotherapy alone.

Dr John Davies, Consultant Haematologist at Western General Hospital, Edinburgh, commented: “The addition of rituximab to chemotherapy is a major advance in the treatment of CLL and this is very welcome news for the entire CLL community. The guidance from the

SMC means that as of today, physicians in Scotland are able to prescribe rituximab for their patients, allowing many to enjoy longer periods of remission without debilitating symptoms.”

The decision supports an important part of rituximab’s broader licence for use with any suitable chemotherapy, which was granted by the EMEA in March 2009.

In the pivotal clinical trial, the addition of rituximab to FC chemotherapy extended progression-free survival by 10.5 months when compared to chemotherapy alone (3.5 years vs. 2.7 years). In addition, the number of patients achieving complete remission was more than twice that of chemotherapy alone (36% vs. 17.2%).

Jane Barnard, Chair of the CLL Support Association, said: “This recommendation puts Scotland in line with many other countries where rituximab is widely used. Every month that can be added to remission is incredibly valuable for a CLL patient, and rituximab has the potential to increase this time for many people.”

NICE is currently reviewing rituximab for England and Wales, with the final guidance expected at the end of July.

Twelve companies received recognition for their outstanding achievements at the BCE Environmental Leadership Awards in London in July, but it was Pfizer that successfully scooped the Management Premier Award.

The award was given for Pfizer’s Green Chemistry Programme, which is helping to reduce and eliminate the use of hazardous materials in the development and manufacture of pharmaceutical products.

Pfizer has established a management system for the integration of the principles of green chemistry into key stages of the R&D timeline and the result has been a significant reduction in the use of specific laboratory solvents and downstream improvements to pharmaceutical products in development and production.

Lorraine Murtagh, Head of Green Chemistry at Pfizer, Sandwich, said: “It’s great to be recognised for the work we’ve done to improve our environmental performance; and specifically the commitment of our scientists advancing our Green Chemistry processes, who’ve worked really hard to enable Pfizer to be acknowledged in this way as a leader of environmental excellence.”

Founded by Sir Peter Parker in 1975, the BCE Awards scheme is one of the world’s longest running environmental award schemes. It celebrates businesses that the BCE independent judging panel recognises as meeting the commercial demands of the present, without compromising the environment for future generations.

Congratulating the winners, Richard Lambert, Director-General of the CBI, said: “Today’s winners are true low-carbon leaders. They have made great strides in curbing their emissions and developing some remarkable low-carbon products and services. It will be their commitment and innovation that will get us on the road to a low-carbon economy.”

The Institute’s guidance does not recommend cetuximab in combination with platinum- based chemotherapy as a treatment for patients with recurrent and/or metastatic squamous cell cancer of the head and neck.

People currently receiving cetuximab in combination with platinum-based chemotherapy for this indication have the option to continue treatment until they and their clinician consider it appropriate to stop.

In announcing its decision, NICE referred to the manufacturer’s cost-effectiveness analysis, which indicated that the addition of cetuximab to chemotherapy would cost an extra £121,367 for a predicted gain in survival of just over two months.

Andrew Dillon, NICE Chief Executive, said: “This would mean the NHS making significant funds available for a very expensive treatment which may or may not benefit individual patients. Those funds would not then be available for treating other conditions with greater and more certain benefits for other patients.

“The Committee also took into account the supplementary advice provided by NICE on appraising treatments at the end of life. The Committee noted that cetuximab was used for a small population with a short life-expectancy for a devastating disorder but it did not offer sufficiently greater benefits to these patients compared to existing treatments.”

Erbitux, a monoclonal antibody and one of a new class of cancer drugs that target genetic mutations, was recommended by NICE last month for the treatment of metastatic colorectal cancer.

The approved indication is for the treatment of adults with locally advanced or metastatic cancer with activating mutations of EGFR-TK (epidermal growth factor receptor-tyrosine kinase) across all lines of therapy.

The EC’s decision was based on a submission package including two pivotal Phase III studies comparing Iressa with chemotherapy (IPASS and INTEREST).

Iressa inhibits the tyrosine kinase enzyme in the EGFR, thus blocking the transmission of signals involved in the growth and spread of tumours. A mutation in the EGFR is a characteristic occurring in 10-15% of lung cancers in non-Asians, and studies have shown that these types of tumours are particularly sensitive to Iressa.

Anders Ekblom, Executive Vice President for Development at AstraZeneca, said: "Iressa is the first truly targeted treatment for lung cancer, and the EU marketing authorisation today represents an important step forward in the treatment of this devastating disease. For the first time, patients with EGFR mutation positive tumours will have a more effective and better tolerated alternative to chemotherapy as a first-line treatment.”

AstraZeneca has said that it will work closely with clinicians and pathology groups on a country-by-country basis to facilitate access to EGFR mutation diagnostic testing.

The company has also agreed to conduct a Follow-up Measure Study to generate further data in a Caucasian NSCLC patient population and is currently in discussion with the EMEA to finalise the study design and endpoints.

The new facility will house the company’s UK  sales and marketing operations and discovery research and clinical development teams, as well as its first manufacturing facility in Europe.

The centre will also bring more than 500 jobs to the area, including 250 newly-created jobs in research.

Speaking at the opening of the EKC, Ivan Lewis MP, Minister of State for Foreign and Commonwealth Affairs, said: “This government has put the pharmaceutical industry at the heart of its economic agenda, and we are delighted to see this level of investment being made by Eisai. It is a real sign of confidence in the direction the UK and European economies are taking.”

President and CEO of Eisai, Mr Haruo Naito CBE, said: “Eisai believe that integrating all company functions on a single site will both encourage the creation of knowledge and improvements in our quality, efficiency and productivity. The newly opened European Knowledge Centre will not only act as a hub for managing our current business across Europe but it will play an important role in supporting our operations in driving further growth for Eisai in Europe, one of our key investment markets.”

Sir Terry Pratchett, the best-selling author and Alzheimer’s disease sufferer, was also present at the opening and welcomed the new research facility as step towards the further development of treatments for the disease, adding: “I hope everyone employed in it works overtime!”

Under the Tamiflu Reserves Program, Roche will produce and ship the drug to developing countries upon order at a "significantly reduced price," the company said.

A treatment of Tamiflu for a single ill person will cost between £2 and £6 ($2.80 and $8.50), depending on the dosage, Roche said in a statement. The price excludes local taxes or tariffs, it added.

Tamiflu sells for as much as $100 per five-day treatment course in countries such as the US, but since 2005 the company has offered a discounted price of $16 per treatment to poor nations.

Roche has also given approval for two companies, one in China and one in India, to produce Tamiflu generically.

Antivirals such as Tamiflu can shorten swine flu illness by about a day if given early. GlaxoSmithKline’s Relenza is also believed to be similarly effective.

David Reddy, who leads Roche’s pandemic preparedness task force, said only six of the world’s low income countries have stockpiled Tamiflu, compared to many wealthy countries that have large stockpiles.

Since populations in developing countries have more health problems like HIV, malaria, tuberculosis and pneumonia, experts believe the pandemic will have a more devastating impact there.

WHO has a stockpile of about five million Tamiflu treatment courses donated by Roche, and sent 2.4 million treatments to 72 poor countries in May.

The research was conducted by Doctors.net.uk, the UK’s largest and most active network of medical professionals.

The poll suggested that many respondents felt they were being deluged with information (44%), but that much of what was being communicated was unclear.

The poll also showed that 16% of GPs felt they had received contradictory advice from their PCT and other organisations.

Dr Tim Ringrose, Medical Director at Doctors.net.uk, said: “Doctors have been battling to make sense of the stream of information from different sources. They are now looking for clear concise information to help them get prepared and to enable them to answer questions from the public.”

Responding to a significant number of questions from doctors about the disease, Chief Medical Officer, Sir Liam Donaldson, will address them directly in an exclusive Doctors.net.uk podcast.

Dr Ringrose added: “The CMO’s decision to answer their questions directly through this online professional network is being welcomed by doctors across the country.”

Under the terms of the agreement, Bayer Schering Pharma will pay Celera a one-time fee for exclusive access to the five targets. Additional payments are due upon achievement of certain development and commercial milestones. Upon commercialization of a product Celera will be entitled to royalties based on sales.

"This agreement allows us to expand our existing research portfolio in the area of cancer-related targets," said Prof. Khusru Asadullah, Head of Target Discovery at Bayer Schering Pharma. "We look forward to exploring the full potential of these promising target candidates with regard to therapeutic interference for anti-tumor therapy as well as in in-vivo diagnostic imaging."

Celera is a California-based healthcare business delivering personalised disease management through a combination of products and services incorporating proprietary discoveries.

Celera added that they are happy to combine their discovery platform with Bayer Schering’s expertise in R&D. Steve Ruben, Vice President of Proteomic Research at Celera, said: "We believe this new relationship with Bayer Schering Pharma allows us the flexibility to advance part of our broad pipeline of validated targets for additional future value."

The company also recently delivered the 250,000,000th treatment of Coartem, a highly-effective artemisinin-based combination therapy (ACT) for the treatment of malaria, with cure rates of more than 95%.

To mark this occasion, Dr Daniel Vasella, Chairman and CEO of Novartis, delivered the milestone dose to Mwananyamala District Hospital in Dar es Salaam, Tanzania.

Although preventable and curable, malaria remains a devastating disease infecting more than 250 million people each year and causing an estimated 880,000 deaths. It is estimated that a child dies of malaria every 30 seconds.

"With 250 million treatments provided and an estimated 630,000 lives saved, the Novartis Malaria Initiative is the industry’s largest access-to-medicines program in the developing world," said Dr. Vasella. "However, malaria demands a collaborative approach. Joining United Against Malaria in its campaign is a promising way to relieve unnecessary suffering due to malaria."

UAM’s founding partners include Comic Relief, Johns Hopkins University, Malaria No More, the ONE Campaign, PATH, Population Services International, Roll Back Malaria and the United Nations Foundation, and the Bill & Melinda Gates Foundation.

Aiming to raise awareness and renew worldwide commitment to ending malaria, UAM will stage several high-profile public events in late 2009 and 2010 leading up to next year’s World Cup in South Africa.

"Novartis is a major player in the global effort to end malaria deaths in Africa by 2015," said Scott Case, CEO of Malaria No More. "We congratulate Novartis on this remarkable achievement and welcome Novartis to the United Against Malaria team. This invaluable partnership shows how teamwork is vital in the race to save lives."

Victoza is the first once-daily human Glucagon-like peptide-1 (GLP-1) analogue which regulates blood sugar in a glucose-dependent manner. It is also the only human GLP-1 analogue with 97% homology to natural human GLP-1 peptide.

An important advance is diabetes treatment, Victoza helps patients maintain normal blood sugar levels with a once-daily injection that can be taken at any time of day, irrespective of meals.

“Our goal for the development of Victoza was to find the best way to help people with type 2 diabetes maintain control over their glucose levels in a manageable way with reduced risk of hypoglycaemia,” said Viggo Birch, Managing Director of Novo Nordisk UK and Ireland.

Victoza stimulates the release of insulin only when glucose levels become too high, so there is reduced risk of blood sugar becoming too low (hypoglycaemia).

It can also help patients achieve weight loss, by increasing satiety and delaying gastric empting, and thus reducing caloric intake. This is significant as weight gain is a side effect of some common treatments for type 2 diabetes, thus increasing the risk of obesity-related illnesses.

Studies have also shown that two further added benefits are a reduction in systolic blood pressure (SBP)1 and improved beta-cell function, allowing for increased insulin secretion.

“This is an important advance for patients with type 2 diabetes, many of whom are already overweight,” said Professor Anthony Barnett, Clinical Director of Diabetes and Endocrinology, Heart of England Foundation Trust. “Additionally, the once-daily formula, independent of meals, should improve patient compliance and in turn clinical outcomes.”

WHO has been informed by health authorities in Denmark, Japan and the Special Administrative Region of Hong Kong, China of the appearance of H1N1 viruses which are resistant to the antiviral based on laboratory testing.

However, the cases were shown to still be sensitive to Relenza (zanamivir) and WHO has confirmed that antiviral drugs remain a key component of its response to the pandemic.

The resistant viruses were found in three patients who did not have severe disease and who have all since recovered. Investigations have not found the resistant virus in the close contacts of these three people.

Close to 1000 pandemic H1N1 viruses have been evaluated by the laboratories in the Global Influenza Surveillance Network for antiviral drug resistance. All other viruses have been shown sensitive to both oseltamivir and zanamivir.

WHO and its partners have stated that they will continue to monitor influenza viruses for antiviral drug resistance.

The NICE panel will review Tyverb as a treatment for ErbB2-positive advanced breast cancer, an aggressive form of the disease.

GSK have said that it is pleased with the decision of NICE’s appeal panel and that this will “provide fresh hope for up to 2,000 women in the UK who could benefit from this effective treatment on the NHS”.

Dr Alison Jones, Medical Oncologist at the University College London Hospital, commented: “It is great that NICE will reconsider the evidence supporting the use of lapatinib as there is a significant unmet medical need for women with this aggressive form of advanced breast cancer. These women have very few treatment options left available to them and lapatinib, when combined with capecitabine, offers a chance of additional time without their disease progressing.”

The appeal has been upheld in light of new NICE advice for the assessment of treatments in small patient populations with a short life expectancy, issued in January this year.

The appeal panel agreed that GSK and other consultees should be given the opportunity to make a full submission under these new ‘end of life’ criteria.

Simon Jose, General Manager, GSK UK, commented: “We welcome the opportunity to make a full submission to NICE under the end of life criteria. We appreciate that NICE has some very tough decisions to make, especially in this end of life setting, but given the considerable survival benefits that Tyverb offers these women, we believe it deserves full and thorough consideration.”

GSK has announced it will continue to offer the Tyverb Patient Access Programme to both NICE and individual NHS Trusts, under which GSK bears the cost of lapatinib for up to the first 12 weeks of treatment.

Within Europe, it was found, prices varied substantially, from an average of 55% of US prices in Italy to 70% of US prices in Germany. European prices for biologics averaged 86% of US prices.

The research was conducted by Decision Resources, a leading research and advisory firm focusing on pharmaceutical and healthcare issues.

The study also showed that many of the drugs that vary the greatest in price between the United States and other markets are older drugs such as Eli Lilly’s Prozac, Sanofi-Aventis’ Ambien and Novartis’ Tegretol that have lost patent protection in some markets.

This could be because, unlike in Europe, where the prices of drugs are lowered following patent expiry, US companies usually maintain brand prices following patent expiration.

Neil Grubert, Director of Pricing and Reimbursement Research at Decision Resources, has said that US companies need to be aware of the extent of the price variations between countries.

He added: “The current economic downturn will focus increasing attention on the cost of prescription drugs, and many payers will look to compare the prices they pay with prices in other markets.”

Decision Resources has released a new report entitled 2009 Chartbook of International Pharmaceutical Prices, which examines overall price differentials among seven of the world’s largest pharmaceutical markets (the United States, France, Germany, Italy, Spain, the United Kingdom and Japan) and reviews pricing hierarchies in each of these markets.

The study, which involved 18,644 women and was published in The Lancet, confirmed that GSK’s Cervarix is highly effective at protecting against the two most common cervical cancer-causing human papillomavirus (HPV) types, 16 and 18.

The study showed that the vaccine also protects against HPV types 31, 33 and 45, the three most common cancer-causing virus types beyond 16 and 18.

Thomas Breuer, Chief Medical Officer of GSK Biologicals, commented: "These excellent study results confirm the efficacy offered by Cervarix against HPV 16 and 18. For the first time the results show that this vaccine was effective against cervical pre-cancers associated with the five most common cancer-causing virus types.

“This is really good news for primary prevention of cervical cancer as it indicates the vaccine could offer women additional protection against cervical cancer beyond what had at first been anticipated."

In women who complied with the trial protocol procedures, the vaccine provided 92.2% protection against cervical pre-cancers associated with HPV 16 or 18.

For the first time Cervarix has been proven to provide significant protection against pre-cancerous lesions beyond HPV types 16 and 18 – approximately 11-16% extra protection against cervical cancer.

Principle investigator, Professor Jorma Paavonen, from the University of Helsinki, said: "The results show Cervarix is highly effective against the most common cervical cancer-causing virus types and has the potential to substantially reduce the incidence of cervical pre-cancers, cervical cancer and the associated diagnostic and surgical procedures. The results re-affirm confidence in vaccination as a primary preventative measure against cervical cancer when used alongside screening.”

The drug has been recommended for approval as monotherapy in metastatic treatment of bladder cancer (advanced or metastatic transitional cell carcinoma of the urothelial tract after failure of a prior platinum-containing regimen).

The positive opinion was based on two phase II study results and a phase III randomised study conducted in the indication of metastatic treatment of bladder cancer after failure of a prior platinum-containing regimen.

If a marketing authorization is granted, Javlor will become the first monotherapy approved in Europe for this indication.

In Europe there are an estimated 100,000 new cases of bladder cancer and 50,000 deaths annually, many of which are related to the use of tobacco products.

Jean-Pierre Garnier, CEO of Pierre Fabre SA, stated: "The favourable opinion of the CHMP for Javlor rewards the quality of work done by our colleagues dedicated to R&D. Javlor will introduce innovative therapy to physicians and patients in an area considered as an unmet medical need."

The WHO decision will mean that UN agencies and the GAVI (Global Alliance for Vaccine’s and Immunisation) Alliance can purchase the vaccine in partnership with developing countries, as well as helping to speed up access to Cervarix globally.

More than 80% of the 280,000 cervical cancer deaths a year occur in resource-poor nations. This high percentage is due to a lack of available screening services and the high prevalence of other serious health conditions such as HIV/AIDS.

"Cervarix can save millions of women’s lives throughout the world, but only if it reaches those who need it most," said Jean Stéphenne, President of GSK Biologicals. "That is why we’re eager to work with our long-term partner GAVI as well as other private NGOs or governments of developing countries to identify financing mechanisms for the vaccine."

The WHO prequalification for Cervarix is the result of a rigorous regulatory process that began nearly two years ago.

GSK currently has more than 10 WHO prequalified vaccines, demonstrating the company’s commitment to making its vaccines available to populations in developing countries.

To overcome the challenges of introducing a cervical cancer vaccine in developing countries, GSK is involved in a number of HPV vaccination demonstration projects. These include those led by PATH in Uganda and India. GSK has donated more than 100,000 doses of Cervarix to these programmes.

"Through our joint demonstration project, we have found that we can achieve high HPV vaccination coverage through proper sensitisation, the strengthening of healthcare systems and the mobilisation of local communities,’ said Christopher J. Elias, President and CEO of PATH.

The European Commission granted approval for the use of Alimta as a monotherapy for maintenance treatment of patients with other than predominantly squamous cell histology in locally-advanced or metastatic non-small cell lung cancer (NSCLC), whose disease has not progressed immediately following platinum-based chemotherapy.

The approval is based on data that showed pemetrexed improved overall survival in other than predominantly squamous NSCLC patients in the maintenance setting.

Pemetrexed is a chemotherapy agent currently approved for first-line treatment of advanced, other than predominantly squamous NSCLC in combination with a platinum-based chemotherapy, and as a single agent in the second-line setting for advanced, other than predominantly squamous NSCLC patients with recurrent disease.

The use of maintenance therapy in this setting represents a change to treatment, as traditionally, patients who respond to first-line chemotherapy were monitored until the disease recurred and then treated with a second-line regimen.

"The idea behind Alimta as maintenance therapy for nonsquamous, non-small cell lung cancer is to treat patients immediately following their initial course of therapy, in an effort to prolong survival," said Richard Gaynor, Vice President, Cancer Research and Global Oncology Platform Leader at Eli Lilly.

"The study that led to this approval was the first that showed improved overall survival in the maintenance setting for NSCLC. This was also the third trial to show the benefit of tailoring ALIMTA treatment to the nonsquamous NSCLC patient population."

The European Commission gave no details of any potential selloffs or commitments put forward, merely saying it would not rule on the deal until it had looked at changes that aim to soothe antitrust concerns.

Pfizer, the world’s largest pharmaceutical company, launched the $68 billion takeover of Wyeth in January. The value of the deal has since declined with Pfizer’s share price.

The acquisition is fueled by Pfizer’s need to address an expected revenue crash in 2011 when the world’s top-selling drug, its cholesterol fighter Lipitor, loses patent protection.

By buying Wyeth, Pfizer aims to move beyond simply a maker of blockbuster pills, including Lipitor, Viagra and Zoloft, to a one-stop shop for vaccines, biotech drugs, traditional pills, nonprescription products and veterinary medicines.

Wyeth makes the world’s top-selling vaccine, Prevnar for meningitis and other pneumococcal diseases, plus blockbuster antidepressant Effexor. It is the world’s 12th-largest drug maker by sales.

Under EU law, European antitrust regulators look at all takeover deals where both companies have an annual turnover of at least €5 billion worldwide combined and more than €250 million each in the 27-nation bloc.

"We are beginning to reap the benefits of Alzheimer’s scientific advancements made in the last two decades, including a robust pipeline of anti-dementia drug therapies and advances in early detection," said William Thies, Chief Medical & Scientific Officer at the Alzheimer’s Association. "The contributions of these leading researchers will help us defeat Alzheimer’s, solve the health epidemic of the 21st century, and save future generations from this progressive and fatal disease."

Henry Wisniewski, Khalid Iqbal, and Bengt Winblad were the founders of ICAD in 1988. Lifetime Achievement Awards named in their honor were given to three scientists who have dedicated their careers to Alzheimer’s research.

The Henry Wisniewski Lifetime Achievement Award was presented to Richard Mayeux, Professor of Neurology, Psychiatry and Epidemiology and Director of the Gertrude H.Sergievsky Center at Columbia University.

The Khalid Iqbal Lifetime Achievement Award was awarded to Virginia M.-Y. Lee, Director of the Center for Neurodegenerative Disease Research at the University of Pennsylvania.

The Bengt Winblad Lifetime Achievement Award was awarded to Martin Rossor, Head of the Division of Neurology and Director of the Dementia Research Centre at the UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery in London.

Another winner, William R. Markesbery, was the recipient of the 2009 Zaven Khachaturian Award, which recognises an individual whose compelling vision, selfless dedication and extraordinary achievement has significantly advanced the field of Alzheimer’s science.

The results of the two clinical trials were presented and discussed at the International Conference on Alzheimer’s Disease (ICAD).

The data shows that Axura/Akatinol (memantine) – an uncompetitive NMDA receptor antagonist – effects language skills in AD patients and improves cognitive abilities and functional communication.

“Effective, individualised treatment of language and communication problems would prolong the patient´s ability to interact with those around them, maintain levels of social and family integration, and reduce caregiver burden,” commented keynote speaker Prof. Jörg Schulz, Director of the Department of Neurology, University Hospital Aachen.

Leading neurologists emphasise that improvement of communication skills is a meaningful treatment target. Communication breakdown can trigger feelings of frustration in Alzheimer’s patients and these feelings may manifest as behavioral instability.

The two trials revealed that patients treated with memantine demonstrated an improvement in functional communication measured by the Functional Linguistic Communication Inventory (FLCI). In the second, 16-week trial, these changes were seen as early as four weeks after the start of treatment.

Prof. Schulz explained: “Memantine has shown to improve and preserve communication skills in patients with AD. This is a meaningful treatment target that can facilitate social interaction, and benefit the daily lives of both patients and caregivers.”

The launch represents a significant milestone in Actavis’ continued expansion into the secondary care market in the UK, following the UK launch of Gemcitabine in March 2009, the company says.

Actavis have now brought a number of key oncology products including epirubicin solution, epirubicin powder, fludarabine and vinorelbine to the UK market in the past few months.

Jonathan Wilson, Marketing Director at Actavis, says: “Irinotecan is another excellent addition to our growing portfolio of hospital products.”

The first Irinotecan packs are planned to be with customers on day one of patent expiry, offering the NHS the maximum opportunity on time to achieve savings.

The Independent Advisory Committee concluded that, although a number of technical problems were highlighted and changes were made to the economic model, these were not enough to change the original conclusion that these treatments are not cost effective in the mild stages of the disease.

According to the pharma companies: “The new model incorporated the latest techniques for determining cost effectiveness and showed a cost saving to the NHS and society by treating mild Alzheimer’s disease patients. NICE recognised the existence of this model and the implications of its results, but chose not to incorporate them into its review of the Guidance.”

Andrew Dillon, NICE Chief Executive, said: “Alzheimer’s disease is one of the most distressing and debilitating disorders but drug treatment is not the only option for these patients. This is why we have published a clinical guideline on the management of dementia (including Alzheimer’s disease) which outlines the package of medical and social care that should be available for people with dementia and their carers.”

He added: "NICE was not asked by the Court of Appeal to carry out a new appraisal of these treatments. However, we operate a process of regularly reviewing our guidance to take into account any new evidence and as long as no appeals are received a review can start as soon as possible.”

The drugs affected by the guideline are donepezil, galantamine and rivastigmine and memantine for the treatment of Alzheimer’s disease, which continue to be recommended only for people with moderate Alzheimer’s disease.

Eisai and Pfizer have expressed their frustration that patients suffering from mild Alzheimer’s disease will “continue to be denied treatment after such a lengthy process”, but have welcomed the opportunity of working with NICE in the new review.

Currently under development by Universal Pictures, Pharm Girl follows the central character’s experiences of big pharma as she rises through the ranks within the company.

Bad Santa screenwriters Glenn Ficarra and John Requa are writing the screenplay and are also possibly to direct the film, which Witherspoon is producing via her ‘Type A’ banner.

The pharmaceutical industry is traditionally a villain in Hollywood productions, The Fugitive being one famous example of such negative potrayals, as well as the more recent The Constant Gardener.

This film represents another comedy role for Witherspoon, who came to prominence in comedies like Legally Blonde, yet took on a more dramatic role with her Oscar-winning turn in Walk the Line.