The UK showed a stable rating among the healthcare systems of Europe when the 2009 Euro Health Consumer Index (EHCI) was presented today in Brussels.

The annual survey of EU healthcare ranked the UK 14th out of 33 countries.

The Netherlands won the ranking for the second year with a record 875 points, followed by last year’s runner-up Denmark (819), newcomer Iceland (811) and Austria

(795).

The UK scored 682 points from a potential 1,000 and performed poorly on waiting times but well on pharmaceuticals. The Index ranks the UK behind Ireland but ahead of Italy or

Slovenia.

“The UK in 2009 has showed surprisingly negative feedback from patient organisations on the waiting time situation, particularly after government spending on the NHS has been increasing heavily,” said Dr. Arne Björnberg, the Euro Health Consumer Index Director. “It seems that management of the behemoth NHS organisation is difficult to do under a centralised paradigm.”

The EHCI ranks 33 national European healthcare systems across 38 indicators, covering: patients’ rights and information, e-health, waiting times for treatment, treatment outcomes, range and reach of services provided, and access to medication.

The Index is compiled from a combination of public statistics, patient polls and independent research conducted by the founders, Brussels-based think tank Health Consumer Powerhouse.

According to this year’s measurement, the top performers in European healthcare are the systems that have started using healthcare information and choice to engage patients in the decision-making, building a pressure from below for improvement. At the lower end of the ranking are the countries that have a traditional hierarchical system and a lack of transparency.

The CHMP has recommended Spanish pharmaceutical firm Zeltia’s drug Yondelis (trabectedin) for use in the treatment of ovarian cancer.

Zeltia has been developing Yondelis for use in combination with Johnson & Johnson’s Doxil for the treatment of ovarian cancer, but has so far failed to win a green light for the medicine in the United States.

Chairman of the struggling company Jose Maria Fernandez Sousa-Faro has predicted that sales from Yondelis could be €300 million a year in Europe and that the company could break even or make a small profit by the end of 2010.

“It’s highly probable that other countries will now approve Yondelis and that within a few months the only country which hasn’t approved it will be the United States,” said Luis Mora, Managing Director for Zeltia’s PharmaMar biotech unit.

The EU decision contrasts with the verdict of the FDA, whose experts were concerned that risks of heart and liver toxicity outweighed the limited ability of Yondelis to keep disease in check.

Yondelis is already available in Europe as a treatment for soft tissue sarcoma, a relatively rare disease affecting soft tissues such as muscle, fat and tissue around joints.

Once-daily Seroquel XR (quetiapine fumarate extended-release tablets) and Seroquel (quetiapine fumarate) have been approved under the European Mutual Recognition Procedure for the treatment of bipolar disorder.

The drugs have been approved specifically to prevent the recurrence of bipolar disorder in patients whose manic, mixed or depressive episode has responded to quetiapine treatment.

Following this new indication, Seroquel and Seroquel XR are the only agents approved in the EU to treat all phases of bipolar disorder: acute depressive episodes, acute manic episodes, and maintenance treatment to prevent recurrence of any mood event in bipolar disorder.

AstraZeneca has said that it will now move forward to obtaining local approvals with the Member States that take part in the Mutual Recognition Procedure.

Launched in 1997, Seroquel (quetiapine fumarate) has been approved in 94 countries for schizophrenia, 91 countries for bipolar mania, in 51 countries for bipolar depression and in 8 countries for bipolar maintenance.

Bipolar disorder is a serious mental illness that causes dramatic and severe mood swings. Bipolar I disorder is the classic form of the disease, characterised by recurrent episodes of mania and depression. Bipolar II disorder involves one or more episodes of major depression with at least one episode of mild to moderate mania (hypomania).

It is estimated that the worldwide prevalence of bipolar disorder is 3–5 per cent.

Wyeth has received a positive opinion from the CHMP for its pneumococcal conjugate vaccine, Prevenar 13 (Pneumococcal Polysaccharide Conjugate Vaccine).

The CHMP has recommended Prevenar 13 for active immunisation of children aged six weeks to five years for the prevention of invasive pneumococcal disease, as well as pneumonia and otitis media (middle ear infection) caused by 13 pneumococcal serotypes.

“The CHMP’s positive opinion brings us one step closer to providing infants and young children in Europe with the broadest serotype coverage of any pneumococcal conjugate vaccine,” said Emilio Emini, Executive Vice President, Vaccine Research and Development, Wyeth Pharmaceuticals. 

“Prevenar, our currently available vaccine, has both proven clinical efficacy and documented effectiveness, which has resulted in a significant public health benefit. Prevenar 13 builds on the scientific foundation of Prevenar and, if approved, will provide coverage for the 13 most prevalent pneumococcal-disease causing serotypes, including serotype 19A, which has emerged as a serious public health threat in Europe and around the world.”

Prevenar 13 is designed to provide the broadest serotype coverage of any pneumococcal conjugate vaccine. The vaccine contains the seven serotypes included in Prevenar (Pneumococcal Saccharide Conjugated Vaccine, Adsorbed), plus six additional serotypes responsible for the greatest remaining burden of invasive disease. 

Released in Europe in 2001, Prevenar is now available in 97 countries and more than 265 million doses have been distributed worldwide.

The vaccine is also being studied in global Phase 3 clinical trials in adults, with regulatory submissions expected in 2010.

Abbott has signed a definitive agreement to acquire Solvay’s pharmaceuticals business for €4.5 billion ($6.6 billion) in cash, providing Abbott with a large and complementary portfolio of products.

The acquisition will give Abbott full global rights to the fenofibrate franchise, for which Abbott currently pays royalties to Solvay.

Solvay will add more than $3 billion in annual sales, as well as approximately $500 million to Abbott’s annual pharma R&D investment. Solvay also has significant presence and infrastructure in key high-growth emerging markets, including Eastern Europe and Asia.

“The acquisition of Solvay Pharmaceuticals further diversifies our pharmaceutical portfolio, expands our presence in key high-growth emerging markets, enhances our investment in R&D and accelerates our long-term earnings-per-share growth outlook,” said Miles D. White, Chairman and Chief Executive Officer, Abbott.

“In anticipation of future market needs, we are ensuring we have the technologies, products, infrastructure and reach to serve patients globally and continue to deliver sustainable industry-leading growth. This acquisition, as well as the others we’ve announced this year, all contribute to achieving that long-term goal.”

Solvay’s portfolio complements Abbott’s presence in specialty markets such as cardiovascular disease, neuroscience and gastroenterology. Solvay has treatments for Parkinson’s disease, Meniere’s disease (abnormality of the inner ear), vertigo and irritable bowel syndrome. The company also offers products to treat men’s and women’s hormonal health and exocrine pancreatic insufficiency (inability to properly digest food).

“With this transaction Solvay Pharmaceuticals has found a new strong home, within a respected company with a solid and committed position in the industry,” commented Christian Jourquin, Chief Executive Officer, Solvay.

The deal includes Solvay’s vaccines business and a small molecular diagnostics unit that will become part of Abbott’s diagnostics organisation.

The CHMP has adopted a positive opinion recommending an EU marketing authorisation for Multaq (dronedarone – 400mg tablets).

The recommendation is for the treatment of adult clinically stable patients with a history of, or current, non-permanent atrial fibrillation (AF) to prevent recurrence of AF or to lower the ventricular rate.

The CHMP also acknowledged that dronedarone has been shown, in addition to its rhythm and rate controlling properties, to decrease the risk of atrial fibrillation-related hospitalisations.

“Sanofi-aventis welcomes the positive CHMP recommendation for the approval of Multaq in the European Union,” said Jean-Pierre Lehner, Chief Medical Officer, sanofi-aventis. “This decision brings new hope to people whose lives are impacted by the potential cardiovascular complications of atrial fibrillation. We do think that Multaq will contribute to fulfill significant unmet medical needs for the patients.”

The positive opinion is based on the submission of a comprehensive clinical data package including seven international clinical trials involving more than 7000 patients and including the ATHENA trial.

The ATHENA trial showed that Multaq, in addition to standard therapy, reduced the combined endpoint of cardiovascular hospitalisation or death from any cause by 24% when compared to placebo.

Atrial fibrillation is emerging as a public health concern and represents one-third of hospitalisations for arrhythmia in the European Union. It leads to potential life-threatening complications such as increasing the risk of stroke up to five-fold and worsening the prognosis of patients with cardiovascular risk factors.

Afinitor (everolimus) has been licensed in the UK for the treatment of advanced kidney cancer after the failure of treatments that prevent the growth of the tumour’s blood vessels.

The European Commission (EC) approved everolimus for this use on 3rd August 2009, prior to which there were no licensed treatment options for patients whose cancer progressed while on or after treatment with these targeted therapies.

“I am delighted that there is now a proven treatment option available to people living with advanced kidney cancer in the UK who have progressed after treatment with a targeted therapy. The availability of Afinitor is an important step in ensuring this population of poor prognosis patients have the potential to control their disease further,” said Professor Tim Eisen, Professor of Medical Oncology at the University of Cambridge.

Data show that everolimus, when compared with placebo, more than doubled the median time without tumour growth or fatality in patients with advanced kidney cancer whose disease progressed following prior vascular targeted therapy (4.9 vs. 1.9 months).

James Whale, Founder of The James Whale Fund for Kidney Cancer, said: “We at the Fund are pleased everolimus has been granted a license in the UK as, given the poor prognosis of kidney cancer, it is critical for people living with the disease to have access to life-extending treatments. This has been proven to provide benefit to kidney cancer patients, enabling them to spend precious time with family and friends.”

The CHMP has recommended marketing authorisations for two vaccines against influenza H1N1.

The Committee conducted a quick assessment of the vaccines Focetria (Novartis) and Pandemrix (GlaxoSmithKline) to ensure that they are available before the start of the flu season in the coming autumn and winter months.

Decisions from the European Commission are expected shortly.

The Committee has recommended a two-dose vaccination schedule, at an interval of three weeks, for adults including pregnant women, and children from six months of age.

The Committee acknowledged that there are preliminary data suggesting that one dose may be sufficient in adults. The Agency is expecting further data from ongoing clinical studies over the coming months, so these recommendations may be updated.

Focetria and Pandemrix were authorised using the ‘mock-up’ approach, where trials are performed with a different virus strain that could have caused a pandemic (an H5N1 influenza virus strain). Once the H1N1 virus strain was identified by the WHO, the manufacturers were able to include it in the mock-up vaccines to prepare final pandemic vaccines.

The Committee’s recommendation is based on information about the vaccines’ quality, safety and immunogenicity, including information on clinical trials in more than 6,000 subjects. These data were generated at the time of the authorisation of the mock-up vaccines, as well as on information relating to the change in strain from H5N1 to H1N1.

Further clinical trials in adults and in children are ongoing and the companies have announced that more results will become available from October/November 2009 onwards.

New NICE guidance has recommended Sutent (sunitinib) for people with non-operable or metastatic gastro-intestinal stromal tumours (GIST) following unsuccessful treatment with imatinib.

Sunitinib is recommended on the basis that the cost of the drug for the first treatment cycle is covered by the manufacturer.

Professor Peter Littlejohns, NICE Clinical and Public Health Director, said: “Gastro-intestinal stromal tumours are difficult to diagnose, but it has been estimated that there are around 240 new cases of unresectable and/or metastatic GISTs per year in England and Wales.

“Today’s guidance provides these patients with a further treatment option and represents a positive move by the manufacturer, who, by reducing the cost the NHS will have to pay for this treatment, will enable as many eligible patients as possible to access it.”

Rob Day, UK Director of Oncology for Pfizer Limited, commented: “We are truly delighted that NICE has taken the decision in its guidance to enable eligible GIST patients to benefit from sunitinib. We hope now that all eligible GIST patients in the UK will quickly have access to this treatment.”

Approximately 50% of GIST patients will eventually see their cancer progress within two years of starting treatment with imatinib. Sunitinib has been shown to delay tumour progression by almost five months versus best supportive care alone in patients with whom imatinib has failed.

The European Commission has granted a conditional marketing authorisation to Cayston (aztreonam lysine) for the treatment of chronic pulmonary infections due to Pseudomonas aeruginosa in patients with cystic fibrosis (CF).

The Cayston 75mg powder and solvent for nebuliser solution (aztreonam lysine) has been approved for the suppressive therapy of chronic pulmonary infections due to Pseudomonas aeruginosa (P. aeruginosa) in CF patients aged 18 years and older.

The drug will be made available from early 2010, subject to the requirements of national authorities.

CF is a debilitating genetic disease that affects 35,000 people in the European Union. Chronic pulmonary infections due to P. aeruginosa are the single greatest cause of morbidity and mortality among patients with CF.

Cayston is an inhaled antibiotic that is delivered via the Altera Nebuliser System, a drug-specific delivery device from the eFlow Technology Platform developed by PARI Pharma GmbH. PARI Pharma also contributed to the development of Cayston’s drug formulation for delivery with the Altera Nebuliser System.

“Cayston is an important addition to the fight against infection in people with cystic fibrosis, and its approval will bring a further treatment option to patients suffering from this debilitating disease,” said Stuart Elborn, Professor of Respiratory Medicine, Queens University of Belfast. “The cystic fibrosis community is very pleased that the EMEA has recognised the importance of bringing forward this effective new treatment.”

Full marketing authorisation will be based on the results of an ongoing Phase III study examining the efficacy and safety of Cayston compared to tobramycin nebuliser solution in CF patients with pulmonary P. aeruginosa.