AstraZeneca has agreed to pay £505 million to HM Revenue & Customs (HMRC) to settle a 15-year tax bill.

The long-running dispute arose over the issue of transfer pricing – the amount a company pays to buy goods from its own overseas subsidiaries. The £505 million payment will resolve all claims made by HMRC in relation to this issue.

The first installment of £350m will be paid in March 2010, with a second final installment of £155m due in March 2011. Pending litigation has now been cancelled in light of the payment.

AZ set aside £890 million to settle the dispute, some of which can now be added to its profit forecast for the year.

Tax authorities believe that large companies sometimes use transfer pricing to move their profits to low-tax countries in order to avoid corporation tax. The HMRC has recently hired specialists to crack down on this activity.

AstraZeneca, a global biopharmaceutical business with a primary focus on the discovery, development and commercialisation of prescription medicines, generated global revenues of US $32.8 billion in 2009.

Retacrit is to become the first biosimilar of epoetin to achieve a subcutaneous licence in renal patients.

The biosimilar, manufactured by Hospira, received a positive opinion from the CHMP for subcutaneous (SC) use in renal anaemia.

Once approved by the European Commission (EC), Retacrit will be the first biosimilar epoetin (EPO) for SC and intravenous (IV) administration in the nephrology setting.

This new recommendation supplements the existing licence of Retacrit IV administration in renal anaemia, plus SC administration in anaemia associated with cancer chemotherapy.

“As part of Hospira’s continued commitment to expand biosimilar options for patients, we are pleased that Retacrit is the first biosimilar epoetin to get a recommendation from the CHMP for subcutaneous administration in the nephrology setting,” said Michael Kotsanis, Hospira’s President of Europe, Middle East and Africa.

“Once approved by the European Commission, Retacrit will be suitable for subcutaneous as well as intravenous administration in the nephrology setting. This will give clinicians greater flexibility in managing symptomatic anaemia in their renal patients and provide healthcare professionals with a cost-effective alternative to originator epoetins.”

Biosimilars can provide a more cost-effective option than originator brands and so help to reduce healthcare costs. The European Generic Medicines Association estimates that biosimilar competition resulting in a 20% price reduction in five off-patent biopharmaceuticals could save the EU over €1.6 billion per year.

Kees Groenhout, Vice President of Global Clinical R&D, Hospira, added: “The approval will be a significant step forward, because patients who aren’t yet on haemodialysis can be treated with Retacrit at home. Many will also be able to self-inject Retacrit for the first time. For several reasons, subcutaneous administration can conserve hospital resources and save valuable time for patients, too.”

The recommendation of Retacrit is based on data from a rigorous Phase III clinical trial demonstrating comparable efficacy and safety between epoetin zeta and the reference product, epoetin alfa, when administered subcutaneously in patients with end-stage renal failure on chronic haemodialysis.

Cilag GmbH has decided to terminate its agreement with Basilea Pharmaceutica following an unsuccessful marketing authorisation application for Zeftera.

The CHMP has rejected the anti-MRSA antibiotic Zeftera (ceftobiprole medocaril) for the treatment of complicated skin and soft tissue infections.

Cilag GmbH International, a Johnson & Johnson company, has given Basilea Pharmaceutica notice of termination of their worldwide collaboration agreement.

This is the second time the CHMP has appraised Zeftera. Despite securing a positive opinion in November 2008, there was severe delay in the approval of the antibiotic, as both the FDA and the EMA expressed concerns about the reliability of its clinical data.

The EMA requested that Good Clinical Practice inspections be carried out at the research sites. In response, Basilea filed a Request for Arbitration against its partner Johnson & Johnson due its loss of earnings as a result of delayed approvals.

Zeftera, including pending applications and in-market products, will now be transitioned back to Basilea under the terms of the companies’ license agreement.

The Royal National Institute of Blind People (RNIB) is to launch an online campaign to improve decision-making about eye health in day-to-day clinical practice.

The five-month awareness and education campaign is designed to improve GP understanding of the diagnosis, treatment and care solutions for patients with eye health problems.

To launch the campaign, the RNIB will work with Doctors.net.uk, the UK’s largest and most active network of medical professionals. The campaign content is to be based on the findings of research into doctors’ confidence when dealing with eye health issues.

Barbara McLaughlan, RNIB Campaigns Manager, said: “Our work has previously focused on influencing national policy or individuals’ health choices, but targeting GPs effectively has been a challenge for us. Thanks to the in-depth research we were able to conduct beforehand, we’ve designed a campaign which addresses the specific areas in which GPs have said they require the most help.”

The RNIB’s 2009 publication Future Sight Loss UK found that 50% of sight loss is avoidable.

Simon Grime, Head of Healthcare Communications for Doctors.net.uk, added: “Thanks to the comprehensive educational resources that have been created, this campaign will bring about a real change in the diagnosis and treatment of ophthalmic patients.”

Roche is to collaborate with Merck to develop a test for a gene mutation related to therapeutic resistance in cancer patients.

The companies aim to achieve better treatment outcomes in cancer patients by determining which patients are most likely to respond to certain investigational therapeutic candidates.

As part of the agreement, Roche will provide Merck with access to its developmental microarray-based AmpliChip p53 Test, which is designed to detect mutations in the tumor suppressor gene p53.

“Roche designed its investigational AmpliChip p53 Test to rapidly provide clinically important information that can be used early in pharmaceutical development to help predict cancer patient responses to certain therapeutic candidates,” said Paul Brown, President and CEO, Roche Molecular Diagnostics.

The p53 protein activates DNA repair proteins, inducing growth arrest for repair of DNA damage. When p53 function is deficient, a cell’s response to DNA damage is severely impaired, contributing to tumor growth and increasing tumor cells’ resistance to chemotherapy.

Roche’s investigational AmpliChip p53 Test is designed to detect damage to p53 DNA in tumor cells to identify which cells carry dysfunctional p53 proteins that can lead to treatment resistance.

“The goal of our research is to discover and develop innovative cancer therapeutics and deliver them to the right patients at the right time,” said Eric Rubin, MD, Vice President, Oncology, Merck Research Laboratories. “By applying the AmpliChip p53 Test in selected clinical trials we hope to identify those patients most likely to respond to specific therapeutic regimens in development.”

Any near-term reforms of the NHS will most likely be gradual, rather than large-scale, and will need to get to the root of how to improve services, argues a new report.

The new Economist Intelligence Unit report, Doing more with less: Britain’s healthcare funding challenges, which is sponsored by BMI Healthcare, also says that funding choices based on clinical evidence could help to avoid expensive reforms.

Economists and healthcare managers interviewed for the report said that key recommendations of the 2002 review of the NHS by Sir Derek Wanless, which included reforms to improve quality and productivity, had not been fulfilled.

The Economist Intelligence Unit forecasts demand for health services to rise at a faster pace than GDP over the next five years, driven by an expanding, ageing and increasingly well-informed population, advances in medical science and a rise in the incidence of chronic disease, among other factors.

“Several important policy steps are available which could help to relieve some of the cost and demand burdens on British healthcare,” said Iain Scott, Senior Editor, Economist Intelligence Unit. “If they are going to work, any reforms ought to rely less on fiddling with institutions and structures, and more on changing the culture of the health service and getting to the root of how to advance the quality of care.”

Those interviewed for the new report warned that staff and managers have been left weary and demoralised by attempts to reorganise the NHS and the emphasis on performance targets. Respondents also indicated a belief that the public would not tolerate a return to longer waiting times as a result of cuts to frontline services.

Meanwhile, the report argues that evidence-based approaches typified by NICE and patient-reported outcomes measures (PROMs) could relieve pressure on the healthcare system without requiring expensive, top-down reforms.

The report Doing more with less: Britain’s healthcare funding challenges used information from the Wanless report, as well as research by The King’s Fund and the Social Market Foundation. Further material came from NHS institutions, separate Economist Intelligence Unit research and in-depth interviews with leading economists and NHS managers.

A new website has been launched to provide straightforward information, advice and support to relatives and friends of people with psychosis.

The site mentalhealthcare.org.uk is a joint venture between The Institute of Psychiatry (IoP) at King’s College London and South London and Maudsley NHS Foundation Trust (SLaM), in association with Rethink, the campaigning mental health charity. It is funded by a public engagement grant from The Wellcome Trust.

Elizabeth Kuipers, Professor of Clinical Psychology at the IoP is leading the development of the website. She said: “Looking after someone with psychosis can, at times, be emotionally demanding. There is still an enormous amount of stigma and shame about psychosis, and worry and upset when a relative is diagnosed with a severe mental illness such as schizophrenia.

“Through this new website we aim to provide clear information about treatment, medication and other support available to carers and people with psychosis.”

mentalhealthcare.org.uk will provide filmed interviews with health professionals and researchers, an area where visitors can submit questions to a pharmacist, psychologist or a psychiatrist and information about psychosis research and how patients can get involved.

The site also provides information about medication and other treatments, such as talking therapies.

“Access to reliable information in the early stages of diagnosis is crucial,” said Marshall Whiting who supported his late brother and now his eldest son, through schizophrenia. “Although therapies and medication have moved on significantly since my brother was diagnosed in 1962, there is still not enough information and support from the authorities or the medical profession.”

All information on the website is provided by IoP researchers and SLaM mental health professionals who have extensive knowledge and experience of psychosis.

Psychosis is a symptom of schizophrenia, bipolar disorder and schizoaffective disorder. It can also be a symptom of dementia, some forms of personality disorder, epilepsy, Parkinson’s disease and other illnesses.

The CHMP has recommended a conditional marketing authorisation for a fifth pandemic influenza vaccine – Humenza from Sanofi Pasteur.

This is the second pandemic vaccine to be assessed by the Committee using an emergency procedure which fast-tracks the evaluation of new vaccines developed during a pandemic.

Information on Humenza was evaluated in an accelerated timeframe using a rolling review which started in June 2009.

A group of vaccination experts were convened to further analyse test results for Humenza in comparison to a previously authorised pandemic vaccine, Celvapan.

Following discussion with these experts, the Committee concluded that despite some variability in the test results, the vaccine is sufficiently effective in all age groups when administered in two doses at an interval of at least three weeks.

The Committee also reviewed further results from clinical studies and post-marketing experience for the three authorised pandemic influenza vaccines, Celvapan, Focetria and Pandemrix. The data confirmed the expected immunogenicity and safety profile for the vaccines.

The European Medicines Agency (EMA) has recommended orphan drug status for an acute myeloid leukaemia (AML) treatment under development by Swedish biotech company Aprea.

The drug is currently undergoing a Phase I clinical study and a final decision from the European Commission is expected in a few weeks.

Aprea is part of the Karolinska Development portfolio.

“Aprea is developing a new class of anticancer drugs for the treatment of acute myelogenous leukaemia, the most common acute leukaemia affecting adults which is currently lacking efficient treatment. An orphan drug status would significantly shorten the development time, lower development costs and, if approved, extend market exclusivity to the benefit of affected patients, Aprea and Karolinska Development,” said Conny Bogentoft, CEO Karolinska Development.

Karolinska Development manages one of the largest portfolios of life science companies in Europe. It holds 43% of Aprea share capital and votes.

Since 2003, Karolinska Development has built a portfolio of around 40 companies. Its portfolio includes 12 compounds that are undergoing clinical trials and a total of 19 potential first-in-class products.

Abbott has completed its EUR 4.5 billion acquisition of Belgium-based Solvay Pharmaceuticals.

The takeover has provided Abbott with a large and complementary portfolio of pharmaceutical products and expanded its presence in key global emerging markets.

It is expected that the acquisition will add approximately $2.9 billion to Abbott’s 2010 total reported sales and approximately $500 million to Abbott’s annual pharmaceutical R&D investment.

“The acquisition of Solvay Pharmaceuticals is a key part of Abbott’s strategy to bolster our presence in key markets and deliver sustainable, industry-leading growth,” said Miles D. White, Chairman and Chief Executive Officer, Abbott. “In addition to taking both Abbott and Solvay products into new and expanding markets, the acquisition enhances our R&D investment, providing Abbott with the opportunity to drive future pharmaceutical growth.”

Solvay’s products complement Abbott’s presence in specialty markets such as cardiovascular disease, neuroscience and gastroenterology, and include treatments for men’s and women’s hormonal health.

“The combination of Solvay and Abbott’s pharmaceutical businesses will enable Abbott to attain leadership in key emerging markets, where there is significant opportunity for branded generics,” said Olivier Bohuon, Executive Vice President, Pharmaceutical Products Group, Abbott. “The addition of Solvay Pharmaceuticals is the catalyst for Abbott’s growth and leadership in this area, and will ensure Abbott has the infrastructure, reach and product offerings to continue meeting the needs of patients around the world.”