Pharmaceutical giant Merck Serono and leading industry service provider Quintiles have formed a five-year clinical development partnership.

The unique collaboration aims to optimise productivity in the design and execution of clinical drug trials, speeding the development of new treatment options in Merck Serono’s core therapy areas: neurology, oncology and immunology.

Merck Serono will shape and lead the partnership’s drug development programme; Quintiles will direct the planning and conducting of clinical trials and contribute to ongoing trial design.

Quintiles will be the sole primary provider of Merck Serono’s outsourced drug development services. It will also participate in strategic decisions regarding the development of the pharma company’s portfolio.

The partnership reflects the pivotal role of contract research organisations and other service providers in the global pharmaceutical industry.

“By combining the strengths of Merck Serono and Quintiles, we are creating a new model in clinical development that will unlock the knowledge and insights of both companies,” said Annalisa Jenkins, Executive VP and Head of Global Development and Medical at Merck Serono.

“This is an innovative and unique collaboration that will help to translate the highest-quality science into efficiency and agility throughout our clinical trials, while enhancing our competitive position in an increasingly challenging environment of clinical drug development.”

Tom Pike (pictured), CEO of Quintiles, commented: “We view this as a key step forward not only for our two companies, but for the way the industry approaches the development of new therapies for the patients we ultimately serve.”

Merck Serono is the biopharmaceutical division of Merck, based in Darmstadt, Germany. Quintiles is the largest global provider of drug development and commercial outsourcing services to the pharmaceutical industry.

London-based pharma company Dainippon Sumitomo Pharma Europe (DSP Europe) has changed its name to Sunovion Europe.

The new name reflects the development of DSP’s European subsidiary into a more active commercial organisation, shortly to launch a new schizophrenia drug.

Sunovion Europe will focus on products to treat mental health and neurological disorders – including the atypical antipsychotic lurasidone hydrochloride, which it plans to launch in Europe shortly.

The company will also develop and market specialised drugs for disease areas where there is unmet medical need.

Lurasidone hydrochloride, a generic drug, has been submitted to the European Medicines Agency (EMA) for treatment of schizophrenia by DSP’s European partner, Takeda.

Dr Mike Taylor, Managing Director of Sunovion Europe, said: “This represents a significant landmark in the evolution of our European business as we prepare to commercialise our first drug in the UK.

“At Sunovion Europe we focus on the development and introduction of innovative medicines that improve people’s health and well-being. We will continue to focus on psychiatry and neurology, and over time will grow the European business to include other areas.”

Dainippon Sumitomo Pharma (DSP) is a multi-billion dollar company based in Japan. It was formed by the merger in 2005 of Dainippon Pharmaceutical Co. and Sumitomo Pharmaceuticals Co.

With a growing product portfolio and pipeline, DSP aims to become a major supplier of innovative treatments in psychiatry, neurology and oncology.

Incivo, Victrelis and Mepact win recognition at the 2012 UK Prix Galien Awards.

Two new medicines for the treatment of Hepatitis C have won the 2012 UK Prix Galien Innovative Product
Award. Incivo (Janssen) and Victrelis (MSD) fought of stiff competition to win the prestigious prize at London’s House of Commons. The chairman of the judging panel, Professor Sir Michael Rawlins, said the treatments provided a perfect example of how the pharmaceutical industry can “demonstrate and justify its place in healthcare by innovating for change and showing real gains to the world.”

The ceremony also saw Takeda become only the third winners of a Prix Galien Award for orphan drug development. Mepact – for the treatment of osteosarcoma, a rare malignant bone tumour – won the Orphan Drug Award.

UK Prix Galien 2012
The UK Prix Galien, organised and managed by the specialist market access consultancy WG Consulting – which owns the UK franchise – is held every two years. The 2012 awards were hosted by former shadow Minister for Health Kevin Barron MP, who was the event’s Parliamentary Sponsor. Barron, who is currently co-Chair of the Associate Parliamentary Health Group, said: “It’s a privilege to be able to witness, at first hand, just a glimpse of the deep volumes of medical innovations being developed here in the UK. As an MP, I’ve had a long-standing professional acquaintance with UK pharma. I know and recognise the many
benefits UK medicines have brought – and continue to bring – to patients all over the world. The sector’s continued commitment to the development of medicines to tackle disease, improve health outcomes and extend life is both remarkable and humbling.”

Barron said there was political consensus that driving improvements in health outcomes across all major diseases is a key priority for the NHS – and this focus had been reflected in the 2012 finalists. “It’s interesting to note that the shortlisted entrants for the 2012 UK Prix Galien show that pharmaceutical innovation is aligned with many of the priority needs identified in the NHS Outcomes Framework. Finalists include innovations for the treatment of diseases in cardiovascular, hepatology, mental health, neurology, gastroenterology and oncology. In addition, Prix Galien’s recognition of the industry’s attempts to treat rare, orphan diseases, once again underlines the very human value of R&D.”

Value-based message
The architect of the NHS Outcomes Framework, former Health Secretary Andrew Lansley, also addressed the audience. Attending his fourth consecutive UK Prix Galien, Lansley said: “Every time I come to this event I hear about fascinating innovations that I know are going to be at the heart of the health service for years to come. I’ve met – and continue to meet – patients that have benefited directly from innovations that I’ve previously heard about at Prix Galien. The HPV vaccination programme we have been able to roll out is just one example of that. So it’s a privilege to be here.”

Lansley said that recognising and rewarding innovation is a key Government priority – and that the publication of Innovation Health and Wealth last December was part of a consistent value-based message
it wanted to send to the NHS. “That message is that as you, the pharmaceutical industry, bring forward new treatments that will clearly add value and improve the quality of healthcare for patients then the NHS should be at the forefront, internationally, of demonstrating that value. Our health service can be an exemplar and inspiration to people around the world because of its capacity to demonstrate the effectiveness of new treatments when they are used within the NHS.”

Lansley praised the UK pharma industry, highlighting the value its innovations bring both to the economy and to patients worldwide. “What you are doing is part of how this country will pay its way in the future,” he said. “And it has the added value of knowing that, in the process, we can give patients in this country access to the very best healthcare anywhere in the world.”

The recognition of innovation that can lead to improved health outcomes is a core aim of Prix Galien, as outlined by Professor Sir Michael Rawlins, who announced the winners. “Prix Galien is about honouring excellence in pharmaceutical research and development,” said Professor Sir Michael. “It is about recognising the contribution that new medicines can make to the lives of people with life-threatening conditions. It is about celebrating the achievements of all those individuals – working as teams – upon whom we rely for the discovery and development of new medicines. Most will be unknown to us – but we all owe them a huge debt of gratitude.”

Innovative Product Award
The prestigious Prix Galien medal for innovation was jointly awarded to Janssen and MSD for their respective hepatitis C treatments Incivo and Victrelis. In the UK, it is estimated that there are between 200,000 and 400,000 people chronically infected with hepatitis C virus. This may lead to liver cancer as well as other serious liver diseases. Infection with the hepatitis C virus poses a substantial global health burden, and is responsible for 40% of all cases of end-stage cirrhosis, 60% of hepatocellular carcinoma and 30% of liver transplants.

Professor Sir Michael Rawlins said: “Hepatitis C virus has become an enormous area of need globally, with many patients unaware that they are infected. The consequences of this virus are considerable and burdensome to both patients and the healthcare system; current treatments remain ineffective in a significant number of cases whilst being unpleasant and poorly tolerated by patients themselves.

“Hepatitis C infection is a perfect example of where the pharmaceutical industry can demonstrate and justify its place in healthcare by innovating for change and showing real gains to the world. It is for this reason that the panel felt that both Janssen and MSD should be celebrated and congratulated for their part in addressing the ongoing challenge in managing HCV and its associated complications.”

Brilique (AZ) and Resolor (Shire) both received commendations. Gilenya (Novartis), Xarelto (Bayer), Xeplion (Janssen), Xgeva (Amgen), Yervoy (Bristol-Myers Squibb), Zelboraf (Roche) and Zytiga (Janssen) were all shortlisted.

Orphan Drug Award
The Orphan Drug Award was introduced as a dedicated category at 2008 UK Prix Galien. There had previously been a special award for orphan products in 2006. The term ‘orphan condition’ is used to describe conditions that affect a very small number of patients in a given population – many of which are either untreatable or treated very inadequately. It is estimated that there are 6,000 orphan diseases – which, in total, affect about 30 million EU citizens.

“For orphan diseases that are potentially treatable with medicines, pharmaceutical manufacturers face a number of hurdles – including concerns about the size of the market and difficulties because of the small numbers of patients – in their development,” said Professor Sir Michael.

The 2012 Orphan Drug Award was won by Mepact from Takeda. Mepact (mifamurtide) is for the treatment of osteosarcoma, a rare malignant bone tumour – mainly of children and adolescents – that affects fewer than 1 per 10,000 individuals in the EU. This is equivalent to 150 children and young adults each year in the UK. Tumours most frequently occur in the long bones and are highly aggressive with a propensity to metastasise, particularly to the lung. If left untreated, the primary tumour will undergo local and systemic progression, leading to death within months.

“To investigate the role of this immune modulator in osteosarcoma required extensive and complex trial design with careful implementation of the study programme,” said Professor Sir Michael. “Apart from its novel mechanism of action – and clear evidence of its clinical effectiveness – the jury were also extremely impressed that such an advance in the management of osteosarcoma represents the first significant change in outcomes in 10–20 years of managing this disease. That Takeda managed to undertake the clinical development of this product – in such a niche indication – is hugely to their credit.”

Dependence on local control for care of neurological conditions has resulted in poorer outcomes than if there were a nationally-led strategy, according to MPs.

A report by the Public Accounts Committee contrasts the “poorly co-ordinated” and inconsistent care of conditions such as Parkinson’s disease with the impact of national targets for cancer and stroke care.

An estimated two million people in the UK have a neurological condition, the report said, but the quality of care provided varies significantly between locations.

The National Service Framework (NSF) for long-term conditions, published in 2005, contained 11 quality indicators. However, there was no national baseline for services or outcomes and no monitoring of progress.

This contrasts with the NSFs for cancer and stroke treatment, which were nationally led to drive improvements.

The report noted that despite their complex needs, spending on social services for people with neurological conditions has not increased since 2006 and healthcare provision remains below the quality requirements set out in the NSF.

This failure is reflected by a 32% increase in emergency admissions and an increase in the rate of readmissions within 28 days from 11.2% to 14%.

Finally, the report observed that only 22% of people with Parkinson’s disease, multiple sclerosis or motor neurone disease have a personal care plan.

It recommended the appointment of a national clinical lead for neurology.

Committee chair Margaret Hodge MP said that for people with neurological conditions “individual care is often poorly co-ordinated and the quality of services received depends on where you live. Some areas simply don’t have enough expertise, both in hospitals and in the community.

“For this clinical area, the department left the implementation to local health commissioners but gave them no leadership at all. It set no baselines and failed to monitor progress. The present government needs to understand what went wrong here for the future.”

Two leading medtech companies have collaborated to provide a system that improves catheter placing during angiography procedures.

Siemens Healthcare has integrated the MediGuide navigation technology from St. Jude Medical into its new Artis zee angiography systems (pictured).

MediGuide makes it possible to place a catheter for angiography very accurately without continuous fluoroscopic tracking, thus reducing the radiation dose and amount of contrast agent needed.

The technology uses electromagnetic tracking to determine the catheter position during a minimally invasive intervention: a miniaturised sensor integrated into the catheter is located from positioning signals emitted by MediGuide transmitters in the Artis zee’s housing; then the position and orientation of the catheter are displayed in real time on previously-acquired fluoroscopic patient images from the patient.

In addition, the technology compensates for movements caused by respiration and heartbeat.

The technology is also available as an upgrade for a number of existing Artis zee systems.

“Siemens is the first to integrate MediGuide technology into its systems, demonstrating our ongoing commitment to lowering dose via our CARE initiative,” said Jane Whittaker, UK Angiography Business Manager at Siemens Healthcare.

The first interventions with the Artis zee and MediGuide technology have been carried out at the Heart Center in Leipzig, Germany.

“The low-radiation, precise localisation of the catheter tip onto the pre-recorded fluoroscopy image is a most impressive function, because the system is able to compensate the motion from heartbeat and breathing,” commented Prof. Dr. Gerhard Hindricks, Director of the Rhythmology Department.

“For my team and me, this is clearly the future in electrophysiology.”

Based in Minnesota, USA, St. Jude Medical specialises in devices for cardiac, neurological and chronic pain treatment. German-based company Siemens Healthcare is a global leader in diagnostic imaging.

The European Commission has approved Novartis’ Votubia (everolimus) for patients aged three and over with subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC), who not amenable to surgery.

The approval is based on a Phase II study that revealed 78% of patients experienced a reduction of 30% of more in the size of largest SEGA, and a third saw a reduction of 50% after six months.

Hervé Hoppenot, President, Novartis Oncology, says patients will have for the first time “an effective therapeutic option”.

TSC affects approximately one to two million people worldwide and is associated with a variety of resulting disorders. In Europe, the prevalence in general population is estimated to be nearly nine cases per 100,000.

Prior to Votubia being approved, the only treatment for patients in the European Union with SEGA associated TSC was brain surgery.

Dr Sergiusz Jozwiak, Professor, Department of Child Neurology, The Children's Memorial Health Institute, Warsaw, Poland, has welcomed its approval by the EC.

“This approval is an important step forward in managing SEGAs associated with tuberous sclerosis complex, as surgery was previously the only available treatment option in the EU for these patients,” he said. “As the first approved medication for this patient community, Votubia will help fill a critical unmet treatment need.”

Valeant Pharmaceuticals has bought cold remedy manufacturer Afexa Life Sciences in a deal worth 76million Canadian dollars.

Afexa, based in Edmonton, Alberta, sells Cold-FX and Coldsore-FXT, totalling annual revenue of approximately C$40million.

Michael Pearson, Chairman and CEO of Valeant, said that the combination of both companies’ products “will provide the critical mass we need in the OTC market and should provide Valeant Canada with another platform for growth”.

Valeant stated that Afexa's board unanimously approved the deal and recommended that the company's shareholders tender their shares, who will receive C$0.71 per share in cash.

Canada-based Valeant is a manufacturer and marketer of a range of pharmaceutical products primarily in the areas of neurology, dermatology and branded generics.

A new brain scan can detect if healthy individuals may be at risk from developing Alzheimer’s, claims a recent study.

Results published in Neurology state that the advanced imaging technique – proton MR spectroscopy – can determine any abnormalities in various brain metabolites that may be Alzheimer’s biomarkers.

Dr Jonathan M. Schott, from the Dementia Research Centre, University College London, said: “There is increasing evidence that Alzheimer disease is associated with changes in the brain that start many years before symptoms develop.”

PET scans assessed amyloid-beta deposits (plaques) in the brain, which are one of the initial signs of Alzheimer’s onset. Volunteers’ language, memory and other skills were also tested.

The study involved 311 participants aged over 70 from the Mayo Clinic Study of Aging, Rochester, USA. One third of participants tested with considerably high levels of amyloid-beta deposits. The same people had high levels of the brain metabolites choline/creatine and myoinositol/creatine, which also tend to correlate with poor scores.

Dr Schott, commented: “If we could identify people in whom the disease process has started but symptoms have not yet developed, we would have a potential window of opportunity for new treatments to prevent or delay the start of memory loss and cognitive decline.”

Dr Kejal Kantarci, who carried out the study, said: “This relationship between amyloid-beta deposits and these metabolic changes in the brain are evidence that some of these people may be in the earliest stages of the disease.

“More research is needed that follows people over a period of years to determine which of these individuals will actually develop the disease and what the relationship is between the amyloid deposits and the metabolites.”

Valeant Pharmaceuticals International has appointed Ronald Farmer to its Board of Directors.

J. Michael Pearson, Chairman and CEO of Valeant, stated that it was a “privilege” to welcome Mr Farmer’s “unparalleled intellect and superior business judgment” to the Board.

Mr Farmer currently works as Managing Director of Mosaic Capital Partners in Toronto, Canada. He is also a Director at Integran Technologies, PowerMetal Technologies and Boatracs Inc.

Valeant Pharmaceuticals International is a global pharmaceutical company that develops, manufactures and markets pharmaceutical products primarily in the areas of neurology, dermatology and branded generics.