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.

NHS chemotherapy services are being stretched to the limit by the combination of increased demand and reduced funding, a new report from Roche warns.

The drug company has published The Cancer Capacity Challenge, which argues that new systems to deliver chemotherapy more rapidly and cheaply are needed.

Over 70% of oncology specialist nurses, responding to questions from their colleagues, said lack of capacity to deliver the service was harming care.

The report says that improvements in diagnosis and treatment have increased the life expectancy of patients with cancer – but this in turn has increased the level of demand for services.

According to oncology specialist nurses surveying the views of their colleagues:

• 71% believe patient care is suffering from lack of NHS capacity in chemotherapy

• 76% believe waiting times for chemotherapy are set to increase

• 67% said their day units are fully stretched or over-full.

The incidence of cancer in the UK has increased by 20% in men and 40% in women over the last 30 years, due primarily to the ageing population.

The CCC report recommends that the capacity of chemotherapy services could be increased by treating more patients at home or in primary care.

To facilitate this, Roche argued, there is a need for chemotherapy drugs that can be administered more quickly and easily in a range of settings. The report suggests that Roche may be planning new products in this important area.

Kate Denby, Haematology Advanced Nurse Practitioner, Royal Exeter and Devon NHS Foundation Trust, said: “The steps involved in each patient visit can take as long as seven hours. Patients usually prefer shorter visits to hospital for their chemotherapy treatment, so it’s essential that we are able to find solutions that help improve the patient experience.”

Pharmaceutical and diagnostics giant Roche has appointed a new General Manager for its UK operation.

Jayson Dallas rejoins Roche UK, where he worked from 1998 to 2000, after 12 years in senior roles at Pfizer, Novartis and Genentech (a Roche subsidiary) in the US.

His appointment follows John Melville’s retirement after 12 years as Roche UK’s General Manager.

After qualifying as a doctor in his native South Africa, Dallas gained an MBA in the UK and then worked as International Medical Medical Marketing Manager at Hoffmann-La Roche for two years.

He leaves the role of Head of Global Product Strategy, Immunology & Ophthalmology, at Genentech in San Francisco, where he led the company’s Global Oncology Launch Excellence and Biosimilar Readiness initiatives.

“I look forward to reconnecting with old colleagues and friends as I return to the UK,” Dallas said.

“The next few years will provide many opportunities for Roche UK and I am excited at the prospect of how we can ensure that more patients can benefit from our innovative medicines, as the access to medicines agenda still remains of critical importance.”

Novartis expects its pharmaceutical division to have at least 14 ‘blockbuster’ products within the next five years.

The Group claims to lead the industry with the number of new approvals it has had globally since 2007 and expects the release of new products to be equally successful.

Joseph Jimenez, CEO of Novartis, said its “leading pipeline... positions us well for continued future growth.”

So far this year the company has received nine approvals or positive recommendations. It aims to build on this within the next 13 to 24 months with a further 11 pivotal trials, 11 filings and 10 regulatory decisions with various health authorities.

In addition, Novartis claims its pipeline boasts 139 projects in clinical development, including more than 73 New Molecular Entities across a multitude of disease areas.

It has highlighted compounds AIN457 from its oncology pipeline and LCZ696 and RLX030 for heart failure to create “significant newsflow” in the future. Also, Novartis claims compound QVA149 has the potential to become the “new standard of care for COPD”.

But within its oncology business is where the greatest growth is expected within the next five years. Novartis points towards its robust late-stage pipeline, which includes 13 new chemical entities and 19 new indications, to combat the upcoming patent expiry on Glivec.

These late-stage products are expected to contribute more than $1bn in sales by 2017, with Afinitor predicted to earn revenues of around $2bn in sales in advanced breast cancer alone in the same period.

Astellas Pharma Europe has chosen an English site to house its new UK and European headquarters.

Offices in Chertsey, Surrey, have been picked by the Japanese pharmaceutical company, which has called its decision an act of faith in the British economy.

Ken Jones (pictured), President and Chief Executive of Astellas Pharma Europe, said the site shows “the confidence” the company has in the UK and it “marks a new chapter” for the organisation.

The firm was previously based in smaller offices in Staines, which employed several hundred people.

The move comes at a time when Astellas said it is now actively employing more staff and hopes to fill the site within the next five years. The company also revealed it is planning to launch ten new products in Europe by 2017.

“Astellas has long been out-performing the market and whilst bigger pharma firms are seeing their revenue shrink from patent expiries, we are seeing ours grow with new products and new areas of interest,” said Ken Jones.

“The UK is in tough times much like the rest of Europe, but we are working hard to get through adversity via innovation.”

The new HQ will be focused on sales and marketing for the company’s key disease areas in urology and transplantation medicines, and its future focus on 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.”

Specialty pharmaceutical company AP Pharma has appointed the former global head of oncology at Bayer Healthcare as its senior VP and Chief Commercial Officer.

Robert Rosen will lead the launch of APF530, AP Pharma’s drug to prevent chemotherapy-induced nausea and vomiting.

He will become a director of the company once the drug has successfully establishes a market presence.

John Whelan, President and CEO of AP Pharma, said: “Robert’s deep and extensive experience commercialising oncology drugs will be instrumental as we enter the commercialisation phase of the company.”

AP Pharma specialises in developing injectable drugs using its Biochronomer polymer-based drug delivery platform, which can reduce the frequency of injection from daily to weekly or fortnightly.

APF30, the company’s lead product, is used to prevent both acute-onset and delayed-onset nausea and vomiting caused by chemotherapy.

Rosen led Bayer’s cancer drugs operation from 2005 to 2011 – including the launch of Nexavar (sorafenib) for the treatment of renal cancers.

Before that, he was VP of oncology at Sanofi-Synthèlabo, where he was responsible for launching the colon cancer drug Eloxatin (oxaliplatin).

Value-based pricing (VBP) is a more fair and balanced way of supplying life-saving drugs for patients than the Government’s Cancer Drugs Fund, a new study shows.

Research by the University of Bangor found that out of more than 4,000 people across Britain 64% agreed that the NHS should not pay more for cancer drugs compared to medicines for other threatening conditions.

Professor Dyfrig Hughes, study author, said “singling out cancer seems to be unfair, but is something which will hopefully be addressed in the value-based pricing system, which has public support.”

The Cancer Drugs Fund was introduced two years ago for the NHS to treat patients with oncology treatments not currently recommended by NICE. It supplies £200m a year until 2013 to pay for drugs.

VBP is the Government’s alternative to the existing 2009 PPRS pricing scheme – set to expire in 2013. It will allow government to set prices for new medicines as they enter the UK market – and set new definitions of value.

Although it has gained support from the general public, the ABPI has raised a number of concerns about the new system and is in negotiations with the Government to create an amended version.

“The funding of high cost cancer treatments is clearly an emotive issue, and it is for politicians to determine the parameters by which the NHS pays for them, however, there are equally distressing conditions affecting patients who are equally deserving, but they have no access to ring-fenced budgets,” said Professor Hughes.

The use of combination therapies in the treatment of cancer patients is set to increase in the future, according to a new report.

Analysis found that oncological treatments are evolving to include biologic medication, which, in combination with cytotoxic drugs, is rapidly becoming the top pharmaceutical therapy.

GBI Research’s report found the effective capabilities of biologics in controlling and treating complications has led to their widespread use and popularity amongst patients and prescribers.

The cytotoxic therapies markets has eight major indications and brands include Taxotere (docetaxel), Alimta (pemetrexed) and Xeloda (capecitabine) – all of which have exceeded sales of $1 billion.

However, these drugs are set to be exposed to generic competition in coming years which will reduce the cost of combinational treatments.

The popularity of such treatments is also expected to convince pharmaceutical companies to apply for label extensions on their existing biologics portfolio for multiple oncology complications.

This, the report said, will support the continued development of cytotoxic drugs in the future, despite significant safety hurdles that have previously led to weak pipelines.

The cytotoxic therapies market accounted for $6.5 billion in revenue ten years ago. It grew at an annual rate of 5.8% to reach $10.1 billion in 2010. The report now expects generic competition to reduce revenues in the market by 2017 to $7.6 billion – despite predicted uptake.