Dr Roger Perlmutter will return to MSD after he was appointed Executive Vice President and President of Merck Research Laboratories (MRL).

He returns 12 years after he departed for Amgen and will succeed Dr Peter Kim, who will retire in August this year.

Kenneth Frazier, Merck Chairman and CEO, called Dr Perlmutter a “world-calls physician-scientist” who has a “proven track record” in leading large research organisations.

Prior to joining Amgen in 2001, Dr Perlmutter served as executive vice president of worldwide basic research and preclinical development after initially joining as senior vice president in February 1997.

“I am honoured to have the opportunity to return to Merck and to lead MRL,” said Dr Perlmutter. “Throughout my career, as both a physician and a scientist, I have drawn inspiration from Merck’s unwavering commitment to scientific excellence. Over time, this commitment has brought forth an unparalleled number of breakthrough medicines and vaccines that improve the lives of patients around the world.”

He will start his new role on April 15 and work closely with Dr Kim until his retirement.

Cancer patients whose disease has spread from a solid tumour to their bones have now been given a new treatment option after NICE backed the use of Amgen’s Xgeva (denosumab).

Xgeva has been recommended to treat the condition known as bone metastases in people suffering from breast cancer or solid tumours other than prostate who would otherwise be prescribed bisphosphonates.

Professor Carole Longson, Director of the Centre for Health Technology Evaluation at NICE, said Xgeva was a “welcome addition” alongside existing treatment options.

Final guidance states that Xgeva should only be prescribed under the terms agreed between the Department of Health and Amgen as part of a patient access scheme.

Amgen estimates there are around 150,000 patients in the UK with solid tumours and bone metastases, of which breast and prostate cancer account for more than 80%.

“We’re pleased to be able to recommend another treatment option for people with bone metastasis from most solid cancer tumours,” said Professor Longson. “This type of metastasis can reduce a person’s mobility and quality of life in general, increasing the risk of complications from bone weakness.”

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.”

NICE has again backed Amgen’s Xgeva (denosumab) as a treatment option for patients with bone metastases from the majority of solid cancer tumours.

The final draft guidance recommends the treatment after NICE produced a review of available evidence and two separate stages of public consultation.

It continues to recommend Xgeva for the prevention of skeletal-related events in:

· people with bone metastases from breast cancer, and

· people with bone metastases from solid tumours who would otherwise be prescribed bisphosphonates.

The guidance also states that Xgeva must only be prescribed under the terms agreed in a Patient Access Scheme between Amgen and the DH.

Bone metastases occur when cancer spreads from its original tumour to the bone. This can lead to bones losing their strength and ultimately lead to skeletal-related events.

Professor Carole Longson, Director of the Centre for Health Technology Evaluation at NICE, said the condition “can severely affect a person’s quality of life” and stop individuals from completing everyday tasks.

NICE has now given consultees another opportunity to request a factual change to the draft guidance or lodge an appeal against its recommendation. If no appeals are received, final guidance will be issued later this year.

Major pharmaceutical companies and medical journals have agreed on 10 steps to improve the credibility of industry-sponsored clinical research.

The recommendations, developed by the Medical Publishing Insights and Practices (MPIP) group, are intended to address concerns about hidden conflicts of interest, ghost-writing and cherry-picking of positive data.

Published in the Mayo Clinic Proceedings, the 10 steps aim to improve transparency in the reporting of trial data, experimental and statistical protocols, adverse events and the professional interests of researchers.

The MPIP initiative was developed with input from GSK, Amgen, AstraZeneca and Sanofi, and is supported by six other major pharma companies.

Journals involved in the discussions included the New England Journal of Medicine and The Lancet.

The 10 steps listed are:

1. Ensure clinical studies and publications address clinically important questions.

2. Make public all results, including negative or unfavourable ones, in a timely fashion, while avoiding redundancy.

3. Improve understanding and disclosure of authors' potential conflicts of interest.

4. Educate authors on how to develop quality manuscripts and meet journal expectations.

5. Improve disclosure of authorship contributions and writing assistance, and continue education on best publication practices to end ghost-writing and guest authorship.

6. Report adverse event data more transparently and in a more clinically meaningful manner.

7. Provide access to more complete protocol information.

8. Transparently report statistical methods used in analysis.

9. Ensure authors can access complete study data, know how to do so, and can attest to this.

10. Support the sharing of prior reviews from other journals.

The authors commented: “Although framed in the context of industry sponsorship, many of these recommendations would enhance the credibility of clinical research publications in general, regardless of the funding source.”

The arthritis therapeutics market is expected to experience significant growth in the coming years, a new report predicts.

Research found that arthritis therapeutics are becoming a “gigantic attraction” for pharmaceutical companies as the condition continues to be one of the most common causes of disabilities.

Rising incidence rates of osteoarthritis, rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis are expected to see revenues reach $35.8 billion by 2018.

Several major pharmaceutical and biotechnology companies have already shown an interest in obtaining market share and have made investments in the potentially lucrative industry.

Pfizer, Amgen, Merck, Roche and Novartis, the report found, have increased R&D efforts in the field with several promising therapies in late-stage development.

The current pipeline includes many small molecule drugs and biologic therapies, as well as novel oral Disease-Modifying Anti-rheumatic Drugs (DMARDs).

Biologics, the report predicts, will feature heavily as the market expands and drive growth during the coming years.

Existing market leaders are also expected to benefit from the predicted demand.

Amgen’s patent on blockbuster drug Enbrel was recently extended until 2028 by the FDA following a number of court proceedings. Other well-established brands have also had their protection protected.

However, the patents for Rituxan (rituximab), Remicade (infliximab), Celebrex (celecoxib) and Humira (adalimumab) will see a number of generic alternatives enter the market.

Despite cheaper therapeutic products being made available, the report estimates the market will grow at a compound annual growth rate (CAGR) of 7.2% for the next six years.

Amgen has entered into an agreement with Turkish pharmaceutical company Mustafa Nevzat Pharmaceuticals (MN) to acquire 95% of its shares for $700 million.

The cash deal will expand Amgen’s presence in Turkey and the surrounding regions, which the company has targeted as large, fast-growing, priority markets.

Levent Selamoglu, General Manager and CEO of MN, says the “combination of MN and Amgen creates an innovation leader in Turkey with unique capabilities”.

Established in the early 20^th Century, MN is the leading supplier of pharmaceuticals to the hospital sector and a major supplier of injectable medicines in Turkey. It also boasts a successful export business.

The company had revenues of around $200m last year and has grown on average at double-digit rates in local currency since 2007.

Robert Bradway, President and Chief Operating Officer at Amgen, says the deal continues the company’s global expansion strategy. He commented: “Amgen is dedicated to making our innovative medicines available to patients in major markets around the world.

“Together with MN’s staff and management team, we plan to grow our business with high quality and innovative medicines in Turkey and the surrounding region.”

The deal has been approved by both sets of board of directors and is awaiting customary closing conditions, including regulatory approvals, before being completed.

Amgen, the world’s largest biotechnology company, already has a presence in Turkey after opening an affiliate in 2010 and currently markets two products there. It plans to develop its robust pipeline of clinical candidates for the benefit of patients in the country, as well as other markets around the world.

Amgen has acquired biopharmaceutical company KAI Pharmaceuticals in a $315 million cash deal.

The deal includes global rights – excluding Japan – for KAI-4169, a novel peptide agonist of the calcium sensing receptor for the treatment of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) currently on dialysis.

Sean Harper, Amgen, Head of Research and Development, said the company is “excited about acquiring KAI, as well as the opportunity to potentially deliver a novel therapy for CKD patients”.

KAI-4169 is currently in Phase II trials. As part of the deal, Amgen has provided a loan to enable the start of Phase III development planning for the treatment.

SHPT is a common yet serious complication for patients with CKD on dialysis.

Amgen currently markets Sensipar (cinacalcet) – known as Mimpara in Europe – for the treatment of SHPT and recorded sales of $808 million in 2011. Sensipar is an oral treatment, while KAI-4169 is administered intravenously.

The acquisition is Amgen’s second this year after it announced it was purchasing biotech firm Micromet for $1.16 billion.

NICE has recommended the use of Xgeva (denosumab) in draft guidance for certain cancer patients whose disease has spread to their bones.

The recommendation covers patients with bone metastasis from breast cancer; people with painful bone metastasis from hormone-refractory prostate cancer when treatment has failed; and for those with bone metastasis from other solid tumours for whom zoledronic acid is indicated.

Professor Carole Longson, Director of the Centre for Health Technology Evaluation at NICE, says the condition can have a “major impact on quality of life” and is therefore “pleased” to recommend the treatment.

The guidance stipulates that Xgeva should only be prescribed under the terms of an agreed Patient Access Scheme between Amgen and the DH.

Amgen estimates there are more than 150,000 patients in the UK with solid tumours or bone metastases, of which breast and prostate cancer account for more than 80%.

The spine, pelvis, hip, upper leg bones and skull are most commonly affected by bone metastases with symptoms including pain, and weakening and eventual destruction of the bone.

The majority of patients with the condition are currently treated with bisphosphonates. NICE’s independent Appraisal Committee considered Xgeva as an alternative to standard treatment options where bisphosphonates are not used.

It noted that in clinical trials where Xgeva was directly compared to standard treatment options it improved skeletal-related outcomes. It was also shown to be more clinically effective in patients with breast, prostate and non-small cell lung cancer.

The initial recommendation is now open for consultation.

The experienced Luigi Costa has joined Swiss-based Onyx Pharmaceuticals as its Vice President and Head of Europe.

He will be responsible for building and leading the biopharmaceutical company’s commercialisation efforts in Europe ahead of a potential launch of cancer treatment carfilzomib.

Dr Helen Torley, Executive Vice President and Chief Commercial Officer, Onyx, says Mr Costa’s “track record of success in growing established brands” will be key towards the global commercialisation of carfilzomib.

Mr Costa previously spent eight years working at Amgen, where he most recently served as the Vice President and General Manager of France. Prior to that, he served as General Manager for Switzerland and Italy, as well as International Head of Nephrology and Oncology Franchise. He joined Amgen from Eli Lilly where he held roles of increasing responsibility, including Business Unit Director and Global Pricing and Access Manager.

“I am delighted to be joining Onyx at this exciting time,” said Mr Costa. “I look forward to partnering with the team to establish Onyx’s European commercial presence and to help bring promising therapies, like carfilzomib, to patients throughout Europe as quickly as possible.”