A new ABPI Vaccine Group has replaced the UK Vaccine Industry Group (UVIG), which represented UK vaccine companies for more than a decade.

Changes in the composition of the group include the addition of AstraZeneca and the loss of Sanofi Pasteur MSD.

The ABPI Vaccine Group will work in partnership with the new Public Health England and NHS England bodies to support UK immunisation programmes.

The new industry group has six members: Abbott Healthcare Products, AstraZeneca, GSK, Janssen, Novartis and Pfizer.

The disbanded UVIG also had six members: Baxter Healthcare, GSK, Novartis, Solvay, Sanofi Pasteur MSD and Wyeth (a subsidiary of Pfizer).

Sanofi Pasteur MSD, the manufacturer of Gardasil – recommended by NICE for immunisation against cervical cancer – plays a major role in the UK’s public health vaccination programmes.

Vaccination is an increasingly important strategy in global health protection, as ease of travel has made infectious diseases harder to control. According to the World Health Organisation, vaccines save 2.5 million lives each year.

Stephen Whitehead, Chief Executive of the ABPI said: “This addition to the ABPI strengthens the unity of the biopharmaceutical industry and further underlines the ABPI’s position as the leading life sciences trade association in the UK.”

“Vaccinations against disease play a vital role in improving public health and help protect us from preventable illnesses.”

Janssen has submitted a Marketing Authorisation Application to the EMA for the approval of a fixed-dose therapy which would combine canagliflozin and immediate release metformin for the treatment of type 2 diabetes.

Canagliflozin is an investigational, oral medication for adult patients which blocks the reabsorption of glucose by the kidney, increasing glucose excretion and lowering blood glucose levels.

Metformin is a first-line pharmacotherapy which is used either alone or in combination with other medications, including insulin, to treat type 2 diabetes.

When combined, the fixed-dose therapy may offer adult patients a convenient medication in a single pill.

Janssen submitted a similar application to the US FDA for canagliflozin on 31 May 2012 and for a fixed-dose therapy combining canagliflozin and immediate release metformin on 12 December 2012.

An entrepreneurial team within Janssen’s R&D operation is working with the NHS to promote innovative dementia care.

Janssen Healthcare Innovation and the NHS have partnered to launch the Innovation Challenge Prize for Dementia.

The biopharma company, a subsidiary of Johnson & Johnson, will award up to £150,000 for solutions that make a lasting difference to the lives of people suffering from dementia.

As a first step, people involved with dementia care as healthcare providers, carers, patients and patient groups are being encouraged to identify the key issues in diagnosis, treatment and management of the condition.

Once the challenges have been agreed, relevant stakeholders will be able to submit innovative solutions to be assessed by a panel of experts from the NHS, industry and academia.

The ageing population is driving up the incidence of dementia in the UK: the terminal condition is estimated to affect 800,000 people, with the cost of NHS care predicted to rise from £23bn to £28bn by 2018.

“We are delighted to be the first industry partner to support the NHS in these important innovation challenges,” said Marco Mohwinckel of Janssen Healthcare Innovation (pictured).

“We hope this initiative will help identify forward-thinking solutions to help transform care for people with dementia and better support their caregivers.”

The deadline for ideas to help define the key challenges is 20 March 2013.

The 27th Pharmaceutical Marketing (PM) Society Advertising Awards had the largest number of entrants ever (350) and saw the event expanding into the digital and exhibition arenas.

Notable winners among the advertising agencies included Langland Advertising, which won in seven categories (with 10 commendations), and VCCP Health, which won in three categories (with two commendations).

Of 36 pharmaceutical companies competing for the PM Society Awards, the most successful was Abbott with four wins and five commendations.

Three pharmaceutical companies – Astellas, Bayer and Johnson & Johnson – won two awards each, and another five – CSL Behring, Eisai, Janssen, Sanofi Pasteur MSD and Takeda – won one each.

Neil Smith, PM Society Advertising Awards Chairman, commented: “As ever, the truly aspirational creative treatments stand head and shoulders above the rest and their success is reflected by our industry and healthcare judges.”

From over 50 campaigns entered for the Awards, the most successful on the day were Langland’s campaign for Abbott’s drug Hidrasec (four wins and one commendation); the same agency’s campaign for Bayer’s Sativex (two wins and two commendations); and Lime’s campaign for Astellas’ Protopic (one win and two commendations).

Remarkably, Concentric Advertising won both the Primary and the Secondary Care Target Awards for one advertisement.

Two of the most coveted awards were the Healthcare Industry Award, won by relative newcomer VCCP Health, and the Geoff Brook Innovation Award, snagged by the Woolley Pau Gyro agency.

New awards were presented in three digital advertising categories, and exhibition displays were recognised in a new category for the first time.

The lunchtime awards ceremony in London was hosted by broadcaster and former MP Gyles Brandreth.

The PM Society, which promotes marketing excellence in the healthcare and life science industries, is a non-profit organisation with members in over 230 UK companies.

In 2012 the Society launched Interest Groups addressing key challenges facing UK pharmaceutical marketers: market access, digital marketing, NHS partnerships, patient engagement and personal development.

A comprehensive global strategy is necessarily to fight the ‘silent epidemic’ of hepatitis C, according to a new report from the Economist Intelligence Unit (EIU).

Social and personal barriers to diagnosis and treatment, combined with the extremely destructive nature of the disease, are contributing to high death rates.

The EIU calls for health systems to develop “innovative ways to reach out to patients”, drawing parallels with the early years of the HIV pandemic.

The Silent Pandemic: Tackling Hepatitis C with Policy Innovation was commissioned by Janssen, a leader in the hepatitis C drug market.

HCV, the virus that causes hepatitis C, is thought to affect 150 million people worldwide – most of whom will develop chronic liver disease. Hepatitis C caused 86,000 deaths in the EU in 2002.

The disease can be prevented and effectively treated, but as few as 10% of people with HCV are receiving treatment.

Causes of the high infection and death rates identified by the report include: transmission through medical equipment and transfusions; transmission through intravenous drug use; poor epidemiological data and a low diagnosis rate; and poor medical compliance by intravenous drug users.

“The report highlights that worldwide, despite the significant burden of HCV, governments have failed to get a grip on the scale and impact of the disease,” said Charles Gore, President of The World Hepatitis Alliance. “In both developed and developing countries, the true human and economic cost of HCV will continue to rise unless policy makers confront this urgent public health issue now.”

The EIU recommends a number of strategies: effective disease surveillance, better public awareness, and measures to reduce high-risk behaviour and transmission via healthcare systems.

It also recommends that health systems find “innovative ways to reach out to patients, rather than relying on traditional healthcare structures”.

Gaston Picchio, Global Hepatitis Disease Area Leader at Janssen, commented: “Janssen is committed to working with the HCV community and will continue to engage with healthcare professionals, government officials and patient advocates around the world to support their efforts to reduce the individual and societal burden of this devastating disease.”

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.”

The Scottish Medicines Consortium (SMC) has approved the restricted use of Janssen’s prostate cancer drug Zytiga (abiraterone acetate).

The treatment has been recommended as a treatment option for men with metastatic castration resistant prostate cancer who have received only one prior chemotherapy regimen.

Zytiga – which was discovered in the UK – has been shown to prolong the life of some patients by nearly five months when compared with placebo plus low dose prednisolone in clinical trials.

Martin Price, External Affairs Director at Janssen UK, said the pharmaceutical company had gone to “significant lengths” to find a solution that allows patients to be treated with the drug.

Annually there are more than 40,000 men diagnosed with prostate cancer in the UK. More than 10,000 men die of the disease – making prostate cancer the second most common cause of cancer deaths.

Dr Rob Jones, Senior Lecturer and Hon Consultant in Medical Oncology, Beatson West of Scotland Cancer Centre, called the decision to approve the restricted use of Zytiga “very good news”.

The treatment was approved for use in the NHS in England when NICE reversed its original recommendation back in June after Janssen had agreed a Patient Access Scheme with the DH.

A host of pharmaceutical and biotechnology companies will join forces alongside public research organisations and scientific experts to address the rising threat from antibiotic resistance.

Companies including GSK, AstraZeneca, Janssen and Sanofi will partner in a new £180 million research programme to boost the discovery and development of new antibiotics.

Patrick Vallance, President, Pharmaceuticals R&D at GSK said the agreement “signals a new model of collaboration” to develop treatments to tackle infections such as MRSA.

NewDrugs4BadBugs is supported by the Innovative Medicines Initiative (IMI) – who will jointly fund the first project with contributions from the pharma and biotech companies involved.

The objective of the collaboration is to improve the underlying scientific understanding of antibiotic resistance and design and implement clinical trials that see novel drug candidates clinically developed.

Currently, the WHO describes the pipeline of future antibiotics to counter emerging resistant bacteria as “virtually dry”.

Antibiotic resistance is increasingly becoming a worldwide health threat with new ‘superbugs’ evolving around the globe.

However, despite the urgent need for effective counteraction, research has diminished over the past 15 years with few companies remaining active in this area due to difficulties in finding new agents and regulatory complexities.

Martin Mackay, President, R&D, at AstraZeneca commented: “It is time to tackle this issue in a different way, sharing information and expertise among public and private partners – collaboration of this type is critical if we are to speed up the discovery of these medicines to improve patient health.”

Janssen’s Nucynta (tapentadol) has been shown in a phase III trial to be effective in relieving pain due to diabetic peripheral neuropathy (DPN).

An extended-release formulation of the drug reduced the level of pain in patients with chronic DPN by half.

Nucynta may offer an effective therapy for a condition difficult to treat with conventional painkillers.

Originally developed by Grünenthal, tapentadol is a new type of centrally-acting analgesic with opioid characteristics.

The extended-release Nucynta gained FDA approval for treatment of chronic pain in August 2011.

The new phase III trial tested Nucynta against placebo in adult patients who had suffered painful DPN for six months or more and in whom conventional painkillers had failed.

After 12 weeks, patients treated with Nucynta reported a drop in pain intensity from an average of 7.3 to 3.6 on a 10-point scale.

The study’s lead investigator, Aaron Vinik of Eastern Virginia Medical School, commented: “Painful DPN is a common and burdensome complication of diabetes, and controlling pain in people with DPN can be challenging. These data suggest tapentadol ER provides a significant reduction in chronic pain in adult patients with DPN.”

The difficulty of treating DPN often leads doctors to prescribe antidepressants as well as painkillers, so Nucynta may represent a breakthrough in this therapy area.

The life of the man convicted of the Lockerbie bombing may have been extended for two years by Janssen’s cancer drug Zytiga (abiraterone).

Released from a Scottish prison in 2009 on health grounds, Abdelbaset al-Megrahi has died from metastatic prostate cancer years later than was predicted.

The case, which has caused political controversy, highlights the availability worldwide of cancer drugs unavailable in the UK.

Ironically, al-Megrahi’s death came within days of NICE revising draft guidance to approve the use of Zytiga following a price deal with Janssen.

The decision to release al-Megrahi, whom doctors had judged to be within three months of death, was widely criticised – and more so as he remained alive through 2010 and 2011.

Controversy over the safety of his conviction added to the political embarrassment resulting from his extended survival, perhaps the only case in which prolonging life has been considered a negative outcome.

Oncologist Professor Karol Sikora examined Megrahi in prison in July 2009 and said he was at the “end stage” of cancer. He has since commented: “The care he received in Libya helped prolong his life.”

Zytiga is an oral medication for advanced prostate cancer that blocks the synthesis of testosterone in the body.