Medicine shortages reach ‘tragic point’ in Greece

by JoelLane 1. March 2013 12:30

greece Greek hospitals and pharmacies are running short of around 300 medicines because drug companies are refusing to supply them.

Hospitals failing to pay drug bills and parallel trading by wholesalers and pharmacists are the main reasons for supplies being withheld.

Major pharmaceutical companies that have admitted halting shipments of some products include Pfizer, Roche and Sanofi.

Medicines for arthritis, hepatitis C and hypertension, statins, antibiotics, anaesthetics, antipsychotics and antidepressants are all affected.

Dimitris Karageorgiou, Secretary General of the Panhellenic Pharmaceutical Association, said: “I would say supplies are down by 90%. The companies are ensuring that they come in dribs and drabs to avoid prosecution. Everyone is really frightened.

“The government is panic-stricken and the multinationals only think about themselves and the issue of parallel trade because wholesalers can legally sell them to other European nations at a higher price.”

According to the Greek government, more than 50 companies are holding back products or planning to do so. The Ministry of Health is intending to fine eight major drug companies, which have not been named.

There are reports of widespread panic and anger among patients who are going from one pharmacy to another with prescriptions. “We have reached a tragic point,” commented Karageorgiou.

With austerity tightening in Greece, the debts owed to pharma companies by hospitals and social insurance funds has reached €1.9bn (£1.6bn).

Pfizer has admitted withdrawing four medicines “because alternatives were available and because of the parallel trade situation”: leukaemia drugs Zavedos and Aracytin, the analgesic Neurontin and the epilepsy treatment Epanutin.

Roche said it was withholding supplies to Greek public hospitals, apart from “critical medicines” such as HIV drugs, but was still supplying pharmacies.

Sanofi claimed it was still supplying public hospitals with life-saving and unique products (for which no generic version or recommended alternative exists).

GSK, AstraZeneca, Novartis and Boehringer Ingelheim denied they had stopped supply of any products to Greece.

The pharmaceutical industry has urged the Greek government to set its drug prices in accordance with a eurozone standard. Greek drug prices are 20% lower than the next lowest in the EU, giving rise to widespread parallel trading.

Greek regulator the National Organisation for Medicines has banned the export of 60 medicines and is considering another 300. It will fine wholesalers and pharmacists who have broken the export ban.

Global strategy needed to fight Hepatitis C

by JoelLane 21. January 2013 16:03

HCV_EM_picture_2 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.”

Fear and loathing on the conference trail…

by IainBate 17. December 2012 10:33

A savage trip through the heart of NHS reform with John Pinching.

FL web My arrival at the Royal College of Physicians, for the annual Wellards Conference, was greeted by a thumping disco beat and the unmistakable brotherly harmonies of the Bee Gees. A quick scan for white polyester garments and ill-advised medallions allayed a nagging fear that I might have boogied into the wrong gig (there were one or two Barry Gibb-inspired beards, however).
I can’t lie, with the effects of three hastily consumed espressos coursing through my frontal lobes, and noticing that the walls were festooned with horrifying surgical instruments from a bygone age, the scene was becoming trippy.

When the funky grooves finally faded, charismatic master of ceremonies and resident DJ Alan Jones (ajc healthcare) explained the nostalgic intro. “We have gone for 70s music because the themes of this conference feel very retro,” he said. “Many of these subjects have done the rounds for decades!” This cat had obviously been here before – who could blame him for turning to Donna Summer for the answers? Granted, Donna is now gyrating across the great dance floor in the sky, but I felt sure that if anyone could resurrect those haunting tones, it was Alan.

Never say ‘never’ again
Among the hired guns at this first shindig was Dr Amit Bhargava, who – in his capacity as a clinical accountable officer at the Crawley Commissioning Group – provided hot gossip straight from the coal face, enthusing about some elements and speculating about others.

He insisted that “the time has come for change in the health service”.

“The structure of the NHS is like a game of Jenga and it is bound to topple eventually as a result of paying more and more for less and less,” he added.

Curious metaphor. Indeed, how interesting to note that, generally, the people who remove bricks from the lurching tower are usually hopelessly drunk. If any analogy should fall down (assuming it has), I suppose it should be one about Jenga.

He also reflected on the challenges CCGs faced when trying to improve patient experiences, with reference to the life span of residents in the Crawley area. “If you take the number 10 bus, within three miles [depending on the stop] you get a seven year age difference,” he said. “Crawley is a relatively new town; these areas don’t look deprived.”

“Look at the maps to identify the need,” Bhargava concluded, “And you’ll do all right.”

All very helpful, sure, but when – like a sniper in the thicket – I fired a slippery missile from the crowd regarding whether Hunt, in light of the Murdoch ‘affair’, was the right cat for the job, he shot me a dead-eyed stare and dodged the ol’ bullet – “I hope so, but I’ve never met him”, he choked. Ye gods, Amit, I’ve never met the Führer, but I’m telling you now, I won’t be breaking Battenberg with him anytime soon. Surely it’s essential for people with influence to hold their ‘leaders’ to account – unelected leaders at that – while forming opinions about their performances, if not their character?

As if by design Hues Corporation’s 1974 hit ‘Rock the Boat’ began playing. Freaky.

Circle of life
Circle Health’s Dr Ali Parsa’s stint at the lectern produced a captivating speech, dispensing with boring Powerpoint slides, and instead relying on the zeal of entrepreneurial spirit. It was a man and his voice, and that voice meant business (quite literally).

After lamenting his own lack of height – “Sorry if you can’t see me!” – Parsa philosophically considered the ‘micro economics’ that influence the future of every individual.

“If I was born in communist Russia or Mao’s China, I was going to do substantially worse than if I was born in the West,” he said. “Bill Gates used to say that the genius in Mumbai did fundamentally worse than the average person born in Baltimore. That world has now changed.

“I look at my children and I ask that question: what will be the micro economic trend that dictates their destiny? The answer to that lies in where Britain sits among those trends. When I first arrived thirty years ago Britain was top five in the prosperity league, it is now 28. One position ahead of Greece.”

He then pontificated about the possibility of a British resurgence, inspired by the candid investment in ‘Team GB’ throughout the years building up to the Olympic Games. He warned, however, against arrogantly assuming we could compete with the manufacturing in Germany or workforce flexibility of China.

“Why can’t Britain have global healthcare companies that sell to the world, like Tesco?” he mused.
Ali reflected on his own rise: from humble beginnings in Iran to a leading light in hospital innovation. He canvassed a firmly held belief that Britain used to be a fertile hotbed of pharmaceutical innovation and could rise once again if only it was prepared to embrace change and look at the situation through the prism of modern patient demands.

Most poignantly, Ali told a story about how he had shown guests around his first private hospital – designed by Sir Norman Foster. The surroundings were so comfortable that after a while someone had asked, “When are we going to see the hospital?” The NHS has conditioned us to assume that hospitals are grisly corridors of uncertainty. How refreshing to hear that it doesn’t have to be this way.

With much to ponder, I lunched on the chicken and apple casserole which – despite my reservations about mixing fruit and flesh – went down well.

Whitehead-strong
The next port of call on my magical mystery tour was the ABPI conference and, while Wellards had provided some interesting sparring, Stephen Whitehead, ABPI’s Chief Executive, ensured the gloves were off straight away, landing some lusty blows.

He started by admitting a handwriting test had revealed he was psychotic and that he was here to explode the myth of a bright new NHS which made pharma a priority.

“Something odd is happening in the UK and I want to take this opportunity to speak out. I don’t want cry fire in a crowded room, but I was raised to tell the truth.”

At this point I sat up and brushed the remaining crumbs of pain au chocolat from my sweater. I think I was about to witness – what do they call it – ‘a happening’.

“The UK is a tough and difficult place. We [pharma] are down 16,000 jobs in four years; we have suffered closures and decline. Pressure is immense. Patients are denied choice and we have the lowest uptake of innovation in Europe,”
he said.

“We have strong new products from the likes of Shire, Novartis and Pfizer, [but] the deal we have, to discover healthcare and provide it to patients, is broken. The industry has changed from the one it was ten years ago. It used to be that the UK was the second market behind the USA: a proud place for discovery, development and launch.

“We still launch great medicines, but suffer from pathetically low levels of uptake. There have been superb breakthroughs in Hepatitis C, for example, but orders are dwindling because of agonising referrals.

“The NHS won’t invest to save longer term and its decision making is often dictated by provider interest rather than patients. Why is my dad, with crippling shingles, given Paracetamol? Why was my good friend given a cancer drug privately, but unable to get it on the NHS? Why was my mum put on a waiting list with a prolapsed bladder for six months? When I called a consultant three days later he said he would do it for £3000.

“The NHS is a religion, but we know what happens to countries that don’t revaluate their faith,” he added.

It’s been emotional
It was a passionate, robust and at times emotional response to what he considered an NHS that was failing miserably in its objectives. What defined Whitehead’s speech was a frustration that manifested itself both professionally and personally. It was terrific to hear him refer to his own personal experiences, adding a devastating cocktail of brutal honesty and spearing clarity, which surely some of the NHS’s policy-regurgitating line-toers can learn from?

All too often we are bombarded by a politically sterilised dogma that jars with reality and falls off the cerebral cortex like so many white papers off a shovel. This was in evidence when one of the NHS’s knights of the realm, Sir Ian Carruthers OBE (no less), attempted to tackle the blaze Whitehead had ignited by randomly dispatching buckets of barely legible civil service twaddle. The numbing jargon that followed was like some kind of linguistic water boarding – “innovative approaches”, “operating framework”, “technology appraisals”, “delivery uptake”, “personal incentives”. Stop, stop, stop! I can’t take it any more!

One sentence contained the word “implementation” half a dozen times. Is it possible that when these ‘honours list parasites’ pick up their prefixes and suffixes, they also agree to wander around in a clanging armour of jargon?

Again, the private sector’s clarity and verve of expression was in stark, embarrassing contrast to some of the insipid management speak on offer here.

Johnny’s final thought
Since the beginning of civilisation words have needed meaning. Organisations which grow out of all proportion to their original concept – like the NHS – often use a dribbling dialect designed to vaporise instantly, lest it should actually seep inside a human brain.

As the multi-tentacled other-worldly creature of NHS reform continues to loom over two very different cultures, it is clear that communication simply has to change – at the moment they are speaking entirely different languages.

Aclimatisation for the NHS has often been the bitterest pill to swallow but now – as Alan would no doubt agree – it’s time to change the record.

Innovation rewarded: Janssen, MSD and Takeda scoop top prizes

by IainBate 25. October 2012 16:45

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

Prix Galien 1 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
Prix Galien 2 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
Prix Galien 3 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.”

Guidance hopes to raise hepatitis awareness

by IainBate 14. June 2012 16:35

Pharma NICE UpdateNICE aims to tackle the ignorance and barriers to effective testing of those at an increased risk of infection of hepatitis B or C in new draft guidance.

Services, organisations and practitioners should promote testing by measures such as raising awareness to the general public and identifying those most at risk, the guidance advises.

Professor Mike Kelly, NICE Director of Public Health, said a “general ignorance” has contributed to a lack of services and poor uptake of testing due to the “stigma surrounding hepatitis B and C”.

According to the Chief Medical Officer, around 180,000 people in the UK are now chronically infected with the hepatitis B virus – with a further 216,000 people chronically infected with the hepatitis C virus.

Hepatitis B and C are blood-borne viruses that predominately infect the liver and can lead to chronic liver damage, cirrhosis and liver cancer.

The draft guidance also recommends testing through contact tracing, testing in prisons and in drug services and commissioning viral hepatitis testing and treatment services.

Professor Kelly added that NICE hopes to raise “general awareness” on myths surrounding the virus within the guidance. “This is aimed at addressing any misconceptions about the risk of hepatitis B and C that can act as barriers to testing, including the belief that treatments are not effective and that treatment is not needed until the illness is advanced,” he said.

“It is also aimed at demystifying the risks of transmission among families, friends and colleagues of people diagnosed with chronic hepatitis B or C, and in doing so reducing much of the stigma attached to the diseases.”

Final guidance is now expected towards the end of the year.

UK innovations shortlisted for top prize at Prix Galien

by JoelLane 29. May 2012 11:24

clip_image001[7]New innovations from ten of the world’s leading drug companies will compete for the most prestigious distinction in pharmaceutical research later this year – a globally revered Prix Galien medal.

Twelve medicines have made the shortlist for the final of UK Prix Galien, which will return to the House of Commons this coming September.

The shortlist reflects the strength and diversity of pharmaceutical innovation, with treatments for a broad range of disease areas set to be assessed by Prix Galien’s esteemed judging panel – led by NICE Chairman Professor Sir Michael Rawlins. Medicines developed to treat schizophrenia, hepatitis C, MS, DVT, constipation, coronary disease and a variety of cancers will battle it out for the Innovative Drug Award. A treatment for the rare bone cancer in adolescents, osteosarcoma, will be considered for the Orphan Drug Award. All shortlisted products were launched or granted a new indication in the UK between 1 January 2010 and March 31 2012.

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The 2012 ceremony comes at a time when the value of medical innovation finds itself under great scrutiny in the UK. The Innovation Health and Wealth Review, published at the end of 2011, outlined the growing need to accelerate the adoption and diffusion of innovation in the NHS – setting out a blueprint designed to ensure innovations that can improve health outcomes actually reach their target patients.

“The challenge for the UK pharmaceutical industry is to demonstrate that its medicines truly add value, and can help the NHS meet its quality and productivity goals. The ethos of Prix Galien is very much aligned with the aspirations of both QIPP and Innovation Health and Wealth. It provides the perfect platform for the UK industry to promote its position as world leaders in pharmaceutical research and development,” says Karen Westaway, Joint Chief Executive at WG Consulting, which has owned the UK Prix Galien franchise for eight years and managed the process since 1996.

UK Prix Galien takes place every two years and is judged by a highly respected panel of influential, eminent and experienced NHS professionals. Alongside Professor Sir Michael Rawlins, the judging team includes experts such as Professor Dame Carol Black, Professor Parveen Kumar, Professor Gordon Duff and the current National Cancer Director, Professor Sir Michael Richards.

“The judges are all high-achieving, influential stakeholders who have shaped, and are still shaping, healthcare,” says Karen Westaway. “Their continued commitment to Prix Galien is itself an endorsement of the process.”

UK Prix Galien 2012

The 2012 ceremony will take place on Wednesday 26 September at the House of Commons, London. The Rt. Hon. Kevin Barron, MP, a former shadow health minister and chair of several all-party parliamentary groups including those relating to the pharmaceutical industry and health, takes over from Lord Walton of Detchant as the Parliamentary Sponsor. Current Secretary of State for Health, Andrew Lansley, is a long-standing supporter of UK Prix Galien and was the Parliamentary Sponsor for many years. The Health Secretary presented the most recent UK Prix Galien awards in 2010, describing them as a ‘fascinating occasion’ that allows people to acknowledge ‘the volume of innovation and new medicines that have been coming through.’

The 2010 Prix Galien medal for innovation was won by Xarelto (rivaroxaban), Bayer Healthcare’s revolutionary treatment for the prevention of venous thromboemolism (VTE). Shire Pharmaceuticals’ Firazyr (icatibant), a treatment for hereditary angioedema, won the Orphan Drug Award.

Prix Galien around the world

Prix Galien is internationally renowned, with a further ten national franchises conducting ceremonies around the globe, as well as an International Prix Galien every two years. The award has been described as ‘the highest distinction which may honour a pharmaceutical product’, and ‘a prestigious testimony and acknowledgement of the vitality of our pharmaceutical research.’ In 2008, US President Barack Obama said: “The Prix Galien is a welcome initiative to stimulate creative research and promote excellence.”

For more information about UK Prix Galien, please visit www.prixgalien.co.uk

Interferon causes depression in hepatitis C patients

by JoelLane 4. May 2012 17:04

PegIntron-Group resized Interferon, part of the standard treatment for hepatitis C, is a major cause of depression in patients with the disease.

A new study has linked the high rate of suicide among hepatitis C patients to side-effects of interferon, which is usually taken together with ribavarin.

These findings will increase clinicians’ interest in alternatives to interferon in the treatment of the life-threatening infectious disease.

Researchers at Loyola University, Chicago, observed: “Depression is a relatively frequent and potentially serious complication of interferon therapy for hepatitis C virus infection.”

Hepatitis C is an increasingly widespread infection worldwide, causing pain, fatigue, disability and death.

The standard treatment is a combination of ribavirin and pegylated interferon. The latter can relieve muscle and joint pain and reduce fatigue.

However, interferon affects serotonin levels and is consequently associated with depression. The study reports that between 10% and 40% of hepatitis C patients receiving interferon experience depression and may be at risk of suicide.

The study authors recommend that patients with a personal or family history of depression or suicide attempts should be carefully assessed and possibly treated for that condition before treatment with interferon begins.

There is conflicting evidence about the effectiveness of antidepressants in patients who are receiving interferon – they may help to reduce the symptoms, but do not seem reliably able to prevent the condition.

Interferon also has flu-like symptoms, and the new study will increase the pressure to develop alternative treatments such as the combination therapy involving drugs from Gilead and BMS that recently demonstrated strong clinical efficacy in a phase II trial.

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News

New pill combination could be hepatitis C cure

by JoelLane 20. April 2012 13:37

Pf product news The combination of two oral drugs from Gilead Sciences and Bristol-Myers Squibb (BMS) has the potential to offer a faster cure for hepatitis C.

Gilead’s GS-7977 and BMS’s daclatasvir, taken daily for six months, cured almost all patients in a phase II clinical trial while sparing them the side-effects of interferon.

However, the lack of a partnership between the two companies could delay patient access to the drug combination.

The companies said that all 88 trial participants who took the two-drug combination had undetectable virus levels after four weeks, and 84 had undetectable virus levels four weeks after the end of the 24-week trial.

The most common side-effects of the combination were fatigue, headache and nausea; the non-ribavirin treatment group also showed low phosphorus and high cholesterol levels.

Gilead also reported two 12-week phase II trials: one where GS-7977 and ribavirin cured 22 of 25 hepatitis C patients (with undetectable virus levels a month after the trial end); and and one where GS-7977, ribavirin and interferon cured 90% of patients.

Hepatitis C is a chronic blood-borne infection than can cause life-threatening liver damage. No complete oral treatment for the infection currently exists.

In 2011, Vertex and Merck introduced oral medications that increased the cure rate from 60% to 80% – but these need to be used alongside alpha interferon, which is injected weekly for up to a year and has flu-like side-effects.

As yet Gilead and BMS have not agreed to collaborate in order to bring the new combination therapy to market.

Dr Douglas J. Manion, a Senior VP at BMS, said the company was “keen” to work with Gilead but the latter was “unwilling to engage in that collaboration.”

Norbert W. Bischofberger, Executive VP for Research and Development at Gilead, said the company wanted to wait for further clinical trial data: “We told them it’s too early to jump wildly into this collaboration.”

In particular, he noted, Gilead wanted to establish whether the combination of GS-7977 with the generic ribavarin would be as clinically effective as using daclatasvir. If so, not only would the combination be cheaper, but Gilead could increase its profits by using its own ribavarin.

Finally, Bischofberger observed that if no collaboration took place, doctors would still be able to use GS-7977 and daclatasvir together.

Janssen creates new division to fight hepatitis C

by JoelLane 19. April 2012 11:49

Pf industry news Janssen Pharmaceuticals, a Johnson & Johnson company, has created a division to commercialise its new drug for hepatitis C in the EMEA region.

The protease inhibitor TMC435, co-developed by Janssen and Medivir AB, is currently in phase III clinical trials.

The creation of Janssen Therapeutics EMEA, based in Belgium, reflects the growth of hepatitis C as an area of unmet medical need.

Hepatitis C, caused by the HCV virus, is a life-threatening chronic disease that affects over 130 million people worldwide.

Patient responses to treatment vary depending on genetic and other factors; many patients lack effective treatment options.

Janssen Therapeutics EMEA is dedicated to bringing TMC435 to hepatitis C patients in Europe, the Middle East and Asia as a once-daily medication.

TMC435 is being investigated in combination with PegIFN/RBV and with Direct-acting Antiviral (DAA) agents in interferon-free combinations.

“The WHO describes hepatitis C as a ‘viral time bomb,’ said Jane Griffiths, Company Group Chairman for Janssen EMEA. “That is why we have created a dedicated division, which will commercialise TMC435 and help meet hepatitis C patients’ needs.”

The new division’s strategy is to work with specialist licensing partners to develop treatments for hepatitis C. It will commercialise Incivo, another protease inhibitor, separately from TMC435 via its local subsidiaries.

Novartis to pay $440m for hepatitis C drug

by JoelLane 22. February 2012 12:03

Pf industry news Novartis has entered into a strategic collaboration with biotech company Enanta Pharmaceuticals to develop, manufacture and commercialise a new targeted drug for hepatitis C.

The agreement gives US-based specialist Enanta the backing of Novartis for EDP-239, the lead drug candidate from its hepatitis C virus (HCV) inhibitor program targeting the NS5A genotype.

Enanta will receive an upfront payment of $34m, and stands to receive a further $406m in clinical, regulatory and commercial milestone payments.

The US company will also receive tiered double-digit royalties on global sales and retain co-detail rights in the US.

Novartis will be responsible for all costs of developing, manufacturing and commercialising EDP-239, and will fund Enanta’s further drug discovery work targeting the same genotype.

NS5A is a non-structural viral protein that is essential to viral replication. Drugs targeting it have been shown to have major antiviral effects.

EDP-239 was recently included in Windhover’s top 10 ‘Most interesting infectious disease projects to watch’ list.

“Novartis is a recognised leader in the field of HCV, and access to its global expertise combined with our shared vision for commercialising HCV therapies will support the successful development and commercialisation of products targeting NS5A,” commented Jay R. Luly, Enanta’s CEO.

“We believe EDP-239 has great potential as a potent ingredient in combination drug therapy, and our preclinical studies have demonstrated high potency against multiple genotypes of the virus, excellent safety profile and a preclinical pharmacokinetic profile amenable to once-a-day dosing in humans.”

Hepatitis C is a chronic and life-threatening disease that affects over 170 million people worldwide. Drugs to inhibit the virus are increasingly a major goal for the pharma industry.

Based in Massachusetts, Enanta Pharmaceuticals is a research and development company specialising in targeted drugs to combat HCV.

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