Gilead sued over Sovaldi price

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A payer is suing Gilead over the price of its hep-c drug Sovaldi in the US after spending $2.4 million on the treatment for its employees.

Sovaldi (sofosbuvir) costs $84,000 per course of treatment in the country, a price that the Southeastern Pennsylvania Transportation Authority (SEPTA) claims is ‘exorbitant’ and in “sharp contrast to the prices at which Sovaldi is being made available by Gilead in other countries”.

Its suit points to Gilead’s licensing of the pill to generic companies in developing countries at a ‘deeply discounted’ price and its estimated $900 cost in Egypt as examples of this ‘obvious paradox’.

“Gilead is not authorized by the patent laws (or otherwise) to abuse its purported monopoly on Sovaldi by charging discriminatory prices that apparently have no rational basis other than to inflate the company’s bottom line,” the company adds.

“Gilead’s price gouging has had at least two detrimental consequences in this country. It has, obviously, resulted in the consumers and entities that have purchased Sovaldi paying significant prices for the drug. It has also effectively priced some consumers and government programs alike out of the Sovaldi market, thereby preventing needed recipients from obtaining this critical drug.

“Notably, there have been reports that this pricing scheme has had a disproportionately high impact on minorities and those in lower income brackets (demographics that have had historically higher incidents of Hepatitis-C infections).”

Separately, the US Senate Finance Committee is investigating the pricing of the drug and whether the market for Sovaldi ‘is working efficiently and rationally’.

Sovaldi is part a of new generation of highly effective hepatitis C drugs and has been shown to effectively cure the disease in more than 90% of patients in just 12 weeks. Gilead has said that this justifies the high cost of the drug as in the long-term it can reduce the need for costly liver transplants.

The effectiveness of the drug combined with its price tag has led to Sovaldi becoming the fastest-selling drug of all time – it made $8.4 billion in its first nine months on the market and is on course to break the $10 billion marker by the end of the year.

The question of Sovaldi’s price is not just an issue in the US, though – in October internal documents revealed that the NHS may be unable to afford the drug despite NICE previously saying that it was willing to pay for it.

Several other pharma firms, including BMS, Merck and AbbVie, have similar hep-c drugs in the pipeline. Meanwhile, Gilead’s Sovaldi combination treatment Harvoni has recently seen approval in the US and Europe.

By George Underwood – Pharmafile online

Roche submits melanoma drug to FDA

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Roche has submitted its melanoma drug cobimeinib for review with the FDA as it confirms the results of its Phase III trial.

The coBRIM study tested the MEK inhibitor combined with Roche’s established treatment Zelboraf (vemurafenib) in patients with BRAF V600 mutation-positive advanced melanoma.

The results showed that the combination therapy increased progression-free survival by 9.9 months compared to 6.2 months with Zelboraf alone.

“In the past several years we have made significant progress in treating advanced melanoma, but it remains a serious and difficult to treat cancer that affects more people each year,” says Sandra Horning, chief medical officer and head of global product development at Genentech.

“We look forward to working with the FDA as they review the NDA and hope the combination of cobimetinib and Zelboraf will soon become a new option for people with BRAF mutation-positive advanced melanoma.”

Melanoma is rarer than other forms of skin cancer, but is one of the most aggressive and deadly forms of the disease and most patients have a poor prognosis. MEK inhibitors like cobimeinib work by blocking the MEK protein and affecting signalling pathways involved in regulating cell division. These pathways are often overactive in cases of melanoma and other cancers.

Zelboraf targets another protein on this pathway – mutant BRAF – to interrupt abnormal signalling that can cause tumours to grow. It has been approved for the treatment of melanoma since 2011 in the US and 2012 in Europe.

Earlier this year GlaxoSmithKline’s own combination treatment of Mekinist (trametinib) and Tafinlar (dabrafenib) was shown to be more effective than Zelboraf in trials, but these latest results may give Roche’s drug a new lease of life.

Cobimeinib was discovered by Exelixis and is being co-developed by Roche’s Genentech subsidiary. It is also being investigated as part of a combination therapy in other cancer types, including non-small cell lung cancer, colorectal cancer and breast cancer.

Roche says that it has already submitted the data from coBRIM to the EMA.

By George Underwood – Pharmafile online

Germany bans 80 generic drugs for insufficient clinical trials by GVK Biosciences

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As many as 80 generic medicines have been banned by Germany’s drug regulator with immediate effect on the grounds that their clinical trials conducted by GVK Biosciences, the home-grown pharmaceutical research company, were insufficient.

Medicines of 16 pharmaceutical companies have been affected by the ban. The drugs include those for treating high blood pressure, depression, migraine, epilepsy and Parkinson’s disease.

The Federal Institute for Drugs and Medical Devices said on Wednesday it had ordered drug manufacturers, wholesale dealers, medical stores and other outlets not to sell or use these medicines any longer.

Patients still using these banned medicines have been advised to consult their doctors, even though the regulator has no information about any health risks for such patients.

The German watchdog said it had informed the drugs manufacturers about its decision on Monday and the ban on the sales of medicines came into effect on Wednesday.

The regulator also suspended the marketing authorisation given to the drugs concerned based on the data of clinical trials supplied by GVK Biosciences, the Hyderabad-based contract research company.

In a press statement, the Federal Institute said it did not expect its ban to cause any shortage of supplies as similar generic versions of these medicines by other drug makers as well as their original branded versions are available in the market.

The regulator investigated the marketing authorisation of 176 medicines by 28 pharmaceutical companies after an inspection of GVK Biosciences’ facility in Hyderabad revealed substantial deficiencies in carrying out the clinical trials of the generic medicines and in the validity of its data to support marketing authorisation applications, the statement said.

In view of these serious and systematic deficiencies, the bio-equivalence studies carried by the domestic drug firm to establish that the generic versions have the same effect on the human body as the original branded versions, cannot be accepted as a basis for marketing approval, the statement said.

Among the 80 drugs banned by the watchdog, marketing authorisations were already withdrawn in the case of 17 medicines by five companies because the authorisation holders either asked for that or did not seek an extension, the statement said.

However, marketing authorisation of these drugs and the remaining 63 medicines by 11 companies will remain suspended until the authorisation holder submits the results of a new bio-equivalence study. Marketing approval given to 96 medicines will remain valid, the regulator said.

Media reports said earlier that the European Union’s drug regulator the European Medicines Agency (EMA) believes that GVK Biosciences has been systematically manipulating its studies carried out on behalf of European drug manufacturers.

EMA had raised concern over the reliability of the studies conducted at the company’s facility between 2008 and 2013 and ordered a review of the marketing approvals based on the data provided by GVK Biosciences.

By  K Mammen Mathew: Business Today, online

Actavis to axe 200 jobs

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Actavis is set to cut 200 jobs in the US just weeks after buying Allergan for $66 billion.

The lay-offs will take effect on 2 January at its operations in Corona, California – although no details on what business areas they will affect have been released yet.

Although the cuts are not directly related to the Allergan buyout, this could still be seen as a worrying sign for the latter firm.

The Botox maker signed the deal with Actavis to fend off a $54 billion hostile takeover attempt from Valeant, that it said would create ‘significant risks and uncertainties’ due to Valeant’s record of slashing costs at acquired firms.

Although both companies were enthusiastic about the ‘financially compelling’ deal – with Actavis’s chief executive Brent Saunders saying that the merger would help establish “an unrivalled foundation for long-term growth” and “accelerate our commitment to build an exceptional, sustainable portfolio” – Actavis has a track record of axing employees at acquired firms.

Last year it cut around 30% of its US workforce after acquiring Warner Chilcott, and in July it laid off about 200 employees that had worked for the recently-acquired Forest Laboratories. Allergan itself cut 1,500 jobs in July as part of a restructuring designed to save around $475 million in 2015.

GSK losses

Actavis is not the only pharma firm to cut jobs in the US recently – UK-based GlaxoSmithKline just confirmed rumours that it will shed hundreds of employees in North Carolina as its respiratory business continues to struggle.

Although exact numbers have not been announced it is rumoured that GSK will axe around 900 jobs over the course of 2015, as the company attempts to save around $1.6 billion in annual costs over three years.

GSK adds that it was looking to “consolidate [its] geographic footprint and locate the majority of [its] R&D organisation into two major centers – in the Philadelphia area and Stevenage (UK)”.

By George Underwood – Pharmafile online

‘Postcode lottery’ still cause of many lung cancer deaths

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Patients are still pointlessly dying of lung cancer due to a ‘postcode lottery’ of services according to new results from the National Cancer Audit (NLCA). 

Its findings show that there remains a marked variation in critical care across the various Trusts and Networks in Great Britain.

Collecting data on 39,203 patients across the UK, the audit reveals that although measures of the overall standard have been sustained or in some cases improved, there still remains a variation in the provision of surgery in advanced and incurable diseases.

Dr Ian Woolhouse, co-clinical lead at NLCA, says: “Whilst there have been important improvements in a number of areas of lung cancer care, this annual report demonstrates that there is still some way to go to reduce variation in key treatments such as lung cancer surgery which is likely to have the biggest impact on survival.”

Lung cancer is the leading cause of cancer deaths globally with around 1.5 million each year, according to the World Health Organization.

For patients not eligible or able to have surgery but can receive radiotherapy, surgical treatment represents the best chance of cure of the disease. The amount of patients with early stage lung cancer who receive surgery varies from 33% to 63% when measured at Network level – with even more deviation at Trust level.

“Over the 10 years of the National Lung Cancer Audit we have definitely seen improvements in the standards of care for lung cancer patients and these are now leading to improvements in survival,” says Dr Mick Peake, clinical Lead, National Lung Cancer Audit.

“However, it is clear that not every patient in every area of the country is receiving optimal care, so our job is not yet done.”

Pharma’s part to play has also been involved in the debate, it provides patients with cancer therapy treatment within an expensive and jam-packed drugs market that can cost up to £90,000 for a course.

One market area that is set to intensify over the coming months is the race for a PD-1 therapeutic vaccine. In a recent trial Bristol-Myers Squibb’s new drug Opdivo (nivolumab) was found to keep 41% of lung cancer patients alive after one year’s treatment.

Already approved in Japan for melanoma, the medicine was given to patients with advanced squamous cell non-small cell lung cancer (NSLC) who have progressed after at least two prior systemic treatments.

Both Roche and AstraZeneca have PD-1 inhibitors in the pipeline. And Merck, who recently teamed up with rival pharma Pfizer to develop a new combination treatment for various non-small cell lung cancers, saw its own PD-1 drug Keytruda (pembrolizumab) gain US approval back in September.

The Department of Health (DOH) recently announced a £50 million investment in early cancer diagnostics after the results of an investigation found that half of GPs are prevented from directly referring suspected cancer patients for scans.

By Tom Robinson – Pharmafile online

Roche buys Ariosa Diagnostics

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Roche has purchased the privately-held US company Ariosa Diagnostics for an undisclosed fee as it looks to expand further into other markets.

Californian-based Ariosa is a molecular diagnostics firm that is mostly known for making a prenatal test that assesses the risk of Down syndrome, among other genetic abnormalities.

Roland Diggelmann who is the chief operating officer of Roche’s Diagnostics division, says: “The acquisition of Ariosa is another example of Roche’s commitment to advanced molecular diagnostics.

“Circulating cfDNA has the promise of providing early diagnostic information through a simple blood test in many important segments including pregnancy, cancer and transplantation, aligning with our strategy in personalised healthcare and commitment to setting new standards of care.”

Basel-based Roche has been looking to diversify its portfolio away from cancer and this move follows hot on the heels of its recent £8.3 billion InterMune buyout, which it paid for in cash.

It was one of several big pharma firms circling the US biotech, all looking to gain access to its new lung scarring drug Esbriet (pirfenidone) for the condition idiopathic pulmonary fibrosis (IPF).

Roche already markets Pulmozyme (dornase alfa) for cystic fibrosis and Xolair (omalizumab), for severe asthma in the US, and has other experimental respiratory products in clinical development –including another severe asthma drug called lebrikizumab.

Whilst it clearly has the cash reserves for acquisitions, such experiments are not without risk. The firm has seen a mixed bag of results after clinical trial failures for treatments in diabetes, schizophrenia and heart disease.

But Roche has been under pressure from investors to spend some of its huge cash reserves, and this Ariosa purchase sits on top of the three deals it completed just in the summer.

It agreed to pay up to $1.7 billion to acquire Seragon Pharmaceuticals to bolster its cancer treatment range and snapped up Santaris, a Swiss rival, in August for $450 million.

It also has added Genia Technologies, a DNA sequencing company, and IQuum, a diagnostics business, this year, but both deals were relatively small.

“We are thrilled to join forces with Roche to continue in our commitment to bringing forward high quality and affordable genetic testing that positively impacts the medical care of patients around the world,” says Ken Song, chief executive of Ariosa.

The closing of the transaction is expected to take place this month.

By Brett Wells – Pharmafile Online

Extra billions will only ‘keep the wolf from the door’ for NHS

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The UK’s national health service is to receive an extra £2 billion in funding next year – but health service leaders say the money is the bare minimum extra cash needed to keep the service running.

Chancellor George Osborne announced yesterday that the Conservative / Lib Dem coalition government would provide an extra £2 bn to frontline health services across the UK. He said the money a “down payment” in response to a plan unveiled by NHS leaders, which calls for an extra £8bn a year above inflation by 2020.

The new funding will be officially announced in the Chancellor’s Autumn Statement on Wednesday – but health service think tanks say the extra funding will only help to address the immediate pressures generated by growing demand for services and a virtually static overall budget.

Rob Webster, chief executive of the NHS Confederation, which represents health service managers, responded to the announcement:

“This announcement is excellent news for the NHS and provides funding to bridge the gap between what we are currently spending and what needs to be spent in 2015/16 to deliver the level of high quality services the NHS must in order to keep the country healthy. We have been saying for some time that NHS finances need to be shored up next year, so we can build a platform for the next five years.

The Confederation had already stated that £2 bn was the minimum needed to ‘keep the wolf from the door’, and warns that the quality of services will suffer if the funding gap is no addressed.

The warning signs that the health service is unable to cope are already starting to show – performance targets in A&E waiting times, cancer and hospital operations have all slipped in 2014, and a severe winter would put the service under even greater strain.

General Election looming

The announcement comes less than six months ahead of the UK general election, and the health of the NHS is set to be one of the key battlegrounds – one in which the Conservatives have traditionally trailed behind the opposition Labour party in terms of public confidence.

The nature of the new funding, and where it has been drawn from has faced a great deal of scrutiny, and scepticism from political opponents. Of the £2bn, around £1.3bn will be money found from savings in other government departments. The remaining £700m is to be taken from within the existing Department of Health budget, but will be guaranteed for use in patient services.

Labour have pledged to add extra funding on top of this announcement, with a further £2.5bn a year to be drawn from a so-called mansion tax and tax loopholes being closed down.

The scepticism about the announcement has not been confined to political opponents. Independent think tank the Nuffield Trust challenged the figures, saying the new spending amounted was not £2 billion, but £1.7 billion.

Nuffield Trust Chief Executive Nigel Edwards said: “This new funding will bring the NHS through what looked like being an impossible year in 2015/16.”

He added: “Our analysis suggests the extra £1.7bn will mean English health service funding keeps pace with the growing and aging population next year. Further increases like this will be needed every year to 2020, alongside deep reform, for the NHS to keep its current shape and standards. I’m glad the Government has started facing up to the very difficult decisions this will mean.”

He added that £550m of the funding would come from the Department of Health’s projected underspend, but that this option may well not be available in future years, and that the next increases needed to be entirely new money.

“The £1.5bn boost to general NHS funding will allow organisations and staff some respite from fire-fighting, and make progress where reform is underway. However, it is only around the sum which will be needed to match the growing costs and demand for treatment — we still need to ensure local leaders have the time and money for long term reform.

“Spending a further £1.1bn over four years to improve general practice and out of hospital services shows the right priorities. GPs working together, often in large organisations, will be the basis for future reforms but they need more money to make this work.”

By Andrew McConaghie, pharmaphorum online

Cubist Joining the Fight Against Antibiotic Resistance in the United Kingdom

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Tuesday, November 18th marked European Antibiotic Awareness Day. Public health experts, hospitals, and physicians in the United Kingdom gathered to raise awareness of what can be done to fight what the World Health Organization (WHO) calls one of the top three threats to human health. The issue of rising antibiotic resistance and the lack of treatment options is causing increasing concern worldwide, including in the UK.

To address the urgent need for new antibiotics, Cubist Pharmaceuticals, Inc. (NASDAQ: CBST), the global leader in the discovery, development, and commercialization of novel antibiotics, is investing significantly in global antibiotic R&D and is focusing its late-stage pipeline on addressing serious and potentially life-threatening healthcare-acquired bacterial infections. To fight the global battle against antibiotic resistance and to support the potential launch of two new antibiotics in Europe in 2015, Cubist is expanding its presence in Europe and has recently begun operations in the UK.

“This year’s awareness day comes at a critical juncture,” said Sebastian Stachowiak, Country Manager, United Kingdom, Ireland and Nordics, Cubist Pharmaceuticals. “With resistant bacterial infections resulting in an estimated 25,000 deaths in the European Union, solutions are needed today to address growing resistance in the United Kingdom and throughout Europe.”

Twenty percent of all deaths due to antibiotic resistance infections in Europe occur in the United Kingdom.

The World Health Organization (WHO) issued its first ever report on antibiotic resistance earlier this year and their characterization of the problem was stark. Less than a century after widely available antibiotics ushered in an era of increasing life expectancy thanks to the ability to fight infection, mankind is now at risk of entering a “post antibiotic era” where doctors no longer have medications to treat serious infections.

As a company at the forefront of antibiotic development, Cubist is a founding member of a recently announced public-private consortium called DRIVE-AB (Driving Reinvestment in R&D and Responsible Antibiotic Use). DRIVE-AB is a €9.4 million public-private consortium, funded by the EU Innovative Medicines Initiative (IMI), with the goal of improving standards for responsible antibiotic use and development of new models for research and development of new treatments. Visit http://drive-ab.eu/about/ to learn more.

About Cubist’s Commitment to Antibiotic R&D

For more than 20 years, Cubist has had an unwavering focus on antibiotics. The Company is committed to global public health through the discovery, development, and supply of antibiotics to treat serious and potentially life-threatening infections caused by a broad range of increasingly drug-resistant bacteria. With one of the strongest antibiotics pipelines in the industry, Cubist expects to invest approximately $400M USD in 2014 on antibacterial R&D and hopes to deliver at least four new antibiotics in support of the Infectious Diseases Society of America (IDSA) goal of 10 new antibiotics by 2020. To learn more about superbugs, the threat of resistance, and the global response visit: http://www.cubist.com/superbugs

Reckitt finalises pharmaceutical demerger plans

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Reckitt Benckiser has confirmed its plans to spin-off its pharmaceutical portfolio from its core consumer products business.

Final details of the proposed separation were outlined earlier this week with the demerged RB Pharmaceuticals (RBP) being renamed as Indivior, and the process should be reach completion before Christmas.

“The demerger will allow the Indivior Group to allocate resources and deploy capital in a manner consistent with the priorities of the Indivior business,” the company says.

The split was first recommended in July after a strategic review by the company. Reckitt Benckiser is best known publicly in the UK as the maker of domestic goods such a Cillit Bang, Vanish and Nurofen, products ­– at odds with its pharmaceutical division’s focus on addiction treatments.

The firm hopes that separating its pharmaceutical business from its consumer side will allow both companies to focus more on core products.

RBP only has one marketed drug – the heroin addiction treatment Suboxone (buprenorphine and naloxone). The business has been lucrative for the company in the past, bringing in sales of $1.2 billion (£767m) last year, but revenues have slid by 8% for the first half of this year as generic competition takes its toll.

Other treatments in its pipeline include its once-a-month injectable version of Suboxone, which it hopes to bring to market in 2017, and a drug overdose rescue nasal spray for use in emergencies that could come to market in the US in 2016.

By George Underwood – Pharmafile online

GSK tops pharma league for access

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GlaxoSmithKline is basking in some good news after topping the league table of pharma companies which do the most to improve access to drugs in developing countries.

The Access to Medicine Index 2014 has put GSK first – for the fourth consecutive year – with Novo Nordisk close behind in second place.

Compiled by the Access to Medicine Foundation, the methodology has been developed with support from academics, NGOs, investors and governments, and pharma companies have been “more transparent with their data and more open about their challenges than ever before”, the Netherlands-based organisation says.

While GSK leads the overall table, data is broken down into seven different areas such as pricing, where Gilead Sciences comes first for implementing equitable pricing strategies more closely targeted toward poor population groups within countries.

One key issue on which pharma needs to do better is public policy and market influence. “Scores are generally low in this area,” the report warns. “There is a clear gap between companies’ stated commitments to ethical behaviour and what actually happens in practice.”

Apart from Gilead and AbbVie, all companies have been the subject of settlements or decisions relating to corruption, ethical marketing or competition this year, “despite almost all having codes of conduct to govern employee behaviour”.

GSK does well on R&D, as does Johnson & Johnson, and the report praises the top five companies in that section for developing many of their products on access-oriented terms.

Access to Medicine Foundation founder and chief executive Wim Leereveld points to pharma’s improving record generally on tackling TB, hepatitis C and neglected tropical diseases.

“These developments show us how much we need the entrepreneurial power of pharmaceutical companies to address access to medicine,” he insists. “But while it is clear that companies have a role to play, there is still no sustainable model for ensuring the poorest patients have access to the medicine they need.”

GSK chief executive Sir Andrew Witty says: “People rightly expect us to do all we can to discover, develop and price our medicines and vaccines so they are accessible to those who need them, wherever they are in the world.”

He points to the company’s work on a new Ebola vaccine and agreements with Save the Children to develop child-friendly medicines as proof of GSK’s commitment.

Praising the Index, Sir Andrew adds: “It challenges us to think harder about how we drive innovation and enable access to our products.”

By Adam Hill – Pharmafile online