Press review

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Pfizer dodges £84 million UK fine over epilepsy drug price

Country : China, France, Germany, Hong Kong, U.S., UK, Europe

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LONDON, 8 June (APM) - Pfizer has won its appeal against an £84.2 million fine imposed by UK regulator the Competition and Markets Authority (CMA) for steep rises in the price of its epilepsy drug Epanutin (phenytoin sodium), the Financial Times and The Times report on Friday.
The fine was imposed following a December 2016 ruling in which the competition regulator said Pfizer and its distributor Flynn Pharma had abused their dominant market position to raise prices for the drug, the FT notes.
Flynn sold the drug as a generic unbranded product after gaining distribution rights from Pfizer in 2012. Because branded drugs are subject to price controls and generics are not, the change allowed the companies to raise the price significantly, the FT said, noting that a pack of capsules which previously cost £2.83 went up to £67.50, while annual NHS spending on the drug leapt from £2 million in 2012 to £50 million the following year.
The price ended up at almost 24 times the original cost, The Times added.
Flynn was also fined a lesser £5.2 million as part of the action, and the two companies were ordered to lower the drug's price.
However, the FT says that on Thursday, the Competition Appeals Tribunal ruled that the CMA had been wrong in its market dominance conclusions as it “did not correctly apply the legal test for finding that prices were unfair”. It said it had also failed to consider what was the right economic value for the drug, or to take sufficient account of other comparable products, according to the report.
The case has provisionally been sent back to the CMA pending written submissions from the parties concerned. Meanwhile, the CMA said it was disappointed with the ruling and that it was considering a further appeal.
It said that it had “several active investigations which may now be severely delayed”, The Times adds.

UK ministers fail to limit medicine costs

Meanwhile, also on Friday, The Times reports that UK spending watchdog the National Audit Office (NAO) has criticised ministers for not stopping "nefarious" pricing practices in which some medicine costs have risen by more than 7,000%. Officials have not found the cause of most rises, according to the paper.
It cites its own reports from last year that patients were struggling to obtain medicines for cancer and mental illness because of "mysterious" shortages which forced the NHS to pay much higher prices for off-patent drugs.
It said at the time that this had cost the NHS £180 million, adding that the NAO concluded in its most recent report that paying above the list price for generic medicines had cost the NHS £315 million in the past financial year.
The Times quotes Meg Hillier, Labour chairwoman of the Commons public accounts committee, as saying there is a “moral issue” with companies increasing prices at these levels.
She said it is difficult for the government to be sure “there are not nefarious practices going on. The Department of Health needs to send out a clear message that they are going to be tough on this. Given the NHS is a buyer of clout, it should be able to do a better deal.”

Merck & Co asserts dominance in cancer immunotherapy at ASCO

Merck & Co asserted its dominance in cancer immunotherapies at the ASCO conference in Chicago, the FT said at the weekend.
The claim was made in relation to a late-stage study of PD-1 inhibitor Keytruda (pembrolizumab) that showed it boosted survival in locally advanced or metastatic non-squamous or squamous non-small cell lung cancer (NSCLC).
Patients taking Keytruda lived for an average of 16.7 months versus 12.1 months on chemotherapy, although people whose tumours contained higher levels of a certain protein did substantially better. (APMHE 58367)

Keytruda has ‘Lazarus’ effect in prostate cancer trial

Merck & Co’s Keytruda also impressed in a trial of men with prostate cancer, the Mail on Sunday reported.
The trial, led by The Institute of Cancer Research and the Royal Marsden Hospital, looked at 258 men whose cancer had progressed despite undergoing numerous other treatments.
Study results presented at ASCO showed more than a third of those treated with Keytruda were still alive after a year. And one in 10 were still actively benefiting from treatment.
Professor Johann de Bono of the Institute for Cancer Research said: “We hope for a cure but we can’t call it that yet. However, many of the men who were at death’s door have been on the drug for more than 18 months and show no signs of the disease.’”
He added: “Some of the patients on this trial are like Lazarus - they were dying of advanced disease. Some were almost too unwell to have any treatment at all and they have been resurrected.”

NHS to get 'significant' cash boost, says UK health secretary

UK Prime Minister Theresa May will give the UK's NHS a “significant increase” in its budget to coincide with the service’s 70th birthday in July, UK health secretary Jeremy Hunt told The Guardian on Wednesday.
The new long-term funding plan will move away from 1% annual rises for the NHS, which it has received since 2010. Hunt said previous policies of small increases and emergency injections of cash are not viable. He noted that the economy is now "back on its feet" and growing more healthily, so a significant increase in resources is now possible.
He told the paper he favours a 10-year plan for substantial annual budget NHS rises.“We have to recognise that we have a once-in-a-generation challenge and the choice we have as a country is: are we going to deal with that challenge in an ad hoc way, living hand to mouth year in year out, or are we going to look at this strategically?”
The NHS should use extra funding to improve cancer survival rates, which lag behind those in France and Germany, he told the paper (APMHE 53945). It should also integrate health and social care; transform mental health services; and cut the number of babies stillborn or born brain-damaged through failings of maternity care, he added.

Pharma continues to push for early EU-UK agreement on medicine

Pharma industry leaders have continued their calls for an interim deal to ease the passage of medicines between the UK and Europe, the FT writes on Friday, noting that fears continue to grow over post-Brexit shortages.
Ministers and senior industry representatives met last month to discuss demands for a mutual recognition agreement under which batch safety inspections and clearance in the UK would continue to apply in Europe and vice versa, the paper noted, citing two people familiar with the discussions.
Without such an agreement, batch release testing, manufacturing site inspections and other key regulatory requirements would need to be duplicated in the EU and UK. Industry heads have previously warned this could add many millions of pounds worth of cost (APMHE 55929, APMHE 57889).
The news follows shortly after reports that Merck & Co could stockpile up to six months worth of supplies and consider altering trade routes to deal with the issues it might face when the UK leaves the EU in March 2019 (APMHE 58425).

Women with breast cancer could be spared harmful chemotherapy

Thousands of women with breast cancer could be spared chemotherapy after a study found that it offered no benefits after surgery, it was reported in the Guardian and the FT on Monday.
The trial followed 10,000 women for nine years. It found an “intermediate group” of patients for whom post-surgery chemotherapy offers no benefits and who can be safely treated with just hormone therapies rather than chemotherapy, which has greater side effects.

Bayer plans to lose Monsanto brand after takeover

Bayer plans to ditch the Monsanto name after it completes a $63 billion acquisition of the chemicals firm, the Guardian said on Monday.
The paper said Monsanto has long been targeted by environmental activists for its pioneering role in creating genetically modified crops and the deadly herbicide Agent Orange, used by the U.S. in the Vietnam war.

BMS shares down after ‘confusing’ data presented at ASCO

Shares in Bristol-Myers Squibb were down 4% following “confusing” data presented at ASCO, the FT said on Monday.
The paper said that data presented by BMS and partners Nektar Therapeutics on a combination of immunotherapies NKTR-214 and Opdivo (nivolumab) appeared less impressive than earlier sets from the trial.
Shares in Nektar fell 39%, added the FT. Despite the results, BMS and Nektar said they will push ahead with Phase III trials.

Takeda shareholders trying to derail Shire deal

A group of shareholders in Takeda are trying to derail the Japanese company’s £46 billion acquisition of Shire, the FT said on Tuesday.
The paper said that the group, which holds just over 1% of Takeda stock, is concerned with the high level of debt that Takeda is taking on to fund the deal. The group is also concerned about the value of Shire's haemophilia business, considering the prospect of a new rival product from Roche.

Oxford BioMedica signs $842 million Parkinson's gene therapy deal with Axovant

British biotech Oxford BioMedica has finalised a $842.5 million deal with U.S. company Axovant Sciences to commercialise its gene therapy for Parkinson's disease, formerly known as OXB-102 but now known as AXO-Lenti-PD.
Axovant expects to begin a Phase I/II dose escalation study for the drug by the end of 2018, according to Oxford BioMedica's statement.
The FT noted on Wednesday that the news had pushed Oxford BioMedica's sales up 19%.
It said the firm will receive a $30 million upfront payment, and that it is eligible to get a further $812 million in development, regulatory and sales milestones, as well as 7% to 10% royalties on sales.

New immunotherapy cures previously untreatable breast cancer

Researchers managed to cure a woman’s advanced breast cancer with a new immunotherapy that involves using white blood cells to attack the tumour, The Times said on Tuesday.
Judy Perkins was told she had weeks or months to live, after a string of other treatments failed and the cancer spread to her liver. She has now been free of disease for two years after treatment using a technique known as tumour infiltrating lymphocyte (TIL) therapy. (APMHE 58377)

AZN’s Lynparza has potential in prostate cancer

AstraZeneca’s Lynparza could be effective in men with prostate cancer, The Times said on Monday.
The PARP inhibitor is already approved for ovarian and breast cancer and is now the first in its class to be effective against late-stage prostate cancer which has spread to other parts of the body, according to data presented at ASCO.
The Phase II trial showed that men who took Lynparza in combination with a hormone therapy, which is the current standard of care for this type of cancer, lived on average five and a half months longer without disease worsening than those who were only taking the hormone drug.

Personalised cancer treatment can increase survival chances

Precision medicine can help cancer patients live longer, it was reported in the Guardian and the Daily Telegraph on Wednesday,
Both papers picked up a study presented at ASCO that showed patients were six times more likely to live 10 years if they received tailored treatment that was specific to their mutation.
The study looked at more than 3,700 people with cancer that had proved difficult to treat and who had already undergone other types of treatments. Of those patients, 1,307 had a known mutation, and 711 received treatment based on that genetic profile.
Six per cent of patients on personalised treatment lived for 10 years compared with just 1% of those on more general treatment.

Chinese regulations on sharing data impacting pharma

Pharma companies working in China are feeling the impact of a new regulation that means foreign scientists and foreign-invested institutions in the country must seek government approval before scientific data can be transferred abroad or to foreign parties in China, said the FT on Wednesday.
The paper spoke to Paul Haswell, a lawyer at Pinsent Masons in Hong Kong, who said that companies conducting drug tests or lab trials in the country might have to put in a request to share those results with their headquarters or overseas regulators.

NHS England and Merck & Co agree access deal for Keytruda

Lung cancer patients in England will have access to Merck & Co’s immunotherapy Keytruda after NHS and England and NICE agreed a deal on the drug’s cost, said The Times on Wednesday (APMHE 58400).
The deal was the first test of a policy that allows NHS England to restrict or delay medicines that will cost taxpayers more than £20 million a year, even if deemed cost-effective by NICE.
To fall into this threshold, Merck will supply the drug at a confidential discount to its £84,000 list price per patient.
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