LONDON, 10 May (APM) - Drug firms will be forced to display prices on TV advertisements in the U.S. as of 1 July under new rules from the US Health and Human Service (HHS), the Daily Mail and the FT said on Wednesday.
The papers said anything advertised that costs more than $35 will need a clear notice of its price.
Pharma R&D investment in cancer therapies outpacing the market
Big pharma investment in cancer therapies has outpaced the market, the Financial Times wrote in a comment piece on Monday, adding that for many companies, commercial rewards will be elusive.
The newspaper quoted figures from IQVIA that the annual cost of treatment with a new cancer drug in 2017 averaged more than $150,000, nearly twice the price in 2013. Revenues can be as much as 10 times higher than research costs, it said.
However cash-strapped the health system, insurers have to pay for whatever oncologists prescribe in most U.S. states, the FT noted.
And the market is crowded and competitive, it said, adding that more than 700 cancer drugs are in late-stage development - up more than 60% from a decade ago. The proportion in the late-stage pipeline of the 14 biggest pharma companies has more than doubled since 2010 to nearly 40%, it added, quoting Deloitte.
Given that cancer drugs now generate just a tenth of industry sales, pharma groups may see poor returns on their R&D, the FT said, quoting UBS, adding it detects signs of a R&D bubble.
Insys case raises risks for drug industry over opioids
U.S. prosecutors are expected to turn up the heat on drugmakers, distribution companies and doctors after the Insys trial showed a jury was prepared to convict defendants for their role in the opioid epidemic, the FT reported on Monday.
Insys founder and chairman John Kapoor was the first high-ranking pharmaceutical executive to face serious criminal charges related to the addiction crisis. He faces up to 20 years in prison after being convicted of racketeering conspiracy for bribing doctors to prescribe its fentanyl spray Subsys (APMHE 62134
), the FT notes.
The conviction of Kapoor and four of his colleagues came the week after the U.S. attorney in New York levelled criminal charges against Rochester Drug Cooperative, a large drug distributor, its former chief executive and former chief compliance officer for unlawfully distributing controlled substances, it said.
Just two weeks earlier, the Department of Justice indicted 53 medical professionals in six states for the illegal prescribing and distributing of opioids and for healthcare fraud schemes, the work of a new “prescription opioid strike force” of federal agents and prosecutors in Appalachia.
Harry Nelson, the managing partner of healthcare law firm NelsonHardiman and the author of The United States of Opioids: A Prescription for Liberating a Nation in Pain, told the newspaper he expects the government to redouble its efforts to pursue criminal prosecutions.
"[The Insys case] is obviously a significant moment in actually getting a criminal conviction against an opioid drugmaker,” he said, adding that he expects prosecutors to "revisit" the case of leadership at Purdue Pharma, the maker of OxyContin that is owned by the Sackler family.
Opioid tycoon Richard Sackler blamed addicts for drug abuse
Richard Sackler, the chief executive of Purdue Pharma who helped to launch OxyContin, sent an email to a friend complaining about reports that the drug had become the centre of an abuse epidemic and laying the blame on addicts, The Times reported on Thursday.
"Abusers aren't victims," he wrote, in an email sent six years after the launch of the painkiller in 1996. "They are the victimisers". The email and other messages have been released by the attorney-general of Connecticut as part of the lawsuit against Purdue Pharma and the Sackler family.
Cultural shift for German investors
Bayer's shareholder revolt could indicate a cultural shift towards traditionally non-confrontational German investors, according to a comment piece carried by the FT on Tuesday.
It was referring to Bayer's shareholder meeting at the end of April where shareholders delivered a vote of no confidence to the serving management (APMHE 62800
), a move the FT marked an "unprecedented act of defiance".
It quoted Michael Wolf, professor of management at Göttingen University, as saying:“Investors in Germany have traditionally tended towards compromise and avoiding conflict. This is a turning point.”
Nostrum Laboratories hikes cold remedy price by 300%
U.S. pharma company Nostrum Laboratories has raised the price of a prescription cold medicine by more than 300 % to over $170, in spite of previous criticism from the former head regulator, the FT reported on Tuesday.
The price rise for the oral solution of promethazine and codeine comes after Nostrum more than quadrupled the price of nitrofurantoin, an antibiotic mixture, to more than $2,000 last year, the newspaper said.
Nirmal Mulye, the firm's chief executive, argued at the time that there was a "moral requirement to sell the product at the highest price" but Scott Gottlieb, then commissioner of the U.S. Food and Drug Administration, responded that there was "no moral imperative to price gouge and take advantage of patients".
Nostrum raised the price of a 473ml bottle of promethazine and codeine by 326% to $170.55 at the end of April, the FT said, citing Elsevier’s drug database. Promethazine is an antihistamine that relieves itchiness and sneezing, while codeine is used to suppress coughs and relieve pain.
Big pharma's R&D not focused on low income countries
There is too little incentive for pharmaceutical companies to work on treatments for diseases of low-income countries, according to an opinion piece carried in the Guardian on Sunday.
The article referred to GlaxoSmithKline rolling out the "first and so far only" vaccine to protect against malaria - RTS,S - under a World Health Organization pilot programme that could immunise more than one million children by 2023 (APMHE 62782
While this is a welcome step in the fight against malaria, it also exposes the problems in developing vaccines for use in non-western countries, it said, quoting GSK as saying that while it is "incredibly proud" to see the vaccine launched, "this kind of endeavour can’t be repeated, from GSK’s point of view".
The article notes that this is because of the drug R&D model, which is based on big pharma charging high prices for products which are tailored to wealthy markets, adding there is little incentive for pharma to fund R&D for countries with limited purchasing power.
GSK ordered to pay $89.7 million in Ellipta damages to Vectura Group
GlaxoSmithKline has been ordered to pay its Ellipta (fluticasone furoate+vilanterol) partner, Vectura Group, $89.7 million in damages after a Delaware jury found that one of Vectura's patents had been infringed by sales of three of GSK's Ellipta products, The Times reported on Wednesday.
Shares in Vectura rose 9p, or 12.5%, to 81.5p, while GSK shares fell 34.5p, or 2.2%, to £15.18.
Wiltshire, UK-based drugmaker Vectura had been in dispute with GSK over its decision to stop paying royalties for the sale of Ellipta respiratory products, The Times noted. The damages awarded cover August 2016 to December 2018, and were based on 3% of U.S. sales for the products.
Vectura said it now expects to seek the 3% royalty on subsequent sales to the middle of 2021 when the patent ends, and noted that the jury had found that GSK's infringement was "wilful", which also gave it the opportunity to seek further damages, the newspaper added. Meanwhile GSK is considering options for appeal under the belief it lives up to the licensing agreement.
Perrigo stung by U.S. tax bill
Perrigo, a U.S. pharma company headquartered in Ireland, has been hit with a €741 million tax bill from the U.S. Internal Revenue Services (IRS), The Sunday Times reported. The IRS bill follows a €1.64 billion tax demand last December from its revenues, the second largest in Ireland's history.
Both tax claims stem from Perrigo's acquisition of the Irish company Elan in 2013, and the development of Tysabri (natalizumab), a treatment for multiple sclerosis which Elan in turn took over along with Athena Neurosciences in 1996.
The IRS claims that when Elan took over the funding of Athena's research and development, it should have paid a substantially higher royalty rate to the U.S. subsidiary for the right to exploit the intellectual property. On the basis of its royalty estimate, the IRS has proposed a payment of $843 million (€741 million), which represents additional tax and a 40% penalty, excluding interest.
Perrigo said it "strongly disagrees with the position taken by the IRS", and said if the matter were resolved "unfavourably" it could harm the company’s "liquidity and capital resources".
Painkillers fuelling headaches
Frequent doses of any commonly used painkiller (typically on at least 14 days a month) can lead to medication-overuse headache (MOH), The Times reported on Monday, noting that the UK's NICE has issued a new guidance for doctors on diagnosing neurological problems.
Some drugs are more likely to cause MOH than others, the newspaper adds, noting the highest risk is with opioids such as codeine and the triptan family of migraine drugs (eg. sumatriptan). Paracetamol and aspirin are regarded as intermediate risk, while anti-inflammatories such as ibuprofen are the least likely to induce MOH.
At least half a million people in the UK are thought to have MOH caused by the very painkillers they are taking to alleviate their symptoms, the article adds.
Allergan lifts 2019 outlook on Botox Q1 earnings
Allergan raised its 2019 guidance after beating analysts' forecasts on earnings and revenue, driven by rising sales of Botox and dermal fillers, the FT reported on Tuesday.
The company now expects full year adjusted earnings per share of more than $16.55, higher than the $16.43 analysts were forecasting. Allergan guided to 2019 revenues of between $15.1 billion and $15.4 billion, compared to the average analyst estimate for $15.2 billion.
However, the company made an operating loss of $2.3 billion (APMHE 62908
), after it recorded a goodwill impairment of $2.5 billion primarily due to the failure of clinical trials for rapastinel, which was a potential treatment for major depressive disorder.
Roche's Ocrevus to be available on NHS in England for primary progressive MS
Several newspapers on Thursday covered NICE's decision to recommend Roche's Ocrevus (ocrelizumab) for primary progressive multiple sclerosis (PPMS) (APMHE 62923
The Daily Mail focused on the angle that the decision overturns a rejection form NICE last September, "sparking fury among campaigners and a 21,000-strong petition".
The Daily Telegraph said the normal price for the drug is £19,000 per patient per year but that NHS England has since struck a deal with Roche to obtain it at a confidential price.
The Guardian quoted the MS Society, which hailed the decision as "a landmark moment" for the estimated 2,700 patients who will now be eligible to obtain it on the NHS.
Half of U.S. population on prescription drugs
Nearly half of people in the U.S. are taking prescription drugs, the Daily Mail said on Wednesday.
It covered a report by the National Center for Health Statistics, which surveyed people across the U.S., and found that about 46% of respondents had taken at least one prescription drug in the past month.
The proportion of U.S. citizens that take pills increases with age, with under 20% of children under 12 regularly taking prescription drugs, and 85$ of adults over 60 on medication.
Takeda sells eye drug to Novartis
Takeda has agreed to sell dry eye drug Xiidra to Novartis for up to $5.3 billion, said the FT on Thursday (APMHE 62926
The paper said Takeda is looking to divest assets to reduce the $48 billion net debt it took on as part of its acquisition of Shire earlier this year. In a separate deal Takeda agreed to sell its TachoSil surgical patch product to Ethicon for $400 million.
Generics heyday comes to a close
The "swashbuckling" era for generic pharma companies has come to a close, the FT wrote in a Wednesday commentary following weak quarterly results for Mylan.
That window of exuberance in 2014 and 2015 opened for complex tax inversion mergers and thwarted hostile takeover attempts among the likes of Mylan, Perrigo, and Teva, it wrote. These generics titans were supposed to be exploiting the troubles of branded big pharma, but the broader healthcare landscape is adjusting to less growth and much more legal and regulatory scrutiny, leaving once-celebrated business models in doubt.
The FT marked narrowing prospects, following Mylan's Q1 on Tuesday, which it said sent shares down by almost a quarter, and its market value down by $4 billion. In the past four years, it shares have fallen more than 70%, it said.