LONDON, 15 Feb (APM) - The Times said on Monday that pharma companies are likely to delay applying for UK licences to sell new drugs if the UK leaves the EU without a deal, according to ministers.
The claim was made in a Whitehall impact assessment signed off by ministers in the Department of Health. It states that “duplicated licensing procedures may act as a disincentive to apply for marketing authorisation in the UK, delaying patient access to new treatments”.
It adds that “in this instance there is the possibility of NHS cost savings due to the high price of innovative medicines”, but “the wider economic costs of any public health impacts from inferior treatment options could cancel out any financial savings made”.
Scotland could deploy planes, ferries to import drugs in emergency Brexit plan
Spare planes and ferries would be deployed to bring continental medicine directly to Scotland under a Brexit emergency plan, according to The Times on Monday.
The paper referenced comments from Mike Russell, the Scottish Brexit secretary, who said that he had lost confidence in Westminster’s ability to keep supply chains open when Chris Grayling, the UK transport secretary, handed a ferry contract to a company that does not have any ferries.
Scottish ministers are looking for their own planes and ferries to ensure goods keep flowing if the main route through Dover is blocked, it added.
Scotland backs Kymriah but not Yescarta
The Scottish Medicines Consortium recommended Novartis’ Kymriah (tisagenlecleucel) for children and young people with acute lymphoblastic lymphoma but did not back Gilead’s Yescarta (axicabtagene ciloleucel) for children with a rare form of leukaemia, The Times said on Tuesday (APMHE 61817
The rejection for Yescarta was due to uncertainty “around its long-term benefits and its cost-effectiveness”, despite the drug being recommended for use in England last year.
Both treatments are CAR-T therapies, in which patients’ immune cells are modified in a laboratory to recognise, seek out and kill cancer cells.
Vertex financial results could inflame UK pricing debate
The Observer on Sunday said that the publication of Vertex Pharmaceuticals’ financial results for the last quarter will anger campaigners who are demanding the company lower the price of a cystic fibrosis drug so it can be used on the NHS in England.
The paper said ministers are already under pressure to step in over Orkambi, for which Vertex has set a price of £104,000 per patient per year. It has turned down NHS England’s offer of £500m over five years for the use of its medicines.
The debate could be inflamed by Vertex’s strong financial results, said the paper. It posted a 40% increase in revenues for the final quarter of 2018, with records suggesting it has around £2.3 billion in the bank.
Vertex also reported that net income in the last quarter more than doubled, from $158m to $337m, “largely driven by the strong growth in total CF [cystic fibrosis] product revenues”.
Keytruda+Inlyta more effective than Sutent in kidney cancer
The combination of Merck & Co’s Keytruda (pembrolizumab) and Pfizer’s Inlyta (axitinib) cut patients’ risk of dying from kidney cancer in half, the FT said on Monday. (APMHE 61845
The paper picked up trial data due to be presented at the American Society for Oncologists genitourinary conference this weekend that it said show the combination significantly outperformed current standard of care, Pfizer’s Sutent (sunitinb), in treating renal cell carcinoma.
The trial showed an almost 50% reduction in risk of death and an almost 40% drop in the risk of disease progression, said the FT. It added that 20% more patients responded to treatment with Keytruda+Inlyta than with Sutent.
Sanofi and Regeneron cut price of Praluent in U.S.
Sanofi and Regeneron have cut the price of anti-cholesterol drug Praluent (alirocumab) in the U.S. by 60% in response to pressure from U.S. health insurers and pharmacy benefit managers, according to the FT on Monday (APMHE 61815
The paper said the drug will have a list price of $5,850 a year from early March, down from its current cost of $14,000. This would cut out-of-pocket costs for Medicare patients to between $25 and $150 a month, depending on the plan.
FDA advisory panel J&J’s ketamine-derived spray for depression
An advisory panel to the U.S. FDA has backed a nasal spray depression treatment from J&J that is derived from ketamine, the Daily Mail said on Tuesday.
The panel voted 14-2 in favour of esketamine, which is developed to treat major depression in patients who have not benefited from at least two different therapies, saying its benefits outweighed the risks (APMHE 61843
J&J to buy Auris Health for $3.4 billion
Johnson & Johnson is to acquire Auris Health for $3.4 billion, the FT said on Wednesday.
Auris develops robotic technologies for surgery and diagnosis.
Teva warns of ‘trough’ in 2019
Teva Pharmaceutical has warned that 2019 will be a “trough” for the company, the FT said on Wednesday (APMHE 61853
The paper said the Israeli firm forecast lower earnings and revenue because of generic competition to its multiple sclerosis drug Copaxone. Shares fell 8%.
AZN continues return to growth
AstraZeneca continued its return to growth for the fourth quarter of 2018, the FT said on Thursday (APMHE 61862
The UK firm posted an 8% rise in product sales to $5.77 billion for the period. This was driven by new medicines and growth in emerging markets.
The Times on Friday also covered the results, leading with remarks from CEO Pascal Soriot that he plans to remain in charge of the company, dispelling speculation over his future.
“I’m committed to this company for the next number of years," he said.
Indivior unable to provide 2019 guidance
Indivior is unable to provide investors with guidance on its 2019 earnings as it prepares for generic competition to its biggest selling product Suboxone Film, the FT said on Thursday.
The UK firm has made a last-ditch attempt to block rival versions, which are expected to launch early next week.
“Given uncertainties surrounding how the U.S. market for both Suboxone Film and generic alternatives will ultimately develop, Indivior is unable to provide FY 2019 net revenue and net income guidance at this time.”
J&J and Novartis among backers for cancer startup
J&J and Novartis are among the backers for startup Vor Biopharma, which is working on a novel way to treat blood cancers with immunotherapies, the FT said on Thursday.
The company, which has raised $42 million, was co-founded with PureTech Health. It is preparing to start clinical trials in acute myeloid leukaemia, said the paper.