Press review

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MSD launches new cut-price HIV drug Delstrigo in France

PARIS, 25 Oct (APM) - Merck Sharp & Dohme has launched a new HIV drug in France, triple-therapy Delstrigo (doravirine/lamivudine/tenofovir disoproxil fumarate), reports Les Echos on Friday (p.22).
To make the drug attractive on a market where there are several competitors, including Janssen's Edurant, MSD has marketed the drug at a price 35-40% lower than its rivals at €470.97.
The drug is said by specialists to be particularly well tolerated, easy to use and less sensitive than other drugs to resistances and analysts believe it could reach global sales of $500 million in 2023.
However, Delstrigo is not the only HIV drug MSD has in its arsenal, with Phase II trials ongoing for islatravir which uses a completely new mechanism of action.
As HIV-infected patients can have a life expectancy similar to that of someone who is not infected, pharma companies are turning towards new medical needs, such as treatment-resistance in patients who have had over 20 years of treatment.
Pharmas are also looking to develop drugs with longer-lasting mechanisms of action to increase patient adhesion. Michel Joly, head of the French arm of Gilead is quoted in the paper as saying that the aim is to replace the current once-a-day tablet with a monthly subcutaneous injection.

Biogen to file Alzheimer's drug in U.S.

Biogen is to file the world's first effective drug for Alzheimer's in the U.S. later this year, reported Les Echos on Thursday (p.17) (APMHE 64826).
This could be good news for Biogen, which having focused on multiple sclerosis treatments is now facing stiff competition from biosimilars, reported the paper.
The Alzheimer's market is believed to be worth $30 billion and is especially attractive given the limited treatment options.
After seeing its share price drop 30% last March when it announced it was ending Phase III of the drug on disappointing results, Biogen's share price went up 38% on Wednesday when it announced it was preparing to file for approval. Meanwhile, the share price of Eisai, Biogen's partner for this drug, saw its share price increase by 18%.

Amgen to invest in French start-ups and research

U.S. biotech Amgen is to invest €8 million in France over the next three years, reported Les Echos on Wednesday (p.20).
Amgen is following in the steps of other large pharma groups which are preferring to invest in hospital or academic research instead of opening up in-house laboratories, the paper continued. The biotech is creating a €2.6 million fund to support medical research and human science projects in France, where it will celebrate 30 years in 2020 and had sales of €580 million in 2018.
In addition to the fund, Amgen is also setting aside a €5 million budget for start-up partnerships, such as the one signed with Owkin for managing data from clinical trials and FeetMe on connected soles intended to stop falls in patients with osteoporosis.

Opioid crisis trial to start in U.S.

The trial deciding how much victims of the ongoing U.S. opioid crisis will get from pharma companies, wholesalers and pharmacies, was to start in the U.S. on Monday, reported Le Figaro on the same day (p.27).
Johnson & Johnson, Mallinckrodt, Endo International and Allergan are all accused of deliberately minimising the addiction risks of their drugs and practising irresponsible but very lucrative mass marketing methods.
At the same time, wholesalers are accused of having closed their eyes to the huge volumes of opioid drugs being delivered to small towns where clearly the legitimate use of these painkillers was not believable. In addition, pharmacy chains like CVS Health and Walmart, are facing charges of selling disproportionate volumes of drugs to clients.
An out-of-court settlement of $48 billion to be paid over 18 years was rejected by plaintiffs last week.

Last minute settlement halts opioid crisis trial

A last minute out-of-court settlement of $260 million between pharma companies, wholesalers and two counties in Ohio, U.S. has halted a lawsuit due to take place on the country's ongoing opioid crisis, reported Le Figaro on Tuesday (p.23) (APMHE 64824).
Some $215 million will be paid by wholesalers Cardinal Health, McKesson and Amerisource Bergen, while $45 million will be paid by Teva, the paper continued. $25 million of Teva's payment will be paid through opioid addiction drugs.
However, a lawsuit against pharmacy chain Walgreen Boots Alliance will continue after it refused to compromise.
While pharma companies and wholesalers have been happy to reach out-of-court settlements, they are refusing to admit full responsibility for the crisis, pointing out that the U.S. Food and Drug Administration approved the drugs they sold and that doctors prescribed them.
Le Parisien also reported on the subject on Tuesday in a brief (p.10). L'Humanite (p.10) and Le Monde (p.18) covered the subject on Wednesday.

Sanofi shakes up its ecosystem

Sanofi is focusing on reducing diagnostic error through its 'UNIR' programme at its first physical laboratory dedicated to e-health, reported Les Echos on Monday (p.35).
The 'UNIR' programme will focus on three projects: one generating statistical data on diagnosis error to create a reference patient pathway and work out the cost of each stage; another giving doctors an artificial intelligence tool which gives an automatic warning in atypical situations to raise doctors' awareness of doubt and finally an early-stage project which would allow doctors to enter in patient details to get rare disease diagnosis suggestions as well information about nearby expert analysis centres.
The laboratory, opened in 2017 and named '39Bis', is believed to be France's first laboratory dedicated to e-health and provides a place for players in the healthcare sector including start-ups and patient associations to work together.

Associations call for Indivior's Nalscue opioid overdose drug to be available in pharmacies

Ten associations are calling for Indivior's Nalscue opioid overdose drug to be available in pharmacies instead of just in hospitals, reported Le Parisien on Thursday (p.13).
France sees around 400 deaths from overdose each year and the associations say the drug needs to be accessible to addicts, their friends and family as well as first-aid responders, especially as nasal spray Nalscue is easier to administer than the other intra-muscular opioid overdose drug on the market.
However, due to Indivior's failure to reach a pricing agreement with France's healthcare products pricing committee (CEPS), not only is the drug not available in pharmacies, but it will no longer be manufactured as of 2020.
The associations want the negotiations between the company and the state to succeed, but when contacted, France's health directorate said that it was up to Indivior to propose a price for Nalscue that was in line with pricing regulations. Indivior meanwhile merely confirmed that the drug will not be manufactured as of 2020.

French biotech sees share price soar after announcing positive trial results

French biotech Abivax saw its share price soar on Monday after announcing positive trial results for its drug ABX464 in ulcerative colitis, reported Le Figaro on Tuesday (p.23).
ABX464 has already shown promising results for AIDS and Abivax believes it could also improve quality of life for patients with Crohn's disease and rheumatoid arthritis.
The potential rewards are huge, as the ulcerative colitis market alone is worth $5.5 billion worldwide. However, Abivax faces stiff competition from U.S. pharmas AbbVie and Pfizer. Abivax is banking on the fact that its drug is administered orally, compared to currently available treatments which all have to be injected.

Mediator warnings were 'hidden at the back of a drawer'

Warnings about the serious adverse effects of Servier's Mediator (benfluorex) were ''hidden at the back of a drawer'' according to representatives from France's social affairs inspectorate (Igas) and doctor Irène Frachon, reported La Croix on Monday (p.5).
During the ongoing trial in the scandal around Mediator, a weight loss drug that has been linked with severe side effects and deaths, Frachon, who initially raised the alert about the drug, said when she told France's then-drugs' regulator Afssaps of the links between Mediator and serious adverse events, she was told that drug's marketing authorisations were never withdrawn for this.
Aquilino Morelle from Igas supported her words saying that the system at the time worked in favour of pharma companies, which believed they had their commercial right to impose a marketing authorisation. Hence Afssaps was more scared of facing legal problems than of protecting patient health.
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