PARIS, 19 June (APM) - Ethypharm's Baclocur (baclofen) was approved in France on Monday as the only baclofen-based treatment for alcoholism, but its licence was suspended on Wednesday, the French press has reported.
Given the controversy around the efficacy of Baclocur, France's drugs' regulator ANSM set up strict conditions for its use: the drug, approved in France on 15 June, is indicated for reduce alcohol consumption in addition to psycho-social follow-up and after the failure of other treatments, reported La Croix on Monday.
Numerous doctors quoted in the article noted that it is not the drug itself, which is the issue, but the dose. A maximum dose of 80 mg per day has a positive benefit-risk ratio, but after that, side effects - including nausea and vertigo - overtake the benefits.
However, some doctors - including Xavier Aknine head of MG Addictions - say that some patients need 120 mg a day to stabilise. Aknine is worried that patients will have to pay out of pocket for the higher dose and already disagrees with the low level of reimbursement - 15% - set out for Baclocur.
However, Le Parisien announced on Thursday (p.11) that the drug's marketing licence was suspended on Wednesday evening by the French justice system. The paper reported on the outrage of recovering alcoholics and patient association SOS Addictions who pointed out that for many, this drug was the only solution that worked.
La Croix also reports on the new twist in the Baclocur story on Friday (p.7), stating that the licence was suspended at the request of a patient association, which found that the maximum legal dose of 80 mg per day was insufficient. In the meantime, other baclofen-based drugs can be dispensed with no maximum dose.
Macron site visit leads to investment announcements from French state and Sanofi
French President Emmanuel Macron visited a Sanofi plant on Tuesday and was set to announce measures to develop R&D and production in the pharma industry, reported La Croix on Tuesday (p.6).
During his visit, Macron announced that relocating is the main focus for France to regain its sovereignty and as such the country will now be able to manufacture and package the drug within its own borders, reported Le Parisien on Wednesday (p.4).
Relocating will go hand-in-hand with a policy to increase the country’s "health resilience", with €200 million of state funding. Liberation (p.17) and L'Humanité (p.4) also covered the story on Wednesday.
However, Macron was not the only person to announce investments into the French pharma industry, reported Les Echos also on Wednesday (p.1 and 16).
Sanofi announced that it will invest €610 million in R&D and vaccine production over a five-year period. The group will build an ultra-modern factory - employing 200 people - capable of producing three to four vaccines simultaneously, a significant increase from the one factories are currently limited to. The pharma pointed out this meant that a specific vaccine could be manufactured a lot quicker if needed.
Le Monde (p.18) and L'Opinion (p.18) also covered the story on Wednesday (APMHE 67787
Dexamethasone shines in UK Recovery trial
Dexamethasone had positive news in the UK's Recovery trial, which is evaluating various drugs in Covid-19, reported Le Figaro (p.13) on Wednesday.
The drug led to the avoidance of one death in eight in patients on ventilators and stopped one death in 25 in patients on oxygen, according to results revealed on Tuesday.
However, there are still numerous questions that need to be answered, noted the paper. Firstly, the mortality rate in the placebo group was very high - 41% for ventilated patients and 25% for patients on oxygen - which leads to questions as to whether the patients were treated the same and whether they were comparable in terms of disease severity.
Less than 24 hours later, reported Libération on Thursday (p.17) the UK authorised the drug for use in patients with Covid-19 receiving oxygen or on ventilators. The paper quoted professor Peter Horby, responsible for the UK trial and noted that to date it is the only drug that is proven to reduce mortality. The World Health Organization (WHO) said it welcomed the decision. La Croix (p.7) and Le Monde (p.9) also covered the story on Thursday (APMHE 67785
France, Germany, Italy and Netherlands sign vaccine agreement with AstraZeneca
France, Germany, Italy and the Netherlands have signed an agreement with AstraZeneca to deliver 300 million vaccines, reported Le Figaro on Monday (p.4).
While it is unknown how much the countries have paid for the order, France's finance ministry noted that the plan is to vaccinate all at-risk populations within Europe with the delivery of the first vaccine doses expected at the end of the year.
AstraZeneca's vaccine - which the company is manufacturing in partnership with Oxford University - is one of the three most advanced to date (APMHE 67746
La Croix (p.6) and Les Echos (p.17) also covered the story on Monday.
Gilead to produce cell therapy in Europe
Gilead is to produce its cell therapy Yescarta (axicabtagene ciloleucel) in Europe after receiving approval from the European Medicines Agency (EMA), reported Les Echos on Monday (p.17) (APMHE 67740
The paper noted that this will simplify the manufacturing process and put Gilead on an equal footing with its competitor Novartis, which already manufactures its drug in Europe. This means it will only take a week to manufacture the drug rather than a month.
Germany invests €300 million in CureVac
The German state has invested €300 million in CureVac to take a 23% stake, reported Les Echos on Tuesday (p.16) (APMHE 67759
The German finance ministry said in a statement that CureVac's technology has the potential to develop new vaccines and new therapies and as such, the German government is hoping to develop and give CureVac the ways to use all the potential of its technology.
This investment is the first stage of Germany's plan to become more independent in producing active drug ingredients and vaccines. Le Monde (p.18) also covered the story on Wednesday.
Paracetamol to be made in France within three years
Paracetamol is to be made in France within three years by three companies, reports Le Parisien on Friday (p.10).
The French health ministry announced on Thursday that Sanofi, UPSA and Sequens have been tasked with this job, to avoid a repeat of paracetamol shortages at the beginning of the Covid-19 crisis in France, where a decree from France's drugs' regulator ANSM was passed in March limiting the number of boxes to be sold to one patient in order to prevent stocks running out in some pharmacies.
This paracetamol announcement is the first step of France's relocation plan to increase its health independence.
La Croix also covers the story on Friday (p.20).