Press review

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First payouts in France for victims of Sanofi's Depakine

PARIS, 24 May (APM) - A victim of Sanofi's Depakine (valproic acid) has received €1.3 million, one of the first payouts from the French authority in charge of compensation of medical accidents (Oniam), reported Le Parisien (p.12) on Tuesday.
The victim is handicapped as his mother took the epilepsy drug while she was pregnant and is just one of the 1,655 cases being studied by Oniam's experts.
A compensation fund was set up two years ago so that families affected by Depakine could be compensated without having to go through the courts. However, not everyone is benefiting.
Oniam's experts are said to be using their own barometer and a matrix found not to favour victims to work out compensation levels. In addition, Oniam's experts did not recognise that Depakine caused autism, scoliosis and ear, nose and throat (ENT) infections, despite the French state listing them in a diagnosis and care protocol in May 2017. This means children in identical situations are getting vastly different levels of compensation, said Charles Joseph-Oudin, lawyer for the victims in the paper.
At the moment, the compensation is being paid by the French state, as Sanofi has refused to contribute. The paper pointed out this will have consequences, quoting the head of Oniam, Claire Compagnon, who said that the organisation will take Sanofi to court for every payment they hand out.
La Croix also reported on the topic on Wednesday (p.11).

France opens up access to simplified hepatitis C treatment

All doctors in France, notably general practitioners, can now prescribe two direct-acting antivirals (DAAs) to treat chronic hepatitis C, reported Le Figaro on Wednesday (p.10) (APMHE 63056).
The two drugs: Gilead's Epclusa (sofosbuvir+velpatasvir) and AbbVie's Maviret (glecaprevir+pibrentasvir) are part of a class of drugs which work over a short period of time and have a very high cure rate.
Allowing all doctors instead of specialists solely to prescribe these drugs is part of France's plan to eradicate hepatitis C by 2025, five years before the deadline set out by the World Health Organization, the paper continued.
France's healthcare technology assessment body HAS defined eradication as ''a 90% decrease in new infections associated with a 65% decrease in death due to hepatitis C''.
According to specialists' estimates, around 100,000 in France in 2018 required treatment for hepatitis C, with 75,000 unaware that they had the disease.

Pharmacists sign petition attacking corticosteroid shortages

Pharmacists have signed a petition calling for further stocks of corticosteroids, saying that some pharmacists are running low on stocks and others have completely run out, reports Le Parisien on Friday (p.12).
Stocks of the widely prescribed corticosteroids including Sanofi's Cortancyl (prednisone) and Solupred (prednisolone) have been running low due to ''delays in the production of these drugs'' France's drug regulator ANSM announced earlier this month (APMHE 62934).
ANSM has said that pharma companies are going to import supplies from other European countries and in the mean time, has told doctors to limit the use of these drugs to situations where they are medically indispensable and there is no alternative.
Pharmacists are not happy, with some saying that ANSM should put more pressure on pharmas to deliver the goods. Some are even saying that the pharma companies are deliberately delaying deliveries of these drugs whose margins are too low in their eyes.

Some doses of Merck & Co's Sinemet for Parkinson's changed

Some doses of Merck & Co's Parkinson drug Sinemet (carbidopa+levodopa) will be changed after a change of factory and fabrication procedure, Le Figaro reports on Friday (p.12).
The changes will see the excipients of the drug changed as well as the shape and colour of the tablets.
However, France's drugs' regulator ANSM has said that the drug's active ingredients, the dose and the number of tablets patients should take will ''remain identical''.
A warning will be put on drug boxes and a flyer given to patients in pharmacies said ANSM, which is still reeling from the Levothyrox affair, which refers to the increase in reported adverse events following a change in the composition of Merck KGaA's thyroid disorder drug Levothyrox (levothyroxine).

Google sister company signs agreement with pharma to transform digital research

Google's sister company Verily, both owned by parent company Alphabet, has signed an agreement with four big pharma companies: Novartis, Otsuka, Pfizer and Sanofi to transform digital research, Le Figaro reported on Wednesday (p.21) (APMHE 63063).
The agreement means the four pharma will be able to use Verily's digital technology and ecosystem to select patients for clinical trial, use the resulting data and generate real world data, the paper continued.
According to Sanofi's clinical research director Lionel Bascles, quoted in the paper, recruiting patients for clinical trials is an expensive part of the drug development process, taking two to three years of the 10 it takes to bring a drug to market.
Verily is already present in the health data sector, after it launched its Baseline project two years ago with the aim of mapping humanity's health. It also runs a pilot programme in India for diabetic patients, helping doctors to diagnosis retinopathy, a disease which can cause blindness.
However, the four pharma know they are taking a risk joining up with Verily, the paper added. There is a big demand for health data currently, but uncertainties around their security and their traceability are worrying the authorities and patient-consumers.
Le Monde also covered the story on Thursday (p.15) again mentioning the ethical questions raised by the agreement.

Sanofi presents pharma version of its Ultimaker 2

Sanofi presented a ''pharmaceutical'' version of its Ulitmaker 2 at the Viva Technology Salon in Paris last week, reported Les Echos on Monday (p.24).
The 3D printer was modified to print drug tablets, which means that drug doses can be personalised, notably for paediatric and geriatric populations, said head of R&D Sanofi Montpellier Jean Alié, quoted in the paper.
However, there are several technical and regulatory challenges that have to be overcome before drugs can be printed. According to Alié, it will be three to 10 years before this technology is ready.

New board members for Pierre Fabre

Three new members have joined Pierre Fabre's board, reported Le Figaro in a brief on Wednesday (p.22).
They are Jean-Laurent Bonnafé, head of BNP Paribas, Eduardo Sanchez a board member of CaixaBank and Rachel Marouani, head of Make Up For Ever.
Bonnafé and Marouani have also joined Sanchez on the group's strategic committee.
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