Press review

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Drug-data combination 'the future of health', says Sanofi France head

PARIS, 19 Oct (APM) - "The future of health is a combination of data and drug", said Guillaume Leroy, head of Sanofi France, at last week's awards ceremony for the eCAC trophies, where Sanofi won the "audacity" prize, Les Echos reported on Monday (p 45).
The economic daily said Sanofi has been dedicated to digital health for about two years, with a digital transformation strategy based on seven areas: digital clinical trials, the transformation of the industry network, multi-channel dialogues with doctors, digital marketing, the use of real world data, digital solutions beyond drugs for patients and integrated care for effective management of diabetes.
These initiatives aim to create value by working faster and creating new marketing models. "Our aim is to construct the most secure solutions and data processing possible for our patients, said Heather Bell, senior vice principal and global head of digital and analytics at Sanofi.
The group has approached tech giants like Google and start-ups for these projects. "We have been working openly for a long time with all the technological ecosystem. We always seek to meet new actors from different sectors," said Bell.
Last January Sanofi opened 39bis, an eHealth "laboratory", Leroy said (APMHE 55916). More than 500 people meet there regularly, seeking out new patient solutions. The group has now launched another innovation centre in Shanghai. It is also investing in a behavioural analysis start-up and in a Californian start-up which carries out 'distributed' clinical trials, enabling patients to participate from their homes.

AstraZeneca chief bemoans time spent on Brexit

Le Monde on Tuesday (economy section p.3) carried an interview with AstraZeneca president Leif Johansson (APMHE 60155), saying that the pharma has increased its stocks at borders and is duplicating scientific equipment in Sweden.
Johansson said his company has "also stopped investing in the UK". He said Brexit takes up "between a fifth and a quarter of my time" and is mentioned at almost all board meetings. He said it is frustrating to work on this while "what currently exists works well. It [Brexit] is costing us money but brings us no advantages".
He said the main thing is to ensure patients have access to drugs "whatever happens". As well as short-term logistical difficulties which seem relatively easy to overcome, there are longer term regulatory problems.
Le Monde said Johansson implied there was a possibility of moving some drugs production outside of the UK: "We might do it, but we haven't taken a decision".
Another worry is the movement of workers after Brexit, given that the company has three research bases, in the U.S., the UK and Sweden. Johansson said some employees are already wondering about potential problems if they move to Cambridge, UK.
He is also asking the EU to keep the UK in the European Medicines Agency: "It's a question of European competitiveness," he said.
AstraZeneca currently works with three big regions, the U.S., China and the EU. "Fragmentation of the EMA would be a serious mistake regarding competition with these giant nations. The more Europeans and the UK remain close, the better it will be for the future".

French tech company runs computer-based clinical trials

French tech company Novadiscovery is running computer-based clinical trials to increase efficacy, Les Echos reported on Thursday (p28). The company was created in 2010 and is now in a period of "hypergrowth".
For its 'virtual' trials, Novadiscovery creates three mathematical and computational models - of the disease, the drug candidate and a population of virtual patients. The longest model to build is that of the disease, which requires long work to compile all the medical literature and convert it into lines of code, which takes between two and nine months.
"When we connect it all up, we can test numerous hypotheses," said president François-Henri Boissel. "The predictions are never perfect, but they reduce the uncertainty". The 20 or so studies carried out by Novadiscovery come before clinical-phase trials to maximise the chances of success in the clinic and reduce per-patient costs.

French research centre wants to spawn entrepreneurs

France's national science research centre the CNRS has held its first start-up day, aiming to highlight the start-ups which are under its responsibility, Les Echos reported on Monday (p32).
"We'd like to be able to get more researchers on the starting blocks for entrepreneurship," said president Antoine Petit. The CNRS is studying the possibility of creating a venture capital fund. Currently, it uses its CNRS Innovation scheme to help researchers see if "a start-up is the best way of bringing their work to fruition".

Populist MP accuses Sanofi

Libération on Tuesday (p 10-11) carried a feature on the accusations of left-wing populist MP François Ruffin (unsubmissive France party) against Sanofi, which he says is putting finance before public health in the Depakine (valproate) affair (APMHE 54856). He said 30,000 children had been born autistic because of Depakine and that Sanofi knew about these problems with its epilepsy drug but had refused to put aside any money for compensation, preferring instead to give its shareholders generous dividends.
He also criticised the pharma company for cutting jobs - including in research - in the context of maximising shareholder returns, saying that this also meant drugs were not being invented.
He went on to say that the fault lies with politicians whose job it is supposed to be to protect the public, health and jobs. He said the ultimate solution would be to nationalise Sanofi, but a first step would be transparency on medicines composition, clinical trials and use of public funds.

Brain scan required for Bayer's Androcur

An MRI brain scan will be necessary before a prescription of Byer's Androcur (cyproterone acetate), said Le Parisien on Monday (p19). This is the "drastic" condition that the French regulator ANSM has imposed after noting the danger of this hormone-based contraceptive, prescribed to 90,000 women in France.
A large study this summer showed that Androcur multiplies the risk of tumour by seven when taken at high dose and over a prolonged period. The drug is not forbidden but can now only be used in France for men with prostate cancer and women with serious hirsutism. Prescriptions are no longer allowed for less serious and closely monitored problems such as acne or greasy skin.

Brexit drug shortages risk

Les Echos on Wednesday (p7), as part of a bigger story on the consequences of a 'hard' Brexit, cited the risk of drug shortages due to the fact that marketing authorisations would no longer be valid on both sides of the border and the return of customs and excise. The paper said pharmas are increasing their stock in consequence, but about 40 medicines could be in short supply.
It quoted AstraZeneca CEO Pascal Soriot as saying: "We have products that do return trips between Great Britain and the European Union at different stages of manufacturing. If they are blocked somewhere, we will have problems".

Pharma companies sued in U.S.

Les Echos on Wednesday in a brief (p16) said that Minnesota is suing Sanofi, Novo Nordisk and Lilly for abusive hiking of insulin prices. The story was picked up on Thursday by Les Echos (p17) and Le Monde (économie et entreprise section, brief p4) (APMHE 60180)

Biosimilars are pharma's new battleground

Le Figaro on Wednesday (p24) reported on the patent expiration of (AbbVie's) Humira in Europe and the fact that several "copies" have immediately been launched. It cited the launch of Amgen's Amgevita (except in France, where approval is "imminent"), Mylan's Hulio, Biogen's Imraldi and - in the UK, awaiting rollout elsewhere - Novartis' Hyrimoz.
The story says the biosimilar market could reach $50 billion in 2025, according to estimates from Bain & Company. Forty-five biosimilars are available in France, twice as many as two years ago, and sales are increasing there by 32% annually.
The story points out that biosimilar profitability is fragile because of the complexity (and cost) to manufacture them and the difficulty in passing regulatory hurdles. Moreover, more time is needed to convince doctors and the authorities to use them.
The story also appeared in Les Echos on Thursday (p22)

Opioid meds biggest cause of overdose deaths in France

Le Monde on Wednesday (p24) reports that the biggest cause of death by overdose in France is opioid medicines, with more than 500 deaths annually, while adding that the phenomenon is still far from the pandemic state in the U.S., where more than 48,000 patients died of painkiller overdoses in 2017.
The report said adverts for medicines are much more regulated in France than in the U.S., as are prescriptions. However, since 2000 the number of deaths from opioids has increased by 172%, hospitalisations have been multiplied by three and sales of Oxycodone, one of the main products responsible for the U.S. epidemic, have shot up by 1950%.

Therapeutic cannabis OKed in UK

Therapeutic cannabis will be authorised in the UK as of 1 November, said Le Parisien on Monday (p19).
Several patients who are being treated illegally with cannabis, including two children with epilepsy taking cannabis oil, have recently featured in the UK media, the paper said.
Since the 1990s, dozens of studies have confirmed the benefits of cannabis in treating muscular spasms in multiple sclerosis and epilepsy, chronic pain and nausea/vomiting in cancer patients.

French pharmacists could dispense prescription drugs without prescriptions

The French national assembly social affairs committee has adopted an amendment to the social security funding bill (PLFSS) which would allow pharmacists to dispense prescription-only drugs without a prescription, Les Echos reports on Friday (p3).
If the measure is finally adopted, it will be tested in two regions for three years.
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