Press review


EU and U.S. sign drug manufacturing site agreement

PARIS, 19 July (APM) - The European Union and the U.S. signed an agreement at the end of last week to mutually recognise the other's inspections of drug manufacturing sites, reported Les Echos on Monday (p.6).
It means that the drug authorities in the EU and U.S. can use inspections carried out by parties the other side of the Atlantic and not have to carry out their own separate evaluations.
The agreement will mean drugs can be marketed quicker and at a lower cost, meaning ''patients can benefit from quality drugs''. said Vytenis Andriukaitis, the EU commissioner for health, quoted in the daily.
From now on, EU pharma companies will also be exempt from carrying out quality control tests on batches if they have already been carried out in the U.S. Work is underway to extend this exemption to vaccines, veterinary drugs and plasma-based medicines.
The agreement, which was initially announced in a joint statement by head of the European Commission Jean-Claude Juncker and U.S. President Donald Trump in July 2018, has been five years in the making.

Keytruda has considerable potential - Merck & Co's CEO

Merck & Co's chief executive Kenneth Frazier said in an interview with Les Echos on Monday (p.16) that the pharma's key product Keytruda has considerable potential.
The pharma wants to build on the drug's success in lung cancer - 23% of patients treated with Keytruda for lung cancer are still alive compared to 5% for those who were not - and expand its use either as a monotherapy or in combinations to other drugs.
Merck & Co is also focusing on other areas, including vaccines and AIDS, Frazier continued, adding that the pharma is spending $10 billion a year on R&D and has 20 drugs in its pipeline.
Frazier was in Paris a year after the French healthcare industry strategic council (Csis) meeting to see what progress has been made since. He said that the French pharma industry is set to grow this year for the first time in 10 years.
He also added that France is important to Merck & Co as it is the second biggest country for patient recruitment for Keytruda trials and that the pharma has benefited from the country's scientific excellence and clinical expert analysis.

Slow progress year after French healthcare industry strategic council meeting

A year after the French healthcare industry strategic council (Csis) meeting some progress has been made, albeit slowly, reported Les Echos on Monday (p.16).
On the positive side, the drugs' market regulation has been made simpler and the time taken for a clinical trial to be authorised has been reduced to 45 days instead of 63 as it was previously, although further progress in this area has been stifled by the ethical research committees (CPP) due to lack of funds and competency.
The pricing negotiation procedure with France's healthcare products pricing committee (CEPS) has been modified to reduce how long it takes for a drug to get to market.
Some progress has been made in this area, with it now taking 498 days for a drug to get to market, instead of 530. However, this is still considerably more than the 180 days set out in European regulation.
Other countries have made far more progress in this area with the result that France is now classed as 23rd in terms of drug market access, instead of 18th.
The real issue and stumbling block is the evaluation of new drugs reform. The two criteria currently being used - therapeutic value where a drug is rated on its own merit and additional therapeutic value where it is compared to similar drugs - are set to be combined and this future value will be used to calculate drug prices.

Gilead invests $5.1 billion in biotech Galapagos

Gilead has invested $5.1 billion in Belgian biotech Galapagos, Les Echos reported in a brief on Tuesday (p.15 and p.26), in return for a 10-year R&D partnership. (APMHE 63699)
Gilead has increased its share of the biotech, which produces filgotinib for rheumatoid arteritis and Crohn's disease, to 22%.

'Generics and biosimilars are a source of savings for healthcare' - Biogaran head

France currently saves around €2 billion a year thanks to the use of generics, and yet generics make up only 36% of drugs dispensed in pharmacies, said head of Biogaran Pascal Brière (Servier group) in an op-ed in Les Echoes on Tuesday (p.8).
Brière added that if the percentage of generics prescribed increased to 50%, France's social security would save an additional €1 billion a year - which is the sum requested via drug price cuts in the social security funding bill (PLFSS).
He added that making full use of biosimilars, which were found in a report dated April 2017 from the European Medicines Agency, to be as safe and effective as their originator drugs, would save the system even more.
Brière pointed out that biosimilar use in hospitals was good, with eight out of 10 patients with some types of blood cancer being treated with a biosimilar.
However, biosimilar use in the community is stagnating and pharmacists need to be allowed to substitute an originator drug for a biosimilar, as they currently do for brand name drugs and generics.
Doing so, he concluded, would benefit everyone, from patients to the social security system as money would be saved and available for other things.

J&J raises annual forecast after better-than-expected Q2

Johnson & Johnson has increased its annual forecast after sales in Q2 were better than forecast, reported Les Echos in a brief on Thursday (p.17).
Although sales were down 1.3% to $20.6 billion, it was better than the $20.3 billion expected. Net profits were up 41.8% to $5.6 billion.
The group is now forecasting annual sales of $80.8 billion to $81.6 billion, instead of the $80.4 billion to $81.2 billion beforehand.

Manufacturer Famar to be broken up

Eleven of Greek drug manufacturer Famar's 12 sites worldwide are to be sold, except for its site near Lyon in southern France, reported Les Echos on Wednesday (p.19).
The French site cannot be sold as it is in receivership, much to the fury of its 284 employees.
Despite good profitability with sales of €500 million, Famar's large debt can no longer be serviced and so the other sites have been put up for sale.
According to chief executive Patrick Puy quoted in the paper, the reason the Lyon site is not profitable is due to a lack of investment, which is ''characteristic of the Famar group''.
He said that the factory will continue to operate for the next 12 to 18 months, the time necessary for pharma companies whose drugs are currently manufactured there to find alternative production sources.

Bayer's damages reduced

A U.S. judge has reduced the amount Bayer will pay a man in California who blamed Roundup weed killer for his cancer, reported La Croix in a brief on Wednesday (p.9).
The damages award was reduced from $75 million to $25 million. However, he rejected the company's request for a new trial.
Bayer's Monsanto was sentenced to pay damages to a man who used Monsanto's weedkiller product RoundUp for 25 years before developing lymphoma.
Les Echos also reported on the subject on Wednesday (p.16).

Louvre museum renames Sackler wing

The Louvre art museum in Paris has renamed the Sackler wing of Oriental Antiquities, reported Liberation in a brief on Thursday (p.13).
This follows a protest demanding the change at the museum on 1 July.
The Sackler family are accused of being involved in the opioid crisis in the U.S. which led to 47,000 deaths in 2017.
La Croix reports on the subject in a brief on Friday (p.15).



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