Press review

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Pfizer stops marketing ulcer drug Cytotec in France due to widespread misuse

Country : Egypt, France, Greece

Keywords :
PARIS, Feb 23 (APM) - Pfizer has announced it will stop marketing ulcer drug Cytotec (misoprostol) in France because of widespread misuse of the product in gynaecology, Le Parisien reported on Monday (p17).
The newspaper noted that many physicians were prescribing the product to women as an abortion pill or to trigger the delivery of babies.
French authorities had been aware of the situation and had already warned healthcare professionals against the use of Cytotec outside of its authorised indications, notably because of the risk of overdose.
The article said the authorities have asked manufacturers of similar products (Exelgyn’s MisoOne and Linepharma’s Gymiso) to increase their manufacturing capacity, which will take time.
“But for the moment there is no solution for triggering delivery,” Le Parisien pointed out, as the above products are only indicated in abortion.
French drug watchdog ANSM told Le Parisien a product from Danish company Azanta, Angusta, with the same active ingredient as Cytotec, has received a marketing authorisation, but will not be available for some time.

France lagging in biomanufacturing

Monday’s Les Echos (p21) published the conclusions of a report from French pharma body Leem saying France is lagging behind its European peers in biomanufacturing. (APMHE 56918)
According to the report written by French consulting firm AEC Partners, “France, despite big investments, is still not well-positioned in the European race for biomanufacturing”.
Despite 32 manufacturing sites and 8,500 jobs in the field, representing 19% of the pharmaceutical manufacturing sector in terms of headcount, “France mostly produces vaccines and recombinant proteins,” the article noted.
“The country has missed the biomanufacturing boat, with only two biologicals produced in the country out of the 76 that approved in Europe since 2012.”
The report also noted that French sites “have limited capacity for large-scale commercial batches, which suggests the country might not be able to attract manufacturers of new biologicals”.

’Novartisgate’ hits Greek political class

Friday’s Libération (p9) reports on the “Novartisgate” scandal in Greece, saying that the parliament has decided to create an investigation committee to clarify bribery accusations targeting 4,200 physicians, 10 ministers and civil servants.
The newspaper notes that Novartis is accused of paying thousands of prescribers and public servants to promote its products. (AMPHE 56779)
It says the case follows on from similar scandals in the U.S. and in China, where the company has already been ordered to pay hefty fines.
According to investigators, Novartis’ methods could have cost Greek public finances about 3 billion euros between 2000 and 2015.
The newspaper also emphasise the fact that this happened at a time when many Greeks had no access to healthcare because of the country’s economic crisis.
The article also says that spending on drugs officially dropped by 35% between 2010 and 2015, but this was due to a 44% increase in spending by patients.
Monday’s Le Figaro (p23) also reported on the issue.

Measures taken over safety of uterine fibroid treatment Esmya

Thursday’s Le Parisien (brief p9) as well as Wednesday’s Le Figaro (p12) reported that the French authorities have suspended treatment initiation with Gedeon Richter’s uterine fibroid drug Esmya (ulipristal acetate), after the EMA announced that 51 women have suffered from severe liver injuries after treatment (APMHE 55866, APMHE 55898).

New alternative to Levothyrox set to arrive in France

Monday’s Le Parisien (p9) and Le Figaro (website) announced that a new alternative to Merck KGaA’s Levothyrox, Tcaps from Laboratoires Genevrier, will be available to patients early April. (APMHE 56959)
In the wake of national controversy over the new formulation of Merck’s product, Tcaps was approved for marketing by the French authorities last week, the two newspapers said.
But according to a French patients' association, Vivre sans Thyroïde, the new product could be much more expensive than the alternatives, with a price of around 9 euros per month, compared to 2 or 3 euros for existing medicines.
The report noted that Levothyrox is no longer the only option for patients suffering from thyroid disorders, as other alternatives have already been made available by Sanofi, Uni-Pharma and Laboratoires Serb.

Vertex’s refusal to carry out clinical trials in France

Monday’s Le Figaro (p11) reported on the refusal of Vertex to carry out clinical trials in France for its next-generation cystic fibrosis treatment Orkambi (lumacaftor+ivacaftor) because of the price proposed by French authorities for its reimbursement.
Les Echos already reported on the matter last week (APMHE 56931).
In its article, Le Figaro interviewed three members of a cystic fibrosis patients’ association, who accused the company of “blackmailing” the French authorities with this decision.
They also asked Vertex’s American management to reconsider their position, launch clinical trials of Orkambi and continue their negotiations with French authorities over reimbursement of the product.

Egyptian pharma sector suffering

Monday’s Le Monde (Eco & Enterprises supplement, p5) reported on the deep crisis faced by the Egyptian pharmaceuticals sector.
The article noted that there are many shortages - including of drugs for serious conditions - as the sector relies mainly on imports, and was destabilised by the depreciation of the Egyptian lira compared to the U.S. dollar in November 2016.
“In December, Egypt faced a new severe shortage of medicines, with penicillin and Parkinson’s, cardiac and hepatic disorder treatments absent from pharmacies,” wrote Le Monde.
The depreciation of the local currency against the dollar, from 8.8 to 18 Egyptian lira, has forced local manufacturers to stop their activity, as they were unable to purchase raw materials and supplies.

291 million euros net income for Servier in 2016-17

Servier generated 291 million euros net income in the 2016-17 fiscal year (ended September 2017), reported Le Figaro on Friday (brief p29). (APMHE 57012)
The company’s sales increased by 3.7% to 4.15 billion euros, thanks to 5.6% growth in its prescription medicines business.
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