Press review


Servier hid danger of Mediator, says former deputy of French drugs' regulator

PARIS, 15 Nov (APM) - Jean-Michel Alexandre, former deputy of France's drugs' regulator ANSM, told the court investigating the scandal around Servier's Mediator (benfluorex) that Servier hid evidence showing how the dangerous the drug was, reports Libération on Friday (p.20).
According to Alexandre, who gave his testimony on Thursday, the appetite-suppressing aspects of the drug were not recorded in the dossier Servier gave to Afssaps, ANSM's predecessor, although they should have been.
He said that this was shown to have been a deliberate choice on behalf of Servier when the link between the drug and these particular side effects was proven in 2001.
Alexandre noted that in his opinion Afssaps was innocent of the harm caused by Mediator prior to 2001, as it was unaware of the side effects linked to it and under the conditions it was impossible to conclude that the product was dangerous.

French drugs' regulator in dock over Servier's Mediator scandal

ANSM is being questioned for ''involuntary homicide through negligence'' in the trial on the scandal surrounding Servier's Mediator reported Le Monde on Wednesday (p.12).
From Tuesday until the end of November, numerous witnesses will take the stand to try and explain why ANSM, known as Afssaps at the time, missed the multiple warning signs which would have stopped the scandal earlier.
The daily listed several examples - from the international primary pulmonary hypertension study (IPPHS) published in 1995 which showed the link between fenfluramines and mortal cases of pulmonary hypertension (PAH), to an alert raised in Italy in 1998 over two Mediator associated cases of heart value disease and PAH.

Vertex's new drug looks to revolutionise cystic fibrosis treatment

Vertex's new drug Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) looks to revolutionise the treatment of cystic fibrosis which affects 70,000 people worldwide, reported Le Monde Science & Medecine (p.2) on Wednesday.
The drug targets the most common mutation behind the disease - Phe508del, responsible for potentially 90% of cases - and has just been approved in the U.S. It is awaiting approval in Europe from the European Medicines Agency.
Two Phase III trials comparing Trikafta to placebo showed forced expiratory volume in one second (FEV1) improved by 14 points with Trikafta. A professor quoted in the paper said that this sort of result could have a significant impact on the everyday life of young people and represents real hope.

Pfizer prioritises rare diseases

Pfizer is set on making rare diseases - currently its smallest division with less than 10% of sales - a priority under head Albert Bourla, reported Le Figaro on Wednesday (p.29).
According to Paul Levesque, head of rare diseases at Pfizer, 20% of the group's R&D investment is going into rare diseases and the division is expected to generate 20% of growth over the next few years.
The company is focusing part of its growth in this sector as due to the discovery of 300 new rare diseases each year and a considerable number of as-yet-untreated patients, its potential growth is significant.
The paper also pointed out that these treatments have high price tags - tafamidis which was recently approved in the U.S. for cardiomyopathy costs $225,000 a year. Analysts believe it could have sales of $2 billion to $4 billion a year.
Bourla, adds the paper, is hoping to launch 25 new drugs - including 15 blockbusters - by 2025.

Takeda's Dengue vaccine poised to replace Sanofi's

Highly encouraging Phase III results from Takeda's dengue vaccine TAK-003 could finish off Sanofi's own Dengue vaccine Dengvaxia, reported Les Echos on Tuesday (p.23).
The results show that TAK-003 has 80% overall efficacy - compared to 60% for Dengvaxia - and is particularly effective against serotype 2 with 97.7% efficacy - while Dengvaxia is only 35-40%.
The paper pointed out that the trial must include over 20,000 people and carry on for another six months - primarily to get more results for serotype 4 which does not yet have statistically significant results.
Despite this, one of the main authors of the results published in the New England Journal of Medicine said the results were very encouraging and that the vaccine could have significant benefits for public health.
This does not look good for Sanofi's Dengvaxia, which is already facing problems as it can cause a more serious form of dengue fever in those who have previously had the disease. This means a patient must be tested before they get the vaccine. Meanwhile, TAK-003 requires no such test.
Le Figaro also reported on the subject on Thursday (p.15).

France's Adocia takes on Lilly and Novo in diabetes

French biotech Adocia is taking on big players Lilly and Novo Nordisk in the field of ultra-rapid acting insulin for diabetes, reported Le Figaro on Thursday (p.26).
Adocia is counting on the ''superiority'' of its product to overcome the fact that Novo Nordisk's product has been on the market for two years, Lilly's is set to arrive next year and its own product still has another three years to go.
The diabetes market is incredibly lucrative, with 442 million cases worldwide and sales of $50 billion. The number of cases is set to grow by 30% by 2030, notably due to the worldwide increase in obesity, the paper noted.

New head for Boehringer Ingelheim France

Erick Lelouche is the new head of Boehringer Ingelheim France, reported Les Echos on Wednesday (p.32) (APMHE 64921).
Lelouche - who will preside over 2,500 personnel across 10 sites - told the economic daily that he intends to continue getting investments for France. The country is the company's primary market for animal health with €180 million in sales on the domestic market and €600 million in export.
He added that when it came to human health, he wanted to ''redefine the business model, to centre it more around patients''.



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