Press review

 - 

Wave of new complaints filed in Levothyrox scandal

PARIS, Sep 15 (APM) - Thursday’s Le Monde online reported around 50 complaints are to be filed by patients using thyroid disorder medicine Levothyrox, after authorities revealed more than 9,000 side effects were notified to health authorities.
The complaints will be filed for "life endangerment", "failure to assist a person in danger" and "aggravated misleading informations", by patients association AFMT (French association of thyroid disease patients).
A total of 12 other complaints have already been filed, Le Monde said.
This new development comes after French health minister Agnès Buzyn announced 9,000 cases of severe side effects were notified to healthcare authorities as reported on Tuesday by Le Figaro (brief p13), Le Parisien (brief p8), Libération (brief p10) and La Croix (brief p11).
The complaints are not only targeting Merck Serono, but also French drug watchdog ANSM and health minister Agnès Buzyn, who are accused of not having properly told patients about the change of formulation in the product.
More than three million patients take Levothyrox, Le Monde added.
On Friday, Le Parisien (brief p10) is reporting Agnès Buzyn announced an equivalent to the previous formulation of Levothyrox will be launched and made available to patients in a month.
This alternative will be accessible "progressively", she added.
In the meantime, some quantities of Merck’s product previous formulation will also be made available.

Combined cancer therapies - 'gold rush paved with challenges'

Thursday’s Les Echos (p20) reported that combinations have become the 'big thing' for pharma companies, also noting these pose major challenges to them.
It cited the example of Merck & Co’s Keytruda, noting it does not have another in-house compound for potential combination, forcing it to have to find partners to develop combinations.
It also pointed out major players in the field like Bristol-Myers Squibb, Roche and Merck KGaA have recently faced major clinical failures, posing the question of the logic of investing so much money for such disappointing results.
Aurélien Marabelle, immunotherapy programme director at Institut Gustave Roussy, one of the most important institutions in cancer research in France, noted it was the design of the trials that was mainly responsible for those failures, more than the compounds themselves.
He pointed out BMS did not select the patients in a proper manner, while Roche has chosen a wrong approach in the hierarchy of endpoints.
Despite those mistakes, Les Echos said immunotherapies had already brought real innovations, notably in melanoma.
Jean-Yves Blay, manager of Léon-Bérard Center in Lyon, told the newspaper it was more than necessary for sponsors to change their methodology habits if they wanted to see their product show their potential in studies.

AstraZeneca maintains ambitions in cancer market

On Thursday, Les Echos (p20) published an interview with AstraZeneca’s chief executive Pascal Soriot, in which he reaffirmed the company’s ambitions in the cancer market, despite the failure of the Mystic trial, which assessed the efficacy of Imfinzi and tremelimumab.
The manager affirmed the company was confident in proving the combination would prove its efficacy in terms of patients survival compared to existing therapies.
He also pointed out Imfinzi alone has a potential for some patients, notably those suffering from advanced lung cancer without surgery possibility that have already been treated with other therapies.
Soriot added the company also hoped its product could be given to patients at an early stage of the disease.
Besides, "we can still be leader in lung cancer", he said, notably with Tagrisso, as well as the Imfinzi-tremelimumab combination, in other indications like pancreas and bladder cancers.

Ipsen’s Cabometyx positive in Phase II in renal cancer

Tuesday’s Les Echos (p20) reported on the positive Phase II results of Ipsen's Cabometyx in renal cancer.
Reminding the company has rights over the products outside of U.S and Japan, Les Echos noted this compound is critical for the company, as it is has bet on cancer to develop its business, beyond metabolic diseases.
The company aims to market the product in Europe thanks to those results, while it is already used in France through a temporary use approval procedure.
It also intends to evaluate the compound in association with BMS’ Opdivo and Yervoy, with results expected in 2019, as well as Roche’s Tecentriq in 2018 in liver cancer.

Malaria drug under fire for side effects

On Monday, Le Parisien (p20) published an article announcing Roche’s malaria drug Lariam is under fire because of the severe psychological side effects it can trigger.
The newspaper noted a collective of patients victims of those side effect has been formed, and intends to file complaints against Roche to have it withdrawn from the market.
The article pointed out the product is already banned in 28 countries.
Roche reacted to the accusations by arguing the product is still considered to have a positive benefit-risk balance by authorities.

New head of Sanofi France

Tuesday’s Les Echos (p34) announced Guillaume Leroy will become chairman of Sanofi France starting on October 1.
Previously, manager of Sanofi’s Dengue vaccine development programme, after having been vice-president of Sanofi Latin America, he will replace Philippe Luscan.
The latter will remain in charge of global industrial affairs, as well as executive vice-president.

Kare Schultz appointed chairman and CEO of Teva

Tuesday’s Les Echos (brief p21) and La Tribune (website) reported that Danish executive Kare Schultz will become chairman and CEO of Teva.
Previously at the head of Lundbeck, he has the challenge to get Teva back on track, as the company is facing high debts after several acquisitions and problems on the U.S. generics market.

Biotech firm raises 15 million euros in antibiotic R&D

Wednesday’s Le Figaro (p23) reported French biotech Deinove has been granted a 15 million euros funding by BPIFrance, the French innovation investment fund.
This will allow the company to speed up development of its new generation of antibiotics.
cm/nh

[NH9OWB9RI]

TRY APM HEALTH EUROPE AND GET ACCESS TO THE FULL CONTENT

Interviews with KOLs/senior executives amongst the Regulators, Payers, Health, Medical & Pharmaceutical organisations

Events coverage with a unique focus on Market Access & sustainability of healthcare systems

6 European bureaus : Berlin, Brussels, London, Madrid, Milan & Paris

Ask for a Free trial and get access to our last stories

Request a trial to assess coverage that includes:
  • Health Care
  • Market Access
  • HTA – policies & practices
  • European medicine regulations
  • Drug safety issues
  • Pricing & Reimbursement
  • International medicines agencies

If you are a Payer, Pharmaceutical or Consulting professional our premium data will keep you informed on the regulatory, pricing, market access and cost-effectiveness issues that impact all stakeholders.

REQUEST

an initial 10 day temporary access of APM Health Europe.