PARIS, 21 Dec (APM) - A group of French patients have launched a lawsuit calling for patents on Merck KGaA’s new Levothyrox formula (levothyroxine) to be revoked following accusations it has caused serious side effects, Le Parisien (p.11) and Libération (p.20) reported in briefs on Thursday.
On Wednesday, 139 plaintiffs petitioned the Paris high court to request the French patent for the drug be annulled, therefore preventing it from being launched elsewhere in Europe.
They are claiming it is invalid because it is insufficient, lacks novelty and/or lacks inventive activity.
The lawsuit follows problems for the German pharma after launching its new formula of Levothyrox on the French market at the end of March 2017. Between March 2017 and April 2018, 31,000 pharmacovigilance reports were filed.
Several Levothyrox lawsuits are ongoing in France, including this case in Paris and one in Lyon, which started last week.
In November, almost 50 French MPs also co-signed a draft resolution demanding a parliamentary inquiry into the pharmacovigilance problems related to the new formulation (APMHE 60725
Pharma companies make French staff cuts in end-of-year restructuring sweep
The end of 2018 has seen announcements from several pharma companies based in France that they are letting people go, reported Les Echos on Tuesday (p.17).
On 5 December, Sanofi said it was cutting 670 posts (APMHE 60900
) and on 9 December Boehringer Ingelheim said it was letting 12% of its staff in France go (APMHE 61003
Meanwhile, on Friday Pierre Fabre announced that 81 people were being made redundant (APMHE 61096
The paper points that out that each announcement was made in a different context, but that all these job cuts are being made to try and improve efficacy.
Taisho Pharmaceutical buys UPSA
Japanese over-the-counter (OTC) drug specialist Taisho Pharmaceutical is buying Bristol-Myers Squibb's French OTC subsidiary UPSA for $1.6 billion, Le Figaro reported on Wednesday (p.21) (APMHE 61136
It is Taisho's second purchase from the pharma giant, after it bought BMS’ self-medication subsidiary in Asia-Pacific (excluding China and Japan) in 2009 for $310 million.
It is hoped the latest deal could expand its OTC presence in Europe (APMHE 61157
). Although Taisho is present on the Asian, U.S. and Mexican markets, it is not yet present in Europe.
UPSA’s two factories in Agen, France are the biggest pharmaceutical manufacturing site in Europe, with 332 million drug boxes being produced per year, or 15 per second, La Croix reported on Thursday (p.12). Last year the OTC pharma had sales of €425 million. Taisho had sales of €2.2 billion last year.
Reports suggest that USPA's staff are wary about whether the acquisition will result in job cuts, as Taisho has factories in Asia, particularly in the Philippines.
UPSA currently employees 1,250 members of staff, with 60% of them over the age of 40, Les Echos reported on Thursday (p.18). BMS said the acquisition could be finalised in the first half of 2019, depending on regulatory authorisation.
GSK and Pfizer create consumer health business
GlaxoSmithKline and Pfizer have combined their consumer health businesses to create a large over-the-counter (OTC) pharma, reported Le Figaro on Tuesday. The new business will control 7.3% of the OTC market and have sales of €10.9 billion. It will also be number one in the U.S. and number two in China.
GSK will own 68% of the new company, and Pfizer 32%, Les Echos reported on Thursday (p.18). The aim is to list the OTC joint venture as a standalone company on the stock market within three years of completion (APMHE 61132
French state looking to sell share in LFB
The French state is looking to see some of the shares it has in the Laboratoire Français du fractionnement et des biotechnologies (LFB), a French pharma that manufactures blood-derived medicinal products, Les Echos reported on Wednesday (p.20) (APMHE 61176
The state has held shares in LFB since 1994, and is looking to sell some of them to raise more than €500 million to build a new factory in northern France. LFB grew significantly last year, with sales growing by 26% to €656 million.
Novartis to buy CellforCure
Meanwhile Novartis is planning to buy CellforCure, a subsidiary of France’s LFB, Les Echos reports on Friday (p.16) (APMHE 61177
The contract manufacturer is already one of Novartis' producers for its CAR-T Therapy Kymriah (tisagenlecleucel) (APMHE 58892
). The Swiss pharma agreed to transfer the technology needed to produce its cell therapy Kymriah to CellforCure last June.
It is hoped acquiring France-based CellforCure could expand Novartis' capacity for the manufacturing of cell and gene therapies. CellforCure is one of the biggest production centres in Europe for genetic and cell therapies.
J&J shares tumble following Reuters talc exposé
Johnson & Johnson’s shares tumbled on the New York stock exchange on Friday after an enquiry by Thomson Reuters was published, Les Echos reported on Monday (p.18) (APMHE 61097
Reuters claimed to have seen documents suggesting J&J deliberately hid data from the public and authorities showing its talcum powder contained asbestos.
The pharma denies the accusations, but saw its share price fall 10.04%, wiping out almost $40 billion of its market capitalisation.
Merck & Co buys Antelliq
Merck & Co has bought Antelliq, a French company specialising in the digital identification and localisation of animals, for €3.25 billion, Les Echos reported (p.16) and Le Monde Economie & Entreprise (p.4) reported on Monday.
Antelliq will be a separate division of Merck & Co’s animal health subsidiary (APMHE 61102
New head for Sanofi Russia
Oxana Monge is the new head of Sanofi Russia, Les Echos reported on Thursday (p.33). Monge will take the role after spending four years in firm's the diabetes department in Moscow.
Sanofi was the first big pharma to open a factory in Russia, where the medicines market is on the rise. Sanofi is ramping up insulin production at its site at Oriol, around 300 km away from Moscow, with the aim of exporting it, said Monge.
Name change for Novacap
French pharma Novacap - a world leader in aspirin and paracetamol - has changed its name to Seqens, Le Figaro reported on Thursday (p.22).
The pharma is owned by Eurazeo investment funds and employs 3,200 people across 24 factories, Les Echos added in a brief on Thursday (p.18).
Increased number of vaccinations given in France
The percentage of people given vaccinations in France has increased since more obligatory vaccines were introduced last year, reported Libération on Tuesday (p.17).
One of French health minister Agnès Buzyn’s first acts was to make 11 vaccines for infants obligatory and results published by the doctor’s daily le Quotidien du médécin show that this act is already having an impact.
The percentage of infants who have received a six-strain vaccine including hepatitis B has increased from 92.3% for those born in May 2017 to 97.8% for those born in May 2018.
Flu vaccine stocks in France almost exhausted
France has almost exhausted its flu vaccine stocks for this year, reported Le Figaro in a brief on Wednesday (p.13), noting this is the first time it has happened.
The French health minister, Agnès Buzyn, said on Monday that new stocks would arrive soon, and that people still have time to get vaccinated. She also said that the vaccination message was clearly spreading through the French population.
Sanofi’s dengue fever vaccine approved in Europe
Sanofi’s dengue fever vaccine, intended for people who have previously contracted the disease, is now available in Europe, La Croix reported on Thursday (p.12) (APMHE 61145
Dengvaxia is the first vaccine against dengue fever in the world. Sanofi invested €1.5 billion to develop this vaccine.
The vaccine has been the subject of controversy after being shown to worsen dengue fever symptoms in people who have never developed the disease, however. There was a safety scare in December 2017 (APMHE 56051
) when it was linked to serious adverse events in children in the Philippines.
This led to withdrawal from the market in the Philippines and resulted in Sanofi recommending that the vaccine should not be used in people who have not previously been infected (APMHE, 56295, APMHE 55897
, APMHE 56019
The vaccine's European approval is for people between the ages of nine and 45 living in at-risk zones, reported Les Echos in a brief on Thursday (p.18). It is also being examined by the U.S. Food and Drug Administration.
Vaccine against opioid addiction
A team from the U.S. Scripps Clinic Institute has created a vaccine that seems to protect against opioid addiction and overdoses in mice, reported Le Figaro (p.11) on Monday.
They created the vaccine by using monoclonal antibodies against opioids, particular fentanyl and carfentanil, according to results presented at the American College of Neuropsychopharmacology congress. Tests in humans are yet to be carried out.