Press review

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French Cortisone stocks officially back to normal but pharmacies still experiencing shortages

PARIS, 9 Aug (APM) - Despite an official announcement from France's drug regulator ANSM that cortisone stocks are back to normal, pharmacies in the country are still running out of the drug, reported Les Echos on Wednesday (p.3).
ANSM said in its announcement on 1 August that stocks of cortisone were progressively ''returning to normal'' with ''potential supply problems on a local level''. These problems seem to be primarily affecting the Aude and Pyrénées-Orientales departments in south France, next to the Spanish border, where stocks were to set to run out within the week.
Cortisone stocks have been low in France since May after the Greek factory manufacturing the pills for several generic companies had quality problems, resulting in reduced production rates fore more than a month.
Numerous generic manufactures turned to a factory belonging to the same manufacturer in France, but due to only having one production line and setting up new traceability procedures, it was unable to respond to the massive increase in demand.
The economic daily pointed out that according to ANSM data, more than 1,200 drugs or vaccines have been affected by shortages this year. This is almost 30 times more than in 2018.

Sanofi's Dupixent approved for expanded use in Europe

Sanofi's Dupixent (dupilumab) has been approved in Europe for adolescents with eczema, after being initially approved for this disease in adults in 2017, Les Echos reported on Wednesday (p.13) (APMHE 63946).
Sanofi said in a statement that it was approved for adolescents aged 12 to 17 with moderate to severe atopic dermatitis.
This is good news for Sanofi's partner on this drug Regeneron, Le Figaro reported on the same subject on Wednesday (p.23). According to a 2007 and 2014 agreement, the two pharmas spilt the profits or losses of Dupixent in the U.S. 50-50, or 65-35 and 55-45 (Sanofi and Regeneron) for profits and losses respectively in the rest of the world.
Dupixent had sales of €219 million in 2018 and looks set to become a blockbuster, a drug with sales of over $1 billion per year as trials to explore the drug's potential in other diseases such as asthma and allergies are ongoing.

FDA accuses Novartis of manipulating Zolgensma data

The U.S. Food and Drug Administration (FDA) has accused Novartis of submitting manipulated data in its marketing authorisation request for Zolgensma, a gene therapy for spinal muscular atrophy which currently costs $2.125 million reported Les Echos (p.15) on Wednesday (APMHE 63960).
The FDA is threatening to take the pharma to court, saying Novartis was aware of the problem before Zolgensma was approved in the U.S. on 24 May, yet only alerted the agency on 28 June.
Novartis has responded to the accusations saying it carried out an internal investigation ''immediately'' after finding out about the data manipulation and that it alerted the FDA as soon as it had concluded its preliminary work.
Novartis insisted that despite the manipulated data, Zolgensma is still safe and effective, with an overall favourable risk-benefit ratio. However, the FDA pointed out that one of the key responsibilities of a pharma company was to provide truthful, complete and exact data during the marketing authorisation process.
Magazine Paris Match reported on Zolgensma on Wednesday (p.92), noting that the drug's $2.125 million price tag made it the most expensive in the world. It added that French patient association AFM-Téléthon, which contributed to the drug's development through research from its own laboratory Généthon, is calling for Zolgensma pricing negotiations between Novartis and France's healthcare products pricing committee (CEPS) to made public and for the extremely high price tag to be justified.

Teva unable to reduce enormous almost $30 billion debt

Teva seems unable to reduce its enormous $28.7 billion debt, reported Les Echos on Thursday (p.15) (APMHE 63972).
This is a considerable increase from the $16.3 billion it reported in 2017, not helped by a net loss of $689 million in 2019's Q2.
Teva is experiencing competition from other generic manufactures, especially for its multiple sclerosis treatment Copaxone (glatiramer acetate) and cancer drug Treanda (bendamustine, also known as Bendeka). The former has seen sales drop by 41% in North America and 24% in Europe, while the latter has seen its sales drop by 28% in North America.
Teva is also facing lawsuits in the U.S. over the role it played in the opioid crisis and stands accused of 44 states for fixing generic prices with other pharmas.
Despite all of the above, the pharma head Kare Schultz remains confident of the company's ability to get itself back on track. Teva presented a strict restructuring programme in 2017 which should result in savings of $3 billion by the end of 2019.

Bayer and Lanxess announce sale of joint company Currenta

German companies Bayer and Lanxess announced that they have sold their joint company Currenta, a chemical park operator, for €3.5 billion to the Australian company Macquarie, reported Les Echos on Thursday (p.15).
Bayer is seeking to reduce its debts after buying Monsanto for $63 billion last year. It has already sold of consumer health brands Dr. Scholl's and Cuppertone and is looking for a buyer for its animal health division.

Transgene stops clinical trial

Transgene has stopped a Phase III clinical trial for an experimental drug for liver cancer, Le Figaro reported in a brief on Thursday (p.26) (APMHE 63964).
The trial was stopped following a recommendation from an independent data Monitoring committee (IDMC).
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