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'The future of pharma innovation in France hangs on bioproduction' - lobby

by Youness Bousenna
PARIS, Feb 16 (APM) - France has 32 bioproduction sites, only four of which belong to groups of foreign origin, according to a report by AEC consultants for the French pharma industry body Leem.
The report, which contains numerous maps and tables (available in French from Leem), was presented at a press conference in Paris on Wednesday.
Thirty-nine percent of the bioproduction sites in France are operated by pharmaceutical companies for themselves only, 32% by contract manufacturing organisations (CMOs), and the other 29% are mixed. The sites featured in the report produce biological substances (at least synthesis and/or purification) for human or animal health, in clinical batches (as of Phase I) or for commercial purposes.
The sites all belong to French groups apart from those of Merck KGaA at Martillac (near Bordeaux in southwestern France), Novartis at Huningue (in northeastern France, close to the Swiss city of Basel), Merial (Boehringer Ingelheim group) at Saint-Priest (close to Lyon in eastern France), and Octapharma at Lingolsheim (in northeastern France, close to Strasbourg).
Bioproduction provides work for 8,463 people in France (including 416 working for subcontractors). More than half (60%) work on vaccine production for large groups (essentially Sanofi). Production which is not outsourced accounts for 81% of the jobs in the sector.
In the coming years, nine groups are planning site extensions and three - Servier, LFB and SME Fab'entech - will create new sites or bioproduction units. This will mean 1,000 jobs created or transferred in the next five years.
“The French bioproduction offer focuses on the production of mature biological substances, such as recombinant proteins (including antibodies), vaccines and protein extraction from biological liquid (plasma fractionation),” the report says.
Of the 3,490 products currently in clinical development in Europe, 1,398 are biological substances, of which 54% are recombinant proteins (including antibodies).
Recombinant proteins can be produced at 14 different sites and vaccines at 10, with protein extraction at nine of them. Only four sites are suitable for gene therapy, two for RNA , and just one for biological tissue engineering.
Concerning clinical batch manufacturing, 16 sites (excluding animal health) manufacture batches for third parties, including six that can also manufacture commercial batches. Three of the six offer recombinant proteins integrated offer and three offer cell and gene therapies.
“A European biotech seeking a production partner in France will only find a limited commercial batch production offering in terms of available substance types," the AEC report says.

‘Opportunity’ for France

The consultancy concludes that "upcoming innovative biological therapies represent an opportunity in a context where French pharmaceutical production is slipping”. While between 2004 and 2014, France went from being Europe's biggest pharmaceuticals producer to fourth-biggest, at 21 billion euros, turning more towards bioproduction “could be a way of boosting pharmaceutical production in the country”.
The AEC report suggests France should capitalise on its competitiveness in cell and gene therapies, as these are the main innovations expected in the coming years. To this end, the consultancy highlights the CellforCure platform (LFB group) in cell and gene therapies, along with ABL Europe and Sanofi’s viral vector platforms.
To meet these objectives, a “coordinated policy” with a “one-stop shop” offering investors visibility and guidance, and a “structured offer” are needed.
At the end of the presentation, Leem chair Patrick Errard said: “The future of innovation in France hangs on bioproduction” as “missing the boat on bioproduction means missing out on the medicine of the future”. He stressed the need to develop an “industry of excellence” with an “unbroken continuum” through all stages in the drugs production chain.

Regulatory inspections in question

The presentation was followed by a symposium organised by the trade body on France's attractiveness for drug manufacturing, with a speech from junior finance minister Delphine Gény-Stephann (APMHE 56911).
During the subsequent discussion, Mayoli Spindler chief executive Stéphane Thiroloix, who is also head of the Polepharma pharmaceutical production cluster, identified the cost of regulatory inspections as a subject for attention in the debate on the country’s competitiveness at the export level.
He said that the delays in an inspection by France’s drug regulator ANSM of one of his sites cost him “between 200,000 and 300,000 euros in sales”, as he was prevented from exporting to several markets. “We were lucky to keep our customers and distributors,” he said, emphasising a need for more “punctuality”.
Thiroloix also highlighted the issue of overseas inspections, which can be used for protectionism, and he cited Russia. “Do we have an approach we can exploit as a State, as a member of the European Union (EU), to restore the balance?” he asked.
He also advanced the idea of including clinical batch production in the scope of research tax credits (CIR).
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