Following the recent approval of two new biologics, Dupixent and Kevzara, and a pipeline stuffed full of large-molecule drugs, Sanofi will invest as much as €2 billion on its biologics manufacturing network over the next several years.
The disclosure came today during a media event, Reuters reports, and was confirmed by a spokesman for the French drugmaker. Philippe Luscan, executive VP of global industrial affairs, said at the event that the company will plow €600 million ($673 million) a year on its biologics production over the next two to three years.
“The investments will reinforce our three major hubs in the U.S., Germany and France,” where Sanofi is doing production of biologics like monoclonal antibodies (mAbs), spokesman Nicolas Kressmann said in a telephone interview. The investments will be for capacity expansion and hiring at different sites in those hubs, he said.
“It’s part of the €1 billion that we invest every year in our global industrial network,” Kressmann explained, with the rest of the money going into small molecule production. The investments are in line with what the drugmaker has been doing for several years, he added.
That comes on top of the €270 million ($286.3 million) Sanofi and Swiss contractor Lonza earlier this year said they will jointly spend to build a plant at Lonza’s site in Visp, Switzerland, which they will share for the production of biologics. That facility, which is expected to employ 200, is slated to be complete at the end of 2019 and operational in 2020.
With about 72% of its R&D projects made up of to biologic drugs, many made from cells, the French drugmaker, like its peers, has shifted its spending to concentrate on production of these more complex drugs. It has chosen to work with contractors for some of its needs. Two years ago, it transferred production on monoclonal antibodies (mAbs) it was working on with its sometimes-partner Regeneron to a Boehringer Ingelheim plant in Germany.
Sanofi’s own production work with mAbs has not always been stellar. In October, when it and partner Regeneron had expected to receive approval of rheumatoid arthritis drug sarilumab, the two instead were issued a complete response letter tied to problems at a plant in France that was doing the fill-finish work on the drug, as well as for dupilumab, which at the time was pending FDA approval as a treatment for a severe form of eczema.
After resolving issues to the FDA’s satisfaction, the two won approval in March for dupilumab, which they branded Dupixent. Late last month, they received the delayed approval of sarilumab, rolled out as Kevzara, for which they are looking at peak sales of as much as $5 billion a year.
By Eric Palmer
Source: Fierce Pharma
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