FRANKFURT, March 11 (Reuters) - Bayer said it plans to spend more than 500 million euros ($694 million) to set up haemophilia drug production sites in Germany, one of the largest investments to date by the German company’s healthcare unit.
Bayer’s established haemophilia A therapy product Kogenate, with 1.2 billion euros in sales last year, has been exclusively produced by a Bayer facility in Berkeley, California.
It has two more drug candidates against the type A of the hereditary bleeding disorder in the third and last phase of testing on humans that is required for regulatory approval.
“Establishing an additional supply source in Germany will help the company to prepare for production of the anticipated new therapy options and address the growing demand in this therapeutic area,” the company said on Tuesday.
One of the two experimental treatments, called BAY 94-9027, was shown in a drug trial in February to help protect against bleeds with fewer infusions than the standard therapy.
As part of the production expansion, Bayer will create about 500 new jobs at its sites in Leverkusen and Wuppertal by 2020.
People with haemophilia have a fault in a gene that regulates the body’s production of proteins called clotting factors. This can cause spontaneous bleeding as well as severe bleeding following injuries or surgery.
The field could see a range of other new treatments soon.
The U.S. Food and Drug Administration is due to decide by mid-year whether to approve a new long-lasting haemophilia B clotting factor from Biogen Idec and partner Swedish Orphan Biovitrum.
Novo Nordisk expects to file next year for regulatory approval of its long-acting haemophilia B drug, N9-GP.