Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Bayer will invest more than €500m at its sites in Wuppertal and Leverkusen, Germany, to expand manufacturing capacities for recombinant factor VIII (rFVIII) hemophilia products that are currently in development.
Subscribe to our email newsletter
The company is exclusively manufacturing the approved hemophilia A therapy drug Kogenate FS/Kogenate Bayer at its Berkeley facility in California.
According to Bayer, 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. About 500 new jobs will be created by 2020 as part of this investment.
Currently, investigational therapy options for hemophilia patients – a plasma protein-free rFVIII (BAY 81-8973) and a long-acting rFVIII (BAY 94-9027) – are both in Phase III clinical trials.
Bayer HealthCare has reported favorable results in February 2014 from the PROTECT VIII trial evaluating its site-specific PEGylated rFVIII (BAY 94-9027).
Bayer HealthCare CEO Dr Olivier Brandicourt said: "This investment will be one of the largest in the history of Bayer HealthCare and reflects our strong commitment in the field of hemophilia A.
Recombinant factor VIII protein is used for the treatment of hemophilia A employing genetically modified cells to produce these human factor VIII molecules.
BAY 81-8973, an investigational plasma protein-free product, is an upgrade of the currently marketed Kogenate FS/Kogenate Bayer product. BAY 81-8973 will be produced without the addition of any components of animal or human origin.
Bayer, subject to the results of the ongoing clinical trials, is planning to file for approval of BAY 81-8973 with the regulatory authorities in the second half of 2014. The company plans to launch the drug in the fourth quarter of 2015.
In addition, a site-specific PEGylated rFVIII product BAY 94-9027 currently being investigated in patients in a once-weekly prophylactic dosing regimen may result in a significant benefit for long-term outcomes and quality of life improvements for people with hemophilia A.
Recently, Bayer reported positive results with the site-specific PEGylated rFVIII product demonstrating protection from bleeds comparable to current prophylactic dose regimens with infusion intervals of up to seven days.
Bayer is planning to file for approval of BAY 94-9027 with the regulatory authorities in the second half of 2015.