Bayer announced it will invest more than 500 million euros or nearly $700 million to establish additional capacities for the manufacture of recombinant factor VIII (rFVIII) hemophilia A drugs currently under development. The planned investment, which will go to Bayer’s sites in Wuppertal and Leverkusen in Germany, is one of the largest ever made by the German company’s healthcare unit.
The company said the establishment of an additional supply source in Germany will help the company gear up for production of anticipated new therapy options and address growing demands. At present, its approved hemophilia A therapy drug Kogenate is exclusively manufactured in Berkeley, California, USA. The investment will open up about 500 new jobs at the Leverkusen and Wuppertal Bayer sites by the year 2020, said Bayer.
Hemophilia A is a hereditary bleeding disorder that affects 400,000 people worldwide. A deficiency in clotting factor VIII impairs the blood clotting process in patients. Repeated episodes of bleeding into the muscles, joints, or other tissues can lead to long-term damage. Bleeding episodes can become rare if a patient receives early prophylactic treatment with Factor VIII (FVIII).
Current investigational therapy options for hemophilia patients are undergoing Phase III clinical trials. These include plasma protein-free rFVIII (BAY 81-8973) and long-acting rFVIII (BAY-94-9027). Investigational rFVIII proteins are intended for the treatment of hemophilia A using genetically modified cells to produce human factor VIII molecules. BAY 81-8973 is an upgrade of the company’s Kogenate FS/Kogenate Bayer product. It will be manufactured without additional components of animal or human origin. BAY 97-9027 is a long acting factor VIII being studied in patients in a once-weekly prophylactic dosing regimen.
Application for regulatory approval for BAY 81-8973 is scheduled in the second half of 2014 with the first launch in the fourth quarter of 2015, while BAY 94-9027 will be submitted for approval in the second half of 2015.