Bayer to Build Hemophilia A New Testing Facility in California
16.04.2015 -
Bayer HealthCare has announced plans to invest $100 million in a product testing facility at its Berkeley, California, US manufacturing site to support the next generation of treatments for patients with hemophilia A.
The new facility will test Bayer's investigational products in accordance with rigorous global regulatory requirements, said David Weinreich, head of global development and specialty medicine at the German-based holding.
Jörg Heidrich, senior vice president for product supply biotech and head of the Berkeley site, said the group is "proud to be making this contribution to the world's richest center of biotech R&D, investment, and production."
The Bay Area of California, headquarters for research, development and biotech manufacturing for Bayer HealthCare, claims to be the area's third largest biotech employer.
Altogether, Heidrich said Bayer has invested more than $500 million at the Berkeley complex over the past decade, including a $100 million manufacturing expansion started in 2009.
Bayer already manufactures and tests Kogenate FS, its Factor VIII coagulation drug - approved in 2000 and with 2014 sales of $1.1 billion currently the group's second-best-selling product following the blood thinner Xarelto - at the California site.
In December 2014, the group filed for FDA Administration approval of its latest experimental hemophila drug, Kovaltry, a long-acting treatment that could allow hemophilia A patients to be dosed once a week, rather than once every four days or so. Approval could come as early as 2016.