Bayer HealthCare said today it will build a $100 million product testing facility at its Berkeley, CA, manufacturing site designed to support the company’s next generation of treatments for patients with hemophilia A.
The company said the new facility will build on the company’s more than 25 years of research and development on products and treatment approaches designed to meet the needs of patients with hemophilia A.
Bayer HealthCare said the testing site also represents a continued commitment to the San Francisco Bay Area region. In addition to the manufacturing facility in Berkeley, the company operates its U.S. research hub, the U.S. Innovation Center, in San Francisco.
“As the Bay Area’s third largest biotech employer, we are also proud to be making this contribution to the world’s richest center of biotech R&D, investment, and production,” Joerg Heidrich, svp for product supply biotech and site head at Bayer Berkeley, said in a statement.
One product envisioned to be tested at the new facility when completed in 2017 is Kovaltry™ (BAY 81-8973), a recombinant Factor VIII compound indicated for treatment of hemophilia A in children and adults, Bayer HealthCare executives told the San Francisco Business Times.
Last month, Bayer HealthCare said that the FDA accepted for review the company’s BLA for Kovaltry. The BLA is based on results from the LEOPOLD (Long-Term Efficacy Open-Label Program in Severe Hemophilia A Disease) clinical trials, which evaluated Kovaltry in adults and children using two- and three-times-per-week protective dosing regimens.
LEOPOLD consisted of three multinational clinical trials designed to evaluate the pharmacokinetics, efficacy, and safety of Kovaltry in subjects with severe hemophilia A.