April 14, 2015
By Mark Terry, BioSpace.com Breaking News Staff
Bayer HealthCare, a division of Germany-based Bayer AG , announced today that it will spend $100 million to expand its facilities near its campus in East Bay San Francisco. The new building will be 80,000-square-feet in size and will replace an older facility.
The new build is part of a long-range plan by the company to upgrade facilities for research, development, manufacturing and testing of replacement products for hemophilia patients, primarily Factor VIII. Factor VIII (FVIII) deficiency is the cause of Hemophilia A, a disorder that prevents blood from clotting.
According to the Centers for Disease Control and Prevention (CDC), about 20,000 people have hemophilia in the U.S. Hemophilia A is four times as common as hemophilia B.
Groundbreaking for the new facility will start this month and is expected to be completed in 2017. The new building will not create more jobs for Bayer, although it will create construction jobs in the area.
“It’s a great story for the Bay Area,” said B>Joerg Heidrich, Bayer’s senior vice president for biotech product supply and site head for Bayer in Berkeley, in a statement. “The research is done in Mission Bay and the development and manufacturing are done on the Berkeley site.”
So far the company has invested $500 million in its Berkeley facility over the last 10 years, including a $100 million manufacturing expansion six years ago in 2009.
Bayer’s current hemophilia therapeutic is Kogenate. In December 2014 the company filed for approval for another hemophilia drug, BAY 81-8973, which is based on Kogenate. In 2013 Bayer indicated it was spending about $622 million to build hemophilia drug production locations in Germany. Kogante sales in 2013 were about $1.5 billion.
On Mar. 4, 2015, Bayer HealthCare announced the U.S. Food and Drug Administration (FDA) had accepted its Biologics License Application (BLA) for BAY 81-8973, which has a proposed trade name of Kovaltry. “Bayer is committed to continually bringing new therapies to hemophilia A patients who need them,” said David Weinreich, head of Global Development, Specialty Medicine, Bayer HealthCare Pharmaceuticals, in a statement. “Today’s milestone represents the next step in that commitment.”
Competitors in the hemophilia therapeutic market include Sangamo BioSciences, Inc. , Biogen, Inc., AstraZeneca PLC , Sanofi and Pfizer Inc. .
The company’s facilities in Berkley manufacture Kovaltry, as well as damoctocog, an experimental compound for hemophilia. Kovaltry is yet to be approved for use in the U.S., although the company hopes approval will happen next year. The current Factor VIII product, approved in 2000, is Kogenate FS, which was Bayer’s second-best-selling product, with sales of approximately $1.1 billion.
BioSpace Temperature Poll
After last week’s news that Gilead had issued a health advisory to doctors, concern is growing after nine patients taking Harvoni or Sovaldi along with another drug, amiodarone, were treated for abnormally slow heartbeats. One of the patients died of cardiac arrest. Three of the nine patients required a pacemaker. That has BioSpace asking, what next?
