With Kovaltry on the Way, 450 Bay Area Bayer HealthCare Workers Finally Settle on New Contracts

With Kovaltry on the Way, 450 Bay Area Bayer HealthCare Workers Settle on New Contracts
August 5, 2015
By Alex Keown, BioSpace.com Breaking News Staff

SAN FRANCISCO – Manufacture of Bayer HealthCare ’s hemophilia drug Kogenate FS will continue unimpeded after a new employee contract that includes a 3.2 percent salary bump was ratified, the San Francisco Business Times reported.

Bayer Healthcare and the union representing approximately 450 workers at its Berkeley, Calif. site agreed to a new four-year contract as the drug manufacturing company, a division of Germany-based Bayer AG , await regulatory approval of its next hemophilia drug, Kovaltry.

The contract was approved just weeks before the Berkeley-based employees’ current contract ended. The current contract was set to expire Aug. 24. Bayer’s Berkeley facility is the only unionized biotech site in the country, the Business Times said. Workers at the site, who earn on average $67,000 annually, manufacture Kogenate FS, a blood-clotting drug used for hemophilia A. There are more than 1,000 employees employed at the Berkeley site, which Bayer has maintained for approximately 40 years since acquiring the space after buying Cutter Laboratories.

In addition to Kogenate FS, the site will also manufacture Kovaltry, an experimental hemophilia A drug under review by the U.S. Food and Drug Administration (FDA). In March, the FDA accepted Bayer’s Biologics License Application (BLA) for Kovaltry, also known as BAY 81-8973.

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.

Kogenate FS was approved by the FDA in 2005 for the treatment of adults with hemophilia A. In 2013, Bayer indicated it was spending about $622 million to build hemophilia drug production locations in Germany. Kogenate sales in 2013 were about $1.5 billion and $1.1 billion in 2014.

In April, Bayer announced 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. 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. Construction began in April and is expected to be completed sometime in 2017.

Bayer is not the only company to make a major investment in hemophilia manufacturing. In May, Denmark-based Novo Nordisk announced it was investing $225 million into a new hemophilia treatment manufacturing site in Kalundborg, Denmark. The new facility is expected to be approved and fully operational in 2020. The company’s NovoSeven, which was approved for use in the United States in 1999, controls bleeding in hemophilia patients by bypassing clotting inhibitors. In March, Novo Nordisk announced it would launch Novoeight in the United States for people living with hemophilia A. The Food and Drug Administration approved the injectable Novoeight for use in adults and children with hemophilia A for the control and prevention of bleeding, perioperative management, and routine prophylaxis to prevent or reduce the frequency of bleeding episodes based on results from the guardian trials.

Competitors in the hemophilia therapeutic market include Sangamo BioSciences, Inc. , Biogen, Inc., AstraZeneca PLC , Sanofi and Pfizer Inc. .

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