Bayer HealthCare to Invest More Than $100 Million in Berkeley Manufacturing Center
New manufacturing process to support production of future versions of Hemophilia drug
BERKELEY, CA — (SEPTEMBER 16, 2009) — Bayer HealthCare will invest more than $100 million at its Berkeley biotech manufacturing center to introduce a new manufacturing process that will be used to produce future versions of Bayer’s hemophilia drug, Kogenate® FS [antihemophilic factor (recombinant)]. The new process involves the application of innovative and first-in-class biotechnology manufacturing technologies. The investment, the largest by Bayer HealthCare in Berkeley to date, will be made over the course of the next four years on facility upgrades, new equipment and state-of-the-art technologies.
“This process innovation is strategically important for the long-term success of Bayer’s Hemophilia franchise,” said Joerg Heidrich, senior vice president of Bayer HealthCare’s global product supply biotech organization and head of the Berkeley site. “The decision by the Bayer Board to make the investment in Berkeley is a significant ‘win’ for our employees and the surrounding communities, following the competitive process involving external contract manufacturing organizations. The investment is both an endorsement of our strong biotechnology expertise and also a mandate to become globally competitive in biotechnology manufacturing.” The 46-acre Berkeley Supply Center has been the global center of all Kogenate manufacturing since the product was approved in 1993. Operations also include a biologics process development and clinical manufacturing facility.
“Bayer is proud to be the East Bay’s largest biotech employer and part of the emerging ‘Green Corridor’,” adds Heidrich. “We appreciate the new incentive programs that are being created by the strong public-private partnership involving the cities of Oakland, Berkeley and Emeryville, as well as the State of California’s Business Investment Services (CalBIS), the East Bay Economic Development Alliance, and PG&E. For Bayer Berkeley, these programs not only helped strengthen our competitive bid for this investment, but also play an important role in helping us create a more globally competitive bio-manufacturing organization.”
“Bayer’s decision is a smart investment that will save hundreds of jobs, help those suffering from hemophilia and further both California’s and Bayer’s leadership in the biotech industry,” said California Governor Arnold Schwarzenegger. “This investment is an excellent example of how California’s incentive programs can encourage great companies like Bayer to continue working in our state.”
BAYER’S HISTORY OF LEADERSHIP IN THE BAY AREA
This new manufacturing infrastructure investment represents the next phase of Bayer’s long-standing presence in Berkeley – which spans more than 100 years so far, from the days of Cutter Laboratories to Bayer’s bio-manufacturing operations today. The company is the second largest biotech employer in the San Francisco Bay Area with professionals in Berkeley, Emeryville and Richmond dedicated to the research, development and manufacturing of novel protein therapeutics.
Bayer has a stellar track record of contributing to its communities and its focus on sustainability aligns well with the Green Corridor initiative of the East Bay communities:
o Biotech Partners was cited by Oakland City Council as a model workforce training program for disadvantaged students at Oakland Tech and Berkeley High.
o Bayer was named 2009 Education Partner of the Year by the San Francisco Business Times for its “Beyond the Check” commitment to education through grants, employee volunteerism and corporate leadership.
o In 2008 the company was celebrated as “Business Partner of the Year” by the Berkeley/Albany YMCA, and distinguished by the Berkeley Unified School District for its long-term commitment to local public schools.
o Bayer’s Berkeley site has been ISO14001 compliant since 2001 (Bayer’s first North American site to earn this rigorous environmental rating), offers a model auto use reduction program, achieved an onsite recycling rate of 86% in 2008, and contributed more than $680,000 to local education, environmental and patient advocacy charities in 2008.
About Hemophilia A
Hemophilia A, also known as factor VIII deficiency or classic Hemophilia, is largely an inherited bleeding disorder in which one of the proteins needed to form blood clots in the body is missing or reduced. Hemophilia A is the most common type of Hemophilia and is characterized by prolonged or spontaneous bleeding, especially into the muscles, joints or internal organs. Approximately 400,000 people around the world have Hemophilia A.
About Kogenate® FS
Kogenate® FS, antihemophilic factor (recombinant), is a recombinant factor VIII treatment indicated for the control and prevention of bleeding episodes and peri operative management in adults and children (0-16 years) with hemophilia A. Kogenate FS is also indicated for routine prophylaxis to reduce the frequency of bleeding episodes and the risk of joint damage in children with hemophilia A with no pre existing joint damage.
IMPORTANT SAFETY INFORMATION ABOUT KOGENATE® FS
The most serious adverse reactions are systemic hypersensitivity reactions and the development of high titer inhibitors necessitating alternative treatments to AHF. The most common adverse reactions observed in clinical trials were inhibitor formation in previously untreated or minimally treated patients, skin-associated hypersensitivity reactions, infusion site reactions, and central venous access device (CVAD) line-associated infections.
Kogenate® FS is contraindicated in patients who have manifested life-threatening immediate hypersensitivity reactions, including anaphylaxis, to the product or its components, including mouse or hamster proteins.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please see the full prescribing information for important risk and use information at www.kogenatefs.com.
About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials. Bayer HealthCare, a subsidiary of Bayer AG, is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company comprises the global activities of the Animal Health, Bayer Schering Pharma, Consumer Care and Medical Care divisions. Bayer HealthCare’s aim is to discover and manufacture products that will improve human and animal health worldwide. Find more information at www.bayerhealthcare.com.
Bayer Schering Pharma is a worldwide leading specialty pharmaceutical company. Its research and business activities are focused on the following areas: Diagnostic Imaging, General Medicine, Specialty Medicine and Women's Healthcare. With innovative products, Bayer Schering Pharma aims for leading positions in specialized markets worldwide. Using new ideas, Bayer Schering Pharma aims to make a contribution to medical progress and strives to improve the quality of life. Find more information at www.bayerscheringpharma.de.
This news release contains forward-looking statements based on current assumptions and forecasts made by Bayer Group management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in our annual and interim reports filed with the Frankfurt Stock Exchange. Bayer assumes no liability whatsoever to update these forward-looking statements or conform to future events or developments.
Sreejit Mohan: 510-705-5477; email@example.com