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Research Triangle Park, N.C. (Dec. 11, 2003)
Bayer Biological Products (BP) today announced it has achieved a major milestone, releasing record levels of Kogenate® products in 2003. Production and releases of Kogenate® FS and KOGENATE® Bayer (Antihemophilic Factor [Recombinant], Formulated with Sucrose) increased by over 35% over 2002 and represented the highest output in the company's 15 years of manufacturing recombinant factor VIII products. Furthermore, 2003 sales are expected to be the highest ever, again representing a record year for the Kogenate® brand.
"This record year for the Kogenate® line of products is a remarkable success story," said Dr. Gunnar Riemann, president, Bayer Biological Products Division. "Leadership in this therapeutic area is a priority for us, and we are expecting continued success for the brand in 2004."
This record year is a direct result of continuing investments supporting the manufacturing process in the Berkeley, Calif., facility. Shortened cycle times, increased production and release efficiencies, and planned additional projects to further increase capacity are attributable to the ongoing strategic investments.
"Remaining true to our history of commitment, investments are continuing to further strengthen the Kogenate® brand and provide services and programs to support the global hemophilia community," said Joel Abelson, vice president, Global Strategic Marketing, Biological Product Division. "Clearly, the hemophilia community recognizes the superb product profile of our Kogenate® products in terms of safety, efficacy, and convenience. We fully intend to build on the success of Kogenate® in 2003 to position the brand for an even stronger 2004 and beyond."
Significant efforts are already underway toward this goal. In addition to the capacity expansion projects at the Berkeley facility, projects that will improve the quality of life for patients through increased safety and convenience are nearing completion. These include regaining room temperature storage labeling for the Kogenate® products - a major development that will further improve patient convenience. Additionally, BIO-SET®, a new needleless device that includes a prefilled syringe for the reconstitution and use of Kogenate® products, is anticipated to launch in mid- to late-2004. Representing the most advanced technology to simplify and increase safety for both patients and caregivers, BIO-SET® will be available exclusively with Kogenate® products. As the only available device without exposed needles, BIO-SET® eliminates the risk of accidental needle sticks and reduces the necessary components in the reconstitution process from seven to three, which makes it easier to use, learn, and teach. Finally, Bayer BP continues to work with Arrowhead Electronic Healthcare, LLC, to develop and make available the only hand-held electronic patient diary with a bar code scanner that more accurately and conveniently captures bleeding and treatment information. This device, which has enjoyed phenomenal early success in pilot studies in Europe and Canada, now is being tested in the United States.
Work toward true breakthrough future products and technologies providing an even bolder vision for patient convenience and quality of life is well underway. Bayer BP's research and technology group is currently being expanded to support Kogenate® production, as well as to conduct extensive research to develop a recombinant factor VIII molecule requiring less frequent dosing for prophylaxis. The company continues to invest in its partnership with Avigen Inc. to develop Coagulin B® gene therapy, a product offering the potential for a cure for people living with hemophilia B.
Bayer BP continues to lead the industry in supporting clinical research in bleeding disorders. Clinical research programs evaluating quality of life assessment tools, the value of prophylaxis treatment, and the importance of characterizing issues related to inhibitor development are advancing knowledge and the state of care for hemophilia. Furthermore, Bayer BP continues to promote and finance the Bayer Hemophilia Awards program, the largest industry-funded grant program to support basic and clinical research and education in hemophilia. Through this important program, which commits nearly $3 million annually in grants to early career investigators, fellows in training, and other hemophilia care professionals, Bayer BP seeks to support the next steps for the next generation of care and treatment options for people with hemophilia worldwide.
"These investments in clinical research and services, such as our Bayer Hemophilia Awards program, not only demonstrate our ongoing efforts for the global hemophilia community, but should be expected of an industry leader preparing for the future," said Dr. Riemann.
About Kogenate® FS/ KOGENATE® Bayer
Kogenate® FS/KOGENATE® Bayer Antihemophilic Factor (Recombinant), Formulated with Sucrose, is a recombinant factor VIII treatment for hemophilia A that offers a more convenient administration by utilizing a 2.5 mL diluent, the smallest among available factor VIII products. Kogenate® FS/KOGENATE® Bayer does not use albumin in its purification or formulation and includes a solvent/detergent viral inactivation step, thereby further reducing the potential risk of viral transmission. Kogenate® FS/KOGENATE® Bayer is manufactured at Bayer BP's state-of-the-art biotechnology facility in Berkeley, Calif.
About Hemophilia
Approximately 400,000 people around the world have hemophilia. Hemophilia is an inherited bleeding disorder characterized by prolonged or spontaneous bleeding, especially into the muscles, joints, or internal organs. The disease is caused by deficient or defective blood coagulation proteins, known as factor VIII or IX. The most common form of the disease is hemophilia A, or classic hemophilia, in which the clotting factor VIII is either deficient or defective. Hemophilia B is characterized by deficient or defective factor IX.
About Bayer HealthCare
Bayer HealthCare AG, a subgroup of Bayer AG with sales of approximately 9.4 billion Euro in 2002, is one of the world's leading, innovative companies in the health care and medical products industry.
The company combines the global activities of the divisions Animal Health, Biological Products, Consumer Care, Diagnostics, and Pharmaceuticals. More than 34,000 people are employed by Bayer HealthCare worldwide.
Our aim is to discover and manufacture innovative products that will improve human and animal health worldwide. Our products enhance well-being and quality of life by diagnosing, preventing, and treating disease.
Information about Bayer Biological Products Division can be found at www.bayerbiologicals.com.
Forward-looking Statements
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 public reports filed with the Frankfurt Stock Exchange and with the U.S.
Securities and Exchange Commission (including our Form 20-F). The company assumes
no liability whatsoever to update these forward-looking statements or to conform
them to future events or developments.
Contact:
Tricia McKernan
Tel: 919.316.6316
Fax: 919.316.6673
E-mail: tricia.mckernan.b@bayer.com
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