| April 15,
2003
World Hemophilia Day, celebrated April 17, takes on special significance in 2003, the year of the 40th anniversary of the World Federation of Hemophilia
(WFH). Bayer Biological Products (BP) previously announced it had donated $40,000 to WFH in recognition of its 40 years of exemplary service to the global
bleeding disorders community. Begun in 1990, World Hemophilia Day is intended to
increase awareness of, and promote support for, the needs of people around the world living with hemophilia. This year, WFH has chosen "40 years of progress in global hemophilia care" as the theme for World Hemophilia Day. It marks the start of WFH's Global Alliance for Progress (GAP) in hemophilia, designed to greatly increase the diagnosis and treatment of hemophilia throughout the world.
"It is good to reflect on the tremendous number of advances that have helped so many people with hemophilia over the last 40 years," said Brian O'Mahony, WFH president. "However, while WFH is proud to be celebrating its 40th anniversary in 2003, we must rededicate ourselves on this World Hemophilia Day to do everything we can to continue increasing access to care for patients around the world. The initiation of the GAP program, and our collaborations with organizations like Bayer BP, are an important part of our overall efforts to achieve this goal." Mary Bauman, director of Global Strategic Marketing, Coagulation, at Bayer BP, commented on the significant progress in hemophilia care seen in the last 40 years. "Bayer BP is dedicated to helping WFH close the treatment gap that still exists for as many as 75 percent of people with hemophilia around the world.
While we are proud of our contributions to the global hemophilia community over
the last 40 years, we remain committed to additional investments in R&D, as well as support programs and product donations, to further improve the quality of life of people living with hemophilia. Our efforts will continue to make more product available, while further advancing treatment technology so patients can feel confident their life-saving therapies are as safe, effective, and as convenient to administer as possible."
40 Years of Treatment Progress
In the past 40 years, treatment technologies and patient services have improved dramatically. (See attached timeline highlights.) Plasma factor concentrates, such as Konyne® and Koate®, introduced by Bayer in the 1960s and 1970s, helped improve the lives of people with hemophilia by making home treatment and surgery possible for the first time.
In the 1980s, the genes that produce the clotting protein factors VIII and IX (absent or deficient in people with hemophilia A and B, respectively) were identified and characterized. Using this knowledge, in the early 1990s Bayer BP introduced Kogenate®, a first-generation recombinant factor VIII product not derived from human plasma. Within a decade, additional advances in recombinant technology and innovations by Bayer BP resulted in the first second-generation recombinant factor VIII product, Kogenate® FS/KOGENATE® Bayer, Antihemophilic Factor (Recombinant) Formulated with Sucrose. This product utilizes additional safety enhancements such as a solvent/detergent viral activation step and no albumin added to final formulation. Further, it features a significantly smaller volume of infusion to increase patient convenience. Throughout this period, Bayer BP's industry-leading pathogen safety research efforts contributed significantly to product purification and viral inactivation techniques that have virtually eliminated the risk of viral transmission.
Continued Commitment to R&D
Bayer BP's continuing commitment to R&D includes focusing on treatment technologies designed to enhance patient convenience and quality of life. Bayer BP has invested significantly in the development of Coagulin-B®, currently focused on advancing the clinical investigation program in hemophilia B. Additionally, Bayer BP is committed to developing a fourth generation of Kogenate®, a product designed to require less frequent dosing for prophylaxis.
In conjunction with efforts to discover and bring new treatments to market for hemophilia, Bayer BP remains diligent in its efforts to further advance product safety. As a result of these efforts, Bayer BP is recognized as a global leader for its work in pathogen safety, with an emphasis lately in demonstrating that current manufacturing methodologies remove emergent viruses, for example West Nile virus, and the pathogenic prions associated with Creutzfeld-Jakob Disease.
Serving the Global Hemophilia Community
As a result of the success achieved by offering innovative and convenient products to the global hemophilia community, Bayer BP also has invested in patient and professional service programs to fulfill its role as responsible corporate citizens. Most recently, the Bayer Hemophilia Awards Program was announced, offering $2.75 million in grants annually to research and education in hemophilia. Further, financial support is offered to multiple local programs around the world for hemophilia programs and services. Bayer BP also has provided product donations to WFH to help meet the treatment needs of people living with hemophilia in developing countries. For example, in 2002 more than 15 million units of Kogenate® FS and Koate® were donated to WFH for distribution in 18 countries worldwide.
Timeline Highlights
40 Years of Progress in Hemophilia
1963-1967
The World Federation of Hemophilia is founded by Frank Schnabel.
Dr. Judith Graham Pool develops cryoprecipitate by using a process of freezing and thawing plasma.
Plasma concentrates become available to treat hemophilia.
Bayer (Cutter) introduces Konyne concentrate (factor IX complex).
The need for high-volume whole plasma transfusions ends.
1968-1972
WFH is officially recognized by the World Health Organization.
The first factor VIII concentrate becomes available.
The WFH International Hemophilia Training Centre program is created for fellowships and workshops in developing countries.
1973-1977
Bayer (Cutter) introduces Koate (Human Antihemophilic Factor ? the first generation of factor VIII concentrate).
First joint WFH/WHO meeting held on hemophilia carrier detection methods.
1978-1982
International Hemophilia Information Clearinghouse is established in Heidelberg, Germany, to serve as a source of socio-medical statistics.
Introduction of the first anti-inhibitor coagulant complex for people who develop inhibitors to factor VIII.
1983-1987
Scientists isolate the specific genes that control the production of factors VIII and IX. The research and development of genetically engineered factor replacement begins.
Virally inactivated factor concentrates become available.
Bayer initiates development of a recombinant factor VIII, and initial human clinical trials of recombinant factor VIII begin.
1988-1992
April 17 is chosen to commemorate the birthday of Frank Schnabel, and the first World Hemophilia Day is celebrated in 1990.
Bayer introduces Koate-HP, an improved formulation of factor VIII, using solvent/detergent viral inactivation treatment and monoclonal antibody purification technology.
Bayer gains approval for Konyne 80, heat-treated factor IX complex.
New, synthetic clotting products based on recombinant technologies are introduced.
Better screening methods emerge to detect and remove viruses and other agents from factor concentrates and blood products.
Medically supervised home-infusion therapy becomes possible, and prophylactic treatment is more widely utilized.
1993-1997
Bayer introduces Kogenate, recombinant factor VIII, for the treatment of hemophilia A.
Bayer initiates the research for a cure through gene replacement therapy.
WFH launches Web site as a resource for the global hemophilia community.
1998-2003
Bayer gains approval of Koate-DVI, a factor VIII concentrate, including both solvent/detergent and 800C heat treatment for viral inactivation.
Bayer gains worldwide approvals for Kogenate FS and KOGENATE Bayer, the first second-generation recombinant factor VIII product.
Bayer launches the Hemophilia Awards Program, a global initiative aimed to improve the lives of people with hemophilia through worldwide research and educational grants.
Bayer scientists confirm manufacturing processes remove the Creutzfeldt-Jakob Disease pathogen.
Bayer enters into collaboration with Avigen, Inc., for the development of a factor IX gene therapy to treat hemophilia B.
WFH celebrates 40th anniversary, initiates Global Alliance for Progress (GAP) program on World Hemophilia Day.
Contact:
Tricia McKernan
Bayer Biological Products
+1-(0)919/316-6316
E-mail: tricia.mckernan.b@bayer.com
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