Bayer to Present Latest Advances in Hemophilia Research at the ISTH 2015 Annual Congress in Toronto
More than 20 abstracts highlight research and Phase III data.
WHIPPANY, N.J., June 15, 2015 /PRNewswire/ -- Bayer HealthCare will present data on hemophilia A at the International Society on Thrombosis and Haemostasis (ISTH) 2015 Annual Congress to be held June 20 - 25, in Toronto. More than 20 abstracts have been accepted for presentation, including five oral and 18 poster presentations.
"As part of our longstanding commitment to the hemophilia community, we are eager to share clinical data from our LEOPOLD trials on the investigational product BAY 81-8973 and from the SPINART trials on Kogenate FS antihemophilic factor (recombinant)," said Dario Mirski, M.D., Vice President and Head of U.S. Medical Affairs, Bayer HealthCare Pharmaceuticals. "And for the first time, we will be presenting our early-stage research on alternate clotting pathways."
Notable studies include:
BAY 81-8973 Phase III Studies
Oral presentation: BAY 81-8973 Prophylaxis Efficacy in Patients With Severe Hemophilia A: Analyses of Annualized Bleeding Rate Outcomes in the LEOPOLD I Trial
Room 71, Tuesday, June 23, 14:00 to 15:15
Oral presentation: LEOPOLD Trial Results: Correlation of von Willebrand Factor Antigen Level With BAY 81-8973 Pharmacokinetic Parameters of Patients with Severe Hemophilia A
Room 801, Monday, June 22, 08:00 to 09:15
Poster #293: Prophylactic Efficacy of Twice-Weekly Versus 3-Times-Weekly BAY 81-8973 in Severe Hemophilia A: Results of the LEOPOLD I and II Clinical Trials
Exhibition Area in Hall D, E, Wednesday, June 24, 17:15 to 18:30
Bayer's Sucrose-Formulated rFVIII Phase III Studies
Oral presentation: SPINART 3-Year Analyses: Patient- and Joint- Level Changes in Colorado Adult Joint Assessment Scale and Magnetic Resonance Imaging Scores With Bayer's Sucrose-Formulated Recombinant Factor VIII in Adolescents and Adults
Room 718, Thursday, June 25, 08:00 to 09:15
Oral presentation: SPINART 3-Year Results with Bayer's Sucrose-Formulated Recombinant Factor VIII: Relationship Between Bleeding Frequency and Joint Health in Adults With Severe Hemophilia A Using Prophylaxis
Room 717, Monday, June 22, 14:00 to 15:15
Poster #292: Bleeding Events in Chinese Children with Severe Hemophilia A Receiving Standard Prophylaxis vs On-Demand Treatment With Bayer's Sucrose-Formulated Recombinant Factor VIII
Exhibition Area in Hall D, E , Wednesday, June 24, 17:15 to 18:30
Additional Studies and Results
In Vitro Studies into BAY 1093884 Anti Tissue Factor Pathway Inhibitor Antibody:
Oral presentation, Exhibit Hall G & F, Monday, June 22, 15:45 to 17:15
Poster #553, Exhibition Area in Hall D, E, Wednesday, June 24, 17:15 to 18:30
Poster #554, Exhibition Area in Hall D, E, Wednesday, June 24, 17:15 to 18:30
Poster #599, Exhibition Area in Hall D, E, Wednesday, June 24, 17:15 to 18:30
Indications
Kogenate® FS antihemophilic factor (recombinant) is a recombinant factor VIII indicated for:
- Control and prevention of bleeding episodes in adults and children with hemophilia A.
- Surgical prophylaxis in adults and children with hemophilia A.
- Routine prophylactic treatment to prevent or reduce the frequency of bleeding episodes in children with hemophilia A and to reduce the risk of joint damage in children without pre-existing joint damage.
- Routine prophylactic treatment to prevent or reduce the frequency of bleeding episodes in adults with hemophilia A.
Kogenate FS is not indicated for the treatment of von Willebrand disease.
Important Safety Information
Kogenate FS antihemophilic factor (recombinant) is contraindicated in patients who have life-threatening hypersensitivity reactions, including anaphylaxis to mouse or hamster protein or other constituents of the product.
Hypersensitivity reactions, including anaphylaxis have been reported with Kogenate FS. Reported symptoms included facial swelling, flushing, hives, decrease in blood pressure, nausea, rash, restlessness, shortness of breath, tachycardia, tightness of the chest, tingling, urticaria, and vomiting. Discontinue Kogenate FS if symptoms occur and seek immediate emergency treatment.
Neutralizing antibodies (inhibitors) have been reported following administration of Kogenate FS predominately in previously untreated patients. Carefully monitor patients for the development of factor VIII inhibitors, using appropriate clinical observations and laboratory tests. If expected plasma factor VIII activity levels are not attained, or if bleeding is not controlled with an expected dose, perform an assay that measures factor VIII inhibitor concentration.
Hemophilic patients with cardiovascular risk factors or diseases may be at the same risk to develop cardiovascular events as non-hemophilic patients when clotting has been normalized by treatment with factor VIII.
Serious adverse reactions seen with Kogenate FS are systemic hypersensitivity reactions including bronchospastic reactions and/or hypotension and anaphylaxis, and the development of high-titer inhibitors necessitating alternative treatments to factor VIII.
The most common adverse reactions (≥4%) observed in clinical trials were inhibitor formation in previously untreated and minimally treated patients, skin-related hypersensitivity reactions, infusion site reactions, and central venous access device (CVAD) associated infections.
For important risk and use information, please see the full prescribing information.
Hematology at Bayer HealthCare includes an approved treatment for hemophilia A and numerous compounds in various stages of development for hemophilia, sickle cell anemia, and other blood and bleeding disorders. Together, these compounds reflect the company's commitment to research and development for these indications, prioritizing specific targets for intervention with the potential to improve the way that rare blood and bleeding disorders are treated.
About Bayer HealthCare Pharmaceuticals Inc.
Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals business of Bayer HealthCare LLC, a subsidiary of Bayer AG. Bayer HealthCare is one of the world's leading, innovative companies in the healthcare and medical products industry, and combines the activities of the Animal Health, Consumer Care, Medical Care, and Pharmaceuticals divisions. As a specialty pharmaceutical company, Bayer HealthCare provides products for General Medicine, Hematology, Neurology, Oncology and Women's Healthcare. The company's aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases.
Forward-Looking Statements
This news release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup 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 Bayer's public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
Bayer®, the Bayer Cross® and Kogenate® FS are registered trademarks of Bayer.
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