Bayer to Present Data on Hemophilia Research at NHF in Washington, D.C.

WHIPPANY, N.J., Sept. 17, 2014 /PRNewswire/ -- Bayer HealthCare will present data on hemophilia A research at the National Hemophilia Foundation's 66^th Annual Meeting, which takes place September 18-20 in Washington, D.C.  The data, which will be shared through poster presentations, showcase Bayer's commitment to advancing hemophilia A treatment and patient care. Data will be presented in a scientific forum.

"With posters that display research into treatment modalities in hemophilia A patients, Bayer is maintaining its commitment to research in bleeding disorders," said Dario Mirski, MD, Vice President and Head, U.S. Medical Affairs, Bayer HealthCare Pharmaceuticals. "As a committed community partner, we are excited to share and discuss our findings."

Notable poster presentations will be displayed in Washington Rooms 5 and 6 all day September 19^th, and from 9:00 a.m. until 1:00 p.m. on September 20^th.  They include:

Three-Year Results from Bayer's SPINART Study:

• Poster: Joint Function and health-related quality of life in adults using prophylaxis after treatment with Bayer's sucrose formulated recombinant factor VIII.

Three-Year Results from Bayer's SPINART Study (cont):

• Poster: Joint outcomes by magnetic resonance imaging after treatment with Bayer's sucrose formulated recombinant factor VIII.

• Poster: Results at the three-year evaluation time point with Bayer's sucrose formulated recombinant factor VIII.

Cardiovascular Comorbidities:

Poster: Analysis of the prevalence of cardiovascular comorbidities in a US patient population with hemophilia A; confirmation of findings

Resource Utilization:

Poster: Changes in healthcare resource utilization and healthcare-related events in patients diagnosed with hemophilia A

Prevalence of Depression:

Poster: Prevalence of depression in US patients with hemophilia A compared to a general medical population; a retrospective database analysis

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 full prescribing information.

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 Pharmaceuticals Inc. 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.

BAYER, the Bayer Cross and Kogenate are registered trademarks of Bayer.

Forward-Looking Statements

This 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.

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SOURCE Bayer Corporation