Bayer HealthCare to Present Data on Secondary Prophylaxis with Kogenate® FS -- antihemophilic factor (recombinant) on Bleeding Frequency in Adults and Adolescents with Severe Hemophilia A

WAYNE, N.J., July 12, 2012 /PRNewswire/ -- Bayer HealthCare announced results from SPINART, a study designed to evaluate the effect of secondary prophylaxis with Kogenate® FS – antihemophilic factor (recombinant) on bleeding frequency and joint damage compared to on-demand treatment in adults and adolescents with severe hemophilia A. These data were presented as a late-breaker at the 50^th annual World Federation of Hemophilia (WFH) World Congress, July 8-12, in Paris, France.

In the SPINART study, 84 subjects ages 12 to 50 were randomized to either prophylaxis (25 IU/kg three times per week) or on-demand treatment, with a total planned follow up period of 3 years.  Results presented focus on the primary endpoint of bleeding frequency after a median follow-up period of 1.7 years.

Primary prophylaxis is defined as treatment started before or immediately after the first joint bleed, and before the age of two years, while secondary prophylaxis is defined as treatment started after multiple bleeding episodes have occurred^[i].

Bayer submitted an application for an adult prophylaxis indication for Kogenate FS to the U.S. Food and Drug Administration on June 21, 2012.

"We are proud of our commitment to studying different treatment modalities, and how they might affect patient outcomes," said Pamela Cyrus, MD, Vice President and Head, U.S. Medical Affairs, Bayer HealthCare Pharmaceuticals.  "We look forward to a robust scientific discussion at WFH, and to continuing our scientific investigation into adult prophylaxis as a potential treatment modality for hemophilia A."

INDICATIONS & USAGE

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 preexisting joint damage.

IMPORTANT SAFETY INFORMATION

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.

For important risk and use information, please see the full prescribing information.

About SPINART

SPINART is an ongoing, phase III study evaluating the effect of secondary prophylaxis with rFVIII on bleeding frequency (number of bleeds per year) and on joint damage compared to episodic treatment in adults and adolescents.

About Hemophilia A

Hemophilia A, also known as factor VIII deficiency or classical 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, joints, muscles or internal organs. Approximately 400,000 people around the world have hemophilia. 

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.

BAYER® and the Bayer Cross® are registered trademarks of Bayer.

Intended for U.S. Media Only

Forward-Looking Statement

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.

[i]   Berntorp E, Astermark J, et al. Consensus perspectives on prophylactic therapy for haemophilia: summary statement. Haemophilia 2003, 9 (suppl), 1-4.

SOURCE Bayer HealthCare Pharmaceuticals Inc.