Bayer Initiates Phase II/III Trial of New Recombinant Factor VIII Compound for Treatment of Hemophilia A

WAYNE, N.J., July 8, 2012 /PRNewswire/ -- Bayer HealthCare today announced the company has started to enroll patients in an international Phase II/III trial to evaluate its investigational compound BAY94-9027 for the treatment of hemophilia A. The PROTECT VIII (PROphylaxis in hemophilia A patienTs via directly pEgylated long-aCTing rFVIII) trial is designed to investigate whether BAY94-9027, a recombinant human factor VIII (rFVIII), can prolong the duration of protection from bleeds and allow for less frequent Infusions when used prophylactically, while also having the ability to treat acute bleeding events.

BAY94-9027 has been engineered to extend the half-life of rFVIII while preserving biologic activity by inserting a single cysteine (amino acid) site to its surface, which serves as an attachment site for a polyethylene glycol (PEG) polymer.

"Bayer continues to invest in research that may provide innovative ways to advance patient care," said Pamela Cyrus, MD, Vice President and Head, U.S. Medical Affairs, Bayer HealthCare Pharmaceuticals. "This study is designed to determine the effects of a long-acting rFVIII product in people with hemophilia A."

About the Phase II/III Study
PROTECT VIII is a multicenter, multinational, partially randomized, open-label trial evaluating the safety and efficacy of BAY94-9027 with different dosing frequencies in both prophylactic and on-demand treatment of bleeding in adults and adolescents with severe hemophilia A. The study will enroll 120 to 140 previously treated subjects (PTP) worldwide.

About Hemophilia A
Hemophilia A, also known as factor VIII deficiency or classic 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, the most common type of hemophilia, is caused by deficient or defective blood coagulation proteins, known as factor VIII.

Hemophilia A is characterized by prolonged or spontaneous bleeding, especially into the muscles, joints, or internal organs.

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.

SOURCE Bayer HealthCare

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