Bayer Initiates Phase III Trial of an Investigational Recombinant Factor VIII Compound in Children with Hemophilia A Phase III PROTECT VIII Kids Trial will Evaluate the Pharmacokinetics, Safety and Efficacy of BAY94-9027 for Prophylaxis and Treatment of Bleeding in Previously Treated Children with Severe Hemophilia A

WAYNE, N.J., July 8, 2013 /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 in children.  The PROTECT VIII (PROphylaxis in hemophilia A patienTs via directly pEgylated long-aCTing rFVIII) Kids trial is designed to determine the effects of BAY94-9027, a recombinant human factor VIII (rFVIII), when used as prophylaxis, dosed at least once weekly and as on-demand for acute bleeding events. 

BAY94-9027 has been designed to extend the circulating half-life of rFVIII through site specific attachment of a polyethylene glycol (PEG) polymer to the light chain of the rFVIII molecule, while preserving its full biologic activity.

"We are happy that prophylaxis with this long-acting compound is now being studied in children younger than twelve years of age to complement our ongoing adult study.  We look forward to sharing clinical trial results on BAY94-9027 when they are available," said Dr. Georg Lemm,  Vice President, Global Clinical Development Hematology, Bayer HealthCare.

Bayer is committed to developing treatment solutions that meet the needs of the hemophilia community.  Whether through research, support or clinical management, Bayer is dedicated to helping persons with hemophilia and their families.

About the Phase III Study
PROTECT VIII Kids is a multicenter, multinational, non-controlled, open-label trial evaluating the pharmacokinetics, safety and efficacy of BAY 94-9027, used as prophylaxis at 25-60 IU/kg at least 1x/week and as on-demand treatment of bleeding in male children with severe hemophilia A.  The study will enroll 50 previously treated patients (PTP) worldwide.  Subjects will be males, up to 12 years of age, who have severe hemophilia A (<1% FVIIIc) and a documented history of at least 50 exposure days (ED) with any FVIII product.  Outcome measures to be evaluated include pharmacokinetics, annualized bleeding episodes, response of acute bleeding episodes to treatment and adverse events, including inhibitor formation.  The total duration of the individual treatment with the study drug is the amount of time required to achieve at least 50 exposure days. 

Subjects will also be offered participation in an optional extension study, during which observations will be collected for at least 50 additional exposure days.

About Hemophilia A
Hemophilia A, also known as factor VIII deficiency or classic hemophilia, is a largely 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 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.

SOURCE Bayer HealthCare Pharmaceuticals Inc.




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