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Not intended for U.S. and UK Media - Hemophilia solutions:
Bayer completes recruitment of first cohort for novel recombinant factor
VIIa (rFVIIa) protein Phase II/III study
Investigational new treatment for Hemophilia A and Hemophilia B patients
who have developed neutralizing antibodies 
Berlin, November 28, 2012 - Bayer`s BAY 86-6150 is being investigated in a
Phase II/III study called TRUST (Treatment with Unique recombinant FVII
STudy) and the recruitment of the first cohort is now complete. The
investigational compound BAY 86-6150, is a novel recombinant factor VIIa
(rFVIIa) protein for potential use in patients with hemophilia A or
hemophilia B who have developed neutralizing antibodies called inhibitors. 
This novel designed compound is being investigated for its ability to
circumvent specific steps of the natural coagulation cascade with the goal
of reducing the dosing frequency as compared to the currently available
recombinant bypassing agent. Minor modifications in the amino acid
composition of BAY 86-6150 increase the circulating half-life of BAY86-6150
and may change its affinity to activated platelets (a key component in the
formation of a clot). 
A Phase I multicenter, randomized, double-blind, placebo-controlled,
single-dose escalation study on BAY86-6150 has already been successfully
"Through our Hemophilia Solutions research initiatives, Bayer continues to
investigate innovative ways to meet the needs of people with hemophilia,
including those affected by the devastating effects of inhibitors to
clotting factor replacement therapies," said Dr Kemal Malik, Member of the
Bayer HealthCare Executive Committee and Head of Global Development. "If it
can achieve its goal, BAY 86-6150 may help patients with inhibitors achieve
better control of their disease." 
About the Phase II/III Study
The TRUST (TReatment with Unique recombinant FVII STudy) trial is a Phase
II / III, multicenter, open-label clinical study which will assess the
safety and efficacy of BAY 86-6150 in patients with hemophilia A or B with
inhibitors. The study is comprised of two parts: Part A includes the
sequential dose escalation for assessing dose response and the
pharmacokinetics and pharmacodynamics evaluation. Part B is to further
investigate the efficacy and safety of a selected dose determined from Part
About neutralizing antibodies ("inhibitors")
Inhibitor formation is considered by leading hemophilia organizations such
as the World Federation of Hemophilia as the most serious complication
facing people with hemophilia today. While standard treatment of hemophilia
is replacement therapy of the deficient clotting factor by intravenous
injection of clotting factor VIII or factor IX, some patients may develop
antibodies against these therapeutic products, rendering standard treatment
ineffective in the control of bleeding events. These neutralizing
antibodies are termed "inhibitors." Hemophilia patients with inhibitors
generally exhibit frequent bleeding that are difficult to control, and have
a greater risk of debilitating injury and death. Approximately 4,000
hemophilia patients with inhibitors are known worldwide. 
About Hemophilia A
Hemophilia A, also known as factor VIII deficiency or classic hemophilia,
is 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 characterized by prolonged or spontaneous
bleeding, especially into the joints, muscles, or internal organs. 
About Hemophilia B
Hemophilia B, also known as "Christmas disease," is a less common type of
hemophilia.  It is characterized by a deficiency in factor IX. 
About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields
of health care, agriculture and high-tech materials. Bayer HealthCare, a
subgroup of Bayer AG with annual sales of EUR 17.2 billion (2011), is one
of the world’s leading, innovative companies in the healthcare and medical
products industry and is based in Leverkusen, Germany. The company combines
the global activities of the Animal Health, Consumer Care, Medical Care and
Pharmaceuticals divisions. Bayer HealthCare’s aim is to discover, develop,
manufacture and market products that will improve human and animal health
worldwide. Bayer HealthCare has a global workforce of 55,700 employees (Dec
31, 2011) and is represented in more than 100 countries. More information
Find more information at 
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 The
company assumes no liability whatsoever to update these forward-looking
statements or to conform them to future events or developments. 
Bayer Pharma AG
Doreen Schröder, Tel. +49 30 468-11399
This press release is available here: 
Yours BayNews Editorial Team 
Bayer AG
Building W11
51368 Leverkusen, Germany 
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