Bayer to Present Hematology Data at the 2018 American Society of Hematology Annual Meeting

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Nov 28, 2018, 09:00 ET

WHIPPANY, N.J., Nov. 28, 2018 /PRNewswire/ -- Bayer announced today that seven abstracts from its Hemophilia portfolio and development pipeline have been accepted for presentation during Scientific Sessions at the 2018 American Society of Hematology (ASH) Annual Meeting, December 1 – December 4, in San Diego, CA. The presentations include five posters highlighting new data for Jivi®, antihemophilic factor (recombinant) PEGylated-aucl (Bay 94-9027), one on new data for Kovaltry®, Antihemophilic Factor (recombinant), and one poster on Anti-TFPI research from Bayer's hematology pipeline.

"Bayer's 25-year history of research and development in hemophilia A is exemplified by the wealth of data from our clinical program that's being presented at this year's congress," said Aleksandra Vlajnic, MD, Vice President of Medical Affairs at Bayer. "These efforts underscore our commitment to science and help to inform physicians when having clinical discussions together with their patients."

The presentations being made are listed below. Please note the posters presentations may discuss a use outside of the approved indications.

Abstract 1189: Extended Interval Prophylaxis With BAY 94-9027 For > 4 Years Leads To Median Spontaneous Annualized Bleeding Rate < 1 in the PROTECT VIII Extension

Date/Time: Saturday, December 1, 6:15pm-8:15pm
Session: 322. Disorders of Coagulation or Fibrinolysis: Poster I
Location: Hall GH, Convention Center
Presenter: Mindy Simpson, MD, RUSH University Medical Center

Abstract 1206: Decrease in Overall and Joint Bleeding Rates With Extended-Interval Dosing

Date/Time: Saturday, December 1, 6:15pm-8:15pm
Session: 322. Disorders of Coagulation or Fibrinolysis: Poster I
Location: Hall GH, Convention Center
Presenter: Mark Reding, MD, University of Minnesota

Abstract 1176: Pharmacodynamics, Pharmacokinetics and Safety of BAY 1093884, an Antibody Directed Against Human TFPI, in Patients With Factor VIII or IX Deficiency (With and Without Inhibitors): a Phase 1 Study

Date/Time: Saturday, December 1, 6:15pm-8:15pm
Session: 322. Disorders of Coagulation or Fibrinolysis: Poster II
Location: Hall GH, Convention Center
Presenter: Pratima Chowdary, MD, Royal Free London NHS Foundation Trust

Abstract 1209: Improved Pharmacokinetic Profile for BAY 81-8973 Due to Increased Branching and Sialylation of N-Linked Glycans of Recombinant Factor VIII

Date/Time: Saturday, December 1, 6:15pm-8:15pm
Session: 322. Disorders of Coagulation or Fibrinolysis: Poster II
Location: Hall GH, Convention Center
Presenter: John Teare, Ph.D. Director, Late Stage Program Management, Biological Development, Bayer Pharmaceuticals

Abstract 2486: Characteristics of Bleed-free Patients on Every-5-day Dosing in the PROTECT VIII (BAY 94-9027) Study

Date/Time: Sunday, December 2, 6:00pm-8:00pm
Session: 322. Disorders of Coagulation or Fibrinolysis: Poster II
Location: Hall GH, Convention Center
Presenter: Elena Santagostino, MD, Centro Emofilia e Trombosi A. Bianchi Bonomi
IRCCS Fondazione Ca' Granda, Ospedale Maggiore Policlinico

Abstract 2492: Efficacy and Safety of BAY 94-9027 is Sustained for 5 Years: Outcomes in 33 Patients in the PROTECT VIII Extension Study

Date/Time: Sunday, December 2, 6:00pm-8:00pm
Session: 322. Disorders of Coagulation or Fibrinolysis: Poster II
Location: Hall GH, Convention Center
Presenter: Mark Reding, MD, University of Minnesota

Abstract 2481: BAY 94-9027 Can Be Accurately Measured Across Regions With Appropriate One-Stage Assay Reagent Use

Date/Time: Sunday, December 2, 6:00pm-8:00pm
Session: 322. Disorders of Coagulation or Fibrinolysis: Poster II
Location: Hall GH, Convention Center
Presenter: Rajiv Pruthi, MD, Mayo Clinic

Jivi Indications and Important Safety Information

INDICATIONS

Jivi is an injectable medicine used to replace clotting factor (Factor VIII or antihemophilic factor) that is missing in people with hemophilia A.
Jivi is used to treat and control bleeding in previously treated adults and adolescents (12 years of age and older) with hemophilia A. Your healthcare provider may also give you Jivi when you have surgery. Jivi can reduce the number of bleeding episodes in adults and adolescents with hemophilia A when used regularly (prophylaxis).
Jivi is not for use in children below 12 years of age or in previously untreated patients.
Jivi is not used to treat von Willebrand disease.

IMPORTANT SAFETY INFORMATION

You should not use Jivi if you are allergic to rodents (like mice and hamsters) or to any ingredients in Jivi.
Tell your healthcare provider about all of your medical conditions that you have or had.
Tell your healthcare provider if you have been told that you have inhibitors to Factor VIII.
Allergic reactions may occur with Jivi. Call your healthcare provider right away and stop treatment if you get tightness of the chest or throat, dizziness, decrease in blood pressure, or nausea.
Allergic reactions to polyethylene glycol (PEG), a component of Jivi, are possible.
Your body can also make antibodies, called "inhibitors," against Jivi, which may stop Jivi from working properly. Consult your healthcare provider to make sure you are carefully monitored with blood tests for the development of inhibitors to Factor VIII.
If your bleeding is not being controlled with your usual dose of Jivi, consult your doctor immediately. You may have developed Factor VIII inhibitors or antibodies to PEG and your doctor may carry out tests to confirm this.
The common side effects of Jivi are headache, cough, nausea, and fever.
These are not all the possible side effects with Jivi. Tell your healthcare provider about any side effect that bothers you or that does not go away.

For additional important risk and use information, please see the full Prescribing Information.

INDICATIONS
KOVALTRY^® is a medicine used to replace clotting factor (Factor VIII or antihemophilic factor) that is missing in people with hemophilia A.

KOVALTRY^® is used to treat and control bleeding in adults and children with hemophilia A. KOVALTRY^® can reduce the number of bleeding episodes in adults and children with hemophilia A when used regularly (prophylaxis). Your healthcare provider may give you KOVALTRY^® when you have surgery.

KOVALTRY^® is not used to treat von Willebrand Disease.

IMPORTANT SAFETY INFORMATION

You should not use KOVALTRY^® if you are allergic to rodents (like mice and hamsters) or any ingredients in KOVALTRY^®.

Tell your healthcare provider if you have heart disease or are at risk for heart disease.
The common side effects of KOVALTRY^® are headache, fever, and itchy rash.

Allergic reactions may occur with KOVALTRY^®. Call your healthcare provider right away and stop treatment if you get tightness of the chest or throat, dizziness, decrease in blood pressure, and nausea.

Your body can also make antibodies, called "inhibitors," against KOVALTRY^®, which may stop KOVALTRY^® from working properly. Consult with your healthcare provider to make sure you are carefully monitored with blood tests for the development of inhibitors to Factor VIII.

Tell your healthcare provider about any side effect that bothers you or that does not go away.

Call your healthcare provider right away if bleeding is not controlled after using KOVALTRY^®.

For additional important risk and use information, please see full Prescribing Information.
*Compared to other recombinant Factor VIII products.

Reference: 1. KOVALTRY^® [prescribing information]. Whippany, NJ: Bayer HealthCare LLC; 2016.

You are encouraged to report side effects or quality complaints of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Bayer: Science for a Better Life
Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At the same time, the Group aims to create value through innovation, growth and high earning power. Bayer is committed to the principles of sustainable development and to its social and ethical responsibilities as a corporate citizen. In fiscal 2017, the Group employed around 99,800 people and had sales of EUR 35.0 billion. Capital expenditures amounted to EUR 2.4 billion, R&D expenses to EUR 4.5 billion. For more information, go to www.bayer.us.

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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