Bayer Inc. receives approval for hemophilia A treatment Jivi®

• Extended half-life product that offers a reduction in dosing frequency and improved bleeding protection
• May be adjusted to every five days and further individually adjusted to less or more frequent dosing

MISSISSAUGA, ON, Oct. 24, 2018 /CNW/ - Bayer Inc. announced today that Health Canada has approved Jivi^® (Antihemophilic Factor [Recombinant, B-domain deleted, PEGylated]) for routine prophylactic treatment to prevent or reduce the frequency of bleeding episodes in previously treated adults and adolescents 12 years of age or older. Health Canada also approved Jivi for control and prevention of episodic bleeding, and peri-operative management of bleeding (surgical prophylaxis.)¹

The recommended initial prophylactic regimen for Jivi is twice weekly, with the ability to dose every five days and further individually adjust to less or more frequent dosing based on bleeding episodes. This approval is based on results from the PROTECT VIII trial.

"In Canada, approximately 2,500 people live with hemophilia A². It is a rare disease where one of the proteins needed to form blood clots is missing or reduced and patients struggle to manage bleeds," said Dr. Alfonso Iorio, professor and researcher of the Department of Health Research Methods, Evidence, and Impact and the Department of Medicine at McMaster University. "Research shows Jivi's novel structural design produces very predictable pharmacokinetics (the way the drug moves through the body). This makes it simpler to build effective treatment regimens and minimize the infusion frequency."

"We welcome the approval of Jivi by Health Canada," said Paul Wilton, president, Canadian Hemophilia Society. "This will add another option for patients with hemophilia A in selecting the factor VIII replacement therapy that is right for them."

About Jivi^® (Antihemophilic Factor [Recombinant, B-domain deleted, PEGylated]) 
Jivi^® was engineered to have an extended half-life by harnessing proven PEG-technology that delivers higher sustained levels of FVIII, which extends the blood's ability to coagulate for longer.

Jivi is a rFVIII replacement therapy, meaning it replaces the reduced or missing FVIII in adults and adolescents 12 years of age or older with hemophilia A. As a site-specifically PEGylated FVIII, Jivi has a half-life of 18.6 hours. rFVIII replacement therapy is the standard of care to stop or prevent bleeding and has proven efficacy and safety established over decades of clinical trials and real-world experiences.

About PROTECT VIII study
The Health Canada approval of Jivi is supported by results from the pivotal PROTECT VIII trial comprised of prophylactic dosing, on-demand treatment, and perioperative management in previously treated adults and adolescents 12 years of age or older with severe hemophilia A.

The PROTECT VIII study was a 36-week, international, open label trial. Overall, 126 patients completed the main study. Part A evaluated pharmacokinetics, efficacy and safety of Jivi for on-demand treatment of bleeds and for prophylactic therapy at different dosing regimens. An optional extension study was available to subjects who completed Part A to assess Jivi over at least 100 accumulated exposure days, which demonstrated bleed protection and a good safety profile of up to a median of 1.9 years (range of 0-2.6 years). Part B evaluated safety and efficacy of Jivi during major surgery. Treatment with Jivi was generally well tolerated. The most frequently reported (?5%) adverse reactions in clinical trials in previously treated patients were headache, cough and pyrexia.

About Bayer in Hemophilia
Bayer is driven by helping people with hemophilia thrive. We have a deep understanding of the evolving needs and aspirations of people with hemophilia, established over 25 years of partnering with the hemophilia community. FVIII replacement treatments are the standard of care to stop or prevent bleeding. Bayer's portfolio of FVIII treatments, including Kovaltry, and now Jivi, offers people with hemophilia A across all stages of life a treatment to suit their individual needs and lifestyles. We work together with researchers, healthcare professionals and patient groups to build a strong community and help people with hemophilia live fulfilling lives. Bayer is passionate about spearheading research and investing in developing the next-generation of therapies and solutions to help people with hemophilia thrive both now and in the future.

About Hemophilia A
Hemophilia affects approximately 400,000 people around the world, including approximately 2,500 people in Canada, and is a largely inherited disorder in which one of the proteins needed to form blood clots is missing or reduced. Hemophilia A is the most common type of hemophilia, in which blood clotting is impaired because there is a lack or defect of coagulation FVIII. Patients therefore repeatedly experience bleeds in muscles, joints or other tissues, which can result in chronic joint damage over time. External injuries can have severe consequences if not treated appropriately, as the blood clots more slowly in these patients than in healthy individuals. Hemophilia A has an estimated frequency of 1 in 5,000 male live births, affecting people worldwide.

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.ca.

Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer 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 Inc.