Bioverativ and Invicro Form Novel, Advanced Imaging Collaboration Focused on Improving Management of Joint Health in People with Hemophilia

Builds on companies’ first-of-its-kind initiative using radiolabeled imaging to understand the impact of the extravascular distribution of factor IX on joint health

Strategic collaboration will seek to advance the adoption of ultrasound imaging in the diagnosis and management of joint disease in people with hemophilia

WALTHAM, Mass. & BOSTON, Mass – August 24, 2017 – Bioverativ Inc. (NASDAQ: BIVV), a global biotechnology company focused on the discovery, development and commercialization of innovative therapies for hemophilia and other rare blood disorders, and Invicro, LLC, a leading provider of imaging services and analysis for pharmaceutical research and development, today announced that they have formed a strategic collaboration focused on expanding the use and adoption of leading imaging technologies, including ultrasound and radiolabeled imaging, to improve the diagnosis and management of joint disease in people with hemophilia.

Debilitating joint disease, which is caused by frequent bleeds into joints over time, is one of the most common complications for people with hemophilia and often results in chronic pain and disability. The ability to identify and treat joint bleeds, including sub-clinical bleeds, is crucial to reduce the risk of joint damage over the long term.

One of the primary focuses of this imaging collaboration will be to investigate the impact of Bioverativ’s leading extended half-life therapies, ELOCTATE® [Antihemophilic Factor (Recombinant), Fc Fusion] and ALPROLIX® [Coagulation Factor IX (Recombinant), Fc Fusion Protein], and its investigational therapy BIVV001 [VWF-XTEN-rFcFVIII], on protection from bleeds and improvement of long-term joint health in people with hemophilia.

This alliance focuses on the novel application of radiolabeled imaging technology to ALPROLIX and other factor IX therapies, to study the importance of factor IX distribution to tissue and its role in improving joint health, which may lead to better patient outcomes. Bioverativ expects to present data from this preclinical study at an upcoming scientific congress.

“It has become apparent that the type of modification used to extend half-life in factor IX therapies can impact the way the therapy is metabolized in the body,” said Maha Radhakrishnan, MD, Senior Vice President of Medical at Bioverativ. “Through this innovative collaboration with Invicro, we hope to create meaningful progress in hemophilia care by helping people with hemophilia, their caregivers, physicians and treatment team monitor bleeding episodes and better understand the impact of different factor replacement therapies on joint health over time using state-of-the-art imaging.”

This collaboration will also focus on advancing the use of ultrasound imaging in the diagnosis and monitoring of joint disease in people with hemophilia as clinical examinations lack the ability to discriminate joint bleeding from other joint conditions.

“The ability to quickly identify and treat joint bleeds is crucial to reducing the risk of long-term joint damage,” said Annette von Drygalski, MD, PharmD, Director, Hemophilia and Thrombosis Treatment Center, University of California San Diego. “While there are a growing number of treatment options for people with hemophilia, the ability to identify subclinical bleeding episodes to optimally treat patients remains a significant challenge for both patients and physicians. Advancing the use of imaging, like musculoskeletal ultrasound, to better understand and manage hemophilia treatment will play a key role in preserving long-term joint health.”

Additionally, Bioverativ and Invicro will develop standardized protocols to monitor and assess joint health using musculoskeletal ultrasound imaging in people with hemophilia in research studies of their marketed and pipeline products and in clinical practice. Invicro will serve as the ultrasound imaging contract research organization for the clinical studies. Together, the companies plan to establish a path for the integration of the ultrasound methodologies in hemophilia clinical practice in the future.

“We look forward to working with Bioverativ on this exciting and important joint health initiative,” said Jack Hoppin, CEO and Co-Founder of Invicro. “Combining our analytic expertise with Bioverativ’s deep understanding of hemophilia, we believe we will be able to develop imaging tools that could be used to improve the management of hemophilia.”