WALTHAM, Mass. & BOSTON--(BUSINESS WIRE)--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.”
About ELOCTATE ®
ELOCTATE® [Antihemophilic Factor (Recombinant), Fc Fusion Protein] is a recombinant clotting factor therapy developed for hemophilia A using Fc fusion technology to prolong circulation in the body. It is engineered by fusing factor VIII to the Fc portion of immunoglobulin G subclass 1, or IgG1 (a protein commonly found in the body), enabling ELOCTATE to use a naturally occurring pathway to extend the time the therapy remains in the body. While Fc fusion technology has been used for more than 15 years, Bioverativ and Swedish Orphan Biovitrum AB (publ) (Sobi) have optimized the technology and are the first companies to utilize it in the treatment of hemophilia. ELOCTATE is manufactured using a human cell line in an environment free of animal and human additives.
ELOCTATE is approved and marketed by Bioverativ in the United States, Japan and Canada. It is also approved in Australia, New Zealand, Brazil and other countries, and Bioverativ has marketing rights in these regions. It is also approved as Elocta® in the European Union, Switzerland, Iceland, Liechtenstein, Norway and other countries where it is marketed by Sobi.
As with any factor replacement therapy, allergic-type hypersensitivity reactions and development of inhibitors may occur in the treatment of hemophilia A. Inhibitor development has been observed with ELOCTATE, including in previously untreated patients. For more information, please see the full U.S. prescribing information for ELOCTATE.
ALPROLIX® [Coagulation Factor IX (Recombinant), Fc Fusion Protein] is a recombinant clotting factor therapy developed for hemophilia B using Fc fusion technology to prolong circulation in the body. It is engineered by fusing factor IX to the Fc portion of immunoglobulin G subclass 1, or IgG1 (a protein commonly found in the body), enabling ALPROLIX to use a naturally occurring pathway to extend the time the therapy remains in the body (half-life). While Fc fusion technology has been used for more than 15 years, Bioverativ and Sobi have optimized the technology and are the first companies to utilize it in the treatment of hemophilia. ALPROLIX is manufactured using a human cell line in an environment free of animal and human additives.
ALPROLIX is approved and marketed by Bioverativ for the treatment of hemophilia B in the United States, Japan and Canada. It is also approved in Australia, New Zealand, Brazil and other countries, and Bioverativ has marketing rights in these regions. It is also authorized in the European Union, Iceland, Liechtenstein, Norway and Switzerland, where it is marketed by Sobi.
Allergic-type hypersensitivity reactions and development of inhibitors have been observed with ALPROLIX in the treatment of hemophilia B, including in previously-untreated patients. For more information, please see the full U.S. prescribing information for ALPROLIX.
Bioverativ is a global biotechnology company dedicated to transforming the lives of people with hemophilia and other rare blood disorders through world-class research, development and commercialization of innovative therapies. Launched in 2017 following separation from Biogen Inc., Bioverativ builds upon a strong heritage of scientific innovation and is committed to actively working with the blood disorders community. The company’s mission is to create progress for patients where they need it most and its hemophilia therapies when launched represented the first major advancements in hemophilia treatment in approximately two decades. For more information, visit bioverativ.com or follow @bioverativ on Twitter.
About Invicro, LLC
Based in Boston, MA, Invicro was founded in 2008 with the mission of improving the role and function of imaging in translational drug discovery and development across all therapeutic areas. Invicro’s multi-disciplinary team provides a full range of image informatics, engineering and operational services. Originally focused on imaging in discovery phase, in 2016 Invicro expanded its offering in clinical phase research with the acquisition of Molecular Neuroimaging, LLC. Now through preclinical and clinical divisions, Invicro develops and leverages the latest approaches in imaging quantitative biomarkers. The successful integration of the discovery and clinical teams onto Invicro’s industry-leading software informatics platforms, VivoQuant® and iPACS®, has inspired a strong and growing presence in the market. For more information, visit invicro.com.
Bioverativ Safe Harbor
This press release contains forward-looking statements, including statements about the potential advancements, developments and potential benefits that may be achieved or derived from the collaboration with Invicro. These statements may be identified by words such as “believe,” “expect,” “may,” “plan,” “potential,” “will” and similar expressions, and are based on Bioverativ’s current beliefs and expectations. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include, among others: uncertainty regarding the ability to achieve the expected benefits from the collaboration, including as a result of risks and uncertainties associated with drug development and commercialization; reliance on third parties over which Bioverativ may not always have full control; risks associated with collaborations; and other risks and uncertainties that are described in the Risk Factors section of Bioverativ’s most recent annual or quarterly report filed with the Securities and Exchange Commission. Any forward-looking statements speak only as of the date of this press release and Bioverativ assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.