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Press Release

Bioverativ to Present New Data on Rare Blood Disorder Programs at ASH 2017 Annual Meeting

Bioverativ Inc.
Posted on: 01 Nov 17

Bioverativ Inc. (NASDAQ: BIVV), a global biopharmaceutical company dedicated to transforming the lives of people with rare blood disorders, today announced that it will present data showcasing its work to advance therapies for people affected by hemophilia, cold agglutinin disease (CAgD), sickle cell disease and beta-thalassemia at the 59th Annual Meeting of the American Society of Hematology (ASH), December 9 -12 in Atlanta, Georgia.

Highlights at ASH will include an oral presentation of Phase 1/1b safety and efficacy data on BIVV009, an investigational first-in-class, monoclonal antibody developed to treat cold agglutinin disease (CAgD). Cold agglutinin disease is a poorly understood chronic, autoimmune hemolytic anemia with no approved therapies. The company will also share new research that will help characterize the burden of CAgD and the risk of thromboembolic events, and increase the understanding of morbidity and mortality associated with this rare blood disorder. Bioverativ plans to start two Phase 3 clinical trials of BIVV009 in CAgD by the end of the year.

The company will also have several presentations on its hemophilia therapies, including preclinical findings froma first-of-its-kind study using radiolabeled imaging to understand the impact of extravascular distribution of factor IX therapies on joint health. Data supporting extended prophylactic dosing intervals with ELOCTATE® [Antihemophilic Factor (Recombinant), Fc Fusion Protein] for hemophilia A and ALPROLIX® [Coagulation Factor IX (Recombinant), Fc Fusion Protein] for hemophilia B will also be discussed in two joint poster presentations with Sobi.

Bioverativ’s oral and poster presentations:

Hemophilia Abstracts

  • Extravascular Distribution of Conventional and EHL FIX Products Using In Vivo SPECT Imaging Analysis in Hemophilia B Mice - Poster #1061 – Saturday, December 9, from 5:30-7:30 PM (ET) - Hall A2
  • Clinical Outcomes of Weekly Prophylaxis with rFVIIIFc: Longitudinal Analysis of the A-LONG and ASPIRE Study Population - Poster #2368 – Sunday, December 10, from 6:00-8:00 PM (ET) - Hall A2
  • Optimization of Clot Formation Under Blood Flow in a Tissue Engineered Blood Vessel – Poster #2304 – Sunday, December 10, from 6:00-8:00 PM (ET) – Hall A2
  • Clinical Outcomes of 14-Day Prophylaxis with rFIXFc: Longitudinal Analysis of the B-LONG and B-YOND Study – Poster #3667 – Monday, December 11, from 6:00-8:00 PM (ET) – Hall A2

Cold Agglutinin Disease Abstracts

  • Incidence of Thromboembolic Events Is Increased in a Retrospective Analysis of a Large Cold Agglutinin Disease (CAD) Cohort – Poster #928 – Saturday, December 9, from 5:30-7:30 PM (ET) – Hall A2
  • Long Term Efficacy, Safety and PK/PD Profile of the Anti-C1s Antibody (BIVV009) in Primary Cold Agglutinin Disease Patients - Oral Presentation #703 – Monday, December 11 at 2:45 PM (ET) –C208 – C210

Beta-Thalassemia and Sickle Cell Disease Abstract

  • ST-400 as a Potential Therapy for Beta-Thalassemia and Sickle Cell Disease – Poster #2066 – Saturday, December 9, from 5:30-7:30 PM (ET) – Hall A2

Bioverativ and Sangamo Therapeutics, Inc. have an exclusive worldwide collaboration to develop and commercialize ZFN-mediated gene-edited cell therapies for the treatment of beta-thalassemia and sickle cell disease.

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, Kuwait and Saudi Arabia 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. Note that the indication for previously untreated patients is not included in the EU Product Information for Elocta.

About ALPROLIX®
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. Note that the indication for previously-untreated patients is not included in the EU Product Information.

About the Bioverativ and Sobi Collaboration
Bioverativ and Sobi collaborate on the development and commercialization of ALPROLIX® [Coagulation Factor IX (Recombinant), Fc Fusion Protein] and ELOCTATE® [Antihemophilic Factor (Recombinant), Fc Fusion Protein], which is marketed as Elocta® in Europe. Bioverativ has final development and commercialization rights in North America and all other regions in the world excluding the Sobi territory, and has manufacturing responsibility for ELOCTATE and ALPROLIX. Sobi has final development and commercialization rights in the Sobi territory (essentially Europe, North Africa, Russia and most Middle Eastern markets).

About the Bioverativ and Sangamo Collaboration
Bioverativ and Sangamo have an exclusive worldwide collaboration to develop and commercialize ZFN-mediated gene-edited cell therapies for the treatment of beta-thalassemia and sickle cell disease. Based on the terms of the agreement, Sangamo is responsible for conducting the ST-400 Phase 1/2 clinical trial, and Bioverativ will be responsible for subsequent worldwide clinical development, manufacturing, and commercialization.

About Bioverativ
Bioverativ is a global biopharmaceutical 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 more than two decades. For more information, visit www.bioverativ.com or follow @bioverativ on Twitter.

Bioverativ Safe Harbor
This press release contains forward-looking statements, including statements about research and development programs, and early stage findings, potential benefits, clinical effects and clinical trials relating to such programs. 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. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early stage research or clinical trials may not be indicative of full results or results from clinical trials and do not ensure regulatory approval. Factors which could cause actual results to differ materially from Bioverativ’s current expectations include uncertainties relating to the initiation, enrollment and completion of stages of clinical trials, unexpected concerns may arise from data, findings, analysis or results obtained during research and clinical trials, regulatory authorities may require additional information or further studies, or may fail or refuse to approve or may delay approval of product candidates, or Bioverativ may encounter other unexpected hurdles. For more detailed information on the risks and uncertainties associated with Bioverativ’s drug development and commercialization activities, please review 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.

View source version on businesswire.com: http://www.businesswire.com/news/home/20171101006075/en/

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Last updated on: 01/11/2017

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