Health Canada Approves Marketing License Transfer for ELOCTATE® and ALPROLIX®

/THIS RELEASE IS INTENDED FOR DISTRIBUTION IN CANADA ONLY/

  • Marketing licenses were transferred to Bioverativ as part of its separation from Biogen Inc.
  • ELOCTATE and ALPROLIX are the leading extended half-life therapies for the treatment of hemophilia A and B

MISSISSAUGA, ON, July 10, 2017 /CNW/ -

Bioverativ Canada Inc. announced it has received notices of compliance from Health Canada approving the transfer of marketing licenses for ELOCTATE® [Antihemophilic Factor (Recombinant), Fc Fusion Protein] and ALPROLIX® [Coagulation Factor IX (Recombinant), Fc Fusion Protein] from Biogen Canada Inc. to Bioverativ Canada Inc., following Bioverativ's separation from Biogen. ELOCTATE and ALPROLIX are the first extended half-life therapies available to the estimated 4,000 Canadians living with hemophilia A and B.

Bioverativ was created as a spin-off from Biogen's hemophilia business and is an independent biotechnology company focused on the discovery, development and commercialization of innovative therapies for hemophilia and other rare blood disorders. Following the spin-off effective February 1, 2017, Biogen was the marketing authorization holder of ELOCTATE and ALPROLIX in Canada until Health Canada approved the transfer of the marketing licenses to Bioverativ Canada Inc.

"At Bioverativ Canada, we are energized by the opportunity to bring meaningful progress to people across this country who are living with hemophilia," said Christopher Aiello, general manager of Bioverativ Canada. "We are committed to expanding access to our leading extended half-life therapies to help people with hemophilia extend bleed protection while reducing the burden on treatment."   

ELOCTATE and ALPROLIX are the leading extended half-life therapies. They are the only hemophilia therapies developed using Fc fusion technology, which uses a naturally occurring pathway to extend the time the therapy remains in the body (half-life). A recent report, "Switching to extended half-life products in Canada - preliminary data" published in the journal, Haemophilia, discusses usage trends of these extended half-life therapies, including a noticeable decrease in the amount of factor used when treating with ELOCTATE and ALPROLIX."i

In addition to commercializing the current portfolio of hemophilia products in Canada, Bioverativ will continue to focus on progressing the next generation of therapies for hemophilia A and B and advancing a pipeline of programs in other rare blood disorders, including sickle cell disease and beta thalassemia.

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

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, Biogen 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 in the United States, Japan, Canada, Australia, New Zealand, Brazil and other countries, and Bioverativ has marketing rights in these regions. It is also approved in the European Union, Switzerland, Iceland, Liechtenstein, Norway and other countries where it is approved as ELOCTA® and 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 Canadian Product Monograph information for ELOCTATE.

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). 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 other countries, 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 Canadian Product Monography information for ALPROLIX.

_____________________________
i Keepanasseril A et al.  Switching to extended half-life products in Canada - preliminary data.  Haemophilia doi:10.1111/hae.13245.

SOURCE Bioverativ Canada Inc.

For further information: MEDIA CONTACT: Marianne McMorrow, +1 (781) 663-4376, media@bioverativ.com; INVESTOR CONTACT: Susan Altschuller, +1 (781) 663-4360, IR@bioverativ.com

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