Swedish Orphan Biovitrum: Alprolix® Obtains Reimbursement across the UK

Swedish Orphan Biovitrum AB (publ) (Sobi™) (https://www.sobi.com/) (STO:SOBI) today announces that the company’s product Alprolix® (eftrenonacog alfa), a recombinant human factor IX Fc-fusion protein with extended half-life for the treatment of haemophilia B, has now been approved for reimbursement across the UK. National Health Service (NHS) England has confirmed reimbursement alongside Scotland, Wales and Northern Ireland where Alprolix is already reimbursed. Alprolix is also approved for reimbursement in Germany and the Netherlands.
This expansion of availability in the UK is supported by global
experience. With more than two years of post-authorisation real-world
experience with Alprolix, more than 1,000 patients have been treated in
countries where Alprolix is commercially available, corresponding to
approximately 1,100 patient-years of experience.
“Securing reimbursement for Alprolix across the UK, relatively soon
after EU marketing authorisation approval is an important milestone
toward making this new development in haemophilia B therapy available to
people and families living with haemophilia B,” said Neil Dugdale,
General Manager UK & Republic of Ireland at Sobi.
Alprolix was first approved for the treatment of Haemophilia B in the
USA in March 2014 and in the EU in May 2016.
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About haemophilia B
Haemophilia B is a rare, genetic disorder in which the ability of a
person’s blood to clot is impaired. Haemophilia B occurs in about one in
25,000 male births annually, and more rarely in females. Worldwide, it
is estimated that more than 70,000 people are living with haemophilia.
People with haemophilia B experience prolonged bleeding episodes that
can cause pain, irreversible joint damage and life-threatening
haemorrhages. Prophylactic infusions of factor IX can temporarily
replace the clotting factor that is needed to control bleeding and
prevent new bleeding episodes.[i] (https://teamsites.sobi.com/s/corporate-communications/Shared%20Documents/Press%20releases/044_Alprolix%20reimbursement%20UK/04Xe_Alprolix%20reimbursement%20UK_final.docx#_edn1)
The World Federation of Hemophilia recommends prophylaxis as the optimal
therapy as it can prevent bleedings and joint destruction.[ii] (https://teamsites.sobi.com/s/corporate-communications/Shared%20Documents/Press%20releases/044_Alprolix%20reimbursement%20UK/04Xe_Alprolix%20reimbursement%20UK_final.docx#_edn2)
About Alprolix®
Alprolix® (eftrenonacog alfa) is a recombinant clotting factor therapy
developed for haemophilia B by fusing factor IX to the Fc portion of
immunoglobulin G subclass 1, or IgG1 (a protein commonly found in the
body). This enables Alprolix to use a naturally occurring pathway to
prolong the time the therapy remains in the body. While Fc fusion
technology has been used for more than 15 years, Sobi and Biogen are the
first companies to utilise it in the treatment of haemophilia.
Alprolix is currently approved for the treatment of haemophilia B in the
European Union as well as Iceland, Liechtenstein Norway, the US, Canada,
Japan, Australia and New Zealand. As with any factor replacement
therapy, allergic-type hypersensitivity reactions and development of
inhibitors may occur following administration of Alprolix.
About Sobi™
Sobi is an international specialty healthcare company dedicated to rare
diseases. Sobi’s mission is to develop and deliver innovative therapies
and services to improve the lives of patients. The product portfolio is
primarily focused on Haemophilia, Inflammation and Genetic diseases.
Sobi also markets a portfolio of specialty and rare disease products
across Europe, the Middle East, North Africa and Russia for partner
companies. Sobi is a pioneer in biotechnology with world-class
capabilities in protein biochemistry and biologics manufacturing. In
2015, Sobi had total revenues of SEK 3.2 billion (USD 385 M) and about
700 employees. The share (STO: SOBI) is listed on Nasdaq Stockholm. More
information is available at www.sobi.com.
About the Sobi and Biogen Collaboration
Sobi and Biogen collaborate on the development and commercialisation of
the haemophilia products Elocta and Alprolix. Sobi has final development
and commercialisation rights in the Sobi territory (essentially Europe,
North Africa, Russia and most Middle Eastern markets). Biogen has
manufacturing responsibility for Eloctate® and Alprolix® and has final
development and commercialisation rights in North America and all other
regions in the world excluding the Sobi territory.
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[i] (https://teamsites.sobi.com/s/corporate-communications/Shared%20Documents/Press%20releases/044_Alprolix%20reimbursement%20UK/04Xe_Alprolix%20reimbursement%20UK_final.docx#_ednref1)
World Federation of Hemophilia. About Bleeding Disorders – Frequently
Asked Questions. Available at: https://www.wfh.org/en/page.aspx?pid=637#Difference_A_B.
Accessed on: June 17, 2016.
[ii] (https://teamsites.sobi.com/s/corporate-communications/Shared%20Documents/Press%20releases/044_Alprolix%20reimbursement%20UK/04Xe_Alprolix%20reimbursement%20UK_final.docx#_ednref2)
Guideline for the management of hemophilia, World Federation of
Hemophilia, 2nd edition, https://www1.wfh.org/publication/files/pdf-1472.pdf.
Accessed in December 2015
Swedish Orphan Biovitrum AB
Postal address SE-112 76 Stockholm, Sweden
Phone: +46 8 697 20 00 www.sobi.com
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