Swedish Orphan Biovitrum AB (publ) (Sobi™) (http://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.
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] (http://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] (http://teamsites.sobi.com/s/corporate-communications/Shared%20Documents/Press%20releases/044_Alprolix%20reimbursement%20UK/04Xe_Alprolix%20reimbursement%20UK_final.docx#_edn2)
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.
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.
[i] (http://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: http://www.wfh.org/en/page.aspx?pid=637#Difference_A_B. Accessed on: June 17, 2016.
[ii] (http://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, http://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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Last updated on: 26/09/2016
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