COMP recommends that Alprolix® maintains orphan designation for treatment of haemophilia B
(Thomson Reuters ONE) -
Swedish Orphan Biovitrum AB (publ) (Sobi(TM)) (STO:SOBI) and collaboration
partner Biogen have received a positive opinion from the Committee for Orphan
Medicinal Products (COMP) of the European Medicines Agency (EMA) recommending
the European Commission (EC) to maintain the orphan designation for Alprolix®
(eftrenonacog alfa), a recombinant factor IX Fc fusion protein therapy for the
treatment of haemophilia B. The COMP's recommendation is now referred to the EC
which is responsible for granting marketing authorisation for medicines in the
EU.
An application for marketing authorisation was submitted to EMA in June 2015. In
February 2016, Sobi and Biogen received a positive opinion from the Committee
for Medicinal Products for Human Use (CHMP) of EMA for Alprolix. If approved and
the orphan designation is confirmed, Alprolix will remain on the Community
Register of Orphan Medicinal Products and receive orphan designation.
---
About orphan designation
To be granted orphan designation in the EU, the new medicine must be for the
treatment of a life-threatening or chronically debilitating condition that
affects no more than five in 10,000 people in the EU and for which no
satisfactory treatments exist or, where they do exist, the new medicine will be
of significant benefit to those affected by that condition. It can also be
granted if a new medicine is not expected to make a sufficient return to justify
the investment. A confirmed designation as an orphan medicinal product within EU
may confer benefits to the product, including a 10-year period of market
exclusivity from similar products following marketing authorisation.
About Haemophilia B
Haemophilia B is caused by having substantially reduced or no factor IX
activity, which is needed for normal blood clotting.[1] The World Federation of
Hemophilia estimates that approximately 28,000 people are currently diagnosed
with haemophilia B worldwide.[2]
People with haemophilia B may experience bleeding episodes in joints and muscles
that cause pain, decreased mobility and irreversible joint damage. In the worst
cases, these bleeding episodes can cause organ bleeds and life-threatening
haemorrhages. Infusions of factor IX temporarily replace clotting factors
necessary to resolve bleeding and, when used prophylactically, to prevent new
bleeding episodes.(1)
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 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 U.S.,
Canada, Japan, Australia and New Zealand, where it was the first haemophilia B
therapy approved to provide prolonged protection from bleeds. As with any
infused protein, allergic type hypersensitivity reactions and development of
inhibitors may occur following administration of Alprolix.
Sobi and Biogen are collaboration partners in the development and
commercialisation of Alprolix for haemophilia B. Sobi has final development and
commercialisation rights in the Sobi territory, essentially Europe, North
Africa, Russia and most Middle Eastern markets. Biogen leads development and
manufacturing for Alprolix and has commercialisation rights in North America and
all other regions in the world excluding the Sobi territory.
About Sobi(TM)
Sobi(TM) is an international speciality healthcare company dedicated to rare
diseases. Our mission is to develop and deliver innovative therapies and
services to improve the lives of patients. The product portfolio is primary
focused on Haemophilia, Inflammation and Genetic diseases. We also market a
portfolio of speciality and rare disease products for partner companies across
Europe, the Middle East, North Africa and Russia. 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 approximately 700 employees. The share (STO:SOBI) is listed on
NASDAQ OMX Stockholm. More information is available at www.sobi.com.
For more information please contact
Media relations Investor relations
Oskar Bosson, Head of Jörgen Winroth, Vice President, Head of Investor
Communications Relations
+46 70 410 71 80 +1 347-224-0819, +1 212-579-0506, +46 8 697 2135
oskar.bosson(at)sobi.com jorgen.winroth(at)sobi.com
--------------------------------------------------------------------------------
[1] 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: February 11, 2016
[2] World Federation of Hemophilia. Report on the Annual Global Survey 2013.
Available at: http://www1.wfh.org/publications/files/pdf-1591.pdf. Accessed on:
February 11, 2016.
014e_Alprolix COMP:
http://hugin.info/134557/R/2002181/738833.pdf
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Source: Swedish Orphan Biovitrum AB (publ) via GlobeNewswire
[HUG#2002181]
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Datum: 11.04.2016 - 08:00 Uhr
Sprache: Deutsch
News-ID 462984
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