Swedish Orphan Biovitrum AB (publ) (Sobi) (STO: SOBI) announced today that the
company has decided to exercise its opt-in right to take over final development
and commercialisation of Elocta (rFVIIIFc) for the territory composed of Europe,
North Africa, Russia and most Middle Eastern markets. Elocta/Eloctate(TM) is a
recombinant factor VIII Fc fusion protein product candidate for the treatment of
haemophilia A. Sobi will make a payment to Biogen Idec of USD 10 million, which
will be held in escrow pending the EU regulatory approval of Elocta. Details
about this and other compensation are described in the Collaboration Agreement
"This is an important milestone for Sobi and the result of a strong
collaboration between our two companies," said Geoffrey McDonough, CEO at Sobi.
"Sobi's legacy in haemophilia and rare diseases provides a platform for making
this innovative treatment available for people with haemophilia A in our
Biogen Idec and Sobi are long-time collaborators in the development and
commercialisation of Elocta/Eloctate for haemophilia A. Biogen Idec leads
development for Elocta/Eloctate, has manufacturing rights, and has
commercialisation rights in North America and all other regions excluding the
On 31 October 2014 Sobi and Biogen Idec announced that the European Medicines
Agency (EMA) validated the Marketing Authorisation Application (MAA) for Elocta.
The validation of the MAA initiated the EMA's review process. Elocta is the
European trade name for rFVIIIFc, also known as Eloctate [Antihemophilic Factor
(Recombinant), Fc Fusion Protein] in the U.S., Canada, and Australia, where it
is approved for the treatment of haemophilia A. Elocta/Eloctate is the first
recombinant clotting factor VIII therapy with prolonged circulation to provide
protection from bleeding episodes with the potential for an extended interval
between prophylactic injections.
About Haemophilia A
Haemophilia A is a rare, chronic, genetic disorder in which the ability of a
person's blood to clot is impaired, due to missing or reduced levels of a
protein known as factor VIII. People with haemophilia A experience bleeding
episodes that may cause pain, irreversible joint damage and life-threatening
haemorrhages. The World Federation of Hemophilia global survey conducted in
2012 estimates that approximately 142,000 people worldwide are identified as
living with haemophilia A.
Elocta/Eloctate is an investigational, recombinant clotting factor therapy
developed for haemophilia A by fusing factor VIII to the Fc portion of
immunoglobulin G subclass 1, or IgG1 (a protein commonly found in the body). It
is believed that this enables Elocta/Eloctate to use a naturally occurring
pathway to prolong the time therapy remains in the body. While Fc fusion has
been used for more than 15 years, Biogen Idec is the only company to apply it to
the treatment of haemophilia.
About the Biogen Idec and Sobi Collaboration
To exercise its opt-in right to take over final development and
commercialization of Elocta for its territory, Sobi will now make a payment into
escrow of USD 10 million. Upon EU regulatory approval of Elocta, Sobi will be
liable to repay approximately half of the development and manufacturing costs
for Elocta/Eloctate incurred by Biogen Idec to date (approximately USD 180
million), as well as for additional investments made until Sobi formally assumes
responsibility as the Marketing Authorization Holder for Elocta. Sobi estimates
the total repayment obligation to reach approximately USD 240 million.
The base royalty structure under the agreement states that Sobi will pay Biogen
Idec 12% of direct sales in the Sobi territory, and Biogen Idec will pay Sobi
12% of direct sales in North America and 17% of direct sales in other markets.
For Sobi to meet its repayment obligation, the base royalty structure will be
adjusted during a repayment period beginning at the time of the first commercial
sale in the Sobi territory, with the difference between the base royalties and
the adjusted royalties being credited to Sobi's repayment obligation. According
to the adjusted schedule Sobi will pay Biogen Idec a 17% royalty on direct sales
in the Sobi territory, and Biogen Idec will pay Sobi a 7% royalty on direct
sales in the Biogen Idec North America territory, and up to 12% in other
markets. Upon complete repayment or July 2020, whichever comes sooner, the base
12% cross-royalty structure will apply.
The cross-royalty and collaboration structure is described in detail in the Sobi
press release dated 2012-02-06 "Sobi's agreement with Biogen Idec regarding
long-lasting rFVIIIFc and rFIXFc hemophilia programs".
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 Inflammation and Genetic diseases, with two late stage biological
development projects within Haemophilia. Sobi also markets a portfolio of
specialty and rare disease products for partner companies. Sobi is a pioneer in
biotechnology with world-class capabilities in protein biochemistry and
biologics manufacturing. In 2013, Sobi had total revenues of SEK 2.2 billion
(€253 M) and about 550 employees. The share (STO: SOBI) is listed on NASDAQ OMX
Stockholm. More information is available at www.sobi.com.
For more information please contact
Charlotte af Klercker
T: +46 70 7 297 327
Investor Relations contact:
T: +1 347-224-0819, +1 212-579-0506