Swedish Orphan Biovitrum's Hemophilia A Therapy Receives European Commission Orphan Drug Designation
Stockholm, Sweden - September 23, 2010 - Swedish Orphan Biovitrum (STO:SOBI)
today announced that the European Commission has granted orphan drug designation
to its long-lasting, fully-recombinant Factor FVIII Fc fusion protein
(rFVIIIFc), which is partnered with Biogen Idec (NASDAQ: BIIB). It was recently
announced that the companies plan to advance the rFVIIIFc program into a
registrational clinical trial in patients with severe hemophilia A.
Treatment of severe hemophilia A requires frequent infusions, creating a
significant burden for individuals with the condition. The rFVIIIFc molecule,
which is based on Biogen Idec's novel and proprietary monomeric Fc-fusion
technology, is being investigated for the potential to prolong protection from
bleeding and reduce the frequency of injections for both prophylaxis and
on-demand therapy in hemophilia A.
"The orphan drug designation is very valuable for our promising and
high-opportunity rFVIIIFc project as it allows European Medicine Agency fee
reduction, protocol scientific advice, and gives market exclusivity once the
product is approved and receives orphan status. This will help us in our efforts
to bring this innovative rFVIIIFc product to hemophilia patients," said Peter
Edman, Ph.D., Chief Scientific Officer of Swedish Orphan Biovitrum.
About Hemophilia A
Hemophilia A is a rare, inherited disorder in which the ability of a person's
blood to clot is impaired. Hemophilia A occurs in about 1 in 10,000 male births
annually and is caused by having substantially reduced or no factor VIII
protein, which is needed for normal blood clotting. People with hemophilia A
therefore need injections of factor VIII to restore the coagulation process and
prevent frequent bleeds that could otherwise lead to pain, irreversible joint
damage and life-threatening hemorrhages. Prophylaxis treatment with infusions
three times per week or every second day to maintain a sufficient circulating
level of coagulation factor is being increasingly used, and long-term studies
demonstrate that such regimens increase the patient's life expectancy and
greatly reduce if not eliminate progressive joint deterioration. The current
global market for recombinant Factor VIII products exceeds 4 BUSD annually.
About Swedish Orphan Biovitrum
Swedish Orphan Biovitrum is a Swedish based niche specialty pharmaceutical
company with an international market presence. The company is focused on
providing and developing specialist pharmaceuticals for rare disease patients
with high medical needs. The portfolio consists of about 60 marketed products
and an emerging late stage clinical development pipe-line. Our focus areas are:
hemophilia, inflammation/autoimmune diseases, fat malabsorption, cancer
supportive care and inherited metabolic disorders. Swedish Orphan Biovitrum had
pro-forma revenues 2009e of about 2 BSEK and approximately 500 employees. The
head office is located in Sweden and the share (STO: SOBI) is listed on NASDAQ
OMX Stockholm. For more information please visitwww.sobi.com.
For more information please contact: Swedish Orphan Biovitrum AB (publ):
Peter Edman, CSO
Phone. +46 8 697 21 77
E-mail:peter.edman@sobi.com
Erik Kinnman, VP Investor Relations
Phone: +46 73 422 15 40
E-mail:erik.kinnman@sobi.com
Swedish Orphan Biovitrum may be required to disclose the information provided
herein pursuant to the Swedish Securities Markets Act. The information was
provided for public release on September 23, 2010 at 8:30 a.m. CET.