SOURCE: Swedish Orphan Biovitrum AB (publ)

September 23, 2010 02:41 ET

Swedish Orphan Biovitrum's Hemophilia A Therapy Receives European Commission Orphan Drug Designation

STOCKHOLM, SWEDEN--(Marketwire - September 23, 2010) -

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

For more information please contact: Swedish Orphan Biovitrum AB (publ):

Peter Edman, CSO
Phone. +46 8 697 21 77

Erik Kinnman, VP Investor Relations
Phone: +46 73 422 15 40

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.


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Source: Swedish Orphan Biovitrum AB (publ) via Thomson Reuters ONE

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