Biogen Idec and Sobi announce European Medicines Agency validates Elocta(TM) (rFVIIIFc) Marketing Authorisation Application for review - Seite 2

About the A-LONG Clinical Study 
The Phase 3 A-LONG clinical study was an open-label, multi-center study involving 165 previously treated males 12 years of age and older with severe haemophilia A. The study evaluated individualized and weekly prophylaxis to reduce or prevent bleeding episodes, and on-demand dosing to treat bleeding episodes. In the individualized arm, each study participant started on a twice-weekly dosing regimen. Participants' pharmacokinetic parameters were used to guide adjustments to dosing interval (every three to five days), and dose (25 to 65 IU/kg) to target a minimum factor VIII level of 1 to 3 IU/dL or higher as needed to prevent and control breakthrough bleeding episodes. In the study, the dose in the weekly prophylaxis arm was 65 IU/ kg/week.

About the Kids A-LONG Clinical Study
The Kids A-LONG study is the first clinical study to evaluate an investigational haemophilia therapy with a prolonged half-life in children younger than 12 years of age. The study was a global, open-label, multi-center Phase 3 study involving 71 boys with severe haemophilia A with at least 50 prior exposure days to factor VIII therapies.

Participants in both the A-LONG and Kids A-LONG clinical trials were able to enroll in ASPIRE, a long-term extension clinical study evaluating the safety and efficacy of Eloctate. For more information about these studies, please visit www.biogenidec.com.

About Elocta
Elocta 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 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 Biogen Idec
Through cutting-edge science and medicine, Biogen Idec discovers, develops and delivers to patients worldwide innovative therapies for the treatment of neurodegenerative diseases, hematologic conditions and autoimmune disorders. Founded in 1978, Biogen Idec is the world's oldest independent biotechnology company and patients worldwide benefit from its leading multiple sclerosis and innovative haemophilia therapies. For product labeling, press releases and additional information about the Company, please visit www.biogenidec.com.