Biogen Idec Inc. announced that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for approval of PLEGRIDY(TM) (peginterferon beta-1a), the company's pegylated subcutaneous injectable candidate for relapsing forms of multiple sclerosis (RMS). This regulatory submission was based on the results from the first year of the two-year global Phase 3 ADVANCE study. The data demonstrated that PLEGRIDY met all primary and secondary endpoints by significantly reducing disease activity including relapses, disability progression and brain lesions compared to placebo, and showed favorable safety and tolerability profiles at one year. In addition to the BLA filing with the FDA, Biogen Idec plans to submit a Marketing Authorisation Application (MAA) for PLEGRIDY to the European Medicines Agency (EMA) in the coming weeks.

Biogen Idec Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted the company's Biologics License Application (BLA) for the marketing approval of ELOCTATE (recombinant factor VIII Fc fusion protein) for the treatment of hemophilia A. ELOCTATE is the first hemophilia A product candidate in a new class of long-lasting clotting factor therapies being developed with the goal of providing long-lasting protection and reducing the burden of treatment for patients with this chronic condition. The ELOCTATE BLA was based on results from A-LONG, the large registrational phase 3 clinical study in hemophilia A to date. In the A-LONG study, patients who injected ELOCTATE once-weekly to twice-weekly had low annualized bleeding rates. Prophylaxis in hemophilia A typically requires injections three times per week or every other day to maintain a sufficient circulating level of factor VIII, which prevents debilitating bleeding episodes.

Biogen Idec Inc. reported unaudited consolidated earnings results for the first quarter ended March 31, 2013. The company reported total revenues of $1.4 billion, an increase of 10% compared to $1.3 billion for the first quarter of 2012. Income from operations was $510.5 million against $369.4 million last year. Income before income tax expense and equity in loss of investee, net of tax was $496.1 million against $384.5 million last year. Net income attributable to the company was $426.7 million or $1.79 per diluted share against $302.7 million or $1.25 per diluted share last year. Non-GAAP diluted EPS for the first quarter of 2013 was $1.97, an increase of 41% over $1.40 for the first quarter of 2012. Non-GAAP net income attributable to the company was $469.4 million against $338.4 million last year. Revenue gains were led by the performance of marketed therapies: AVONEX(R) (interferon beta-1a) with revenues increasing 13% year-over-year to $746 million; and TYSABRI(R) (natalizumab) with revenues increasing 9% year-over-year to $312 million. RITUXAN(R) (rituximab) revenues from unconsolidated joint business arrangement were $265 million for the quarter, a decrease of 7% from the prior year. The company updated its full year of 2013 financial guidance. This guidance consists of the following components: revenue growth is expected to be approximately 16% to 18%; tax expense is expected to be approximately 22% to 23% of pretax income; non-GAAP diluted EPS is expected to be between $7.80 and $7.90; GAAP diluted EPS is expected to be between $6.69 and $6.79; capital expenditures are expected to be in the range of $250 million to $270 million. Projected GAAP net income attributable to the company is $1,608 million and non-GAAP net income attributable to the company is $1,872 million.