Key Developments: Biogen Idec Inc (BIIB.O)
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21 May 2013
$6.15 (+2.73%)
$226.85
$226.17
$234.20
$226.00
1,364,463
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$234.46
$126.39
Latest Key Developments (Source: Significant Developments)
Biogen Idec Inc Submits Application To FDA For Approval Of Plegridy (Peginterferon Beta-1A) In Multiple Sclerosis
Biogen Idec Inc announced it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for approval of PLEGRIDY (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. The Company anticipates hearing from regulatory authorities regarding the status and acceptance of these submissions within the next couple of months. Full Article
FDA Accepts Biogen Idec Inc's Biologics License Application For First Long-Lasting Factor VIII Therapy For Hemophilia A
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. ELOCTATE is a clotting factor developed using Biogen Idec`s novel and proprietary monomeric Fc fusion technology, which makes use of a naturally occurring pathway to delay the destruction of factor and cycles it back into the bloodstream, resulting in a longer circulating half-life. Full Article
Biogen Idec Inc Raises FY 2013 Guidance
Biogen Idec Inc updated its fiscal 2013 financial guidance. For fiscal 2013, the Company expects revenue growth to be approximately 16% to 18%, non-GAAP diluted EPS to be between $7.80 and $7.90 and GAAP diluted EPS to be between $6.69 and $6.79. The Company reported revenues of $5.5 billion in fiscal 2012. According to I/B/E/S Estimates, analysts on an average were expecting the Company to report revenue of $6.4 billion and EPS of $7.81 for fiscal 2013. Full Article
Biogen Idec Inc's Biogen Idec Canada Secures Approval For TECFIDERA As First-Line Oral Treatment For Multiple Sclerosis From Health Canada
Biogen Idec Inc's Canadian affiliate, Biogen Idec Canada announced the Health Canada approval of TECFIDERA (dimethyl fumarate) delayed-release capsules, formerly BG-12, as a first-line oral treatment for adults with relapsing-remitting multiple sclerosis (RRMS). TECFIDERA is indicated as monotherapy for the treatment of RRMS to reduce the frequency of clinical exacerbations and to delay the progression of disability. Findings from both Phase III two-year studies, DEFINE and CONFIRM, showed that TECFIDERA demonstrated robust clinical and radiological efficacy over time in a broad range of patients with RRMS, while maintaining consistently favourable safety and tolerability. Full Article
Elan Corporation PLC Closes TYSABRI Collaboration Transaction With Biogen Idec Inc
Elan Corporation PLC announced the closing of the TYSABRI (natalizumab) Collaboration Transaction with Biogen Idec. The agreement was announced on February 6, 2013. Under the terms of the agreement, Elan has received $3.25 billion in cash and will receive double digit tiered royalty payments, on all indications, for the life of the complete TYSABRI asset. For the first twelve months Elan will receive 12% royalties on in-market sales of TYSABRI, and thereafter, Elan will receive 18% royalties on in-market sales up to $2 billion and 25% royalties on in-market sales exceeding $2 billion. In 2012, in-market sales of TYSABRI were $1.6 billion. Full Article
Biogen Idec Inc Completes Purchase Of Full Rights And Control Of TYSABRI
Biogen Idec Inc announced that it has completed its purchase of Elan Corporation's interest in TYSABRI (natalizumab) and has gained full strategic, commercial and decision-making rights to TYSABRI. The transaction was originally announced on February 6, 2013. Full Article
US Patent Office Grants Patent Claiming Dosing Regimen For TECFIDERA To Biogen Idec Inc
Biogen Idec Inc announced that the U.S. Patent and Trademark Office (USPTO) has granted U.S. Patent No. 8,399,514, which offers additional protection for TECFIDERA (dimethyl fumarate), the Company's oral therapeutic candidate for the treatment of multiple sclerosis (MS). The patent, which will expire in 2028, covers the dosing regimen of daily administration of 480 mg of TECFIDERA. This regimen is included in the proposed marketing application for TECFIDERA, which is currently under review by the U.S. Food and Drug Administration (FDA). Full Article
Biogen Idec Inc And Elan Corporation, plc Announces Results From Several Studies Of TYSABRI
Biogen Idec Inc and Elan Corporation, plc announced results from several studies of TYSABRI (natalizumab) that demonstrate its efficacy compared to other multiple sclerosis (MS) treatments, provide additional data supporting anti-JC virus (JCV) antibody status stability, and suggest better outcomes when progressive multifocal leukoencephalopathy (PML) is detected early. These data will be presented at the 65th Annual Meeting of the American Academy of Neurology (AAN) in San Diego. The results indicate that relapses were not only more likely to occur in patients taking IFN and GA, but that they occurred more quickly, when compared to patients taking TYSABRI (hazard ratio 2.73, 95% confidence interval 2.10-3.55, p<0.001). An analysis of data from the longitudinal, observational U.S. study of TYSABRI-treated patients, STRATIFY-1, demonstrates that anti-JCV antibody status remained consistent in 90% of the study population when tested every six months over an 18-month period. Approximately 38% of patients tested consistently negative and 52% tested consistently positive. Results from Biogen Idec’s ongoing research into PML, an infrequent but serious brain infection, suggest that TYSABRI-treated patients who develop PML and are asymptomatic at time of diagnosis may have improved survival and less functional disability compared with patients who are diagnosed when symptomatic. Full Article
Swedish Orphan Biovitrum AB and Biogen Idec Inc Announce New Phase 3 Data Reinforcing Long-Lasting Protection from Bleeding for Patients with Hemophilia A and B
Swedish Orphan Biovitrum AB announced that Biogen Idec Inc and Swedish Orphan Biovitrum (Sobi) released data that confirmed the ability of investigational recombinant factors VIII Fc fusion protein (rFVIIIFc) and IX Fc fusion protein (rFIXFc) to provide long-lasting protection from bleeding with fewer injections than are required with the current standard of care for people with hemophilia. Phase 3 registrational studies compared the pharmacokinetic activity of rFVIIIFc for hemophilia A and rFIXFc for hemophilia B to available treatments. In the studies, the long-lasting candidates stayed active in the body longer, enabling study participants to prevent bleeding with less frequent injections than are required with the current standard of care. In the A-LONG study, patients with hemophilia A were able to use once to twice weekly prophylactic (preventative dosing) injections of rFVIIIFc while maintaining low bleeding rates. In the B-LONG study, rFIXFc allowed patients with hemophilia B to use prophylactic injections every one to two weeks with low bleeding rates. Recombinant FVIIIFc and recombinant FIXFc were developed using Fc fusion technology, which has safely been used in FDA-approved medicines for over a decade. Biogen Idec and Swedish Orphan Biovitrum applied Fc fusion technology in hemophilia for the first time with the goal of making clotting factors last longer and reduce the burden of injections for patients and their families. Full Article
Biogen Idec Inc To Acquire Full Rights And Control of TYSABRI From Elan For Upfront Cash and Contingent Payments
Biogen Idec Inc announced that it has agreed to purchase Elan’s interest in TYSABRI (natalizumab) and upon closing will gain full strategic, commercial and decision making rights to TYSABRI. Upon the closing of the transaction, the previous collaboration agreement between the companies, whereby worldwide TYSABRI profits were split 50:50, will be terminated along with the agreement’s change of control provisions. Under the terms of the agreement, Biogen Idec will use its existing cash reserves to make a payment of $3.25 billion to Elan upon the closing of the transaction and make future contingent payments to Elan in an amount equal to 12% of global net sales of TYSABRI for the first twelve months, and thereafter, Biogen Idec will continue to make contingent payments of 18% on annual global net sales of TYSABRI up to $2.0 billion and 25% on annual global net sales that exceed $2.0 billion. In 2014 only, the $2.0 billion threshold will be pro-rated for the portion of 2014 remaining after the first 12 months expires. Biogen Idec anticipates the transaction will be approximately $0.20 to $0.30 accretive to 2013 GAAP earnings per share and $0.50 to $0.60 accretive to non-GAAP earnings per share, and will continue to be accretive thereafter, depending on the sales trajectory of TYSABRI. Full Article
Biogen profit beats estimates, raises 2013 forecast
- Biogen Idec Inc reported higher-than-expected first quarter profit on Thursday and raised its full year forecasts, and the U.S. biotechnology said it sees its new drug Tecfidera becoming the leading oral medicine for multiple sclerosis.
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