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Biogen Inc   (BIIB)
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    Sector  Healthcare    Industry Biotechnology & Drugs
   Industry Biotechnology & Drugs
   Sector  Healthcare
 


Biogen Inc Segments

 
AVONEX
   29.25 % of total Revenue
TYSABRI
   22.02 % of total Revenue
PLEGRIDY
   3.54 % of total Revenue
Other
   -3.94 % of total Revenue
FAMPYRA
   1 % of total Revenue
TECFIDERA
   42 % of total Revenue
ALPROLIX
   2.59 % of total Revenue
ELOCTATE
   3.53 % of total Revenue
 

Business Segments (June 30. 2015)
Revenues
(in millions $)
II. Quarter
%
(of total Revenues)
(June 30. 2015)
Income
(in millions $)
II. Quarter
%
(Profit Margin)
AVONEX
615.20 29.25 % 0.00 -
TYSABRI
463.10 22.02 % 0.00 -
PLEGRIDY
74.50 3.54 % 0.00 -
Other
-82.90 -3.94 % 0.00 -
FAMPYRA
21.10 1 % 0.00 -
TECFIDERA
883.30 42 % 0.00 -
ALPROLIX
54.40 2.59 % 0.00 -
ELOCTATE
74.30 3.53 % 0.00 -
Total
2,103.00 100 % 0.00 -

• View Income Statement • View Competition by Segment • View Annual Report

Growth rates by Segment (June 30. 2015)
Y/Y Revenue
%
II. Quarter
Q/Q Revenue
%
(June 30. 2015)
Y/Y Income
%
II. Quarter
Q/Q Income
%
AVONEX
-20.5 % -11.19 % - -
TYSABRI
-13.18 % 0.11 % - -
PLEGRIDY
- 20.55 % - -
Other
- - - -
FAMPYRA
-5.38 % 5.5 % - -
TECFIDERA
26.11 % 7.08 % - -
ALPROLIX
423.08 % 26.22 % - -
ELOCTATE
- 38.62 % - -
Total
2.27 % 0.6 % - -

• View Growth rates • View Competitors Segment Growth • View Market Share

To get more information on Biogen Inc 's AVONEX, TYSABRI, PLEGRIDY, Other, FAMPYRA, TECFIDERA, ALPROLIX, ELOCTATE, Total segment. Select each division with the arrow.

  Biogen Inc 's

Business Segments Description



AVONEX

We currently market and sell AVONEX worldwide for the treatment of relapsing MS.

MS is a progressive neurological disease in which the body loses the ability to transmit messages along nerve cells, leading to a loss of muscle control, paralysis and, in some cases, death. Patients with active relapsing MS experience an uneven pattern of disease progression characterized by periods of stability interrupted by flare-ups of the disease after which the patient returns to a new baseline of functioning. AVONEX is a recombinant form of a protein produced in the body by fibroblast cells in response to viral infection. AVONEX has been shown in clinical trials in relapsing forms of MS both to slow the accumulation of disability and to reduce the frequency of flare-ups. AVONEX is approved to treat relapsing forms of MS, including MS patients with a first clinical episode and MRI features consistent with MS. Biogen, Inc. began selling AVONEX in the U.S. in 1996, and in the EU in 1997. AVONEX is on the market in more than 60 countries. Based on data from an independent third party research organization, information for our distributors and internal analysis, we believe that AVONEX is the most prescribed therapeutic product for the treatment of MS worldwide. Globally, over 130,000 patients have selected AVONEX as their treatment of choice.

As part of our commitment to AVONEX, we work to make treatment and delivery more convenient. For example, AVONEX is now available in a pre-filled syringe formulation as well as a dry powder form. A syringe grip device to aid patients with compromised manual dexterity in injecting AVONEX was approved by the FDA in 2004.

We also continue to work to expand the data available about AVONEX. We have extended the Controlled High Risk AVONEX Multiple Sclerosis Prevention Study In Ongoing Neurological Surveillance, or CHAMPIONS. CHAMPIONS was originally designed to determine whether the effect of early treatment with AVONEX in delaying relapses and reducing the accumulation of MS brain lesions could be sustained for up to five years. The study results showed that AVONEX altered the long-term course of MS in patients who began treatment immediately after their initial MS attack compared to initiation of treatment more than two years after onset of symptoms. The five-year study extension is intended to determine if the effects of early treatment with AVONEX can be sustained for up to 10 years. We are conducting a study with Surromed, Inc. to investigate the biologic markers and phenotype of MS patients with and without AVONEX treatment. We also continue to support Phase 4 investigator-run studies evaluating AVONEX in combination with other therapies. In addition, we recently initiated enrollment into a Phase 2b study of AVONEX as a treatment for Chronic Inflammatory Demyelinating Polyradioneuropathy.

In February 2005, in consultation with the FDA, we and Elan voluntarily suspended the marketing and commercial distribution of our other MS drug TYSABRI and suspended dosing in all clinical studies of TYSABRI, including clinical studies of TYSABRI in combination with AVONEX. These decisions were based on reports of two serious adverse events that have occurred in patients treated with TYSABRI in combination with AVONEX. These events involved two cases of PML, a rare and frequently fatal, demyelinating disease of the central nervous system. Both patients received more than two years of TYSABRI in combination with AVONEX.

RITUXAN
RITUXAN is a widely prescribed monoclonal antibody therapeutic used to treat non-Hodgkin’s lymphoma, rheumatoid arthritis, chronic lymphocytic leukemia and two forms of ANCA-associated vasculitis. Non-Hodgkin’s lymphoma and chronic lymphocytic leukemia are cancers that affect lymphocytes, which are a type of white blood cell that help to fight infection. Rheumatoid arthritis is a chronic disease that occurs when the immune system mistakenly attacks the body’s joints, resulting in inflammation, pain and joint damage. ANCA-associated vasculitis is a rare autoimmune disease that largely affects the small blood vessels of the kidneys, lungs, sinuses, and a variety of other organs.

We collaborate with Genentech on the development and commercialization of RITUXAN. For information about this collaboration, please read Note 20, Collaborations to our consolidated financial statements included in this report.

TYSABRI

Overview. The FDA granted accelerated approval for TYSABRI in November 2004 to treat relapsing forms of MS to reduce the frequency of clinical relapses. The approval was based on one-year data from two Phase 3 clinical studies: AFFIRM (natalizumab safety and efficacy in relapsing-remitting MS) and SENTINEL (safety and efficacy of natalizumab in combination with AVONEX), each a two-year, randomized multi-center, placebo-controlled and double blinded study. In February 2005, in consultation with the FDA, we and Elan voluntarily suspended the marketing and commercial distribution of TYSABRI, and informed physicians that they should suspend dosing of TYSABRI until further notification. In addition, we suspended dosing in clinical studies of TYSABRI in MS, Crohn’s disease and RA. These decisions were based on reports of two serious adverse events that occurred in patients treated with TYSABRI in combination with AVONEX in MS clinical studies. These events involved two cases (one confirmed and one suspected at the time of the decisions) of PML, a rare and frequently fatal, demyelinating disease of the central nervous system. The suspected case of PML was subsequently confirmed. Both patients received more than two years of TYSABRI therapy in combination with AVONEX. In light of the two reports of PML, the companies initiated a systematic review of the TYSABRI safety database. On March 30, 2005, we and Elan announced that the review of the safety database led a serious adverse event previously reported by a clinical investigator in a clinical study of TYSABRI in Crohn’s disease to be reassessed as PML. The case was originally reported by the investigator as malignant astrocytoma in July 2003. The patient died in December 2003. The patient had received 8 doses of TYSABRI over an 18 month period and prior medication history included multiple courses of immunosuppressant agents. We and Elan are working with clinical investigators to evaluate patients treated with TYSABRI in clinical trials and are consulting with leading experts to better understand the possible risk of PML. The outcome of these evaluations will be used to determine possible re-initiation of dosing in clinical studies and future commercial availability. We cannot predict the outcome of these evaluations.

In June 2004, Elan submitted a Marketing Authorisation Application, or MAA, to the EMEA for approval of TYSABRI in MS. We are working closely with the EMEA in order to provide them with information regarding the status of our evaluation of the possible risk of PML with TYSABRI and any additional information that they may request so that they can conduct a risk/benefit assessment in accordance with regulatory requirements.

TYSABRI binds to adhesion molecules on the immune cell surface known as alpha-4 integrin. Adhesion molecules on the surface of the immune cells play an important role in the migration of the immune cells in the inflammatory process. Research suggests that by binding to alpha-4 integrin, TYSABRI prevents immune cells from migrating from the bloodstream into tissue where they can cause inflammation and potentially damage nerve fibers and their insulation.

PHASE 3 Studies of TYSABRI in MS. Prior to the suspension of dosing in clinical studies of TYSABRI we, along with Elan, had completed the AFFIRM study and had substantially completed the SENTINEL study. The AFFIRM study was designed to evaluate the ability of natalizumab to slow the progression of disability in MS and reduce the rate of clinical relapses. The SENTINEL study was designed to evaluate the effect of the combination of natalizumab and AVONEX compared to treatment with AVONEX alone in slowing progression of disability and reducing the rate of clinical relapses. Both studies have protocols that included a one-year analysis of the data. The one-year data from the AFFIRM study showed that TYSABRI reduced the rate of clinical relapses by 66% relative to placebo, the primary endpoint at one year. AFFIRM also met all one-year secondary endpoints, including MRI measures. In the TYSABRI treated group, 60% of patients developed no new or newly enlarging T2 hyperintense lesions compared to 22% of placebo treated patients. On the one-year MRI scan, 96% of TYSABRI treated patients had no gadolinium enhancing lesions compared to 68% of placebo treated patients. The proportion of patients who remained relapse free was 76% in the TYSABRI treated group compared to 53% in the placebo treated group. The one-year data from the SENTINEL combination study also showed that the study achieved its one-year primary endpoint. The addition of TYSABRI to AVONEX resulted in a 54% reduction in the rate of clinical relapses over the effect of AVONEX alone. The annualized relapse rate was 0.36 for patients receiving TYSABRI when added to AVONEX versus 0.78 with AVONEX plus placebo. SENTINEL also met all secondary endpoints, including MRI measures. In the group treated with TYSABRI plus AVONEX, 67% of the patients developed no new or newly enlarging T2 hyperintense lesions compared to 40% in the AVONEX plus placebo group. On the one-year MRI scan, 96% of TYSABRI plus AVONEX treated patients had no gadolinium enhancing lesions compared to 76% of AVONEX plus placebo treated patients. The proportion of patients who remained relapse free was 67% in the TYSABRI plus AVONEX treated group compared to 46% in the AVONEX plus placebo treated group. In February 2005, we and Elan announced that the AFFIRM study also achieved the two-year primary endpoint of slowing the progression of disability in patients with relapsing forms of MS. In the TYSABRI treated group, there was a 42% reduction in the risk of disability progression relative to placebo, and a 67% reduction in the rate of clinical relapses over two years, which was sustained and consistent with the one-year results.

TYSABRI in Crohn’s Disease. We, along with Elan, have completed two Phase 3 studies of TYSABRI in Crohn’s disease. In February 2005, we suspended dosing in an additional fully enrolled Phase 3 induction study of TYSABRI in Crohn’s disease until we complete our evaluation of the possible risk of PML in patients treated with TYSABRI. On March 30, 2005, we and Elan announced that the review of the safety database led a serious adverse event previously reported by a clinical investigator in a clinical study of TYSABRI in Crohn’s disease to be reassessed as PML. The case was originally reported as malignant astrocytoma. The two completed Phase 3 studies are known as ENACT-2 (Evaluation of Natalizumab as Continuous Therapy-2) and ENACT-1 (Evaluation of Natalizumab as Continuous Therapy-1). In the double-blinded, placebo controlled ENACT-2, 428 patients who were responders in ENACT-1, the Phase 3 induction study, were re-randomized to one of two treatment groups, TYSABRI or placebo, both administered monthly for a total of 12 months. In ENACT-1, the primary endpoint of “response,” as defined by a 70-point decrease in the Crohn’s Disease Activity Index, or CDAI, at week 10, was not met. In ENACT-2, the primary endpoint of “maintenance of response,” as defined by a sustained CDAI score of less than 220 as well as no use of rescue intervention throughout six months of the study, was met. The primary endpoint of ENACT-2 looked at results through month six. Through month six, there was a significant treatment difference of greater than 30% in favor of patients taking TYSABRI compared to those taking placebo. In September 2004, we and Elan announced new 12-month data from ENACT-2 showing a sustained and clinically significant response throughout 12 months of extended TYSABRI infusion therapy, confirming findings in patients who had previously shown a sustained response throughout six months. Maintenance of response was defined by a CDAI score of less than 220, and less than 70-point increase from baseline, in the absence of rescue intervention throughout the study. Response was maintained by 54% of patients treated with natalizumab compared to 20% of those treated with placebo. In addition, 39% of patients on TYSABRI maintained clinical remission during the study period, versus 15% of those on placebo. By the end of month  12, 49% of patients treated with TYSABRI who had previously been treated with corticosteroids were able to withdraw from steroid therapy compared to 20% of placebo-treated patients. In September 2004, Elan submitted an MAA to the EMEA for approval of TYSABRI as a treatment for Crohn’s disease. This application is at an earlier stage than the MS application. However, as with the MAA for MS, we are working closely with the EMEA in order to provide them with information regarding the status of our evaluation of the possible risk of PML with TYSABRI and any additional information that they may request.

TYSABRI in RA. In February 2005, we, along with Elan, suspended dosing in a recently fully enrolled Phase 2 study of TYSABRI in RA until we complete our evaluation of the possible risk of PML in patients treated with TYSABRI. The study is a multi-center, double-blind, placebo-controlled study of the efficacy, safety and tolerability of intravenous TYSABRI in patients with moderate-to-severe RA receiving concomitant treatment with methotrexate.

FAMPYRA
FAMPYRA is the first treatment that addresses the unmet medical need of walking improvement in adult patients with MS who have walking disability. FAMPYRA is a prolonged-release tablet formulation of the drug fampridine. We launched FAMPYRA in Australia, Denmark, Germany, Norway and the U.K. in 2011 and plan to launch in additional markets during 2012. We have a license from Acorda Therapeutics, Inc. to develop and commercialize FAMPYRA in all markets outside the U.S.

   

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