07.21.14
Headquarters: Cambridge, MA
twitter.com/biogenidec
www.biogenidec.com
Top Selling Drugs
Fast growing Biogen Idec made major headway in 2013, advancing its most promising pipeline candidates and establishing a dominant position in the MS market. In looking at the snowballing numbers, revenues climbed 26% to $6.9 billion powered by sales of new multiple sclerosis (MS) drug, Tecfidera, with sales of $876 million for the year (and a whopping $506 million in 1Q14), along with Tysabri, up 34% to $1.5 billion as a result of recording 100% of revenues after gaining full rights from Elan.
To top it off, the EMA’s Committee for Medicinal Products for Human Use (CHMP) determined that dimethyl fumarate in Tecfidera qualifies as a new active substance (NAS), a designation that provides 10 years of regulatory exclusivity in the EU. Moreover, Elan and Biogen secured additional patent protection on Tysabri, taking exclusivity out to 2020 from 2017.
Hemophilia Wins, Tecfidera Drove Success Last Year
Several big wins for Biogen’s hemophilia assets and Tecfidera drove success in 2013. Eloctate just recently received FDA approval for the control and prevention of bleeding episodes in hemophilia A. Extending the interval between infusions, Eloctate is the first recombinant hemophilia A therapy with prolonged circulation in the body, and the only treatment to reduce the frequency of bleeding episodes. The drug entered a $6 billion hemophilia A market—six times larger than that of hemophilia B treatments—with a survey of analysts by Reuters estimating an average peak sales forecast of $1.5 billion.
Likewise, Alprolix, the first recombinant DNA derived hemophilia B therapy with prolonged circulation in the body, was also approved (U.S. and Canada), marking a significant advance in treatments in more than 17 years. The therapy is shown to reduce bleeding episodes with protective infusions starting at least a week apart.
The hemophilia wins follow the landmark approval for Tecfidera, which has emerged as a new standard therapy. This past February the drug was approved in the EU as a first-line oral treatment in relapsing-remitting multiple sclerosis (RRMS). The drug was first approved in the U.S. in March 2013 and became the number one prescribed oral therapy for relapsing forms of MS after six months, indicating blockbuster potential. Tecfidera was also approved in Canada and Australia in 2013.
Additionally, the EMA issued a positive opinion for Plegridy, a pegylated interferon with extended half-life and prolonged exposure in the body, for adults with RRMS—a decision is expected in the coming months. All of these aforementioned therapies, and then some, will be made available throughout Asia under an exclusive agreement with UCB, leveraging its resources in the region.
Beyond these therapeutic areas, Biogen has several R&D collaborations underway in neurological diseases. Eisai and Biogen entered an Alzheimer’s drug development pact for two of Eisai’s Phase II candidates, E2609 and BAN2401, and two of Biogen’s AD candidates, an anti-amyloid beta (A) antibody BIIB037 and an anti-tau monoclonal antibody. Eisai’s candidates have shown potential to reduce A plaques that form in the brain and to stop the formation of new ones. Should they gain approval in the U.S. and the EU, both companies will promote the products.
Technology Platforms
Biogen also entered into a couple of technology platform pacts with Isis and Sangamo BioSciences, each with potential R&D spend of $320 million. The Isis alliance aims to advance therapies for neurological diseases using Isis’ antisense technology, and the Sangamo alliance, to develop treatments targeting sickle cell disease (SCD) and beta-thalassemia using Sangamo’s zinc finger nuclease (ZFN) genome-editing technology platform. Under each, Biogen will be responsible development and commercialization of any resulting products.
Also, as part of its corporate objective to leverage its manufacturing expertise for biosimilar therapies, Biogen, through its joint venture with Samsung Bioepis, took the deal to the next level, exercising its right to commercialize anti-TNF biosimilar product candidates in Europe, which includes widely used therapies to treat rheumatoid arthritis and Crohn’s disease (most likely Johnson & Johnson’s Remicade and Amgen’s Enbrel). Europe is seen as one of the most accessible markets for biosimilars since their regulatory pathway has been in place since 2005.
Coming off a great year, 2014 promises to bring even greater financial success for the burgeoning biopharma, barring any deleterious side effects for new products. It’s what’s in the pipeline that draws future concern. Alzheimer’s drug development has proven elusive so far, meeting many failures along the way. Let’s hope one of the four candidates that are now in development with Eisai, succeeds for the sake of many.
twitter.com/biogenidec
www.biogenidec.com
Headcount: | 5,950 | |
Year Established: | 2003 | |
Biopharma Revenues: | $5,542 | 33% |
Total Revenues: | $6,932 | 26% |
Net Income: | $1,862 | 35% |
R&D Budget: | $1,444 | 8% |
Top Selling Drugs
Drug | Indication | 2013 Sales | (+/- %) |
Avonex | multiple sclerosis | $3,005 | 3% |
Tysabri | multiple sclerosis | $1,526 | 34% |
Rituxan | NHL | $1,100 | -1% |
Tecfidera | multiple sclerosis | $876 | N/A |
Fast growing Biogen Idec made major headway in 2013, advancing its most promising pipeline candidates and establishing a dominant position in the MS market. In looking at the snowballing numbers, revenues climbed 26% to $6.9 billion powered by sales of new multiple sclerosis (MS) drug, Tecfidera, with sales of $876 million for the year (and a whopping $506 million in 1Q14), along with Tysabri, up 34% to $1.5 billion as a result of recording 100% of revenues after gaining full rights from Elan.
To top it off, the EMA’s Committee for Medicinal Products for Human Use (CHMP) determined that dimethyl fumarate in Tecfidera qualifies as a new active substance (NAS), a designation that provides 10 years of regulatory exclusivity in the EU. Moreover, Elan and Biogen secured additional patent protection on Tysabri, taking exclusivity out to 2020 from 2017.
Hemophilia Wins, Tecfidera Drove Success Last Year
Several big wins for Biogen’s hemophilia assets and Tecfidera drove success in 2013. Eloctate just recently received FDA approval for the control and prevention of bleeding episodes in hemophilia A. Extending the interval between infusions, Eloctate is the first recombinant hemophilia A therapy with prolonged circulation in the body, and the only treatment to reduce the frequency of bleeding episodes. The drug entered a $6 billion hemophilia A market—six times larger than that of hemophilia B treatments—with a survey of analysts by Reuters estimating an average peak sales forecast of $1.5 billion.
Likewise, Alprolix, the first recombinant DNA derived hemophilia B therapy with prolonged circulation in the body, was also approved (U.S. and Canada), marking a significant advance in treatments in more than 17 years. The therapy is shown to reduce bleeding episodes with protective infusions starting at least a week apart.
The hemophilia wins follow the landmark approval for Tecfidera, which has emerged as a new standard therapy. This past February the drug was approved in the EU as a first-line oral treatment in relapsing-remitting multiple sclerosis (RRMS). The drug was first approved in the U.S. in March 2013 and became the number one prescribed oral therapy for relapsing forms of MS after six months, indicating blockbuster potential. Tecfidera was also approved in Canada and Australia in 2013.
Additionally, the EMA issued a positive opinion for Plegridy, a pegylated interferon with extended half-life and prolonged exposure in the body, for adults with RRMS—a decision is expected in the coming months. All of these aforementioned therapies, and then some, will be made available throughout Asia under an exclusive agreement with UCB, leveraging its resources in the region.
Beyond these therapeutic areas, Biogen has several R&D collaborations underway in neurological diseases. Eisai and Biogen entered an Alzheimer’s drug development pact for two of Eisai’s Phase II candidates, E2609 and BAN2401, and two of Biogen’s AD candidates, an anti-amyloid beta (A) antibody BIIB037 and an anti-tau monoclonal antibody. Eisai’s candidates have shown potential to reduce A plaques that form in the brain and to stop the formation of new ones. Should they gain approval in the U.S. and the EU, both companies will promote the products.
Technology Platforms
Biogen also entered into a couple of technology platform pacts with Isis and Sangamo BioSciences, each with potential R&D spend of $320 million. The Isis alliance aims to advance therapies for neurological diseases using Isis’ antisense technology, and the Sangamo alliance, to develop treatments targeting sickle cell disease (SCD) and beta-thalassemia using Sangamo’s zinc finger nuclease (ZFN) genome-editing technology platform. Under each, Biogen will be responsible development and commercialization of any resulting products.
Also, as part of its corporate objective to leverage its manufacturing expertise for biosimilar therapies, Biogen, through its joint venture with Samsung Bioepis, took the deal to the next level, exercising its right to commercialize anti-TNF biosimilar product candidates in Europe, which includes widely used therapies to treat rheumatoid arthritis and Crohn’s disease (most likely Johnson & Johnson’s Remicade and Amgen’s Enbrel). Europe is seen as one of the most accessible markets for biosimilars since their regulatory pathway has been in place since 2005.
Coming off a great year, 2014 promises to bring even greater financial success for the burgeoning biopharma, barring any deleterious side effects for new products. It’s what’s in the pipeline that draws future concern. Alzheimer’s drug development has proven elusive so far, meeting many failures along the way. Let’s hope one of the four candidates that are now in development with Eisai, succeeds for the sake of many.