Product Pipeline

To reinvigorate our research and development organization in 2011, we streamlined our pipeline to eliminate programs that either fell outside of our areas of focus or were no longer competitive. Doing so allowed us to reallocate resources to higher potential programs, aggressively advance our late-stage pipeline and start preparing for the potential launches of BG-12 in MS, our long-acting factor VIII and IX programs for hemophilia and dexpramipexole for ALS.

Our late-stage pipeline advanced substantially in 2011 led by BG-12 and other significant milestones. SELECT, the first of two registrational studies for daclizumab-HYP showed impressive clinical results in 2011 and supported the continuation of the second registrational study, DECIDE. We also completed enrollment for ADVANCE, our phase III study evaluating once monthly subcutaneous PEGylated interferon for relapsing remitting MS, and we completed enrollment for EMPOWER, our first global phase III study of dexpramipexole for the treatment of ALS or Lou Gehrig's Disease. In our hemophilia programs, we anticipate important data readouts in 2012 for ongoing phase III clinical trials of our factor VIII and factor IX product candidates.

In our early-stage pipeline, our anti-LINGO program, which could potentially reverse the damage caused by MS, as well as our anti-TWEAK program for lupus nephritis, are advancing into phase II studies. In 2012, we will continue to work to strengthen our pipeline through internal research and also through strategic collaborations.

  Phase 1 Phase 2 Phase 3 Filing Approved
AVONEX (INTERFERON BETA-1A)
Multiple Sclerosis, Relapsing-Remitting

AVONEX (Interferon beta-1a) is a leading therapeutic for relapsing forms of MS to slow the progression of disability and reduce relapses. AVONEX is also approved for patients who have their first clinical MS attack and have a brain MRI scan consistent with MS.

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TYSABRI (NATALIZUMAB)
Multiple Sclerosis, Relapsing-Remitting

TYSABRI is being developed and co-marketed under a collaboration agreement with Elan.

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TYSABRI (NATALIZUMAB)
Crohn's Disease (U.S.)

TYSABRI is being developed and co-marketed under a collaboration agreement with Elan.

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RITUXAN (RITUXIMAB)
Non-Hodgkin's Lymphoma

RITUXAN is being developed and co-marketed under a collaboration agreement with Genentech, a wholly-owned member of the Roche Group.

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RITUXAN (RITUXIMAB)
ANCA-Associated Vasculitis

RITUXAN (Rituximab) is in development for the treatment of ANCA Associated Vasculitis, and is not currently approved for this indication. RITUXAN is being developed and co-marketed under a collaboration agreement with Genentech, a wholly-owned member of the Roche Group.

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RITUXAN (RITUXIMAB)
Anti-TNF Refractory Rheumatoid Arthritis

RITUXAN is being developed and co-marketed under a collaboration agreement with Genentech, a wholly-owned member of the Roche Group.

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RITUXAN (RITUXIMAB)
Chronic Lymphocytic Leukemia

RITUXAN is being developed and co-marketed under a collaboration agreement with Genentech, a wholly-owned member of the Roche Group.

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FUMADERM (FUMARIC ACID ESTERS)
Psoriasis (Germany)

FUMADERM is an oral product containing fumaric acid esters, and was approved in Germany in 1994 for treatment of severe psoriasis. Acquired with the Fumapharm purchase.

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FAMPYRA (PROLONGED-RELEASE FAMPRIDINE TABLETS)
Multiple Sclerosis (Walking Ability)

FAMPYRA is an investigational oral, prolonged-release formulation of 4-aminopyridine, that has been developed to improve walking ability in adult patients with multiple sclerosis (MS). Studies have shown that fampridine can increase conduction velocity along damaged nerves, which may result in improved neurological function. This compound is approved in the US (where it is known as AMPYRA) and is being commercialized outside of the US by Biogen Idec under a licensing agreement with Acorda Therapeutics.

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BG-12 (DIMETHYL FUMARATE)
Multiple Sclerosis, Relapsing Forms

Small molecule immune modulator, oral formation. Acquired with Fumapharm purchase.

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PEG IFN (PEGYLATED INTERFERON BETA-1A)
Multiple Sclerosis, Relapsing Forms

PEGylated Interferon beta-1a is a chemically modified version of interferon beta-1a, designed to increase half-life and systemic exposure of the protein.

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DACLIZUMAB
Multiple Sclerosis, Relapsing Forms

Humanized antibody specific for IL2 receptor. Daclizumab is being developed under a collaboration agreement with Abbott Biotherapeutics.

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Long-lasting factor IX fusion protein for the treatment of hemophilia B. Acquired with Syntonix transaction. Biogen Idec and Swedish Orphan Biovitrum are working in collaboration on co-development.

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Long-lasting factor VIII fusion protein for the treatment of hemophilia A. Acquired with Syntonix transaction. Biogen Idec and Swedish Orphan Biovitrum are working in collaboration on co-development.

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GA101 (HUMANIZED ANTI-CD20 MAB)
Chronic Lymphocytic Leukemia

Humanized monoclonal antibody specific for CD20. Humanized anti-CD20 mAb is being developed under a collaboration agreement with Genentech, a wholly-owned member of the Roche Group.

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GA101 (HUMANIZED ANTI-CD20 MAB)
Non-Hodgkin's Lymphoma

Humanized monoclonal antibody specific for CD20. Humanized anti-CD20 mAb is being developed under a collaboration agreement with Genentech, a wholly-owned member of the Roche Group.

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DEXPRAMIPEXOLE
Amyotrophic Lateral Sclerosis

Novel oral neuroprotective therapy. Dexpramipexole is being developed under a licensing agreement with Knopp Biosciences.

X X X    
TYSABRI (NATALIZUMAB)
Secondary-Progressive MS

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OCRELIZUMAB (HUMANIZED ANTI-CD20 MAB)
Multiple Sclerosis, Relapsing-Remitting

Humanized monoclonal antibody specific for CD20. Humanized anti-CD20 mAb is being developed under a collaboration agreement with Genentech, a wholly-owned member of the Roche Group.

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ANTI-TWEAK
Lupus Nephritis

Humanized monoclonal antibody specific for TWEAK.

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Anti-LINGO
Multiple Sclerosis

Anti-LINGO 1 is being investigated for use in multiple sclerosis.

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Neublastin
Neuropathic Pain

Neublastin is being investigated for use in neuropathic pain.

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CD40L
Systemic Lupus Erythematosus

CD40L is being investigated for use in systemic lupus erythematosus.

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BART is being investigated for use in Alzheimer's disease.

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SMN
Spinal Muscular Atrophy

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STX-100
Idiopathic Pulmonary Fibrosis

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Syk inhibitor
Rheumatoid Arthritis

 

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