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  • BIIB098 (diroximel fumarate)

    Multiple sclerosis (MS)

    Licensed from Alkermes.

    MS causes the body’s immune system to attack myelin, a protective sheath covering nerve fibers. Damage to myelin “short circuits” communication between the brain, spinal cord and other areas of the body, severely impairing such neurological functions as mobility, vision and thinking. Over time, the nerves themselves can become damaged permanently.

    How this investigational therapy could help:

    Diroximel fumarate (DRF) is an investigational, next-generation, oral fumarate for the treatment of MS and is differentiated from the currently marketed TECFIDERA (dimethyl fumarate) based on its chemical structure. Upon oral administration, DRF is rapidly converted to its active metabolite monomethyl fumarate (MMF). If approved, DRF may potentially offer differentiated gastrointestinal tolerability profile and offer patients with relapsing forms of MS another treatment choice.

  • BIIB067 (tofersen^)

    SOD-1-Amyotrophic lateral sclerosis (ALS)

    Developed in collaboration with Ionis Pharmaceuticals.

    *Option to acquire from Ionis Pharmaceuticals.

    ^Biogen is collaborating with regulators to further define the scope of the clinical data package required to support the registration of BIIB067.

    ALS is a progressive neurodegenerative disease that results in the loss of motor neurons in the brain and the spinal cord. Motor neurons provide the ability to move, speak, swallow, and breathe. As the disease progresses, ALS patients gradually lose these abilities.

    ?

    How this investigational therapy could help:?

    In a rare form of ALS, a mutated protein called superoxide dismutase (SOD1) has been associated with the degeneration of motor neurons. ?SOD1-ALS is the second most common form of inherited or familial ALS, accounting for up to 20 percent of familial ALS and 2 percent of all ALS cases.?

    BIIB067 (tofersen^) is thought to reduce the production of SOD1 protein and is being evaluated to see if it can potentially slow the fatal progression of SOD1-ALS.

  • BIIB093 (glibenclamide IV)

    Large hemispheric infarction

    It is estimated that nearly two million people in the United States and the European Union will have a stroke each year. Stroke is a leading cause of mortality and serious long-term disability. There is a substantial unmet medical need for new therapies that can improve outcomes in acute stroke. The target indication for BIIB093 (glibenclamide IV) is large hemispheric infarction (LHI), a severe form of ischemic stroke where brain swelling (cerebral edema) often leads to a disproportionately large share of stroke-related morbidity and mortality.

    ?

    How this investigational therapy could help:

    In pre-clinical studies, BIIB093 (glibenclamide IV) has been shown to block SUR1-TRPM4 channels that mediate stroke related brain swelling. Clinical proof-of-concept studies have demonstrated the potential of?BIIB093 to reduce brain swelling, disability and the risk of death in patients with LHI.

  • BIIB111 (AAV2-CHM)

    CHM gene therapy

    Choroideremia (CHM) is a rare, inherited, X-linked recessive retinal disease caused by mutations in the CHM gene. The CHM gene encodes Rab-escort protein-1 (REP1), which plays a role in intracellular protein trafficking and the elimination of waste products from retinal cells. The disease primarily affects males and typically presents with night blindness and progressive visual field restriction in late childhood, leading to profound vision loss in men beyond the fourth decade.

    How this investigational therapy could help:

    There are currently no treatments for CHM, which represents a significant unmet medical need. BIIB111 is comprised of an AAV2 vector containing recombinant human DNA that is designed to produce REP1 inside the retinal cells. Delivery of the CHM gene is thought to allow expression of the functional REP1 protein, thereby potentially reducing the accumulation of waste products in the retinal cells and slowing or reversing the early stages of cell death in already damaged retinal cells. BIIB111 is being evaluated to see if it can potentially slow or stop decline in visual acuity due to mutations in the CHM gene.

    Learn more about the clinical trial for BIIB111 for CHM

  • Elenbecestat (E2609)

    Alzheimer's disease

    Developed in collaboration with Eisai Co., Ltd.

    Alzheimer’s disease (AD) is a progressive neurodegenerative disease that damages healthy cells in the brain causing cognitive impairment and functional disability. It is estimated that more than 25 million individuals are living with AD worldwide1.

    Today we understand that AD is a continuum with a long silent phase that begins years before symptoms appear. As AD progresses, symptoms like memory loss, personality and behavioral changes commonly associated with AD begin to manifest.

    ?

    How this investigational therapy could help:

    The memory loss and functionality decline of Alzheimer’s disease have been linked to amyloid plaques, abnormal protein deposits that build up in the brain. E2609 is a small-molecule inhibitor of beta-secretase, a protein that cleaves enzyme 1 (BACE1). By inhibiting BACE1, E2609 blocks amyloid production, potentially slowing the progress of the disease.

    1 World Health Organization Dementia a Public Health Priority. http://www.who.int/mental_health/publications/dementia_report_2012/en/. Accessed 23 May 2016.

  • BAN2401 (Aβ mAb)

    Alzheimer’s disease

    Developed in collaboration with Eisai Co., Ltd.

    Alzheimer’s disease (AD) is a progressive neurodegenerative disease that damages healthy cells in the brain causing cognitive impairment and functional disability. It is estimated that more than 25 million individuals are living with AD worldwide1.

    Today we understand that AD is a continuum with a long silent phase that begins years before symptoms appear. As AD progresses, symptoms like memory loss, personality and behavioral changes commonly associated with AD begin to manifest.

    ?

    How this investigational therapy could help:

    The memory loss and functionality decline of Alzheimer’s disease have been linked to amyloid plaques, abnormal protein deposits that build up in the brain. BAN2401 is an antibody that binds to amyloid, which could reduce its presence in the brain and potentially slow the progress of the disease.

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    1 World Health Organization Dementia a Public Health Priority. http://www.who.int/mental_health/publications/dementia_report_2012/en/. Accessed 23 May 2016.

  • BG00011 (STX-100)

    Idiopathic pulmonary fibrosis (IPF)

    Pulmonary fibrosis is a disease in which lung tissue becomes thickened and stiff due to scarring. The formation of scar tissue is called fibrosis. As the disease progresses, it becomes harder for the lungs to work properly and the body cannot get the oxygen it needs. This debilitating disease is almost always fatal.

    ?

    How this?investigational therapy could help:

    The TGF-beta brain cell pathway is involved in several fibrotic diseases. The BG00011 (STX-100) antibody may selectively block the TGF-beta pathway, and may slow the development of fibrosis in IPF patients.

  • BIIB054 (anti-α-synuclein)

    Parkinson's disease

    Acquired from Neurimmune.

    Parkinson's disease is a disorder of the central nervous system. People who have this disease experience tremors, slow movement, muscle stiffness, and impaired balance.??As these symptoms become progressively worse, patients have difficulty walking, talking, or completing other simple tasks.

    ?

    How this investigational therapy could help:

    BIIB054 targets abnormal alpha-synuclein protein that is associated with the destruction of nerve cells. This progressive degeneration is the cause of Parkinson's disease.

    Learn more about SPARK, a clinical trial for Parkinson’s disease

  • BIIB059 (anti-BDCA2)

    Systemic lupus erythematosus

    This chronic inflammatory disease occurs when the body’s own immune system mistakenly attacks healthy tissue in skin, joints, kidneys, the brain and other organs. It is a difficult disease to diagnose because it resembles several other conditions.

    ?

    How this investigational therapy could help:

    BDCA2 is a protein present in specific cells within the immune system. An antibody against BDCA2 can potentially interrupt production of interferons, inflammatory molecules that are increased in patients with lupus and contribute to disease activity.?

  • BIIB074?(vixotrigine)

    Trigeminal neuralgia

    Trigeminal neuralgia is an extremely painful, rare condition usually involving one side of the face. Trigeminal neuralgia is characterized by sudden, brief, stabbing, recurrent episodes of pain which frequently occurs spontaneously but is also commonly evoked by trivial stimuli including washing, talking or brushing teeth (trigger factors). The pain follows one or more branches of the trigeminal nerve, which provides nerve sensation from the mouth, face and the front of the scalp. The intensity, frequency and unpredictability of the pain results in profound effects on the quality of life of patients and their caregivers.

    ?

    How this investigational therapy could help:

    Vixotrigine is a state- and use-dependent, Nav1.7 channel blocker that also inhibits other voltage-gated sodium channels. It is a centrally and peripherally acting small molecule.

  • BIIB074 (vixotrigine)

    Small fiber neuropathy (SFN)

    Small fiber neuropathy (SFN) is a condition characterized by severe pain attacks that typically begin in the feet or hands. Patients may experience spontaneous burning, itching or shooting pain which may be triggered by stimuli that are ordinarily not painful, such as hot or cold temperatures or light touch. SFN is a neuropathic pain condition which can have different causes, such as diabetes or vitamin B12 deficiency, or the cause may be unknown.

    How this investigational therapy could help:

    Vixotrigine is a state- and use-dependent, Nav1.7 channel blocker that also inhibits other voltage-gated sodium channels. It is a centrally and peripherally acting small molecule.

    Learn more about the clinical trial for BIIB074 in SFN. ?

  • BIIB092 (gosuranemab)

    Progressive supranuclear palsy (PSP)

    Licensed from Bristol-Myers Squibb.

    Progressive supranuclear palsy (PSP) is a rare neurodegenerative disease that affects adults.?This devastating disease typically advances quickly and affects movement, speech, vision and cognitive function. Currently, there are no effective therapies for PSP.

    ?

    How this investigational therapy could help:

    In PSP, deposits of abnormal tau, so-called neurofibrillary tangles, form within neurons and are linked to increasing impairment and loss of brain cells. BIIB092 (gosuranemab) is an antibody targeting?extracellular tau which may reduce the spreading of the abnormal form of this molecule from one nerve cell to the next, potentially slowing the progression of the disease.

    Learn more about PASSPORT, a clinical trial for PSP

    ?

  • BIIB092 (gosuranemab)

    Alzheimer's disease

    Licensed from Bristol-Myers Squibb.

    Alzheimer’s disease (AD) is a progressive neurodegenerative disease that damages healthy cells in the brain causing cognitive impairment and functional disability. It is estimated that more than 25 million individuals are living with AD worldwide1.

    Today we understand that AD is a continuum with a long silent phase that begins years before symptoms appear. As AD progresses, symptoms like memory loss, personality and behavioral changes commonly associated with AD begin to manifest.

    ?

    How this investigational therapy could help:

    The memory loss and functional decline of AD have been linked to abnormal protein deposits that build up in?the brain. Among those proteins are amyloid and tau. Deposits of abnormal tau, so-called neurofibrillary tangles, form in the neurons and are linked to increasing impairment and loss of brain cells associated both with AD and with other neurodegenerative diseases, known as tauopathies, such as progressive supranuclear palsy and frontotemporal dementia. BIIB092 (gosuranemab) is an antibody targeting?extracellular tau and may reduce the spreading of tau from one cell to the next, potentially slowing the progress of the disease.

    1 World Health Organization Dementia a Public Health Priority. http://www.who.int/mental_health/publications/dementia_report_2012/en/. Accessed 23 May 2016.

  • BIIB104 (AMPA)

    Cognitive impairment associated with schizophrenia (CIAS)

    Acquired from Pfizer Inc.?

    Worldwide there are greater than 20 million people living with schizophrenia and it is estimated that the majority of them live with some degree of cognitive impairment attributable to the disease. When cognition is impaired, processing information, planning, and remembering become difficult or impossible. Cognition can be impaired in multiple neurological diseases and neurocognitive disorders, including schizophrenia.?

    BIIB104 is a first-in-class, Phase 2b ready asset for CIAS

    ?

    How this investigational therapy could help:

    BIIB104 is an AMPA receptor potentiator designed to facilitate neurotransmission in the central nervous system, a process which can be disrupted in a number of neurological diseases and neurocognitive disorders, including schizophrenia.

    ?

  • BIIB112 (AAV8-RPGR)

    XLRP gene therapy

    X-linked Retinitis Pigmentosa (XLRP) caused by mutations in RPGR gene is a form of retinitis pigmentosa, a rare, inherited retinal disorder. The RPGR gene encodes retinitis pigmentosa GTPase regulator, a protein involved in protein transport within photoreceptors required to convert light into visual signals. Mutations in the gene result in loss of photoreceptors, accumulation of retinal pigment deposits and progressive vision loss. The disease primarily affects males and typically presents with night blindness in childhood, followed by worsening of peripheral vision and progressive loss of central vision, often leading to legal blindness by the end of the fourth decade.

    How this investigational therapy could help:

    There are currently no treatments for XLRP, which represents a significant unmet medical need. BIIB112 consists of a standard AAV8 vector carrying a codon-optimized RPGR gene. BIIB112 is thought to potentially slow, stop or prevent further degeneration of photoreceptors in patients with RPGR-associated XLRP and is being evaluated to see if it is well-tolerated and if it can potentially stabilize or improve central vision using a visual field test.

    Learn more about the clinical trial for BIIB112 for XLRP

  • Dapirolizumab pegol (anti-CD40L)

    Systemic lupus erythematosus

    Developed in collaboration with UCB, Inc.

    This chronic inflammatory disease occurs when the body’s own immune system mistakenly attacks healthy tissue in skin, joints, kidneys, the brain and other organs. It is a difficult disease to diagnose because it resembles several other conditions.

    ?

    How this investigational therapy could help:

    CD40L is a protein in B and T cells, which helps regulate the immune system. Dapirolizumab pegol (anti-CD40L) is an antibody that blocks CD40L, potentially lessening disease activity in lupus patients.

  • Natalizumab?(α4-integrin inhibitor)

    Drug resistant focal epilepsy

    Focal epilepsy is the most common form of epilepsy and is characterized by seizures resulting from abnormal signaling in one region of the brain. Epilepsy is estimated to be the fourth most common neurological disease, affecting 3.4 million people in the US. Given the morbidity and mortality associated with uncontrolled epilepsy, drug-resistant epilepsy patients have a high degree of unmet need.

    ?

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    How this investigational therapy could help:

    Natalizumab is being investigated as an adjunctive therapy in the treatment of adult patients with drug-resistant focal epilepsy.

    Learn more about the clinical trial for natalizumab in drug resistant focal epilepsy

    ?

  • Opicinumab (anti-LINGO)

    Multiple sclerosis (MS)

    This disease causes the body’s immune system to attack myelin, a protective sheath covering nerve fibers. Damage to myelin “short circuits” communication between the brain, spinal cord and other areas of the body, severely impairing such neurological functions as mobility, vision and thinking. Over time, the nerves themselves can become damaged permanently.

    ?

    How this investigational therapy could help:

    LINGO-1 is a CNS specific-protein that is involved in the development of myelin. In patients with MS, LINGO-1 may inhibit myelin growth when it binds with its receptor. Data suggest that the antibody anti-LINGO-1 could block this process, potentially allowing for the re-myelination and restoration of nerve communication in MS patients.

  • TMS-007 (plasminogen modulator)

    Stroke

    *Option to acquire from TMS Co., Ltd.

    It is estimated that nearly two million people in the United States and the European Union will have a stroke each year. Stroke is a leading cause of mortality and serious long-term disability. There is a substantial unmet medical need for new therapies that can improve outcomes in acute stroke.

    How this investigational therapy could help:

    TMS-007 is a plasminogen activator with a novel mechanism of action associated with breaking down blood clots and is believed to inhibit local inflammation at the site of thrombosis. This unique combination could position TMS-007 as a best in class thrombolytic for individuals with acute ischemic stroke (AIS) with potential for an extended treatment window as compared to current thrombolytic agents.

    TMS-007 is a small molecule which has previously demonstrated an acceptable safety profile in a Phase 1 study and has also reduced infarct volume (area of dead tissue resulting from failure of blood supply) in experimental, preclinical, embolic and thrombotic stroke models.

    TMS-007 is currently being evaluated in a double-blind, placebo-controlled Phase 2 study in Japan, designed to investigate the safety and efficacy of a single IV administration of TMS-007 in approximately 90 patients with AIS up to 12 hours after stroke onset. The Phase 2 study initiated with the first patient dosed in February 2018.

  • BIIB061 (oral remyelination)

    Multiple Sclerosis (MS)

    MS causes the body’s immune system to attack myelin, a protective sheath covering nerve fibers. Damage to myelin “short circuits” communication between the brain, spinal cord and other areas of the body, severely impairing such neurological functions as mobility, vision and thinking. Over time, the nerves themselves can become damaged permanently.

    How this investigational therapy could help:

    BIIB061 is an oral small molecule that induces growth of the cells that make myelin potentially allowing for the re-myelination and restoration of nerve communication in MS patients.

  • BIIB076 (anti-tau mAb)

    Alzheimer's disease

    Alzheimer’s disease (AD) is a progressive neurodegenerative disease that damages healthy cells in the brain causing cognitive impairment and functional disability. It is estimated that more than 25 million individuals are living with AD worldwide1.

    Today we understand that AD is a continuum with a long silent phase that begins years before symptoms appear. As AD progresses, symptoms like memory loss, personality and behavioral changes commonly associated with AD begin to manifest.

    ?

    How this investigational therapy could help:

    The memory loss and functional decline of AD have been linked to abnormal protein deposits that build up in?the brain. Among those proteins are amyloid and tau. Deposits of abnormal tau, so-called neurofibrillary tangles, form in the neurons and are linked to increasing impairment and loss of brain cells associated both with AD and with other neurodegenerative diseases, known as tauopathies, such as progressive supranuclear palsy and frontotemporal dementia. BIIB076 is an antibody targeting tau, the protein that forms the deposits, or tangles, in the brain.

    1 World Health Organization Dementia a Public Health Priority. http://www.who.int/mental_health/publications/dementia_report_2012/en/. Accessed 23 May 2016.

  • BIIB078 (IONIS-C9Rx)

    Amyotrophic lateral sclerosis (ALS)

    Developed in collaboration with Ionis Pharmaceuticals.

    *Option to acquire from Ionis Pharmaceuticals.

    Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disease that results in the loss of motor neurons in the brain and the spinal cord. Motor neurons provide the ability to move, speak, swallow, and breathe. As the disease progresses, ALS patients gradually lose these abilities.

    How this investigational therapy could help:

    The most commonly inherited cause of ALS is a mutation in the C9orF72 gene. The mutation is a sequence of six nucleotides, which gets repeated hundreds to thousands of times in the disease-causing variants. Mutations in C9orF72 account for about 34 percent of familial ALS cases and 12 percent of all ALS cases.

    BIIB078 targets specific messenger RNA emerging from the C9orf72 gene and degrades it, removing the RNA and preventing production of the abnormal protein it encodes. Importantly, BIIB078 largely preserves the normal C9orf72 protein coming from the gene. Preclinical researchers have found this approach to be useful, decreasing ALS-related pathology in preclinical models and improving behavioral function.

    Learn more about the BIIB078 (IONIS-C9Rx) clinical trial.

  • BIIB080?(IONIS-MAPTRx)

    Alzheimer's disease

    Developed in collaboration with Ionis Pharmaceuticals.

    *Option to acquire from Ionis Pharmaceuticals.

    Alzheimer’s disease (AD) is a progressive neurodegenerative disease that damages healthy cells in the brain causing cognitive impairment and functional disability. It is estimated that more than 25 million individuals are living with AD worldwide1. Today we understand that AD is a continuum with a long silent phase that begins years before symptoms appear. As AD progresses, symptoms like memory loss, personality and behavioral changes commonly associated with AD begin to manifest.

    ?

    How this investigational therapy could help:

    The memory loss and functional decline of Alzheimer’s disease have been linked to amyloid plaques and tau tangles, abnormal protein deposits that build up in?the brain and in the brain cells. BIIB080 (IONIS-MAPTRx) is an antisense oligonucleotide (ASO) that may reduce production of the tau protein and its accumulation in brain cells, potentially slowing the progress of the disease.

    Learn more about the BIIB080 (IONIS-MAPTRx) clinical trial

    1World Health Organization Dementia a Public Health Priority.?http://www.who.int/mental_health/publications/dementia_report_2012/en/. Accessed 23 May 2016.?

  • BIIB095 (Nav 1.7)

    Neuropathic pain

    Neuropathic pain affects more than 12 million adults in the US, and is a type of chronic pain that occurs when nerves in the central nervous system become injured or damaged. These damaged nerve fibers send incorrect signals to other pain centers. The impact of a nerve fiber injury includes a change in nerve function both at the site of injury and areas around the injury.?

    ?

    How this investigational therapy could help:

    BIIB095 is a state- and use-dependent blocker of multiple Nav channels relevant to neuropathic pain. Nav1.7 is a genetically-validated key pain target, with gain-of function mutations linked to severe chronic pain syndromes and loss-of-function mutations linked to the inability to sense pain.

    Learn more about the clinical trial BIIB095 in neuropathic pain

  • BIIB110 (ActRIIA/B ligand trap)

    Spinal muscular atrophy (SMA)

    Acquired from AliveGen, Inc.

    SMA is a genetic, progressive and often terminal rare disease that affects an individual’s ability to walk, eat and, ultimately, breathe. Debilitating and often fatal, SMA affects approximately one in 10,000 live births and is a leading genetic cause of death among infants.

    How this investigational therapy could help:

    Inhibition of the myostatin pathway is a genetically validated target for muscle enhancement. BIIB110 is a hybrid activin II receptor (ACTIIR) ligand trap that sequesters both myostatin and activins while sparing the related ligand bone morphogen protein 9 (BMP9). This targeted mechanism of action may result in greater muscle mass, function and improved safety compared to other myostatin inhibition approaches.?

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