Extending Our Leadership Position
`in Multiple Sclerosis
`
`December 12, 2018
`
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`MYLAN PHARMS. INC. EXHIBIT 1088 PAGE 1
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`

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`Forward-Looking Statements
`
`This presentation contains forward-looking statements, including statements relating to: our strategy and plans; clinical trials and data readouts and presentations; the timing and
`status of current and future regulatory filings; potential regulatory approval and the timing thereof; the potential benefits, safety, and efficacy of BIIB098 (diroximel fumarate),
`opicinumab, extended interval dosing (EID) TYSABRI, an intermuscular formulation of PLEDGRIDY, BIIB061, and BIIB107; the design, enrollment, and timing of the Phase 3b
`NOVA study of EID TYSABRI; the design, enrollment, and timing of the Phase 3 study of BIIB098 (diroximel fumarate); the design and timing of the Phase 2b study of
`opicinumab; the design and timing of the planned Phase 2 study of BIIB061; results from certain studies of BIIB098 (diroximel fumarate), opicinumab, EID TYSABRI, an
`intermuscular formulation of PLEDGRIDY, and BIIB061; the identification and treatment of multiple sclerosis; potential of our commercial business and pipeline programs;
`uncertainties associated with drug development and commercialization; capital allocation and investment strategy; and anticipated benefits and potential of investments,
`collaborations, and business development activities. These forward-looking statements may be accompanied by such words as “aim,” “anticipate,” “believe,” “could,” “estimate,”
`“expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “potential,” “possible,” “will,” and other words and terms of similar meaning. Drug development and commercialization involve a
`high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early stage clinical trials may not be
`indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements or
`the scientific data presented.
`
`These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including: we may not fully enroll our
`clinical trials or it will take longer than expected; the actual timing and final results of our clinical trials; the risk that unexpected concerns may arise from additional data or
`analysis, or regulatory authorities may require additional data or information or further studies, or may fail to approve, or refuse to approve, or may delay approval of our drug
`candidates; uncertainty of success and timing in the development and potential commercialization of our drug candidates, including BIIB098 (diroximel fumarate), which may be
`impacted by, among other things, unexpected concerns that may arise from additional data or analysis, the occurrence of adverse safety events, failure to obtain regulatory
`approvals in certain jurisdictions, failure to protect and enforce data, intellectual property, and other proprietary rights and uncertainties relating to intellectual property claims and
`challenges; actual timing and content of submissions to and decisions made by the regulatory authorities regarding BIIB098 (diroximel fumarate); regulatory submissions may
`take longer or be more difficult to complete than expected; risks relating to the potential
`launch of VUMERITY (diroximel fumarate), including preparedness of healthcare
`providers to treat patients, the ability to obtain and maintain adequate reimbursement for VUMERITY (diroximel fumarate), and other unexpected difficulties or hurdles; product
`liability claims; and third party collaboration risks. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any
`forward-looking statement. Investors should consider this cautionary statement, as well as the risk factors identified in our most recent annual or quarterly report and in other
`reports we have filed with the U.S. Securities and Exchange Commission.
`
`These statements are based on our current beliefs and expectations and speak only as of the date of this presentation. We do not undertake any obligation to publicly update any
`forward-looking statements, whether as a result of new information, future developments or otherwise.
`
`Note regarding trademarks: AVONEX®, PLEGRIDY®, TECFIDERA®, TYSABRI®, and ZINBRYTA® are registered trademarks of Biogen. Other trademarks referenced in this
`presentation are the property of their respective owners.
`
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`MS R&D Webcast Call Agenda
`
`Introduction
`
`Overview
`
`Matt Calistri
`VP, Investor Relations
`
`Tracey Dawson, Ph.D.
`VP, Product Development and Commercialization Lead for Multiple Sclerosis
`
`Late Stage Programs
`
`Aaron Deykin, M.D.
`VP, Head of Multiple Sclerosis and Acute Neurology Late Stage Clinical Development Unit
`
`Early Portfolio Overview Nathalie Franchimont, M.D., Ph.D.
`VP, Head of Multiple Sclerosis Research and Early Development Unit
`
`Available for Q&A
`
`Michael Ehlers, M.D., Ph.D.
`EVP, Research & Development
`
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`Overview
`Tracey Dawson, Ph.D.
`VP, Product Development and
`Commercialization Lead for
`Multiple Sclerosis
`
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`Biogen’s Strategy in Multiple Sclerosis
`
`Biogen is the global market leader in MS and our MS business has remained resilient
`
`We believe there are significant opportunities to address the remaining unmet needs of
`MS patients
`
`Advancing BIIB098 (diroximel fumarate) as a novel oral option with a potentially
`differentiated GI tolerability profile
`
`Opicinumab is a potential first-in-class remyelination agent to promote neuronal repair
`and potentially improve disability in MS
`
`Reinvesting in lifecycle management across our entire MS portfolio, including ongoing
`studies with TECFIDERA, investigation of extended interval dosing for TYSABRI, and
`development of an intramuscular (IM) formulation of PLEGRIDY
`
`Leveraging our established asymmetric expertise in MS and capabilities in
`neuroscience with the goal of developing an innovative pipeline of new molecules
`
`1 2 3 4 5
`
`=
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`Multiple Sclerosis is a Large Global Market
`
`> $20 Billion Annual Global Market
`
`~ 2.5 million prevalence, including progressive forms
`~ 1 million treated patients worldwide, has
`been growing in mid single digits
`
`~ 15k new to
`therapy each
`year
`
`~ 315k treated patients
`
`~ 60k patients
`change
`therapy each
`year
`
`Source: Biogen market research
`
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`Deep History Developing Transformative Treatments for Multiple Sclerosis
`
`1978
`Biogen is founded by
`a small group of
`visionary scientists
`
`1996
`Biogen launches AVONEX,
`an interferon treatment for
`relapsing MS
`
`2004
`TYSABRI receives
`FDA approval
`
`2014
`Biogen launches
`PLEGRIDY
`
`2013
`Biogen acquires full
`rights to TYSABRI
`from Elan
`
`2013
`TECFIDERA launches
`and becomes the most
`prescribed oral MS
`therapy1
`
`2011
`AVONEX Pen
`approved by the
`FDA
`
`Anti-
`LINGO
`
`BIIB098
`
`~349k
`Patients on
`a Biogen
`treatment2
`
`2016
`FAMPYRA, Biogen’s
`symptomatic MS treatment,
`receives full EC approval
`
`2017
`Biogen initiates Phase
`2b trial of opicinumab
`
`2017
`Biogen acquires global
`rights for BIIB098
`(diroximel fumarate)
`from Alkermes
`
`2018
`Initiation of TYSABRI EID
`NOVA study and development
`of PLEGRIDY IM
`
`2018+
`Biogen plans to
`continue to invest in
`new treatments for MS
`
`Biogen data on file.
`1.
`2. Represents patients as of September 30, 2018.
`
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`Demonstrated Resilience in our $9 Billion MS Business
`
`Biogen MS Patients
`Thousands
`
`331k
`
`306k
`
`343k
`
`350k
`
`349k
`
`HIGHLIGHTS
`► Biogen products treat ~35% of all
`treated MS patients globally1
`
`► Focused on maintaining resilience in
`the face of new competition
`
`2014
`
`2015
`
`2016
`
`2017
`
`Q3'18
`
`AVONEX
`
`PLEGRIDY
`
`TYSABRI
`
`TECFIDERA
`
`ZINBRYTA
`
`2
`
`Note: Patient numbers represent estimated ending patient count as of December 31st of each year, except for 2018 which represents
`patients as of September 30, 2018.
`Biogen data on file as of September 30, 2018.
`1.
`ZINBRYTA was withdrawn from the market in March 2018.
`2.
`
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`Biogen’s Portfolio Covers the Treatment Spectrum in Relapsing MS
`
`DMT-Treated Relapsing MS Patients
`
`Newly Diagnosed Active
`
`Newly Diagnosed
`More Active
`
`Non-Efficacy Switch
`(safety, tolerability)
`
`Efficacy Switch
`(active and more active)
`
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`Focused on Maximizing Patient Access
`Broad U.S. Commercial Access
`
`Step Edit
`
`Not Covered
`
`1%
`13%
`
`Unrestricted
`2%
`1%
`8%
`
`17%
`
`2%
`
`16%
`
`14% 13%
`15% 10%
`
`85% 90% 82%
`
`71% 77% 82%
`
`10%
`
`23%
`
`28% 28%
`
`16% 13%
`
`56% 60% 67%
`
`Pioneering U.S. Value-Based Contracts
`
`• Working to tie pricing to clinical value while
`maximizing patient access
`
`• 9 contracts ongoing covering ~ 80 million
`covered lives
`
`• Either aligning price to patient outcomes,
`or adjusting price for patients initiating
`therapy who discontinue
`
`• Initial insights have helped identify
`opportunities to potentially improve
`patient outcomes
`
`2016
`
`2017
`
`2018
`
`2016
`
`2017
`
`2018
`
`2016
`
`2017
`
`2018
`
`“We want to provide open access to different MoAs given differential patient response. This helps us avoid downstream costs.” – National Payer
`
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`

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`Investing in Lifecycle Management and New Data Generation
`
`• Comparative efficacy
`analyses have shown that
`PLEGRIDY has potentially better
`clinical outcomes than REBIF,
`AUBAGIO, and COPAXONE1-3
`• Recently generated data on the
`safety of interferons used during
`pregnancy
`• Continued investment in IFN
`through efficacy and safety data
`generation and PLEGRIDY IM
`
`• Recent comparative effectiveness
`data showed TECFIDERA has
`relative improvement in real-world
`effectiveness versus interferon,
`COPAXONE, and AUBAGIO, and
`similar effectiveness versus
`GILENYA4
`• Continued investment in data
`generation - novel endpoints and
`real-world data
`• Ongoing ENDORSE study to
`generate long-term safety and
`efficacy data
`
`• Advances in anti-JCV antibody
`index as well as MRI monitoring
`have helped physicians monitor
`for PML
`• Continuing to generate long-term
`data from the TYSABRI
`Observational Program (TOP) to
`reinforce the effectiveness of
`TYSABRI
`• Initiated the Phase 3b NOVA
`study evaluating the efficacy of
`extended interval dosing of
`TYSABRI
`
`• New oral fumarate
`investigational drug
`• Potential for improved GI
`tolerability vs. TECFIDERA
`• Head to head study vs.
`TECFIDERA ongoing with data
`expected in mid-2019, U.S. filing
`expected very soon
`• Additional lifecycle investments
`being made to support
`differentiation
`• Plans to file outside the U.S.
`under consideration as well as
`exploratory work on new
`indications
`
`Note: The brand name VUMERITY has been conditionally accepted by the FDA and will be confirmed upon approval.
`1. Newsome SD et al. Presented at American Academy of Neurology 2018 Annual Meeting; Poster 360. Biogen co-authored this research.
`2. Coyle PK et al. Mult Scler Rel Disord. 2018. Biogen co-authored this research.
`3. Scott, T. Presented at Congress of the European Committee for Treatment & Research in Multiple Sclerosis 2018. Biogen co-authored this research.
`4. Braune S et al. Comparative effectiveness of delayed-release dimethyl fumarate versus interferon, glatiramer acetate, teriflunomide, or fingolimod: results from the German
`NeuroTransData registry. J Neurol. 2018. Biogen co-authored this research.
`
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`Comparative Effectiveness Data Reinforce Efficacy Profile of TECFIDERA
`
`•
`
`•
`
`Recent data from the German
`Neurotransdata MS registry
`demonstrated relative
`improvement in real-world
`effectiveness for TECFIDERA
`(DMF) versus interferon-β
`(IFN), glatiramer acetate (GA),
`and teriflunomide (TER)
`Similar effectiveness was
`observed between DMF and
`fingolimod (FTY)
`
`Braune S et al. Comparative effectiveness of delayed-release dimethyl fumarate versus interferon, glatiramer acetate,
`teriflunomide, or fingolimod: results from the German NeuroTransData registry. J Neurol. 2018. Biogen co-authored this
`research.
`
`TTFR = time to first relapse
`
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`Long-term Rates of Brain Atrophy Remain Low with TECFIDERA
`
`Yearly PBVC in ENDORSE
`(Baseline to year 5)
`
`TECFIDERA
`
`•
`
`In the ENDORSE study
`(baseline to year 5), yearly
`percentage brain volume
`change (PBVC) for patients
`treated with TECFIDERA
`was within the range of that
`expected in healthy
`individuals (based on an
`estimated 0.1–0.3% change
`per year)
`
`Estimated yearly PBVC in healthy
`individuals1
`
`Mean PBVC for placebo-treated
`patients was –0.43% from baseline to
`Year 1 in DEFINE/CONFIRM (n=307)
`
`1. Miller DH et al. Measurement of atrophy in multiple sclerosis: pathological basis, methodological aspects and clinical relevance. Brain. 2002.
`
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`10-Year Data Support Strong Efficacy of TYSABRI
`
`Real-world data from over 10 years in the TYSABRI (natalizumab) Observational Program
`
`Kappos L et al. Real-world data from over 10 years in the TYSABRI® Observational Program: Long-term safety and effectiveness of
`natalizumab in relapsing-remitting multiple sclerosis patients. Presented at Congress of the European Committee for Treatment &
`Research in Multiple Sclerosis 2018. P908.
`
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`Advancing the Standard of Care beyond Disease-Modifying Therapies
`
`•
`
`•
`•
`
`•
`
`•
`
`Collaboration with 10 leading MS centers to collect longitudinal clinical, MRI, and
`biologic data from patients in real time, at the point of care. Over 14,000 patients
`enrolled to-date.
`iPad-based assessment to monitor motor, visual, and cognitive function
`Data has the potential to help identify or validate biomarkers and MRI metrics, enable
`precision medicine, and generate real-world evidence for disease modifying
`therapies
`
`Free iPad-based assessment tool designed to evaluate cognitive function in MS
`patients
`
`Developing a serum NfL blood test with the aim of providing a highly sensitive,
`robust, and validated assay to better understand disease activity and monitor
`treatment response
`
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`Advancing Biomarkers to Monitor Disease Progression
`
`In RRMS, elevated levels of serum neurofilament
`light (sNFL) at baseline were associated with:
`
`TYSABRI treatment is associated with reduced
`sNFL levelsd
`
`Continued natalizumab, all
`with no Gd+ lesions (n=45)
`
`Discontinued natalizumab,
`developed Gd+ lesions (n=65)
`
`Greater Gd+ lesion count at baselinea
`
`Increased T2 lesion volume over 5
`yearsb
`
`Increased brain atrophy over 5 yearsb
`
`Worsened clinical disability over 5 yearsc
`
`a Combined data from ADVANCE, CHAMPS, and SENTINEL studies.
`b Data from CHAMPS/CHAMPIONS studies.
`c Data from CHAMPS.
`d Fox RJ et al. Temporal Relationship of Serum Neurofilament Light (NfL) Levels and
`Radiological Disease Activity in MS Patients. Presented at Congress of the
`European Committee for Treatment & Research in Multiple Sclerosis 2018. P532.
`RRMS = relapsing-remitting multiple sclerosis
`
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`Future Opportunities Across Spectrum of the Disease
`
`2.5 MM Prevalent Patients Worldwide
`
`1.6 MM Prevalent Patients in U.S. & EU
`
`70-75% Diagnosed
`
`60%
`
`15%
`
`15%
`
`10%
`
`Treatment
`Rate
`
`RRMS
`
`Relapsing SPMS Non-Relapsing SPMS
`
`PPMS
`
`70-80%
`
`30-50%
`
`30-50%
`
`30-50%
`
`RRMS = relapsing remitting multiple sclerosis
`SPMS = secondary progressive multiple sclerosis
`PPMS = primary progressive multiple sclerosis
`
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`Pursuing Potential Transformative Investigational Therapies
`
`Our Mission
`Be the most valued leader in MS by transforming the care of people living with MS
`
`Modify course of disease
`with transformative therapies
`for relapsing MS
`• Pursue next generation therapies
`in relapsing MS
`
`• Advance lifecycle management
`for current portfolio
`
`Advance the care in
`progressive MS
`• Grow pipeline with targets
`leveraging emerging insights /
`advances in progressive MS
`biology
`
`Slow or reverse disability
`and restore function
`• Develop novel therapies that can
`reverse or halt disability
`progression through CNS repair
`or remyelination
`
`• Develop capabilities to support
`innovative approaches for
`remyelination and axonal
`protection / repair
`
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`Investing in Lifecycle Management and R&D
`
`Strategic Area
`
`Preclinical
`
`Phase 1
`
`Phase 2
`
`Phase 3
`
`LCM
`
`VUMERITYTM (diroximel fumarate)*
`
`Transformative
`Relapsing MS
`
`Lymphocyte trafficking agent
`
`Additional mechanisms
`
`Progressive MS
`
`Additional mechanisms
`
`Improve
`Disability
`& Restore
`Function
`
`Opicinumab (anti-LINGO)
`
`BIIB061
`
`Additional mechanisms
`
`Life-Cycle
`Management
`
`PLEGRIDY IM
`
`TYSABRI EID
`
`IFN PREGNANCY
`
`*In collaboration with Alkermes.
`
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`

`

`Late Stage Programs
`Aaron Deykin, M.D.
`VP, Head of Multiple Sclerosis and
`Acute Neurology Late Stage Clinical
`Development Unit
`
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`Diroximel Fumarate Is a Potential Novel Oral Option
`
`DMF
`Dimethyl Fumarate
`
`DRF
`Diroximel Fumarate
`
`THE MOLECULE
`• Rapidly converts to monomethylfumarate (MMF)
`and (inactive) leaving group
`• May offer differentiated GI profile versus
`TECFIDERA (DMF) and potential to expand oral
`market
`
`DEVELOPMENT PATH
`Plan to file via 505 b(2) pathway very soon:
`• Pharmacokinetic bridging to TECFIDERA
`• Study 301: Single-arm two-year safety study of
`RRMS patients. June 2018 data cut to support filing.
`
`Study 302: Head-to-head comparison of DRF vs
`TECFIDERA on GI symptoms. Data expected mid-
`2019.
`
`MMF
`Monomethyl Fumarate
`
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`Efficacy of DRF Appears Comparable to TECFIDERA
`
`*
`
`•
`
`•
`
`•
`
`Interim data from EVOLVE-MS-1
`(N=617) as of January 12, 2018
`demonstrated no unexpected
`safety findings based on the
`known safety profile of
`TECFIDERA
`GI adverse events (AEs) leading
`to discontinuation were below 1%
`GI AEs occurred in 28.5% of
`patients overall (up to 24 months)
`
`Leigh-Pemberton, R. MRI and Relapse Results for ALKS 8700 in RRMS: 1-year Interim Results from the Phase 3
`EVOLVE-MS-1 Study. Presented at the American Academy of Neurology Annual Meeting 2018. 006.
`*N=374 as of January 12, 2018
`
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`DRF May Potentially Offer a Differentiated GI
`Tolerability Profile vs. TECFIDERA
`
`HYPOTHESIS
`DRF may elicit less localized irritation
`• Possibly due to less irritant leaving group
`
`The clinical implications of the distinct chemical features of DRF are being
`evaluated in the ongoing head-to-head study with TECFIDERA
`
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`Opicinumab: Investigating Remyelination to Potentially Reverse Disability
`
`Fully human anti-LINGO-1 monoclonal antibody
`
`THERAPEUTIC HYPOTHESIS:
`LINGO-1 is a negative regulator of oligodendrocyte precursor cell differentiation
`•
`Blocking LINGO-1 with opicinumab may enhance remyelination
`•
`
`Lymphocyte-driven Inflammation
`
`Demyelination
`
`Axonal loss and
`neurodegeneration
`
`Axon maintenance and
`neuronal viability
`
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`

`Novel Patient Selection Criteria and Endpoints for Opicinumab
`
`SYNERGY
`• Multimodal MRI analysis identified lesions
`characterized by reduced myelin content
`but preserved axon integrity
`This analysis may identify a patient
`population amenable to remyelination-
`mediated repair
`
`•
`
`Clinical Efficacy for Identified Subpopulation
`
`AFFINITY
`Leverages learnings from SYNERGY
`•
`to inform patient selection and dose
`Enrollment completed ~7 months
`ahead of schedule; data expected
`mid-2020
`
`•
`
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`

`Furthering Understanding of PML Risk for TYSABRI
`
`2010–11: Prior immunosuppressant
`& treatment duration
`
`2011–12: Presence of anti-JCV
`antibodies
`
`2013–16: Anti-JCV antibodies
`index values
`
`2014–16: Guidelines on
`frequency of MRI monitoring
`
`2018: Exploring potential of
`Extended Interval Dosing (EID)
`
`JCV=John Cunningham virus.
`
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`

`Real-World Data to Assess PML Risk with TYSABRI EID
`
`• Restricted program under a REMS, focused on safety and developed with the help of U.S. regulators1
`• All prescribers, infusion sites, and patients receiving TYSABRI are required to enroll1
`
`• Largest data source that could inform on PML risk in patients on EID (90,038 patients as of June 1, 2017)2
`• Accurate capture of the 3 risk factors for PML (anti-JCV antibody status, prior immunosuppressant use, exposure)
`
`Analysis
`Objective2
`
`To determine whether EID is associated
`with lower PML risk compared with SID in TOUCH
`
`EID = extended interval dosing; SID = standard interval dosing; REMS=Risk Evaluation and Mitigation Strategy.
`1. Panzara M et al. Presented at Congress of the European Committee for Treatment & Research in Multiple Sclerosis 2009. P458. 2. Zhovtis Ryerson L et al.
`Presented at Congress of the Americas Committee for the Treatment & Research in Multiple Sclerosis 2018. LB350.
`
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`EID was Associated with Significantly Lower PML Risk versus SID
`
`US TOUCH Registry Analysis
`
`95% confidence
`intervals indicate a
`78%-99% reduction
`in PML risk
`
`P value from log-rank test: <0.001
`HR (95% CI) from Cox regression analysisa:
`0.06 (0.01–0.22); P<0.001
`
`The analysis populations include anti-JCV antibody positive patients without a treatment gap (>12 weeks between doses) or overdosing (<3 weeks between doses).
`Data shown are for the primary analysis in which EID was defined as ≤ 15 infusions in the last 18 months and SID was defined as > 15 infusions in the last 18
`months. Additional analyses examined secondary and tertiary definitions of EID. aEID vs SID. Model includes age, sex, prior use of immunosuppressants, EID/SID
`group, and calendar year at the start of natalizumab treatment as covariates; HR=hazard ratio. Zhovtis Ryerson L et al. Presented at Congress of the Americas
`Committee for the Treatment & Research in Multiple Sclerosis 2018. LB350.
`
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`

`

`Phase 3b NOVA Study to Assess Efficacy of TYSABRI EID
`
`Study
`Objective1
`
`To evaluate the efficacy, safety, and tolerability of 6-week TYSABRI dosing intervals in patients with RRMS who
`switch to EID after one year of treatment with standard TYSABRI dosing in relation to continued SID treatment
`
`SID TYSABRI 300 mg IV (n=240)
`Every 4 weeks (28 -2/+5 days)
`
`EID TYSABRI 300 mg IV (n=240)
`Every 6 weeks (42 -2/+5 days)
`
`Follow up
`
`6
`
`12
`
`18
`
`24
`
`36
`
`48
`
`60
`
`72
`
`84 – 96*
`
`Randomization
`
`0
`
`Screening: SID
`(≥11 doses and stable
`in prior 12 months)
`
`Study Week
`
`-4
`
`Primary
`Endpoint
`
`Dosing intervals assessed in the NOVA study encompass the EID practice associated with the lower risk of
`PML in the TOUCH analysis.2
`
`The primary objective is to estimate differences in new or newly enlarging T2 lesions between the SID and EID
`regimens at 48 weeks.
`
`*Follow up end of study visit at 84 weeks and safety phone call at 96 weeks
`1. https://clinicaltrials.gov/ct2/show/NCT03689972
`2. Zhovtis Ryerson L et al. Presented at Congress of the Americas Committee for the Treatment & Research in Multiple Sclerosis 2018. LB350.
`
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`

`

`Intramuscular PLEGRIDY May Provide Improved Tolerability Profile
`
`BACKGROUND
`• Tolerability (~50% split between injection site reactions
`(ISRs) and flu like symptoms) has been the leading cause of
`discontinuations from PLEGRIDY (subcutaneous) in the first
`3 years after launch
`• AVONEX IM vs. subcutaneous interferon demonstrated
`fewer ISRs¹
`• Hypothesis: Reducing ISRs with PLEGRIDY IM decreases
`discontinuation rates
`
`DEVELOPMENT PATH EMBRACES SPEED TO MARKET
`• Goal: Demonstrate reduction in ISRs with PLEGRIDY IM to
`levels comparable to AVONEX IM while maintaining
`PLEGRIDY efficacy and convenience of twice monthly dosing
`• Recent milestone: In December 2018 first patient was dosed
`in bioequivalence study
`
`PLEGRIDY SWITCH OUTS BY REASON2
`
`18%
`
`43%
`
`4%
`
`36%
`
`29%
`
`47%
`
`7%
`
`17%
`
`2015
`(n=84)
`
`112
`
`2016
`(n=110)
`
`160
`
`Patient
`n-size:
`
`41%
`
`45%
`
`42%
`
`3%
`14%
`
`2017
`(n=107)
`
`163
`
`36%
`
`3%
`15%
`
`2018
`(n=69)
`
`93
`
`Administration preference
`
`Safety
`
`Tolerability
`
`Efficacy
`
`1. Balak D et al. Prevalence of cutaneous adverse events associated with long-term disease-modifying therapy and their impact on health-related quality
`of life in patients with multiple sclerosis: a cross-sectional study. BMC Neurol. 2013.
`2. Based on market research in each given year, not full year data; Biogen data on file (U.S. + EU5 + Canada).
`
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`MYLAN PHARMS. INC. EXHIBIT 1088 PAGE 30
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`

`

`Early Portfolio Overview
`Nathalie Franchimont, M.D., Ph.D.
`VP, Head of Multiple Sclerosis Research and
`Early Development Unit
`
`31
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`

`

`Significant Remaining Unmet Needs for Patients with MS
`
`Relapsing MS DMTs need more favorable
`benefit-risk profiles and lower patient burden
`
`Few DMTs have proven to be
`effective in progressive MS
`
`Current MS treatments cannot fully halt
`or reverse disease progression
`
`X
`
`BIIB
`
`BIIB
`
`BIIB
`
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`

`

`No Longer a Binary View of MS
`
`Relapsing MS
`
`Progressive MS
`
`Relapsing MS
`
`Progressive MS
`
`INFLAMMATION
`
`NEURODEGENERATION
`
`Shift in disease paradigms…
`
`Demyelination and Neurodegeneration
`
`White matter lesions
`
`Cortical lesions
`
`Inflammation
`
`Peripheral inflammation
`
`Chronic CNS-resident inflammation
`
`33
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`MYLAN PHARMS. INC. EXHIBIT 1088 PAGE 33
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`

`

`Drawing on Our MS Experience Coupled with Emerging Biology
`
`DEVELOP TRANSFORMATIVE THERAPIES
`FOR RELAPSING MS
`
`ADVANCE CARE IN
`PROGRESSIVE DISEASE
`
`IMPROVE DISABILITY
`AND RESTORE FUNCTION
`
`• Target validated pathways with
`promise of added efficacy as
`compared to B-cell depletion alone
`
`• Target CNS-resident immune cells, a
`key driver of cortical demyelination in
`PMS
`
`• Enhance the intrinsic remyelination
`capability of oligodendrocyte
`precursor cells (OPCs)
`
`• Blockade of inflammation similar to
`TYSABRI/OCREVUS
`
`• MoAs that offer add-on mechanisms
`to B cell inhibition (e.g. T cells;
`myeloid cells)
`
`• Engineering new molecules with the
`potential for enhanced brain
`penetration
`
`• Understand and release the molecular
`brake on endogenous remyelination
`mechanisms
`
`• Protect or restore the functional
`integrity of axons that have been
`damaged in the course of chronic
`disease
`
`SCIENTIFIC OBJECTIVE
`
`We will continue to assess and maximize our access to new modalities and capabilities and
`explore emerging biology with the goal of bringing innovative medicines to patients
`
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`MYLAN PHARMS. INC. EXHIBIT 1088 PAGE 34
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`

`

`Addressing the Remaining Unmet Needs of Relapsing MS Patients
`
`Current pipeline:
`
`VUMERITY (DRF)
`(Phase 3)
`
`• Novel oral option with potential for differentiated GI tolerability vs. TECFIDERA
`
`• Plan to file in U.S. very soon
`
`New Lymphocyte
`Trafficking Agent
`(Pre-IND)
`
`• Aiming for TYSABRI-like efficacy or increased potency
`
`• Potential for IV or subcutaneous formulation
`
`Additional
`Mechanisms
`(Preclinical & Clinical
`Assets)
`
`• Targeting clinically validated targets such as B-cell in addition to other cells
`(e.g. myeloid cells, T cells)
`
`• Aiming for high efficacy with a differentiated safety profile
`
`Small molecule
`Monoclonal antibody
`
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`MYLAN PHARMS. INC. EXHIBIT 1088 PAGE 35
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`

`

`Targeting CNS-Compartmentalized Inflammation for Progressive Disease
`
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`MYLAN PHARMS. INC. EXHIBIT 1088 PAGE 36
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`

`

`Working to Improve Disability and Restore Function
`
`Current pipeline:
`
`Opicinumab
`anti-LINGO-1
`(Phase 2b)
`
`• Potential first-in-class therapy for CNS repair in MS through remyelination,
`resulting in improvement in disability
`
`• Ongoing Phase 2b (AFFINITY) study: Data expected mid-2020
`
`BIIB061
`(Phase 2 Ready)
`
`• Small molecule designed to promote differentiation of oligodendrocyte
`progenitors and enhance remyelination
`
`• Planning to initiate Phase 2 study in 2019
`
`Additional
`mechanisms
`(Preclinical)
`
`• Leveraging internal expertise and external collaboration to nominate and validate
`new targets
`v
`• Exploring multiple approaches and multiple modalities
`
`Small molecule
`Monoclonal antibody
`
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`
`MYLAN PHARMS. INC. EXHIBIT 1088 PAGE 37
`
`

`

`Building Core Capabilities to Increase Probability of Success
`
`• Better understanding of CNS
`inflammation, pathology and imaging
`• Remyelination and repair platform
`(in vitro and in vivo)
`• Advanced MS animal models that
`are closer to PMS
`
`• Large Biobanks and
`Epidemiology resources
`• Monitoring tools to increase
`cognition decline diagnosis
`rates and accelerate therapy
`development
`• Multimodal neuroimaging to
`inform patient selection
`
`• Leverage new
`modalities and
`capabilities
`• Explore emerging biology to bring
`innovative medicines to patients
`• PK/PD modeling platforms
`
`Greater
`understanding of
`disease biology
`
`Regulators’
`openness to
`new ideas
`
`Greater patient
`stratification
`by disease
`pathology
`
`NEUROSCIENCE
`LEADER
`
`New
`tech-enabled
`biomarkers
`
`Improved
`modalities
`
`Advances
`in genetics
`
`•
`
`Leverage expertise to
`accelerate clinical development
`• Novel MS clinical endpoints
`• Pre and post market
`Real-World Evidence
`
`•
`
`In vivo imaging and
`fluid biomarkers
`• Markers of meningeal
`inflammation and damage
`• Remyelination and
`synaptic density imaging
`biomarkers
`
`• Agreement with UK Biobank to
`enable deeper genetic insights
`• Genetics & disease
`progression analysis
`iPSC Technologies and 3D
`Human Tissue Models
`• Genome-wide CRISPR screening
`
`•
`
`38
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`MYLAN PHARMS. INC. EXHIBIT 1088 PAGE 38
`
`

`

`Leveraging our Depth in MS to Expand Neuroscience Leadership
`
`MULTIPLE SCLEROSIS /
`NEUROIMMUNOLOGY
`
`NEUROMUSCULAR
`DISORDERS
`
`PAIN
`
`ALZHEIMER’S DISEASE /
`DEMENTIA
`
`PARKINSON'S DISEASE /
`MOVEMENT DISORDERS
`
`ACUTE
`NEUROLOGY
`
`OPHTHALMOLOGY
`
`NEUROCOGNITIVE
`DISORDERS
`
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`
`MYLAN PHARMS. INC. EXHIBIT 1088 PAGE 39
`
`

`

`Questions & Answers
`
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`MYLAN PHARMS. INC. EXHIBIT 1088 PAGE 40
`
`