Hemophilia R&D Roundtable

September 28, 2010

 Forward-Looking Statements

This presentation includes forward-looking statements about the anticipated development

and timing of programs in our clinical pipeline, regulatory actions and potential markets
for our product candidates, among others. These forward-looking statements may be
accompanied by such words as anticipate, believe, estimate, expect, forecast,
intend, may, plan, will and other words and terms of similar meaning. You should
not place undue reliance on these statements.
These statements involve risks and uncertainties that could cause actual results to differ
materially from those reflected in such statements, including the risk that we may not fully
enroll our planned clinical trials, unexpected concerns may arise from additional data or
analysis, regulatory authorities may require additional information, further studies, or may
fail to approve any product candidate, we may encounter other unexpected hurdles and
the other risks and uncertainties that are described in the Risk Factors section of our
most recent annual or quarterly report and in other reports we have filed with the SEC.
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.

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Hemophilia R&D Roundtable

Glenn Pierce, VP and Chief Medical Officer BIIB Hemophilia

Matt Ottmer, VP and General Manager BIIB Hemophilia

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 Agenda

Welcoming Comments George Scangos, PhD

Overview of Hemophilia Matt Ottmer

Background Glenn Pierce, MD, PhD
Current Clinical Treatments
Market Dynamics
Patient Perspective
Q&A
Recombinant Long Acting Coagulation Factors Glenn Pierce, MD, PhD
Fc Fusion Technology Platform
rFIXFc Preclinical and Clinical Data
rFVIIIFc Preclinical Data and Development Plan
Q&A
Key Opinion Leader Panel Margaret Ragni, MD, MPH
Ellis Neufeld, MD, PhD

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Recombinant Long Acting Coagulation Factors

Background
Current Clinical Treatments
Market Dynamics
Patient Perspective

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 History of Biogen Idecs Entry into Hemophilia

Syntonix founded in 1998 based on Harvard and

Brandeis research
Neonatal Fc receptor, FcRn, expressed in human
endothelial cells
In 2003 focused on long-lasting versions of drugs
for the treatment of hemophilia
BIIB acquired Syntonix in 2007
Moved programs forward aggressively utilizing CMC
and manufacturing expertise
Established a core of hemophilia experience

Founded Initiated Hemophilia Acquired by rFVIIIFc A-LONG

Programs Biogen Idec Ph I/II rFVIIIFc Ph 3

1998 2000 2002 2004 2006 2008 2010

Monomer Partnership rFIXFc B-LONG

Patents filed w/ Biovitrum Ph I/II rFIXFc Ph3

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 Hemophilia A and B Represent a Combined $6+ Billion Market
With Tremendous Potential for Differentiated Products

FIX 2009 W.W. Revenues FVIII 2009 W.W. Revenues

100 100 Refacto/Xyntha

Recombinant $241M (Pfizer)
Helixate FS
$441M (CSL, mfg by Bayer)

75 75
$730M BeneFIX $3.8B Kogenate FS
(Pfizer) $803M (Bayer)

50 50
Percentage

Advate/
25 25 $2,289M Recombinate
$320M Plasma-derived (Baxter)

$1.1B Plasma-
derived
0 0
Market
Source: Analyst Share
reports and internal analyses based on quant market research Market Share Market Share

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 Hemophilia Demographics

Hemophilia A Hemophilia B
(Classic Hemophilia) (Christmas Disease)

Portion of Hemophilic Population 80% 20%

Deficient Clotting Factor in the Body Factor VIII (FVIII) Factor IX (FIX)

Approx Incidence (CDC) 1 in 5,000 male births 1 in 20,000 male births

Approx Number of Hemophilia Patients
in U.S. 16,000 3,300

Identified Patients Globally (WFH) 108,000 22,000

Calculated Expected Global Prevalence 680,000 170,000

70% of patients inherit Hemophilia and 30% develop spontaneous genetic mutations

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 Hemophilia Breakdown in the
Coagulation Cascade

Intrinsic Pathway Extrinsic Pathway

FXII FXIIa FVIIa FVII

FXI FXIa
FX
Hemophilia B FIX FIXa

Hemophilia A FVIII
FVIII FVIIIa
FXa
FVa FV FXIII

FII FIIa
FXIIIa

FI Fibrin Fibrins Fibrinj

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 Severity of Hemophilia is Defined by
Functional Factor Levels

Severe Patient Patient with a factor level less than 1% of the normal factor level

Moderate Patient Patients with a factor level from 1% to 5% of the normal factor level

Mild Patient Patients with a factor level of >5% to 30% of the normal factor level

Patient Segmentation by Severity

Severity is largely, but not always, predictive of bleeding frequency

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 Clinical Manifestations of Hemophilia

Acute Trauma or Spontaneous Hemorrhage Soft Tissue Bleeds

Joint Bleeds (hemarthroses)

Closed Space Bleeds Major

Mortality
Intracranial
Retroperitoneal
Retropharyngeal

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 Evolution of Hemophilia Treatment

Recombinant Era
Late
1969 1993 2000s Development 2008
1990s

Plasma-derived Bio-Similar
rFactor VIIIs Factors VIII,
Factor VIII and Factor IX rFactor IX
Concentrates IX
rFactor VIIa
Widespread viral
Fusion,
contamination PEG
Improved devices FVIIIs,FIXs
for reconstitution
PEG,
Enhanced
rFVIIas
Future Therapies

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Prophylaxis is the Standard of Care in the Developed World

Home Treatment
IV injections of Factor VIII or IX
Administered by self or family member

On-Demand Therapy
Injection to stop bleeds, as needed
On-demand treatment decreasing

Regular Prophylaxis
Regular injections to maintain a minimum
Factor level to avoid spontaneous bleeds
Hemophilia B: 2-3x/week
~110 infusions per year for FIX
Hemophilia A: 3-4x/week
~150-180 infusions per year for FVIII

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 Prophylaxis Has Been Demonstrated to
Yield Significant Benefits

Proven reduction in bleeding frequency

Proven preservation of joint structure in young patients
May reduce other morbidities (e.g., ICH)
May reduce risk of inhibitor formation when started early
May improve quality of life and productivity
May reduce healthcare utilization

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 Prophylaxis with Short-Acting Factors
Has Significant Hurdles

Clotting factors have short half-lives in circulation

Prophylaxis requires intravenous infusion as often
as every other day
Up to 180 i.v. infusions per year
A longer-acting factor product may
Allow reduced infusion frequency
Goal of decreasing number substantially (by
50-100 per year)
Improve adherence to prophylaxis
Avoid need for central catheter implantation
Reduce total factor consumption
Result in fewer bleeding episodes via increased
compliance with regimen

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Hemophilia R&D Roundtable

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Recombinant Long Acting Coagulation Factors

Fc Fusion Technology Platform

rFIXFc Preclinical and Clinical Data
rFVIIIFc Preclinical Data and Development Plan

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 Fc Fusion Proteins Mechanism of Action

Roopenian, Akilesh, Nat Rev

Immunol 2007

Fc portion of IgG interacts with an Fc receptor (FcRn) in endothelial cells

for recycling in the circulation
Fc fusion proteins piggyback on this recycling system, resulting in
extended circulatory half-life

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 Therapeutic Utility of Fc Fusion Proteins

Model of Orencia
Numerous recombinant Fc fusion proteins
approved for clinical use
Traditional Fc fusion proteins are dimeric
Enbrel (Etanercept, TNFR, 1998)
Dimeric Amevive (Alefacept, LFA-3, 2003)
Effector Orencia (Abatacept, CTLA-4, 2005)
Molecules Arcalyst (Rilonacept, IL-1R, 2008)
Nplate (Romiplostim, TPO peptide, 2008)
Well established safety profile for chronic
therapy
Several more in clinical trials
Biogen Idec has prior experience in
developing Fc fusion proteins for clinical
use

Dimeric Fc
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 Biogen Idec Fc Fusion Proteins

Immunoglobulin G BDD-rFVIII

Variable Variable
Region Region

Constant Constant
Region (Fc) Region (Fc)

Fully Recombinant FVIII-Fc

Fusion Protein
Expressed in human cell line as a single FVIII (Monomer)
protein
Co-expressed with additional Fc
Purified as monomeric rFVIIIFc Fc (Dimer)

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 rFIXFc is a Monomeric Fc Molecular Fusion

Model of rFIXFc
Monomer technology is being
applied to FIX for treatment of
Hemophilia B
rFIXFc monomer exhibits
FIX improved properties compared to
the rFIXFc dimer
Monomeric
Effector Monomer configuration has
Molecule demonstrated a range of
improvements for a variety of
Fc proteins

Dumont JA et al Biodrugs 20(3):151: 2006

Dumont JA and AB Bitonti ADDR 58: 1106: 2006
Bitonti AB et al PNAS 101(26)9763: 2000

Dimeric Fc

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Recombinant Long Acting Coagulation Factors

Fc Fusion Technology Platform

rFIXFc Preclinical and Clinical Data
rFVIIIFc Preclinical Data and Development Plan

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 Clinical/Regulatory Approach for
Coagulation Factors

Establish safety in adult PTPs (previously treated patients)

Then move to pediatric (<12 yrs) PTPs

Finally evaluate in PUPs (previously untreated patients)

1Hemophilia, 2004
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 Orphan Designation for rFIXFc and rFVIIIFc

rFIXFc rFVIIIFc

9 OrphandesignationinUS OrphandesignationinUSplanned
9 Orphan designation in Europe 9 Orphan designation in Europe

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 Overview of rFIXFc Phase III Trial

An Open-Label, Multicenter Evaluation of the Safety, Pharmacokinetics,

and Efficacy of Recombinant, Long-acting Coagulation Factor IX Fc Fusion
(rFIXFc) in the Prevention and Treatment of Bleeding in Previously Treated
Subjects With Hemophilia B

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 rFIXFc Phase III Trial Endpoints

Primary Outcome Measures

Safety/tolerability include clinically notable changes from baseline in PE, vital
signs, lab values, and incidence of AEs, including the incidence of inhibitor
development
Number of breakthrough bleeding episodes with rFIXFc

Secondary Outcome Measures

PK parameter estimates of rFIXFc and BeneFIX at baseline in the Sequential PK
subgroup as well as rFIXFc at Week 26
Efficacy of rFIXFc used on-demand and surgical subgroup
Subjects' response to treatment
rFIXFc consumption

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 rFIXFc Phase III Trial Design

Four experimental arms to administer (IV) rFIXFc (n=75)

Low dose prophylaxis
High dose prophylaxis
On demand
Surgical

Inclusion
9 Male, 12yrsofageand 40kg
9 SevereHemB(2%FIX:C)
9 100EDs withanyFIXtherapy
9 Platelets 100,000cells/L
Exclusion
8 HistoryofFactorIXinhibitors
8 Kidneyorliverdysfunction
8 Diagnosiswithanothercoagulation
defectotherthanhemophiliaB
8 Priorhistoryofanaphylaxisassociated
withanyFIXorIV IgG administration

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Recombinant Long Acting Coagulation Factors

Fc Fusion Technology Platform

rFIXFc Preclinical and Clinical Data
rFVIIIFc Preclinical Data and Development Plan

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Hemophilia R&D Roundtable

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