defa14a
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
SCHEDULE 14A
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Soliciting Material Pursuant to § 240.14a-12 |
BIOGEN IDEC INC.
(Name of Registrant as Specified In Its Charter)
N.A.
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Evan Beckman, M.D.
SVP, Immunology R&D
Immunology Pipeline
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Safe Harbor Statement
This presentation contains forward-looking statements about:
the sales potential of baminercept alfa (LTbR-Ig) in rheumatoid arthritis
the sales potential of RITUXAN(r) (rituximab) in lupus
the sales potential of TYSABRI(r) (natalizumab) in Crohn's disease
the anticipated development and timing of programs in our clinical pipeline
our expected filings with regulatory agencies
In addition, in the course of the presentation, we may provide additional information of a forward-looking nature.
Each forward-looking statement is subject to risks and uncertainties that could cause actual results to differ materially from those
that we express or imply.
Important factors that could cause our actual results to differ include our continued dependence on our two principal products,
AVONEX(r) and RITUXAN(r), the uncertainty of success in commercializing other products including TYSABRI(r), the occurrence of
adverse safety events with our products, the consequences of nomination of directors for election to our Board by an activist
shareholder, the failure to execute our growth strategy successfully or to compete effectively in our markets, our dependence on
collaborations over which we may not always have full control, possible adverse impact of government regulation and changes in
the availability of reimbursement for our products, problems with our manufacturing processes and our reliance on third parties,
fluctuations in our operating results, our ability to protect our intellectual property rights and the cost of doing so, the risks of doing
business internationally and the other risks and uncertainties that are described in Item 1.A, Risk Factors, in our Annual Report on
Form 10-K for the year ended December 31, 2007 and in our quarterly reports on Form 10-Q and in other periodic and current
reports we file with the SEC.
These forward-looking statements speak only as of the date of this presentation, and we do not undertake any obligation to
publicly update any forward-looking statements, whether as a result of new information, future events, or otherwise.
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Proxy Communication Statement
Biogen Idec and its directors, executive officers and other members of its management and employees may
be deemed to be participants in the solicitation of proxies from the stockholders of Biogen Idec in
connection with the Company's 2008 annual meeting of stockholders. Information concerning the interests
of participants in the solicitation of proxies will be included in any proxy statement filed by Biogen Idec in
connection with the Company's 2008 annual meeting of stockholders. In addition, Biogen Idec files annual,
quarterly and special reports with the Securities and Exchange Commission (the "SEC"). The proxy
statements and other reports, when available, can be obtained free of charge at the SEC's web site at
www.sec.gov or from Biogen Idec at www.biogenidec.com. Biogen Idec stockholders are advised to read
carefully any proxy statement filed in connection with the Company's 2008 annual meeting of stockholders
when it becomes available before making any voting or investment decision. The Company's proxy
statement will also be available for free by writing to Biogen Idec Inc., 14 Cambridge Center, Cambridge,
MA 02142. In addition, copies of the proxy materials may be requested from our proxy solicitor, Innisfree
M&A Incorporated, by toll-free telephone at (877) 750-5836 or by e-mail at info@innisfreema.com.
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Immunology at Biogen Idec
Experience
Veteran team of immunology discovery researchers with record of
generating product development candidates
(LTbR-Ig, anti-CD40L PEG-Fab, BR3-Fc, anti-BR3 mAb, LFA3-Fc, anti-
CD20 mAb, anti-CD23 mAb)
BIIB products approved worldwide in a wide range of indications
including rheumatoid arthritis, psoriasis and MS - experienced
development team
With additional development experience in Lupus, Crohn's disease
Diseases have predictive clinical endpoints
Broad application across a range of diseases / markets
Lifecycle opportunities
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Immunology
Autoimmune
RA, SLE, MS, IBD
Inflammatory Diseases
COPD, Asthma,
Atherosclerosis,
Metabolic syndrome
Infectious Disease
Hepatitis
Organ Protection
Stroke, MI
Oncology
NHL, CLL, solid tumor
Opportunities for Life Cycle Management
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Immunology Strategy
Disease Lupus Scleroderma Neuro-degenerative RA Asthma IBD Transplant Psoriasis
Unmet Need + + + + + + +++ + + + + + + + + +
Immune Targets
T Cells ^ ^ ^ ^ ^ ^ ^ ^
Adhesion/ Migration ^ ^ ^ ^ ^ ^ ^ ^
B Cells ^ ^ ^ ^ ^ ^
Monocytes/ Dendritic Cells ^ ^ ^ ^ ^ ^
Cytokines/ Chemokines ^ ^ ^ ^ ^ ^
Eosinophils/ Mast Cells ^
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B Cell
Modulation
RITUXAN
hu Anti-CD20
LTßR-Ig
Anti-CD40L
Cytokines
Chemokines
AVONEX(r)
LTßR-Ig
Anti-TWEAK
Tolerance
Anti-CD40L
Cell
Trafficking
TYSABRI
LTßR-Ig
Mechanisms of Interest
We have chosen to focus on certain key areas of biology
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Biogen Idec Immunology Pipeline
Stage
Phase 3
Phase 2
SLE - Phase 2/3
LN - Ph 3
TNF-IR - Marketed
DMARD-IR - Ph3
Phase 1
Market
RITUXAN
Ocrelizumab
(2nd gen. CD20 MAb)
Phase 2
Phase 3
Pre-Clinical
LTbR-Ig
(baminercept alfa)
RITUXAN
Indication
Rheumatoid arthritis
Rheumatoid arthritis
Lupus - SLE &
Lupus Nephritis
Rheumatoid arthritis
TYSABRI
Marketed - US
Crohn's disease
Marketed - Germany
FUMADERM
Psoriasis
Anti-CD40L
Preclinical
Lupus
Anti-TWEAK
Preclinical
Rheumatoid arthritis
Collaboration and
Partnered Programs
Internal and
Licensed Programs
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Rheumatoid Arthritis in the United States
Chronic, progressive disease that
results in disability and reduced
quality and duration of life
The RA biologics market is
expected to reach $10B by 2015
Standard of care evolving toward
using novel therapies earlier in
disease for better outcomes
The RA market place will
become increasingly competitive
Sources: Datamonitor, Decision Resources
0
200
400
600
800
1,000
1,200
1,400
1,600
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
Patients (,000's)
TNF IR
DMARD IR
320K TNF
Treated
210K
TNF-IR
2006
DMARD IR
915K
1.5 M Mod/Severe
Growth in Treated RA Mod/Severe Patients
2006
- -
2015
2.8M RA Prevalence
2.1M RA
Diagnosed
Prevalence per 100,000: 0.9%
Incidence per 100,000: 32.7
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Strategic Opportunities for RA
Biologics
TNF-IR / DMARD-IR
Early RA
Combination therapy
Oral small molecules
Personalized approaches
RITUXAN, LTbR-Ig, Anti-
TWEAK
Preclinical candidates
Translational medicine
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RITUXAN / B Cell Therapies
for Rheumatoid Arthritis
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RITUXAN
Mechanism of Action
ADCC = antibody-dependent cellular cytotoxicity.
CDC = complement-dependent cytotoxicity.
Macrophage,
monocyte, or
natural killer cell
CDC
Fc?RII, Fc?RIII
Cell lysis
CD20
CD20
Cell lysis
MAC
Complement activation (C1qC1rC1s)
Apoptosis
RITUXAN
ADCC
B cell
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RITUXAN Clinical Development
Rheumatoid Arthritis
Anti-TNF
Inadequate
Responders
Anti-TNF
Inadequate
Responders
Methotrexate
Naive
Methotrexate
Inadequate
Responders
Phase III
SERENE
(n = 512)
Phase III
IMAGE
Radiographic
Study
(n = 750)
Phase III
SUNRISE
Controlled
Re-treatment Study
(n = 555)
Phase III
REFLEX
Study
(n = 520)
1-year
radiographic
data added to
label Jan 2008
June 2006
EULAR
Initiated Q1-06
Completed
enrollment Q4-06
Positive top line
data announced
Q4-07 earnings
Initiated Q4-05
Completed
enrollment Q4-06
Positive top line
data announced
Jan 2008
Initiated Q1-06
Completed
enrollment Q4-07
Top line data in
H1-2009
Patient
Population
Phase
Study
# of patients
Status
DMARD - IR RA
Anti-TNF - IR RA
Data Readout
RITUXAN approved in RA for anti-TNF IR patients - Q1 2006
Phase III trials in DMARD-IR - met primary endpoint - Jan 2008
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LTbR-Ig
(baminercept alfa)
A Soluble Lymphotoxin b Receptor
for Rheumatoid Arthritis
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LTbR-Ig (baminercept alfa; BG9924)
Fusion protein
Human lymphotoxin beta
receptor (LTbR)
Fc portion of human IgG1
Disulfide-linked
glycosylated, dimeric
protein
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Lymphtoxin ?/? Pathway is implicated in:
Liver, spleen and lymph nodes
Gut mucosa and Peyer's patches
Surface LTa/b and LIGHT pathways
LT? Receptor
LT?/?
(lymphotoxin)
Organization of lymphoid architecture,
cellular positioning, etc.
Activated
lymphocytes and
resting B cells
Stromal cells,
myeloid lineage
cells
LIGHT Pathway is implicated in:
Mucosal and hepatic inflammation
HVEM Receptor
LIGHT
T-cell, dendritic cell activation
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Lymphtoxin ?/? Pathway is implicated in:
Liver, spleen and lymph nodes
Gut mucosa and Peyer's patches
LIGHT Pathway is implicated in:
Mucosal and hepatic inflammation
Surface LTa/b and LIGHT pathways
LT? Receptor
HVEM Receptor
LIGHT
LT?/?
(lymphotoxin)
LTbR-Ig
Dual Pathway
Inhibitor
T-cell, dendritic cell activation
Organization of lymphoid architecture,
cellular positioning, etc.
Activated
lymphocytes and
resting B cells
Stromal cells,
myeloid lineage
cells
X
X
X
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RA Synovium
Normal Synovium
Ectopic lymphoid
structures
Inhibition of the LT
pathway can disrupt
ectopic lymphoid
organization and limit B-
and T-cell activation.
LTbR-Ig can disrupt
the formation of
ectopic lymphoid
structures in RA
synovium
Synovial Ectopic Lymphoid Structures in
Chronic Inflammatory Diseases Like RA
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LTbR-Ig
Phase 2a Data
Presented Phase 2a data as poster at ACR meeting on November 9th
Clinically meaningful ACR responses 8 weeks after the final 4th weekly SC dose
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LTbR-Ig (baminercept alfa) Status
Initiate Phase 2b RA trial in DMARD-IR mid-2007
380 patients, dose ranging trial
Primary endpoint ACR50 at 3 months
Initiate Phase 2b RA trial in TNF-IR mid-2007
120 patients
Primary endpoint ACR50 at 3 months
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Systemic Lupus Erythematosus in the US
Chronic autoimmune disorder
which may affect virtually any
part of the body and can range in
severity from mild to life-
threatening
An estimated 425,000 diagnosed
patients in US
High unmet need due to limited
efficacy of current therapies
Long-term use of current drugs
such as Cytoxan have poor
safety profile
Sources: Datamonitor, Decision Resources
Growth in Treated ERL and LN Patients
2007-2015
2007
630K Lupus
Prevalence
425K Diagnosed
Class II-V
70%
130K
Mod/Severe
50%
150K
300K
SLE
190K
30% LN
0
50
100
150
200
250
300
350
400
450
500
2007
2008
2009
2010
2011
2012
2013
2014
2015
Patients (,000's)
Lupus Nephritis
SLE
Hematologic
Cardio-
pulmonary
Neurologic
Joint
Dermatologic
Renal
Malar rash
Discoid rash
Photosensitivity
Vasculitis
Anemia
Thrombocytopenia
Leukopenia
Arthritis
Nephritis
Minimal change
Mesangial
FSGN
PGN
Membranous
Seizures
Psychosis
Immunologic
Anti-DNA
Anti-Ro
Anti-Sm
Pericarditis
Pleuritis
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RITUXAN / B Cell Therapies
for Systemic Lupus Erythematosus
/ Lupus Nephritis
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RITUXAN Clinical Development
SLE and Lupus Nephritis
Lupus
Nephritis
Systemic
Lupus
Erythematosus
Phase II/III
EXPLORER
(n=260)
Phase III
LUNAR
(n=140)
Initiated Q2-05
Completed
enrollment Q1-07
H1 2008
Initiated Q1-06
Completed
enrollment Q4-07
2009
Patient
Population
Lupus Program
Status
Phase
Study
# of patients
Data Readout
RITUXAN development ongoing in SLE and LN
Enrollment for both completed in 2007
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BILAG Index in EXPLORER
EXPLORER Primary Objective - summary
To assess the efficacy of rituximab compared to placebo in achieving and
maintaining clinical response based on monthly BILAG assessments to week 52
BILAG-2004 Index (Disease Activity Instrument)
An index that assesses 97 clinical signs, symptoms and laboratory
measures across 9 organ systems (Isenberg, et al, 2005)
Categorizes activity based on severity, change over the past month and
need to change therapy
Clinically relevant, validated and sensitive to change
Other Disease Instruments (Exploratory Assessments)
SELENA-SLEDAI (Disease Activity)
An index that measures disease activity in 9 organ systems over the
past 10 days (Liang MH, et al, 1989)
SLICC / ACR-SDI (Damage)
An Index that measures damage according to 12 different systems
and categories (Gladman, et al, 1996)
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TYSABRI
for Crohn's Disease
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Crohn's Disease & Market Opportunity
Crohn's Disease
Chronic and progressive inflammatory disease of the gastrointestinal tract
Unmet medical need as many patients fail to respond to current therapies
~500,000 CD patients in the US
TYSABRI(r) Market Opportunity
Estimated 40,000 - 50,000 CD patients in the US are currently being
treated with a biologic therapy
Sales of anti-TNF agents for CD estimated at ~$700 million in 2007
Anticipated Market Dynamics
Crohn's Disease biologic market expected to grow with recent approvals
Reduced immunosuppressive use with new entrants, particularly in
combination with biologics
Steroid sparing ability will be become more important
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TYSABRI Induction Data is
Comparable to Anti-TNFs
Placebo N=25 5 mg/kg N=27 10 mg/kg N=28 20 mg/kg N=28 Placebo N=74 40/20 mg N=74 80/40 mg N=75 160/80 mg N=76 Placebo N=73 100 mg N=74 200 mg N=72 400 mg N=72 Placebo N=250 300 mg N=259
Observed 16 81.5 50 64.3 37 54 59 59 31.1 41.9 54.2 54.2 37 51
Targan et al. N Engl J Med. 1997;337:1029-1035. Hanauer et al. Gastroenterol. 2006;130:323-333. Schreiber et al.
Gastroenterol. 2005 Sep;129:807-18
P<0.01
p=0.01
P<0.002
P=0.003
P=0.003
P<0.05
REMICADE
CIMZIA
HUMIRA
P=0.01
P=0.007
TYSABRI
P=0.001
Clinical Response at 4 weeks
Competing
Therapy
TYSABRI
Placebo
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TYSABRI Maintenance Data
Compares Favorably to Anti-TNFs
ENACT-2
(300 mg/q4w)
CHARM
(40 mg/eow)
ACCENT 1
(5 mg/kg q8w)
REMICADE
HUMIRA
TYSABRI
P=0.007
P<0.001
P<0.001
Remission at 1 year
Competing
Therapy
TYSABRI
Placebo
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Month 6 Month 12
placebo (ITT) 30 22
natalizumab (ITT) 55 55
placebo (-IMM) 31 21
natalizumab (-IMM) 54 53
placebo (+IMM) 30 23
natalizumab (+IMM) 58 60
- - IMM
- - IMM
+ IMM
+ IMM
Month 6
Month 12
ITT
ITT
P ^ 0.002 for all comparisons with placebo
Placebo
TYSABRI
Concomitant Immunosuppressives are
Not Needed to Maintain Remission
(171)
(168)
(111)
(106)
(60)
(62)
(171)
(168)
(111)
(106)
(60)
(62)
Note: Patient numbers are indicated in numbers in parentheses
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TYSABRI Crohn's Disease
TYSABRI(r) approved in US on January 14th 2008
Approved for inducing and maintaining clinical response and
remission in adult patients with moderately to severely active
Crohn's disease (CD) with evidence of inflammation who have had
an inadequate response to, or are unable to tolerate, conventional
CD therapies and inhibitors of TNF-alpha
Tysabri is available to CD patients through a CD-specific risk
management plan that includes participation in the mandatory
TOUCH(tm) Prescribing Program
Anticipated to be available to CD patients by the end of February
2008
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Immunology Development Summary
Biogen Idec currently has important marketed
products targeting key immunologic pathways
Unmet need remains in many autoimmune diseases
Leveraging our core expertise in immunology, next
generation projects will bring further value in
autoimmune disease
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Cardiopulmonary and
Emerging Therapeutic Areas
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Acute Heart Failure
Disease Characteristics & Unmet Medical Need
Heart failure patients can't pump enough blood to the body's other organs
Significant morbidity and mortality
Five year mortality higher than most cancers
Frequent cause of hospitalizations
Hyponatremia and renal complications extend the length of hospital stays and
increase readmissions
Limiting toxicities associated with current therapies
Market Opportunity
Heart failure leading cause of hospitalizations in the world
Top three healthcare system cost burden (heart failure, diabetes & asthma)
>1 million hospitalizations each year in the U.S.
~35% heart failure patients hyponatremic on admission
Growing patient base
Addressable with specialty hospital based sales force
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Acute Heart Failure Therapies
Current therapeutic approaches
Fluid restriction to remove water
Only current therapy for hyponatremic heart failure patients
Diuretics remove water, but also remove sodium
Can induce hyponatremia and worsen renal function
Positive inotropes inhibit sodium pump, increase heart contraction strength
Potential increase in the incidence of cardiac arrhythmias, other limitations
Potential therapeutic improvements
"Aquaretics" regulate water volume independent of sodium or other
electrolytes
Lixivaptan
Renal protectants
Adentri
Combination therapies
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Cardiopulmonary & Emerging
Therapeutic Area Pipeline
Stage
Acute - Phase 2
Chronic - Phase 2
Phase 1
Market
Phase 2
Phase 3
Pre-Clinical
ADENTRI
Indication
Acute Heart Failure - IV
Chronic Heart Failure - Oral
Phase 2
Aviptadil
Preclinical
Long Acting
rFactor IX
Pulmonary arterial
hypertension
Hemophilia B
Preclinical
Long Acting
rFactor VIII
Hemophilia A
Lixivaptan
Acute Heart Failure with
Hyponatremia
Phase 3
Collaboration and
Partnered Programs
Internal and
Licensed Programs
Cardiopulmonary
Emerging Therapeutic Areas
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Lixivaptan
Late stage asset lixivaptan
Collaboration agreement with Cardiokine announced July 2007
Selective oral V2 vasopressin receptor antagonist
Promising Phase 2 activity for hyponatremia (low plasma sodium concentration)
Phase 3 recently initiated
Randomized, placebo controlled, double blind, multicenter trial
Over 600 heart failure patients with hyponatremia randomized 1:1
Dosing titrated for each patient
Primary Endpoint: Increase in serum sodium
Special Protocol Assessment with FDA
Additional trials planned to begin in 2008
Hyponatremia (plasma sodium <135 mmol/L)
Common complication associated with heart failure and other disorders
Often leads to fluid volume overload and hospitalization
~1.4 million hyponatremic patients in U.S. (~60% associated with heart failure)
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Cecil B. Pickett, Ph.D.
President, R&D
Research and Development
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Safe Harbor Statement
This presentation contains forward-looking statements about:
the anticipated development and timing of programs in our clinical pipeline
our expected filings with regulatory agencies
In addition, in the course of the presentation, we may provide additional information of a forward-looking
nature.
Each forward-looking statement is subject to risks and uncertainties that could cause actual results to differ
materially from those that we express or imply.
Important factors that could cause our actual results to differ include our continued dependence on our two
principal products, AVONEX(r) and RITUXAN(r), the uncertainty of success in commercializing other
products including TYSABRI(r), the occurrence of adverse safety events with our products, the
consequences of nomination of directors for election to our Board by an activist shareholder, the failure to
execute our growth strategy successfully or to compete effectively in our markets, our dependence on
collaborations over which we may not always have full control, possible adverse impact of government
regulation and changes in the availability of reimbursement for our products, problems with our
manufacturing processes and our reliance on third parties, fluctuations in our operating results, our ability to
protect our intellectual property rights and the cost of doing so, the risks of doing business internationally
and the other risks and uncertainties that are described in Item 1.A, Risk Factors, in our Annual Report on
Form 10-K for the year ended December 31, 2007 and in our quarterly reports on Form 10-Q and in other
periodic and current reports we file with the SEC.
These forward-looking statements speak only as of the date of this presentation, and we do not undertake
any obligation to publicly update any forward-looking statements, whether as a result of new information,
future events, or otherwise.
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Proxy Communication Statement
Biogen Idec and its directors, executive officers and other members of its management and employees may
be deemed to be participants in the solicitation of proxies from the stockholders of Biogen Idec in
connection with the Company's 2008 annual meeting of stockholders. Information concerning the interests
of participants in the solicitation of proxies will be included in any proxy statement filed by Biogen Idec in
connection with the Company's 2008 annual meeting of stockholders. In addition, Biogen Idec files annual,
quarterly and special reports with the Securities and Exchange Commission (the "SEC"). The proxy
statements and other reports, when available, can be obtained free of charge at the SEC's web site at
www.sec.gov or from Biogen Idec at www.biogenidec.com. Biogen Idec stockholders are advised to read
carefully any proxy statement filed in connection with the Company's 2008 annual meeting of stockholders
when it becomes available before making any voting or investment decision. The Company's proxy
statement will also be available for free by writing to Biogen Idec Inc., 14 Cambridge Center, Cambridge,
MA 02142. In addition, copies of the proxy materials may be requested from our proxy solicitor, Innisfree
M&A Incorporated, by toll-free telephone at (877) 750-5836 or by e-mail at info@innisfreema.com.
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Agenda
R and D Strengths
R and D Strategy
Biogen Idec Pipeline
2008 R and D Goals
Q & A
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Biogen Idec's R and D Strengths
Strong R&D fundamentals
World class biotherapeutic discovery and development
organization
Focused drug discovery and development efforts:
Neurology
Immunology
Oncology
Cardiopulmonary & Emerging areas
Strong link between discovery research, clinical development, and
strategic business units
Proven track record of discovering and developing innovative
molecules
Extensive biologic manufacturing expertise
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R and D Strategy
Focus on the discovery and development of novel therapeutics
to address areas of high unmet medical need
Recommend six new development candidates each year:
Biologics and Small Molecules
Internal Discoveries and in-licensing opportunities
Innovative First in Class Molecules as well as Best in Class
Molecules
Conduct scientifically rigorous clinical Proof of Concept
experiments
Execute Pivotal Registration Programs with a Global Clinical
Operations Organization
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Biogen Idec Pipeline
Robust Pipeline:
3 new indication programs for Rituxan
5 novel phase III programs by year end
8 phase II programs
10 pre-clinical/phase I programs
A good mix of biologics and small molecules
Both internally discovered and in-licensed
compounds in development
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Biogen Idec Pipeline
Late Development
Program Status Indication
BG-12 Phase 3 RRMS
Galiximab Phase 3 Relapsed NHL
Lumiliximab Phase 3 Relapsed CLL
Lixivaptan Phase 3 Acute heart failure with hyponatremia
Adentri (IV) Phase 3 in 2008 Acute decompensated congestive heart failure
Program Status Indication
Daclizumab Phase 2 RRMS
CDP323 Phase 2 RRMS
LTbR-Ig (baminercept alfa) Phase 2 RA
M200 (volociximab) Phase 2 Solid Tumors (ovarian, NSCLC, melanoma)
Hsp90 Inhibitor (2024) Phase 2 Solid Tumors (FDG-PET GIST)
Aviptadil Phase 2 PAH
Adentri (oral) Phase 2 Chronic heart failure
BIIB14 Phase 2 Parkinson's disease
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Biogen Idec Pipeline
Early Development
Program Status Indication
Anti-IGF-1R Phase 1 Solid Tumors
Anti-Cripto-DM4 Preclinical Solid Tumors
Hsp90 Inhibitor 3647 Preclinical Solid Tumors
Tysabri (natalizumab) Preclinical Multiple Myeloma
Raf Inhibitor Preclinical Solid Tumors
CD40L-Fab Preclinical SLE
Anti-TWEAK Preclinical RA
Neublastin Preclinical Neuropathic Pain
Long Acting rFactor IX Preclinical Hemophilia B
Long Acting rFactor VIII Preclinical Hemophilia A
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2008 R and D Goals
Advance registrational studies to achieve accelerated approval
dates:
Lumiliximab in relapsed CLL
Lixivaptan in acute heart failure with hyponatremia
BG-12 in RRMS
Galiximab in relapsed NHL
Adentri (IV) in ADHF
Advance proof of concept programs to next decision point:
BIIB14 in Parkinson's
CDP323 in RRMS
Baminercept alfa in RA
Volociximab monotherapy in Ovarian Cancer 3rd line
Hsp90 Inhibitor (2024) in GIST
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2008 R and D Goals
Advance early stage pipeline cont.
Initiate first in human studies
Anti-CRIPTO-DM4 in solid tumors
Anti-IGF-1R in solid tumors
Anti-TWEAK in RA
Hsp90 Inhibitor (3647) in solid tumors
Neublastin in neuropathic pain
Long Acting rFactor IX in hemophilia B
Initiate proof of concept studies:
IFN-beta 1a in UC
Mefloquine in PML
Tysabri in multiple myeloma
BG-12 in RA
BG-12 in CD
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Data Readouts to Year End 2008
Completed:
Daclizumab Phase 2 CHOICE in Relapsing Remitting MS
Baminercept Phase 2a in RA
Rituxan Phase 3 SERENE in DMARD-IR RA
Still to Come:
Rituxan Phase 2/3 EXPLORER in SLE
Rituxan Phase 2/3 OLYMPUS in Primary Progressive MS
Baminercept alfa Phase 2b in RA
BIIB14 Phase 2a in Parkinson's Disease
Hsp90 Inhibitor (2024) Phase 1/2 in FDG-PET GIST
Volociximab Phase 2 in one of several solid tumors
Long Acting Factor IX Phase 1/2 in Hemophilia B
Rituxan Phase 3 REACH in CLL
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Summary
Outstanding people at all levels in the R and D Organization
Robust pipeline with important compounds at all stages of
development
World-class expertise in discovery and development of
biologics
Building capability in small molecule discovery and
development
NEED TO FOCUS ON ADVANCING PIPELINE
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