This exhibit contains
“forward-looking statements” relating to expectations or
forecasts of future events, including statements relating to
prospective products, the status of product approvals, future
performance of current and anticipated products, sales efforts, the
size of markets for products, expenses and our programs to reduce
expenses, the outcome of contingencies such as litigation and
investigations, growth strategy and financial results.
Any of our forward-looking statements here or in
other publications or our remarks may turn out to be wrong. Our
actual results may vary materially, and there are no guarantees
about the performance of Schering-Plough stock. Schering-Plough does
not assume the obligation to update any forward-looking statement.
For further details and a discussion of factors that
may cause actual result to differ from forward looking statements and
other risks and uncertainties that may impact our business, see
Schering-Plough's Securities and Exchange Commission (SEC) filings,
including Schering-Plough's third quarter 2003 10-Q.
DISCLOSURE NOTICE
Our presentations may contain "forward-looking statements" within the
meaning of the Securities Litigation Reform Act of 1995 relating to
expectations for future events and estimates of various figures. Many
factors could cause actual results to differ from these forward-looking
statements. For further details about such factors and a discussion of
other risks and uncertainties that may affect the forward-looking
statements, see the Disclosure Notice included in Schering-Plough's
SEC filings, including the third quarter 2003 10-Q.
Fred Hassan
Chairman and Chief Executive Officer
Introducing the New
Schering-Plough
November 18, 2003
Carrie Cox
Executive Vice President
and President
Global Pharmaceuticals
Bob Bertolini
Executive Vice President
and Chief Financial Officer
Ron Cheeley
Senior Vice President
Global Human Resources
Brent Saunders
Senior Vice President
Global Compliance and
Business Practices
Tom Koestler
EVP, Worldwide Regulatory
Affairs, Worldwide Research
QA & Project Mgmt.
John Landis
SVP, Analytical Chemical,
Pharmaceutical and
Biotechnology Development
Agenda
Fred Hassan Introducing the New Schering-Plough
Rick Veltri The ZETIA Promise
Carrie Cox Firing Up the Growth Engines
Cecil Pickett Building the Future Growth Engines
Carrie Cox Building the Future Growth Engines
Fred Hassan Conclusions
Q&A
Seven Critical Questions
1. What Did This Team Inherit?
2. Despite The Wait, Is There Reason To Believe In
The Turnaround?
3. Can Even This Team Do It?
4. What Will Give The New Schering-Plough An Edge?
5. When Will We Know Success Is Beginning?
6. What Will Ultimate Success Look Like?
7. What Should We Expect Over The Next Five Years?
1. What Did This Team Inherit?
What Did This Team Inherit?
A Wounded Company -
in prolonged decline...
...but one that can be turned around
We have taken ownership of the issues
What Did This Team Inherit?
A Wounded Company - In Prolonged Decline
End of US CLARITIN Rx
Steep downward market share + earnings slopes!
The Situation We Inherited
TRx Market Shares
Product July '02 Jan '03 Jul '03
PEG-INTRON 89.0% 86.4% 62.6%
REBETOL 100.0% 98.0% 74.0%
CLARINEX/CLARITIN RX 39.4% 23.0% 15.1% (a
NASONEX 24.2% 24.9% 22.2%
US Market Share Declines
*Source: IMS July '02, Jan '03, July '03
a) Based on IMS Information as of July '03. Actuals for the Total Defined Antihistamine Market.
Total Defined antihistamine Market includes CLARINEX, CLARINEX REDITABS, CLARITIN-D12,
CLARITIN-D24 and CLARITIN SYRUP
What Did This Team Inherit?
A Wounded Company - In Prolonged Decline
End of US CLARITIN Rx
Steep downward market share + earnings slopes
Disconnects
Under-funding in key areas
Poor processes
Talent gaps
FDA issues and consent decree
Legal issues and fallout
Morale at benchmark lows!
What Did This Team Inherit?
"Single Stepping Stone Syndrome" - Missed
opportunity to reinvent the company during
the CLARITIN years
Focus on high margins versus long-term
investment
Holding company silos disconnects
What Did This Team Inherit?
Volatility
Tough near-term comparisons
Losec, 1H Declining slopes, (Hep C, Allergy)
Need to invest in ZETIA + eze/simva
Need to lock in long-term financing
Baseline hard to determine due to multiple moving
parts
REBETOL
Manufacturing issues and consent decree impact
Consent Decree Impact
Special Challenges in Addition to Substantial Annual Expenditures
Consent
Decree
Infrastructure
(e.g., IT)
R&D costs
and processes
Rx Customer
Service
OTC Customer
Service
Supply
Chain Pressure
AH Customer
Service
Consent Decree Impact
Special Challenges in Addition to Substantial Annual Expenditures
Severe Scheduling Challenges
Equipment Qualification Studies
Manufacturing Process Optimization
Product Process Validation Studies
Support Systems Qualification Studies
Facility and Laboratory Upgrades
Mandated Third-Party Certifications
...While producing product at the same time!
Accomplished
Remaining
1st Qtr 2nd Qtr 3rd Qtr 4th Qtr
East 20.4 0.21 15 0.79
West 30.6 38.6 34.6 31.6
North 45.9 46.9 45 43.9
South 3 10 2 15
1st Qtr 2nd Qtr 3rd Qtr 4th Qtr
East 20.4 0.35 15 0.65
West 30.6 38.6 34.6 31.6
North 45.9 46.9 45 43.9
South 3 10 2 15
Validation
Actions
Significant
Steps
Consent Decree Status
October 2003 Key Metrics
(11 actions)
(42 actions)
(78 actions)
(142 actions)
What Did This Team Inherit?
Some Solid Assets
Global Reach; 11,700 Sales Reps
$1.5 billion R&D; Unexpectedly good innovation
content in early pipeline
Products/franchises that are leaders in their own
tight markets
ZETIA Franchise Allergy Rx
Hep C REMICADE
Allergy OTC Cancer Segments
Good exclusivity on existing products
What Did This Team Inherit?
Some Solid Assets
Significant upside potential in key markets,
e.g., Japan
Motivated and resilient frontline people
2. Despite The Wait, Is There
Reason To Believe In The Turnaround?
Action Agenda
New Thinking, New Capabilities, New Urgency
Stabilize
Repair
Turnaround
Build the Base
Breakout
Despite the Wait, Is There
Reason To Believe?
Clear Action Agenda in place
Building a Strong New Team - with proven
track record in transformational change
Proven New Talent
Stan Barshay - Chairman, Consumer Health Care
Robert Bertolini - E.V.P. and Chief Financial Officer
Robert Boisclair - S.V.P., Global Supply Chain
Ron Cheeley - S.V.P., Global Human Resources
Carrie Cox - E.V.P. and President, GPB
Mike DuBois - S.V.P., Global Licensing
Margriet Gabriel-Regis - S.V.P., Specialty Care Customer Group
Ellen Geisel - S.V.P., Primary Care Customer Group
Apet Iskenderian - President, EUCAN Region
Tom Koestler, Ph.D. - E.V.P., W.W. Regulatory Affairs, W.W. Quality Assurance and
Project Management, SPRI
Tasos Konidaris - G.V.P., GPB Finance
John Landis, Ph.D. - S.V.P., Analytical, Chemical, Pharmaceutical and Biotechnology
Development, SPRI
Bruce Reid - S.V.P., Global Business Operations
Brent Saunders - S.V.P., Global Compliance and Business Practices
Jeff Winton - G.V.P., Global Communications
Chuck Ziakas - V.P., Primary Care Sales
Despite the Wait, Is There
Reason To Believe?
Clear Action Agenda in place
Building a Strong New Team - with proven
track record of success
Firing up the growth engines
Powering up the ZETIA franchise
Restarting the existing growth engines
Pursuit of new engines - both in-house and
external innovation
Despite the Wait, Is There
Reason To Believe?
Clear Action Agenda in place
Building a Strong New Team - with proven
track record of success
Firing up the growth engines
Powering up the ZETIA franchise
Restarting the existing growth engines
Pursuit of new engines - both in-house and
external innovation
Relentless cost-cutting and cost-control (VEI)
Despite the Wait, Is There
Reason To Believe?
Good Bet for a Turnaround
Potential for Top Tier, Long-Term Growth
3. Can Even This Team Do It?
Can Even This Team Do It?
Special strength for driving
change, executing turnarounds,
and building for the long term
Action Agenda
Gear-Shifting Ability
Gear 1
Hands on
Fast action
based on
experience
Recruit top
talent
Deselect
Connect with
& motivate
Front Lines
Prioritize &
Triage
Gear 2
Team Building
& Delegation
Hot pursuit of
licensing deals
Drive
Executional
Excellence
Build
processes
Coach
Build pipeline
Gear 3
Transformational
deal making
Accelerate
internal breakout
potentials
Build long-term
bench strength
4. What Will Give the NEW
Schering-Plough an Edge?
What Will Give the NEW
Schering-Plough an Edge?
Transforming A Wounded Player Into
An Effective Global Competitor
Innovation, Speed and Flexibility
Executional Excellence
What Will Give the NEW
Schering-Plough an Edge?
Globalized and integrated
Re-engineered and revitalized business units -
e.g., Marketing teams, US Sales Force
Talent upgrades
Executional Excellence
Transformation in Operations and
Way Of Working
Executional Excellence
Conventional Strategy & Execution
Strategic
Direction
Transmission
Execution
Course
Correction
Strategy divorced
from Execution -
not only in terms
of ownership and
accountability -
but also in terms
of transmission
losses and
time lags
STRATEGY
EXECUTION
When the Strategy is clear,
Execution becomes the Strategy
The New Schering-Plough
Strategy Linked with Execution - Interactive as Opposed to Linear
Portfolio
Management
Resource
Allocation
Functional
Excellence
Cross-Functional
Process
Excellence
Business Integrity
Quality
Compliance
STRATEGY
EXECUTION
Customer Focus
Top Talent
Cost-Conscious - Lean & Flat Organization
The New Schering-Plough
Project Excellence
Decision
On Target
Decision On Lead
Compounds
Decision
On Product
Candidate
Decision To
Proceed with
Full Development
Decision To Proceed
with Pivotal Trials &
Commercialization
Plan
Decision
To Submit
Decision
To Launch
Executional Excellence
Customer-Centered Product Flow
Key Decisions
Research
Development
Life Cycle
All functions own Product Flow - Only the roles change along the way
"Killer Experiments" and "Smoking Guns"
Key decisions to be taken collaboratively at gating milestones
Rigorous technical and marketing expertise brought to bear
Key Success Metric: Success with the customer
Phase IV
Phase III
Phase II
Phase I
Phase 0
Discovery
Executional Excellence
Behavior-Based Management
Leader Behaviors
Shared accountability and transparency
Cross-functional teamwork
Listen and learn
Benchmark and continuously improve
Coach and develop others
Business integrity
What Will Give the NEW
Schering-Plough an Edge?
Transformation in Operations and
Ways Of Working
Superior Global Supply Chain
Superior Quality, Compliance,
and Business Integrity
Transformed Portfolio
2004 a difficult year...
...Bridging to an
evolving fresh portfolio
What Will Give the NEW
Schering-Plough an Edge?
Bridge to a Changing Portfolio
1998-2002
2004
The Bridge
2005-2007
and Beyond
CLARITIN / CLARINEX
Hep C
REMICADE
NASONEX
INTEGRILIN
TEMODAR /
CAELYX
ZETIA
REMICADE
ZETIA
eze/simva*
REMICADE
NOXAFIL*
SARASAR*
Established
Growth Drivers
PEG-INTRON
NASONEX
CLARINEX
TEMODAR
CAELYX
INTEGRILIN
* 2005-2007 Anticipated Launch
What Will Give the NEW
Schering-Plough an Edge?
2005 and Beyond: An Exciting Product Array
Established Growth Engines - restarted!
Hep C
NASONEX
CLARINEX
Oncology
What Will Give the NEW
Schering-Plough an Edge?
2005 and Beyond: An Exciting Product Array
New Growth Engines
ZETIA
eze/simva
The ZETIA and eze/simva
Opportunity
Cholesterol Market - #1 market in the world*
Zocor - Not just #2 statin, but #2 best-selling
pharmaceutical in the world*
ZETIA - Most widely prescribed non-statin
product
eze/simva - Important new entry that should
successfully compete against any statin
*IMS Health MIDAS, MAT 6/03
What Will Give the NEW
Schering-Plough an Edge?
2005 and Beyond: An Exciting Product Array
New Growth Engines
ZETIA
eze/simva
Plus
REMICADE
NOXAFIL
SARASAR
What Will Give the NEW
Schering-Plough an Edge?
2005 and Beyond
Exciting Pipeline Potential
NOXAFIL
A2a Receptor Antagonist
CCR5 Receptor Antagonist
PDE 5 Inhibitor
HCV Protease Inhibitor
5. When Will We Know Success
Is Beginning?
When Will We Know Success
Is Beginning?
Early Signs Are Already Visible
200 Day Action Checklist
Transformed business model: Globalize + Integrate
Rolled out Global Org changes to implement new model
Launched VEI initiative targeted for annual savings of +$200
million; announced voluntary early retirement program
Installed new US team
Aligned and motivated frontline managers
Attracted top talent
Announced results of 100-day, 360-degree review
Stabilization actions begin in Hep C franchise: head-to-head
trial; REDIPEN
Achieved European approval of new REMICADE indications
Revitalized US Sales Force, including watershed US Sales
Meeting
200 Day Scorecard
Key Performance Indicators
Early Indicators of Success
eze/simva tablet FDA application submitted
REMICADE AS approval in Europe before US
REDIPEN for PEG-INTRON approved
Stabilizing NASONEX market share
CLARINEX market share stabilizing
ZETIA market share moving past 5% threshold in
US
Successfully stabilizing CLARITIN OTC in spite of
recent deep discount private label competition
Total US Outlets
Dollar Share Leading Loratadine Brands
Selected Periods
$ Share
TTL ALG-SIN
TTL CLARITIN TTL ALAVERT TTL PL ALG-SIN LORATADINE BENADRYL
11/16/02 0 0 0 35
12/14/02 9.5 0 0 31
01/11/03 41.9 0.7 0 20
02/08/03 41.1 3.5 0.1 19.1
03/08/03 39.1 6.4 0.5 19
04/05/03 40.3 7.2 5.5 17
05/03/03 42.2 8.8 6.1 15.9
05/31/03 40.9 8.3 7.2 16.7
06/28/03 36.5 8 8.3 18.3
07/26/03 32.2 7.2 9.7 21.5
08/23/03 32.4 7.4 8.7 21
09/20/03 35.8 7.3 9.6 18.7
10/18/03 34.5 6.7 9.4 17.9
CLARITIN OTC
Launch
Approved
11/27/02
Loratadine
Competition
Approved
12/20/02
Arrival of Deep Discount
Loratadine Competition
At Retail (Approval of
10 Mg Tablet)
Added Heavy Media
Wt. (8/12/03);
Subsequent to that, new
CLARITIN campaign on-air
CLARITIN
P/L Loratadine
Alavert
Benadryl
200 Day Scorecard
Key Performance Indicators
Early Indicators of Success
eze/simva tablet FDA application submitted
REMICADE AS approval in Europe before US
REDIPEN for PEG-INTRON approved
NASONEX market share stabilization
CLARINEX stabilizing
ZETIA market share > 5% in U.S
CLARITIN OTC stabilizing
Customer feedback improving
Internal morale turning around
Consent decree progress: 78 of 220 significant steps
completed
Legal progress - 2 resolutions
VEI savings for '03 on track
When Will We Know Success
Is Beginning?
Early Signs are already visible
eze/simva and ZETIA begin to fulfill potential
Existing growth engines restarted; downward
slopes flatten and growth begins
Increasing dynamism of product flow
Pursuit of new products begins to pay off
6. What Will Ultimate Success
Look Like?
What Will Ultimate Success
Look Like?
Attractive long-term growth
Attractive long-term shareholder return
Steady product flow
Superior supply chain infrastructure
Superior business integrity, quality and
compliance
What Will Ultimate Success
Look Like?
More than 50% of sales coming from 4-6
growth engine products
Product portfolio with relatively long exclusivity
Expanding and diverse R+D product flow -
50% or more from external labs
Robust, compliant processes
Competent, aligned and motivated global
workforce
Innovation, speed, and flexibility remain a
competitive edge - even as size increases
7. What Should We Expect
Over the Next Five Years?
Action Agenda
New Thinking, New Capabilities, New Urgency
Stabilize
A Long Haul...
Repair
Yielding A Successful
Turnaround...
Turnaround
Followed by Sustained
High Performance
Build the Base
Breakout
Rick Veltri, M.D.
Vice President, Clinical Research
Cardiovascular Department
November 18, 2003
ZETIA and eze/simva
Evolving Product Profiles
Hypercholesterolemia Is a Risk Factor
for Atherosclerosis and CHD
Davies MJ. Circulation. 1996;94:2013-2020.
Cardiovascular Disease Is the Leading
Cause of Death in the United States
Total CVD
Cancer
Accidents
Respiratory
Diseases
Diabetes
Influenza &
Pneumonia
CVD = Cardiovascular disease.
American Heart Association. 2002 Heart and Stroke Statistical Update.
CVD Causes 40% of All Deaths
(1999 Mortality Data)
Number of
Deaths, 1,000
Lipid-Lowering in Practice
Patients at LDL-C Goal - A Large Treatment Gap
% at LDL-C targets
LDL-C target levels (mg/dL)
? 2 RF: <130
CAD: £100
NHANES III L-TAP
45 37
18 18
North
? 2 Risk Factors Coronary Artery Disease
Risk Profile
National Center for Health Statistics. NHANES III 1994 (data collected 1991-1994);
Pearson et al. Lipid Treatment Assessment Project (L-TAP) Arch Intern Med. 2000;160:459.
Many Reasons for
LDL-C Goal Treatment Gap
Aggressive goals recommended by NCEP
ATP III guidelines
Identification of more patients who require
LDL-C < 100 mg/dL (e.g., Coronary Heart Disease
equivalent)
Undertreatment in clinical practice
Compliance challenges
Diet and therapeutic lifestyle changes
Drug therapy
Limitations of current therapies
Pharmacologic Therapy
Statins-Dose Response
% Reduction in LDL-C
Lovastatin
20/80 mg
Fluvastatin
20/80 mg
Simvastatin
20/80 mg
Pravastatin
20/80 mg
Atorvastatin
10/80 mg
Response to Minimum / Maximum Statin Dose
31
37*
40
47
55
Adapted from Illingworth. Med Clin North Am. 2000;84:23.
*Pravachol(r) (pravastatin) Package Insert.
*Crestor (rosuvastatin) for active control study Package Insert.
Rosuvastatin
10/40 mg
55
Cholesterol Sources
Liver (Production) and Small Intestine (Absorption)
SMALL
INTESTINE
LIVER
? Dual Inhibition Targets for Lipid Management
ZETIA
Novel Cholesterol Absorption Inhibitor
First in New Class of Cholesterol Lowering Drugs
Approved in US, October 25, 2002
Monotherapy
Primary Hypercholesterolemia
Homozygous Sitosterolemia
Coadministration with statins
Primary Hypercholesterolemia
Homozygous Familial Hypercholesterolemia
> 4 Million Prescriptions Filled in US
> 1 Million Patients Treated in US
eze/simva
Product Profile
Dual Inhibition in a single agent
Maximizes LDL-Cholesterol reduction by
inhibiting both Cholesterol production
and absorption
Favorable effects on TG and HDL-C
Favorable effects near maximum by 2 weeks,
sustained long-term
Safe and well tolerated similar to simvastatin
monotherapy
eze/simva Coadministration
Phase III Results
Two near-identical multicenter, randomized, double-
blind, placebo-controlled trials; Patients with primary
hypercholesterolemia
LDL-C 145 - 250 mg/dL and TG ?350 mg/dL
4 week placebo lead-in/diet phase
Randomized to initiate therapy on one of the following
daily treatments for 12 weeks
Placebo
Ezetimibe (eze) (10 mg)
Simvastatin (simva) (10, 20, 40, 80 mg)
eze + simva (10/10, 10/20, 10/40 or 10/80 mg) as
coadministration
Sager et al. AHA Scientific Sessions November 12, 2003
Effect of Treatment on
Lipid Indices
Lipid
Parameter
LDL-C
Total-C
TG1
HDL-C
Placebo
(n = 114)
1.1
1.5
0.2
2.3
Ezetimibe
(n = 103)
-18.9*
-12.9*
-8.6*
6.4*
Pooled simva
Monotherapy
(n = 436)
-37.5*
-26.0*
-17.8*
7.6*
Pooled
eze/simva
(n = 436)
-52.3**
-37.0**
-28.3**
9.1
** p < 0.01 compared with pooled simvastatin monotherapy;1 Median
* p < 0.01 compared to Placebo
Sager et al. AHA Scientific Sessions November 12, 2003
Mean % Change In LDL-C
Mean % Change
Simvastatin (simva)
Ezetimibe + Simvastatin (eze/simva)
** p<0.01: coadministration versus simvastatin alone
-70
-60
-50
-40
-30
-20
-10
0
10mg
10/10mg
20mg
10/20mg
40mg
10/40mg
80mg
10/80mg
**
**
**
**
-55.0
-30.6
-44.8
-34.8
-39.7
-48.7
-44.4
-60.4
simva eze/simva
Sager et al. AHA Scientific Sessions November 12, 2003
eze/simva Coadministration
LDL-C Summary
eze/simva provides incremental LDL-C
lowering compared to simvastatin monotherapy
across all doses (10-80 mg)
eze/simva provides LDL-C lowering in range of
approximately 45%-60% which is favorable or
competitive to all currently approved statin
monotherapies
eze/simva at lowest dose (10 mg/10mg)
appears comparable to the highest dose of
simvastatin monotherapy (80mg)
Median % Change In HS-CRP
Median % Change
-40
-30
-20
-10
0
10
20
Placebo
(n=114)
Ezetimibe
10 mg
(n=103)
Pooled
Simvastatin
(n=436)
Pooled
eze/simva
(n=436)
3.2
-6.3
-14.3
-33.3
p<0.01
Sager et al. AHA Scientific Session November 12, 2003
Median % Change
Simvastatin (simva)
Ezetimibe + Simvastatin (eze/simva)
*p^0.01; # p=0.03: coadministration versus simvastatin alone
-50
-40
-30
-20
-10
0
10/10mg
20mg
10/20mg
40mg
10/40mg
80mg
10/80mg
-4.4
-26.3
-8.3
-31.8
*
*
#
*
-26.9
-35.9
-20.0
-44.4
10mg
simva eze/simva
Median % Change In HS-CRP
Sager et al. AHA Scientific Session November 12, 2003
eze/simva Coadministration
CRP Summary
eze/simva provides incremental CRP lowering
compared to simvastatin monotherapy across
all doses (10-80 mg)
eze/simva at lowest dose (10mg/10mg) appears
comparable to the highest doses (40-80 mg) of
simvastatin monotherapy (80mg)
The clinical relevance of reductions of CRP,
i.e., improvement in cardiovascular morbidity
and mortality, is currently unknown, however
Safety and Tolerability
Pooled simva Pooled
Placebo Ezetimibe Monotherapy eze/simva
(n=114) (n=103) (n=436) (n=436)
Serious Adverse Events 4 (4%) 3 (3%) 7 (2%) 5 (1%)
Discontinuations due to
Adverse Events 3 (3%) 5 (5%) 10 (2%) 14 (3%)
LFTs (^ 3 x ULN)
ALT (consecutive) 0 0 2 (<1%) 4 (<1%)
AST (consecutive) 0 0 1 (<1%) 1 (<1%)
CPK (^ 10 x ULN) 1 (<1%) 0 2 (<1%) 2 (<1%)
Sager et al. AHA Scientific Session November 12, 2003
ZETIA and eze/simva
Conclusion
ZETIA, as the first of a new class of cholesterol
lowering drugs, has provided a significant
addition to the therapeutic armamentarium in
lipid management
eze/simva, an investigational drug with dual
inhibition of cholesterol production and
absorption in one pill, has the potential for
significant further inroad into lipid management
Firing Up the
Growth Engines
Carrie Cox
Executive Vice President
and President
Global Pharmaceuticals
Action Agenda
New Thinking, New Capabilities, New Urgency
Diagnosis of the
Prescription Business
June 2003
Poor sales and marketing execution
Internally focused
Sub-optimal resource deployment
Under-sized primary care and under-utilized
specialty sales forces worldwide
Damaging US primary care sales force cut in
August '02
Little product differentiation and poor flow of
new clinical data
Must-win US business in serious condition
We Have Good
Product Assets
and Country Opportunities
SP's Portfolio Highlights
Primary Care
ZETIA & eze/simva compete in the largest global
therapeutic category
CLARINEX and NASONEX are established products
with untapped potential
Specialty Products
Top-tier biotech company
Long periods of expected exclusivity on core
brands
Surprisingly strong early and late stage pipeline
for our size
2007
Strong Exclusivity Position
on Core Products
CLARINEX(1)
TEMODAR
REMICADE(2)
ZETIA
NASONEX
PEG-INTRON
2007
2012
2011
2018
2015
2019
2003
2020
Projected Loss of US Exclusivity
Emphasizing the Opportunity to Stabilize,
Recharge, and Invest for Breakout
(1) Projected loss of data exclusivity
(2) Projected loss of EU exclusivity
Strong Performance
in 2nd Tier Markets
Must-win
markets
Size of Bubble
Represents
SP sales
Underperformance in Must-Win Countries is an Opportunity
SGP
Performance
Geographic
Market Potential
Mexico
Spain
France
Canada
Italy
US
Japan
Germany
UK
Although There Are
No Quick Fixes,
We Are Executing with
Speed and Flexibility
Improving the US Sales Force
Is the Single Biggest and Fastest
Lever in Stabilizing the Business
US Sales Force Actions to Date
Recruited top-notch US sales and marketing
leadership team
Developing new efficacy-based positioning
for all brands
Held 1st National Sales Meeting in 5 years
Revamped representative compensation plan
Redeployed existing sales force to stabilize
core primary care products
...and the primary care business is
beginning to show signs of stabilization
?
?
?
?
?
PEG-INTRON Market Share
in Other Core Countries
Italy Mexico France Spain UK Germany
East 0.97 0.89 0.88 0.72 0.7 0.48
Source: Q2 IMS data
Near-Term Portfolio Action Plan
S = Stabilize R = Recharge I = Invest for Breakout
US
Europe
Japan
ZETIA
Hepatitis-C
Allergy/
Respiratory
REMICADE
INTEGRILIN
Oncology
-
I
S
R
R
I
S
R
I
S
I
S/I
I
-
-
R/I
R/I
R/I
Stabilize, Recharge and Invest for Breakout
New Product Introductions
Drive Future Growth in Japan
REBETOL 2001‡
CLARITIN
(SP and Shionogi) 2002‡
REBETOL/PEG-INTRON (CHC*) 2005-06
ZETIA 2005-06
TEMODAR 2005-06
ASMANEX 2006-07
NASONEX 2006-07
REBETOL/PEG-INTRON (LC*) 2006-07
Product
Anticipated
Launch Date
* CHC - chronic hepatitis C; LC - liver cirrhosis
‡ Actual launch date
Bridge to a Changing Portfolio
1998-2002
2004
The Bridge
2005-2007
and Beyond
CLARITIN / CLARINEX
Hep C
REMICADE
NASONEX
INTEGRILIN
TEMODAR /
CAELYX
ZETIA
REMICADE
ZETIA
eze/simva*
REMICADE
NOXAFIL*
SARASAR*
Established
Growth Drivers
PEG-INTRON
NASONEX
CLARINEX
TEMODAR
CAELYX
INTEGRILIN
* 2005-2007 Anticipated Launch
2003/2004 - The Years
of Stabilization and Repair
2004 is a difficult year as the portfolio transitions
from legacy to future growth drivers
Rebuild sales and marketing capabilities
Fund incremental resource requirements through VEI
Requires investments in sales force, Phase IV,
and lifecycle management
Growth Drivers:
ZETIA and
REMICADE
Loss of Losec
Alliance Revenue,
Continued Pressure
on Hepatitis C and
Tough Comparisons
2004 Global Sales Force Expansion:
Driving for 2005 Sales Growth
Significant opportunity to maximize
growth drivers
Restoring what was cut in primary care
Selectively adding to support Hepatitis C
and REMICADE
Expansion also benefits NASONEX and
CLARINEX, high gross margin brands
Optimize sales force in advance of allergy
season and eze/simva rollouts
-
US Exclusivity through 2019
We're Back in the Game and
Committed to Leadership in
Hepatitis C
Hepatitis C Therapy
The goal of treatment is viral eradication
Weight-based dosing gives every patient
an equal chance at success
Only PEG-INTRON has weight-based dosing
REBITOL not indicated for weight-based dosing in US
Hepatitis C Market Dynamics
Declining flow of treated patients
Little patient switching during the year-long
therapy
"Two-horse" race encourages "splitter"
behavior
In a flattening market, there is only market
share; competition is paying for market
share at a very high price
Immediate Actions to Stabilize Share
- Hepatitis C
Launched efficacy message
IDEAL Trial initiated
?
?
Pegylated Interferon Dosing
Evaluations for Patients Living
with Hepatitis C (IDEAL)
What is the IDEAL trial?
Robust, head-to-head clinical trial of PEG-INTRON
versus Pegasys in HCV genotype 1 patients
Genotype 1 are most common (70%-80%) of all patients
and "toughest to treat"
Launched in September 2003
2,880 patients at 100 US leading academic centers
Expected to conclude in 2006
Immediate Actions to Stabilize Share
- Hepatitis C
Launched efficacy message
IDEAL Trial initiated
REDIPEN approved
?
?
?
Enhanced Convenience
and Dosing Consistency
PEG-INTRON Vials
and Syringe
Pegasys Vial
and Syringe
PEG-INTRON REDIPEN
REDIPEN will launch
in 2004; no competitor
device expected for
the foreseeable future
Immediate Actions to Stabilize Share
- Hepatitis C
Launched efficacy message
IDEAL Trial initiated
REDIPEN approved
"Top 300" conference in Kenilworth
Senior management listening to global
thought leaders
?
?
?
?
?
Immediate Actions to Stabilize Share
- Hepatitis C
Launched efficacy message
IDEAL Trial initiated
REDIPEN approved
"Top 300" conference in Kenilworth
Senior management listening to global
thought leaders
Targeted global sales force expansion
?
?
?
?
?
?
Providing Scientific Answers
to Improve Patient Care
Trial Name Completion Patient Population
HBV 99-01 2003-2004 Hepatitis B (HBV)
COPILOT 2004 Maintenance in Cirrhotics
RIBAVIC 2004 HIV/HCV Co-infection
WIN-R 2004 Flat versus Weight-Based REBETOL Dosing
EPIC3 2006-2008 Nonresponders, disease progression
Evaluating the Safety and Efficacy
of PEG-INTRON-Based Regimens
PEG-INTRON Will Win
Doctor by Doctor,
One Patient at a Time
Focus on EXECUTION
Regain Competitive Edge
Longer Term Hepatitis C Growth
Opportunity to double number of diagnosed
patients who are treated
Increase diagnosis rate
US HCV Patient Population
1st Qtr 2nd Qtr
East 1000 2400
3.4 Million Chronic Patients
Sources: Schering-Plough data on file.
Wright,Theresa, AASLD 2003.
NIH Consensus Statement, v.19, no,3; 6/02.
CDC MMWR, v.47,no.RR-19.
1,000
2,400
Undiagnosed
70%
Diagnosed
30%
1st Qtr 2nd Qtr
East 335 165 400 100
1.0 Million Diagnosed Patients
Treatment
Failure/
Drop-offs
33.5%
Successfully
Treated
16.5%
Untreated
40%
Ineligible
10%
In Thousands of Patients
Longer Term Hepatitis C Growth
Opportunity to double number of diagnosed
patients who are treated
Increase diagnosis rate
Pursue additional indications
HIV/HCV
Asymptomatic patients
Cirrhosis
SP has pipeline in Hepatitis C
Hepatitis C Summary
2004 franchise sales may decline as much
as in 2003
Introduction of generic ribavirin
Continued competitive pressure on PEG-INTRON
US share stabilization expected second
half 2004
Japan launch of PEG-INTRON (used in
combination with REBETOL) will boost franchise
long term (2005)
PEG-INTRON is an important product long term;
its near term potential will be limited
US Exclusivity through 2007
US Exclusivity through 2018
US Exclusivity through 2014
SP Has Broadest
Respiratory Portfolio
Respiratory Conditions
Allergy
Congestion
Rhino
Sinusitis
Polyposis
Asthma
COPD
CLARINEX
CLARINEX D
ASMANEX
FORADIL
ASMANEX + FORADIL
NASONEX
Approved Indication
Under Development
Still has some growth potential worldwide
Efficacious and non-sedating
Promotion responsive and high gross margin
90%+ US managed care access
70%+ unrestricted
Rollouts of CLARINEX D and CLARINEX
SYRUP with pediatric indication anticipated
2005
SP has additional pipeline products
Excellent product characteristics, efficacy, and
safety
Promotion responsive and high gross margin
Indicated for prevention and treatment of SAR
and PAR
Only NIS indicated for prevention and to age 2
Moving to earlier treatment represents real
opportunity
New indications in sinusitis and polyposis
anticipated by 2006 and 2008, respectively
Changing market has shifted to combination
therapy
Single ICS use supported by current
treatment guidelines
ASMANEX efficacious at low doses,
once a day
Superior efficacy to budesonide (ex-US)
Delayed US entry has limited the
opportunity, but there is still some potential
Oncology Portfolio
US Exclusivity through 2013
US Exclusivity through 2019
EU Exclusivity through 2010
Marketing rights excluding US, Japan and Israel
Oncology
Small but growing presence with
TEMODAR, INTRON A and CAELYX (EU)
Each product highly significant in its area
Medium-term opportunity to expand
TEMODAR and INTRON A labels into
additional tumor types
Longer term, SARASAR anticipated by
2007
In-license/acquire additional products
EU Exclusivity through 2012
Market leader in Europe
Growing at high double-digit rate
Broadest range of indications; more to come
Infusion is both disadvantage and advantage
Unique mechanism of action versus other
marketed anti-TNF agents
Does this create the potential for superior
efficacy?
SP markets REMICADE outside the US excluding Japan and parts of the Far East
New Indications Will Provide
Major Source of New Patients
in the Future
150
600
100
Slice 4 950
Psoriasis/
Psoriatic arthritis
(2004 -2006)
Crohn's Disease
(1999)
Ankylosing spondylitis
(2003)
Thousands of Diagnosed patients
(REMICADE approval year)
RA
(2000)
In market
*Estimate of diagnosed moderate to severe patients based on US prevalence data
Source: ACR; medical societies; physician interviews; McKinsey analysis
US Exclusivity through 2015
Cholesterol Market Dynamics
$20+ billion market with intensifying
competition
Most physicians initiate therapy but don't
follow through to get to goal
60% of cholesterol patients not at goal
50% require change in therapy to
reach goal
The ZETIA Opportunity
Educate physicians that ZETIA...
Increases the efficacy of any statin
monotherapy at any dose with no more side
effects than statin alone
Provides efficacy benefits across all lipid
parameters of LDL, HDL and TG
Makes sense to inhibit BOTH sources of
cholesterol through dual inhibition
Dual Inhibition Targets the Two
Primary Sources of Cholesterol
Primary Sources of Cholesterol
Primary Sources of Cholesterol
Produced in
Liver
The production
pathway
includes the liver
and peripheral
tissue
Absorbed by
Intestine
The absorption
pathway includes
the small intestine
ZETIA + Statins
Provide
Dramatic LDL-C
Reduction Through
Dual Inhibition
*Dual Inhibition:
Statins inhibit cholesterol production in the liver.
Ezetimibe inhibits cholesterol absorption in the intestine.
The ZETIA Opportunity
Educate physicians that ZETIA...
Increases the efficacy of any statin
monotherapy at any dose with no more side
effects than statin alone
Provides efficacy benefits across all lipid
parameters of LDL, HDL and TG
Makes sense to inhibit BOTH sources of
cholesterol through dual inhibition
Though titration is infrequent, physicians
overestimate the benefit from a one-dose
statin titration
Physicians Overestimate
the Benefit of Statin Titration
Source: Prescriber/non-prescriber study (n=80)
Titrate
Statin
Add ZETIA
Physician's perception of
incremental LDL-C
reduction from baseline
Actual incremental
reduction in LDL-C
from baseline
Titrate
Statin
Add ZETIA
4% - 6%
15% - 18%
18% - 21%
19%
ZETIA Current Usage
Source: NDTI YTD September
Monotherapy
51%
Concomitant
Therapy
49%
1st Qtr 2nd Qtr 3rd Qtr 4th Qtr
East 0.27 0.18 0.21 0.45
Zocor
27%
Pravachol
18%
Other
21%
Lipitor
45%
ZETIA Current Usage
Source: IMS; external literature; interviews; McKinsey analysis
Statin Users
Complicated /
high risk
ZETIA
Statin
intolerant
Estimated Depiction
8.4 Million Potential ZETIA Patients - US Example
ZETIA Potential Usage
8.4 Million Potential ZETIA Patients - US Example
Source: IMS; external literature; interviews; McKinsey analysis
Statin Users
Complicated /
high risk
Statin
intolerant
Estimated Depiction
ZETIA
ZETIA & eze/simva Potential Usage
eze/simva
14 Million Potential ZETIA & eze/simva Patients - US Example
Source: IMS; external literature; interviews; McKinsey analysis
Statin Users
Complicated /
high risk
Statin
intolerant
Estimated Depiction
ZETIA
+ eze/simva
Future Potential for ZETIA
and eze/simva
Slower-than-expected uptake of Crestor
suggests doctors may be averse to high
dose/high potency statins - and may
welcome the new mechanism of dual
inhibition to get greater efficacy
Recent Launch Comparisons
with Crestor
* Holiday week
Note: Data for each product based on first week of Rx activity observed by IMS
Source: IMS NPA + 7 Weekly
Week 1 Week 2 Week 3 Week 4 Week 5 Week 6 Week 7 Week 8 Week 9 Week 10 Week 11 Week 12 Week 13 Week 14 Week 15 Week 16 Week 17 Week 18 Week 19 Week 20
Zetia (11/08/02)
Lipitor (1/31/97)
Crestor (8/15/03)
Baycol (1/30/98)
Lipitor
Crestor
Baycol
ZETIA
NRx Volume Same Week Post-Launch
*
*
Future Potential for ZETIA
and eze/simva
Slower-than-expected uptake of Crestor suggests
doctors may be averse to high dose/high potency
statins - and may welcome the new mechanism of
dual inhibition to get greater efficacy
eze/simva expected US launch second half 2004
Mutual recognition process begins in 2004
Allows ~1 year to establish eze/simva before
Zocor patent expiry in mid 2006
ZETIA and eze/simva co-position well and can
grow together
ZETIA and eze/simva expected exclusivity until 2015
SP Portfolio Sales Potential
Product Peak Sales Peak Sales Peak Sales Peak Sales Peak Sales Expected US Exclusivity
Product A B C D E Expected US Exclusivity
eze/simva E 2015
ZETIA E 2015
REMICADE E 2012*
CLARITIN /
CLARINEX E 2007
NASONEX D/E D/E 2018
PEG-INTRON D 2019
TEMODAR C/D C/D 2011
CAELYX B 2010*
INTEGRILIN B 2014
ASMANEX A/B A/B 2014
A < $250 Million
B > $250 Million
C > $500 Million
D > $750 Million
E > $1 Billion
*Projected loss of EU exclusivity
Why Can We Expect the SP
Turnaround to be Successful?
Evolving portfolio is marked with innovation
Company will have broad portfolio of new and
established growth drivers with growth potential in
2005 and beyond
SP in Japan could grow to $1B+ in coming years
Long periods of expected exclusivity for most
brands
Large enough for critical mass and impact;
small enough for agility, flexibility, and being a
good partner
Will aggressively manage costs and prudently
invest to drive growth
The new Schering-Plough
organization is already becoming
aligned, effective, confident, and is
gaining momentum - we've made
enormous strides already!
Cecil B. Pickett, Ph.D
President
Schering-Plough Research Institute
November 18, 2003
Highlights of Development Projects
Status Development Project Indications
Submitted eze/simva Lipid Lowering
Filed ASMANEX Asthma
Phase III REMICADE Inflammatory Diseases
Phase III NOXAFIL Fungal Infections
Phase III SARASAR Various Cancers
Phase II A2a Receptor Antagonist Parkinson's Disease
Early Phase CCR5 Receptor Antagonist HIV Infection
Early Phase Hepatitis C Virus Protease Inhibitor HCV Infection
Early Phase Thrombin Receptor Antagonist Acute Coronary Syndromes
Early Phase PDE5 Inhibitor Erectile Dysfunction
Cholesterol Absorption
Cholesterol Production
eze
blocks
intestinal
absorption
LDL
Cholesterol
eze + STATIN
STATINS
blocks
synthesis in
liver
LDL
Cholesterol
Further LDL
Cholesterol
reduction
eze + Statin: Dual Inhibition
Ezetimibe
Mechanism of Action Studies
Mechanism of cholesterol absorption
Approach
Used a novel genomics approach incorporating SPRI
proprietary bioinformatics tools and genetic models
Results
Discovered a novel target that is critical for absorption of
cholesterol
Target participates in the Ezetimibe-sensitive cholesterol
absorption pathway
Manuscript was submitted for publication
REMICADE
Anti-inflammatory (anti-TNF?) monoclonal antibody
Int'l marketing rights licensed from Centocor/J&J
Approved for Crohn's Disease: 1999
Approved for Rheumatoid Arthritis
Signs & symptoms: 2000
Improvement in physical function: 2001
Reduction in rate of progression of joint damage: 2001
Psoriatic Arthritis Overview
150,000 to 260,000 new cases of psoriasis annually
25% of psoriasis patients develop psoriatic arthritis
~ 1 million persons affected
Age of onset: 30-40; men & women equally affected
40% of patients with psoriatic arthritis have severe,
progressive and destructive polyarthritis
Psoriatic arthritis and rheumatoid arthritis are distinct
diseases
Before
16 weeks after
REMICADE in Psoriatic Arthritis
Successful Life Cycle Management
of REMICADE
Ankylosing Spondylitis - May '03
Additional Crohn's Disease Labeling
Disease Maintenance - May '03
Maintenance of Fistulizing Disease - Oct '03
Ulcerative Colitis - Phase III
Psoriasis - Phase III
Early Rheumatoid Arthritis - Phase III
Psoriatic Arthritis - Phase III
NOXAFIL
Oral triazole antifungal agent with broadest
spectrum of activity against yeasts (e.g.,
Candida), molds (e.g., Aspergillus, Fusarium)
and zygomecetes
Mechanism of action
Inhibits fungal ergosterol biosynthesis
(specific fungal cytochrome P-450)
Active against most azole-resistant strains
Binding site is different from Fluconazole and
Voriconazole
NOXAFIL
Clinical trials have demonstrated:
42% successful clinical outcomes in patients with Aspergillus
infections who are refractory to or intolerant of standard
antifungal therapy
71% successful clinical outcomes in patients with Zygomycosis,
a frequently fatal fungal infection against which most therapies
have little activity
55% success outcomes in patients with CNS fungal infections
73% successful clinical outcomes in chronic fungal infections of
the skin and soft tissues that do not respond well to current
treatments
NOXAFIL
Comparison to Voriconazole and Caspofungin
SARASAR
Potent, selective inhibitor of farnesyl
transferase
Blocks farnesylation of proteins involved in
transformation and growth of cancer cells
Preclinical activity against a number of cancer
types (e.g., lung, breast, leukemia)
Synergistic activity when combined with other
chemotherapeutic agents (e.g., Taxol and
Gleevec)
Farnesyl Transferase
(FT)
Ras - FT Complex
Structure of Farnesyl Transferase
SARASAR
SARASAR
Bound to Farnesyl Transferase
SARASAR
Activity in combination with Taxanes in non-
small-cell lung cancer and as monotherapy
in leukemias
Development status
Non-small cell lung cancer:
Phase III in combination with carboplatin/paclitaxel
Leukemia: Phase II
Breast cancer: Early Phase
Head & neck cancer: Early Phase
Adenosine A2a Antagonist
A2a Receptor Antagonist
Novel anti-Parkinsonian mechanism
Orally active in rodent and primate models of
Parkinson's Disease
Synergy with L-Dopa; no dyskinesia
Potential indications: monotherapy and
combination with L-Dopa
Adenosine A2a Antagonist
Development Status
Designated for fast-track development by FDA
(July '03) for patients with severe movement
disorders
Well-tolerated in Phase I clinical studies
Phase II (monotherapy) in patients with mild-to-
moderate Parkinson's disease
Phase II (combination with L-Dopa or dopamine
agonists) in patients with moderate-to-severe
Parkinson's disease
CCR5 Receptor Antagonist Program
Targets for Viral Entry
CCR5 Receptor Antagonists
CCR5 is the primary co-receptor used in early
HIV infection
Naturally occurring CCR5 deletion in humans
HIV "resistance" or delayed disease progression
Current combination therapy ("HAART")
Emerging resistance
CCR5 Receptor Antagonists
Shows potent anti-viral activity against several
HIV primary isolates
Orally bioavailable with a long half-life
Demonstrated anti-viral activity in HIV patients
CCR5 Receptor Antagonist
Development status
CCR5 antagonist for HIV infections
Safe and well-tolerated in Early Phase studies
Initiating Phase II studies in treatment-experienced
patients
NS3 Protease
Helicase
RNA-Dependent
RNA Polymerase
Hepatitis C Enzymes
Targets for HCV Therapy
Hepatitis C Protease Inhibitor
HCV protease is critical for replication of all
viral genotypes
Potent and selective inhibitor identified
Good oral bioavailability
Inhibits Viral Activity in Cells
Activity is potentiated by INTRON A
Currently in Early Phase Clinical Studies
Active
Site
Lead Inhibitor, potency 14
nM
Backup Inhibitor, potency 1.4
nM
Hepatitis C Protease Inhibitor
Thrombin Receptor Antagonist
Thrombin receptor located on human platelets
and smooth muscle
Responsible for thrombin-mediated platelet
aggregation
SPRI has identified orally active thrombin
receptor antagonists
Inhibits platelet aggregation without bleeding liability
Inhibits restenosis
Thrombin Receptor Antagonist
Clinical Indication
Prevention of ischemic complications in patients with
acute coronary syndromes (e.g., unstable angina,
acute myocardial infarction)
Currently in Early Phase Clinical Studies
PDE 5 Inhibitor
PDE 5 inhibitors effective for erectile dysfunction
Side effects arise from lack of specificity: blue vision
(PDE6), testicular function (PDE 11) and drug-drug
interaction (CYP 3A4)
SPRI has identified a potent, selective PDE 5 inhibitor
with reduced potential for drug-drug interactions
Good oral bioavailability
Completed Phase I
Safe and well-tolerated at projected clinical doses
Phase II program will define product profile
Most Selective PDE5 Inhibitor
Described to Date
Isozyme PDE6 PDE11 PDE11
Function Vision Testicular Testicular
Selectivity Ratio (in vitro) Selectivity Ratio (in vitro) Selectivity Ratio (in vitro) Selectivity Ratio (in vitro)
S-P 160 3300
Viagra 6 575
Levitra 5 650
Cialis 240 8
11 PDE isozymes contribute to a diverse human biology
Improved selectivity anticipated to enhance efficacy:
tolerability ratio over current therapies
ASMANEX
Activity in mild, moderate and severe
asthma patients
Once-daily dosing in most patients
Favorable therapeutic index: desired activity
with favorable safety margin
Dry powder inhaler delivery system
Low systemic bioavailability
Status of ASMANEX DPI Registration
European submission
EU launch - UK and Nordic first countries (1Q'03)
US Submission
Approvable Oct. '99
Provided FDA with responses to outstanding
questions
Discovery Research
Integrated new technologies into discovery research
Genomics
Combinatorial Chemistry and parallel synthesis
High-throughput screening
Structure-based drug design
Genomics
Focus on families of protein targets to facilitate
the discovery process
G Protein Coupled Receptors (GPCRs)
Kinases
Enzymes
G Protein Coupled Receptors
Family of cell surface proteins that are the targets
for ~50% of marketed drugs
GPCRs are targets of several successful programs
for SP
CCR5, A2a, Thrombin Receptor Antagonist
Six additional GPCR programs in late preclinical and early
clinical development
Focused effort to identify novel and orphan GPCRs
Novel targets identified for pain, metabolic syndrome,
inflammation, depression and cardiovascular disease
Chemistry
Internal investment in technologies to support
chemical research
Supplement internal medicinal chemistry excellence
with external collaborations to access additional
technologies
Outcome: SP compound collection has increased
7-fold over last 10 years
Faster time to lead identification
Larger variety of lead compounds to support medicinal
chemistry efforts
Growth of SPRI Compound Collection
Structural Chemistry
Strategic decision to build strong internal
structural chemistry group to facilitate
compound optimization
X-ray crystallography of enzyme targets
Protein NMR
Mass spectrometry
Computer-assisted drug design
Direct analysis of interaction of compounds with
protein targets greatly facilitates compound
optimization
Summary
New development candidates focus on novel
mechanisms to treat serious diseases
Centers of excellence for both traditional small
molecules and protein therapeutics
well-established
Kenilworth: small molecules
DNAX/Canji: protein therapeutics
Summary
Research and development efforts focused on:
Respiratory & allergic diseases
Immunologic diseases
Central nervous system diseases
Infectious diseases
Oncologic diseases
Cardiovascular diseases
Remain focused on discovering and developing
novel compounds to address unmet medical
needs
Building the Future
Growth Engines
Carrie Cox
Building the Future
Growth Engines
NOXAFIL (Invasive Fungal Infections)
SARASAR (NSCLC and MDS)
A2a Receptor Antagonist (PD)
CCR5 Receptor Antagonist (HIV)
Protease Inhibitor (HCV)
Thrombin Receptor Antagonist (ACS)
PDE-5 Inhibitor (MED)
NOXAFIL Will Compete in Global Fungal
Infection Market With Strong Profile
Global antifungal market ~ $4 Billion
40% invasive fungal infections (IFI) where
majority of uses will be
Active against a range of molds and fungi
Convenient oral suspension
Potentially excellent safety profile: No visual
disturbances, fewer drug contraindications,
safe for hepatic and renal impaired
Likely to be used in hospitalized patients
SARASAR May Complement
Chemotherapy
SARASAR is being added to standard chemotherapy
in NSCLC Phase III trials looking for survival benefit
Lung cancer market > $1 Billion, +200,000 new pts/yr
SARASAR in Phase III for myelodysplastic syndrome
SARASAR, a new class
Oral therapy dosed twice daily during
chemotherapy
Will not compete with chemotherapy,
may complement
Manageable toxicity profile in early trials
Additional early investigation in large markets such as
breast and ovarian cancers
A2a May Address Unmet Need in
Parkinson's Disease (PD)
PD is chronic, progressive neurogenerative
disease affecting 2.7M patients globally(1)
PD market is $1.2B(2) - growth driven by
increasing age of population and combo therapy
A2a launch indication for signs/symptoms of
idiopathic PD
Potential equal efficacy to 2nd generation
dopamine agonists, possibly with better safety
May treat advanced disease without dyskinesias
Likely to be used in combination with other agents
(1) Major markets, Decision Resources Pharmacor/Cognos, 10/8/02
(2) IMS, MAT 3Q02, constant US dollars
CCR5 is Novel Approach
to Block HIV
HIV Market $4.7B(1) is composed of NRTI,
NNRTI, and PI products
Increased resistance drives need for new
classes of anti-retroviral treatments
Once-a-day tablet will be complementary
to existing agents due to novel
mechanism; Regulatory Fast Track
(1) IMS, 2002
Initial Launch Population Will be
Treatment Experienced Patients
Expected to be used
as "second-line"
therapy
Little salvage patient
use anticipated as
most have viruses
where CCR5 less
effective
Treatment Experienced Naive/First Line Salvage Setting
42.5 42.5 15
Salvage
Setting
10-20%
Naive/
First Line
40-45%
Treatment
Experienced
40-45%
Protease Inhibitor (PI) Complementary
to PEG-INTRON Could be Superior
New Therapy Regimen for Hep C
SP PI is an orally-delivered, unique PI that
targets Hepatitis C virus
Program is in early development; potential to
combine treatment with PEG-INTRON
Thrombin Receptor Antagonist:
1st in Class Adjunctive Therapy for ACS
Target Product Profile
Acute Coronary Syndromes market $5B++
Oral,once-daily anti-platelet agent with
potential incremental efficacy over current
therapies (aspirin and clopidogrel)
No increase in bleeding liability
No monitoring required (unlike warfarin)
May be used in combination with other
anti-platelet or anti-thrombotics (e.g.,
INTEGRILIN, heparins)
Erectile Dysfunction Market
Driven by New Entrants
Market expected to double to $2.6B by
2006 and to $3.6B by 2011
New entries have expanded the market
Still opportunities for better products
SP PDE 5 is a highly selective PDE 5
Potentially strong safety and tolerability
profile (e.g., no vision abnormalities)
Potentially greater consistency of response
Building the Future
Growth Engines
A < $250 Million
B > $250 Million
C > $500 Million
D > $750 Million
E > $1 Billion
Product Peak Sales Peak Sales Peak Sales Peak Sales Peak Sales
Product A B C D E
CCR5 Receptor Antagonist (HIV) C/D C/D
PDE 5 Inhibitor (MED) C/D C/D
Protease
Inhibitor (HCV) C/D C/D
SARASAR
(NSCLC and MDS) C C
NOXAFIL
(Invasive Fungal
Infections) B/C B/C
A2a Receptor Antagonist (PD) B/C
B/C
Thrombin Receptor Antagonist E
Indications currently
under development only.
Does not include
additional potential
development.
The Current and Future
SP Portfolio Potential
2003
2006
2009
2012
2015
2018
PEG-INTRON
D
NASONEX
D/E
ZETIA and eze/simva
E
INTEGRILIN
B
ASMANEX
A/B
REMICADE
E
TEMODAR
C/D
CAELYX
B
CLARITIN/CLARINEX*
E
NOXAFIL
B/C
SARASAR
C
A2a
B/C
CCR5
C/D
PDE 5
C/D
PI
C/D
Length of arrow represents projected loss of exclusivity
* Represents US data exclusivity; ex-US exclusivity through 2010
Aspirational
TRA
E
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