Transcript R&D Global Locations - Swedish

Big Pharma - The Way Forward
Swedish-American Life Science Summit
20th August 2009
Anders Ekblom
Executive Vice President
Global Drug Development
AstraZeneca
Global R&D organisation
Reims
Osaka
Bangalore
Shanghai
Big Pharma: The Way Forward
Mountain View
Anders Ekblom, Executive VP Drug Development
Montreal
Boston
Wilmington
Gaithersburg
Alderley Park
Charnwood
Cambridge
Södertälje
Mölndal
Lund
Agenda
 The Pharmaceutical Industry in Perspective
 Scorecard for Future Success – AZ Case Study
Big Pharma: The Way Forward
 Opportunities
Anders Ekblom, Executive VP Drug Development
 Challenges
The Pharmaceutical Industry
in Perspective
Pharmaceutical Industry -
Global sales
Global Pharma Historical Market Dynamics & Current Economic Environment
Pharmaco challenges
Global Sales and Market Growth
800
25%
> The USA/top 5 Europe/Japan no
longer ‘Mr Atlas’
700
400
10%
300
5%
200
> Biotechnology, a big growth area,
affected by lack of investment
funds
0%
100
0
-5%
2002
2003
Global
Japan
2004
2005
2006
USA
Pharmerging
2007
2008
> Several big selling drugs will face
patent expires during the next few
years
EU5
> The most attractive areas for
growth are in emerging markets
Source: IMS Health MIDAS MAT December 2008, Pharmerging markets = China, India, Russia, Brazil, Mexico, Turkey and South Korea.
Presentation prepared for AstraZeneca: 14 th May 2009
Anders Ekblom, Executive VP Drug Development
15%
500
> Lower GDP growth and tax
revenues will impact healthcare
budgets/promote more aggressive
cost containment
Big Pharma: The Way Forward
VALUE SALES US $ BN
600
VALUE GROWTH % (US $)
20%
Pharmaceutical Industry -
Key facts
> $897+ million USD
to bring one drug from
concept to market
> One in 5000
new chemical
compounds make it to
market
> 80% drugs fail
leaving 20% to fund
the R&D engine
Anders Ekblom, Executive VP Drug Development
to develop a new
medicine
Big Pharma: The Way Forward
> 12 years
Pharmaceutical Industry -
60
50
40
30
10
0
USA
Europe
Japan
Rest Of World
This graph is based on data from 22 companies (10 Major and 12 Mid and Other)
Major companies are defined as those spending ≥US$ 1.8 billion in 2005 on ethical pharmaceutical R&D.
Mid and Other companies are defined as those spending <US$ 1.8 billion in 2005 on ethical pharmaceutical R&D.
Anders Ekblom, Executive VP Drug Development
20
Big Pharma: The Way Forward
% of total R&D expenditure
R&D expenditure
Pharmaceutical Industry
Challenges
Challenges -
Industry Trends
Industry Overview: Global R&D expenditure, development times,
global sales and NME output 1998 - 2008
R&D expenditure
Development times
NME output
Sales
+ 80% R&D
150
+30%
Dev.times
100
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008*
-43% NMEs
50
0
*The development time data point for 2008 includes data from 2007 and 2008 only
Source: CMR International (2009 FactBook) & IMS Health
Big Pharma: The Way Forward
Indexed to 1998
200
Anders Ekblom, Executive VP Drug Development
+160%
Sales
250
Challenges -
R&D Productivity
Source: PBF R&D General Metrics 2008, slide 198
Cohort: PBF member companies
Anders Ekblom, Executive VP Drug Development
Black numerals refer to number of NME entries required in each phase to
obtain 1 Approval; figures in red box are success rates for each phase
Big Pharma: The Way Forward
NME Success Rates By Phase And Overall
2004-2008 Industry Portrait, Pure
Challenges -
Industry Trends continued
> Mergers (risk vs. reward)
> 75% of large mergers fail to create shareholder value
greater than industry averages
> Patent Expiry
> 20 year patent – 12 year development time = limited time
to recoup R&D costs
Anders Ekblom, Executive VP Drug Development
> NICE and HTA
Big Pharma: The Way Forward
> Pricing Pressures (ROI on R&D)
NICE: Impact so far
Research only
Restricted
No use
Anders Ekblom, Executive VP Drug Development
Approved
Big Pharma: The Way Forward
Result of 232 reviews and decisions
Pharmaceutical Industry
Opportunities
Opportunities -
Future Unmet Medical Need
Smoking addiction
Allergy
Stress/Pain
> Symptomatic

Disease modification/prevention
> One size fits all

Personalised medicine
> Ageing population
> Rational sequence of treatment and combinations
Anders Ekblom, Executive VP Drug Development
Obesity
Big Pharma: The Way Forward
Living longer
Opportunities -
Predictive Science
We apply our extensive scientific expertise in this field to
> drive greater disease understanding
> ensure the safety of medicines
Model
Marker
Patients
Big Pharma: The Way Forward
Mechanism
Anders Ekblom, Executive VP Drug Development
> improve efficacy & success rate
Examples of Predictive Science
> Looking for a better model for animal-to-man
predictions through translational understanding of
PK/PD relationships.
Anders Ekblom, Executive VP Drug Development
> Using sophisticated computational and imaging
technologies to model what happens in biological
systems, which can help us predict safety, efficacy
and doses before moving our studies into man.
Big Pharma: The Way Forward
> Identifying and using biomarkers to measure
disease progress or the effects of a drug or
combination of drugs in treatment.
Opportunities -
Biologics & Genetics
> Researchers are discovering how to
use human molecules—genes,
proteins, and antibodies as drugs
> Fewer toxicological issues with
biologics
Anders Ekblom, Executive VP Drug Development
> Biologics are increasing due to
genomics
Big Pharma: The Way Forward
> Emerging areas of research that
promise to transform our
understanding of human health and
disease in the coming years
Opportunities -
Emerging Markets
“ Emerging markets will play a
major part in the future of the (life
science) industries. Companies
across a wide range of activities,
including Research and
Development. “
- Economist Intelligence Unit
& Deloitte Touche Tohmatsu
Big Pharma: The Way Forward
investment in emerging markets
Anders Ekblom, Executive VP Drug Development
will have to significantly expand
Scorecard for Future Success
AZ case study
AstraZeneca - Our
Strategy
The Fast Forward plan
“MAKING
THE MOST MEANINGFUL DIFFERENCE
TO PATIENT HEALTH THROUGH GREAT MEDICINES”
Lean and agile
medicines
mindset
organisation
Responsible leaders
who make every
interaction count
the pipeline
Grow
the business
the business
Change our
behaviour and our
culture
Products
Patient Needs
Performance
People
Strengthen
Reshape
Anders Ekblom, Executive VP Drug Development
Customer-centric
Big Pharma: The Way Forward
Valued
AstraZeneca
Areas of Medical Focus
> Cardiovascular and Gastrointestinal
> Oncology and Infection
> New Opportunities
> Across Biologicals, Small
Molecules, Vaccines
Big Pharma: The Way Forward
> Respiratory and Inflammation
Anders Ekblom, Executive VP Drug Development
> Neuroscience
AstraZeneca
Innovation Center China (ICC)
>Provide science support
for our activities in this
region
>Tap into the large talent
pool and increasing
innovation
ICC facility opening ceremony, Oct 15, 2008
Anders Ekblom, Executive VP Drug Development
>Focus on translational
science by developing
knowledge on potential
ethnic difference and
regional unmet medical
needs
Big Pharma: The Way Forward
>AZ’s newest global R&D
centre site
AstraZeneca
Personalised Healthcare (PHC)
> IRESSA – PHC in action
> Dedicated team within R&D
“PHC aims to create superior
patient outcomes through the use of
healthcare tools and diagnostics,
achieving “right treatment, right
patient, right dose, right (first) time”
Anders Ekblom, Executive VP Drug Development
> Key AZ projects in regulatory
development actively testing PHC
strategies
Big Pharma: The Way Forward
> AZ evaluates every new drug
candidate for PHC opportunity as a
core component of the R&D
Operating Model
AstraZeneca
LCM Update - Iressa
EU approval received across all lines of therapy for EGFR mutation positive
NSCLC based on INTEREST, IPASS & full data review – July 09
Probability
of PFS
In EGFR mutation-positive patients, IRESSA reduces the risk of
1.0
progression by 52% vs. doublet chemotherapy
0.6
Gefitinib EGFR M+ (n=132)
Gefitinib EGFR M- (n=91)
Carboplatin / paclitaxel EGFR M+ (n=129)
Carboplatin / paclitaxel EGFR M- (n=85)
0.4
0.2
0.0
0
4
8
12
16
Time from randomisation (months)
M+, mutation positive; M-, mutation negative
Pre-planned analysis of patients in which EGFR mutation status was available
20
24
Anders Ekblom, Executive VP Drug Development
Treatment by
subgroup
interaction test,
p<0.0001
Big Pharma: The Way Forward
0.8
AstraZeneca
Innovative Partnerships
> In-licensing
• DSP, Dynavax, Argenta
> Acquisitions
• Arrow, Kudos, MedImmune
> Fostering
• Cancer Research UK
> Research and Screening
• Alcon
> Risk-Sharing
• BMS
> Combination Therapy
• Pozen, Abbott, Merck
Big Pharma: The Way Forward
• Albireo
Anders Ekblom, Executive VP Drug Development
> Spin Outs
AstraZeneca & Merck
Phase 1 Collaboration
 First combination of two unapproved agents in early development,
from separate pharma companies to treat patients with cancer
AZD6244
 Combination has much higher chance of providing benefit to
patients with cancer than either agent alone
Anders Ekblom, Executive VP Drug Development
MK-2206
Big Pharma: The Way Forward
 Combination will block signalling in
the two key pathways involved in
cancer cell survival and growth
AstraZeneca
BPO in Clinical Data Management (CDM)
> December 2007: AZ partnered with Cognizant for CDM operations
> Largest outsourcing agreement of it’s kind in the pharmaceutical
industry
> Benefits:
> $150Mn cost reduction over 5 years
> Standardised high quality delivery process and tools
> $10Mn joint investment to fund continuing transformation and
innovation
> Transition successfully delivered in 6 months
> In ‘business as usual’ the CDM engagement is delivering to targets
and meeting the broader organization goals of AstraZeneca
Big Pharma: The Way Forward
> Process simplification and efficiencies
> Reduce costs
> Strategic decision to invest in core capabilities
Anders Ekblom, Executive VP Drug Development
> Drivers:
AstraZeneca
Case study
Vaccines
Focus on speed, quality and cost
Production & distribution capability
Global reach
Leverage emerging markets
Personalised Healthcare
Innovative Partnerships
NO
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



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Anders Ekblom, Executive VP Drug Development
Biologicals
YES
Big Pharma: The Way Forward
Scorecard for Long-Term Success
Success Factor
Small molecules