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Big Pharma - The Way Forward. Swedish-American Life Science Summit 20 th August 2009 . Anders Ekblom Executive Vice President Global Drug Development. AstraZeneca Global R&D organisation. Södertälje Mölndal Lund. Alderley Park Charnwood Cambridge. Montreal Boston Wilmington

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big pharma the way forward

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
AstraZenecaGlobal R&D organisation

Södertälje

Mölndal

Lund

Alderley Park

Charnwood

Cambridge

Montreal

Boston

Wilmington

Gaithersburg

Reims

Osaka

Mountain View

Big Pharma: The Way Forward

Anders Ekblom, Executive VP Drug Development

Shanghai

Bangalore

agenda
Agenda
  • The Pharmaceutical Industry in Perspective
  • Challenges
  • Opportunities
  • Scorecard for Future Success – AZ Case Study

Big Pharma: The Way Forward

Anders Ekblom, Executive VP Drug Development

slide5

Pharmaceutical Industry -Global sales

Global Pharma Historical Market Dynamics & Current Economic Environment

Pharmaco challenges

Global Sales and Market Growth

  • The USA/top 5 Europe/Japan no longer ‘Mr Atlas’
  • Lower GDP growth and tax revenues will impact healthcare budgets/promote more aggressive cost containment
  • Biotechnology, a big growth area, affected by lack of investment funds
  • Several big selling drugs will face patent expires during the next few years
  • The most attractive areas for growth are in emerging markets

Big Pharma: The Way Forward

Anders Ekblom, Executive VP Drug Development

Source: IMS Health MIDAS MAT December 2008, Pharmerging markets = China, India, Russia, Brazil, Mexico, Turkey and South Korea.

Presentation prepared for AstraZeneca: 14th May 2009

slide6
$897+ million USDto bring one drug from concept to market

12 yearsto develop a new medicine

One in 5000new chemical compounds make it to market

Pharmaceutical Industry -Key facts

Big Pharma: The Way Forward

Anders Ekblom, Executive VP Drug Development

  • 80% drugs fail leaving 20% to fund the R&D engine
slide7

Pharmaceutical Industry -R&D expenditure

Big Pharma: The Way Forward

Anders Ekblom, Executive VP Drug Development

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.

slide9

Challenges -Industry Trends

Industry Overview: Global R&D expenditure, development times,

global sales and NME output 1998 - 2008

+160% Sales

+ 80% R&D

Big Pharma: The Way Forward

Anders Ekblom, Executive VP Drug Development

+30% Dev.times

-43% NMEs

*The development time data point for 2008 includes data from 2007 and 2008 only

Source: CMR International (2009 FactBook) & IMS Health

slide10

Challenges -R&D Productivity

NME Success Rates By Phase And Overall

2004-2008 Industry Portrait, Pure

Big Pharma: The Way Forward

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

Source: PBF R&D General Metrics 2008, slide 198

Cohort: PBF member companies

slide11

Challenges -Industry Trends continued

  • Mergers (risk vs. reward)
    • 75% of large mergers fail to create shareholder value greater than industry averages
  • Pricing Pressures (ROI on R&D)
  • NICE and HTA
  • Patent Expiry
    • 20 year patent – 12 year development time = limited time to recoup R&D costs

Big Pharma: The Way Forward

Anders Ekblom, Executive VP Drug Development

nice impact so far
NICE: Impact so far

Result of 232 reviews and decisions

Big Pharma: The Way Forward

Anders Ekblom, Executive VP Drug Development

Approved

Research only

Restricted

No use

opportunities future unmet medical need
Opportunities -Future Unmet Medical Need

Smoking addiction

Living longer

Obesity

  • Symptomatic  Disease modification/prevention
  • One size fits all  Personalised medicine
  • Ageing population
  • Rational sequence of treatment and combinations

Big Pharma: The Way Forward

Anders Ekblom, Executive VP Drug Development

Allergy

Stress/Pain

slide15

Mechanism

Model

Marker

Patients

Opportunities -Predictive Science

We apply our extensive scientific expertise in this field to

  • drive greater disease understanding
  • ensure the safety of medicines
  • improve efficacy & success rate

Big Pharma: The Way Forward

Anders Ekblom, Executive VP Drug Development

examples of predictive science
Examples of Predictive Science
  • Identifying and using biomarkers to measure disease progress or the effects of a drug or combination of drugs in treatment.
  • 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.
  • Looking for a better model for animal-to-man predictions through translational understanding of PK/PD relationships.

Big Pharma: The Way Forward

Anders Ekblom, Executive VP Drug Development

slide17

Opportunities -Biologics & Genetics

  • Emerging areas of research that promise to transform our understanding of human health and disease in the coming years
  • Biologics are increasing due to genomics
    • Researchers are discovering how to use human molecules—genes, proteins, and antibodies as drugs
    • Fewer toxicological issues with biologics

Big Pharma: The Way Forward

Anders Ekblom, Executive VP Drug Development

slide18

Opportunities -Emerging Markets

“ Emerging markets will play a major part in the futureof the (life science) industries. Companies will have to significantly expand investment in emerging markets across a wide range of activities, including Research and Development. “- Economist Intelligence Unit & Deloitte Touche Tohmatsu

Big Pharma: The Way Forward

Anders Ekblom, Executive VP Drug Development

the fast forward plan

AstraZeneca - Our Strategy

The Fast Forward plan

“MAKING

THE MOST MEANINGFUL DIFFERENCE

TO PATIENT HEALTH THROUGH GREAT MEDICINES”

Valued

medicines

Customer-centric

mindset

Lean and agile

organisation

Responsible leaders who make every interaction count

Big Pharma: The Way Forward

Anders Ekblom, Executive VP Drug Development

Change our behaviour and our culture

Strengthen

the pipeline

Grow the business

Reshape

the business

Products

Patient Needs

Performance

People

slide21
Cardiovascular and Gastrointestinal

Oncology and Infection

Neuroscience

Respiratory and Inflammation

New Opportunities

Across Biologicals, Small Molecules, Vaccines

AstraZenecaAreas of Medical Focus

Big Pharma: The Way Forward

Anders Ekblom, Executive VP Drug Development

astrazeneca innovation center china icc
AstraZenecaInnovation Center China (ICC)

AZ’s newest global R&D centre site

Focus on translational science by developing knowledge on potential ethnic difference and regional unmet medical needs

Provide science support for our activities in this region

Tap into the large talent pool and increasing innovation

Big Pharma: The Way Forward

Anders Ekblom, Executive VP Drug Development

ICC facility opening ceremony, Oct 15, 2008

astrazeneca personalised healthcare phc
AstraZenecaPersonalised Healthcare (PHC)
  • AZ evaluates every new drug candidate for PHC opportunity as a core component of the R&D Operating Model
  • Key AZ projects in regulatory development actively testing PHC strategies
  • IRESSA – PHC in action
  • Dedicated team within R&D

Big Pharma: The Way Forward

Anders Ekblom, Executive VP Drug Development

“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”

astrazeneca lcm update iressa
AstraZenecaLCM Update - Iressa

EU approval received across all lines of therapy for EGFR mutation positive NSCLC based on INTEREST, IPASS & full data review – July 09

Probabilityof PFS

In EGFR mutation-positive patients, IRESSA reduces the risk of progression by 52% vs. doublet chemotherapy

Treatment by subgroup interaction test, p<0.0001

Gefitinib EGFR M+ (n=132)Gefitinib EGFR M- (n=91)Carboplatin / paclitaxel EGFR M+ (n=129)

Carboplatin / paclitaxel EGFR M- (n=85)

Big Pharma: The Way Forward

Anders Ekblom, Executive VP Drug Development

M+, mutation positive; M-, mutation negative

Pre-planned analysis of patients in which EGFR mutation status was available

astrazeneca innovative partnerships
AstraZenecaInnovative Partnerships
  • In-licensing
    • DSP, Dynavax, Argenta
  • Acquisitions
    • Arrow, Kudos, MedImmune
  • Spin Outs
    • Albireo
  • Fostering
    • Cancer Research UK
  • Research and Screening
    • Alcon
  • Risk-Sharing
    • BMS
  • Combination Therapy
    • Pozen, Abbott, Merck

Big Pharma: The Way Forward

Anders Ekblom, Executive VP Drug Development

slide26

MK-2206

AZD6244

AstraZeneca & Merck

Phase 1Collaboration

  • First combination of two unapproved agents in early development, from separate pharma companies to treat patients with cancer
  • Combination will block signalling in the two key pathways involved in cancer cell survival and growth

Big Pharma: The Way Forward

Anders Ekblom, Executive VP Drug Development

  • Combination has much higher chance of providing benefit to patients with cancer than either agent alone
astrazeneca bpo in clinical data management cdm
AstraZenecaBPO 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
  • Drivers:
    • Process simplification and efficiencies
    • Reduce costs
    • Strategic decision to invest in core capabilities
  • 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

Anders Ekblom, Executive VP Drug Development

astrazeneca case study
AstraZenecaCase study

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Big Pharma: The Way Forward

Anders Ekblom, Executive VP Drug Development

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