Growth through Innovation

1. Growth through Innovation Dr Paul Denerley Diretor Mundial de Propriedade Intelectual AstraZeneca

2. Themes • Challenges facing Health Care • Partnership • Innovation and Investment

3. Living longer Obesity epidemic Smoking addiction Stress • Symptomatic Disease modification/prevention • One size fits all Personalised medicine • Rational sequence of treatment and combinations BENEFIT/RISK Meeting future unmet medical need

4. Challenges • HIV/AIDS • Diabetes • Hypertension and cholesterol • Schizophrenia • Cancer • Malaria • TB • Others...

5. Partnership • Right drugs to right patient at the right time • Diagnosis • Availability • Affordability • Prevention of disease • Solution • Innovation • Finance • Human resources • Regulatory environment

6. Partnership • Academia • Small and Medium Size Companies • Public-Private Collaborations • TDR : Tropical Diseases • MMV : Medicines for Malaria venture • Global Alliance for TB • Dedicated Research Centres • AstraZeneca – Bangalore • Novartis – Singapore • GlaxoSmithKline - Spain

7. Partnership: Global • China • Health care strategically important • Huge population; rapid growth • Focussed Government R&D spending • Government at all levels strongly supporting ‘Development of science and Technology is a decisive factor in international competition’ – Premier Wen Jiabao, March 28, 2005 Good Patent Law Source: Ministry of Education, China; Xinhua News Agency,

8. Lund l Bangalore Osaka Wilmington AstraZeneca R&D Globally managed research organization employing 12,300 people at 11 sites located in 7 countries: • Canada (Montreal) • France (Reims) • India (Bangalore) • Japan (Osaka) • Sweden (Lund, Mölndal & Södertälje) • UK (Alderley Park & Charnwood) • US (Boston & Wilmington) R&D investment - $14M each working day

9. Vision for R&D “As part of a leading ethical pharmaceutical company, R&D’s vision is to combine world class science and innovation to discover, develop and deliver medicines that make a difference and improve patients lives.”

10. Research & Development Discovery Development Research Areas: - Respiratory & Inflammation- Cardiovascular & Gastrointestinal - Cancer & Infection- CNS & Pain Control Global Marketing PA R&D Clinical Development Regulatory Affairs Safety Ass. ProcessR&D Cardiovascular & Gastrointestinal Product Teams Cancer & Infection Respiratory & Inflammation Neuroscience

11. Start Development for Launch Start Lead Optimisation Start Principle Testing Start Concept Testing Tollgates Start Launch Phase TG 1 2 2.5 3 4 5 DISCOVERY DEVELOPMENT Target Id. Hit Id. Lead Id. Lead Opt. CD Pre. Principle Test. Concept Test. Dev. For Launch Launch Phase Product LCM MS 1 2 3 4 5 6 7 8 9 Launch & Life Cycle Management CD Prenomination CD Nomination Target Identified Leads Identified Submission(s) Hits Identified Proof of Concept First Time in Man Proof of Principle Phase III Results Milestones Science and Innovation : Process

12. Target Identification Concept Testing Lead optimisation The Drug Discovery & Development Process What is the target disease? What type of (bio-chemical) approach are we going to take? Innovation: Biologists Lead Ident Devt for Launch Product Maintenance and Life Cycle Support Hit Ident Launch

13. Hit Identification Concept Testing Lead optimisation The Drug Discovery & Development Process How viable is the target? Innovation: biologists/chemists Lead Ident Devt for Launch Product Maintenance and Life Cycle Support Target Ident Launch

14. Lead Identification Concept Testing Lead optimisation The Drug Discovery & Development Process What compounds have the potential to have a useful medical outcome? Innovation: chemists Devt for Launch Product Maintenance and Life Cycle Support Target Ident Hit Ident Launch

15. Lead Optimisation Concept Testing The Drug Discovery & Development Process Can we refine these new potential drugs to meet the needs of a new drug to get to market? Innovation: chemists process chemists Lead Ident Devt for Launch Product Maintenance and Life Cycle Support Target Ident Hit Ident Launch

16. Concept Testing Lead optimisation The Drug Discovery & Development Process Is the drug safe in humans? Does the drug have a clinical effect in humans? How much of the drug should be given and how? Innovation: pharmacists; doctors; biologists Lead Ident Devt for Launch Product Maintenance and Life Cycle Support Target Ident Hit Ident Launch

17. Concept Testing Lead optimisation The Drug Discovery & Development Process Development for Launch Does the drug work in largescale clinical studies? Establish commercial manufacturing facilities Prepare market place for launch Innovation: doctors; biologists; process chemists Lead Ident Product Maintenance and Life Cycle Support Target Ident Hit Ident Launch

18. Launch Concept Testing Lead optimisation The Drug Discovery & Development Process Secure world-wide regulatory approval Get to patients as soon as possible Lead Ident Devt for Launch Product Maintenance and Life Cycle Support Target Ident Hit Ident

19. Extending the Benefit Concept Testing Lead optimisation The Drug Discovery & Development Process Benefit to the patient Further medical uses? Further formulations Innovation: doctors, biologists, pharmacists Lead Ident Devt for Launch Target Ident Hit Ident Launch

21. Summary • Challenges facing Health Care • Partnership • Innovation and Investment

22. Back-Up slides