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Campbell Wilson
- 1. Industry-academia co-operation to sustaininnovation in drug discovery BioDundee 30 May 2012 Campbell Wilson AstraZeneca
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- 5. The Perfect Stormfor Pharma REGULATORY HURDLES PRICING & REIMBURSEMENT PATENT EXPIRIES
- 6. The Patent Cliff PatentExpiring Condition Company 2010 U.S. Sales in 2011 Lipitor cholesterol Pfizer $5,329,000,000 Zyprexa antipsychotic Eli Lily $2,496,000,000 Johnson & Levaquin antibiotics $1,312,000,000 Johnson Johnson & Concerta ADHD/ADD $929,000,000 Johnson Protonix antacid Pfizer $690,000,000
- 7. Patent Expiring in Condition Company 2010 U.S. Sales 2012 Bristol-Myers Plavix anti-platelet Squibb / $6,154,000,000 Sanofi-Aventis Seroquel antipsychotic AstraZeneca $3,747,000,000 Singulair asthma Merck $3,224,000,000 Actos type 2 diabetes Takeda $3,351,000,000 Enbrel arthritis Amgen $3,304,000,000
- 8. Clinical success rates 2004-2011success rate from Ph I to FDA approval is: 6.7% for oncology 12.1% for other indications
- 9. Health Technology AssessmentAgency reimbursement decisions Disease Recommend Recommend Not recommended Total Decision R* Decision Decisions Cardiovascular 23 27 Decision 14 64 (36%) (42%) (22%) (100%) Cancer 29 52 49 130 (22%) (40%) (38%) (100%) Total decisions 52 79 63 194 (27%) (41%) (32%) (100%) *R = Recommended decision with restriction to clinical classification or patient group. Source – Health Economics Consortium, 2008
- 10. Impact on thepharmaceutical industry AstraZeneca 2011 annual results 2011 2010 Actual CER $m $m growth growth Revenue 33,591 33,269 +1% -2% Core Operating Profit 13,167 13,603 -3% -4% Core EPS $7.28 $6.71 +9% +7% Reported EPS $7.33 $5.60 +31% +29% Full Year Dividend $2.80 $2.55
- 11. •Fewer successful productlaunches •Negative growth •Long term sustainability of pharma operating model questioned
- 12. Pharma’s response Costconstraints Divert resources to filling and progressing late- stage pipeline Consequential reduction in resourcing of drug discovery
- 13. Pharma’s challenge Howdo we secure long-term sustainability through innovative drug discovery?
- 14. Pharma’s challenge Creativecollaboration!
- 15. Collaboration models - theold and the new • Pharma fully funds • Pharma and academia share • Pharma retains all rights resources, risk and reward • Pharma reaps all commercial • Payment for successful outcomes benefit rather just for the work being done • Significant success means significant reward • Hand-back rights to academic partner if Pharma does not prosecute • Pharma contribution in kind such as access to compound collection
- 16. AstraZeneca-Cancer Research Technology StrategicAlliance in Cancer Metabolism CRT show selected targets in theme area Joint activities within a JMT managed portfolio of projects with 50/50 resourcing (approx. 30 FTE in total) Target Assay Early Lead Validation Development HTS Hit-to-Lead Optimisation Joint project acceptance via JMT. Project Project passes managed by JPT to AZ but monitored via JMT until enters AZ Development
- 17. Deal terms –financial structure • Access fee - in recognition of AstraZeneca gaining access to CR UK’s network of scientific investigators in cancer metabolism • Each party covers its own costs • Success based milestone payments - Each project start (start of screening) - Each project that successfully delivers (adopted by AZ) - Formal entry to AZ Development - Clinical development milestones through to launch • Royalty on product sales
- 18. AZ – MRCT AZ pursue – Research Collaboration / licence Model or AZ & MRC pursue jointly Study / licence Research Collaboration •AZ licence joint results & MRC compound if H2 Exercise Option 2 £20K Option Fee £20K Option Fee Exercise Option1 L Selected required Ch MR e Target m C i st Sc ree ry n •AZ assigns interest in joint results •MRC licence AZ compound if Reject Option 1 Reject Option 2 required MRC Rejected pursue Target •No further obligations to AZ Hit from MRC CC •AZ assigns interest in joint MRC can screen up to 5 Rejected Targets results using the AZ CC – AZ retains Options •AZ grants use of joint results / 1&2 Hit from AZ CC AZ compound to allow MRC to perform H2L chemistry •AZ retains Option 2
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