Industry-academia co-operationto sustain innovation in drugdiscoveryBioDundee 30 May 2012Campbell WilsonAstraZeneca
The Perfect Storm
The Perfect Storm for Pharma REGULATORY HURDLES PRICING & REIMBURSEMENT PATENT EXPIRIES
The Patent CliffPatent Expiring Condition Company 2010 U.S. Salesin 2011Lipitor cholesterol Pfizer $5,329,000,000Zyprexa antipsychotic Eli Lily $2,496,000,000 Johnson &Levaquin antibiotics $1,312,000,000 Johnson Johnson &Concerta ADHD/ADD $929,000,000 JohnsonProtonix antacid Pfizer $690,000,000
Patent Expiring in Condition Company 2010 U.S. Sales2012 Bristol-MyersPlavix anti-platelet Squibb / $6,154,000,000 Sanofi-AventisSeroquel antipsychotic AstraZeneca $3,747,000,000Singulair asthma Merck $3,224,000,000Actos type 2 diabetes Takeda $3,351,000,000Enbrel arthritis Amgen $3,304,000,000
Clinical success rates2004-2011 success rate from Ph I to FDA approval is: 6.7% for oncology 12.1% for other indications
Health Technology Assessment Agency reimbursement decisionsDisease Recommend Recommend Not recommended Total Decision R* Decision DecisionsCardiovascular 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
Impact on the pharmaceutical industry AstraZeneca 2011 annual results 2011 2010 Actual CER $m $m growth growthRevenue 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
•Fewer successful product launches•Negative growth•Long term sustainability of pharmaoperating model questioned
Pharma’s response Cost constraints Divert resources to filling and progressing late- stage pipeline Consequential reduction in resourcing of drug discovery
Pharma’s challenge How do we secure long-term sustainability through innovative drug discovery?
Pharma’s challenge Creative collaboration!
Collaboration models- the old 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
AstraZeneca-Cancer Research TechnologyStrategic Alliance in Cancer MetabolismCRT showselectedtargets intheme 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
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
AZ – MRCT AZ pursue – Research Collaboration / licenceModel 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 jointMRC can screen up to 5 Rejected Targets resultsusing 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