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Industry-academia co-operation to sustain innovation in drug discovery
BioDundee 30 May 2012
Campbell WilsonAstraZeneca
The Perfect Storm
REGULATORYHURDLES
PATENT EXPIRIES
PRICING &REIMBURSEMENT
The Perfect Storm for Pharma
Patent Expiring in 2011
Condition Company 2010 U.S. Sales
Lipitor cholesterol Pfizer $5,329,000,000
Zyprexa antipsychotic Eli Lily $2,496,000,000
Levaquin antibioticsJohnson & Johnson
$1,312,000,000
Concerta ADHD/ADDJohnson & Johnson
$929,000,000
Protonix antacid Pfizer $690,000,000
The Patent Cliff
Patent Expiring in 2012
Condition Company 2010 U.S. Sales
Plavix anti-plateletBristol-Myers Squibb /Sanofi-Aventis
$6,154,000,000
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
Clinical success rates
2004-2011 success rate from Ph I to FDA approval is: 6.7% for oncology12.1% for other indications
Health Technology Assessment Agency reimbursement decisions
Disease Recommend Decision
Recommend R* Decision
Not recommended
Decision
Total Decisions
Cardiovascular 23
(36%)
27
(42%)
14
(22%)
64
(100%)
Cancer 29
(22%)
52
(40%)
49
(38%)
130
(100%)
Total decisions 52
(27%)
79
(41%)
63
(32%)
194
(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
Core Operating Profit 13,167 13,603 -3% -4%
Revenue 33,591 33,269 +1% -2%
Core EPS $7.28 $6.71 +9% +7%
Reported EPS $7.33 $5.60 +31% +29%
Full Year Dividend $2.80 $2.55
CERgrowth
2011$m
Actualgrowth
2010$m
•Fewer successful product launches
•Negative growth
•Long term sustainability of pharma operating 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 and academia share resources, risk and reward
• Payment for successful outcomes 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
• Pharma fully funds• Pharma retains all rights• Pharma reaps all commercial
benefit
AstraZeneca-Cancer Research TechnologyStrategic Alliance in Cancer Metabolism
TargetValidation
Assay Development HTS Hit-to-Lead
Early Lead Optimisation
Joint project acceptance via JMT. Project managed by JPT
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)
Project passes 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
Rejected Target
Selected Target MRC Screen
Ex
erc
ise
Op
tio
n1
£2
0K
Op
tio
n F
ee
AZ pursue – Research Collaboration / licence
orAZ & MRC pursue jointly Research Collaboration
MRC can screen up to 5 Rejected Targets using the AZ CC – AZ retains Options 1&2
Re
jec
t O
pti
on
1
Hit from MRC CC•No further obligations to AZ•AZ assigns interest in joint results
Hit from AZ CC•AZ grants use of joint results / AZ compound to allow MRC to perform H2L chemistry•AZ retains Option 2
H2L C
hemistry
Ex
erc
ise
Op
tio
n 2
Study / licence
•AZ licence joint results& MRC compound if required
£2
0K
Op
tio
n F
ee
Reject Option 2
MRC pursue
•AZ assigns interest in joint results•MRC licence AZcompound if required
AZ – MRCTModel
The future?
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