The market opportunity for ADC manufacturing

Report
ADCs: the
opportunity
Barry Heavey,
Head of Life Sciences
IDA Ireland
June 20th, 2014
ADC market opportunity
7000000
– Herceptin:




Launched 1998
patent expiration 2014
Controversy over price/efficacy
Mylan & Biocon Biosimilars in India
– Kadcyla:



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6000000
5000000
4000000
3000000
2000000
1000000
0
2006
2007
2008
2009
2010
2011
2012
Herceptin ADC
80% of US oncologists are prescribing only 9 months after FDA approval
$100M in Q1 2014
Peak sales estimate $2-5bn
2
ADC market opportunity
– Brentuximab
 Millenium/Takeda pipeline antibody
 2000-2010: Failed to show efficacy in clinical trials for Hodgkins
Lymphoma
– Brentuximab-vedotin (ADCetris)




Partnership with Seattle Genetics to develop ADC version
34% complete remission, 40% partial remission
Accelerated approval 2012
2015 sales target €420M
3
ADC market opportunity
– “Biobetters” of existing Mabs: kadcyla
– “Reactivate” shelved Mabs: Adcetris
– Precedents for strong efficacy, fast track status
– Part of overall strong momentum in oncology
 €42Bn chemotherapy market growing through innovation
– Regulators/payors/clinicians getting familiar with ADC technology
– All major pharma companies now developing ADCs
 2013: 100 ADCs in clinical trials
4
Selected ADCs in clinical development
Antibody-drug conjugate
Sponsor company
Cellular target
Phase of development
Mylotarg (gemtuzumab
ozogamicin)
Pfizer
CD33
withdrawn from market
CD30
Approved
HER2
Approved
CD22
phase III
Seattle
Adcetris (brentuximab vedotin,
Genetics/Millennium
SGN-35)
(Takeda)
Roche/Genentech/
trastuzumab-DM1
Chugai
inotuzumab ozogamicin
Pfizer
lorvotuzumab mertansine
ImmunoGen
CD56
phase II
glembatumumab vedotin
Celldex Therapeutics
GPNMB
phase II
BT-062
Biotest + ImmunoGen
CD138
phase I/II
SAR-3419
Sanofi + ImmunoGen
CD19
phase I
IMGN529
SGN-75
ImmunoGen
Seattle Genetics
Agensys (Astellas) +
Seattle Genetics
Agensys (Astellas) +
Seattle Genetics
CD37
CD70
phase I
phase I
SLC44A4
phase I
Nectin-4
phase I
ASG-5ME
ASG-22ME
5
ADC market opportunity
– Technology maturing
 VC backing for novel technology
• linker/conjugation chemistry/site-specific conjugation/payload
 Investment in supporting services
• Specialised CMOs – linkers, conjugation, high containment FF
• Specialised CROs for QA/QC?
 Investment by equipment/technology companies
•
•
•
•
Process engineering for conjugation
Improved containment tech
Improved analytics (process and product)
Single use ADC mfng systems
 Specialised conferences, industry working groups etc etc
– Broad investment helps mitigate technology risk
6
ADC Global Manufacturing Capabilities
Future location
…
7
Case study: Adcetris supply chain
Abbvie
(Antibody)
AMRI (Drug
linker mfmg)
SAFC (Drug
linker mfng)
Piramal
healthcare
(Conjugation)
Pierre Fabre
(Fill/finish)
8
ADCs: B-2-B collaboration essential
9
The opportunity for Ireland
– Ireland is winning high value manufacturing FDI

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Biotech DS/DP
High potency API/formulation
Single product sites transitioning to multiproduct sites
Combination products: drug-device combos
Global release testing
Packaging
Responsibility for management of complex supply chains
– VC funds being attracted to Ireland
 Can attract innovator companies
– Technology providers in Ireland
 Indigenous: PM, DPS, Prosys…
 MNC: GE, Waters, PPD, Millipore…
– Manufacturing a priority area for state investment (R&D grants)
10
$2bn in Recent Investment Wins
April. 2014
Manufacturing
of biologic
device
combination
product.
270 jobs $100M
Apr. 2012
$200m
investment
Employs > 300
April. 2014
Global supply
chain, quality
fill finish &
packaging.
250 jobs $100M
Aug. 2013
$300M investment
in 400,000ft2
biotech drug
substance facility
July. 2013
Establishing
packaging, quality
and supply chain
function in Dublin
Employs > 500
Employs > 100
Apr. 2012
Jan. 2012
$500m investment in $350m
two strategic sites
investment
Respiratory and
Manufacturing &
sterile fill finish
development
$420m/200 jobs
Employs > 700
200 new jobs
Apr. 2012
New Biotech
facility in Cork
Feb. 2013
$44m investment
in Biotech campus
June. 2011
Manufacturing
plant
$50m/100 jobs
11
Biopharma Cluster
In Ireland
More than 5,000 people
employed in Biotech
development and
manufacturing in 2014
7% employment growth per
annum since 2009
NIBRT provided training in
biopharma manufacturing to
2,000 people in 2013
Recent supply chain management projects in pharma
Company
Project
Location Functions
Jazz
Nov 2012
Dublin
Tech ops, SCM, QC, finance, Athlone
Legal, treasury
Regeneron June 2013
Dublin
Regulatory affairs, SCM
Limerick
300 jobs
Alexion
Sept 2013
50 +
250jobs
Dublin
SCM, procurement
Athlone
70 jobs
Endo
April 2014 Dublin
SCM, Regulatory, quality, IP, Athlone
commercial
Biomarin
May 2014
50 jobs
International Sales support,
SCM, procurement
Dublin
Second
site
Cork
100 jobs
13
Why Ireland for biopharma FDI?
– 9 of the world’s top 10 Pharmaceutical companies
– 83 plants - 33 FDA approved.
– 17 Biopharmaceutical plants
– Exports €55 billion in 2012.
– 24,500 people directly employed plus 24,500 indirect
– Strong regulatory track record – FDA/IMB
– Government R&D support through IDA and SFI
– National Institute for Bioprocessing, Research and Training (NIBRT)
– Construction/engineering capacity and capability.
– Strategic sites.
– Cluster development
Developing an “ADC Cluster”
– IDA committed to supporting ADC investments through grant aid
 Biopharma companies: grants for in-house process R&D
 Supplier companies: grants for new product/service development
15
Developing an “ADC Cluster”
– IDA committed to supporting ADC investments through grant aid
 Biopharma companies: grants for in-house process R&D
 Supplier companies: grants for new product/service development
EPA
1%
Government
spend on
R&D
(€800M in 2012)
IRCSET 3%
DJEI 3%
DAFM 4%
Others
6%
HEA
28%
HRB
5%
Teagasc
7%
IDA
Ireland
8%
EI
14%
SFI
20%
16
Developing an “ADC Cluster”
– IDA committed to supporting ADC investments through grant aid




Biopharma companies: grants for in-house process R&D
Supplier companies: grants for new product/service development
Indigenous companies – support from Enterprise Ireland
Opportunities for B-2-B collaboration
– SFI/EI supports for industry academic collaborations/consortiums
– NIBRT as a neutral venue/pilot scale test-bed/showcase facility
 R&D programs = marketing collateral for FDI
– Networking/mobilising the sector
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Biopharma industry tech group
Establish Subgroup on ADCs?
Spot opportunities for B-2-B collaboration
Develop proposals for publically funded research programs
17
To learn more log on to idaireland.com
+353 1 6034285
[email protected]

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