ADCs: the opportunity
Barry Heavey, Head of Life SciencesIDA Ireland
June 20th, 2014
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ADC market opportunity
– Herceptin: Launched 1998 patent expiration 2014 Controversy over price/efficacy Mylan & Biocon Biosimilars in India
– Kadcyla: Herceptin ADC 80% of US oncologists are prescribing only 9 months after FDA
approval $100M in Q1 2014 Peak sales estimate $2-5bn
2006 2007 2008 2009 2010 2011 20120
1000000
2000000
3000000
4000000
5000000
6000000
7000000
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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
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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
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Selected ADCs in clinical developmentAntibody-drug conjugate Sponsor company Cellular
target Phase of developmentMylotarg (gemtuzumab
ozogamicin) Pfizer CD33 withdrawn from market
Adcetris (brentuximab vedotin, SGN-35)
Seattle Genetics/Millenniu
m (Takeda)CD30 Approved
trastuzumab-DM1 Roche/Genentech/ Chugai HER2 Approved
inotuzumab ozogamicin Pfizer CD22 phase IIIlorvotuzumab mertansine ImmunoGen CD56 phase IIglembatumumab vedotin Celldex
Therapeutics GPNMB phase II
BT-062 Biotest + ImmunoGen CD138 phase I/II
SAR-3419 Sanofi + ImmunoGen CD19 phase I
IMGN529 ImmunoGen CD37 phase ISGN-75 Seattle Genetics CD70 phase I
ASG-5ME Agensys (Astellas) + Seattle Genetics SLC44A4 phase I
ASG-22ME Agensys (Astellas) + Seattle Genetics Nectin-4 phase I
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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
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ADC Global Manufacturing Capabilities
…
Future location
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Case study: Adcetris supply chain
Abbvie (Antibody)
AMRI (Drug linker mfmg)
SAFC (Drug linker mfng)
Piramal healthcare
(Conjugation)
Pierre Fabre (Fill/finish)
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ADCs: B-2-B collaboration essential
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The opportunity for Ireland
– Ireland is winning high value manufacturing FDI 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)
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$2bn in Recent Investment Wins
April. 2014Global supply chain, quality fill finish & packaging.250 jobs $100M
Aug. 2013$300M investment in 400,000ft2 biotech drug substance facility
Feb. 2013 $44m investment in Biotech campus
Employs > 500
Apr. 2012New Biotech facility in Cork
$420m/200 jobs
June. 2011Manufacturing plant
$50m/100 jobs
Jan. 2012$350m investmentManufacturing & development200 new jobs
Apr. 2012$500m investment in two strategic sitesRespiratory and sterile fill finishEmploys > 700
April. 2014Manufacturing of biologic device combination product.270 jobs $100M
Apr. 2012$200m investment
Employs > 300
July. 2013 Establishing packaging, quality and supply chain function in Dublin
Employs > 100
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
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Recent supply chain management projects in pharmaCompany Project Locatio
nFunctions Second
siteJazz Nov 2012 Dublin Tech ops, SCM, QC, finance,
Legal, treasuryAthlone
Regeneron June 2013 Dublin Regulatory affairs, SCM Limerick300 jobs
Alexion Sept 201350 + 250jobs
Dublin SCM, procurement Athlone70 jobs
Endo April 2014 Dublin SCM, Regulatory, quality, IP, commercial
Athlone
Biomarin May 201450 jobs
Dublin International Sales support, SCM, procurement
Cork100 jobs
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
– National Institute for Bioprocessing, Research and Training (NIBRT)
– Construction/engineering capacity and capability.
– Strategic sites.– Cluster development
– Government R&D support through IDA and SFI
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
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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
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HEA28%
SFI20%EI
14%IDA Ire-
land8%
Teagasc7%
HRB5%
DAFM 4%DJEI 3%IRCSET 3%
EPA1%
Others6%
Government spend on
R&D (€800M in 2012)
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 Biopharma industry tech group Establish Subgroup on ADCs? Spot opportunities for B-2-B collaboration Develop proposals for publically funded research programs
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To learn more log on to idaireland.com+353 1 6034285 [email protected]
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