biomanufacturing in canada- opportunity for development? · biomanufacturing in canada- opportunity...
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![Page 1: Biomanufacturing in Canada- Opportunity for Development? · Biomanufacturing in Canada- Opportunity for Development? Bernard Massie General Manager (acting) Human Health Therapeutics](https://reader035.vdocuments.mx/reader035/viewer/2022062602/5ee0046cad6a402d666b4756/html5/thumbnails/1.jpg)
Biomanufacturing in Canada- Opportunity for
Development? Bernard Massie General Manager (acting) Human Health Therapeutics December 7th 2016
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2011 2012 2013 2014 2015 2016
Annu
al S
ales
(CAN
$B)
Biologics market: Double-digit growth! • Canadian biologics market 2015 >$5B growing at 11% 4YR CAGR
• Biologics market share grew from 11% (2008) to 24% (2015)
• WW biologics are 8 of top 10 and 47 of top 100 pharmaceuticals
Source: IMS, PMPRB Annual Report 2014, Biologic Therapeutic Drugs-BCC Research, Outsourcing-DataMonitor2013, EvaluatePharma.
187 biologics
f f
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Small molecules vs. Biologics
Small molecules
Production in living organism (cell, bacteria,
yeast, plant, egg)
Aspirin 0.18kDa - 1x
Antibody 150kDa - 850x
Biol
ogic
s
Chemical synthesis
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THREE R&D PROGRAMS FOCUSED
ON BIOLOGICS AND VACCINES
CANADIAN BIOMANUFACTURING
INITIATIVE AT NRC
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Canadian Biomanufacturing Initiative
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Small molecules Biologics
Production complexity
Characterization
Relocating production
Complexity of Biomanufacturing
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Small molecules Biologics
Production complexity Low
Characterization
Relocating production
Complexity of Biomanufacturing
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Small molecules Biologics
Production complexity Low
Characterization Extensive
Relocating production
Complexity of Biomanufacturing
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Small molecules Biologics
Production complexity Low
Characterization Extensive
Relocating production Easy
Complexity of Biomanufacturing
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Small molecules Biologics
Production complexity Low High
Characterization Extensive
Relocating production Easy
Complexity of Biomanufacturing
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Small molecules Biologics
Production complexity Low High
Characterization Extensive Limited
Relocating production Easy
Complexity of Biomanufacturing
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Small molecules Biologics
Production complexity Low High
Characterization Extensive Limited
Relocating production Easy Difficult
Complexity of Biomanufacturing
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Small molecules Biologics
Production complexity Low High
Characterization Extensive Limited
Relocating production Easy Difficult
Complexity of Biomanufacturing → Stickiness
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Worldwide Investment in Biomanufacturing
$11B Global investment in biomanufacturing facilities
Sept 2016
Oct 2015
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Worldwide Investment in Mammalian Cell Biomanufacturing
>90% Investment in facilities with mammalian cell capacity
Sept 2016
Oct 2015
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* Monoclonal antibody production
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Biomanufacturing capacity is controlled by product companies Only 21% of biomanufacturing capacity is accessible for contract
CMOs 21% of capacity 11yr CAGR 15%
Product Companies 79% of capacity 11yr CAGR 17%
Source: BioPlan estimates 2008-2013; Ransohoff, T. Bioprocess Technology Consultants, 2003-2007 data
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3 CMOs Control Mammalian Cell Biomanufacturing Offer
33%
27%
16%
24%
Lonza
Boehringer Ingelheim
Celltrion
Others
Eric S. Langer, 2015 12th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production, BioPlan Associates, Inc. April 2015 http://www.biopharminternational.com/global-biomanufacturing-outsourcing-market Outsourcing, DataMonitor 2013
Canadian biotechs have limited access to large integrated CMOs.
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“Globally, there exists a shortage of [CMOs] to support the development and manufacture of biologic drugs...”
- Branch et al., American Pharmaceutical Review, September 2015
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WHY INVEST IN BIOMANUFACTURING?
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Retain Pharmaceutical import/export
balance
Nat
iona
l bi
osec
urity
High quality job creation
Strengthen pharmaceutical value-chain
Increase access to therapeutics Reduce cost of therapeutics
economic impact ecosystem
pharma Fill gap in
Support local biotechs
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CAN OUR LOCAL PIPELINE SUPPORT LOCAL BIOMANUFACTURING?
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Competitive Canadian Biologics Pipeline
institutions developing
Produced in Mammalian Cells
55%
71 a combined pipeline of biologics 196
Discovery + Pre-clinical Stage 72%
Source: MedTrack, company websites, Industry Canada and NRC (and partners)
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LOCAL BIOMANUFACTURING?
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Gaps in Canadian Biomanufacturing Capabilities?
With 55% of the Canadian pipeline
requiring production in
mammalian cells, is our capacity sufficient?
Company Location / Type Capacity GMP Clinical Commercial
PRO
DUCT
CO
MPA
NIE
S Medicago QC – plant plants PlantForm QC – plant plants Apotex ON – microbial 3X 14kL, 2X 30kL X X Emergent MB – microbial 2kL X Eleven Bio MB – microbial 1.5kL X PnuVax QC – microbial 0.5kL, 2kL X
CMO
s Bio Vectra PEI – microbial 2X 17kL, 15kL X X Biodextris QC – microbial n/a KABS QC – microbial 4kL X Therapure ON – mammalian 0.5kL X
IDLE
PnuVax QC – mammalian 0.5kL, 2kL Ex-Bioniche ON – microbial 5kL
Biomanufacturing facilites in academia, hospitals or research institutions are not included
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Canadian investments in the last 2 years
Medicago $245M plant-based production in Quebec with $68M from Qc BioVectra $30M to expand microbial plant Green Cross $315M plasma plant in Montréal with $8M from Qc Therapure $20M contribution from FedDev for expansion of plasma plant Sterinova $20M for fill & finish facility
? ? ? ? ? ? ? ? ?
$0 in mammalian cell facilities
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IS BIOMANUFACTURING A CORNERSTONE
OF THE ECOSYSTEM?
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CMOs = contract manufacturing organizations Average cost of developing a new drug. Tufts CSDD 2014 Amgen Annual Report 2014, Cost of sales / Net Sales = 23%; Novo Nordisk (2012-2014) = 16% to 17%; W. Nicholson, Boston Law Review 2014 = 14%
Biologics Development Value Chain
Preclinical R&D Clinical Development Approval Commercialization CTA NDS
$1-5M
CMO
$2-13M
CONTRACT SERVICES LICENSE+
$50-350M
CONTRACT SERVICES
$10M
CONTRACT SERVICES
$2M/yr
CONTRACT SERVICES
$5-50M
CMO
Up to $100M/yr
CMO
? ? ?
NOC
Is Biomanufacturing a Cornerstone of the Ecosystem?
14% OF AVG WW SALES $714M/Y
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Market Potential for Mammalian Systems in Canada
Preclinical Phase 1
Phase 2
Phase 3
R+M
111 biologics
$1.6B
$600M/Y Annual commercial CMO revenues 6Y+
5Y CMO revenue (cumulative)
In the absence of local CMOs, this market potential will be captured abroad
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CMOs – Key to Retaining Value of Biologics
$5B/y Biologics sales in Canada
55% Canadian pipeline in mammalian cells
$1.6B Potential 5Y revenue from Canadian mammalian cell pipeline
$0 Supporting large scale mammalian cell biomanufacturing in Canada
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Canadian Biomanufacturing Opportunity
Sustained growth trends of biologics sales
Complexity of biomanufacturing → stickiness factor for local production
Major worldwide investment in mammalian cell biomanufacturing, yet shortage of CMO offer
Gap in mammalian cell biomanufacturing offer in Canada
Is there a case for investing in mammalian cells CMO offer in Canada?
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“Every biologic developed in Canada will be manufactured in Canada.”
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Acknowledgments - Team work Alex Serrano, Technology Business Analyst Eileen Raymond, Portfolio Business Advisor Frank van Lier, Director R&D - HHT Thomas Loisel, Section Head - HHT Guy Le Houillier, Client Relationship Leader Vivian Woo, Knowledge Management
Consulting: Gérald André, VieTech Terrence Cochrane, BioProcessing Alliance Inc.