overcoming process development and biologics manufacturing challenges
DESCRIPTION
Speakers: Tom Wellner and David Bell from Therapure Biopharma Part of the Drug Development Discussion Group Event Series at MaRS. For more information, please visit: http://www.marsdd.com/Events/Event-Calendar/Drug-Development-Discussion-Group/therapure-05152009.htmlTRANSCRIPT
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MaRS | May 15, 2009Thomas G. Wellner – President & CEO
Dr. David N. Bell – VP Drug Development & CSOwww.therapurebio.com
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13/ of all newproducts
The future of medicine
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$51B
$87B
$25B
$89B
2001
Protein therapeutic market
2005 2010 2010
Worldwide mobile technology market
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You discovered a protein with blockbuster potential
Specific
Safe
Targeted
Efficacious
Novel
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Ultimately, to get your product approved you will invest…
You are working hard to develop it
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11 years 5 clinical
trials 2,000
patients 39 patents ~$1 billion
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What about manufacturing?
What about manufacturing?
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Discovery Development
Marketing Manufacturing 7
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Scaling up is not easy
Simple
Quick
Inexpensive
Milligrams
commercialbench
Complex
Long lead times - 4-5 years
Expensive -
$150+ million
Kilograms8
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Therapure Biopharma:Overcoming the manufacturing barrier
Complex We know protein purification
Long lead times Ready to go now
Quality cGMP compliant
Expensive Established Meadowpine Facility
Regulated We have 8 INDs under our belts
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Committed to the development, manufacture, purification, and packaging of high-quality biological therapeutics
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Therapure Biopharma Inc.
• Flexible, modern cGMP manufacturing facility
• Expertise in manufacturing & downstream purification
• Extensive quality systems• Deep understanding of
advanced biology & complex proteins
• Creative partnering options
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Therapure Biopharma – Key Facts
Company Established
• Assets of former Hemosol business acquired Q3/2007 including modern and flexible Health Canada approved facility
• Therapure Biopharma Inc. launched Q3/2008
Ownership Financing
• Privately held by Catalyst Fund Limited Partnership II, a Canadian based private equity fund, and management
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Modern and Flexible Facility
Facility Built: 2003
Size: 130,000 ft2 (12,000 m2)
Location: Toronto, Canada (Mississauga)
Minutes from Toronto’s Lester B.Pearson International Airport
Employees: 65
Capabilities
• Development, manufacture and fill/finish of therapeutic proteins
• Product development
• Process development
• Manufacturing
• Fill/finish
• Lyophilization
Designed to meet U.S. FDA, Health Canada and EMEA requirements
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Our Business Strategy
CornerstoneCDMO Business
Unique & Flexible Facility
Scientific & Biomanufacturing
Expertise
Creative Financing
Develop Products-TBI Pipeline
-Joint Venture
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Key Milestones
Therapure Biopharma Inc. established July/08
Manufacturing plant re-validated Sept/08
Key talent retained and hired
Plant upgraded to create flexible multi-use facility Dec/08
Several key partner/client agreements executed
Revenue generation in 2008
Break even goal in 2009
Business development activities increasing
Pipeline milestones achieved for core assets
Health Canada re-certification of plant – May/09
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Key Clients / Global Collaborations
Client project opportunities continue to grow
Rare protein development project Growth factors for stimulating bone regeneration
Iron Chelating Agent for thalassemia
PEGylated biologic oncology product
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Experienced Sr. Management Team
• Thomas Wellner President and CEOEli Lilly & Co.
• Dirk Alkema, Ph.D.Vice President, OperationsConnaught Labs and Hemosol
• Peter Winkley, CA Vice President Finance and CFOMDS and Ernst & Young
• David Bell, Ph.D. Vice President, Drug Development and CSOBioChem Therapeutic Inc and FAA
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Sophisticated Biologic Development &Manufacturing Services
Sophisticated Biologic Development &Manufacturing Services
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Integrated Full Service Provider
• “One stop-shop” for development and manufacture of therapeutic proteins
• Cost-effectively manage all aspects of development and manufacturing at both small (mg) and large (kg) scale:– Upstream processing– Downstream processing– Clinical supplies including distribution– Commercial manufacturing– Fill and finish– Lyophilization– Full analytical support
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Fully Integrated Services
Upstream Processing Molecular biology Cell line creation &banking Mammalian cell culturesDownstream Processing• Protein modification• Purification• Stabilization
mg to kg scale batches Preclinical scale Clinical scale Commercial scale
• Aseptic filling of glass vials & preformed bags• Lyophilization• Clinical supplies including distribution
CommercialProduct
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High Quality Manufacturing Facility
Chromatography Analytical Laboratory
Vial filling line Buffer farm
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Support Beyond Development & Manufacturing
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Creative Financing Opportunities
Therapure can potentially offer creative financing to partners who require development and biomanufacturing services:
Secured DebtEquity partnershipJoint Venture
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Your trusted partner for protein development & manufacturing
Your trusted partner for protein development & manufacturing
23www.therapurebio.com