Presentation Patheon Biotuesday · ¹Source: PharmSourceestimates, 2014. Development market...
Transcript of Presentation Patheon Biotuesday · ¹Source: PharmSourceestimates, 2014. Development market...
PatheonPresentation
Biotuesday
March 2016
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Patheon Overview
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Patheon is a leading provider of contract development and commercial manufacturing services to the pharmaceutical & biotechnology sectors.
We offer the broadest set of solutions to clients including
3 Confidential
We offer the broadest set of solutions to clients including development and commercial manufacturing services for both large and small molecule drug substance and drug product in a wide range of dosage forms.
Appointed James C. Mullen as Chief Executive Officer and to Board of Directors
2011 20132012 2014
DPx was formed as a part
of a $2.7 billion transaction between JLL Partners and
Royal DSM
2015
Acquisition of IRIXadded North American API
services
Inspire & Simplify.
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2011 20132012
Acquisition of Banner Pharmacaps, a market leader in soft gelatin capsule technology, adding a new
proprietary products and
technology business
Acquisition of Gallus BioPharmaceuticals, adding North American capabilities to
its existing biologics operations
in Groningen, Netherlands and
Brisbane, Australia
2014 2015
Acquisition of Agereadded low solubility
Legacy Patheonbusiness had a strong
PDS and DPS offering
PharmSource Report cites Patheon winning the greatest % of NMEs and non-NMEs over the last 10 years
Single Source Provider, End-to-End
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Process Development and production of active pharmaceutical ingredients for small molecule drugs and biologic drug substances for preclinical studies through commercialization
Drug Substance Services
Single Source Provider, End-to-End
Pharmaceutical
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Pharmaceutical Development
Services
Full spectrum of advanced scientific services from discovery to
regulatory approval. Services include formulation development
across approx. 40 dosage forms, analytical services, and life cycle
management.
Single Source Provider, End-to-End
Drug
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Commercial manufacturing, packaging and other support
for marketing prescription, OTC and nutritional products in
a wide range of dosage forms
Drug Product Services
Patheon #2
Contract Pharmaceutical
Manufacturing Market2
100+
Others
Patheon #1
Contract Pharmaceutical
Development Market¹
A Recognized Leader in Contract Development and Manufacturing
200+
Others
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The highly fragmented manufacturing market was worth $15.1B in 2013
Patheon is second in the market witha 7% share
¹Source: PharmSource estimates, 2014. Development market estimate includes preformulation, formulation, and clinical dose manufacturing.2Source: PharmSource estimates, 2014. Contract Manufacturing market estimate excludes enhanced packaging. Includes DPP data
Others
The contract development market was worth $1.9B in 2013
Patheon is the market leader with a 9% share
Others
Whitby, Canada
Toronto, Canada
Cincinnati, OH USA
Boston, MA USA
Durham, NC USA
High Point, NC USA
Greenville, NC USA
Princeton, NJ USA
Capua, Italy
Monza, Italy
Ferentino, Italy
Milton Park, UK
Swindon, UK
Bourgoin, France
Groningen, Netherlands
Utrecht, Netherlands
Tilburg, Netherlands
Linz, Austria Tokyo, Japan
Patheon is a Global Service ProviderMore than 25 locations across
North America, Europe, Latin America & Australia
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Princeton, NJ USA
St. Louis, MO USA
Bend, OR USA
Florence, SC USA
Greenville SC, USA
Manatí, Puerto Rico
Linz, Austria
Regensburg, Germany
Tokyo, Japan
Shanghai, China
Brisbane, Australia
As of April 2015
Small Molecule Drug Substance
Large Molecule Drug Substance
Drug Product
Patheon Bourgoin Overview
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� Pharmaceutical site since 1960’
� PATHEON site since1999
� Manufacturing Area: 25 250 m2
� Employees: 262 (Commercial) + 50 (Development Services)
Bourgoin Overview
Site authorized and focused on High-potent compounds (up to Cat3B)
PDS (Development) co-located with commercial plant (DPS).
Solid oral dosage forms manufacturing
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Solid oral dosage forms manufacturing
Compatible processes to allow smooth scale up of solid dose manufacturingprocesses from� clinical batches and small commercial batches (5 – 150 kg) to
� larger commercial (150 – 750kg) process scales
EU Center of Excellence Packaging: blisters, bottling, sachets
� The Bourgoin facility is routinely inspectedby both its international clients and its localRegulatory Body – ANSM.
� ANSM approved site (June 2014)
� US FDA approved site (March 2014)
Date of Inspection Regulatory Authority Inspection Type
Nov 2015 ANSM GMP
June 2015 ANVISA GMP
March 2015 Kenyan Inspection GMP
November 2014 Turkish Inspection GMP
June 2014 ANSM (France) GMP
March 2014 FDA PAI
Regulatory and inspection history
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� PMDA accreditation (Japanese authority) (February 2012)
� The facility is approved for all Europeancountries, Canada, New Zealand,Australia, Kenya and Japan throughmutual recognition (MRAs)
� Shipment to worldwilde destinations suchas, Asia, MEAF, South America etc.
March 2014 FDA PAI
December 2013 Turkish Inspection GMP
April 2012 ANSM (France) GMP
July 2011 ANSM (France) for PDS GMP
November 2009 ANSM (France) GMP
November 2008 KFDA (Korea) PAI
July 2008 GISK (Russia) GMP
June 2008 ANVISA GMP
PRODUCT DEVELOPMENT SERVICES PDS October 2015
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Product Development Services GrowthBuilt in 2010 – Started in 2011
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- Safely APIs process with a minimum OEB 4 / OELs >10 ng/m3 (Cat 3b)
-Contained processing design concept to minimise the need for PPE (personal protective equipment) for routine
operations. Compliant with Big Pharma HiPo Health-Security-Environment internal rules
- Design-for-manufacture approach enabling reproducibility from development scale (1kg) to commercial scale
High Potent Oral Solid Dose Center Of ExcellenceSeamless contained development and manufacturing service
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EOB 4EOB 5
Bourgoin Development Services Capabilities
Technologies• High potency containment at source• Powder blending (5 - 150 kg)
• Granulation (30 - 150 kg)
• Dry compaction
• Compression (conventional, minitabs & bilayer tablets)
Dosage forms• Tablets• Capsules
• Sachets• Oral Solutions
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• Compression (conventional, minitabs & bilayer tablets)
• Coating
• Encapsulation
Packaging • Semi automatic packaging lines:
� Bottles � Blisters ( PVC, PVDC, Aclar®)
Services• Clinical supply• Process Development
• Quality by Design• DoE
• Small scale commercial supply
Exemples de produits hautement actifs novateurs développés sur le site de Bourgoin-Jallieu
Projet P232: traitement du cancer du myélome, Leucémie aigue (US)
Projet P470: traitement du cancer de la prostate (US)
Projet P448: traitement du cancer de la prostate (Finland)
Projet P549: traitement des tumeurs solides, cancer du sein / des poumons, (France)
Projet P497: traitement de la leucémie aigue (Japan)
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Projet P497: traitement de la leucémie aigue (Japan)
Projet P513: traitement de la maladie de Parkinson (Switzerland)
Projet P460: traitement du cancer du sein (US)
QUESTIONS?
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Contact
Francois Berthier: Pharmaceutical Expert & Innovation Contact
Patheon
40 Boulevard de Champaret - CS 11006
38307 Bourgoin-Jallieu Cedex France
Phone: +33 (0)4 74 93 87 63
Mobile: +33 (0)6 46 63 52 62
Fax: +33 (0)4 74 93 87 94
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Fax: +33 (0)4 74 93 87 94