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

francois.berthier@patheon.com