Amatsigroup CORP PRES HUMAN HEALTH 19 05 2016

Amatsigroup presentationHuman HealthMay 2016

2 Nom de la présentationCorporate Presentation Human Health

Sept 2014

Leading EarlyCDMO * Partner

in Pharmaceutical Product Development

* Contract Development And Manufacturing Organization

Expertise


Vision Leading partner in the early phases of pharmaceutical development Active contributor to health improvement.

* Co

ntra

ct D

evel

opm

ent M

anuf

actu

ring

Org

aniza

tionMission As a major European early CDMO*, we collaborate with small to large

bio/pharmaceuticals companies offering integrated high-added-value drug development services.We apply a unique & innovative HighWay-to-Clinic™ approach delivering tailored and troubleproof solutions which help advancing our client’s programs in a timely & cost effective manner.We support life science development through our scientific, technological & regulatory expertise.

Amatsigroup Identity

Transparency, team spirit, authenticity & trust, are the core values that we share with clients.

Values


Sept 2014

78%

22%

2015 Revenues

Spanning Human & Animal Health

Expertise

2015 Revenues

Clients Typology

2015 Revenues

Geographic Split


Jan 2016Q BiologicalsAcquisition

Sept 2014

25 years of experience

Key Steps

2012AVEPHARMAcquisition

1987 CRID PHARMA Creation

2010• AVOGADRO

acquisition• CRID renamed AMATSI

2000AVEPHARMCreation

2006DBI Creation

2011DBIAcquisitionQ-BiologicalsCreation

1998AVOGADROCreation

2008SEPS PHARMACreation

2013Legal merger

Jan 2015SEPS PHARMA Acquisition

Nov 2015PIERRE FABRE ST AUGUSTIN Acquisition

Oct 2014 Creation


Sept 2014

• 300 active clients

• 8 operational sites

• 280 employees

• 33 M € of revenue in 2015

ADMIN. OFFICE

Inc.

Key Figures


Sept 2014

Accreditations | Inspections


5 areas covering Drug Product Development

* Excluding Clinical Monitoring

Portfolio

CMC & RACMC & RA


Expertise

Sept 2014

160 batches released yearly

3 000 shipments yearly

Clinical Trial SupplyPackaging & Logistics

300 + bioanalytical methods developed in 30 + matrices

100 in life studies yearly

Bioservices

Formulation Development & Manufacturing

30 formulation development projects yearly

100 sterile & 145 non-sterile batches manufactured yearly

PharmaceuticalAnalysis Solutions

150 + analytical methods developed yearly

500 analytical CoA, 1200 microbial tests monthly

25 lots put into stability monthly

Experience with 200+ proteins

75 R&D projects in 4 years

Biologicals


Sept 2014

Organization highlightsExperienced Senior Management

| Pharmacist| 25 years in

Pharma Industry

Alain SainsotPresident

Jean-Pierre ArnaudCEO

| Veterinarian| 35 years in

Animal Health

Marie-Christine BodinierEVP, Global Business Development

| Biochemist| 25 years in

US & EU Life Sciences

Experts for BUs supervision / cross-sites management| Ph.D. Pharma

Technology| 15 years in

Pharma Industry

Yves GonnissenBU DirectorFormulation Development& Manufacturing

| Ph.D. Chemistry

| 20 years inPharma Industry

Gérald de FontenayBU DirectorPharmaceutical Analysis Solutions

Annie Van BroekhovenBU DirectorBiologicals

| Ph.D. Cell Biology| 35 years in

Biologicals


Sept 2014

Organization highlights

Technical & scientific expertise of the Business Team| Business Development Managers with scientific degrees| Commercial Business Unit Managers with strong technical expertise| Quotation Specialists with operational knowledge

| Large scope of expertise : M.Sc, Ph.D, D.V.M. Pharm.D., Eng., B.Sc.| 1 project manager / study director for 2 Technicians (B.Sc.)

Multidisciplinary Operational Teams


PHARMA EXPERTISE• Merger of 4 expert companies• Group managed by Industrials for Industrials

Sept 2014

• Customized solutions• Adaptability to schedule changes• Industrial modularity

FLEXIBILITY

PROXIMITY• Dedicated Project Manager• Lean structure• Study designs & quotations supervised by scientists

Core Values

QUALITY• 9 QPs – 12 QA people• GMP & GLP compliance


Comprehensive Customer Service

* Chemistry Manufacturing Control

• CMC files drafting Gap analysis & updates IVP & Market Authorization dossiers Variation dossiers

• Product development management Internal CMC*-Regulatory Affairs team Internal coordination of all phases Dedicated customer contact (SPOC) Statistical measurements & Analyses

• Response to Agencies


Project management under CMC & RA

Human Health

PRODUCTFormulatio

nAnalytica

l Package

CMC Regulato

ry studies

Manufacturing

QP ReleaseDistribution of

clinical batches

Constitution of CMC

file

Antiseptic Topical SolutionGENERIC

Transfer

AntihypertensiveCapsules

NCEPhase 2

AntiepilepticPediatric soluble

tabletPhase 2

CNS disorderPediatric oral

solutionPhase 2

AntineoplasicSolution for injection

NCEPhase 1

AntiallergenicCutaneous patches

Phase 1 to 3


Sept 2014

FREQUENT

Communication

TECHNICAL &

REGULATORY INPUT

For Study Design

INDUSTRIAL

Modularity

FOCUS ON

DATA RELIABILITY

For Regulatory submission

Assets for a sucessful collaboration

Amatsigroup CORP PRES HUMAN HEALTH 19 05 2016

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