Human Health - Amatsigroup Corporate Presentation

Amatsigroup presentationHuman Health

2 Nom de la présentationCorporate Presentation Human Health

Sept 2014

Leading EarlyCDMO * Partner

in Pharmaceutical Product Development

* Contract Development And Manufacturing Organization

Expertise


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

2006• DBI • US Business

Office Creations

2011DBIAcquisition

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


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 prepared by scientists

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

Core Values


Sept 2014

• 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

• Multidisciplinary Operational Teams Large scope of expertise : M.Sc, Ph.D, DV.M. Pharm.D., Eng., B.Sc. 1 project manager / study director for 2 Technicians (B.Sc.)

EVP, Global Business Development

Biochemist25 years in US & EU Life Science

• Experienced Senior Management

Veterinarian35 years in Animal Health

Pharmacist25 years in the Pharma Industry

President

Organization highlights


5 areas covering Drug Product Development

* Excluding Clinical Monitoring

Portfolio

CMC & RA


Expertise

Sept 2014

160 batches released yearly

3 000 shipments yearly

Clinical Trial SupplyPackaging & Logistics

110 + 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


Comprehensive Customer Service

* Chemistry Manufacturing Control

• CMC files drafting Gap analysis & updates IMP & 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

AntibioticSterile

Nanosuspension NCE

Phase 1

CNS disorderPediatric oral

solutionPhase 2

AntiepilepticPediatric soluble

tabletPhase 2

AntineoplasicSolution for injection

NCEPhase 1


Human Health

PRODUCTFormulatio

nAnalytica

l Package

CMC Regulato

ry studies

Manufacturing

QP ReleaseDistribution of

clinical batches

Constitution of CMC

file

AntiallergenicCutaneous patches

Phase 1 to 3

OphtalmicSolution for injection

NCEPhase 3

Project management under CMC & RA


Case study Context NCE for human health Biotech company Antibiotic, IV formulation

Challenge To develop a bioanalytical method to assay a drug without metabolite interferences To manage the whole analytical part (CMC) from pre-clinical studies to phase II clinical trial

Solutions oriented proposals Development of a bioanalytical method with incurred sample analysis (clinical PK study) Development of the API control monograph including all relevant tests Identification and characterization of impurities Level of method validation in relation with development stage Insuring lifecycle management of the analytics

Key successful outcomes IND and IMPD submission without any questions from the authorities (on the analytical part) The method allowed the specific assay of the drug in clinical trial The product in phase II then, was sold to a big pharma company and is now commercialized


Sept 2014

FREQUENT

Communication

TECHNICAL &

REGULATORY INPUT

For Study Design

INDUSTRIAL

Modularity

FOCUS ON

DATA RELIABILITY

For Regulatory submission

Assets for a sucessful collaboration

Human Health - Amatsigroup Corporate Presentation

Healthcare

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