animal health - amatsigroup corporate presentation

Amatsigroup presentationAnimal Health

2 Nom de la présentationCorporate Presentation Animal 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


Sept 2014

Core ValuesVETERINARY EXPERTISE• Merger of 4 expert companies in IVP services• Amatsi Avogadro founded by ex MERIAL staff• Amatsigroup Inc. site dedicated to Animal Research

on veterinary species

• 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


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 & RAAnimal Health

PRODUCTDevelopment

program & Formulation

Analytical Package

CMC Regulatory studies

Submission of MA dossier

Transfer to manufacturin

g site

KETOPROFEN solutionInjection

Multi dosesGENERIC

Granted in Spain

CEFALOSPORIN intramammary

SuspensionGENERIC Deformulatio

nGranted (Analytical)

EYE DROPSANTIVIRAL

NCE

ENDECTOCID Oral Paste

GENERIC Deformulation

Reformulation

ANTIVIRAL solution

InjectionNCE

ANTALGIC tablet

GENERIC


Case study Context

Challenge To develop an ophthalmic formulation for cats containing a new antiviral API, insoluble in water To manage all the CMC studies from early development up to regulatory phases for Market Authorization

Application To conduct cat PK studies (collection and analysis of tears)

Solutions oriented proposals To establish the CMC development program To fully manage the product development

Key successful outcomes Big Pharma licensed the antiviral veterinary drug candidate Ongoing pivotal field study in Europe, anticipated EU regulatory filing early 2015 Amatsigroup people cited among the inventors in the formulation patent*

Biotech company Innovative antiviral

treatment

* International Publication Number: WO 2013/107515 A1


Sept 2014

Assets for a sucessful collaboration

IN LIFE &

ANALYTICAL

Capabilities

MASTERING

GUIDELINES

For IVP*

EXPERIENCE

INTERACTING WITH

EU & US veterinary authorities

CMC REGULATORY SUPPORT

To ensure relevant data

For dossier submission

animal health - amatsigroup corporate presentation

Healthcare