pharmaceutical development for rare diseases at amatsigroup
TRANSCRIPT
Pharmaceutical Development for Rare Diseases
2 Nom de la présentationPharmaceutical Development for Orphan Drugs - 11 2015
Sept 2014
Leading EarlyCDMO * Partner
in Pharmaceutical Product Development
* Contract Development And Manufacturing Organization
Expertise
3 Nom de la présentationPharmaceutical Development for Orphan Drugs - 11 2015
Sept 2014
Expertise
Biotechs companies Pharmaceutical
Laboratories
Market
Discovery - Research Preclinical & Clinical
PharmaceuticalDevelopment
OUTSOURCING
MarketAuthorization
Patients
Pharmaceutical Development
4 Nom de la présentationPharmaceutical Development for Orphan Drugs - 11 2015
Sept 2014
78%
22%
2015 Revenues
Spanning Human & Animal Health
Expertise
2015 Revenues
Clients Typology
2015 Revenues
Geographic Split
5 Nom de la présentationPharmaceutical Development for Orphan Drugs - 11 2015
Sept 2014
• 300 active clients
• 8 operational sites
• 280 employees
• 33 M € of revenue in 2015
ADMIN. OFFICE
Inc.
Key Figures
6 Nom de la présentationPharmaceutical Development for Orphan Drugs - 11 2015
5 areas covering Drug Product Development
* Excluding Clinical Monitoring
Portfolio
CMC & RA
7 Nom de la présentationPharmaceutical Development for Orphan Drugs - 11 2015
We optimize development timelines by managing project continuum
under supervision of our CMC-Regulatory Affairs team
We maximize regulatory validation providing reliable data
We can dedicate GMP area for specific projects => Industrial modularityADDED VALUE
Sept 2014
Acompanying your drug product development
8 Nom de la présentationPharmaceutical Development for Orphan Drugs - 11 2015
Case studyContext
Drug product developed in 2007
Commercial batches manufactured for compassionate use since 2007
CTD dossier approved in 2013
Marketed in France since 2013
Key successful outcomes
Non sterile process optimization
Biotech company (France)
Orphan drug
Capsules of 50 and 250mg
Change in API particle size distribution
Challenge Adapt manufacturing process and validation for industrial batches
Offer services from development to industrial batches
Solutions oriented proposals Optimization of process by addition of API crushing and sieving step
Robustness for industrial market and validation of process
Manufacturing of industrial batches of 5,000 capsules
9 Nom de la présentationPharmaceutical Development for Orphan Drugs - 11 2015
Experience with rare, orphan & pediatric drug projects
Orphacol | CTRS | oral form
Zanosar | Keocyt | lyophilized injectable
Small Batch ManufacturingCommercial Use
Current manufacturer for 4 commercial drugs | small batches
Orphacol | CTRS | oral form | 5,000 capsules/batch | EU market
Zanosar | Keocyt | lyophilized injectable | 3,000 vials/batch | EU & Japan Market
Spirolept | Imaxio | 36,000 syringes/batch | EU market
Fav-Europe & Fav-Bothrops | Sanofi Pasteur | 1,700 & 700 vials / batch | EU market
…
10 Nom de la présentationPharmaceutical Development for Orphan Drugs - 11 2015
Sept 2014
Thank’s !
Meet us on our booth !