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GALENIX GLOBAL OFFER
PRESENTATION
DRUG PRODUCT DEVELOPMENT
DRUG DELIVERY SOLUTIONS
LICENSING-OUT OPPORTUNITIES
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CONTENTS
1. MISSION AND VALUES2. HISTORY3. GALENIX GROUP STRUCTURE4. INTEGRATED SERVICES5. GALENIX INNOVATIONS PLATFORMS6. GALENIX EARLY PHARMACEUTICAL DEVELOPMENT7. QUALITY CONTROL ACTIVITY8. GALENIX INNOVATIONS DDS DEPARTMENT9. IP FOR DEVELOPED PRODUCT10 . GALENIX STRATEGY & BUSINESS MODEL ADD-VALUE
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1. MISSION AND VALUES
Galenix provides a range of full R&D pharmaceutical services and Drug Delivery Solutions to health companies for fast access of their products on the market.
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●●● From the sourcing of the API through the Drug Product development process, including preformulation, formulation, to clinical supplies, quality control, ICH stabilities and regulatory dossier submission for Europe and US FDA registration. Galenix provides its customers drug products “ready to launch” holding a Marketing Authorization.Galenix DDS and Innovative products Galenix DDS and Innovative products portfolio improve competitiveness in an portfolio improve competitiveness in an increacisinglyincreacisingly challenging Industry.challenging Industry.
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CONTENTS
1. MISSION AND VALUES2. HISTORY3. GALENIX GROUP STRUCTURE4. INTEGRATED SERVICES5. GALENIX INNOVATIONS PLATFORMS6. GALENIX EARLY PHARMACEUTICAL DEVELOPMENT7. QUALITY CONTROL ACTIVITY8. GALENIX INNOVATIONS DDS DEPARTMENT9. IP FOR DEVELOPED PRODUCT10. GALENIX STRATEGY & BUSINESS MODEL ADD-VALUE
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2. HISTORY
1993 : Galenix was founded to develop drug products, in close cooperation with the University of BORDEAUX II - FRANCE
1995 : Quality control department
1998 : Regulatory affairs department
2000 : Strategic intelligence, innovative DDS and patents constitute the new research structure Galenix Innovations
2006 : Acquisition of the Saint-Nazaire B.M.S. Pharmaceutical Research Institute by Galenix Pharma
2007 : Authorization for cGMP manufacturing, importation and distribution of human medicinal products and investigational medicinal products AFSSAPS # F07/32
2008 : Update of the Authorization for cGMP manufacturing, importation and distribution of human medicinal productsand investigational medicinal products AFSSAPS # M08/246Authorization for cGMP manufacturing, importation and distribution of veterinary medicinal products andinvestigational medicinal products AFSSA # V 1515/08
2009 : Update of the Authorization for cGMP manufacturing, importation and distribution of human medicinal products and investigational medicinal products AFSSAPS # M09/168
GALENIX cGMP Authorizations Europe
and US Standards
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CONTENTS
1. MISSION AND VALUES2. HISTORY3. GALENIX GROUP STRUCTURE4. INTEGRATED SERVICES5. GALENIX INNOVATIONS PLATFORMS6. GALENIX EARLY PHARMACEUTICAL DEVELOPMENT7. QUALITY CONTROL ACTIVITY8. GALENIX INNOVATIONS DDS DEPARTMENT9. IP FOR DEVELOPED PRODUCT10 . GALENIX STRATEGY & BUSINESS MODEL ADD-VALUE
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3. GALENIX GROUP STRUCTURE
Highly qualified staff
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Galenix
Galenix Innovations
GalenixInc.
GalenixBiotech
Saint-Jean d’Illac (Bordeaux)
New York (USA)
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CONTENTS
1. MISSION AND VALUES2. HISTORY3. GALENIX GROUP STRUCTURE4. INTEGRATED SERVICES5. GALENIX INNOVATIONS PLATFORMS6. GALENIX EARLY PHARMACEUTICAL DEVELOPMENT7. QUALITY CONTROL ACTIVITY8. GALENIX INNOVATIONS DDS DEPARTMENT9. IP FOR DEVELOPED PRODUCT10 . GALENIX STRATEGY & BUSINESS MODEL ADD-VALUE
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4. INTEGRATED SERVICES
Drug DeliverySolutions
Early pharmaceutical
Development
Clinical supply:ManufacturingPackagingDistribution
QC/QP release
Technology transfer
Production,
Market
Regulatory affairs
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CONTENTS
1. MISSION AND VALUES2. HISTORY3. GALENIX GROUP STRUCTURE4. INTEGRATED SERVICES5. GALENIX INNOVATIONS PLATFORMS6. GALENIX EARLY PHARMACEUTICAL DEVELOPMENT7. QUALITY CONTROL ACTIVITY8. GALENIX INNOVATIONS DDS DEPARTMENT9. IP FOR DEVELOPED PRODUCT10. GALENIX STRATEGY & BUSINESS MODEL ADD-VALUE
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5. GALENIX INNOVATIONS PLATFORMS
●●● Galenix Innovations includes 6 different innovative technology platformsfocusing on drug delivery solutions for life cycle management, new chemical entitiesand Biologicals using conventional medicinal presentations or its own patentedtechnologies.
«« Patients are central to Patients are central to ourour approachesapproaches »»Galenix team is focusing to preserve and/or to increase market shares on products through differentiation in accordance with regulations.
●●● GALENIX includes two divisions:
● Drug Delivery Solutions department
● Early pharmaceutical development department
Galenix Innovations offers full drug product development services for oral, parenteral and
topical administration 11
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CONTENTS
1. MISSION AND VALUES2. HISTORY3. GALENIX GROUP STRUCTURE4. INTEGRATED SERVICES5. GALENIX INNOVATIONS PLATFORMS6. GALENIX EARLY PHARMACEUTICAL DEVELOPMENT7. QUALITY CONTROL ACTIVITY8. GALENIX INNOVATIONS DDS DEPARTMENT9. IP FOR DEVELOPED PRODUCT10. GALENIX STRATEGY & BUSINESS MODEL ADD-VALUE
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6. GALENIX INNOVATIONS Drug Product development expertise and experience
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●●● Product development highlights
More than 45 Marketing Authorizations granted since 1993
More than 250 scale-up manufacturing processes since 1993
More than 250 technologies and patented products since 1993
New Entities, line extension and generic products
● Market: RxOTCGeneric
● Territories: EuropeUSNorth AmericaJapan
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6.1 Early Development DptCapabilities
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●●● The early pharmaceutical development department offers a full range of services for NCE, Biologicals or mature molecules
PreformulationAPI characterization,, In-vitro / In-vivo correlation studies.
FormulationSolid dosage forms: controlled release tablet (immediate, modified, sustained release), multilayer tablets, coated tablet, pellets, implants, powders, granules, capsule.
Semi-solid and liquid dosage forms: solutions, suspensions, gels (aqueous or lipidic), liposomes, microemulsions, emulsions, TTS.
Development of comparatorMatching placebo, over encapsulation, film coating.
Taste masking
Manufacturing scale-up Internal and external (worldwide CMO selection and customers)
Analytical development, validations and QC
All the Drug Product Development activities are supported by our Regulatory and Project management team to better support
the Customers needs
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Preformulation- Lasergranulometer, - Optical microscopy, - DSC, - HPLC,- IR, NIR, - Karl Fisher, - IR balance, - Density,- Rheology- Frantz cells, - In-vitro dissolution apparatus II with optical fiber
●●● A wide range of equipment is available for the manufacturing and characterization of laboratory batches
6.2 Formulation DepartmentEquipements
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FormulationSolid dosage forms:
Manufacturing (from 10g to 2kg): - Roller compactor, - Granulator (Bolhe, Mi-Pro, Mi-airpro, Rotolab, Miniglatt, Hobart), - Alternative tablet press, - Rotative tablet press, - Coating equiment for granules (MiniGlatt), - Coating equipment for tablets (Erweka coating pan)Characterization: -IR balance, flowability, tapped density, tablet hardness tester, disintegration tester, friability tester, - Lasergranulometry dry & liquid way tester, - In vitro dissolution apparatus type I, II, III, online spectro UV, off line HPLC, online optical fiber
●●● A wide range of equipment is available for the manufacturing and characterization of lab-scale batches
6.2 Formulation DepartmentEquipements
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FormulationSemi-solid and liquid dosage forms (from 10mL to 2L):
Manufacturing: -Turbotest Rayneri, - Overhead stirrer, - Disperser ultraturax®, - Rotavapor, - MiniextruderCharacterization: - Anton Paar rheometer, - Brookfield viscometer DV1/DV2,- Penetrometer, - pHmeter/conductimeter, - Laser granulometer liquid way, - Frantz cells
●●● A wide range of equipment is available for the manufacturing and characterization of scale-lab batches
6.2 Formulation DepartmentEquipements
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●●● Formulation strategy to guarantee a successful development
Formulation stability testing
Request for proposal: customer criteria
Under regulatory requirements
Selection of formulationsHigh screening level : climatic
and/or chemical stress
Analytical tests and physicaltests
Formulation plan with or without
technologySelection of rawmaterials and process in accordance with customer requirements
Strategic intelligence
Technological & bibliographic survey
Process optimisationProcess robustness study
6.3 Formulation DepartmentStrategy
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- Expertise and experience development methodology
●●● Formulation strategy to guarantee a successful development
PRE-FORMULATION
FORMULATION
LAB-SCALE VALIDATION
PRELIMINARY STABILITY
ANALYTICAL VALIDATION
MANUFACTURING PROCESS VALIDATION
ICH STABILITY STUDIES
REGISTRATION
MAA / License
PRE
-REG
I
STRAT
I
ON
POST
-MA
6.3 Formulation DepartmentStrategy
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Active substancesPhysical and chemical characterization
FormulationsAnalytical screening: characterization on intermediate and finishedproducts (assay, content uniformity, mass variation…)
Forced degradation studiesTemperature, photostability, chemical degradation testing are performed according regulatory requirements (ICH…)
●●● Analytical quality control team characterizes the active substances and formulations during the early development program (screening stage)
6.4 Analytical DepartmentCapabilities
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Development methodAssay method development of active substance in drug product, impurities in drug product, active substance in drug product in dissolution medium based on client documentation
Pre validation requirementsSpecificity, Linearity, Precision are checked
ValidationSpecificity, Linearity, Accuracy, Precision, Stability, Robustness, Stability indicating are performed according ICH guidelines
Transfer
●●● Analytical development team develops, validates, transfers the methods to control the formulations during the early development program (from screening to clinical batch release)
6.4 Analytical DepartmentCapabilities
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HPLC / UV, visible, conductimitry, refractometry,
In-Vitro Dissolution / off line, on line spectroUV or HPLC, (USP type I, II and III)Potentiometer, Karl Fisher,
Differential scanning calorimetry,
Microscopy,
Laser Granulometry,
In-Vitro permeation on Franz cells for topical forms.
●●● Analytical development team supports the full testing and screening formulations during the early development program with a range of technics and equipments
6.5 Analytical DepartmentEquipments
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●●● Development of easy-used analytical methods
Developement methodology:
→ supported by ● Client’s needs,
● Galenix experience – expertise
● Client request for proposal (RFP)
6.6 Analytical DepartmentExpertise
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CONTENTS
1. MISSION AND VALUES2. HISTORY3. GALENIX GROUP STRUCTURE4. INTEGRATED SERVICES5. GALENIX INNOVATIONS PLATFORMS6. GALENIX EARLY PHARMACEUTICAL DEVELOPMENT7. QUALITY CONTROL ACTIVITY8. GALENIX INNOVATIONS DDS DEPARTMENT9. IP FOR DEVELOPED PRODUCT10. GALENIX STRATEGY & BUSINESS MODEL ADD-VALUE
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● Pilot batches
● Clinical batches
● Commercial batches
● Imported medicines
►Q.P. release
●●● Galenix supports any required testing of products
7. QUALITY CONTROL ACTIVITY
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● ICH standards
API’s, finished products, all types of containers,
including semi-permeable containers
Climatic zones I, II, III, IVa, IVb
● Other stress conditions
Photo-stability UV and Visible
Cyclic temperature conditions from -15°C to +40°C
●●● Full ICH stability testing
21 CFR Part 11 environment for data acquisition
7. QUALITY CONTROL ACTIVITY
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●Development & validation of methods
●Analytical transfer supply
●Raw material & packaging certification
- 19 HPLC Alliance Waters, Agilent, GC- 13 dissolutests UV/Visible on line, off line- IR spectrophotometer Perkin Elmer Nicolet 380 - NIR spectrophotometer Thermo Fisher - 2 automated dissolutests Multidose Plus Zymark-Vankel- 2 automated equipment for samples prep. Zymark TPWII- Karl-Fisher with Metrhom sampler- Potentiometer Mettler Toledo …. and more ….
●●● Full analytical support
●Wide range of technics and equipment
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CONTENTS
1. MISSION AND VALUES2. HISTORY3. GALENIX GROUP STRUCTURE4. INTEGRATED SERVICES5. GALENIX INNOVATIONS PLATFORMS6. GALENIX EARLY PHARMACEUTICAL DEVELOPMENT7. QUALITY CONTROL ACTIVITY8. GALENIX INNOVATIONS DDS DEPARTMENT9. IP FOR DEVELOPED PRODUCT10. GALENIX STRATEGY & BUSINESS MODEL ADD-VALUE
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8. GALENIX INNOVATIONSDrug Delivery Solutions Department
●●● The mission of DDS Department is to bring solutions for the improvement of the patient compliance and/or to enhance API’s therapeutic properties with controlledrelease technologies.
Galenix optimizes formulation of drug products and uses its experience, expertise and know-how to improve confidence and observance of treatmentsto reduce patient anxiety and pain.
Innovative Drug Delivery Solutions6 patented DDS and more than 10 patents on compositions
Patents strategy and managementWorldwide patents
Feasibility studiesAssessment of compatibility API/DDS
Licensing outLicensing out to pharmaceutical companies
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●●● Galenix Innovations is an innovative technology platform focusing on drug delivery solutions for life cycle management, new chemical entities and Biologicals using conventional dosage forms or its own patented technologies.
GALENIX INNOVATIONS includes 6 patented technology platforms:
● MICROGIX®
● MINEXTAB®
● MINEXTAB® FLOATING
● MUCOLYS® FILM
● MUCOLYS® FLASH
● ODTx®
8. GALENIX INNOVATIONSDrug Delivery Solutions Department
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●●● Several patent families around 6 patented technologies
MINEXTAB® MINEXTAB® Floating MICROGIX®
8. GALENIX INNOVATIONSDrug Delivery Solutions Department
Patient’s compliance, improved formulations,Life Cycle Management
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MUCOLYS® Film MUCOLYS® Flash ODTx®
●●● Several patent families around 6 patented technologies
Patient’s compliance, improved formulations,Life Cycle Management
8. GALENIX INNOVATIONSDrug Delivery Solutions Department
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CONTENTS
1. MISSION AND VALUES2. HISTORY3. GALENIX GROUP STRUCTURE4. INTEGRATED SERVICES5. GALENIX INNOVATIONS PLATFORMS6. GALENIX EARLY PHARMACEUTICAL DEVELOPMENT7. QUALITY CONTROL ACTIVITY8. GALENIX INNOVATIONS DDS DEPARTMENT9. IP FOR DEVELOPED PRODUCT10. GALENIX STRATEGY & BUSINESS MODEL ADD-VALUE
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●●● Licensing out and other strategies
9. IP FOR DEVELOPED PRODUCTS
- Drug Product Development with GALENIX patented technologies
- Licensing out:Free of charge during feasibility study
Go/No Go decision after critical pharmaceutical step and/or PoC
GO → DPD follow up NO GO
Licensing out – signature STOP Milestones(Exclusivity/No exclusivity)
Milestones/Royalties and supply agreement (Min. 5 years)
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●●● Licensing out and other strategies
- Developed product without Galenix patented technology
Discussions with Customer to find the most appropriate strategy:
CUSTOMER Results ownerGALENIX Know-how owner
Licensing-out (Milestones/royalties)
MAA or Cession/Transfer Agreement
Supply agreement
9. IP FOR DEVELOPED PRODUCTS
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CONTENTS
1. MISSION AND VALUES2. HISTORY3. GALENIX GROUP STRUCTURE4. INTEGRATED SERVICES5. GALENIX INNOVATIONS PLATFORMS6. GALENIX EARLY PHARMACEUTICAL DEVELOPMENT7. QUALITY CONTROL ACTIVITY8. GALENIX INNOVATIONS DDS DEPARTMENT9. IP FOR DEVELOPED PRODUCT10. GALENIX STRATEGY & BUSINESS MODEL ADD-VALUE
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10. GALENIX BUSINESS MODEL
●●● Galenix revenues come from the following activities:
→ Drug Product Development - Contract services
→
→ Supply agreement
Licensing-out
• MAA and Product
• Patented Technologies
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LCM Development between 2 to 5 years
Mature molecules
Preclinicaldevelopment
Pharma-ceutical
developmentClinicalPhase I
ClinicalPhase II
ClinicalPhase III
Outsourcedactivities
Galenix activities
Licensing-out → Upfront payment
→ Milestones
→ Royalties/Supply agreement
Low risk and higher profit
M.A.A.
Customer Control
10. GALENIX BUSINESS MODEL
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●●● The Customer is the corner stone of GALENIX business model
●●● A very important experience and expertise in Drug Product Development since 1993
More than 50 M.A.A. approval
●●● Full pharmaceutical offer: Drug Product Development Drug Delivery Solutions – an important patented technologies portfolio Innovative Drug Product licensing-out
●●● cGMP activities including strategic agreement Human medicinal & investigational medicinal products
●●● Full R&D project management and regulatory support
10. GALENIX Business Model Add-value
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●●● From Drug and Biologics product development to technologydelivery and supply solutions,
We are the corn stone for your success
Your contacts for more information:
Allée des Palanques33 127 St Jean d’Illac - FranceTel : +33 (0) 826 39 69 18Fax : +33 (0) 556 688 301
M. Jerome BESSE – [email protected]
Business Development – [email protected]
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Thank you for your attention
Allée des Palanques33 127 St Jean d’Illac - France
Tel : +33 (0) 826 39 69 18Fax : +33 (0) 556 688 301
60 Broad Street - New YorkUSA - NY – 10004
Tel : +33 (0) 826 39 69 18Fax : +33 (0) 556 688 301
Galenix, a Key pharmaceutical R&D partner, helps you to reduce your timeline by offering innovative solutions
E-mail: [email protected]: www.galenix.fr
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