galenix global offer presentation

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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

CONFIDENTIAL – PROPERTY OF GALENIX

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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.


●●● 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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3. GALENIX GROUP STRUCTURE

Highly qualified staff


Galenix

Galenix Innovations

GalenixInc.

GalenixBiotech

Saint-Jean d’Illac (Bordeaux)

New York (USA)

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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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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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6. GALENIX INNOVATIONS Drug Product development expertise and experience


●●● 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


●●● 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



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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



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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



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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



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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



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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®



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●●● Several patent families around 6 patented technologies

MINEXTAB® MINEXTAB® Floating MICROGIX®


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



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CONTENTS



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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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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


galenix global offer presentation

Health & Medicine