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DRUG DELIVERY SOLUTIONS

DRUG PRODUCT DEVELOPMENT

CLINICAL SUPPLIES

SUMMARY

Business opportunities

Galenix Innovations Galenix Development Galenix Pharma

Quality standards

History and group structure

Galenix integrated services

Mission and values

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 development process including formulation, stability, quality control, clinical supplies and regulatory file submission,

Galenix provides its customers with “ready to launch” drug products holding a Marketing

Authorization

PHOTO

History1993 : 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 GMP manufacturing and import of drug products AFSSAPS # F07/32

Saint-Jean d’Illac

Saint-Nazaire

GMP Europe and US FDA

Group structureHighly qualified staff of 90

Galenix

Galenix Inc

Galenix Biotech

Saint-Jean d’Illac (Bordeaux)Saint-Nazaire

(Nantes area)

Galenix Innovations

Galenix Pharma

Galenix Développeme

nt

New York

(USA)

Integrated services

Quality standards

ISO 9001 version 2000 compliance - BVQIFirst French R&D company certified in year 2000

GMP Europe and US FDA standards

Authorization for GMP manufacturing and import of drug products AFSSAPS # F07/32

For Galenix Pharma

Strategic intelligence

Galenix Innovations

Worldwide technology and market surveys

Innovative Drug Delivery Solutions6 patented DDS and more than 10 patents on compositions

Feasibility studiesAssessment of compatibility API/DDS

Patents strategy and managementWorldwide patents

Licensing outLicensing out to pharmaceutical companies

Galenix Patented DDS

MINEXTAB®

Patient’s compliance, improved formulations, Life Cycle Management

MICROGIX® MINEXTAB® Floating

Several patent families around 6 patented technologies

MUCOLYS® Film

Patient’s compliance, improved formulations,

Life Cycle Management

ODTx®MUCOLYS® Flash

Galenix Patented DDS

Several patent families around 6 patented technologies

Formulation

All dosage forms, optimization of manufacturing process and composition

Analytical development and validation

Special automated equipment

Technology transfer team

Worldwide scale-up and analytical transfers

Conventional development or improved formulation

with patented DDS

Galenix Development

Dry dosage formsTABLETS - multi-layers,immediate or sustained release, mucoadhesive, effervescent

PELLETS, CAPSULES

TASTE MASKING

FILM FORMING POWDER

FLASH RELEASE POWDER

Topical forms

EMULSIONS, MICROEMULSIONS

GELS - thermoreversible, bioadhesive

OPHTALMIC, VAGINAL forms

TRANSDERMAL and TRANSMUCOSAL systems

PATCHES

Injectable and oral dosage formsDRUG DELIVERY SYSTEMS SOLUTIONSSUSPENSIONSIMPLANTSLIQUID AND PASTY FORMSTASTE MASKING

Spray dosage forms

DRY and LIQUID

Galenix DevelopmentPreformulation, formulation, scale-up

Galenix Development

HPLC / UV, visible, ionic,

refractometry, fluorimetry GC / FID

Microscopy Laser Granulometry

Differential scanning

calorimetry

In Vitro Dissolution / off line, on line

(USP type II and III) Zymark automation

In Vitro permeation on Franz cells

for topical forms

Characterization of API’s

Analytical development and validation

Galenix Development

Product development highlights

More than 40 Marketing Authorizations granted in 14 years

New Chemical Entities, line extension and generic products

Stability studies

Quality control

Import QP release

Clinical supplies

QP release of GMP Batches

Regulatory Affairs

Global IT support

Galenix Pharma

GMP Europe and US FDA facilities

- 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

21 CFR Part 11 environment for data acquisition

Galenix Pharma

Stability studies

Galenix Pharma

- Pilot batches

- Clinical batches

- Commercial batches

- Imported medicines

Quality Control

►Q.P. release

- Bulk, semi-finished

- Finished products

- Pharmaceutical specialties for the European market

- Pharmaceutical specialties, other drug products for clinical batch production

Galenix Pharma

Import

►Q.P. release

Galenix Pharma

21 CFR Part 11 environment

Analytical Equipment

- 19 HPLC Alliance Waters, Agilent, GC

-13 dissolutests UV/Visible on line, off line

- IR spectrophotometer Perkin Elmer Nicolet 380 - NIR spectrophotometer Thermo Fisher

Nicolet Antaris II and Nicolet Antaris target

- 2 automated dissolutests Multidose Plus Zymark-Vankel

- 2 automated equipment for samples prep. Zymark TPWII

- Karl-Fisher Titrino with Metrhom sampler

- Potentiometer Mettler Toledo…. And more ….

Clinical supplies

Manufacturing

- Dosage forms- Blinding into capsules- Manufacturing equipment

Packaging

- Primary packaging- Clinical batches final packaging

Distribution

Galenix Pharma

■ Manufacturing

- Dosage forms

• SOLID dosage forms tablets (plain, coated, multi-layer), capsules, powders, sachets, pellets (1 kg to 150 kg)

• LIQUID and SEMI-SOLID dosage forms (max 500 l)

GMP Europe and US FDA standards in the same facilities

Galenix Pharma

Fluid bed dryersVector FLN 30 Glatt GPCG1

Wet granulationColette Gral 75Aeromatic Fielder PMA 1 Lödige M5R, M20R, FM50

Dry granulationRoller compactor Alexanderwek WP120

Examples:BSI blenders

2,5 l, 10 l, 15 l, 75 l, 150 l, 250 l

Roue Rohn blenders TE 6503 l, 5 l, 10 l, 20 l, 30 l, 35 l

Galenix Pharma■ Manufacturing

- Manufacturing equipment

Tablet machinesKillian S100Frogerais MR6 Manesty tri-layers LP39

Coating equipment

Hi Coater Vector VHC 1355

Hard caspsules fillingMacophar MT5, MT13 Bosch GKF 400

Liquid/ semi-solid vesselSOGEVAL 500 l

Galenix Pharma■ Manufacturing

- Manufacturing equipment

- Formulation development

- Macophar MT5, MT13, Bosch GKF 400, Bonapace BB6

- Comparative In Vitro dissolution testing

- Analytical methods development and validation

- Stability studies

- DBcaps ® or Coni-Snap ®

Galenix Pharma■ Manufacturing

- Blinding into capsules

Labelling

- Multi-lingual labels design and printing, boolklet labels, code-break enveloppes, randomization list

Patient Kits

- Blister-cards design suitable for ambulatory clinical trials

- Patient kits design in accordance with the study protocol

• Kits labeling and assembly

►Q.P. release

Galenix Pharma■ Packaging

- Clinical batches final packaging

- Clinical Trials Units shipment to Europe and Worldwide

- Room and controlled temperature (+2 +8°C)

- Carrier selection according to several criteria (delivery place, quantity, deadlines, storage conditions, nature of the products)

- Returns

Distribution

Galenix Pharma

Global IT support

- Stability

- QC

- Production

HB mesure

Applied Biosystems V06 - LIMS

CAPM PMX Rockwell Automation

21 CFR Part 11 environment

Galenix Pharma

- Coordination of Phase I clinical studies Partnerships with more than 10 C.R.O. in Europe and worldwide, and laboratories

- IMPD, IND, pre-IND meeting, etc.

- Regulatory Consulting

- Marketing Authorization Application C.T.D., ANDA, NDA, compiling and Submission on customer’s behalf or Galenix’s

Pharmaceutical Affairs

Galenix Pharma

Comprehensive pharmaceutical services

from the API selection to the marketed drug product

GMP EUROPE and US FDA standards on the Technologies platform

Innovation: NEW Drug Delivery Solutions

Accelerated development timelines

Quality standards ISO 9001 and GMP

Customization of services

Business opportunities Galenix

Allée des Palanques

33 127 St Jean d’Illac - France

Tel : +33(5) 56 68 83 00

Fax : +33(5) 56 68 83 01

galenix@galenix.fr

GALENIX INNOVATIONS&

GALENIX DEVELOPPEMENT

GALENIX INCGALENIX PHARMA

Thank you for your attention

www.galenix.fr

Rond Point de Brais

Rte St André des Eaux

44600 St Nazaire - France

Tel : +33(2) 51 10 30 00

Fax : +33(2) 51 10 20 19

galenix@galenix.fr

60 Broad Street

NY-10004 New York - USA

galenix@galenix.fr