Introduction to NOVOCAT Formulation Development Services

2017 Our Global Footprint

United Kingdom (HQ)

Cambridge China

United States Chengdu, Sichuan

Philadelphia

New Zealand Auckland Czech Republic

Prague

Romania

India

Mumbai

Research Facilities

NOVOCAT has expanded its R&D capabilities into a 1500 square meter, state- of-the-art lab to meet the increasing formulation and analytical testing demands from its global client pool located at Barcelona

NOVOCAT formulation scientists operate a Good Laboratory Practice (GLP) compliant analytical facility, registered with International Accreditation New Zealand (IANZ), under a co-development agreement with Auckland University l

www.elc-group.com Product Expertise and Capabilities

SOLID ORAL DOSAGE FORMS  QbD Implementation for new product development . •Tablets & capsules, including modified/delayed/ controlled release/ MUPS/ fixed-dose combinations •Oral disintegrating tablets/films, effervescent tablets  Developing drug products with patent non-infringing drug formulations for US, Europe, Canada, Brazil, South LIQUIDS & SEMI-SOLIDS* Africa, Australia, WHO-PEPFAR •Liquids, suspensions, syrups markets. •Powder for oral suspension •Creams, lotions, gels, ointments  End to end product delivery support •Ophthalmic drops, Otic/nasal drops from product identification to IP STERILE INJECTABLES* evaluation, formulation, scale-up, technology transfer, BE studies, •Clear injectable solutions registration, assistance in query •Pre-filled syringes •Lyophilized powder for suspension for injection response, life cycle management and •Liposomes (Micro and Nano tech) licensing.

*Through channel partners R&D Team Head: Profile

R&D expertise Australia and USA EU Canada Russia/CIS South Africa Asia-Pacific

13 29 5 25 17 13

• More than 30 years of experience in heading R & D Teams

• Co-inventor of more than 30 registered patents, and delivered more than 100 products for diverse global markets (see regional distribution below)

• 4 First-to-File (Para IV) products developed for US Market, involving 3-Platform PCT patents.

• Expert in QbD development for new products, CRAMs business model and evaluating REMS strategies.

• Involved in globalization of product development by “bridging/cloning” to different regulated markets R&D Team Expertise

Avg. No. of Dosage Forms Designation Qualification Market Expertise Therapeutic Areas Experience Personnel Handled Technical Team Team Leaders  Tablets/Capsules Anti-Neoplastic (Oncology): 6 Formulation . Immediate Release Abiraterone, Erlotinib Ph. D / Masters in  US 12-19 years . Extended release Pharmacy.  Europe Team Leaders . Controlled and Anti-Hypertensive (Cardiovascular): 6  Canada Analytical Delayed release Atenolol/ Nifedipine ER Tablet in Capsule  LATAM  Oral liquids Senior Managers  ASEAN 6 . Solutions Immunomodulators (Multiple Sclerosis): Formulation  Australia/New . Suspensions Fingolimod, Teriflunomide, Dimethyl Fumarate DR Zealand  Liposomes  GCC Master of Science /  Dermal / transdermal Anti-Coagulants: 8-12 years  Russia/CIS Senior Managers Masters in Pharmacy  Emulsions Dabigatran 6  MENA Analytical  Depotherapy  WHO-PEPFAR  Ophthalmic Metabolic Disorder (Diabetes): Metformin ER, Sitagliptin/Metformin  Injectables

Junior Scientists Gastric Acid Secretion Inhibitor: 5 Formulation Esomeprazole MUPS Tablets

Anti-retroviral: Masters in Pharmacy Darunavir, Tenofovir / Masters in Science /  US Immediate and Extended 5-6 years Bachelors in  EU Antidepressants (CNS): Junior Scientists release oral dosage forms 18 Pharmacy / Bachelors  Rest of World Duloxetine DR, Fluoxetine DR Analytical in Science Anti-inflammatory/allergy: Ebastin ODT, Fexofenadine/Pseudoephedrine ER, Zileuton ER List of Equipment

Dispensing Granulation Room II Liquid Formulation  Microbalance and Weighing Balance  Extruder 60- Spheronizer 250  Stirrer  Homogenizer Sifting &Milling Compression Room I  SS Jacketed Mixing Tank  Vibratory Sifter  Mini Tablet Presses  SS Vessels  Oscillating granulator  CEMECH R & D Tablet Press Packing  Multimill  Dehumidifier  Elmach Blister Packing Machine  Manual Sifter  Weighing Balance  Pouch Sealing Machine Fluid Bed Processing Room Compression Room II  Leak Test Apparatus   Mini Rotary Tableting Bilayer Laboratory Stirrers Capsule Filling Room  Magnetic Stirrers with heater  Weighing Balance  MF 30 Deluxe Manual Capsule Filling  High Shear Homogenizer Machine  Hot Plate IPQC Room  Dehumidifier  Peristaltic Pump  Hardness Tester  Weighing Balance  Fluid Bed Processor with 6” Wurster  Halogen Moisture Analyzer  Tray Dryer  Karl Fischer Titrator Coating Room  Planetary Mixer  DT Apparatus  Peristaltic Pump  Weighing Balance  Tapped Density Tester  Automatic Coating for Tablets Granulation Room I & Blending  Electromagnetic Sieve Shaker  Stirrer  Rapid Mix Granulator  Friabilator  Colloidal Mill  V-Blender (2L, 8L)  Brookfield Viscometer  Homogenizer  Octagonal Blender  Vernier Caliper  Weighing Balance  pH Meter

List of Equipment

Gas Chromatography Room HPLC Room Stability Room  Gas Chromatography Assembly  Shimadzu HPLC (16)  Stability Chambers for:  Shimadzu UFLC (1) Dissolution Room . 40°C ± 2 °C/75% RH ± 5% RH  Agilent HPLC (8) . 30°C ± 2 °C/75% RH ± 5% RH  Electrolab Dissolution Tester (3) 8 bowls with . 30°C ± 2 °C/65% RH ± 5% RH Auto sampler Balance Room . 25°C ± 2 °C/60% RH ± 5% RH  LabIndia Dissolution Tester (3) 14 bowls with  Analytical Balance . 2°C to 8°C auto sampler  Micro Balance  Photo Stability Chamber  Semi Micro Balance Instrumentation Lab  Cold Cabinet  pH Meter Wet Lab  Karl Fischer Titrator  Fume Hood Refrigerator  Melting Point Apparatus  Cooling Chamber  UV-VIS Spectrophotometer  pH Meter  UV Cabinet  Pure Water System  Vacuum Oven  Ultrasonic Bath Cleaner  Micro Osmometer  Centrifuge Hot Lab  Balance   Water Batch Temperature Cyclo Mixer Controller  Orbital Shaker  Wrist Shaker  Hot Plate  Hot Air Oven Product Development to Technology Transfer

Q0 Q1 Q2 Q3 Q4 Q5 Q6 Q7 Q8

Milestone I  Project sign off

 Formulation Development: Interim Product Development Report with Comparative dissolution results Milestone II against RLD and 1 M stability data

Milestone III  3 Months Stability Data of Selected Prototype: stability data of prototype

Milestone IV  Pilot Batch Manufacturing: samples of Pilot Batches

*Timeline is not universally Milestone V  Stability studies on pilot batches: stability data of pilot batches proportional and may  Scale up and formulation optimization studies: formulation differ based on product Milestone VI complexity optimization report

 Analytical method validation: analytical method validation report Milestone VII

 Scale up, technology transfer, process optimization studies at CMO/client site: technology transfer report Milestone VIII

 Analytical method transfer: analytical method transfer report Milestone IX

Project  Consultation and registration batch manufacturing: execution of the exhibit batch Milestone X Completion Full Process Overview

QP declaration

Medical writing

RA Scientific Submission advice strategy Distribution Licensing Preclinical and Marketing Formulation clinical Authorization Batch release development strategy Application Batch testing

Post Product Preclinical Clinical Regulatory Commer- Early development Registration approval development Phase Phase approval cialization (LCM)

API Preclinical Clinical GMP Variations Manufacturing studies studies, Mock Audit Renewal API Sourcing BE studies GMP Training Transfer Withdrawal Dossier P&R preparation GAP Analysis, Pharmacovigilance eCTD

RESEARCH APPROVAL COMERCIALIZATION Business Models

 Fee for Service

 Co-Development

 Portfolio Development / Management

 Lab to Market ELC Product List

• ELC’s current Product Development portfolio:

Active Ingredient Dosage Strengths Pharmaceutical Form Therapeutic Area

Abiraterone 250mg Tablet Oncology Ticagrelor 60mg, 90mg Tablet Cardiovascular Apixaban 2.5mg, 5mg Tablet Cardiovascular Azilsartan 20mg, 40mg, Tablet Cardiovascular Medoxomil 80mg Sacubitril/ Valsartan 24/26mg, 49/51mg, Tablet Cardiovascular 97/103mg Apremilast 10mg, 20mg, Tablet Immunology 30mg Canagliflozin 100mg, 300mg Tablet Metabolic Disorder Canagliflozin/ 50/500mg, 50/1000mg, Tablet Metabolic Metformin 150/500mg,150/1000mg Disorder Linagliptin/Metformin 2.5mg:1gm, 2.5mg:500mg, Tablet Metabolic 2.5mg:850mg Disorder • Name your product…

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