Summary of Aesica Pharmaceuticals, presented at the informEx Showcase, February 2012

1. Exhibitor Showcase
at
14 February 2012
3:40 PM in Room 266

2. What We Do
Established and Integrated provider of
Manufacturing & Development services,
for Finished Dose Forms & APIs
Global network of six development &
manufacturing sites
Annual turnover ~ $260M
Staff of ~ 1300

3. Timeline
Pianezza, IT
Monheim, DE Zwickau, DE
Queenborough, UK
UCB
Zwickau DE
Monheim DE
Nottingham, UK
Pianezza IT
Cramlington, UK R5 Pharma
Abbott Nottingham, UK
Queenborough, UK
BASF
Cramlington, UK
2004 // 2007 2008 2009 2010 2011 2012

4. Business Units
Lead Selection Pre-clinical Phase I Phase II Phase III Commercial
API
Kilo Lab Pilot Plant Scale-up Manufacturing
Formulation
Development
Screening Development Clinical Supply
Formulated
Products
Bulk Packaging Distribution
Pharmaceutical
Support Services
Clinical QA RA CTD

5. Active Pharmaceutical
Ingredients

6. Development
Route selection, optimisation, process R&D, DOE
Reactions to 50L scale
5L Hastelloy® filter drier
-20 ºC to 150 ºC reaction temperatures
Distillation, hydrogenation, RC1, DSC
cGMP preparation for preclinical & early clinical

7. Scale Up
Process scale up to pilot plant & commercial scale
Glass-lined reaction vessels to 250L volume
Hastelloy® filter drier with glove box isolation technology
-20 ºC to 150 ºC reaction temperature capability
Campaigns from 10kg to 100kg
Clinical supply or small scale commercial manufacture

8. Manufacturing
2 computer controlled multi- Bespoke software solutions for
purpose plants complex inter-reaction chemistry
Reactors: 1m³ to 10m³
Filter driers: 1m² to 6m² High vacuum distillation & drying
Blender driers: to 1m³ equipment
Temps: -15 ºC to 150 ºC
Clean room facilities for finished
Home Office licenses for product handling, milling
manufacture & handling of
controlled substances and highly
potent drug classes Commercial scale pressure
hydrogenation, hydrochloric acid
gas & bromine technology
Approvals to supply into US &
other major markets

9. Potent & Controlled
Substances
Capable of handling SafeBridge® category 3
450 liter scale, filter dryer, glove box charging
Preparative HPLC system
Controlled drug licences for Schedule I - IV
Manufacture from laboratory through commercial scale
Secure storage for intermediates & APIs

10. Quality & Compliance
FDA MHRA ISO 14001 ISO 9001 Licence of Licence to
Possession Manufacture
of Controlled
Controlled Drugs
Drugs
Cramlington √ √ √ √ √ √
UK Jun-06 Nov-08 Schedule 1, Schedule 2,
2, 3, 4 3, 4
Queenborough √ √ √ √ √
UK 2010 2010 Schedule 2, Schedule 2,
3, 4 3, 4

11. Formulation Development

12. Formulation Development
Capabilities
Formulation, process and analytical development
Clinical trial manufacture
QP release
Expert in Sterile, Topical, and Oral dose forms
Manufacture for Phase I & Phase 2 Clinical Trials
IMP & Specials licensed facility

13. Oral / Topical
Fourteen GMP flexible manufacturing Manufacturing equipment for:
rooms
• Tablets up to 100,000/hour
Positive Pressure Corridor with100% • Coated tablets 500g – 12kg
fresh intake • Capsules 200 – 3,000/hour
• Powders up to 50kg
Plumbed cleaning systems • Creams up to 20kg
• Ointments up to 20kg
Temperature / Humidity • Oral liquids up to 500 litres
17 C – 23 C
35%RH – 65%RH

14. Steriles
Aseptic filling, terminal sterilisation & Vial Data
lyophilisation services • Sizes: 2ml to 50ml
• Aseptic fill batch size
Formulation & process development 2ml vials is 1800 vials
• Aseptic fill batch size
Manufacture for Phase I & II Clinical Trials 50ml vials is 650 vials
• Lyophiliser size
Solutions / Suspensions / Powders 770 x 2ml vials
Aseptic Filling Pre-filled syringes
Sterilisation by filtration, dry & wet heat
Freeze Dryer in Grade A UDAF Infusion bags
100% visual inspection

15. Spray Drying
Bench-top Buchi*:
• Upto 5l
• 100mg – 100g spray-dried material (efficiency dependent)
• Flow rate – up to 1 l/hr
Niro Mobile Minor*:
• Upto 50l
• 100g – 10kg (efficiency dependent)
• Flow rate – upto 6.5l/hr
Inert handling available - process under N2
*Material dependant

16. Quality & Compliance
MHRA IMP MHRA IMP Home Office MHRA General Cytotoxic
Manufactur Manufacture Controlled Specials Commercial Commercial
e & Testing & Testing of Drugs Licence Licence Licence
of Steriles Non-Steriles Licence
Nottingham √ √ √ √ √ √
UK Dec-07 Mar-07 Apr-07 Jun-10 Apr-11 May-11
Mar-09 Mar-09 Apr-11
Apr-11 Apr-11

17. Formulated Products
Manufacture

18. Timeline
Pianezza, IT
Monheim, DE Zwickau, DE
Queenborough, UK
UCB
Zwickau DE
Monheim DE
Nottingham, UK
Pianezza IT
Cramlington, UK R5 Pharma
Abbott Nottingham, UK
Queenborough, UK
BASF
Cramlington, UK
2004 // 2007 2008 2009 2010 2011 2012

19. Bulk Formulation & Packaging
Manage complexity
Quality ingrained in our culture
Proven technical transfer procedures
Cost effective processes
Global supply chain

20. Capabilities
Technical Capability Capacity (per annum)
Wet granulation - low shear, high > 1000 tonnes
shear, fluid bed
Tablet production - single, bilayer > 4 billion tablets
Encapsulation > 1 billion capsules
Liquids - temperature non-critical 2 million litres
Liquids - temperature critical 300,000 litres
Blister packing 300 million packs
Bottle packing - tablets & granules 15 million bottles
Bottle packing - liquids 30 million bottles
Terminal sterlisation 25 million ampoules & vials

21. Additional Capabilities
Granulation / Drying - vacuum, solvent based, fluid bed, blending
Tableting - bilayer, multiple lines, B&D tooling
Potent Manufacture – to SafeBridge® Category 3 solid dose
Coating - actives, controlled release, pellets
CTM Support – encapsulation, tableting
Packaging - in-line printing, cold chain, devices, patches
Other technologies - sachet/bottle filling, device assembly

22. Quality & Compliance
FDA MHRA Multi Region Japanese QP Release EU Approved
Supply Supply Line
Queenborough √ √ √ √ √ √
UK
Monheim √ √ √ √
DE Local German
Health
Authority
Zwickau √ √ √ √
DE Inc. Korean Local German
FDA Health
Authority
Pianezza √ √ √ √
IT Local Italian
Health
Authority

23. Pharmaceutical Support
Services
Quality Services
Regulatory Affairs
Analytical Services
Supply Chain & Distribution
Artwork Services

24. The Aesica Offer
An Established and Integrated contract
manufacturing and development organisation
Delivering rapid, cost effective & compliant solutions
Providing our customers with assurity of supply
Our expertise delivers your peace of mind

25. Meet Us in 2012
informEx Booth #1606
DCAT
CPhI Japan
Interphex
Bio International
CPhI China
ChemOutsourcing
Contract Pharma
CPhI WW
AAPS
www.aesica-pharma.com

26. Meet Us in 2012
informEx Booth #1606
DCAT
CPhI Japan
Interphex
Bio International
CPhI China
ChemOutsourcing
Contract Pharma
CPhI WW
AAPS
www.aesica-pharma.com