Presentation of the biopharmeceutical company BioUetikon, comprising a general presentation on the company, marketing considerations, and specific issues regarding building the company.

1. BioUETIKON Limited
Oct 2009
27/03/13 www.biouetikon.com 1

2. Agenda
□ General Presentation of the company:
□ Marketing consideration:
 Target audience profile
 type of clients (current and prospects)
□ Specific issues that you may have:
 Improve brand awareness EU & US
 Reach a target audience as a new entrant
 Gain credibility as a competent CMO for development
and GMP production

3. Mission Statement
□ BioUetikon provides high quality
Process Development/Optimisation
and cGMP Bioproduction Services.
BioUetikon actively works to achieve
a leading position in development and
execution of efficient bio-processing
systems to maximise value to clients,
shareholders and employees.
27/03/13 www.biouetikon.com 3

4. BioUETIKON Services Menu
 BioProcess Development/Optimisation
 Cell Line Development*
 GMP Cell Banking & Storage
 cGMP Production in multi-suite facility
 Mammalian/Insect Cell Culture
 DSP Development and Processing
 Analytical Development
 Quality Assurance/ In house QP
 In House Microbiology/Environmental
 Contract Based Research with
NICB/NIBRT/CBAS/DCU
 >10 years experience of project delivery
* with partner Fusion Antibodies Limited
27/03/13 www.biouetikon.com 4

5. Where does BioUETIKON fit in?
Discovery Development Market
Targets
Hits
Leads
BioUETIKON
Pre-clinical
Development
Phase 1 Phase 2 Phase 3 Submission
/Approval
Lifecycle
Management
Candidates
1-5 yrs 0.5-2 yrs 1-2 yrs 1.5-3.5 yrs 2.5-4 yrs 0.5-2 yrs 10-20 yrs
GMP Requirement
27/03/13 www.biouetikon.com 5

6. Experience
□ Full compliance with international quality
standards like cGMP, EMEA, FDA, ISO
13485
□ Investigational Medicinal Products
Authorisation (Ref. no.-057) Irish
Medicines Board
□ Obtained Manufacturing License 1995
 renewed in 1998, 2001, 2004
□ Passed All Inspections regulatory &
quality audits (IMB, ISO, Client)
□ Successful Track Record
 Biologic API Production History (e.g. FSH for 10 years)
 API Process Development (e.g. Biosimilar EPO)
 Implant Device Development & GMP Production
27/03/13 www.biouetikon.com 6

7. Business Concept ‘Simple’
□ BioUETIKON is a pureplay CMO
 Development thro’ GMP production
 Fee for service model
 Client part of project plan and may participate
operationally where relevant
 Client retains full IP
 Transparency and Confidentiality at every
stage
27/03/13 www.biouetikon.com 7

8. Business Concept
□ Partner Support with
 QA GMP batch release Testing
 Cell Line Testing and Characterisation
 Virus Clearance Safety Testing
 Formulation/Fill finish/Stability
 Regulatory Support
 Research & Development Services
□ Cell Engineering & Development
□ Media Screening
□ Sequencing
□ Sophisticated Analytics
27/03/13 www.biouetikon.com 8

9. Project Management & Control
□ Dedicated Project Manager
□ Regular Review and
Planning Meetings
(Tele/Videocon, face to face
meetings)
□ Client Work on site as
appropriate to progress to
next project phase.
□ Transparent Service
□ Confidential Service
New Customer Confidentiality
Enquiry Agreement
27/03/13 www.biouetikon.com 9

10. BioUETIKON Organogram
27/03/13 BioUETIKON Limited 10

11. Parent company cph overview
□ Swiss Industrial Group
□ Founded 1818
□ ~ 600M CHF Sales
□ ~ 900 employees
□ Profitable
□ > 185 Yrs in Business
□ Continuous Investment
□ International
27/03/13 www.biouetikon.com 11

12. Operating Division: CU Chemie Uetikon GmbH
CPH Fine Chemistry Division
 Flat and efficient organisation - two
reporting levels will minimise overheads and
speed up communication
 Long term investment strategy and stable
financial background
 Full service provider - from development
through production to registration
 Broad and strong technology base - all
key technologies available
 Excellent regulatory track record with
authorities like FDA (USA), EMEA (EU), and
PMDA (Japan)
 Profound R&D and production know how
to serve our customers through all project
phases (…from kilogram to ton…)
12

13. GMP Facilities BioUETIKON, Dublin
□ High Quality Manufacturing Suites
with fully independent ambient and
4oC Grade C production environment
□ 3 Separate Cell Culture Suites for
multi-product projects with multiple
air-handling systems
□ 3 Separate DSP Suites (2 are 2-8oC)
□ Unidirectional people & material flow
□ Separate Media Prep & Support Areas
□ Cold storage (100m2 +4oC Rooms,
various -20oC etc.)
□ Secure Access, Alarmed, Monitored
LN2 storage
□ Room for Expansion
 Development and GMP space available (e.g.
long term client projects)
27/03/13 www.biouetikon.com 13

14. Utilities
□ Distributed Purified Water to
Ph.Eur/ USP (18 pt loop)
□ Centralised distributed gas
system, N2, CO2, O2, Air and
Mixed gas
□ Central process alarm
system, with alarm inputs in
all production suites, linked to
security system
□ Temperature Monitoring
□ Back up generator system
available in all production
suits
□ Plant steam
□ Full range of ancillary
equipment on site including
GMP and waste autoclaves,
washers etc.
27/03/13 www.biouetikon.com 14

15. GMP Suites Layout
Cell Culture Suites DSP Suites
Stairs Stairs
Cell Culture DSP 2
Cell Culture 2 4o C
1 29m2 DSP 1
28.5m2
24m2 4o C
23m2
Lift Lift
Cold Prep
Store Lab.
8.6m2 7.5m2
EXIT
EXIT
Cold
Cleaning/ Analytical Store
Sterile Sterilisation
Cell Culture Media / Lab. 21.5m2
Store 20m2
3 Buffer Prep. 31.5m2 DSP 3
18m2
23m2 Lab. 27m2
22m2
Corridors Class C Class D Lab. Class C
(Class D) Production Anteroom
Process Flow
27/03/13 www.biouetikon.com 15

16. Other Space
□ Long Term Client
Dedicated purpose built
GMP space
□ GMP Cell Banking Area
□ GMP Cell Storage Area
□ GMP Microbiology Lab
□ Development Labs
□ Older lab & clean room
space available for client
projects long & short term
□ Office Areas
□ Conference Room
27/03/13 www.biouetikon.com 16

17. Services: Quality Assurance
□ Robust Quality System
□ IMP Authorisation (IMB-
057)
□ In House Qualified Person
(QP)
□ Successfully in all IMB
(EMEA) Audits since 1998
□ Support for Regulatory
Filings & Documentation
for EMEA, FDA, ISO
□ QA Department with
 Validation
 In House Microbiology
 Environmental Monitoring
27/03/13 www.biouetikon.com 17

18. Services: Cell Culture
□ GMP Cell Banking & Storage
□ CO2 Incubators/ Flasks/ Spinners/
Roller Bottles/Hollow Fibre
□ Small Scale Process Development
Bioreactors
□ 10L wv Batch/Perfusion
□ 100L wv Batch/Perfusion
□ .25L to 50L Single Use ‘WAVE’
Bioreactor Batch/Perfusion
□ SUB Disposable bioreactor 50 &
250L 2009 (Fed) Batch/Perfusion
□ SUB to 1000L 2009 (Fed)
Batch/Perfusion
□ 3 independent cGMP Cell Culture
Suites
□ Media/Buffer Prep Lab
□ Media Screening
27/03/13 www.biouetikon.com 18

19. Services: Down Stream Processing
□ Process Development
□ GMP Purification
□ 3 DSP rooms
□ 2 rooms can operate 2 to 8oC
□ Dedicated room per process
□ Chromatography/Purification
 GE Akta Explorer for
development and small scale
GMP
 Millipore K-Prime for process
scale
 UFF/TFF etc.
 Produced Commercial
therapeutic r-glycoprotein (9
unit operations/5 column
steps)
27/03/13 www.biouetikon.com 19

20. Services: In Process Analytical
□ UVA280
□ pH & Appearance
□ SDS-PAGE (R) & SDS-PAGE (NR)
□ IEF
□ Endotoxin & Bioburden
□ Mass Spec*
□ HCP
□ HPLC
□ DNA
□ Cell Based Bioassay*
□ ELISA Assay Development
□ TOC
□ IEF-Western
□ In Process Assays/Testing
□ In House Microbiologist &
Environmental Monitoring
□ Method Development/Validation
□ Final Release Testing with Partner
* with contract research partner
27/03/13 www.biouetikon.com 20

21. Services: Fill Finish
□ Manual Fill capabilities
□ Produce the
penultimate API
material
□ Grade A cabinet in
Grade C/D background
□ Manual Labelling &
Packaging
27/03/13 www.biouetikon.com 21

22. Why BioUETIKON?
□ Good People Skills & Experience
□ Good Facility (Space & Layout)
□ Good Location (Ireland has excellent compliance
record for API manufacture & easy access US/EU)
□ Quality System, QP, Audit record
□ Local Contract Research Network
□ Flexibility to Respond to Needs
□ Financial Backing & Stability
27/03/13 www.biouetikon.com 22

23. Marketing consideration
• Target audience profile
□ Start Up and Mid Size Biotech with funded clinical development
pipeline/programs
□ EU, Switzerland and US
□ Innovator and biosimilar
□ Many are ‘virtual’ organisations and outsource already ‘C’ level
targets
□ Very conservative, pay a premium to established players
□ Long, detailed decision making process, ‘big’ decision
□ High due diligence (site audit, formal suitability assessment)
□ High regulatory compliance requirement
• type of clients (current and prospects)
□ International
 UK start up, e.g. spin out from Cambridge Uni.
 German biotech start up
 US Cancer Institute
 Dutch biotech start up etc.

24. Specific issues
□ Limited Market Reputation
as New company in CMO Development and GMP
Space. How to get considered as a service
provider?
□ Visibility
□ Coverage with limited resource
□ Website –How could it improve? Interactive?
□ Search engine optimisation – are we getting the
most out of our Google Adwords?
□ Technical Competence

25. Specific issues
□ Conferences – how can we entice more people to our
booth without spending a fortune?
□ Our competitors – how can we stand out against
Lonza, Cobra, Eden Biodesign, BioAlliance, Avid
Bioservices, ProBioGen?
□ Video any ideas about how this could be done using
some of the footage already taken? May need to be
reshot in the future – could they work with the DCU
Communications Department?
□ Tag line – do we need one? If so it should be simple
yet effective e.g. “Supporting Biopharmaceutical
Visions” – ProBioGen.
□ Logo (does it represent honesty, integrity,
professionalism?) Possible redesign. Should there be a
positive emotional attachment to the logo?

26. To End
□ Prize
□ Questions?