BioApproaches South West is managed by Great Western Enterprise and funded by the South West RDA

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South West Bio UK plc
Business driven through Finance
BioApproaches South West is managed by Great
Western Enterprise and funded by the South West
RDA
Tuesday 6th September 2005
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Gugs Lushai
BioApproaches SW
Programme Manager
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South West Bio UK plc
Welcome National and regional delegatesSupport
of our Partners the BIA and BioprocessUKOur
Chair, speakers and Round-table Chairs Business
supportProactive engagement to help with
commercialisationPromotional Activity - maps,
press releases, publications, high impact
websites to spread the word1000 e-mails a month
and other communications Survey to develop
investment potential
BioApproaches SW
Update
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South West Bio UK plc
New sponsorships and partnerships Network of
networksSponsorship programmePartnerships to
develop commercialisation potential
BioApproaches SW
Update
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Emily Wislon
BioApproaches SW
Programme Co-ordinator
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BioApproaches SW Update

• CORDIA
• New BioApproaches SW Website
• Staff changes

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CORDIA Convention

• BioApproaches SW SW RDA exhibiting at CORDIA
  with
• Enigma Diagnostics
• Knight Scientific Ltd
• Plymouth Marine Laboratories
• CardioAnalytics
• TRAC Services

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www.bioapproaches.co.uk
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www.bioapproaches.co.uk
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www.bioapproaches.co.uk
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www.bioapproaches.co.uk
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www.bioapproaches.co.uk
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www.bioapproaches.co.uk
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www.bioapproaches.co.uk
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www.bioapproaches.co.uk
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www.bioapproaches.co.uk
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Staff Changes

• Web Editor
• Mutamba McCormack
• Mutamba.McCormack_at_greatwesternenterprise.co.uk

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Matthew Anderson
Montage Communications
Commercial Director
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Spreading the word The South Wests best kept
secret
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Speaker profile

• Commercial Director of Montage Communications,
  a Bristol-based PR agency. The agencys four
  specialist areas are b2b, high-tech, public
  sector and consumer.Heading up some the
  agencys key accounts from BioApproaches, SWAIN
  and South West Ventures Fund to the National
  Lottery, National Express and BQ.Backed up by
  a team of journalists and marketing strategists,
  he implements national and regional campaigns to
  raise the visibility and credibility of his
  clients.

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The regions best kept secret

• Healthcare
• Marine
• Agbio
• Environmental

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Healthcare
New chemical hope for Alzheimers Scientists
from Bristol University are confident they have
identified a chemical that could lead to a cure
BBC April 2005
Development of inhaled drugs breathes life into
Vectura Vectura along with privately owned
Arakis, signed a deal with Novartis worth up to
205m Financial Times June 2005
New weapon in fight with MRSA superbug Acolyte
Biomedica can slash the time taken to detect the
bacteria from five days to just five hours
Western Daily Press June 2005
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Marine
Marine biotechnology is a thriving industry
that has seen its market value increase by 25
since 1999. Scandinavian Life Science - 2005
Plankton provides clues to understanding climate
change Scientists from PML hope to find a link
between marine organisms and changing climate by
finding out whether they act as a source of
greenhouse gases to the atmosphere or a sink in
which the gases are contained in the
ocean. Plymouth Evening Herald May 2005
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Agbio
Key advice gains entry into Swedish markets Key
Organics has made significant inroads into the
Swedish pharmaceutical market and agrochemical
market. The company researches sophisticated
tools to screen compounds which are needed for
growth promoters for seedlings. Cornish Guardian
May 2005
Animal nutrition is big business in
Marlborough South West-based Danisco Animal
Nutrition has pioneered the development and use
of enzymes and betaine in animal nutrition, since
its establishment in the early 1980s. Employing
160 people across 13 international locations.
Charles Sheppy Danisco, Strengths of the South
West May 2005
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Environmental
...Biotechnology is the only industry that can
clean up the environment through a variety of
bioremediation processes!..
Brixham Environmental looks at environmental effec
ts caused by drugs Dr Jason Snapeat, a senior
scientist at AstraZeneca (Brixham Environmental
Laboratory), said The research work being
conducted at AstraZeneca is focused on
understanding how medicines are removed from the
environment through the action of the good or
friendly bacteria. Western Morning News April
2005
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South West Bio UK plc
Business driven through Finance
BioApproaches South West is managed by Great
Western Enterprise and funded by the South West
RDA
Tuesday 6th September 2005
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South West Bio UK plc
Business Driven Through Finance Tuesday 6th
September 2005 David Wragg Saffery Champness
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Definitions
Core Biotechnology Sector
Those firms whose primary commercial activity is
involved in the application of biological
systems, organisms or processes.
Biotechnology Sector
All firms involved in the application of
biological systems, organisms or processes.
Life Support Sector
Includes Core and Related Biotechnology Sectors
and comprises those industrial activities which
directly support and improve the life processes
of all living organisms and the environment in
which they exist. 3 main subsectors Agriculture,
food and drink Health and care
Environmental Industries
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Economic profile of the South West Biotechnology
sector
Core/Pure Biotechnology Sector Companies 41
Employment 1400 Output 46 million
'
(
Biotechnology-related Sector Companies 147
Employment 7,200 Output 354 million
'
(
Life Science Sector
excluding retail and wholesale Companies
8,800 Employment 300,000 Output 7.9
billion
including retail
and wholesale Companies 150,824 Employment
452,737 Output 10.5 billion
Source Economic Profile of the South West
Biotechnology Sector, April 2005. Great Western
Enterprise (GWE)
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Recent South West Highlights
Salisbury Acolyte Biomedica Rapid MRSA
screening test launched Chippenham Vectura de
al worth 198 million agreed to develop
treatment for chronic obstructive pulmonary
disease Exeter and Peninsula Medical
School Plymouth gene responsible for around
one third of neonatal diabetes cases located
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Finances

• The fall-off in venture capital recovered in late
  2003
• 2004 investment in biotechnology and
  pharmaceuticals increased by 41
• The UK has the second most developed environment
  for venture capital funding ideal for
  attracting funding
• 2004 Several successful IPOs
• Successful Mergers Acquisitions
• Foreign competition is fierce, heavy investment
  abroad means many countries are catching up with
  the UK

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The Future - Nationally

• The European market dependent on biotechnology is
  forecast to exceed 100,000 million this year
• The UK Government will spend 1 billion on
  biotechnology by 2008
• National strategy to ensure the UK retains its
  current leading position in biosciences
• BioScience 2015 Improving National Health,
  Increasing National Wealth

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The Future in the South West

• Biotechnology sector identified as important
  emerging sector to be given special support
• Significant new developments include
• Emersons Green Science Park, Bristol
• Porton BioScience Centre, Wiltshire
• Exeter Innovation Centre and Tamar Science Park,
  Devon
• The RDA and its partners have significantly
  increased investment over the past few years

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South west Bio UK plc
Business Driven Through Finance Tuesday 6th
September 2005 David Wragg Saffery Champness
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South West Bio UK plc
Business driven through Finance
BioApproaches South West is managed by Great
Western Enterprise and funded by the South West
RDA
Tuesday 6th September 2005
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Making the Grade Getting the MoneyRichard J
TurnerCatalyst Venture Partnerswww.catvp.com
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Bio tech projects Some characteristics

• Intellectual property driven
• Large up-front investment
• Significant time before revenues
• Binary unless portfolio
• Dominated by large companies

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Funding up the curve Stages of Growth

• Pre-seed Creation and formulation of IP
• Seed Product /service is under
  development and pre sales
• Start-up Product in Beta version and in
  discussions with customers
• Early stage Done deals. Pre-profit but sales
  growing rapidly
• Expansion Profitable

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Fast Growth Companies move up a value curve
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Matching funding to stages
Seed Grant. Friends Family Startup Series
A investors Early stage Series B
investors Expansion Series C Aim.
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(No Transcript)
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What you have to have

• World leading IP
• Great management team
• A sponsor
• Clear understanding of the market
• Path to revenues and exit
• Portfolio of products

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Investment climate

• Bio tech investors have become very cautious
• Underestimation of complexity of the problem
• Many bio projects have yet to deliver
• Bio tech has not proved to be the golden goose
• Emphasis on portfolio to reduce risk
• Experienced team essential

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What is the process

• Appoint an advisor
• Get the proposition right
• Identify the right investors
• Approach investors in a systematic manner
• Allow enough time
• Be reasonable but not a push over

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How long does it take ?
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Conclusions

• Concentrate on the proposition
• Match funding to stage
• Allow enough time

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QUESTIONS ANSWERSCatalyst Venture
Partnerswww.catvp.com
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South West Bio UK plc
Business driven through Finance
BioApproaches South West is managed by Great
Western Enterprise and funded by the South West
RDA
Tuesday 6th September 2005
49
Business Driven Through Commercialisation

• Nigel Crockett, Ph.D.
• Commercial Director
• 6 September 2005
• South West Bio plc

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Astex Overview

• Pipeline of novel molecularly targeted oral and
  iv oncology drugs
• First product in clinical trials in Q3 2005
• Three INDs by mid 2006
• Multiple strategic alliances with leading
  pharmaceutical companies
• Validated, revenue generating technology platform
• Milestones and royalties on partnered programs
• Proprietary fragment-based discovery engine
• Improved success in lead discovery
• Strong management, board, and advisors, raised
  51m in VC funding
• Abingworth, Oxford, Alta, Advent, GIMV and Apax

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Business strategy
Small molecule product engine
Pyramid ? platform
Partnered programs
Internal programs

• Focused area (oncology)
• Next generation targets
• Downstream partnering
• Retain more value

• Revenue through collaborations
• Validates technology
• Offsets cash burn (milestones)
• Royalties on compounds

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Internal programs
Compound name/ Pyramid Mechanism

Preclinical
Phase 1 Phase 2 Phase 3
lead discovery
clinical clinical clinical
Current clinical candidates
AT7519
AT9283
AT9311
Current lead optimisation
Akt
/PKB pathway
HSP 90
RAS/RAF pathway
Growth factor
Cell cycle
Progression through 2H 2006
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Partnered programs
Compound out-licensing
PKB/Akt oncology AstraZeneca
Fragment-based Drug discovery
Structure-based ADME
Cytochrome P450s sanofi-aventis
Cytochrome P450s AstraZeneca
Cytochrome P450s Astellas Pharma
Cytochrome P450s Mitsubishi Pharma
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Industry needs
Pharmaceutical industry target rich, lead poor
G. Milne, Pfizer Inc, Drug Discovery Conference
Boston Aug 14th 2001
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Astex Technology .2000

• Established in December 1999
• (Founders- Sir Tom Blundell, Drs Harren Jhoti
  Chris Abell)
• First-round financing raised over US45M in 2001
• (Abingworth, Oxford Bioscience, Advent Intl,
  Alta Partners, GIMV)
• Based in Cambridge (UK)
• First deal with Janssen
• 40 employees
• Fragment-Based Drug Discovery

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Fragment based lead discovery

• Low quality HTS hit High quality fragment
  hit (HTXTM)

2uM 500uM Low ligand
efficiency High ligand efficiency
Significant attrition during hits-to-leads
chemistry
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Deal Portfolio

Deal making for growth, Carsten Geyer et al.,
Nature Biotechnology 17, 645 - 648 (1999)
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Astex drug discovery engine
Clinic
Lead optimisation
Lead generation

Target selection
Lead to Candidate
PyramidTM
Hit to Lead
Pre-PyramidTM
Pre-clin
Lead generation Early partnerships validate/levera
ge technology
Metabolic optimisation Rescue P450 problem
compounds

• Drug candidates
• Portfolio of novel drug leads
• Astex clinical candidates

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Competition

• Licensors (Biotech) licensees (Pharma)
• Technology assessment (Structure Based Drug
  Design)
• Fee for service vs. FTEs/milestones/royalties
• Differentiation

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Structure-based ADME profiling

• Cytochrome P450 enzymes major cause of lead
  compounds failing in ADMET (40-50 all drugs
  affected)
• Structures of human P450 enzymes complexed to
  drug leads

Target active site
P450 active site
Mediate metabolism using rational design
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World-class science First Human P450 crystals

• Novel pocket for drug binding
• Reduce CYP450 liabilities
• Publication in Nature

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P450 Collaborations

• Presented to ALL major mid-sized pharma
• Negotiations established with four majors
• Signed first P450 deal with (April 2001)
• Signed similar deals with
• Upfront/access fees, milestones

• Relationships for future drug discovery
  interactions

Structural biology and DMPK groups, chemists,
CADD
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Licensing by development stage
2000-2001
Reuters Business Insight, 2002
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Fragment-based discovery using Pyramid
Less than 100 analogues
Proprietary fragment libraries
Optimised drug candidate
Pyramid generated leads
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Discovery collaboration

• May 2002 - Mitsubishi P450 collaboration

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Competitive Landscape H202

• Partnerships established
• P450 Drug discovery collaborations
• Validation of core company capabilities
• Drug metabolism (cytochrome P450s)
• Fragment Based Drug Discovery
• Opportunity for larger discovery collaborations

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Discovery collaboration
PRESS RELEASE   Astex announces Alzheimers
drug discovery collaboration with
AstraZeneca   Cambridge UK, 3rd March 2003 Astex
Technology, the structure-based drug discovery
company, today announced a collaboration with
AstraZeneca. The agreement relates to the
discovery of novel drugs against a key protein
target implicated in Alzheimers disease.
AstraZeneca will fund Astexs research programme
and will provide milestone payments of
approximately 40m, in addition to royalties
based on sales of an approved product.   Astex
will provide an initial series of small molecule
inhibitors, and apply its high throughput X-ray
crystallography and Pyramid? approach for
fragment-based drug discovery against the target
to rapidly identify additional novel drug
candidates.

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Multi-target collaboration
Astex and Schering AG announce multi-target drug
discovery alliance with focus on cancer drugs
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High value 2003
  30M convertible
  Astex
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Increasing Early Deal Values
Average Total Deal Value (m)
June 22, 2004 -- Merck Co. and Vertex
Pharmaceuticals announced today that they have
entered into a global collaboration to develop
and commercialize VX-680, Vertexs lead Aurora
kinase inhibitor that is expected to enter
clinical development this year for the treatment
of cancer.Under the terms of the agreement,
Vertex will receive a 20 million up-front
payment and an additional 14 million in research
funding over the next two years. In addition,
Vertex could receive as much as 350 million in
milestone payments, including 130 million for
the successful development of VX-680 in the first
oncology indication.
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Astex Internal programs
Compound name/ Pyramid Mechanism

Preclinical
Phase 1 Phase 2 Phase 3
lead discovery
clinical clinical clinical
Current clinical candidates
AT7519
AT9283
AT9311
Current lead optimisation
Akt
/PKB pathway
HSP 90
RAS/RAF pathway
Growth factor
Cell cycle
Progression through 2H 2006
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Preclinical stage Strategic Partnership

• 27th July 2005
• AstraZeneca and Astex announce new anti-cancer
  drug discovery alliance
• Small molecule inhibitors of PKB/Akt for use as
  anti-cancer agents
• Upfront payment of 2.75 million (5 million)
• Research funding, milestone payments of up to
  150 million (270 million)
• Astex eligible to receive up to double-digit
  royalties on product sales
• Astex option to co-promote in the USA

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IND approval for novel cancer drug AT7519
PRESS
RELEASE Astex announces IND approval for novel
cancer drug AT7519 Cambridge, UK, 27th June
2005. Astex, the fragment-based drug discovery
and development company, today announced that the
United States Food and Drug Administration (FDA)
has approved its Investigational New Drug (IND)
application for the clinical development of its
proprietary cell cycle inhibitor, AT7519, for the
treatment of cancer. AT7519 was discovered and
developed internally using Astexs fragment-based
drug discovery platform, Pyramid?, and progressed
from first synthesis to regulatory approval in
just 14 months. The Company is in the process of
initiating a multi-centre Phase I trial of AT7519
in patients with refractory solid tumours in the
US and in the UK.
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Company Value Drivers

• Progression of internal programs
• New discovery deals
• New compound deals
• Revenue breadth/depth from up-fronts,FTEs,
  milestones
• RANPV stacking from internal and partnered
  programs - derived from completed deal terms

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www.astex-therapeutics.com
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South West Bio UK plc
Business driven through Finance
BioApproaches South West is managed by Great
Western Enterprise and funded by the South West
RDA
Tuesday 6th September 2005