bioScienceUK - Biotechnologie.de

Transcription

A20072 - bioScience Booklet Art
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bioScienceUK
2005
encouraging & supporting innovation
supporting
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bioScienceUK 2005
contents
Minister for Trade, foreword to BioScience 2015
02
Introduction
03
Oncology
14
Vaccines
18
Stem Cells and Cell Therapy
22
Neuroscience
26
Drug Discovery and Development
32
Bioprocessing
38
Contacts
42
bioScienceUK 2005 CD-ROM directory
49
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2 - bioScienceUK 2005
Minister for Trade
foreword
Since the discovery of the structure
of DNA over 50 years ago the UK
IAN PEARSON,
has continued to be a world leader
MINISTER FOR TRADE
in biotechnology, with a sector second
only to the US in terms of size and
importance. The strength of the sector comes from the excellent
network of advanced biotech clusters that exist across the UK
and the supporting infrastructure in our academic base including
over 20 Nobel Prize winners.
The UK offers a sophisticated financial market,
effective clinical and pre-clinical trial expertise,
skilled manufacturing and talented
management.
To remain at the forefront of the life sciences
we have continued to innovate and invest
in the sector. The UK government will increase
its support in science from £3.9 billion this year
to £5 billion by 2008. This extra funding is part
of a 10-year strategy to further boost our
science and innovation excellence.
A major achievement in 2004 was the opening
of the UK’s Stem Cell Bank. The first of its kind
in the world, it will store and supply ethically
approved, quality controlled stem cell lines
for research, and, ultimately, treatment.
UK companies are actively developing and
exploiting biotechnology across the whole
breadth of its applications including
pharmaceuticals, medical devices and
diagnostics, through to the manufacturing
industries such as speciality chemicals,
food and agriculture, and the environment.
I am delighted to contribute to this edition
of BioScienceUK, which showcases the UK’s
strengths in biotechnology and the life
sciences. I look forward to the UK’s
continued success in the sector in 2005.
IAN PEARSON, MINISTER FOR TRADE
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bioScienceUK 2005 - 3
UK Bioscience – Vibrant and growing
introduction
Welcome to the 2005 edition of bioScienceUK, published
by the BioIndustry Association (BIA). We work on behalf
of member companies to help translate scientific advances
into improvements in healthcare and promote
the development of the bioscience sector.
This booklet provides a summary of commercial
developments in 2004 and examines progress
in implementing ‘BioScience 2015 – Improving
National Health, Increasing National Wealth’
– the national strategy for the sector initiated at
the end of 2003. It goes on to single out some
of the most important therapeutic areas and
their supporting technologies and to analyse
how UK companies are contributing
to advances in each.
Bioscience is one of the fastest growing sectors
of the British economy. After a period of
consolidation in the downturn of 2002 - 2003
the sector began a new growth spurt in 2004.
This was initiated by the cautious re-opening
of the capital markets - enabling a number of
companies to list in London - and underpinned
by the intrinsic strength of UK bioscience
companies and the Government’s proactive
and constructive approach to the sector.
Governments worldwide
vie to take over the UK’s
leading European position
Attracted by the promise of improved
healthcare and economic growth, governments
worldwide are drawing up strategies for
bioscience. They are all committing to create
favourable regulatory and fiscal regimes for
biotechnology, and each has the same target –
to take over the position of the UK bioscience
sector as the largest in Europe.
While many countries are beginning from
a standing start, the UK is building on strong
and deep roots. Figures compiled for the
Government by market analysts, Critical I,
show that the UK began 2004 with the most
sustainable bioscience sector in Europe.
Although employee and company numbers fell
in 2003 there was a 6 percent revenue growth
and at the start of 2004 UK companies were
the best financed. The UK was dominant
in therapeutics, starting the year with 200
compounds in development, 35 of which were
in Phase III. In second place was Switzerland
with 41 compounds in development,
of which 12 were in Phase III.
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The objective of Bioscience 2015 (the
recommendations and outcomes are discussed
in more detail at the end of this section) is for
the UK to maintain its European dominance
and the global number two spot, by addressing
requirements for change in the regulatory and
fiscal framework and continuing to build on
existing strengths, such as the strong academic
and clinical science base, the wealth of managerial
and technical skills and a sympathetic
investment community.
Bioscience 2015 made six key recommendations
[see opposite]. Since the strategy was published
in late 2003, the Government has moved
on each of these, taking steps to improve
the funding environment, strengthening
the regulatory framework, providing £100 million
to establish a National Clinical Trials Agency,
investing £6 million in the bioprocessing
subsector and launching various skills initiatives.
The measures are discussed in greater detail
later in the introduction.
The BIA has been a prime player - promoting
member companies’ concerns and interests and seeing through the implementation of the
BioScience 2015 recommendations. It has been
heavily involved also in other legislative
changes, including the introduction of the EU’s
new clinical trial regulations in May 2004,
the UK Human Tissue Act and the introduction
of a new law to control the use of extreme and
intimidatory tactics by animal rights activists.
Animal rights extremists now face jail terms
of up to five years if they cause “economic
damage” to any company doing business
with animal research companies or facilities.
1. Build a mutually advantageous
collaboration between the National Health
Service and industry for patient benefit
through the creation of a National Clinical
Trials Agency
2. Create a public and regulatory
environment supportive of innovation
3. Ensure sufficient and appropriate funding
is available, including supporting measure
to improve the liquidity of bioscience
companies
4. Build a strong bioprocessing subsector
within UK bioscience
5. Develop, attract and retain a high quality
scientific and managerial talent base
6. Create a Bioscience Leadership Council
(BLC) to oversee implementation of the
Bioscience 2015 strategy
Financial Environment
At the start of 2004 market analysts, Critical I,
found the biotechnology sector in the UK
to be more robust than elsewhere in Europe,
and said that companies were more sustainable
because they are better funded. “As it entered
2004 the UK had more companies in a healthy
financial state, and able to support renewed
growth through recent equity funding
or revenue generation than any country
in Europe.” In addition the UK had more
companies that might potentially attract
relatively large sums of equity finance.
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“As it entered 2004 the UK had more companies in a healthy financial
state, and able to support renewed growth through recent equity
funding or revenue generation than any country in Europe.”
SOURCE: CRITICAL 1
However, future growth remains dependent
on a continuing supply of external equity capital.
Prompted by the Bioscience 2015 report,
the Government has taken steps to improve
access to investment capital for biotech
companies. It commissioned a report into
pre-emption rights and the enforcement of the
current, widely accepted, 5 per cent level which
can hinder growing technology companies
in accessing capital swiftly and most effectively.
The BIA believes the industry should be singled
out as a special case and has campaigned
successfully for changes to the guidelines and
of investors’ attitudes, towards the appropriate
levels of pre-emption disapplication - of up
to 20 percent - or even higher, bringing the UK
more into line with the US. The Governmentsponsored report by Paul Myners, published
in February 2005, has recommended that
pre-emption rights should be a matter
for dialogue and agreement between
companies and their shareholders.
Commercial Developments in 2004
In 2004, UK bioscience played a key role in
leading the sector out of the millennial doldrums
that afflicted biotechnology worldwide.
Perhaps the most significant breakthrough
came at the beginning of March 2004, when
Ark Therapeutics Group plc raised £55 million
in an initial public offering, becoming the first
bioscience company to join the main market
of the London Stock Exchange for more than
three years.
Whilst Ark’s success did not signal an
immediate end to the funding drought
on Europe’s public markets, other companies
did follow. Highlighting London’s strength
as a financial centre, the next to list was an
Australian company, Norwood Immunology Ltd.
The immunotherapy specialist was drawn to
London’s junior Alternative Investment Market
(AIM) over the Australian Stock Exchange
because it wanted to attract international
institutional investors, and because AIM has
created a user friendly interface to make
it easy for overseas companies to list.
A further example of London’s attractiveness
to overseas companies came later in the year
when Inion Group of Finland raised £33 million
in an initial public offering on the main market.
Inion considered listing in Helsinki, Frankfurt
and Zurich, and on Nasdaq, before selecting
London as the only market that was receptive
to small biotechnology companies.
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Although it remained a tight market, with two
companies Microscience Ltd and Cyclacel Ltd
canceling proposed IPOs, Norwood
was followed onto AIM by others including
Vectura Ltd, Evolutec Group plc,
Allergy Therapeutics Ltd, Sareum Holdings,
Synairgen Ltd, Physiomics Ltd and VASTox Ltd.
The last of these, VASTox, is notable because
it became the first genomics company to list
since the genomics bubble burst four years
earlier. The company has made genomics
investor friendly again by reversing the
gene-to-screen approach advocated by its
antecedents, to a screen-to-gene approach
using live zebrafish to screen chemical libraries.
Building on the advances of 2004, 2005 began
in a similar vein with Ardana Bioscience plc
joining the main market and Plethora Solutions
Holdings, BioFusion plc and Proximagen
Neuroscience plc all listing on AIM.
Examining the many and varied propositions
put before investors, several common threads
emerge. Companies have drawn on the lessons
of the downturn, balancing the risk
in development strategies and reshaping
business models.
Follow-on offerings
Alongside the new listings there were some
significant follow-on offerings by listed
companies including £6.5 million raised
by Phytopharm plc, £20 million by Neutec
Pharma plc, £10 million by Protherics plc
and £11.4 million by CeNeS Pharmaceuticals plc.
In 2005 Phytopharm raised a further £10.1
million, while Vernalis plc raised £30.3 million.
Follow-on investments
in private companies
In parallel with the warmer sentiment
in the public markets, 2004 saw a number
of significant investments in private companies.
Highlights include Cyclacel raising £21.3 million
in its fourth funding round, Domantis Ltd
£17.5 million, Arakis £29 million, Chroma
Therapeutics £15 million, ReNeuron £10 million,
ProStrakan £22 million, Inpharmatica plc
£13.9 million, Procognia Ltd £10 million,
Argenta Discovery £5.9 million and Paradigm
Therapeutics Ltd £5.5 million, while as
a prelude to its initial public offering in 2005
Ardana raised £9 million privately in mid 2004.
Mergers and acquisitions
reshape the sector
Consolidation continued to be a driving force
in shaping the sector. The most significant
move of 2004 was the purchase of the UK’s
oldest and largest biotech, Celltech Group plc,
by the Belgian pharma and chemicals
conglomerate, UCB Pharma SA, for £1.5 billion.
The deal created the world’s fifth largest
biopharmaceutical company with revenues
of €2.1 million. The Research and Development
headquarters for the combined company
is based in the UK.
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This snapshot of corporate activity in bioscience gives only a flavour
of the vibrancy of the sector in the UK; it illustrates its global reach
and the high level of interchange of its participants with their peers
and counterparts, in the UK and overseas.
On a smaller scale, another UK company, Sterix
Ltd was acquired by the French pharmaceutical
company Ipsen Group, and Adprotech Ltd was
acquired by the Canadian company Inflazyme
Pharmaceuticals Ltd in an all share-deal valued
at US $14.9 million.
Within the UK, Arakis acquired Sirus
Pharmaceutical Ltd, also in an all-share deal,
while two other privately held companies
Etiologics Ltd and Argenta Discovery Ltd merged
to create a drug discovery services company with
a combined turnover of £12 million.
Deal-making continues apace
UK companies were also active on the dealmaking front. Structure-based drug design
specialist Astex Technology Ltd, agreed a multitarget drug discovery deal with Boehringer
Ingelheim International GmbH in which each
target could be worth up to US $45 million in R&D
costs and milestones up to the point where any
product reaches the market. Ardana Bioscience
strengthened its hold on its treatment for
prostate cancer and endometriosis, acquiring
outstanding rights from Zentaris GmbH of
Frankfurt, Germany, while SkyePharma plc agreed
a US marketing deal worth a potential US $50
million in milestone payments plus 25 per cent
of net sales for a cardiovascular product
it is developing.
The largest headline figure on any deal was that
between Vernalis plc and BiogenIdec Inc for
Vernalis’s Parkinson’s Disease programme, worth
a potential $100 million. Vernalis completed a
hat trick, signing deals with Novartis Institute for
Biomedical Research and Endo Pharmaceuticals
Inc also. Meanwhile Phytopharm plc agreed
a £21 million deal with Unilever plc to use its
appetite suppressant in a range of slimming foods.
Of course the focus of all this activity is to get new
treatments to market. At the end of 2004 GW
Pharmaceuticals scored a significant first, receiving
notice of approval for its cannabis extract Sativex
in Canada. Sativex, which is sprayed under the
tongue, was approved initially for the relief
of pain in multiple sclerosis, becoming
the first cannabis-based prescription medicine.
New companies continue to emerge
There was a steady flow of company formations,
some were the fruit of previous consolidation.
For example, Bioventix Ltd was created by
a management buyout from Xenova Group plc
of the sheep monoclonal antibody business
it acquired when it took over KS BioMedix.
Similarly, PowderMed Ltd, was formed by
spinning out the DNA vaccines technology
Chiron Corp acquired when it took over
PowderJect Pharmaceuticals plc in 2003.
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The UK’s leading universities for bioscience research all have
technology transfer operations and captive seed funds to encourage
company formation.
Other companies, such as Grannus Biosciences Ltd
and Lectus Therapeutics arose from the UK’s
strong science base, Grannus spun out of
Glasgow University backed by seed funding
from Glasgow and Strathclyde Universities’
Synergy Fund, and Lectus from Bristol University
to develop drugs based on a new approach
to targeting ion channels.
The UK’s leading universities for bioscience
research all have technology transfer operations
and captive seed funds to encourage company
formation. In addition, the Government
provides a range of support to encourage
technology transfer from other publicly funded
research establishments such as the research
councils and the National Health Service.
These include the Research Exploitation Fund,
set up in 2001 with £25 million to build better
relationships with industry, create networks and
promote the commercialisation of intellectual
property generated by the public sector.
Another example is the NHS Innovation Hubs,
which provide intellectual property managements
and knowledge transfer services to the NHS.
Genetics Knowledge Parks have also been set
up by the Department of Trade and Industry
(DTI) to encourage entrepreneurship, consultancy
services technology transfer and commercial
exploitation of advances in human genetics.
The Government recently announced new rules
for technology transfer from universities based
on a series of model agreements that
are designed to speed up negotiations
for intellectual property. These form part
of a technology transfer toolkit that can be
accessed on the Web. The toolkit focuses on
financial contribution, the use and exploitation
of IP, academic publication and confidentiality.
The toolkit is part of the Science and
Innovation Investment Framework 2004 - 2014,
which outlines the Government’s long-term
vision for UK Science.
Bioscience 2015 – the UK’s strategy
for maintaining its No 2 position
and building on its strengths
The UK bioscience sector is built on strong
foundations. It was in order to ensure that
the supporting infrastructure reflected the
requirements of a changing and maturing
sector, that the UK Government instigated,
with the BIA, the BioScience 2015 strategy.
This is based on the biggest policy review
of the sector to date, to which more than
70 members of the industry contributed.
A year and a half after it was published
the main recommendations of the report
have been acted on.
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The UK Clinical Research Collaboration
The centrepiece of Bioscience 2015 is the creation
of the UK Clinical Research Collaboration
(UKCRC). This is a new partnership with
a shared vision to establish the position of the
UK as a world leader in contributions to clinical
research by harnessing the power of the NHS.
The UKCRC brings together the major
stakeholders that influence clinical research in the
UK and particularly in the NHS. The Collaboration
includes representatives from the main funding
bodies for clinical research in the UK, academic
medicine, the NHS, regulatory bodies and
representatives from industry and patients.
The ultimate goal underpinning this initiative
is to create a clinical research environment that
will benefit patients and the public by improving
national health and wealth and enrich
world knowledge.
The model for these centres is the National
Cancer Research Institute, set up in April 2001.
The NCRI is a partnership between the
Government, cancer research charities and
industry to streamline cancer research in the
UK. It provides a single point of access
to information on all cancer clinical trials
running in the country.
The Network is one aspect of a 10-year plan
for medical science, which will see spending
on research and development by the NHS rise
by £100 million to £1.2 billion a year.
Creating synergies between the bioscience
sector and the NHS to translate scientific
advances into improved healthcare
Another major initiative that will create
channels and carry out research to enable
the bioscience sector to build on the resource
of the National Health Service is UK BioBank.
This is the world’s largest study of the links
between genes and disease and will collect
DNA samples and health and lifestyle
information from 500,000 volunteers.
Those individuals, aged 45 to 69 at the time of
donation, will be tracked over 10 years, mainly
through their National Health Service records.
The project has funding of £45 million to set
up a number of regional centres that will be
responsible for recruiting the volunteers, along
with the national coordinating centre based in
Manchester that is overseeing the project.
The samples collected will be held in the public
domain for public benefit. Bioscience companies
will have access, but no exclusive rights will be
granted to any element of the data.
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Bringing the benefits of the genetics
revolution to patients
in Birmingham to spearhead education and
training in genetics for all health care staff.
A further example of how the Government
is creating synergies between the NHS and the
industry is an ongoing £50 million programme
to expand the use of genetic testing in the
National Health Service, with the aim of making
the UK a leader in genetics-based health care.
A number of schemes are being established
to pilot the introduction of large-scale screening
programmes, including testing people at risk
of familial cancers and the identification and
treatment of people with hypercholesterolemia,
a cause of heart attack at an early age.
A policy paper outlining the project stated,
“Genetics will permeate health care, bringing
more accurate diagnosis, more personalised
prediction of risk, new drugs and therapies.”
Treatment will be better targeted to the disease
and to an individual’s genetic profile.
Some of the funding is devoted to new
research to help convert advances in genetics
into better patient care, including £3 million
to support gene therapy research on single-gene
disorders, and £2.5 million for gene therapy
research in cystic fibrosis. A further £4 million
will be spent on gene vector production facilities
for the NHS and publicly funded researchers.
About £4 million of the funding is being spent
on pharmacogenomic research on existing
medicines, and the first university chair and
department in pharmacogenomics has been
established at Manchester University.
Money is also being spent on existing centres
of expertise, to strengthen and enable them
to diffuse skills across the NHS. Gene testing
is being integrated into clinical specialties in
hospitals and into primary care, and £18 million is
being spent on capital improvements to genetics
testing laboratories, cutting the time taken for
results to be processed.
A National Genetics Education and
Development Centre has been set up
The UK currently leads Europe in gene therapy,
carrying out 11.4 percent of global gene therapy
trials to date, compared with 66.5 percent
in the US, and Germany where 6.5 percent
of trials have taken place in third place.
Building an international centre
of excellence for Stem Cell Research
and Therapy
The UK is also taking a lead in translating
the promise of stem cells into new therapies.
In 2002 legislation was passed to ban
reproductive cloning and to allow therapeutic
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cloning under licence. As a result, the UK has
attracted internationally renowned researchers
in the stem cell field to base themselves
in Britain. To date, two licences have been
granted to create stem cells from embryos
produced by cell nuclear replacement. These
licences have gone to researchers in Edinburgh
and Newcastle, for motor neurone disease
and diabetes, respectively.
A second £1.75 million project, to engineer highthroughput embryonic stem cell-based screens
for use in drug discovery, is led by Stem Cell
Sciences Ltd. Initially, mouse stem cells will be
used, but human stem cells grown in serum-free
conditions will be incorporated into the screen
as they become available, and procedures would
be developed for using the arrays on industrystandard automated screening platforms.
Apart from creating a supportive legislative
environment and funding academic research,
the Government has provided money
to promote commercialisation of stem cells,
supporting three multi-partner bioprocessing
projects that aim to speed the translation
of early stage academic research into practical
applications. The projects involve 16 academic
and commercial partners and have a total value
of £9.9 million.
A third £3.75 million project, to be led by tissueengineering specialist NovaThera Ltd, will work
to identify the factors that control the
reproduction and differentiation of stem cells
and their interaction with biomaterials and
scaffolds. The aim is to develop intelligent
bioprocessors capable of delivering the requisite
numbers of appropriately differentiated cells,
reproducibly and automatically.
The largest project, at £4.4 million, led by
ReNeuron Ltd aims to push stem cell technology
for the treatment of neurodegenerative
diseases to the point that it is ready for
commercialisation. ReNeuron’s commercial
partners, Angel Biotechnology Ltd and
RegenTec Ltd, will develop manufacturing
processes and delivery systems, while academic
partners will offer access to patients.
Growing the Bioprocessing subsector
The projects outlined above are concerned
with developing bioprocesses for stem cell
products, but following on from the
recommendation of BioScience 2015, there has
been significant help for bioprocessing overall.
This is based on the recognition that
bioprocessing is economically important, both
in its own right as a high value manufacturing
sector, and as a critical component
of the overall biosciences sector.
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‘Achieving Critical Mass for Sustainable Growth – a 20:20 vision,’
Scotland set out a life sciences strategy to produce self-sustaining
companies with leading positions in their market niche
Bioscience 2015 highlighted a shortage
of production facilities for early stage clinical
trials saying bioprocessing is a potential source
of wealth if the sector is properly nurtured,
and a brake on the biotechnology industry
in general if it was not.
The report called for the creation of a network
of Bioprocessing Centres of Excellence to carry
out graduate training and research and
to collaborate with industry. Since the report
was published the Government has announced
funding the Bioprocessing Knowledge Transfer
Network, bioProcessUK, which will be set
up and run by the BioIndustry Association.
bioProcessUK will play a pivotal role
in delivering the Bioscience 2015 agenda.
The National Biomanufacturing Centre
The North West Development Agency (NWDA)
has been active in building on its existing
cluster of bioprocessing facilities, including
MedImmune, Chiron Inc’s vaccines plant
and Eli Lilly’s insulin plant, in Liverpool.
NWDA sponsored the building of the National
Biomanufacturing Centre in Liverpool. The £20
million centre, which opened earlier in 2005 will
fill the gap in provision for early stage process
development and clinical trials manufacture,
and will also supply biomaterials for research
and clinical trials up to Phase II. There will be
three GMP pilot plants for producing
mammalian, microbial and live virus products.
Central focus, local control
The overview of central Government initiatives
in support of bioscience may be in danger of
giving the impression of central direction only.
But as the example of the NWDA support for
the National Bioprocessing Centres illustrates,
another great strength of UK bioscience is the
diversified nature of public support. Central
Government sets the general policy direction
and creates an environment in which the sector
can flourish, but there is also strong support at
a regional and local level from local authorities,
Regional Development Agencies and the
Scottish Parliament and Welsh Assembly.
The Scottish Executive, through Scottish
Development International, its development
arm, and the Welsh Assembly through the
Welsh Development Agency (WDA), have set
policies for developing bioscience. They, and
the other Regional Development Agencies are
charged with supporting technology transfer
from research institutions and helping
institutions to work together with industry.
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For example, in ‘Achieving Critical Mass for
Sustainable Growth – a 20:20 vision,’ Scotland
set out a life sciences strategy to produce
self-sustaining companies with leading
positions in their market niche.
To move this forward, ITI Life Sciences was
created with £150 million of public money
to invest over the next ten years in near market
programmes. Its first investment of £3.7 million
brought together three Scottish companies
to develop three-dimensional, cell-based
pharmaceutical screening systems. It has
also committed £30 million to the formation
of Stirling Medical Solutions (SMS), a subsidiary
of the US company Inverness Medical
Innovations. The US company will invest
£67.5 million, alongside ITI’s investment.
SMS will use novel biomarkers (proteins that
are produced as the result of a disease process)
as the basis of home use diagnostic tests for
monitoring chronic diseases. ITI will have rights
to markets outside healthcare, including
biodefence, environmental monitoring
and food testing, and intends to use these
as the foundation of a series of vertical
market ventures.
Wales has around 250 companies in its life
sciences sector, employing around 15,000
people. The Welsh Development Agency
encourages technology transfer through
the Wales Innovation Relay Centre.
This runs a Bioscience Brokerage Event
that brings together academic institutions
with commercial partners.
Similarly, the 9 regional development agencies
in England have policies and strategies for
supporting the growth of bioscience. There
are also specific regional bodies such as the
Eastern Region Biotechnology Initiative (ERBI)
and the London Biotechnology Network (LBN),
that support bioscience clusters.
The remaining sections of this booklet
describes the activities of some of the BIA
member company in six key areas of
bioscience - Oncology, Vaccines, Bioprocessing,
Drug Discovery and Development,
Neurosciences, and Stem Cells and Tissue
Therapy. Each highlights the mix of factors - a
strong academic base, an educated workforce
with both scientific and commercial skills, high
quality infrastructure, sophisticated technology
transfer mechanisms, a receptive financial
community, and a mature and consensual
approach to regulation - that underpin and
contribute to the UK’s strong and growing
biosciences sector.
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bioScienceUK 2005
oncology
The last twenty years have seen significant advances
in understanding of the underlying cellular mechanisms
involved in cancer, leading to many new approaches
to tackling the disease.
These range from new chemotherapeutics
that target specific pathways in tumourigenesis,
to antibody or gene targeted chemoand radiotherapeutics, oncolytic viruses that
are genetically engineered to be harmless
to normal cells whilst killing tumour cells,
and cancer vaccines that aim to activate the
patient’s immune system against the disease.
Because they are aimed at such specific targets,
these new treatments have fewer side effects
than existing chemotherapies that affect both
normal and cancerous cells. This specificity
and reduced side effect profile should
allow them to be used in combination
with existing treatments.
One UK company that gives a good idea
of the range of targets that UK companies are
working with is Antisoma plc. The company
in-licenses its products from academic and
clinical research groups worldwide, and
its portfolio is a reflection of the diverse
mechanisms that are being harnessed
in a bid to improve cancer treatments.
Their lead product, AS1404, is a small molecule
that disrupts existing tumour blood vessels,
acting on the endothelial cells lining tumour
blood vessels and causing apoptosis. This is
distinct from angiogenesis inhibitors that block
development of new blood vessels.
The molecule also prompts the release of von
Willebrand’s factor, leading to blood clots
and occlusion of blood vessels, and triggers
a cascade of cytokines, culminating in the
breakdown of blood supply and the death
of tumour cells.
Another Antisoma product, AS1411, targets
nucleolin. This protein is normally found within
cells, but is expressed on the surface of
a wide range of cancer cells. AS1411 binds
to nucleolin, prompting apoptosis. Meanwhile,
another of the company’s compounds, AS1410,
kills cancer cells by inhibiting telomerase.
Antisoma also has a number of products
that illustrate the ways in which monoclonal
antibodies can be used against tumours.
The company has extensive experience with
radiolabelled antibodies, and its lead product
in this area, AS1405, delivers the radioisotope
yttrium-90 to disrupt blood vessel formation.
Another of its antibodies, R1550, binds
to MUC1, a cell membrane protein present
in a variety of tumours. The antibody
is believed to work by potentiating the body’s
immune system to recognise tumours as
foreign bodies and act against them.
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In the past eleven years the UK Gene Therapy Advisory Committee,
which oversees gene therapy trials, has approved 96 clinical trials.
Of these 68 are for the treatment of cancer.
While gene therapy was hailed as a way
of correcting the underlying basis of disease
by replacing faulty genes, it turns out that most
clinical trials of gene therapy to date have been
targeted at cancer.
One of the most advanced of these is Cerepro,
Ark Therapeutic plc’s treatment for glioma,
currently in Phase III trials in Europe. After surgery
to remove the tumour, Cerepro - which contains
the gene for the enzyme thymidine kinase is
injected into surrounding brain cells. Five days
later ganciclovir is administered. This drug reacts
with the thymidine kinase produced by the
healthy brain cells to produce a substance that
kills dividing cells. Unlike glioma cells, the healthy
cells are non-dividing and thus are unaffected.
Another UK company making headway with
using gene therapy to treat cancer is Oxford
BioMedica plc. Its product MetXia uses a
genetically modified virus to deliver the gene
for human cytochrome P450. The P450
subsequently expressed in the tumour converts
the inactive prodrug cyclophosphamide into its
active, cytotoxic, form.
Many current approaches to cancer therapy
are building on advances in immunology
to develop products that enable the body
to recognise tumours as foreign, and mount
an immune response.
For example, Oxford BioMedica's lead product
TroVax uses a viral vector to deliver the gene
for 5T4, an antigen found on a wide range
of tumours, and whose presence correlates
with a poor prognosis. The latest results
from an ongoing Phase II trial of TroVax
in metastatic colorectal cancer show all
33 patients mounted an immune response,
and 18 of 19 patients evaluated at that
point showed a clinical response.
This example demonstrates how gene therapy
is combined with vaccinology to generate
new routes to tackling cancer. Other UK
companies are developing cancer vaccines
using a variety of methods to activate
the body’s immune system.
Onyvax Ltd has a different approach to cancer
vaccines. Its lead product Onyvax-P consists
of three inactivated cell lines derived from
prostate tumors at different stages of
development. In a Phase IIa trial, patients who
showed a clinical slowdown in disease also
exhibited evidence of an immune response.
In many cases, cancer vaccines are combined
with standard treatments, chemo- and radiotherapies, and there is some evidence that
alongside their own effects, vaccines enhance
the effect of chemo- and radiotherapy.
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Hand in hand with the development of new therapies, new diagnostics
are being developed that will enable cancer to be diagnosed sooner
and by less invasive means.
The antibody-directed therapies and cancer
vaccines developed to date all target antigens
that are expressed on the surface of tumour
cells. Now a number of UK companies
are developing methods to target antigens
expressed within cells.
For example, Avidex Ltd is developing
monoclonal T-cell receptors that it claims can
target any internal tumour antigen. It is
currently working on linking a T-cell receptor
that targets the NY-ESO intracellular antigen
to a radioisotope.
Meanwhile Icelectus Ltd is developing Intrabodies
– antibody fragments that can function inside
cells. These fragments can be engineered
to cause apoptosis.
Advances in the understanding of the intricate
cellular mechanisms at the heart of
tumourigenesis are also opening up the way
for the development of orally available small
molecule drugs. Again, it is intended that these
will be administered alongside conventional
treatment, and it is hoped they will have
minimal side effects, allowing them to be
used as maintenance therapy.
A good example here is Cyclacel Ltd, which
focuses on the complex mechanisms used
to control the growth and division of cells.
While many chemotherapeutics disrupt the
cell cycle of tumour cells they also have
a toxic effect on normal cells. Cyclacel believes
it can precisely target the mechanisms whereby
cell cycle regulatory proteins, such as cyclin
dependent kinases, induce apoptosis in
damaged cells, thus impacting only tumour
cells. The company uses a structure-based
drug design approach, working with scientists
at Edinburgh University to solve the structure
of proteins that regulate the cell cycle and
then designing small molecule inhibitors.
Hand in hand with the development of new
therapies, new diagnostics are being developed
that will enable cancer to be diagnosed sooner
and by less invasive means. This will help
clinicians select the most appropriate treatments.
Proteomics is becoming particularly important
in this respect, as it makes it possible to detect
the proteins, or biomarkers, that are expressed
by tumours.
Interest in biomarkers is rising, not only for their
diagnostic and prognostic power, but also as a
means of assessing efficacy in clinical trials and
in the development of personalised medicine.
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Onyvax Ltd has a different approach to cancer
vaccines. Its lead product Onyvax-P consists
of three inactivated cell lines derived from prostate
tumors at different stages of development.
In a Phase IIa trial, patients who showed a clinical
slowdown in disease also exhibited evidence
of an immune response.
For example, Chroma Therapeutics Ltd,
a specialist in chromatin biology, is developing
proprietary biomarker technology to identify
patients who are appropriate for clinical trials
and to monitor response to therapy. Chromatin
from tumors is found in the blood of cancer
patients, and Chroma has rights to chromatin
biomarkers discovered by its founding scientists
Tony Kouzarides and David Allis.
Similarly, Onyvax has discovered a series of
biomarkers that are correlated with a patient’s
ability to mount an immune response to its
prostate cancer vaccine. The company is part
of a research consortium, the European
Network for the Identification and Validation
of Antigens and Biomarkers in Cancer and
Their Application in Tumour Immunology
that aims to identify biomarkers that would
indicate if patients are likely to benefit
from immunotherapy.
This snapshot of the range of approaches
UK companies are taking to find new treatments
for cancer highlights the strong foundation
they have from academic and clinical researchers.
Apart from a high level of government
investment there is also significant research
funding from charities, most notably Cancer
Research UK, the largest cancer charity in Europe.
The charity has a well-established technology
transfer arm, Cancer Research Technology Ltd,
which works to ensure the research it funds
is translated into improved treatments.
The charity also carries out fundamental
research projects that inform the development
work carried out by companies.
For example, it recently launched a £500,000
project to use RNA interference (RNAi)
technology to systematically uncover the
function of all human genes, with the ultimate
aim of identifying all genes involved in cancer
that would be good drug targets.
The project will use RNAi’s ability to specifically
switch off individual genes while leaving others
unaffected, in order to find out how a
particular gene might contribute to the
development of cancer. At the same time
the researchers will apply RNAi to cancer
cells to try to find the genetic essence of
a malignant cell. After bombarding cancer
cells with RNAi, they will be screened for
any that have reverted to type and become
normal again, thus identifying genes involved
in proliferation. In essence, this research
should uncover precisely what needs
to be removed from a cancerous cell
in order to make it normal again.
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bioScienceUK 2005
vaccines
Advances in understanding of the immune system,
coupled with the tools and techniques of genetic
engineering, have expanded the horizons of vaccinology.
The field has moved on from one circumscribed
by the ability of an attenuated or killed form
of a virus or bacteria to elicit an immune
response and thus prevent a dozen
or so infectious diseases.
Now immunotherapeutics are being designed,
which apart from combating infectious diseases
that cannot be controlled by traditional
vaccines, can prime the immune system to fight
cancer, provide long term control of high blood
pressure, or help an addict break an addiction.
Not only are the numbers and types of diseases
that vaccines are active against increasing, but
production and manufacturing techniques are
improving too, leading to safer and more
potent products, which are easier to transport
and administer.
The UK has an extremely strong and
well-established vaccines production and
manufacturing base, featuring most of the
leading lights of the pharmaceutical sector.
The country also has many high calibre
academic and clinical institutions, carrying out
world-leading research in the field. Drawing
on the resources and intellectual capital of
these two is a range of biosciences companies
that are working a fascinating array
of different approaches to produce
new immunotherapeutics.
The largest of these, Acambis plc, shot to fame
when it won a US government contract to
develop and manufacture 182.5 million doses
of smallpox vaccine as part of Project Bioshield.
The contract called for the company to use cell
culture techniques to develop a product with
equivalent efficacy to Dryvax, the vaccine
used during the world smallpox eradication
programme. Dryvax is produced in the skin
of calves, a method that is no longer
considered safe.
However, Acambis is also developing a range
of vaccines based on a platform technology,
ChimeriVax. This uses a live Yellow Fever virus,
which has been genetically manipulated so it
is unable to replicate, as the vector for genes
encoding surface antigens found on the
protein coat of other viruses.
Acambis is using the ChimeriVax technology
to develop vaccines against West Nile disease,
Dengue fever and Japanese Encephalitis.
In 2003 it became the first company to take
a West Nile disease vaccine into the clinic.
Meanwhile the Japanese Encephalitis vaccine which is expected to be safer and require
fewer doses than existing vaccines against the
disease - is due to enter Phase III trial during
2005. The Dengue fever vaccine, which
protects against all four serotypes,
has completed Phase I.
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Microscience’s oral typhoid vaccine based on this
technology is now ready for Phase III trials. The
company is also working on vaccines for Traveller’s
diarrhoea, hepatitis B, meningitis B and neonatal
group B streptococcus. Microscience also has
a collaboration with the US Navy to develop
an oral vaccine against anthrax.
The ChimeriVax platform is an exemplar of
how viruses can be manipulated to remove
virulence genes, whilst retaining or adding in
genes for surface antigens that stimulate the
production of antibodies.
This raises the question of how to pinpoint
and rank virulence genes and immunogenic
genes, and UK companies have developed
different technologies to do this. For example,
Microscience Ltd’s Signature Tagged
Mutagenesis technology allows for the
simultaneous identification of virulence genes.
The company has built on this to develop
an attenuated Salmonella as the vector
for genes encoding for antigens for other
disease-causing bacteria. The transgenes
are inserted where one of the Salmonella’s
virulence genes has been removed, ensuring
stable incorporation. A promoter sequence
is inserted next to the transgene that ensures
the gene is activated in the body within
antigen presenting cells. This method
of delivery induces both a mucosal
and a systemic response, and can elicit
a powerful immune reaction to antigens
that are weakly immunogenic in their
native forms.
Oxxon Therapeutics Ltd has developed
another approach to elicit immune
responses to antigens that do not normally
prompt an immune reaction. Called
PrimeBoost, the company’s method involves
using two different, non-replicating vectors
to deliver the same antigen(s). The antigen
|is first administered by a DNA plasmid vector,
followed by a booster in which the antigen
is delivered by modified vaccinia Ankara.
This has been shown to provoke
an unusually high level of cytotoxic
T-lymphocyte activity. The plasmid DNA
plus antigen provokes a modest, but focused
response. This is amplified by presenting
the same antigen in a different context –
that is in the presence of other viral proteins
–sending out a danger signal that prompts
the pre-primed T-cells to react.
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UK companies are active in devising new ways of
formulating vaccines to overcome handling problems,
such as the need to keep products refrigerated.
Oxxon has used the technology to develop
vaccines to treat hepatitis B and melanoma,
both of which are in Phase II trials.
The company also has an HIV immunotherapy
in preclinical development that carries
the genes for multiple antigens and epitopes
that represent HIV strains infecting
an estimated 91 percent of people who are
HIV-positive. The aim is to get the immune
system to recognise and destroy cells infected
with the HIV virus. It is thought this could
be a complementary therapy to reduce the
number of anti-retroviral drugs that patients
must take to prevent HIV infection progressing
to AIDS.
Oxxon also has rights to another HIV PrimeBoost
vaccine, plus malaria and tuberculosis vaccines
that are being developed by academic partners
and have charitable funding.
The vaccines being developed by Acambis,
Microscience and Oxxon all use viral vectors
to deliver the antigen genes. One company,
Powder Med Ltd is developing vaccines made
of antigen genes only. This so called ‘naked
DNA’ consists of a powder formulation of DNA
with a gold coating that is administered using
a needleless injection system that delivers the
antigens directly to Antigen Presenting Cells
in the epidermis.
The DNA then expresses the encoded antigens,
which are presented by the antigen presenting
cells to lymphocytes, initiating a T-cell
mediated immune response.
PowderMed’s lead product, for treating
non-small cell lung cancer, entered clinical
trials in September 2004. The vaccine consists
of DNA encoding for NY-ESO-1, an antigen
that is expressed on the surface of a number
of tumours. The company is developing
DNA vaccines against genital warts,
HIV and hepatitis B also.
A potent example of how far vaccines have
moved on from their roots in preventing
infectious diseases is Protherics plc’s vaccine
for treating hypertension.
Hypertension is a major risk factor for heart
attacks and strokes. Although it can be
controlled with drugs such as angiotensin
inhibitors, they must be taken daily, and since
high blood pressure requires long-term control,
compliance is poor.
The Protherics’ vaccine is designed to produce
antibodies that bind to angiotensin, neutralising
its effect. In a Phase IIa study all 17 patients
developed antibodies, and there was a
subsequent reduction in levels of another
hormone, aldosterone, whose production
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is dependent on angiotensin. The company
is now working to optimize the formulation
to increase antibody production. The aim
is to develop a long-acting vaccine involving
primary immunisation, followed by booster
injections once or twice a year.
But the products that perhaps best demonstrate
the dramatic extension of the range of health
problems that vaccines can now deal with are
Xenova plc’s anti-addiction vaccines. TA-CD is
a cocaine derivative conjugated to recombinant
cholera toxin B. This generates antibodies that
bind cocaine in the bloodstream, preventing
it crossing the blood brain barrier and thus
blocking ‘high’ production. TA-NIC uses
a similar construct to prevent nicotine
reaching the brain.
The rationale is that blocking the effects of
these drugs will help addicts who are trying
to break addictions because - if they relapse
and use them again - they will not experience
any pleasurable effects.
UK companies are active also in devising new
ways of formulating vaccines to overcome
handling problems, such as the need to keep
products refrigerated.
Cambridge Biostability Ltd (CBL) is using
its glass stabilising technology to develop
a vaccine in a temperature-stable liquid form
for use in developing countries, where there
is often no ‘cold chain’ infrastructure to keep
vaccines refrigerated. CBL’s technology
produces vaccines that are stable up to
55 degrees centigrade, removing the need
for refrigeration.
While freeze-dried formulations of some
vaccines are available that can be stored
at ambient temperature, they must be
reconstituted, thus introducing a risk
of contamination. CBL intends to package
its vaccines in ready-to-use disposable
injectors that can be administered by staff
with minimal training.
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bioScienceUK 2005
stem cells
and cell therapy
Stem cells are the key to a new era of regenerative medicine in which
the body’s own biological repair system will be harnessed to create
new cells and organs to replace those that are compromised through
This law was not passed opportunistically to
old age, death or accident.
This is a tantalising and enticing prospect,
but stem cells have also elicited unprecedented
levels of controversy for a branch of science
that is, in many respects, preliminary.
Having said that, stem cell therapy has been
used for the last thirty years in bone marrow
transplants. But this, and other current
treatments use adult stem cells that, it is
believed, can only produce a limited range
of cell types.
In 1998 the first embryonic stem cells were
isolated. These cells, because they are
pluripotent, have the potential to be a source
for culturing any cell in the body. However,
it is the prospect this raises of using human
embryos – created through in vitro fertilisation
or therapeutic cloning – as the source of stem
cells, which is the focus of ethical and religious
objections to stem cell research.
In 2002, the UK became the first country to
pass a law approving therapeutic cloning under
licence – whilst at the same time strengthening
existing legislation that makes reproductive
cloning a criminal act.
allow the UK to step into the vacuum created
by ethical and religious objections elsewhere,
but was based on more than two decades of
public debate that was prompted by the birth
in the UK of Louise Brown, the world’s first
test tube baby.
The subsequent investigation into the issues
surrounding in vitro fertilisation led to the
creation of the Human Fertility and Embryology
Agency (HFEA) to oversee the act of the same
name passed in 1990. This allowed research
on embryos that were created during IVF but
were unsuitable for implantation. Following
the isolation of the first human embryonic
stem cells the law was amended to allow
research on embryos for the development of
stem cell therapies, and extended still further
in 2002, to allow therapeutic cloning using
eggs donated during IVF treatment. Explicit
and informed consent is needed from donors
of embryos, and of eggs for use in therapeutic
cloning, allowing them to be used for research.
The clear and stable regulatory framework
has attracted renowned researchers to come
to the UK from overseas and left the way
clear for publicly-funded research in the field.
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As a result, scientists in the UK are now rising
to the challenge of finding safe, effective and
scalable approaches to fulfilling the therapeutic
promise of stem cells.
Although much basic research still needs
to be done before stem cell therapies are
ready for commercialisation, a number of
companies have been spun out from academic
laboratories, most of which are concentrating
on developing stem cell research tools
and processing techniques.
The UK Government has followed up on its
vision in legislating to allow therapeutic cloning,
with some significant grants and other initiatives
to promote the field, with £60 million of funding
earmarked for stem cell research from 2002
to 2006.
This has generated some significant results.
Following the decision to allow research on IVF
embryos that are unsuitable for implantation,
the first human embryonic stem cell line was
grown in the UK at the stem cell Laboratory
at King’s College London. The head of the
laboratory is Stephen Minger who was drawn
from the US to work here because of the clear
regulatory framework.
His laboratory followed this breakthrough with
the development of an embryonic stem cell
line with the mutation for cystic fibrosis,
opening a new route to develop treatments
for the inherited disease.
The cystic fibrosis line is being used to study
how the single gene defect that causes cystic
fibrosis affects cell function. It will also be used
to screen for new drugs and to research gene
therapies. As animal models do not fully repeat
all aspects of the disease, this cell line provides
a potent example of the contribution stem cell
research is beginning to make to the discovery
and development of conventional therapies.
The two stem cell lines, along with others
developed at King’s College and elsewhere will
be deposited in the UK Stem Cell Bank, the first
such in the world, which opened in May 2004.
The adult, foetal and embryonic cell lines held
in the bank are ethically approved and quality
controlled. They are available for use by
scientists worldwide, providing their research
fulfils the required criteria. The bank’s code
of practice sets out donor information and
informed consents that must be given in relation
to embryo or egg donation and the licences,
approvals, and accreditation needed both
to deposit stem cell lines and to use them.
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Another UK company that has made hugely
significant progress in terms of translating stem
cells into treatments is ReNeuron Ltd. The company
is aiming to begin clinical trials this year using
a neural stem cell line to treat stroke.
Key motivations behind the formation of the
Stem Cell Bank are to ensure all lines are from
ethical sources, and to reduce the need for
individual researchers to generate their own
stem cell lines, reducing the overall use of
human embryos.
Stem Cell Sciences is working on technologies
to permit the generation and genetic selection
of unlimited quantities of highly purified stem
cells and their differentiated progeny for use
in genetic, pharmacological and toxicological
screens.
While the lines themselves have no intellectual
property rights attached to them, patents
could still be granted around products derived
from them.
A further company, Odontis Ltd, has
demonstrated that tooth development can
be initiated by stem cells, and is working
to develop stem cell implants that will grow
and replace missing teeth.
In 2004, the Human Embryonic Stem Cell
Group at the Centre for Life in Newcastle
was granted the first approval to carry out
therapeutic cloning, in a research project that
aims to treat diabetes by growing replacement
islet cells.
Subsequently, a second therapeutic cloning
licence was granted to a team at the Roslin
Institute in Edinburgh, for research into motor
neuron disease.
While research such as this is extremely early,
UK companies are beginning to commercialise
aspects of stem cell research. Most are
concentrating first on developing tools.
For example Cerestem Ltd is isolating the
growth factors that stimulate the proliferation of
specific stem cell populations, whilst ReInnervate
Ltd is developing neural stem cell-based assays
for studying drug toxicity and activity.
CellCentric Ltd is taking an entirely different
approach. Regardless of function every cell
in the adult body carries the same DNA.
CellCentric’s expertise is in epigenetics –
or the genes that control how a cell’s fate
is regulated. The company is still early stage,
but its ambition is to develop small molecule
inhibitors of these master control genes,
and thus reprogramme cells.
In many respects, stem cell companies are
building on an already strong base in tissue
engineering and cell replacement, which
includes expertise in areas including
biomaterials, methods for proliferating and
differentiating cells, and understanding of
the role of proteins such as angiogenic factors,
growth factors and differentiation factors
in driving development of particular cell types.
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One of the leading companies in this field
is Intercytex Ltd, which has two cell therapies
in clinical trials. The company does not work
with stem cells, but with whole human cells.
Its lead product is intended to stimulate
healing of chronic wounds, the second,
comprising dermal papillae cells,
is for treating male pattern baldness.
Another tissue engineering company is
RegenTec Ltd, a spin-out from the tissue
engineering group at Nottingham University.
It produces tissue by seeding isolated cells
onto polymer scaffolds, and also provides
tissue engineering services.
Meanwhile, CellTran Ltd in Sheffield has
devised ways to grow a patient’s skin cells
outside the body on a polymer layer
containing factors that accelerate the
expansion of keratinocytes.
The companies working in the stem cell field
are all very reliant on academic partners.
To help foster these relationships and promote
synergies in the stem cell base, stem cell
networks have been set up in Scotland and
in the area of the east of England centred on
Cambridge. The Scottish Stem Cell Network
and the East of England Stem Cell Network
link all the academic, clinical and industrybased research groups in their regions.
Earlier this year the Scottish Stem Cell network
staged its first international conference in
Edinburgh, bringing together leading
researchers from the UK, mainland Europe,
the US and Asia.
While some stem cell companies have received
venture funding, the science is as yet too
immature to attract major private investment.
In the latest move to build on the country’s
strengths in stem cells UK biotech leaders
have set up the UK Stem Cell Foundation.
This will be modelled on the research charity,
the Wellcome Trust, and aims to raise £100
million to plug the funding gap between early
stage research and clinical proof of concept.
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bioScienceUK 2005
neuroscience
The living brain is no longer a closed system – functional
magnetic resonance and other high-resolution imaging
techniques make it possible to lift the lid and study what
is happening inside in real time.
This is underpinning some huge strides in
neurosciences, from assessing developmental
deficits in the brains of premature babies,
to pinpointing cellular mechanisms involved
in memory and learning, monitoring how
therapeutics affect the brain, and following
the progressive deformation of brain structures
in neurodegenerative diseases.
At the same time neurogenetics is identifying
genes that are involved in central nervous
system (CNS) disorders. This is leading to the
development of animal models for studying
disease processes and testing drugs, providing
targets for drug discovery, and enabling
researchers to uncover the precise biology
of CNS disorders.
The UK has many world-ranking academic
and clinical institutions working on many
aspects of neurosciences. There is also a broad
array of charities promoting patients’ interests
and funding research into CNS disorders. These
include Alzheimer’s Disease, Parkinson’s Disease,
Motor Neurone Disease and Multiple Sclerosis
charities, each of which have significant
influence in directing research in their field.
For example, the Epilepsy Research Foundation
recently announced a series of grants, including
one to scientists at Edinburgh University to use
in vitro models to identify how neurotransmitters
are released from epilepsy specific cells in real
time, and another to researchers at Glasgow
University who will use high resolution imaging
to monitor how anti-epileptic drugs work in an
animal model, thus providing an anatomically
precise evaluation of a drug’s effects over time.
As is the case with many CNS drugs, it is not
known precisely how current anti-epileptic
drugs work. This research should elucidate that,
and at the same time generate more precise
targets. The hope is that drugs designed
against these targets will have far greater
specificity, since rather than reducing general
brain excitability, only neurones undergoing
epileptic fits would be affected.
The epilepsy example highlights how new
tools such as imaging and neurogenetics
are removing some of the road blocks in CNS
drug development. The market for CNS drugs
is now the fastest growing sector of the
pharmaceuticals market. However, many CNS
disorders remain untreatable and there is much
room for improvement in terms of efficacy and
side effect profile of some of the drugs on the
market currently. UK companies are working to
translate the huge progress in basic research in
neurosciences into new and improved therapies.
Getting a CNS drug through discovery and
development costs more and takes longer than
in other therapeutic areas. The availability of
new targets and more powerful animal models
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should speed up the process, but significant
obstacles remain, such as developing drugs
for chronic use that can be administered by
an amenable route and are able to cross the
blood brain barrier.
One company, Pharmidex Ltd is using new
CNS targets and animal models to provide
services that are tailored for CNS drug
discovery and development. These range
from target identification and validation where
targets are screened for both neurochemical
and behavioural measures, to in silico and in
vitro screening for assessing a compound’s
ability to cross the blood brain barrier,
to early assessments of pharmacokinetics
of compounds in the brain and the side
effect profile.
The higher risk profile around developing
CNS drugs, and the more preliminary nature
of much of the research, means there are not
as many companies involved in this activity
as there are in other fields such as the
development of cancer and cardiovascular
treatments and vaccines.
But evidence that investors are warming
to the field came recently when Proximagen
Neurosciences plc went public on the
Alternative Investment Market in London,
raising £12 million, having raised just
£400,000 in seed capital previously.
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The company has turnover from providing
drug discovery services in neurodegeneration
and neuroinflammation, and is now
in developing four treatments for Parkinson’s
Disease. In the lead programme, PRX1
comprises a number of derivatives of the
dopamine replacement therapy levodopa.
In contrast to levodopa, which has a short half
life and poor bioavailability, these analogues
are stable, and show improved absorption and
increased duration of action. It is believed that
this will reduce the incidence of dyskinesia,
the involuntary movements that are a major
side effect of levodopa.
Proximagen’s second product, PRX2, is designed
to be used as a combination therapy with
levodopa. In animal models the compound
suppresses dyskinesia without inhibiting the
activity of levodopa. A third product, PRX3,
prevents or slows neuronal cell death by
interfering with an (unspecified) pathway
involved in the pathology of Parkinson’s
Disease, while PRX4 is a protein that is
implicated in control of inflammatory changes
that are involved in the degeneration
of dopaminergic neurones.
Another company focusing on Parkinson’s and
Alzheimer’s diseases is Zyentia, a protein-folding
specialist. The aim is to discover proteins that
inhibit the early stages of protein aggregation
in Parkinson’s, Alzheimer’s and other diseases
that are characterised by amyloid deposits.
Although amyloid deposits are a distinctive
feature of these diseases, Zyentia argues that
they are the result, rather than the cause of
the pathological process. The company focuses
on the initial stages of amyloid formation,
which is when, it believes, the cytotoxic effects
occur. For example, Zyentia points to increasing
evidence supporting the active involvement
of misfolding of the protein alpha-synuclein in
the promotion of cytotoxicity, and subsequent
neorodegeneration, in Parkinson’s disease.
Zyentia’s skills in protein folding enable it to
take any protein sequence and predict which
areas are most important in causing it to
aggregate. The company has assays for
measuring protein folding in vitro, and also
cell-based assays that can be used to assess a
compound’s ability to control aggregation and
inhibit cytotoxicity.
Another company, Senexis Ltd is also
developing inhibitors of amyloidosis. It has
discovered a novel class of inhibitors that can
block and reverse the process. Amyloid is
made of ribbon like beta-amyloid peptides that
are ‘sticky’ on both sides and hence clump
together. Senexis’ Beta-sheet breakers bind to
one side of the ribbon, preventing aggregation
from occurring.
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Zyentia and Senexis are both at the early stage
of discovery and development. One company
further down the line with a novel treatment
for Parkinson’s Disease is Vernalis plc, which
at the end of 2004 licensed the Phase I
programme to the US company Biogen Idec
Inc, in a deal potentially worth $100 million.
The lead compound V2006 is a selective
adenosine A2A antagonist, which is designed
to restore the imbalance of neurotransmitters
caused by the loss of dopamine, but without
the debilitating side effects - such as nausea
and dyskinesia – caused by existing dopamine
replacement or enhancement treatments.
Adenosine also plays a role in motor coordination
and movement control and, as dopamine and
adenosine co-exist in the brain, it is thought
that blocking adenosine will make dopamine
more effective.
Two other UK companies are coming at the
problem of neurogenerative disease from a very
different angle – selecting traditional remedies,
and deconstructing them to determine the
mode of action and find the active constituents.
Phytopharm plc is a botanicals specialist, taking
herbal treatments and turning them into licensed
pharmaceuticals. The company’s compounds
for treating CNS diseases are based on
a traditional tonic for the elderly in use
in parts of Asia.
Phytopharm’s initial interest in the tonic arose
from a small double-blind study in patients
with mild to moderate senile dementia,
which demonstrated a significant improvement
in cognitive function with the tonic.
The company then began a programme
of research into the mode of action,
and developed a library of compounds
This has led on to programmes in Alzheimer’s,
Parkinson’s and Motor Neurone diseases.
The Alzheimer’s Disease compound Cogane,
currently in Phase II, has been shown to protect
against beta amyloid and glutamate damage,
to reverse the decrease in neuronal growth
factors and reverse neuronal ageing. In animal
models it restores learning and memory ability.
Similarly, ReGen Therapeutics plc is developing
an Alzheimer’s Disease product, Colostrinin,
that is derived from ovine colostrum, a prolinerich poly peptide complex. A 106 patient trial
in Poland completed in 2002 demonstrated
efficacy, and since then the company has been
working with scientific partners to uncover
the active components of Colostrinin
and determine their mode of action.
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Ionix Pharmaceuticals Ltd is a pain specialist,
focusing on calcium and sodium ion channel
targets to develop analgesics tailored to treat
the pain caused by specific chronic diseases
such as multiple sclerosis and diabetes.
The research shows that different constituents
of Colostrinin have the ability to reduce
oxidative stress, to encourage neuronal cell
production, prevent apoptosis and inhibit
beta amyloid aggregation.
ReGen recently produced data showing
Colostrinin protects dopaminergic neurones
against degeneration and is now planning to
test it in an animal model of Parkinson’s disease.
Pain, of all forms and causations, remains an
area of huge unmet medical need. Increased
understanding of the molecular pathology of
pain and new targets promises to lead to the
development of novel analgesics.
Similarly, CeNeS Pharmaceuticals plc is
developing CNS 5161, a modulator of the
NDMA ion channel that is up-regulated
in chronic pain states, for the treatment
of neuropathic pain.
A significant breakthrough in the treatment
of severe and chronic pain came earlier this
year when GW Pharmaceuticals plc received
approval from Canadian regulators for Sativex,
a cannabis extract that is delivered as an oral
spray, for treating pain in multiple sclerosis.
This is the first cannabis-based product
to be registered as a pharmaceutical.
While the initial approval is for the treatment
of pain, GW’s clinical trials data show Sativex
also improves other symptoms of multiple
sclerosis, including spasticity. In addition,
the company has data indicating the product
modifies the disease process.
GW has carried out clinical trials that show
Sativex relieves pain caused by other diseases,
including cancer and rheumatoid arthritis.
In the past year the general public has been
inspired by the therapeutic potential of stem
cells. A leading UK company in the field,
ReNeuron, is in the final stages of getting
approval for the first clinical trial of its neural
foetal stem cell line in treating the effects
of stroke.
The company is also developing neural stem
cell lines for treating neurodegenerative
diseases, including Huntington’s disease
and Parkinson’s disease, which are both
effective in animal models. The cell lines
are generated using a fully controllable
system for producing cell lines that are
not tumourigenic and have stable,
normal genomes.
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THE VOICE OF UK BIOSCIENCE
The BioIndustry Association (BIA) is the trade association for innovative
enterprises in the UK’s bioscience sector. We monitor and influence
the national and EU regulatory and legislative environment to ensure
the continued and future competitiveness of UK bioscience. Members
have a voice in shaping the industry's future and setting the BIA’s
policy agenda. We have exclusive networking events, top-level
briefings and alerts, best practice seminars and a weekly newsletter.
Discounts to global industry events, journals, insurance and security
solutions are offered.
For further information call:
+44 (0)20 7565 7190 and ask for Membership Services
or visit www.bioindustry.org
6/6/05
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bioScienceUK 2005
drug discovery
and development
The past decade has seen an explosion in the number and
in the variety of technologies for drug discovery and development.
The revolution began with the advent of
combinatorial chemistry and high throughput
screening, which has turbo - charged traditional
small molecule discovery. This was followed by
the rise of genomics, proteomics, metabolomics
and other ‘omics’ that are generating
unprecedented numbers of new targets.
Underlying these are huge advances in
chemoinformatics and bioinformatics that
make it possible to accumulate, interrogate and
manipulate the vast databases these individual
technologies generate.
The confluence of biology and information
technology has given rise to a new discipline,
“systems biology”, which dissects out the
components, identifies how they operate and
relate to each other, and thus understands how
they act and interact to produce a living organism.
At the same time advances in the information
sciences, coupled with greater knowledge of
protein structures, have transformed structurebased drug discovery from an expensive
specialty to a mainstream activity.
This explosion in the number of technologies
supporting drug discovery and development has
prompted the formation of many and varied
bioscience companies around proprietary drug
discovery and development platforms generated
in UK universities and other academic institutions.
Some companies are exploiting proprietary
technologies for in-house programmes, others
operate as service providers, while others have
a hybrid business model, providing services as
a source of revenue whilst using the platform
technology to develop their own portfolios.
What follows is intended to illustrate the huge
number of drug discovery and development
technologies and services provided by UK
companies - and demonstrate the contribution
they can make to every stage of producing a
new therapeutic - from laboratory to bedside.
However, in the space available it is only
possible to give a flavour of the diversity
and innovation on offer.
Structure-based drug design was first proposed
in the 1980s to replace the ‘random’ screening
of chemicals with a ‘rational’ approach. But it
is only in the past five years with a dramatic
fall in the cost of computing power and
advances in software and graphics that
the technique has come into its own.
Armed with a protein crystal structure it is now
also possible to do virtual screening, using
‘docking’ programmes that score predicted
ligand-protein binding affinities. Chemical
structures can also be assembled within
active sites in silico.
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Astex Technology Ltd has, in effect, industrialised the
structure-based drug design process. The company
has developed a high throughput X-ray crystallography
system for solving crystal structures that goes from
crystal to structure automatically, cutting the data
analysis time from months to days. From here it
selects compounds that are compatible with the
active site. The structure of these compounds is then
screened to pick out low molecular weight hits that
do not have sufficient affinity to be picked out in
high throughput screens. Astex was first to solve the
structure of P450 enzymes that are involved in drug
metabolism, making it easier to design drugs rationally
with reduced metabolic and toxicity problems.
De Novo Pharmaceuticals Ltd’s Skelgen
technology is a structure generator,
incorporating synthetic chemistry know-how
that makes it possible to generate chemical
entities within protein target sites in silico and
provides reaction chemistry for their
preparation. The technology has the benefit
that it can lead to original molecular structures
against disease targets, whist ruling out
molecules that are too complicated to be
synthesised commercially.
The facilities supporting structure-based drug
design in the UK will be enhanced significantly
in 2007, when a new synchrotron, Diamond, is
due to be commissioned in Harwell, near
Oxford. Diamond will have the power to
elucidate structures that cannot be determined
by other methods, because the protein crystal
is large and complex, or alternatively, very
small. A good example is membrane proteins.
Although 30 per cent of gene products are
membrane proteins and more than 50 per cent
of marketed drugs target them, there has been
relatively little progress to date in determining
their structure. Diamond will have the ability
to probe these complex proteins.
The ‘omics’ have lived up to their promise of
generating many new targets, but there has
been some dissatisfaction with their quality, and
this is leading on to more refined approaches
that can sort the wheat from the chaff and
single out tractable and drugable targets.
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Beyond screening a growing number of companies offer
comprehensive discovery services in which they take hits
and move them through to validated leads.
For example, VASTox plc, has reversed the
paradigm of finding genes and then subjecting
them to high throughput screening. It uses
a high throughput screen-to-gene approach
in which chemical libraries are screened in vivo,
first in zebrafish, then in fruit flies. This allows
the simultaneous identification of drugable
targets for human disease and of molecules
that modulate them. Using the VASTox system
it is also possible to examine what a particular
molecule does to other genes on the same
pathway, or across other pathways.
Beyond screening a growing number
of companies offer comprehensive discovery
services in which they take hits and move
them through to validated leads. One such
is BioFocus Dicovery Ltd, an integrated drug
discovery services company whose capabilities
extend from gene to development candidate,
taking in high throughput screening, assay
development, medicinal chemistry, parallel
synthesis and chemo- and bioinformatics.
The company also designs and synthesizes
a range of focused chemical libraries aimed
at both kinase and G-Protein coupled receptor
proteins that are implicated in a broad range
of disease processes.
Focusing further down the discovery process is
CXR Biosciences Ltd, whose services are based
on preclinical models for assessing absorption,
distribution, metabolism and excretion (ADME)
characteristics of compounds that were
developed in a joint research programme
between researchers at the University of Dundee
and a consortium of 10 leading pharmaceutical
companies. The company says its models are
more rapid, more data rich and more relevant
to man than existing animal models.
Meanwhile, Physiomics plc provides
an example of how “systems biology”
is translating into practical applications
with its in silico system, which integrates
pharmacokinetics and pharmacodynamics.
This enables the company to predict how
much of a compound will get to a disease site,
and create representations of what happens
inside a cell when the drug is administered.
This dual approach enables optimum doses
to be predicted and could provide
an interpretation of why apparently
promising compounds fail in the clinic.
Xceleron Ltd has different approach
to elucidating pharmacokinetics in advance
of Phase I. It is pioneering microdosing,
a technique that has the potential
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to circumvent most of the animal studies that
are currently required before drugs are tested
in man. This involves administering
radiolabeled drugs at microdoses not exceeding
100 micrograms and subsequently assessing
ADME characteristics using its Accelerator
Mass Spectrometer.
The company recently validated the technology
in five marketed drugs. Both the FDA and
European Agency for the Evaluation of Medicinal
Products (EMEA) have set out guidelines indicating
they will allow microdosing in man in advance of
the full range of animal testing required currently.
Other companies provide a myriad of process
and manufacturing services for both small
molecule drugs and biopharmaceuticals.
For example, in the antibody field there is a
broad range of supporting service companies.
One of the longest standing, AERES Biomedical
Ltd, has successfully humanised more than two
dozen antibodies over the past 13 years, of
which several are now in clinical development.
Fusion Antibodies Ltd provides a range of custom
antibody production services. The company can
take a client’s antigen gene sequence, clone the
gene of interest, express and purify the protein
and then generate antibodies.
Another company Haptogen Ltd is able to
engineer therapeutic antibodies to haptens,
small antigens that up to now could not be
targeted by antibodies. Many haptens are
central to cell-to-cell signaling processes that
play a role in triggering disease or infection.
The company has cloned a series of large
antibody libraries and isolated anti-hapten
antibodies to a range of targets.
BioAnaLab Ltd has particular expertise in the
clinical development of monoclonal antibodies,
and has developed proprietary assays for
measuring serum concentrations of monoclonal
antibodies and the associated immune system
response. The company applies these
techniques to other protein-based
therapeutics also.
Beyond drug discovery and preclinical testing
the UK has an impressive resource in clinical
development. This ranges from multinational
contract research organisations such as
Quintiles, Inversk and BioReliance, to smaller,
specialist consultancies such as Endpoint
Research UK Ltd, a contract research
organisation that specialises in oncology
and respiratory diseases.
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Many biotechnology companies rely on
outsourcing of some, or all, elements of drug
development. Fulcrum Pharma Developments
Ltd manages all aspects of the outsourcing
process, from preclinical development of an
optimised lead, to Phase III trials, manufacturing
and approval. The company also provides
consultancy services, such as clinical trial design.
One of the largest clusters of clinical trials
services companies in Europe is in Scotland.
Here there are over 40 CROs, backed
by a further 200 companies which supply
supporting services. This includes several
drug delivery specialists with distinctive
technologies. One such is Controlled
Therapeutics Ltd, which has developed
a hydrogel polymer delivery system that
allows precise delivery of drugs over
an extended period of time. The technology
is suitable for biopharmaceuticals, where unlike
other delivery methods such as pegylation,
there is no chemical modification of the drug.
As can be seen, the UK has an
abundance of drug discovery and
development services companies.
Supporting the sector is a strong
base of academic and clinical
research. In combination this
is translating into new drugs and
diagnostics leading to significant
improvements in healthcare.
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bioScienceUK 2005
bioprocessing
Moving a biopharmaceutical from early discovery through to the end of
clinical trials is a long, fraught and expensive business. It is a curiousity then
that one of the most critical elements – that of devising a safe, reproducible,
scalable and economic method for making the end product – rarely gets
a mention in company press releases and progress reports for analysts.
Yet bioprocessing is at the heart of the
biosciences industry, and in many senses
the fundamental properties of a biologic
depend on the bioprocess used to produce it.
Manufacturing even the least sophisticated
biological medicine is fundamentally different
and far more complex than manufacturing
small molecule pharmaceuticals, and relies
on different skills sets and process equipment.
The hand-in-hand nature of product and process
means that devising a GMP manufacturing
process for a biologic is a critical part of the
development process, and not an add-on at the
end. However, given the high attrition rate of
drugs in development, companies may be loath
to dedicate too many resources to manufacturing
issues early on in development.
of their products to market, bioprocessing is
a growth industry. Establishing robust and
safe manufacturing processes for novel
treatments such as gene and cell therapies that
are currently in development will require a high
level of innovation in bioprocessing techniques.
Similarly, one implication of developments
in pharmacogenomics – which promises
medicines targeted at genetic subsets of the
population – is that bioprocessing will have
to develop techniques for mass customisation
of biopharmaceuticals. The same is true
of tissue replacement products.
Innovation is also needed to drive down
the cost of established processes and reduce
the price of protein drugs, many of which are at
(some would say beyond) the limits of economic
acceptability. In contrast to other forms of
manufacturing this does not mean increasing
the scale of operations, but looking for ways
to improve throughput and boost yields.
The UK has a vibrant and growing bioprocessing
subsector, and in the past five years the
Government has funded a number of initiatives
to promote further expansion and ensure it
is able to innovate - both to continue to meet
the process development and manufacturing
needs of UK-based companies - and to attract
overseas contracts and inward investment.
The UK bioprocessing subsector is economically
important, both in its own right, as a high
value manufacturing sector, and as a critical
component of the biosciences sector overall.
Biologics now account for 15 percent of
registered drugs and with that proportion
due to increase as biotech companies get more
The bioscience sector currently comprises of
over 480 companies, employing 26,000 people,
and generating annual revenues of £4 billion.
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One of the biggest contract bioprocessing manufacturers
in the UK is Avecia Biotechnology. The company has
two business units, Avecia Biologics, which does mammalian and microbial manufacture, and Avecia DNA.
The Biologics unit has worked on more than 25 different
protein -based therapeutics and has supported all phases
of clinical development. Avecia DNA manufactures
oligonucleotides and has worked on a range of
programmes for more than 20 different customers.
Another large bioprocessing operation
is Lonza Biologics, the world’s leading contract
manufacturer of therapeutic antibodies and
recombinant proteins from mammalian cell
culture. The facility in Slough was granted
its FDA licence for the production of
monoclonal antibodies as far back as 1985,
and the company can carry out projects
from initial evaluation of a customer’s
cell line to the provision of data packages
for product registration.
On a smaller scale, Angel Biotechnology Ltd
provides contract R&D and manufacturing
services in microbial strain development and
mammalian cell culture, taking strains and
cell lines from customers and developing
them to production scale, or improving
expression levels. The company recently
won a Government grant to establish the
capability to manufacture stem cell banks
to GMP standards for clinical trials.
While Angel was founded in 2001, one of its
peers, Delta Biotechnology Ltd, traces its roots
back to 1984 when it was set up by a brewery
to capitalise on its skills in fermentation.
The company now manufactures therapeutic
recombinant proteins, vaccines and
fusion proteins.
Another specialist is Cobra Biomanufacturing,
which has the capability to produce protein,
virus and DNA products at its facilities in Keele,
Staffordshire and in Oxford. Current projects
include producing clinical trials supplies
of vaccines against Dengue Fever and
West Nile disease that consist of a number
of genetically engineered antigens linked to
adjuvants; a TNF-alpha kinoid in development
as an immunotherapy for treating autoimmune
and inflammatory disease that consists of an
inactivated form of the cytokine conjugated
to a carrier; and manufacturing Reolysin,
a cancer therapy based on the Reovirus.
Most small biotechnology companies are
obliged to use contract manufacturers, but
one, Protherics plc, has established its own
processing plant for its FDA-approved sheep
monoclonal antibody products. The sheep
the antibodies come from live in New Zealand,
but the antibodies themselves are extracted
at the plant in Wales.
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The UK is also home to one of the leading
biogenerics manufacturers GeneMedix plc.
The company does not have a manufacturing
plant in the UK, but its factory in Shanghai
produces GM-CSF, and GeneMedix expects
to apply for European marketing approval
in 2006 for erythropoietin manufactured
at its facility in Tullamore, Ireland.
To address this, BioScience 2015 recommended
the setting up of Bioprocessing Centres of
Excellence in a number of universities, to train
graduates in the set of cross-disciplinary skills
required in the industry, to carry out and
commercialise leading edge research, and
to build relationships with UK biotechnology
and bioprocessing companies.
As this snapshot of corporate activity shows,
the bioprocessing subsector is well-established
and thriving. However, the BioScience 2015
strategy for the development of the biosciences
sector recognised that there are some potential
constraints on its growth and in turn
of the biosciences sector overall.
Further measures to strengthen the links
between industry and academe, recommended
in Bioscience 2015, have also been acted on.
A national Bioprocess Industry Development
Director has been appointed with a brief
to develop and coordinate strategic initiatives
and build links within the sector; the BioIndustry
Association was given funding to set up
and run a Bioprocessing Knowledge Transfer
Network; bioProcessUK, and the first annual
bioProcessUK Forum held its inaugural meeting
at the end of 2004 in Newcastle. This event
brought together academic and industrial
delegates to define their priorities for the
future development of the subsector.
Most biotechnology companies in the early
stages of development are obliged to rely
on contract manufacturers for producing
biopharmaceuticals for clinical trials.
BioScience 2015 highlighted a shortage
of suitable production facilities, a problem
that was compounded last year when
the European Union brought in new rules
mandating all clinical trial material must
be produced to GMP standards.
Bioscience 2015 also pointed to the need to
make bioprocessing an attractive career and
train more people to work in this knowledge
intensive area.
As described in the overview of the biosciences
sector the government has provided money
to support the development of manufacturing
facilities for gene and stem cell therapy
products also.
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The National Biomanufacturing Centre (NBC), situated in the midst
of one of the UK’s largest bioprocessing clusters, is currently being
commissioned and will be open for business early in 2006.
Two significant infrastructure projects,
each five years in gestation, are due to come
on stream soon. Once they are both up
and running, the resources provided by the
National Biomanufacturing Centre in Liverpool
and Biocampus in Edinburgh, will provide an
exponential increase in the UK’s bioprocess
development and manufacturing capabilities.
The National Biomanufacturing Centre (NBC),
situated in the midst of one of the UK’s largest
bioprocessing clusters, is currently being
commissioned and will be open for business
early in 2006. The £20 million centre is set
to become Europe’s leading biopharmaceutical
design centre, capable of working with
smaller biotechnology companies
to develop and manufacture a wide variety
of biopharmaceuticals for Phase I and Phase II
clinical trials. There will be an access fund
to assist qualifying companies in purchasing
services from the centre. The NBC will run
a graduate training programme also.
The centre has three GMP pilot plants, catering
for mammalian, microbial and live virus
products, three process development suites
and a quality control and analytical laboratory
that will be able to perform the majority
of techniques required for biopharmaceutical
batch release and in-process testing.
The building of the NBC has been financed
by the public sector under the leadership
of the North West Development Agency,
but it will be operated by Eden Biodesign,
a private sector bioprocessing consultancy.
In Scotland, the first phase of Biocampus,
a £100 million dedicated biomanufacturing
centre, opened recently. Apart from providing
extensive GMP production facilities, Biocampus
will provide accommodation for bioprocessing
companies – from units suitable for pilot
production to large scale manufacturing. Like
the National Bioscience Centre it is situated
at the heart of a strong bioscience cluster and
close to several leading academic institutions.
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BIA (BioIndustry Association)
contacts
>
David Chiswell
Chairman
For more information on UK bioscience
companies, the industry as a whole,
or the BIA itself, contact:
>
Aisling Burnand
Chief Executive
BIA
14-15 Belgrave Square
London SW1X 8PS
United Kingdom
Tel: +44 207 565 7190
Fax: +44 207 565 7191
Email: admin@bioindustry.org
>
Barbara Blaney
Director (Scotland)
BIA Scotland
Centre House, Midlothian Innovation Centre,
Pentlandfield, Roslin
Midlothian EH25 9RE
Scotland
Tel: +44 131 440 6161
Fax: +44 131 440 2871
Email: bblaney@bioindustry.org
Aisling Burnand
Chief Executive
Barbara Blaney
Director (Scotland)
UK Trade
& Investment
Harriet Fear
Team Leader
Biotechnology
& Pharmaceuticals
Sector Team
David Chiswell
Chairman
BioIndustry Association
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UK Trade & Investment
Regional Contacts
>
East of England
Harriet Fear
Team Leader
Biotechnology & Pharmaceuticals Team
The Business Centre
Station Road, Histon
Cambridgeshire CB4 9LQ
Tel: +44 1223 484 671
Fax: +44 1223 200 853
Email: harriet.fear@uktibiotech.org.uk
>
Mark Wathen
Cluster Manager
Tel: +44 122 371 3900 (EEDA office)
Tel: +44 122 324 2946 (Home office)
Mobile: +44 776 430 1397
Fax: +44 122 324 2946 (Home office)
Email: markwathen@eeda.org.uk
Invest Northern Ireland
For help to internationalise your business, contact:
>
>
>
>
Anil Vaidya - UKTI Sector Specialist
Asian markets
Email: avaidya@dial.pipex.com
Dr Iain Cloughley - UKTI Sector Specialist
USA/Canada/NZ and Australia markets
and nominally on Europe
Email: Noeticnutrition@aol.com
David Hawkins - UKTI Sector Specialist India
and the Central European markets
Email: dvs.hawkins@btinternet.com
For further information on Biotechnology &
Pharmaceuticals please contact Harriet Fear
For Inward Investment queries
>
Marketing Unit - Room 308
1 Victoria St
London SW1H 0ET
Tel: +44 207 215 8000
Fax: +44 207 215 5651
Minicom: +44 207 215 2417
Email: inward.investment@uktradeinvest.gov.uk
Teresa Madden
Trade Development Services-Technology Sector
Upper Galwally
Belfast BT8 6TB
Tel: +44 289 069 8067
Fax: +44 289 049 0549
Mobile: +44 788 443 8589
Email: teresa.madden@investni.com
Website: www.investni.com
London
>
Dr Damian Lynch
Life Sciences Manager
London Development Agency
Devon House
58-60 St Katharine's Way
London E1W 1JX
Tel: +44 207 954 4161
Fax: +44 207 680 2040
Email: damianlynch@lda.gov.uk
Website: www.lda.gov.uk
6/6/05
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BIA (BioIndustry Association)
contacts
The Midlands
Scotland
>
>
Dr Ken Larkin
International Investment Manager
Healthcare Technologies
The British Midlands: Nottingham Office
Apex Court
City Link
Nottingham NG2 4LA
Tel: +44 115 988 8567
Fax: +44 115 853 3666
E-mail: kenlarkin@thebritishmidlands.com
Website: www.thebritishmidlands.com
Mrs Connie Ness
Senior Development Executive
Scottish Development International
150 Broomielaw
Atlantic Quay
Glasgow G2 8LU
Tel: +44 141 228 2560
Fax: +44 141 228 2114
Email: connie.ness@scotent.co.uk
Website: www.scottishdevelopmentinternational.com
South East England
North East England
>
>
Dr Fred Wright
Chief Executive
Centre of Excellence for Life Sciences
Bioscience Centre
International Centre for Life
Times Square
Newcastle-upon-Tyne NE1 4EP
Tel: +44 191 211 2560
Fax: +44 191 211 2561
E-mail: fred.wright@celsatlife.com
Website: www.cels@life.com
North West England
>
Dr Linda Magee
Biotechnology Sector Director & Head of Bionow
Bionow, NWDA - North West RDA
Renaissance House
PO Box 37
Centre Park
Warrington, Cheshire WA1 1XB
Tel: +44 192 540 0100
Fax: +44 192 540 0400
Email: bionow@nwda.co.uk or
Linda.Magee@nwda.co.uk
Website: www.bionow.co.uk
Dr Clare Robinson
Bio Pharma & Healthcare Sector Manager
SEEDA
Cross Lanes
Guildford
Surrey GU1 1YA
Tel: +44 148 347 0158
Fax: +44 148 348 4247
Email: clarerobinson@seeda.co.uk
Website: www.seeda.co.uk
South West England
>
Ms Nicola Daniels
Sector Development Advisor,
Biotechnology/Pharmaceuticals
South West of England
Regional Development Agency
North Quay House
Sutton Harbour
Plymouth, Devon PL4 ORA
Tel: +44 175 223 4846
Fax: +44 175 223 4840
Mobile: +44 771 267 8963
Email: nicola.daniels@southwestrda.org.uk
Website: www.southwestrda.org.uk
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Yorkshire
International Technology Promoters
>
>
Ms Caroline Kirby
Bioscience & Chemicals Cluster
Yorkshire Forward / Yorkshire & Humber
Victoria House
2 Victoria Place
Leeds LS11 5AE
Tel: +44 113 394 97214
Fax: +44 113 243 3930
Email: caroline.kirby@yorkshire-forward.com
Website: www.bioscience-yorkshire.com
>
>
>
>
>
Wales
>
Sadie Whatling
WalesTrade international
Welsh Assembly Government
Cathays Park
Cardiff CF10 3NQ
Tel: +44 292 080 6154
Fax: +44 292 082 3964
Email: sadie.whatling@wales.gsi.gov.uk
Andy Sutton - North America
Email: andy.sutton@pera.com
Nigel Whittle - Australasia
Email: nigel.whittle@pera.com
Pete Kitchin - North America
Email: pete.kitchin@pera.com
Kieran Rooney - Europe
Email: Kieran.rooney@pera.com
Philip Oliver – Europe
Email: philip.oliver@pera.com
Jiansheng Du - China, Asia Pacific
Email: jiansheng.du@pera.com
Sector Analyst
>
Tara Sharpe
Email: tara.sharpe@pera.com
For more information
on individual International
Technology Promoters please visit:
www.globalwatchonline.com/itp
DTI Global Watch Service
For any other International Technology
Promoters enquiries please contact:
The International Technology Promoters
use their experience to bring together
people and organisations across national
boundaries, enabling businesses to access
and transfer global technology based
opportunities.
>
Claire McCartney
Tel: +44 166 450 1551
Email: Claire.McCartney@pera.com
Images courtesy of Cambridge Antibody Technology Group plc, Astex Technology and Trigen Ltd.
Designed and produced by Seton Design Telephone: +44 (0)131 664 7557
6/6/05
11:16 AM
Page 48
BIA Electronic
Newsletter Services
NewsCAST- A trusted source of information
NewsCAST delivers biotechnology, political,
financial and corporate news affecting the sector.
It summarises the latest news and press releases
from member companies. New member companies
are highlighted and industry appointments noted. It
is a weekly email newsletter delivered to individuals
within member companies of the BioIndustry
Association. It contain and corporate news, as well
as up-to- the-minute information on BIA activities
and links to articles of general interest on the web.
NewsCAST is a free service for BIA members.
Cost for non-members is GBP400 + VAT per annum.
To sign up for a free 4-week trial, please contact:
>
Ryan Tinggal
Email: rtinggal@bioindustry.org
Regulatory Briefing- regulatory update
The BIA Regulatory Briefing, our monthly
newsletter on regulatory issues. Our aim
is to update members on the latest developments
in bioscience-related regulations and legislative
and policy developments in the UK and EU.
The Regulatory Briefing is a free service for
BIA members. The subscription cost for nonmembers is GBP1000 + VAT per annum.
For further information please contact:
>
Christiane Abouzeid
Email: cabouzeid@bioindustry.org
BIA Regulatory Affairs Manager
6/6/05
11:16 AM
Page 49
Notes
6/6/05
11:16 AM
Page 50
6/6/05
11:16 AM
Page 51
bioScienceUK 2005 CD-ROM directory
A CD WHICH GIVES YOU FREE ACCESS TO OVER 400 UK BIOTECH
ORGANISATIONS WITH THEIR PROFILES, AND FORMS PART
OF THE DTI GLOBAL WATCH SERVICE SUIT CAN BE REQUESTED.
FOR THIS CD OR MORE INFORMATION PLEASE VISIT:
WWW.GLOBALWATCHONLINE.COM
www.uktradeinvest.gov.uk
6/6/05
11:16 AM
Page 52

bioScienceUK - Biotechnologie.de

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