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UK Scientists Deliver on Breakthrough Treatment for Rheumatoid Arthritis Sufferers September
19 2003 News that HUMIRAÒ,
a ground breaking new drug for Rheumatoid Arthritis (“RA”), has received
regulatory clearance for marketing in Europe and will be launched in the UK
shortly represents a major success for the UK scientists who have helped to
unlock the potential of antibody based drugs. Such
treatments can mimic the effects and harness the body’s own immune system, by
using the antibody molecule, a molecular format produced “naturally” by the
immune system, as the drug molecule. HUMIRA,
also known as adalimumab, was isolated and optimised by Cambridge Antibody
Technology (“CAT”), the leading UK biotechnology company - using its
patented, world-leading phage display technology - in collaboration with Abbott
Laboratories, the US pharmaceutical giant that owns exclusive worldwide rights
to the product. HUMIRA
was specifically designed by CAT scientists to neutralise a protein called TNFa
which is produced in excess in joints of suffers of Rheumatoid Arthritis.
Excess TNFa
produces inflammation which causes pain and swelling.
It also promotes destruction of the joints. HUMIRA
is the first therapeutic human monoclonal antibody to be approved in both US and
Europe. It is specifically
indicated for the treatment of the symptoms of RA and inhibiting the progression
of the disease. The product offers
a real improvement in treatment for RA sufferers by not only easing symptoms
such as pain and swelling of joints, but also by slowing or even halting joint
destruction, together with less frequent and more convenient dosing for patients
than earlier products. HUMIRA has
already been launched very successfully in the US by Abbott who expect it to
become a blockbuster drug with sales of over $1 billion per annum at its peak. Dr
David Glover, Chief Medical Officer of CAT said: “Due to their natural role in
eliminating foreign molecules and organisms from the body and protecting the
body from invasion, antibodies have long been recognised as having great
potential for treating certain diseases. However
complications with immune responses in patients meant that early attempts at
developing antibody drugs were unable to fulfil their promise. HUMIRA is the first example of how CAT’s pioneering work in
antibodies has enabled development
of a human antibody drug leading to a product with disease modifying effects,
few side effects and an improved more convenient dosing regimen for patients. “HUMIRA
is the first product originating from CAT to reach the market. Last week’s
European regulatory approval represents a major endorsement of our technology.
Looking ahead, Abbott expects to expand the approved indications to
include juvenile RA, early RA, Crohn’s Disease, Psoriasis and ankylosing
spondylitis with late-stage clinical trials already underway.
With nine human antibody drug candidates derived from CAT's antibody
libraries at various stages of clinical development, the era of human antibodies
making a real contribution to addressing areas of unmet medical need is just
beginning”. The
news about HUMIRA is the culmination of nearly thirty years of scientific
endeavour. A Nobel Prize winning scientific breakthrough in the mid-1970s by
Milstein and Kohler working at the Laboratory of Molecular Biology at the
Medical Research Council in Cambridge, UK, made it possible to reliably produce
mouse monoclonal antibodies in sufficient quantities for research purposes and
subsequently for drug development. Almost
immediately these molecules were hailed as potential ‘magic bullets’ for
treating diseases. However, the
production method produced mouse antibodies which were subsequently injected
into humans. It soon became evident
that the human immune system recognised the mouse monoclonal antibodies as
foreign and so triggered an immune response against them causing serious side
effects and rendering them ineffective. The solution to this problem was to
develop a way of making human monoclonal antibodies, which would reduce, and
possibly eliminate, the possibility of immune rejection and be more effective at
interacting with the human immune system.
This however remained a considerable technical challenge into the 1990s. CAT
was established in 1990 and has pioneered the technique of ‘phage display’,
the engineering of bacteriophages (viruses that infect bacteria but are harmless
to humans) to display fragments of human monoclonal antibodies on their surface.
CAT, now based at Granta Park, Cambridge, employs over 200 scientists.
The Company has used this proprietary technology to create in a test tube
libraries containing over 100 billion human monoclonal antibodies, which it uses
in the discovery and development of antibody-based drugs. The need for mice in
the production process of antibodies is thus no longer required.
Each of the phage antibodies in CAT’s libraries contains a different
combination of human antibody variable region genes, giving each one a unique
specificity. When the antibody
libraries are selected against a single protein antigen, many hundreds, if not
thousands, of different functional antibody fragments can be identified capable
of recognising, binding and even neutralising the biological activity of its
target antigen. The future potential of CAT's antibody libraries is evidenced
not only by HUMIRA but also by collaboration and licensing agreements that CAT
has made with major pharmaceutical and biotechnology companies worldwide. -
ENDS - Notes
to Editors: How
Does HUMIRA Work?
While
the exact cause of RA is not known, in the last decade researchers have
determined that people with RA tend to have an excess of protein called tumour
necrosis factor alpha (TNFa),
which triggers inflammation as part of the body's normal immune system response.
Overproduction of TNFa
can lead to excessive inflammation such as that found in patients with RA.
HUMIRA works by targeting and binding to TNFa
thus blocking the activity of TNFa
and helping to prevent inflammation.
About
Antibodies Antibodies
are a pivotal part of the body's immune system. They are naturally produced
proteins capable of specifically recognising, and binding to, foreign, and
potentially toxic, molecules or pathogens such as bacteria or viruses (the
“antigen”). Each
antibody is highly specific to its antigen, meaning it is capable of recognising
it amongst thousands of other, often similar, targets. Once the target antigen
is recognised, the antibody binds to it tightly and aids its elimination from
the body. These properties make antibodies a very attractive proposition as
potential therapeutic drugs. A
monoclonal antibody is derived from a single clone of cells, all molecules of
which have identical target (antigen) binding sites. About
RA More
than five million people worldwide suffer from RA, a chronic autoimmune disease
that causes pain, swelling and stiffness in the joints of hands, feet and
wrists, and often leads to the destruction of joints. Unlike osteoarthritis, the
most common form of arthritis, RA is an autoimmune disease where joints are
inflamed, resulting in eventual destruction of the joint's interior and the
surrounding bone. The
long-term prognosis for patients with RA is poor, and as a result, many patients
face increased disability and premature death. Patients interested in more
information about RA can visit the Web site, www.RA.com Cambridge
Antibody Technology (CAT) ¨
CAT is a UK-based biotechnology company using its proprietary
technologies and capabilities in human monoclonal antibodies for drug discovery
and drug development. Based near Cambridge, England, CAT currently employs
around 270 people. ¨
CAT is a leader in the discovery and development of human therapeutic
antibodies and has an advanced proprietary platform technology for rapidly
isolating human monoclonal antibodies using phage display systems. CAT has
extensive phage antibody libraries, currently incorporating more than 100
billion distinct antibodies. These libraries form the basis for the Company’s
strategy to develop a portfolio of antibody-based drugs. ¨
HUMIRA,
the leading CAT-derived antibody, isolated and optimised in collaboration with
Abbott, has been approved by the US Food and Drug Administration for marketing
in the US and by the European Commission for marketing in the EU as a treatment
for rheumatoid arthritis. ¨
Eight
further CAT-derived human therapeutic antibodies are at various stages of
clinical trials. There are five candidate therapeutic antibodies in pre-clinical
development. ¨
CAT has alliances with a number of
pharmaceutical and biotechnology companies to discover, develop and
commercialise human monoclonal antibody-based products. CAT has co-development
programmes with Amgen, Amrad, Elan and Genzyme. ¨
CAT has also licensed its technology to several
companies. CAT’s licensees include: Abbott, Amgen, Chugai,
Human Genome Sciences, Merck & Co, Pfizer and Wyeth Research. ¨
CAT is listed on the London Stock Exchange and
on NASDAQ since June 2001. CAT raised £41m in its IPO in March 1997 and £93m
in a secondary offering in March 2000. ¨
Further information can be found at www.cambridgeantibody.com Application of the Safe Harbor of the Private Securities Litigation Reform Act of 1995: This press release contains statements about Cambridge Antibody Technology Group plc ("CAT") that are forward looking statements. All statements other than statements of historical facts included in this press release may be forward looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934. These forward looking statements are based on numerous assumptions regarding CAT’s present and future business strategies and the environment in which CAT will operate in the future. Certain factors that could cause CAT’s actual results, performance or achievements to differ materially from those in the forward looking statements include: market conditions, CAT’s ability to enter into and maintain collaborative arrangements, success of product candidates in clinical trials, regulatory developments and competition.
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