CAT reports HUMIRA approval
January 02 2003 - 6:17AM
UK Regulatory
RNS Number:7166F
Cambridge Antibody Tech Group PLC
02 January 2003
03/CAT/01
FOR IMMEDIATE RELEASE
12.00 GMT 07.00 EST 2 January 2003
For further information contact:
Cambridge Antibody Technology
Tel: +44 (0) 1223 471 471 Weber Shandwick Square Mile (Europe)
Peter Chambre, Chief Executive Officer Tel: +44 (0) 20 7067 0700
John Aston, Chief Financial Officer Kevin Smith
Rowena Gardner, Director of Corporate Cass Helstrip
Communications
BMC Communications/The Trout Group (USA)
Tel: 001 212 477 9007
Brad Miles, ext 17 (media)
Brandon Lewis, ext.15 (investors)
CAMBRIDGE ANTIBODY TECHNOLOGY REPORTS HUMIRA APPROVAL
Cambridge, UK... Cambridge Antibody Technology (LSE: CAT; NASDAQ: CATG) today
acknowledges the announcement by Abbott Laboratories that it has received US
Food and Drug Administration (FDA) approval to market HUMIRATM (adalimumab,
previously known as D2E7) for the treatment of rheumatoid arthritis (RA),
earlier than anticipated.
In an announcement dated 31 December 2002, Abbott Laboratories reported that
HUMIRA is the first human monoclonal antibody approved for reducing the signs
and symptoms and inhibiting the progression of structural damage in adults with
moderately to severely active RA who have had insufficient response to one or
more traditional disease modifying antirheumatic drugs (DMARDs).
Abbott Laboratories also stated that HUMIRA will offer convenient every other
week dosing by subcutaneous injection (shot beneath the skin). A specially
designed prefilled syringe for RA patients whose hands may be affected by
crippling joint destruction will be available in pharmacies next month. Abbott
is confident it can supply sufficient quantities to meet patient demand and
recently announced a manufacturing expansion to meet future demand for HUMIRA.
The FDA's approval of HUMIRA comes only nine months after simultaneous
regulatory submissions in the United States and Europe.
HUMIRA was discovered through a broad scientific collaboration between CAT and
Abbott. As part of the collaboration, Abbott had the right to select several
target antigens for which a joint CAT/Abbott research team would discover human
antibody therapeutics. HUMIRA was isolated and optimised by Abbott and CAT as
part of this collaboration. Abbott owns exclusive worldwide rights to HUMIRA,
including responsibility for clinical development, manufacturing, sales and
marketing. Abbott will book all revenues for HUMIRA, and CAT will receive a
royalty fee based on HUMIRA sales.
The European Agency for the Evaluation of Medicinal Products (EMEA) accepted
Abbott's submission for HUMIRA for the treatment of RA in April 2002, and Abbott
anticipates approval in mid-2003.
-ENDS-
Notes to Editors
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 290
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.
HumiraTM is the leading CAT-derived antibody. Six other CAT-derived human
therapeutic antibodies are at various stages of clinical trials.
CAT has alliances with a large number of pharmaceutical and biotechnology
companies to discover, develop and commercialise human monoclonal antibody-based
products. CAT has also licensed its proprietary human phage antibody libraries
to several companies for target validation and drug discovery. CAT's
collaborators include: Abbott, Amgen, Amrad, Chugai, Elan, Genzyme, Human Genome
Sciences, Merck & Co, Pharmacia 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.
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.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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