EU approval of Humira
Cambridge Antibody Tech Group PLC
11 September 2003
03/CAT/23
FOR IMMEDIATE RELEASE
09.15 BST, 02.15 EST Thursday 10 September 2003
For further information contact: Weber Shandwick Square Mile (Europe)
Cambridge Antibody Technology Tel: +44 (0) 20 7067 0700
Tel: +44 (0) 1223 471 471 Kevin Smith
Peter Chambre, Chief Executive Officer Rachel Lankester
John Aston, Chief Financial Officer
Rowena Gardner, Director of Corporate
Communications
BMC Communications/The Trout Group (USA)
Tel: +1 212 477 9007
Brad Miles, ext 17 (media)
Brandon Lewis, ext.15 (investors)
CAMBRIDGE ANTIBODY TECHNOLOGY REPORTS EUROPEAN APPROVAL OF HUMIRA(R)
Cambridge, UK... Cambridge Antibody Technology (LSE:CAT; NASDAQ: CATG)
acknowledges the announcement by Abbott Laboratories that it has received
approval from the European Commission to market HUMIRA(R), previously known as
D2E7, for the treatment of adult rheumatoid arthritis (RA) in Europe. HUMIRA was
isolated and optimised by CAT as part of a broad scientific collaboration with
Abbott.
In an announcement dated 10 September 2003, Abbott stated that HUMIRA will be
available at pharmacies in Germany and the United Kingdom within five days.
Availability in other European Union (EU) countries will occur in subsequent
months as each country adopts pricing and reimbursement policies. In recent
months, the drug has been made available in Europe through patient named basis
programme or clinical study protocols. Abbott filed for EU approval in April
2002 and received a positive opinion from the European Medicines Evaluation
Agency (EMEA) in May 2003. HUMIRA received approval from the US Food and Drug
Administration on December 31, 2002, and since then in nine additional
countries. Also in May, as a result of the strong physician uptake and positive
patient response in the US, Abbott raised the global sales expectations of
HUMIRA for this year from more than $200 million to more than $250 million.
Abbott reported that the EU approval for HUMIRA was based on data obtained in
four controlled clinical trials. In all, 23 trials have been conducted with
HUMIRA, involving more than 2,400 RA patients worldwide. The drug's
effectiveness was evaluated by measuring patients' improvement in RA signs and
symptoms response scores. Safety also was assessed in these trials, which
included one of the largest prospective safety trials of a TNF-antagonist. Some
patients in trials have been taking HUMIRA for more than five years.
CAT will receive royalties on the sales of HUMIRA.
-ENDS-
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 and ribosome 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, 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 as a treatment for rheumatoid arthritis.
Approval in Europe is expected by Abbott in mid-2003.
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 proprietary technologies 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.
As set out in CAT's interim results for the six months ended 31 March 2003,
CAT's entitlement to royalties in relation to sales of HUMIRA is governed by an
agreement dated 1 April 1995 between Cambridge Antibody Technology Limited and
Knoll Aktiengesellschaft (now a subsidiary of Abbott Laboratories). The
agreement allows for offset, in certain circumstances, of royalties due to third
parties against royalties due to CAT, subject to a minimum royalty level. Abbott
indicated to CAT in March 2003 its wish to initiate discussions regarding the
applicability of these royalty offset provisions for Humira. CAT believes
strongly that the offset provisions do not apply and will seek an outcome
consistent with that position.
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