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Cambridge Antibody Technology (CAT) Group plc announces first quarter financial results Monday
9 February 2004.
Cambridge,
UK … Cambridge
Antibody Technology Group plc (LSE: CAT; NASDAQ: CATG)
today announces financial results for the first quarter of its financial year,
from 1 October
2003 to 31 December 2003, and an update on business since the Preliminary
Results
Announcement on 17 November 2003. Summary Continued
progress in CAT core development programmes: -
preliminary results show primary objective of CAT-192 Phase I/II clinical trial
met: CAT-192 found to be generally safe and well-tolerated -
enrolment complete in Phase III pivotal International clinical trial of TrabioTM Further
steps taken in strategy to focus investment on core programmes: -
co-development agreement with Amgen restructured on attractive terms -
co-development agreement with Elan in the fields of neurology and pain
terminated by CAT Extension
of manufacturing agreement with Lonza to secure supply of clinical
grade
antibody drugs to the end of 2006 Second
tranche of equity investment by Genzyme Reduced
net cash outflow before management of liquid resources and financing: £6.6
million for the three months ended 31 December 2003 compared with £7.2 million
for the three months ended 31 December 2002 Net
cash and liquid resources increased to £115.1 million at 31 December 2003 from
£107.8 million at 30 September 2003 CAT
Product Candidates Enrolment
is complete in the Phase III pivotal International clinical trial of Trabio,
a human anti-TGFb2
monoclonal antibody, in patients undergoing first time surgery for glaucoma
(trabeculectomy). A total of 393 patients in six European countries and South
Africa
were randomised in the double-blind trial which compares Trabio with placebo.
Data
from this trial are expected in early 2005 when all patients will have completed
at least
one year of follow-up post surgery. CAT
and Genzyme Corp today announce preliminary results from a Phase I/II clinical
trial
of CAT-192,
a human anti-TGFb1
monoclonal antibody. The primary objective of the
trial was to assess the safety, tolerability and pharmacokinetics of CAT-192 in
patients suffering from diffuse systemic sclerosis. The secondary objective was
to evaluate the potential clinical outcomes for any future trial in systemic
sclerosis. The
double-blind, placebo-controlled trial enrolled 45 patients at 12 medical
centres in the US and Europe. Patients were randomised to receive one of three
dose levels of CAT-192 (0.5 mg/kg, 5 mg/kg or 10 mg/kg) or matching placebo,
given as an intravenous infusion every six weeks for four doses. Preliminary
results show that the primary objective of the trial was met; CAT-192 was
generally safe and well-tolerated at each dose level. Elimination half-life was
consistently around three weeks. There were no treatment-related serious adverse
events observed. Four patient deaths occurred during the trial (one at 0.5 mg/kg
and three at 5 mg/kg) and were determined by independent medical reviewers to be
attributable to patients’ underlying disease, and unrelated to treatment. For
the secondary objective of the trial a number of clinical endpoints and
biological markers, potentially indicative of disease progression, were
evaluated. Preliminary
review of these markers indicated that disease duration and gender played
important
roles in the results seen, and that the placebo group’s skin score did not deteriorate
during the trial as anticipated. Given these factors and the small sample size,
no definitive conclusions regarding the efficacy of CAT-192 can be drawn at this
time. Additional
analyses and alternative trial designs are being evaluated. An
Investigational New Drug application for a Phase I trial in the US in idiopathic
pulmonary
fibrosis (IPF) of GC-1008,
a pan-specific human anti-TGFb
monoclonal
antibody
being developed by CAT and Genzyme, has been filed with the US Food and
Drug
Administration (FDA). Discussions with the FDA are ongoing. HUMIRATM In
January, Abbott Laboratories announced increased worldwide 2004 sales forecasts
for HUMIRATM
(adalimumab),
a human anti-TNFa
monoclonal
antibody and the first CATderived antibody
to receive approval for marketing. Abbott reported that HUMIRA is now
approved for sale in 37 countries and achieved full year sales in 2003 of $280 million.
Based on this performance, Abbott has raised its sales expectations for 2004 to
more
than $700 million. The
legal proceedings CAT commenced against Abbott Biotechnology Limited and Abbott
GmbH in November 2003 in the High Court in London are continuing. Other
Licensed Product Candidates LymphoStat-BTM,
a human monoclonal antibody which modulates the activities of Blymphocytes, was
isolated at CAT in collaboration with Human Genome Sciences, Inc (HGSI)
and licensed to HGSI in 2001. In January 2004, HGSI announced that it has begun
dosing patients in a Phase II clinical trial of LymphoStat-B for the treatment
of rheumatoid arthritis. The double-blind, placebo-controlled multi-centre Phase
II trial will evaluate safety, optimal dosing and efficacy of LymphoStat-B in
approximately 230 patients with active rheumatoid arthritis who have failed
prior therapy. Also, HGSI continues to enrol and dose patients in its
double-blind, placebo-controlled, multi-centre Phase
II clinical trial of LymphoStat-B in patients with active systemic lupus erythematosus.
HGSI plans to complete enrolment of both Phase II clinical trials in 2004. HGSI
has completed enrolment in its Phase I placebo-controlled, dose-escalation
clinical trial
to evaluate the safety, tolerability and pharmacokinetics of ABthraxTM,
a human anti-protective
antigen monoclonal antibody isolated and developed by HGSI from antibody
libraries licensed from CAT. HGSI has announced that it intends to submit an
abstract from the trial for presentation at the American Society of
Microbiology’s Biodefence
Meeting, scheduled for March 2004. HGSI has stated that further development of
ABthrax will depend on US government funding. HGSI
continues with the Phase I clinical trials to evaluate the safety and
pharmacology of HGS-ETR1
(previously
known as TRAIL-R1 mAb) in patients with advanced solid tumours
and has submitted an abstract from the Phase I clinical trials for presentation
at the Annual Society of Clinical Oncology meeting, scheduled for June. HGSI
plans to initiate Phase II clinical trials in 2004. In
the Phase I open-label, dose-escalating clinical trial of HGS-ETR2
(previously
known as
TRAIL-R2 mAb), HGSI continues to enrol patients with advanced tumours. Additionally,
HGSI has recently received clearance from the FDA to commence a Phase I clinical
trial in the US. HGSI plans to complete enrolment of both Phase I trials in
2004. There
are four product candidates at pre-clinical development stage at CAT’s
collaborators. Discovery
Stage Programmes There
are ongoing research programmes to 14 distinct molecular targets at CAT. Half
are funded or co-funded by CAT and half are funded by CAT’s licensees. In
December CAT restructured its agreement with Amgen, with Amgen taking over
responsibility for the further development and marketing of the therapeutic
antibody candidates isolated by CAT against two targets identified by Amgen and
covered by an earlier
collaboration agreement between CAT and Immunex. In return, CAT receives from
Amgen an initial fee and potential milestone payments and royalties on future
sales. This
agreement allows CAT to focus its investment on a smaller number of core programmes,
while retaining significant interest in the success of these two antibody
candidates. After
three years, CAT has exercised its right to terminate its agreement with Elan,
effective
from 21 February 2004.
The
collaboration involved research on a number of targets.
Terminating this exclusive agreement will allow CAT to collaborate with third In
December, the research collaboration with Pfizer was extended for a further six
months to 30 May 2004. Operations In
January CAT and Lonza announced the extension of their November 2001 agreement,
confirming that Lonza Biologics will manufacture and supply clinical grade
antibody drugs to CAT through to the end of 2006. This will enable CAT to plan
further ahead with confidence and will guarantee that CAT and its collaborators
have access to Lonza’s world-class manufacturing capability at production
scale (up to 2,000L), for both ongoing programmes
and future projects, in a cost-effective way. Financial
Results A review of the financial results for the three months ended 31 December 2003 is set out in the enclosed PDF file. 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 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 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. Three
CAT human therapeutic antibody products are now in clinical development, with
two further product candidates in pre-clinical development. 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 and
by the European Commission for marketing in the EU as a treatment for rheumatoid
arthritis. Five
further licensed CAT-derived human therapeutic antibodies are in clinical
development, with three further licensed product candidates 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. In
particular, CAT has a broad collaboration with Genzyme for the development and
commercialisation of antibodies directed against TGFb,
a family of proteins associated with fibrosis and scarring. This collaboration
has so far given rise
to one antibody product candidate at clinical development stage, and one at
pre-clinical development
stage. 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. 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 the
company’s present and future business strategies and the environment in which
the company will operate in the future. Certain factors that could cause the
company’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.
We caution investors not to place undue reliance on the forward looking
statements contained in this press release. These statements speak only as of
the date of this press release, and we undertake no obligation
to update or revise the statements. For
further information contact: Cambridge
Antibody Technology Tel:
+44 (0) 1223 471 471 Peter
Chambré, Chief Executive Officer John
Aston, Chief Financial Officer Rowena
Gardner, Director of Corporate Communications Weber
Shandwick Square Mile (Europe) Tel:
+44 (0) 20 7067 0700 Kevin
Smith Rachel
Lankester BMC
Communications/The Trout Group (USA) Tel:
+1 212 477 9007 Brad
Miles, ext 17 (media) |
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