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CAMBRIDGE ANTIBODY TECHNOLOGY
(CAT) GROUP PLC ANNOUNCES FIRST QUARTER RESULTS
Monday 7 February 2005 Cambridge, UK…
Cambridge Antibody Technology (LSE: CAT; NASDAQ: CATG) today announces
financial results for the first quarter of its 2005 financial year, from 1
October 2004 to 31 December 2004, and an update on business since the
Preliminary Results Announcement on 22 November 2004.
Summary
• Major strategic alliance with AstraZeneca in the field of
inflammatory diseases:
o £75 million subscription in new CAT shares
o Alliance operations being established in line with plan
• Successful outcome to legal action against Abbott Laboratories in
relation to HUMIRA® royalties:
o US$23.73 million back royalties received from Abbott (not reflected in
Q1 results)
• Abbott reports worldwide sales of HUMIRA at $852 million for 2004 and
raises guidance for 2005 to more than $1.3 billion
• IP licensing – product candidates from Dyax and Micromet enter clinical
trials
Page 2 of 16
• Net cash outflow before management of liquid resources and financing:
£9.7 million for the three months ended 31 December 2004 (£6.6 million for
three months ended 31 December 2003)
• Net cash and liquid resources of £159.3 million at 31 December 2004
(£93.7 million at 30 September 2004)
AstraZeneca Strategic Alliance
In November 2004, CAT announced a major strategic alliance with
AstraZeneca for the joint discovery and development of human monoclonal
antibody therapeutics, principally in the field of inflammatory disorders.
Since that time, the joint infrastructure to manage the alliance has been
put in place, joint teams are being established and work is underway to
commence the 2005 research programme.
The alliance will become the principal focus of CAT's research activity
over the next five years and will include a five-year discovery initiation
phase during which the partners will jointly initiate a minimum of 25
discovery programmes. The principal focus of the discovery programmes will
be in inflammatory disorders, however the research may extend to other
therapeutic areas. The committed joint research investment will be a
minimum of $175 million during this phase, which the companies will fund
50:50.
CAT’s financial participation reflects its level of investment in the
programme. CAT has the option of co-investing and co-managing all
programmes through to Clinical Proof of Concept, and of continuing to fund
jointly the development of one in every five product candidates that reach
Clinical Proof of Concept up to product launch. If CAT opts out after the
discovery phase it receives milestones and royalties. If it opts out at
Clinical Proof of Concept it receives milestones and royalties at a higher
level. For those programmes which it funds to product launch it receives
higher royalties, sales milestones and an option to co-promote these
products in the US.
CAT will be principally responsible for antibody discovery, manufacturing
process development and the supply of material for exploratory clinical
trials. AstraZeneca will be principally responsible for translational
biology, clinical development programmes, regulatory filings and
commercialisation.
The alliance was conditional on the completion of the subscription of
10,217,983 new CAT shares by AstraZeneca for £75 million which duly
completed in December 2004.
Abbott Litigation Update
In November 2003, CAT commenced legal proceedings against Abbott
Biotechnology Limited and Abbott GmbH in the High Court in London
concerning the level of HUMIRA royalties due to CAT. On 20 December 2004,
the judge, Mr Justice Laddie, ruled in CAT’s favour stating that “Abbott
was in error when it made its first royalty payment to CAT calculated on
the basis that only two per cent of Net Sales was due. It should have
calculated on the basis of the full royalty of just over five per cent and
should have paid and continue to pay CAT accordingly.”
In January 2005, Mr Justice Laddie announced his decision on various
procedural matters arising from this judgment and ruled in CAT’s favour on
all counts. In particular, he denied Abbott’s request for permission to
appeal his judgement of 20 December 2004, though Abbott can now apply to
the Court of Appeal directly for permission to appeal. The judge also
ordered that Abbott pay CAT’s costs of the case (to be assessed in due
course). Part of these costs will be assessed, as sought by CAT, on a
higher basis than the norm to reflect the judge’s view of the merits on
that part of the case.
In January 2005, Abbott paid to CAT US$23.73 million, representing royalty
arrears due to CAT arising from the original judgment, and an additional
sum of US$1.29 million, representing interest and compensation for
currency loss on this amount. Abbott also paid CAT £2.85 million
representing an interim payment of legal costs due. These amounts are not
reflected in these first quarter results. Were Abbott to receive
permission to appeal and be successful on such appeal these amounts would
be repayable.
Product Development
CAT Product Candidates
CAT-354 is a fully human anti-IL13 monoclonal antibody being developed by
CAT, initially as a potential treatment for severe asthma. In September
2004, CAT commenced a Phase I clinical trial in the UK. Preliminary
results are expected to be available at the end of the second quarter of
2005. If this initial trial meets its primary objectives, CAT intends to
progress CAT-354 in further clinical trials later in 2005.
Genzyme Alliance
CAT and Genzyme believe that the neutralisation of TGF offers a number of
important and valuable opportunities for addressing unmet medical needs in
a number of disease conditions.
GC-1008 is a pan-specific fully human anti-TGF monoclonal antibody being
developed by CAT and Genzyme. The companies have received approval from
the US Food and Drug Administration (FDA) to begin a Phase I clinical
trial of GC-1008 in Idiopathic Pulmonary Fibrosis (IPF). Preparations for
this trial are now underway. During 2005 it is also intended to commence a
clinical trial of GC-1008 in various cancers. Pre-clinical studies in
support of this oncology study and further IPF studies are ongoing.
CAT-192 (metelimumab), a fully human anti-TGF1 monoclonal antibody, is
being jointly developed by CAT and Genzyme as a potential treatment for
scarring and fibrotic conditions, including scleroderma. Following a study
in 45 scleroderma patients that demonstrated that CAT-192 was safe and
well-tolerated, an analysis of all existing scleroderma study results is
being undertaken to facilitate understanding of the disease and its
progression. Once fully evaluated, the results will be discussed with a
panel of experts in an effort to identify the appropriate route for
clinical trials in diffuse systemic sclerosis.
CAT and Genzyme believe that there are further therapeutic opportunities
for the collaboration and pre-clinical work is continuing to evaluate
these.
Trabio® (lerdelimumab) is a fully human anti-TGF2 monoclonal antibody
developed by CAT as a potential treatment for improving the outcome of
glaucoma surgery. In November 2004, CAT announced the failure of Trabio to
meet the primary endpoint of improving the outcome of surgery for glaucoma
compared to placebo in its first pivotal ('European' Phase III) clinical
trial. Preliminary results of a second pivotal ('International' Phase III)
clinical trial in 393 patients in six European countries and South Africa
are expected in April 2005. In the US clinical trial comparing Trabio with
5-Flurouracil (5-FU) in 236 patients, enrolment is complete and
preliminary results are expected at the end of 2005. Following the
preliminary results of the first pivotal trial, CAT has minimised future
development costs of Trabio, consistent with its obligations in the two
continuing trials.
CAT-213 (bertilimumab) is a fully human anti-eotaxin1 monoclonal antibody
which CAT has been evaluating as a treatment for severe allergic
disorders. Discussions continue with potential partners to commercialise
CAT-213.
Licensed Products and Product Candidates
HUMIRA (adalimumab) is a fully human anti-TNF monoclonal antibody,
isolated and optimised by CAT in collaboration with Abbott and approved
for marketing as a treatment for rheumatoid arthritis (RA) in over 50
countries. In January, Abbott reported worldwide sales of $852 million for
2004 and raised its 2005 worldwide sales expectations for HUMIRA to more
than $1.3 billion.
Abbott continues to develop HUMIRA as a potential treatment for a number
of additional indications and reported in January that supplemental
biologics license applications (sBLAs) had been made for two HUMIRA
indications, early RA and psoriatic arthritis. Abbott also indicated that
it expects to file applications in 2005 for ankylosing spondylitis, for RA
in Japan and, possibly, for Juvenile RA. It has further indicated that a
regulatory submission for Crohn's disease is expected in 2006. In
psoriasis, Phase III clinical trials began at the end of 2004 and Phase II
clinical trial data will be available later this month. Abbott expects to
submit a regulatory application for psoriasis in 2006 or early 2007.
ABT-874 is a fully human anti-IL12 monoclonal antibody, isolated and
optimised by CAT in collaboration with Abbott, and licensed to Abbott.
Abbott continues to evaluate ABT-874 as a potential treatment for a number
of autoimmune diseases including Crohn's disease, psoriasis and multiple
sclerosis, in which Abbott announced the start of a Phase II clinical
trial in June 2004. Abbott has also indicated that it expects to begin
Phase II studies of ABT-874 in psoriasis by the end of 2005.
LymphoStat-BTM (belimumab) is a fully human anti-BLyS monoclonal antibody
and the first of four antibody drug candidates to be licensed by CAT to
Human Genome Sciences, Inc (HGSI). HGSI is developing LymphoStat-B as a
potential treatment for systemic lupus erythematosus (SLE) and RA. Phase
II trials in each indication continue, with the RA results expected in
Spring 2005 and the SLE results expected in Autumn 2005.
HGS-ETR1 is a fully human anti-TRAIL Receptor-1 monoclonal antibody
licensed by CAT to HSGI and being developed by HGSI as a potential
treatment for a number of cancers. In November 2004, HGSI announced that
it had completed the enrolment and initial dosing of patients in a US
Phase II clinical trial of HSG-ETR1 in patients with advanced non-small
cell lung cancer. The primary objective of the study is to evaluate tumour
response. The secondary objectives are to evaluate the safety and
tolerability of HGS-ETR1, and to determine plasma concentrations of
HGS-ETR1 for use in a population pharmacokinetic analysis. Phase II
clinical trials of HGS-ETR1 in patients with advanced colorectal cancer
and in patients with relapsed or refractory non-Hodgkin's lymphoma
continue.
Two Phase Ib clinical trials of HGS-ETR1 to evaluate safety and
tolerability in combination with chemotherapy also continue in patients
with advanced solid malignancies.
In January 2005, HGSI reported plans to complete all three of the ongoing
Phase II trials and both of the Phase Ib clinical trials of HGS-ETR1 in
2005.
HGS-ETR2 is a fully human anti-TRAIL Receptor-2 monoclonal antibody
licensed by CAT to HGSI, and being developed by HGSI as a potential
treatment for cancer. A Phase I clinical trial of HGS-ETR2 in patients
with advanced solid tumours continues. In January 2005, HGSI reported
plans to initiate Phase II clinical trials of HGS-ETR2 as a single agent,
and to initiate Phase Ib clinical trials of HGS-ETR2 in combination with
chemotherapeutic agents in 2005.
ABthraxTM is a fully human anti-protective antigen monoclonal antibody
isolated and developed by HGSI from antibody libraries licensed by CAT to
HGSI. It has been developed as a potential treatment for anthrax. HGSI has
stated that further development of ABthrax will depend on the US
government's willingness to commit to the purchase of ABthrax.
MYO-029 is a fully human monoclonal antibody which neutralises the effects
of GDF-8 (a protein which is associated with reduced skeletal muscle
mass). The antibody was discovered by CAT in collaboration with Wyeth and
is licensed to Wyeth, which is studying it as a potential therapy for
muscle-wasting diseases, including muscular dystrophy and age-related
sarcopenia. Wyeth announced in June 2004 that it had filed an
Investigational New Drug (IND) application for MYO-029 and a Phase I
clinical trial is now underway.
Licensed Pre-clinical Product Candidates
There are six antibody drug candidates licensed to partners which are at
the pre-clinical stage of development.
IP Licensing Agreements
In January 2003, CAT and Dyax Corp. announced the expansion of their 1997
licensing agreement. Under the terms of this expanded agreement, CAT
receives milestone and royalty payments on antibody products developed by
Dyax and Dyax's licensees. In January 2005, Dyax announced that two fully
human monoclonal antibodies from Dyax's proprietary phage display
libraries, IMC-11F8 and IMC-1121B, entered Phase I clinical development at
ImClone Systems. Accordingly, CAT received a milestone payment from Dyax
in January 2005.
In September 2003, CAT granted Micromet a patent licence for the
development and commercialisation of Micromet's human therapeutic antibody
candidate MT201 (adecatumumab), specific for the epithelial tumour target
Ep-CAM. In December 2004, Micromet and Serono signed an exclusive
collaboration and licence agreement for the development and
commercialisation of MT201 which is currently being tested in two
multi-centre Phase II clinical trials. CAT receives milestone and royalty
payments on human antibody-based products developed against the Ep-CAM
target by Micromet and its partners. The first milestone payment would be
due on filing for product approval.
Senior Management Changes
In January, CAT announced that Dr David Glover, Chief Medical Officer at
CAT, would take early retirement from the Company and the Board after the
Company's Annual General Meeting (AGM) on 4 February 2005. Dr Patrick
Round, VP Development at CAT, has assumed responsibility for all of CAT's
development activities and has joined the Executive Group, responsible for
the operational management of the Company. In addition, Diane Mellett,
General Counsel at CAT and Company Secretary, joined the Board of
Directors following the Company's AGM.
Financial Results
A review of the financial results for the three months ended 31 December
2004 is set out below. The comparative figures in brackets are for the
corresponding period in the prior financial year.
CAT made a loss after taxation for the three months ended 31 December 2004
of £11.7 million (2003: £9.1 million). Net cash outflow before management
of liquid resources and financing for the period was £9.7 million (2003:
£6.6 million outflow). Net cash inflow after financing for the period was
£65.6 million (2003: £7.2 million inflow). Net cash and liquid resources
at 31 December 2004 amounted to £159.3 million (30 September 2004: £93.7
million).
Revenue in the period was £2.7 million (2003: £3.8 million). Licence fees
of £1.2 million were recognised as revenue in the period having been
released from deferred income brought forward at 30 September 2004.
Milestone payments of £1.1 million were received during the quarter. Other
revenues of £0.4 million, were received during the quarter. In October
2003 Abbott paid to CAT the first royalties on HUMIRA resulting in
revenues of £1.0 million being recognised in the quarter ended 31 December
2003. As a result of an agreement reached in October 2003 on the timing of
royalty payments, royalty payments by Abbott are now due in September and
March of each year. There was, therefore, no royalty payment and no
royalty revenue recognised in the first quarter of the current financial
year, accounting for the decrease in revenue.
The payment by Abbott of royalty arrears and other related payments
pursuant to the High Court judgment, received in January 2005, are not
reflected in these results. Pending resolution of Abbott's request for
permission to appeal and any resultant appeal, the royalty arrears payment
will not be recognised as revenue, the payment on account of costs will
not be recognised in the profit and loss account and revenue in respect of
subsequent royalty receipts will only be recognised at the two per cent
rate argued by Abbott. A proportion of CAT's royalty receipts, and of the
royalty arrears payment, are payable to the Medical Research Council and
other licensors.
Operating costs for the period amounted to £15.6 million (2003: £13.6
million). Research and development expenses decreased to £9.2 million for
the three months ended 31 December 2004 (2003: £10.4 million). External
development costs for the three month period were £3.5 million (2003: £4.7
million). This decrease was due to cost savings made on the Trabio
programme following the announcement of the European Phase II/III trial
result.
General and administration expenses increased to £6.4 million for the
three months ended 31 December 2004 (2003: £3.2 million). Litigation
expenses rose by £1.5 million from the three months ended 31 December 2003
to £1.9 million in the three months ended 31 December 2004, due to the
cost of the trial against Abbott in November 2004. There was an increase
of £0.8 million to £1.9 million in foreign currency translation charge due
to the significant depreciation of the US Dollar compared to the British
Pound over the period. This change arises primarily from the retranslation
of CAT’s trading balances with its US subsidiary, Aptein Inc., and is
non-cash. AstraZeneca transaction costs and staff reallocations (from
research and development to general and administration), account for a
further part of the increase.
On 21 November 2004, CAT and AstraZeneca signed a major strategic alliance
and, under the terms of a separate Subscription Agreement, AstraZeneca
subscribed, in December 2004, £75.0 million for 10.2 million shares in
CAT.
Financial Statements
The preceding information, comprising the Consolidated Profit and Loss
Account, Consolidated Statement of Total Recognised Gains and Losses,
Consolidated Balance Sheet, Consolidated Cash Flow Statement and
associated notes, does not constitute the Company’s statutory financial
statements for the year ended 30 September 2004 within the meaning of
section 240 of the Companies Act 1985, but is derived from those financial
statements. Results for the three month periods ended 31 December 2004 and
31 December 2003 have not been audited. The results for the year ended 30
September 2004 have been extracted from the statutory financial statements
which will be filed with the Registrar of Companies after the Company’s
Annual General Meeting and upon which the auditors reported without
qualification.
The annual report and financial statements for the year ended 30 September
2004 are available from our registered office:
The Company Secretary
Cambridge Antibody Technology Group plc
Milstein Building
Granta Park
Cambridge
CB1 6GH, UK
Tel: +44 (0) 1223 471471
-ENDS-
Notes to Editors
Cambridge Antibody Technology (CAT):
• CAT is a biopharmaceutical 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 280 people
• CAT is a leader in the discovery and development of human therapeutic
antibodies and has an advanced proprietary 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.
• Four CAT human therapeutic antibody products are now at various stages
of clinical development, with one further product candidate in
pre-clinical development.
• HUMIRA, the leading CAT-derived antibody, isolated and optimised in
collaboration with Abbott, has been approved for marketing as a treatment
for rheumatoid arthritis in 51 countries.
• Six further licensed CAT-derived human therapeutic antibodies are in
clinical development by licensees, with six 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.
• On 22 November 2004, CAT announced a major strategic alliance with
AstraZeneca to discover and develop human antibody therapeutics in
inflammatory disorders.
• CAT has a broad collaboration with Genzyme for the development and
commercialisation of antibodies directed against TGF, a family of
proteins associated with fibrosis and scarring.
• CAT has also licensed its proprietary technologies to several companies.
CAT’s licensees include: Abbott, Amgen, Chugai, Genzyme, 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
Page 16 of 16
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
Yvonne Alexander
BMC Communications/The Trout Group (USA)
Tel: +1 212 477 9007
Brad Miles, ext 17 (media)
Brandon Lewis, ext 15 (investors)
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