LONDON, May 17 /PRNewswire/ -- Celltech today announces further
substantial progress with its two leading product candidates. Both of these
have now reached key stages in their paths to registration, with a US NDA
expected to be filed during Q3 1999 for Celltech's pioneering treatment for
acute myeloid leukaemia, CMA 676. These advances were coupled with a strong
growth in licensing income arising from Celltech's antibody technology, which
nearly doubled on a like for like basis.
NEW PRODUCT PIPELINE
CMA 676 -- Acute Myeloid Leukaemia
-- Promising new results were reported at the American Society for
Clinical Oncology Meeting on 16th May 1999 with this novel treatment for acute
myeloid leukaemia (AML), developed by Celltech and American Home Products. In
a multi-centre US pivotal study, an overall remission rate of 36% was achieved
in the initial 59 patients treated with CMA 676, with complete clearance of
clinically evident leukaemic cells. Preliminary results from over
100 patients treated in the pivotal and two supporting Phase II studies are
closely comparable, with remission rates in these studies being between
36% and 44%. The product's excellent safety profile, compared with current
chemotherapy, was maintained.
-- A US NDA submission, seeking marketing authorisation, is in preparation
and is expected to be filed during Q3 1999.
-- A new study in relapsed paediatric patients has begun. Further studies
are planned in induction of first remission in AML, in myelodysplastic
syndrome and in chronic myeloid leukaemia.
CDP 571 -- Crohn's Disease
-- Two Phase IIb double-blind placebo-controlled multi-centre studies in
Crohn's disease are ongoing in the US, Canada and the UK, involving a total of
240 patients. In the main study, treatment for six months with CDP 571 is
being evaluated in 170 patients with active disease. The treatment phases of
these studies have been completed, and initial results are expected to be
available during Q3 1999. Patients completing these studies are eligible to
enter a follow-on six month open safety and efficacy study, and a high
proportion of the patients have done so.
-- Results in the major study can be utilised as pivotal data if supported
by satisfactory safety and efficacy data from the other studies. A US
Biologics Licence Application is currently expected to be filed in 2000.
Celltech intends to enter a partnership for CDP 571 and is evaluating
structures which could provide an optimal return on its investment in this
product.
Other products in Celltech's development pipeline are continuing to
progress, including:
-- CMB401 -- Ovarian Cancer
This antibody cytotoxic conjugate, developed with American Home Products,
is being evaluated in a Phase II study in ovarian cancer, in seven US and
two UK centres. Results in an initial group of patients are expected in the
second half of 1999.
-- CDP 870 -- Rheumatoid Arthritis
This potent anti-cytotoxic antibody fragment, produced by Celltech's
proprietary low cost manufacturing technology, is now being studied in an
initial Phase II study in 36 rheumatoid arthritis patients, in four UK
centres. Results are expected in Q3 1999.
FINANCIAL RESULTS FOR SIX MONTHS ENDED 31 MARCH 1999
-- Licensing income from Celltech's antibody technology nearly doubled on
a like for like basis to 5.3 million pounds sterling net
(1998 2.7 million pounds, excluding a Centocor licence access payment), due to
recently launched antibody products.
-- Celltech's net loss for the period increased to 5.7 million pounds
sterling (1998 2.9 million pounds, excluding an exceptional profit item), due
to significantly higher R&D investment of 11.5 million pounds
(1998 9.4 million pounds) arising from the ongoing CDP 571 studies.
-- The Company's cash position remained strong at 34.3 million pounds,
following a cash outflow of 5.9 million pounds.
INTERIM REPORT FOR THE SIX MONTHS ENDED 31ST MARCH 1999
Celltech's two leading product candidates have now reached key stages in
their paths to registration, following further substantial progress during the
past six months. A US NDA is in preparation, and is expected to be filed
during the third quarter of 1999 for CMA 676, Celltech's novel treatment for
acute myeloid leukaemia.
Important new results with CMA 676 were presented at the American Society
of Clinical Oncology Meeting on 16th May 1999, showing that in 59 first
relapse patients treated in a US pivotal study an overall remission rate of
36% was achieved. Preliminary results in over 100 patients in the pivotal and
two supporting studies are closely comparable with remission rates of between
36% and 44%. The product's excellent safety profile was maintained.
Also expected during the next quarter are key results from potentially
pivotal Phase IIb studies with CDP 571 in Crohn's disease.
A further candidate, CDP 870, in earlier Phase II studies for rheumatoid
arthritis, has also made significant progress.
In addition to the advances with its new product pipeline, Celltech's
licensing income, arising from its antibody technology, nearly doubled on a
like for like basis to 5.3 million pounds net (1998 2.7 million pounds,
excluding a Centocor license access payment) due to the rapid growth of
recently introduced third party antibody products.
Overall, Celltech recorded a net loss for the six month period of
5.7 million pounds (1998 loss 2.9 million pounds, excluding an exceptional
profit arising from the sale of its remaining share of Biologics). The higher
loss was due to the large R&D investment of 11.5 million pounds
(1998 9.4 million pounds) which was increased significantly by the ongoing CDP
571 clinical studies. The cash position remained strong at
34.3 million pounds, with a cash outflow of 5.9 million pounds.
DEVELOPMENT PIPELINE
-- CMA 676
Approval for US marketing authorisation is expected to be sought during
the third quarter of 1999 for Celltech's most advanced product CMA 676. This
new treatment for acute myeloid leukaemia, developed with the Wyeth-Ayerst
Research Division of American Home Products, consists of an engineered human
antibody linked to the potent cytotoxic drug calicheamicin, which specifically
targets leukaemic cells. The US NDA submission is currently in preparation.
It will be supported by the results of a multi-centre US pivotal clinical
study in adult first relapse patients, together with the findings from multi-
centre Phase II studies in (i) adult first relapse patients in Europe, and
(ii) US and European elderly patients in first relapse.
Results obtained with the initial group of 59 patients in the US pivotal
study were presented at the American Society of Clinical Oncology Meeting on
16th May 1999. They show an overall remission rate of 36% in patients treated
with two doses of CMA 676. In these patients, complete clearance of
clinically evident leukaemic cells is achieved. The product's excellent
safety profile, compared with current chemotherapy, continued to be
maintained. Preliminary results from over 100 patients, in the pivotal study
as reported at the ASCO Meeting, and in the two supporting Phase II studies,
are closely comparable, with overall remission rates being between 36% and
44%.
A new study in relapsed paediatric acute myeloid leukaemia patients was
begun during the first quarter of 1999 and further studies are being planned
to evaluate the product in induction of first remission in acute myeloid
leukaemia, in myelodysplastic syndrome, and in chronic myeloid leukaemia.
-- CDP 571
Celltech's other leading product, a fully humanised anti-TNF alpha
antibody, is being evaluated in two Phase IIb double-blind placebo-controlled
studies in centres in the US, Canada and the UK, involving a total of
240 patients. In the larger study the efficacy and duration of action of the
drug are being evaluated in 170 patients with active Crohn's disease, with
four different dosing regimens over six months. In the second study the
ability of the drug to maintain remission in Crohn's disease is being studied
in 70 patients who are currently receiving high doses of steroids, with the
steroid dose being progressively reduced over the four month study period.
The treatment phases of these studies have both been completed, and initial
results are expected to become available in the third quarter of 1999.
Patients from both studies are eligible to enter a follow-on six month
open study, to further evaluate the safety and efficacy of the product in
chronic use. A high proportion of the patients who have completed the
placebo-controlled treatment phases have elected to enter the open study.
If the results from the major study in active Crohn's disease are positive
they can be utilised as pivotal data, if supported by satisfactory efficacy
and safety data from the other above mentioned studies.
Celltech intends to enter a collaboration partnership for CDP 571, and is
continuing to evaluate potential partnership structures to provide the Company
with an optimal return on its investment in the development of this product.
-- CMB401
This engineered human antibody linked to calicheamicin, which targets
ovarian cancer cells, is being evaluated by Wyeth-Ayerst in an ongoing Phase
II study. This is being undertaken in seven US and two UK centres, in
relapsed ovarian cancer patients who have previously responded to platinum-
containing chemotherapy. An interim review of the findings in an initial
group of patients will be carried out, and the results of this are expected
during the second half of 1999.
Celltech is continuing to undertake a pilot ascending dose safety and
efficacy study with CMB401 in non-small cell lung cancer patients. This
study, which has been extended, is expected to be completed during this year.
-- CDP 870
This potent humanised anti-cytokine antibody fragment is being produced by
fermentation in E.coli, using Celltech's proprietary low cost manufacturing
technology. It is being assessed in an initial ascending dose Phase II study
in approximately 36 rheumatoid arthritis patients, in four UK rheumatology
centres. The initial phase of the study is placebo-controlled, and will
assess the effects of a single dose over eight weeks. Patients are then
eligible to receive a second dose in an open phase of the study. The results
from this study are currently expected during the third quarter of 1999. In
an earlier Phase I study this modified antibody fragment had a plasma
half-life of approximately 11 days, and no safety issues were identified.
-- SCH55700
SCH55700, which is being developed by Schering-Plough, is a humanised
anti-interleukin 5 antibody, which can potentially block the accumulation of
inflammatory cells, principally eosinophils, in the lungs of asthma patients.
Schering-Plough has been undertaking an initial ascending dose clinical
study with this antibody, and this study is still ongoing. The antibody has a
prolonged plasma half-life in patients (25 days), as previously reported, with
relatively high antibody levels detectable for several months. Consequently
the observation period is being extended to fully characterise the clinical
profile of the antibody.
-- CDP 860
This modified antibody fragment, which is also produced by E.coli
fermentation, binds to the platelet-derived growth factor beta receptor. It
has undergone extensive preclinical safety and metabolism studies and is
expected to enter Phase I clinical studies in mid- 1999. If the results from
these studies are satisfactory, it will enter a Phase II proof-of-concept
study in stented angioplasty patients, to assess whether it can reduce the
recurrence of coronary artery restenosis which can occur after angioplasty.
CDP 855
This humanised antibody, which binds specifically to a region of the Class
II MHC complex, has potent immunosuppressive activity. It has been evaluated
by Celltech in a number of preclinical models for the prevention of graft
rejection. However, results from extensive preclinical studies identified
potential safety issues, and this antibody will therefore not be entered into
clinical development
DISCOVERY PROGRAMMES
During the six month period a far-reaching reorganisation of Celltech
Discovery has been implemented, and its programme portfolio has undergone an
extensive review. The aim of the reorganisation was to optimise the
allocation of resources to key programmes, and to put in place a new
organisational structure that addresses fully and effectively the therapeutic
areas and programmes which have been identified as key priorities. These
programmes continue to be in the areas of immune and inflammatory disorders
and in cancer. Key decision points and objectives for each programme within
the current portfolio have been defined, for both pre-existing and new
programmes.
Integrin receptor antagonists represent Celltech's largest unpartnered
investment in small molecule drug discovery at this time. Other unpartnered
programmes include KDR kinase inhibitors and antibody targeted gene therapy,
both primarily aimed at cancer targets, and a novel approach to controlling
allergy. Progress with the major current internal and partnered programmes is
summarised below:
Integrin Antagonists
The largest programme in the integrin field, the VLA-4 antagonist
programme, is focused upon identifying novel orally active treatments for
airway inflammation in asthma. Substantial effort is continuing to both
optimise the efficacy, oral activity and pharmacokinetics of compounds from
several non-peptidic series.
Within the integrin receptor family, there is a range of potentially
important targets, and Celltech is using its expertise in the integrin
antagonist field to pursue a further programme to develop new treatments for
inflammatory bowel disorders. It is also undertaking an exploratory programme
targeted at osteoporosis.
Discovery Partnerships
Celltech's collaborative discovery programmes with major pharmaceutical
companies have all achieved encouraging progress during the six month period,
as follows:
-- Phosphodiesterase IV Inhibitors for Asthma
This substantial collaborative programme with Merck aims to identify
potent and selective PDE IV inhibitors as novel oral treatments for mild to
moderate asthma. Further progress has been made, and Merck is continuing to
optimise and extensively evaluate candidates for entry into development.
Further time-based payments of 0.7 million pounds were made during the
six month period, with total payments of 14 million pounds since the beginning
of the collaboration.
-- Aggrecanase Inhibitors for Osteoarthritis
The programme, which is partnered with AstraZeneca, aims to develop a
novel approach to the treatment of osteoarthritis. Aggrecan is the
predominant component of human cartilage and a treatment that is able to
retard its destruction would be a major new therapy for the disease. Most of
the work is being undertaken within AstraZeneca, and significant progress has
been made with the identification of promising lead inhibitors of aggrecanase.
-- Antibody-Cytotoxic Drug Conjugates for Cancer
Celltech and Wyeth-Ayerst are currently applying their proprietary
antibody-calicheamicin technology to a range of further cancer therapy
targets. This collaborative research effort is currently creating an
innovative research pipeline of new product opportunities.
FINANCIAL RESULTS
In the six months ended 31st March 1999, the net royalties received by
Celltech nearly doubled to 5.3 million pounds from 2.7 million pounds in 1998
(on a like for like basis, being 5.7 million pounds less a licence access fee
paid by Centocor). The actual licence income received amounted to
5.9 million pounds, but this was reduced by 0.6 million pounds as a result of
royalty payments by Celltech to Genentech and the Medical Research Council,
under the terms of cross-license agreements, representing a proportion of
certain royalties received by Celltech. These arrangements will continue in
the future and relate to the Boss patent. Licensing income has grown
substantially during the period because there are now seven antibody products
on the market licensed to Boss. Further growth in licensing income is
anticipated, as the sales of these recently launched products continue to
increase as the products mature.
Investment in research and development increased 22% to
11.5 million pounds. Underlying this was an increase in external development
expenditure, principally clinical trial costs and product purification for CDP
571, from 2.2 million pounds in 1998 to 4.2 million pounds in 1999. Internal
costs advanced marginally to 7.3 million pounds from 7.2 million pounds in
1998. The costs of developing CDP 571 to the conclusion of the two large
clinical trials which are currently ongoing will continue to impact external
development costs until the end of the calendar year.
Other operating income of #0.7 million was at the same level as 1998 and
for both years represented time-based payments received under the continuing
Merck collaboration.
Overall the net loss for the six month period of 5.7 million pounds
increased from a loss of 2.9 million pounds in 1998 (excluding the
5.4 million pounds exceptional profit on disposal in December 1997 of the
remaining interest in the Biologics business).
The financial position of Celltech remained strong at the end of the
period with cash of 34.3 million pounds, reflecting cash outflow of
5.9 million pounds in the six month period.
Consolidated Profit and Loss Account
for the six months ended 31 March 1999
Unaudited Unaudited Audited Year to
6 months to 6 months to 30 September
31 March 1999 31 March 1998 1998
Notes pounds m pounds m pounds m
Turnover 1 5.9 5.7 11.7
Cost of sales 2 (0.6) -- --
Gross profit 5.3 5.7 11.7
Investment in research
and development (11.5) (9.4) (21.5)
Corporate and general
administrative expenses (1.4) (1.2) (2.9)
Other operating income --
research and development
milestones 0.7 0.7 1.5
Operating loss (6.9) (4.2) (11.2)
Net interest receivable 1.2 1.3 2.7
Profit on sale of Biologics -- 5.4 5.4
(Loss)/profit on ordinary
activities before taxation (5.7) 2.5 (3.1)
Taxation -- -- --
(Loss)/profit on ordinary
activities after taxation (5.7) 2.5 (3.1)
Accrual for unpaid preference
share dividend
transferred to other reserves 0.1 0.1 0.2
Transfer (from)/ to profit &
loss account reserve (5.8) 2.4 (3.3)
Net transfer (from)/ to reserves (5.7) 2.5 (3.1)
(Loss)/earnings per share (7.6p) 3.1p (4.4p)
Note 1
The results have been prepared in accordance with the accounting policies
set out in the Annual Report for the year to 30 September 1998. The results
for the year to 30 September 1998 are an abridged version of the full accounts
for that year which received an unqualified audit report and have been filed
with the Registrar of Companies.
Note 2
Cost of sales comprises royalties payable under cross licences in respect
of income generating patents, together with the costs of maintaining and
defending the groups income generating patent position. No such costs arose in
the year to 30 September 1998.
Consolidated Balance Sheet
at 31 March 1999
Unaudited at Unaudited at Audited at
31 March 31 March 30 September
1999 1998 1998
pounds m pounds m pounds m
Fixed assets
Tangible assets 7.2 6.7 7.1
Investments -- 0.2 --
7.2 6.9 7.1
Current assets
Stock 1.2 -- 0.9
Debtors 1.2 1.2 0.8
Cash and Liquid resources 34.3 43.7 40.2
36.7 44.9 41.9
Creditors: amounts falling
due within one year (7.2) (4.5) (7.1)
Net current assets 29.5 40.4 34.8
Total assets less current
liabilities 36.7 47.3 41.9
Creditors: amounts falling
due after more than one year
Obligations under
finance leases (0.2) (0.2) (0.2)
Net assets 36.5 47.1 41.7
Capital and reserves
Called up share capital 42.0 41.8 41.8
Share premium account 61.2 60.7 60.9
Other reserves 10.4 10.3 10.3
Profit and loss account (77.1) (65.7) (71.3)
Shareholders' funds 36.5 47.1 41.7
Consolidated Cash Flow Statement
for the six months ended 31 March 1999
Unaudited Unaudited Audited Year to
Six months to Six months to 30 September
31 March 1999 31 March 1998 1998
pounds m pounds m pounds m
Net cash outflow from
operating activities
(see below) (6.8) (4.0) (8.4)
Returns on investments
and servicing of finance -
Net interest 1.2 1.3 2.7
Taxation -- (0.2) (0.1)
Capital expenditure
and financial investment -
Payments to acquire
tangible fixed assets (0.6) (0.7) (1.5)
Acquisitions and disposals -
Proceeds from sale of
24.9% of Lonza Biologics plc -- 10.5 10.5
Earn out payment from
Alusuisse-Lonza -- 0.1 0.1
-- 10.6 10.6
Financing -
Proceeds of exercise of
share options 0.5 0.6 0.8
Other (0.2) (0.2) (0.2)
0.3 0.4 0.6
(Decrease)/increase in Cash
and Liquid resources (5.9) 7.4 3.9
Operating loss (6.9) (4.2) (11.2)
Depreciation 0.6 0.5 1.0
Movement in working capital (0.5) (0.3) 1.8
Net cash outflow from
operating activities (6.8) (4.0) (8.4)
SOURCE Celltech plc
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Related links:
http://www.celltech.co.uk
CONTACT:
Peter Fellner, +44-1753-777101, or Peter
Allen, +44-1753-777100, both of Celltech; or Jon Coles of
Brunswick, +44-171-404-5959, for Celltech
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