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Biotech / Medical : Celltech Group (NYSE: CLL)

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To: keokalani'nui who wrote (76)6/16/2003 3:35:58 AM
From: nigel bates   of 123
 
Research update:



16 June 2003

CELLTECH GROUP PLC
ONCOLOGY PIPELINE UPDATE

Celltech Group plc (LSE: CCH; NYSE: CLL) is today providing a comprehensive
update on recent developments within its oncology pipeline and discovery
programmes, including new elements resulting from the integration of OGS.

In-house oncology development pipeline

• CDP 791

CDP 791 is an extremely high affinity PEGylated antibody fragment targeting the
VEGF pathway. Data published at the recent ASCO meeting from a clinical trial in
colorectal cancer with an anti-VEGF antibody have highlighted the potential for
this class of drugs as adjunctive agents to be used alongside existing
chemotherapeutic regimens.

CDP 791 will this month enter Phase I clinical studies in patients. Preclinical
studies with CDP 791, highlighted at Celltech's R&D day in October 2002, have
demonstrated potent anti-angiogenic activity. CDP 791 is produced using
Celltech's proprietary microbial manufacturing technology and is expected to
have a competitive cost of goods profile, along with the potential for
subcutaneous dosing.

• CDP 860

CDP 860, an anti-PDGF-beta receptor PEGylated antibody fragment, has recently
completed a small Phase II proof-of-concept study to determine whether it is
able to increase the permeability of tumours, which may facilitate an increased
uptake of chemotherapeutic agents, thereby increasing their effectiveness. The
effects observed in this study, in which a single dose of CDP 860 was
administered to patients with colorectal and ovarian cancer, were consistent
with the proposed mechanism of action and confirmed the potent biological
activity of this molecule. The side effects observed in this study were also
consistent with the mechanism of action, including reversible edema.

Celltech intends to partner CDP 791 and CDP 860 with companies possessing
significant oncology development expertise that have the ability to explore
their utility in a broad range of tumour types alongside existing
chemotherapeutic regimens. Celltech is currently pursuing discussions about
potential partnerships that enable it to maximise its return from these
programmes.

Partnered oncology development pipeline

• BMS-275291

Celltech's partner, Bristol-Myers Squibb company (BMS), has been evaluating this
selective matrix metalloproteinase inhibitor in a large Phase II study in
non-small cell lung cancer (NSCLC) in combination with Taxol (paclitaxel) and
Paraplatin (carboplatin). Following a planned interim analysis BMS and Celltech
were informed by the Drug Safety Monitoring Committee that BMS-275291 was
unlikely to reach its pre-determined efficacy end point. Accordingly, this study
was interrupted and treatment ceased in nearly all patients. BMS does not plan
to develop BMS-275291 further in this indication.

BMS-275291 continues to be evaluated in small pilot studies in
hormone-refractory prostate cancer and Kaposi's sarcoma.

Dr. Goran Ando, Chief Executive Officer, commented: 'It has long been widely
understood that this was a high-risk programme, undertaken at no cost to
Celltech, with a compound in a class of treatments that have previously failed
to show benefits.'

• CMC-544

CMC-544 is an anti-CD22 antibody linked to calicheamicin, a potent cytoxic drug,
using technology developed for the FDA-approved drug Mylotarg. Celltech's
partner, Wyeth, will shortly initiate Phase I studies in Non-Hodgkin's lymphoma
with CMC-544.

Under the terms of Celltech's collaboration, Wyeth funds the majority of
clinical trial for CMC-544, with Celltech receiving a significant royalty on
future sales of the product, if successfully commercialised.

Discovery programmes

• Integration of Oxford GlycoSciences (OGS) oncology activities

Celltech's integration of OGS has included a detailed review of scientific
skills and programmes, with a particular focus on its oncology research
activities. Through this review, Celltech has identified both a highly skilled
research team and a number of established oncology research programmes, in both
the antibody and small molecule areas.

In support of Celltech's corporate objective of enhancing its oncology
activities as a strong second franchise alongside its existing research in
immune disorders and inflammatory diseases, Celltech will adopt a number of
these oncology research programmes within its own pipeline. The most advanced of
these programmes would be expected to yield antibody development candidates
within two years. In addition, Celltech plans to retain a significant number of
research staff working in the oncology area, and is pleased to report 100%
acceptance of positions offered to date.

These early-stage activities will be incorporated within Celltech's existing R&D
budget, reflecting Celltech's previously stated goal of an earnings- and
cash-neutral acquisition of OGS.

Dr. Goran Ando, Chief Executive Officer, commented: 'We are very excited about
the prospects for Celltech's early stage pipeline, and are focused on strategies
to maximise value from these programmes by progressing them rapidly through the
clinic ourselves, where we have the requisite capabilities, or in collaboration
with other leading companies.

Celltech's partnering approach, which enables us to limit our exposure to
development costs in large scale clinical programmes, remains an important
component of maintaining an appropriate risk/reward profile for the company.

Through increased research productivity we see a number of exciting
opportunities to further expand Celltech's oncology development pipeline, which
should be further enhanced in the mid-term through the addition of OGS'
promising early stage research portfolio.'
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