SOURCE: Antisoma plc
Antisoma AGM update and Interim Management Statement
LONDON and CAMBRIDGE, MA--(Marketwire - November 18, 2008) - Cancer drug
developer Antisoma plc (
Glyn Edwards, Antisoma's CEO, said: "We are finishing 2008 in a
strong position, with a broad and maturing portfolio of cancer drug
candidates, a valuable partnership with Novartis, and significant
cash resources at our disposal."
ASA404 - potential blockbuster, expanding programme
Our tumour-vascular disrupting agent, ASA404, is making good progress
in the capable hands of our partner, Novartis. A 1200-patient phase
III trial (ATTRACT-1) is testing the drug as a first-line treatment
for non-small cell lung cancer. This is the setting in which we
observed a five-month improvement in median survival in a randomised
phase II trial. Should the phase III trial also produce positive
data, we expect applications for marketing licences in 2011.
Non-small cell lung cancer is among the most common cancers
worldwide. It therefore represents both a significant unmet medical
need and a substantial commercial opportunity. Novartis is expanding
its trial programme to ensure
that a wide variety of lung cancer patients could be eligible for
treatment with ASA404. A second, large pivotal trial (ATTRACT-2),
including 900 patients receiving second-line treatment for non-small
cell lung cancer, will begin shortly. Novartis is also considering
options for developing the drug in other cancer types.
In addition to the USD 100 million that we have already received from
Novartis, we can earn substantial further milestone payments based on
progress of ASA404 in development and achievement of sales targets.
We will also earn royalties on all sales of the drug worldwide, and
have a strategically important option to co-commercialise ASA404 in
the US.
AS1413 - new addition with significant potential
The novel chemotherapy drug AS1413 was added to our pipeline through
the acquisition of Xanthus earlier this year. Along with ASA404, this
drug has become a key asset in the Company's portfolio. A phase III
trial is ongoing in secondary acute myeloid leukaemia (secondary AML)
under a Special Protocol Assessment from the US Food and Drug
Administration (FDA). We are expanding the study so that it will now
include around 450 patients at hospitals in North America, Europe and
other territories.
The phase III trial builds on positive data from a phase II study in
secondary AML, from which the latest, updated findings will be
presented in early December at the Annual Meeting of the American
Society of Hematology (ASH).
AS1413 has the potential to be the first drug to gain a licence
specifically for secondary AML, a disease which is poorly treated by
currently available therapies.
We retain all rights to this drug. If the phase III trial is
successful, we intend to commercialise it ourselves in the US. We
plan to form partnerships to commercialise AS1413 in other
territories.
Oral fludarabine - FDA decision anticipated
Fludarabine is a drug widely used to treat chronic lymphocytic
leukaemia (CLL). It is currently available in the US only as an
intravenous infusion. We have US rights to the oral, tablet
formulation of the drug and have submitted a marketing application to
the FDA. We expect a decision on its approval some time between now
and the end of June 2009.
Outside the US, oral fludarabine is marketed by Bayer Schering Pharma
AG. In European countries, the oral formulation has assumed a
substantial share of the fludarabine market since its launch, so we
believe the drug represents an attractive niche sales opportunity in
the US.
We have decided that the best way to realise the value of oral
fludarabine is through a commercialisation deal with a partner that
has established marketing infrastructure in the US. We have initiated
talks with a number of potential partners, and believe that FDA
approval of the product would put us in a strong position to close a
deal.
AS1411 - roll out of phase II data begins
Our aptamer drug AS1411 is entering a critical phase in its
development, with two phase II studies now underway. We have reported
promising initial findings from a randomised trial in acute myeloid
leukaemia, and there will be more data from this study presented at
the forthcoming ASH meeting. The other trial is in renal cancer,
where we saw cases of profound tumour shrinkage in phase I. We expect
a cascade of data from these two phase II trials, culminating with
final results from the AML and renal trials in mid-2009 and 2010,
respectively.
Portfolio - other clinical and preclinical products advancing
Our earlier stage pipeline continues to advance and expand. Our
antibody drug AS1402 has now entered a randomised phase II study in
breast cancer and our antibody-cytokine fusion product AS1409 is
being tested in a phase I study in renal cancer and melanoma
patients. We have expanded our preclinical pipeline this year with
three new and highly novel programmes - AMPK activators licensed from
Betagenon, PPM1D inhibitors licensed from The Institute of Cancer
Research, and an exciting programme of FLt-3 inhibitors for
auto-immune conditions acquired with Xanthus.
Solid financial position supports momentum in products
We have a solid financial position that reflects the impact of
milestone payments from Novartis and support from investors who
provided new funds to support the development of products acquired
with Xanthus. Thus, at the end of June 2008 we had GBP 66.9 million
of cash and liquid resources, giving us the ability to continue
investment in all our key pipeline programmes.
Positive outlook
With our expanded and well-funded pipeline, we look forward to
reporting a wealth of new data over the short and medium term. We
believe that, with a number of products now in late-stage
development, we are primed to make the transition from being a
development company to being a company that both develops and
commercialises novel cancer drugs.
Except for the historical information presented, certain matters
discussed in this statement are forward looking statements that are
subject to a number of risks and uncertainties that could cause
actual results to differ materially from results, performance or
achievements expressed or implied by such statements. These risks and
uncertainties may be associated with product discovery and
development, including statements regarding the Group's clinical
development programmes, the expected timing of clinical trials and
regulatory filings. Such statements are based on management's current
expectations, but actual results may differ materially.
Background on Antisoma
Antisoma is a London Stock Exchange-listed biopharmaceutical company
that develops novel products for the treatment of cancer. The Company
has operations in the UK and the US. Please visit
www.antisoma.com for further information about Antisoma.
This announcement was originally distributed by Hugin. The issuer is
solely responsible for the content of this announcement.
Enquiries:
Glyn Edwards, CEO
Daniel Elger, Director of Communications +44 (0)7909 915 068
Antisoma plc
Mark Court/Lisa Baderoon/Rebecca Skye +44 (0)20 7466 5000
Dietrich
Buchanan Communications
Seth Lewis +1 617-583-1308
The Trout Group
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