Antisoma Interim Management Statement
08:05 13.10.10
London, UK, and Cambridge, MA: 13 October 2010 - Cancer drug developer Antisoma
plc (LSE: ASM; USOTC: ATSMY) today publishes its Interim Management Statement
for the period from 1 July to 12 October 2010.
Antisoma's CEO, Glyn Edwards, said: "We are on track to report pivotal trial
results for AS1413 in the first half of next year. If these are positive, we
will file marketing applications. Our latest market research suggests that
AS1413 could generate very substantial sales revenues."
Highlights
AS1413
* New market research indicates potential sales of up to $670 million per
annum in acute myeloid leukaemia (AML)
* Phase III trial in secondary AML fully enrolled
* Phase III trial results expected H1 2011
AS1411
* Phase IIb trial in AML ongoing, extended to India
* Phase IIb data expected H1 2011
Joint Chairman and CEO's statement
We will soon report data from two important clinical trials: a phase III study
of AS1413 and a phase IIb study of AS1411. The AS1413 trial is most critical
because positive data would lead to submissions for marketing authorisations.
AS1413 in the spotlight
In September we announced that we had completed the enrolment of over 420
patients into 'ACCEDE', a pivotal phase III trial evaluating AS1413 as a
treatment for secondary AML. This put us on track to report the trial's outcome
in H1 2011. Collection and collation of data remains on course for that timing.
ACCEDE is the biggest randomised trial conducted to date in secondary AML.
We have recently completed a large market research and forecasting exercise to
evaluate the revenues that could be achieved following launches of AS1413. This
focused mainly on the opportunity in the U.S., but has also served to refine our
view of potential sales in other markets. The exercise included an analysis of
all claims made under the U.S. Medicare system for the treatment of AML during
2008 and a survey of 150 U.S. oncologists and haematologists who treat AML
patients.
Our forecasts based on this research indicate that peak global sales of AS1413
could reach $670 million per annum if we gain initial approvals for treatment of
patients with secondary AML and subsequent approvals for use in older 'de novo'
AML patients. With approvals in secondary AML alone, we could expect global peak
sales in the range of $440 to $580 million.
We continue to talk to potential licensing partners for AS1413. There is
interest in global and regional partnerships. However, we will only conclude a
deal or deals before phase III data if compelling terms are available.
AS1411 also approaching key results
We are enrolling patients into a phase IIb trial of AS1411 in AML, which builds
on positive findings from an earlier phase II trial in the same setting. We
recently expanded the geographical reach of the study to include India in
addition to sites already active in the U.S., South Korea, Taiwan, Australia and
New Zealand.
We expect to report headline findings from the phase IIb trial in the first half
of 2011. If these are positive, the next step will be a pivotal phase III trial
in AML, as well as consideration of opportunities for the drug in other cancer
settings. Clinical and non-clinical data suggest that AS1411 could have
application across a number of blood cancers and solid tumours.
DCAM programme progressing towards partnering
Our DCAMs (dendritic cell auto-immune modulators) are highly specific, small-
molecule inhibitors of wild-type Flt3 designed for oral treatment of auto-immune
conditions. Following positive results in animal models of inflammatory bowel
disease and rheumatoid arthritis, we are working towards establishing a
licensing partnership for further development of the programme.
Cash resources meet business needs
Our existing cash resources are anticipated to cover the needs of the business
until well after we report our critical trial data in the first half of calendar
2011.
Outlook
Our current focus is delivery of the clinical data for AS1413 and AS1411 and
preparation to ensure we can move rapidly to exploit positive outcomes from the
trials of either or both of these drugs.
Barry Price
Chairman |
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