Algeta Results for the First Quarter 2010
(Thomson Reuters ONE) -
Oslo, Norway, 7 May 2010 - Algeta ASA (OSE: ALGETA), the focused oncology
company, today announces its results for the first quarter 2010. A presentation
of the results will be webcast live from 09.45 CET and can be accessed from
www.algeta.com/webcast where questions can be submitted live during the
presentation.
Highlights of the first quarter 2010:
* Recruitment of patients into the ALSYMPCA phase III trial of Alpharadin
(radium 223 chloride) for treating bone metastases arising from
castration-resistant (hormone-refractory) prostate cancer (CRPC) continues
well and ahead of schedule.
* Alpharadin clinical development program expanded with the first patients
recruited into an open label phase II study to treat bone metastases in
endocrine-refractory breast cancer. This is the second tumor type under
investigation with Alpharadin.
* Continued progress towards initiating a phase I/IIa clinical study
evaluating Alpharadin in combination with docetaxel chemotherapy in CRPC
patients with bone metastases. The trial is expected to start in mid 2010.
* New analyses from Alpharadin phase I and II clinical development program
presented at 2010 Genitourinary Cancers Symposium support earlier findings
that Alpharadin is specifically targeted to bone metastases and has a highly
favorable safety profile.
* First phase of manufacturing strategy completed for supply of Alpharadin for
future commercial use and clinical trials through collaboration with
Oslo-based Institute for Energy Technology (IFE).
Post-period update
* Sample size re-estimation of Algeta's pivotal ALSYMPCA trial, planned for
the first half of 2010, was completed successfully on schedule. The sample
size re-estimation confirmed that the current plan to recruit 750 patients
into the ALSYMPCA study will meet the goals originally set for the study.
* Algeta and its partner Bayer Schering Pharma AG ("Bayer") have in parallel
decided to increase recruitment for ALSYMPCA to 900 patients. This will
increase the power of the trial to 90% thereby further increasing the
statistical likelihood of proving the efficacy of Alpharadin. It will also
allow the study to recruit more US patients, and allow US clinical
oncologists to gain experience with the use of Alpharadin. Recruitment in
ALSYMPCA passed 600 patients during April.
* Importantly, based on the rapid recruitment already seen in this pivotal
study, Algeta and Bayer anticipate the enrolment of ALSYMPCA will still
complete as planned in the second half of 2010 with results of the trial
anticipated in 2012. This would allow for a filing in 2012 as planned.
Key financials:
* Operating revenue for the first quarter amounted to NOK 64 million compared
to NOK 24m in the last quarter and zero in the same period in 2009. The
amount included recognition of deferred upfront signing fees and
cost-sharing payments from Bayer.
* Operating expenses for the quarter amounted to NOK 64 million compared with
NOK 57 million in the last quarter and NOK 41 million in the first quarter
2009.
* Liquid funds amounted to NOK 504 million as of 31 March 2010, compared to
NOK 514 million at the end of the last quarter and NOK 327 million at the
end of the first quarter 2009.
Andrew Kay, Algeta's President and CEO, said: "Algeta, in close collaboration
with Bayer, our partner for Alpharadin, is very pleased with progress made in
our pivotal ALSYMPCA phase III trial since the start of 2010. The recruitment
rate into the trial remains very good and the sample size re-estimation we have
just completed confirms the trial is robust. The companies' decision to increase
the size of ALSYMPCA from 750 to 900 is expected to further improve the
likelihood of proving the efficacy of Alpharadin and should allow for a filing
in 2012 as planned."
"In addition, the start of a Phase II clinical trial for bone metastases in
breast cancer patients was particularly exciting as it, if successful, will
highlight the potential of Alpharadin to treat bone metastases in a second major
cancer population after prostate cancer. In addition, we continue to evaluate
promising opportunities that will enable us to develop new, targeted cancer
product candidates based on our preclinical thorium alpha-pharmaceutical
platform."
###
From 09:45 CET a presentation of the results will be webcast live. It can be
accessed from www.algeta.com/webcast where questions can be submitted live
during the presentation. The webcast can also be accessed after the
presentation.
For further information, please contact
Andrew Kay, CEO +47 2300 7990 / +47 4840 1360 (mob)
Øystein Soug, CFO +47 2300 7990 / +47 9065 6525 (mob)
post(at)algeta.com
International media enquiries: +44 207 638 9571
Mark Swallow/Helena Galilee/David Dible mark.swallow(at)citigatedr.co.uk
Citigate Dewe Rogerson
US investor enquiries: +1 646 378 2928
Jessica Lloyd jlloyd(at)troutgroup.com
The Trout Group
About Algeta
Algeta is a focused oncology company developing novel targeted therapies for
patients with cancer based on its alpha-pharmaceutical platform.
Algeta's lead product Alpharadin (based on radium-223) is a first-in-class,
highly targeted alpha-pharmaceutical under clinical evaluation to improve
survival in patients with bone metastases from advanced cancer. Its localized
action helps preserve the surrounding healthy tissue thereby limiting
side-effects.
The development of bone metastases represents a serious development for cancer
patients as they are associated with a dramatic decline in patient health and
quality of life, ultimately leading to death. Bone metastases represent a major
unmet medical need, occurring in up to 90% of certain late-stage cancers, e.g.
prostate, breast and lung.
Alpharadin is partnered with Bayer Schering Pharma AG, a major pharmaceutical
company, and is in a global phase III clinical trial (ALSYMPCA) to treat bone
metastases resulting from castration-resistant (hormone-refractory) prostate
cancer. Alpharadin is also under investigation in phase II clinical trials as a
potential new treatment for bone metastases in endocrine-refractory breast
cancer patients.
Algeta also aims to develop a future pipeline of tumor-targeting
alpha-pharmaceutical candidates based on the alpha particle emitter thorium-227,
through selective in-licensing and/or acquiring innovative technologies and
tumor-targeting molecules.
The Company is headquartered in Oslo, Norway, and was founded in 1997. Algeta
listed on the Oslo Stock Exchange in March 2007 (Ticker: ALGETA).
Alpharadin and Algeta are trademarks of Algeta ASA.
Forward-looking Statement
This news release contains forward-looking statements and forecasts based on
uncertainty, since they relate to events and depend on circumstances that will
occur in the future and which, by their nature, will have an impact on results
of operations and the financial condition of Algeta. There are a number of
factors that could cause actual results and developments to differ materially
from those expressed or implied by these forward-looking statements. Theses
factors include, among other things, risks associated with technological
development, the risk that research & development will not yield new products
that achieve commercial success, the impact of competition, the ability to close
viable and profitable business deals, the risk of non-approval of patents not
yet granted and difficulties of obtaining relevant governmental approvals for
new products.
###
This information is subject of the disclosure requirements acc. to §5-12 vphl
(Norwegian Securities Trading Act)
[HUG#1412911]
Press release: http://hugin.info/134655/R/1412911/365046.pdf
First Quarter Report 2010: http://hugin.info/134655/R/1412911/365034.pdf
First Quarter Presentation 2010: http://hugin.info/134655/R/1412911/365033.pdf
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Datum: 07.05.2010 - 02:02 Uhr
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