Algeta results for the second quarter and first half 2010

Friday, 13. August 2010 08:03
Oslo, Norway, 13 August 2010 - Algeta ASA (OSE: ALGETA), the focused oncology
company, today announces its results for the second quarter and the six months
ending 30 June 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 second quarter 2010:

* Algeta and its partner Bayer Schering Pharma AG ("Bayer") decided to
increase recruitment for the ALSYMPCA phase III trial of Alpharadin (radium
223 chloride) for treating bone metastases arising from castration-resistant
(hormone-refractory) prostate cancer (CRPC) to 900 patients.  This decision
increases the power of the trial to 90% and further increases the
statistical likelihood of proving the efficacy of Alpharadin.


* Recruitment in ALSYMPCA passed 700 patients during June 2010. Based on the
rapid recruitment rate in this pivotal study, Algeta and Bayer anticipate
the enrolment of ALSYMPCA will be completed as planned towards the end of
the second half of 2010 with results of the trial anticipated in 2012. This
would allow a regulatory filing in 2012 as planned.


* Analyses of clinical data from Algeta's phase I and phase II clinical
program with Alpharadin were presented at the 46th Annual Meeting of the
American Society for Clinical Oncology (ASCO) in June 2010. Findings support
specific targeting of Alpharadin to bone metastases and a highly tolerable
safety profile. These data were also presented at the 2010 Genitourinary
Cancers Symposium in March 2010.


* A phase I/IIa clinical study evaluating Alpharadin in combination with
docetaxel chemotherapy in CRPC patients with bone metastases was initiated
on schedule at the end of June 2010 at Memorial Sloan Kettering Cancer
Center. The first patient was dosed on 10 August.


Highlights of the first quarter 2010:

* 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.


Post-period update

* Algeta concluded agreements for the exclusive manufacture and supply of
Alpharadin for future commercial sale, triggering a EUR 5m milestone payment
from Bayer. The second agreement sees Algeta significantly extend its
collaboration with Norway's Institute for Energy Technology (IFE), which
currently manufactures Alpharadin for the ALSYMPCA study and other clinical
trials. In conjunction with Algeta, IFE will expand the existing Alpharadin
production facility at IFE. The upgrade, which will be paid for by Algeta,
will create a state-of-the-art manufacturing platform to supply the expected
commercial world demand following approval and launch.



Key financials:

* Operating revenue for the second quarter amounted to NOK 54m compared to NOK
64m in the first quarter and zero in the same period in 2009. The amount
included recognition of deferred upfront signing fees and cost-sharing
revenues from Bayer. Operating revenue for the first half of 2010 were NOK
119m compared to zero in the same period in 2009 .


* Operating expenses for the second quarter amounted to NOK 54 million
compared with NOK 45m in the second quarter 2009. Operating expenses for the
first half of 2010 were NOK 118m compared to NOK 86 in the same period in
2009.


* Liquid funds amounted to NOK 445m as of 30 June 2010, compared to NOK 514m
at the end of December 2009.


Andrew Kay, Algeta's President and CEO, said: "Algeta continued to make good
progress across its entire business during the first half of 2010. The clinical
development of Alpharadin in conjunction with our partner Bayer is advancing as
planned and we have signed an agreement with IFE to build our state-of-the-art
manufacturing facility for commercial supply. We are also working together with
Bayer to build the profile of this exciting potential new treatment for bone
metastases with the medical community. In addition, Algeta has recently begun to
execute the new strategy for our Thorium platform and we have initiated key
technology programmes. The momentum we have generated post our deal with Bayer
means that Algeta is well positioned to grow shareholder value over the next
6-12 months and we look forward to the future with confidence."

###



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@algeta.com


International media enquiries: +44 207 638 9571
Mark Swallow/Helena Galilee/David Dible mark.swallow@citigatedr.co.uk
Citigate Dewe Rogerson


US investor enquiries: +1 646 378 2928
Jessica Lloyd jlloyd@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 being developed under a development and commercialization
agreement 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#1437780]





Second Quarter Presentation 2010:
http://hugin.info/134655/R/1437780/382471.pdf

Press release:
http://hugin.info/134655/R/1437780/382473.pdf

Second Quarter Report 2010:
http://hugin.info/134655/R/1437780/382472.pdf




This announcement is distributed by Thomson Reuters on behalf of
Thomson Reuters clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
All reproduction for further distribution is prohibited.

Source: Algeta ASA via Thomson Reuters ONE
Related Links: 
Author:
Hugin
Copyright GlobeNewswire, Inc. 2016. All rights reserved.
You can register yourself on the website to receive press releases directly via e-mail to your own e-mail account.