Algeta results for the first half and second quarter 2011
(Thomson Reuters ONE) -
Not intended for U.S. Media
Oslo, Norway, 11 August 2011 - Algeta ASA (OSE: ALGETA), a company focused on
the development of novel targeted cancer therapeutics, today announces its
results for the first half and second quarter ending 30 June 2011.
A presentation of the results in Oslo will be webcast live from 10:30 CET and
can be accessed from www.algeta.com/webcast where questions can be submitted
live during the presentation. A conference call will take place at 14:30 CET.
Details of both events are below.
Highlights of the first half and second quarter 2011:
· In June, Alpharadin met the primary endpoint of overall survival in a
pre-planned interim analysis of the pivotal phase III ALSYMPCA trial for the
treatment of symptomatic bone metastases in patients with castration-resistant
prostate cancer
· The trial was stopped early on the basis of statistically significant
improvement in overall survival (two-sided p-value = 0.0022, hazard ratio =
0.699, the median overall survival was 14.0 months for Alpharadin and 11.2
months for placebo) and following a recommendation from an Independent Data
Monitoring Committee
· Algeta and Bayer, its global partner for Alpharadin, will present the
ALSYMPCA results at scientific major medical conference and submit them for
publication in a peer-reviewed journal
· Alpharadin showed further promise in a Phase IIa trial for bone
metastases in endocrine-refractory breast cancer patients. Preliminary top-line
results found that Alpharadin reduced the levels of bone alkaline phosphatase
(bALP) and urine N-telopeptide (uNTX), two key markers of bone turnover
associated with bone metastases in breast cancer
· Algeta announced agreements with Genzyme (Sanofi) and Affibody to
progress its Thorium platform aimed at generating novel tumor-targeted alpha-
pharmaceuticals based on thorium-227 (also known as Targeted Thorium Conjugates,
TTCs). The collaboration agreement with Genzyme is evaluating a Genzyme antibody
combined with Algeta's Thorium payload. With Affibody, Algeta has exclusive
worldwide licenses to develop TTCs against HER-2 (breast cancer target) and
PDGFRß (angiogenesis target) using Affibody's proprietary technology
· Algeta was awarded a NOK 10m ($1.9m) grant from the Research Council
of Norway to develop Targeted Thorium Conjugates
Key financials:
· Operating revenue for the second quarter amounted to NOK 59m compared
with NOK 54m in the second quarter in 2010. Operating revenue for the first half
of 2011 was NOK 115m compared with NOK 119m in the same period in 2010
· In May 2011, Algeta recognized a EUR 0.5m (NOK 4m) payment from Bayer
to initiate a project designed to increase the production of actinium-227, the
source material for Alpharadin, consequently securing its long-term supply
* Operating expenses for the second quarter 2011 amounted to NOK 73m compared
with NOK 54m in the second quarter 2010. Operating expenses for the first
half of 2011 were NOK 135m compared with NOK 118m in the same period in 2010
* Liquid funds amounted to NOK 432m as of 30 June 2011, compared with NOK
445m at the end of June 2010
Andrew Kay, Algeta's President and CEO, said: "The positive interim analysis is
an outstanding achievement for Algeta, reinforcing our belief in Alpharadin's
potential to become an important treatment for bone metastases in prostate
cancer patients. Our partner Bayer is focused on the regulatory strategy and
global commercialization of Alpharadin to ensure it reaches patients as quickly
as possible.
"We are also delighted with the promising initial results Alpharadin showed in
endocrine refractory breast cancer patients with bone metastases, a second
potential major indication with unmet clinical need. Furthermore, we have
continued to make solid progress advancing our strategy for our Thorium
platform. The agreements with Genzyme and Affibody, as well as the grant from
the Norwegian Research Council, demonstrate the significant interest in our
Thorium alpha-pharmaceutical technology to develop targeted antibody conjugated
cancer therapeutics.
"Algeta has delivered key clinical milestones for Alpharadin ahead of schedule
and anticipates a first regulatory filing in mid 2012, earlier than previously
planned. The next 12 months will be very busy and exciting as we get closer to
introducing our first product for cancer patients."
Details of presentation and webcast
A presentation to investors, analysts and the press will take place in Oslo at
10:30 CET. Algeta's President and CEO Andrew Kay, CMO Gillies O'Bryan-Tear, CTO
Thomas Ramdahl and CFO Øystein Soug will present.
The presentation will also be webcast live and can be accessed from
www.algeta.com/webcast where questions can be submitted live during the
presentation.
The presentation will take place at 10:30 CET at:
Shippingklubben
Haakon VIIs gate 1
0161 Oslo
Norway
Details of international conference call
An international conference call will take place at 14:30 CET (details below).
Andrew Kay, Gillies O'Bryan-Tear, Thomas Ramdahl and Øystein Soug will
participate.
To participate in the conference call, please dial the appropriate number below
five minutes prior to the call:
800 80 119 (in Norway)
+47 23 18 45 01 (from abroad)
To access the replay, please dial +47 23 18 45 02. Enter account no. 1428
followed by #, then press 1, conference no. 428 followed by #. Press 1 to play.
A replay version of the conference call will also be available at
www.algeta.com.
The results report and the presentation will be made available on www.algeta.com
in the Investors section from 07:00 CET.
###
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/David Dible/Sita Shah 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 company focused on 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 frequently in certain late-stage cancers, e.g.
prostate (in up to 90% patients), breast (up to 60 %) and lung (up to 40%).
Alpharadin is being developed under a development and commercialization
agreement with Bayer HealthCare Pharmaceuticals AG, and is in a global phase III
clinical trial (ALSYMPCA) to treat bone metastases resulting from castration-
resistant prostate cancer (CRPC). In June 2011, the trial was stopped early on
the basis of showing an overall survival benefit. Alpharadin is also under
investigation in phase II clinical trials as a potential new treatment for bone
metastases in endocrine-refractory breast cancer patients, and in a phase I/IIa
trial in combination with docetaxel chemotherapy in for bone metastases CRPC
patients.
Algeta is also exploring the potential of Targeted Thorium Conjugates (TTCs),
which are based on conjugating the alpha-emitter thorium-227 to targeting
molecules, as a basis of a future pipeline of tumor-targeting alpha-
pharmaceutical candidates.
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. These
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 pursuant to section
5-12 of the Norwegian Securities Trading Act.
Press release:
http://hugin.info/134655/R/1537702/469439.pdf
Second Quarter Report 2011:
http://hugin.info/134655/R/1537702/469441.pdf
Second Quarter Presentation 2011:
http://hugin.info/134655/R/1537702/469440.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.
Source: Algeta ASA via Thomson Reuters ONE
[HUG#1537702]
Unternehmensinformation / Kurzprofil:
Datum: 11.08.2011 - 07:01 Uhr
Sprache: Deutsch
News-ID 57137
Anzahl Zeichen: 11380
contact information:
Town:
Oslo
Kategorie:
Business News
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