Algeta results for the third quarter 2011

Thursday, 10. November 2011 07:01
Oslo, Norway, 10 November 2011 - Algeta ASA (OSE: ALGETA), a company focused on
the development of novel targeted cancer therapeutics, announces its results for
the third quarter 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 at the end of this announcement.

Highlights of the third quarter 2011:

* In September, the positive data from the phase III ALSYMPCA study of
Alpharadin (radium-223 chloride) in patients with castration-resistant
prostate cancer (CRPC) and symptomatic bone metastases were presented during
the Presidential Session I: Best and Late-Breaking Abstracts at the 2011
European Multidisciplinary Cancer Congress (EMCC: 16th ECCO-36th ESMO-30th
ESTRO) in Stockholm, Sweden.


The study found that Alpharadin improved overall survival by 44% [hazard ratio
(HR)=0.695; p=0.00185] in CRPC patients vs. the placebo group. The Alpharadin
group had a median overall survival of 14.0 months compared to 11.2 months for
the placebo group.

In addition, the Alpharadin group had a median time to first skeletal-related
event (SRE) of 13.6 months (64% improvement, HR=0.610, p=0.00046) vs. 8.4 months
for the placebo group. All of the other main secondary endpoints were met,
including changes in key biomarkers indicative of disease status.

The trial was stopped early in June 2011 when it met the primary endpoint of a
statistically significant improvement of overall survival in a pre-planned
interim analysis and following a recommendation from an Independent Data
Monitoring Committee.

The ALSYMPCA study accrued 922 patients, of which 809 were randomized at the
data cut-off point for the interim analysis.

* In August, Alpharadin was granted Fast Track Designation by the US Food &
Drug Administration (FDA)

* In September, Dr. Mike Booth was appointed as Senior Vice President,
Communications and Corporate Affairs. Dr. Booth joins Algeta from Trout
International in London, the European operations of The Trout Group, LLC, a
leading global life sciences-focused investor relations and strategic
advisory firm. He took up his role on 17 October 2011


Key financials

* Operating revenue for the third quarter amounted to NOK 63m compared with
NOK 96m in the third quarter in 2010. Third quarter 2011 revenues comprised
NOK 27m of the deferred Bayer signing fee and NOK 36m from Alpharadin cost-
sharing, compared to NOK 20m and NOK 35m, respectively, in the third quarter
2010. There were no milestone recognitions in third quarter 2011, whereas
the same period last year included a NOK 40m (EUR 5m) milestone from Bayer

* Operating expenses for the third quarter 2011 amounted to NOK 69m compared
with NOK 60m in the third quarter 2010

* As of 30 September 2011, net cash and cash equivalents amounted to NOK 356m
compared to NOK 414m at the end of the same quarter 2010 and NOK 479m at
year end 2010


Andrew Kay, Algeta's President and CEO, said: "We are delighted with the
positive ALSYMPCA results. The reaction to these data from the prostate cancer
community has been very positive and reinforces our belief in Alpharadin's
potential to become an important treatment for CRPC patients whose disease has
spread to the bones. Activities from Algeta and Bayer to support the regulatory
filing and global commercialization of Alpharadin are well underway to ensure it
reaches patients as quickly as possible. 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 by Algeta's senior management team to investors, analysts and the
press will take place in Oslo at 10:30 CET.

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. To participate,
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:

Algeta ASA:

Mike Booth +47 2202 4510
Communications & Corporate Affairs ir@algeta.com


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


US investor enquiries:
Jessica Lloyd +1 646 378 2928
The Trout Group jlloyd@troutgroup.com



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 (radium-223 chloride) 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.

Alpharadin is being developed under a development and commercialization
agreement with Bayer HealthCare Pharmaceuticals AG. In June 2011, a global phase
III clinical trial (ALSYMPCA) of Alpharadin to treat symptomatic bone metastases
in patients with castration-resistant prostate cancer (CRPC) was stopped early
after meeting its primary endpoint of significantly improving overall survival.
The US Food and Drug Administration (FDA) has granted Alpharadin Fast Track
designation for this indication. 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.

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 75%) and lung (up to 40%).

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 is listed on the Oslo Stock
Exchange (Ticker: ALGETA).

Alpharadin and Algeta are trademarks of Algeta ASA.


Forward-looking Statements
This news release contains certain 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. Algeta cannot give
any assurance to the correctness of such statements. 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 or uncertainties associated with the
success of future clinical trials, collaborations with other companies in the
development of targeting molecules and alpha particle payloads, risks associated
with technological development, the ability to successfully commercialize
Alpharadin and our other products, the risk that research & development will not
yield new products that achieve commercial success, the impact of competition,
manufacturing capacity, the ability to close viable and profitable business
deals, the risk of non-approval of patents not yet granted, risks in obtaining
regulatory approvals for Alpharadin and our other products and difficulties of
obtaining relevant governmental approvals for new products, and the other risks
and uncertainties described in our annual report.

###



Press release:
http://hugin.info/134655/R/1562694/484207.pdf

Third Quarter Report 2011:
http://hugin.info/134655/R/1562694/484204.pdf

Third Quarter Presentation 2011:
http://hugin.info/134655/R/1562694/484205.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#1562694]
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