2012-11-15 07:04:54 -
Not intended for US media
Oslo, Norway, 15 November 2012 - Algeta ASA (OSE: ALGETA), a company focused on
the development of novel targeted cancer therapeutics, announces its results for
the third quarter 2012.
A presentation of the results in Oslo will be webcast live from 10:00 CET and
can be accessed at www.algeta.com/webcast.An international conference call will
take place at 14:30 CET/ 08:30 Eastern Time (US). Details of both events are at
the end of this announcement.
Andrew Kay, Algeta's President and CEO, said: "Algeta is entering a
transformational period where our focus is on the preparations needed for a
successful launch of
radium-223 dichloride, pending regulatory approvals. We
have been working with Bayer to complete the documentation required for the
first submissions seeking marketing approval, and we are very pleased to report
that these remain on schedule for this year."
Highlights of the third quarter 2012 and significant post period events:
* Algeta's new commercial production facility for radium-223 dichloride
(radium-223, Alpharadin) was completed during the quarter and the three
documentation batches required for the CMC[1] sections of the submissions to
regulatory authorities have been successfully produced. Stability testing of
these batches is now underway. These data analyses are being shared with
Bayer for the completion of the regulatory dossiers.
First submissions seeking marketing approval for radium-223 are expected
by the end of 2012.
* In September, the Algeta Group celebrated the official opening of the
offices and facilities of Algeta US in Cambridge, MA. Algeta US has already
established an experienced oncology management team who will continue to
build a highly focused organisation.
Algeta US currently employs 17 people and plans to deliver a phased build-up of
resources in anticipation of a US commercial launch, with Bayer, of radium-223,
pending approval by FDA.
* In September, further data from the phase III ALSYMPCA trial of radium-223
in castration-resistant prostate cancer patients with bone metastases was
presented in two analyses at the ESMO 2012 Congress.
The first analysis indicated that hematologic safety profiles for patients
receiving chemotherapy after radium-223 were similar to those for patients
receiving chemotherapy after placebo.
The second analysis indicated that radium-223 was superior to placebo in health-
related quality of life (QOL) measures.
* In November, based on the results of the dose escalation (phase I) portion
of the BC1-10 trial of radium-223 in combination with docetaxel
chemotherapy, the decision was taken, by Algeta and Bayer, to progress to
the phase IIa (expanded safety cohort) portion of the study. Enrolment of
approximately 45 CRPC patients with symptomatic bone metastases will now
begin in eight centers across the US and Europe.
* In August, Algeta disclosed its fourth TTC program to investigate a novel
Targeted Thorium Conjugate addressing hematological cancers.
* In November, Algeta further strengthened its R&D capabilities, particularly
in chelation and conjugation technologies, with the appointment of Dr Alan
Cuthbertson as Senior Vice President, Research and Development. Dr
Cuthbertson spent the past 20 years at GE HealthCare at which he held
parallel senior roles managing international teams focused on medicinal
chemistry and new product discovery and development. He joins the senior
management team at Algeta and will lead the R&D department in Oslo,
reporting to Thomas Ramdahl, Executive Vice President and Chief Technology
Officer.
Key financials
* Operating revenue for the third quarter 2012 amounted to NOK 60m compared
with NOK 63m in the third quarter in 2011.
* Core operating expenses[2], which exclude currency effects, interest income
and costs directly related to preparation of commercial launch in the US, if
approved, for the third quarter 2012 amounted to NOK 74m, compared with
NOK 69m in the third quarter 2011.
* Algeta's recognized share of US co-promotion activity expenses for the third
quarter of 2012 was NOK 17m.
* Liquid funds amounted to NOK 426m as of 30 September 2012, compared with
NOK 317m at the end of December 2011.
The full Third Quarter Report 2012 and accompanying presentation will be
available at www.algeta.com in the Investors section from 07:00 CET.
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 10:00 CET.
Shippingklubben
Haakon VIIs gate 1
0161 Oslo
Norway.
The presentation will also be webcast live and can be accessed at
www.algeta.com/webcast. Questions can be submitted live during the webcast.
Details of international conference call
To participate in the conference call, please dial the appropriate number below
five minutes prior to the call:
USA: +1 866 5088 015
UK: +44 203 147 4601
Norway: +47 21 01 09 30
Sweden: +46 850 559 840
Denmark: +45 701 404 50
Switzerland: +41 225 802 964
Participant pin code: 598258#
----
To access the replay, please dial:
USA: +1 866 3056 292
UK: +44 207 750 99 28
Norway: +47 21 01 09 26
Sweden: +46 850 626 949
Conference reference: 275589#
A replay version of the conference call will also be available at
www.algeta.com.
###
For further information, please contact
Mike Booth +47 2202 4510
Communications & Corporate Affairs
ir@algeta.com
Media enquiries:
Mark Swallow +44 207 638 9571
Citigate Dewe Rogerson
mark.swallow@citigatedr.co.uk
Knut Ekern +47 22 04 82 00
Gambit Hill & Knowlton
knut.ekern@hkstrategies.com
US investor enquiries:
Tricia Swanson +1 646 378 2953
The Trout Group
tswanson@troutgroup.com
About Algeta
Algeta is a company focused on developing novel targeted therapies for patients
with cancer based on its alpha-pharmaceutical platform. The Company is
headquartered in Oslo, Norway, and has a US subsidiary, Algeta US, LLC, based in
Cambridge, MA performing commercial marketing operations in the US. Algeta is
listed on the Oslo Stock Exchange (Ticker: ALGETA). For more information please
visit www.algeta.com.
Forward-looking Statements
This news release contains certain forward-looking statements that are based on
uncertainty, as they relate to events and depend on circumstances that will
occur in the future and which, by their nature, may have an impact on results of
operations and the financial condition of Algeta. Such forward-looking
statements reflect our current views and are based on the information currently
available to Algeta. Algeta cannot give any assurance as to whether such forward
looking statements will prove to be correct. These forward looking statements
include statements regarding expected timing of regulatory filings, the build
out of our US commercial organization and future development activities. 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, unforeseen delays in the
timing of expected regulatory filings, risks or uncertainties associated with
the success of future clinical trials, collaborations with other companies in
the development of targeting molecules, the ability to identify and hire a
sufficient number of qualified employees for the US field force, growth
management, general economic and business conditions and the pricing
environment, the impact of competition, the ability to successfully
commercialize radium-223 and our other products, the risk that costs associated
with the co-promotion of radium-223 may be greater than anticipated, the risk
that research & development will not yield new products that achieve commercial
success, manufacturing capacity, the risk of non-approval of patents not yet
granted, risks in obtaining regulatory approvals for radium-223 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.
--------------------------------------------------------------------------------
[1] CMC: Chemistry, Manufacturing and Controls
[2] Defined as the sum of External R&D expenses, Payroll and related costs,
Depreciation and General and Administrative expenses, and excludes net loss from
co-promotion while including some US overhead costs
Press release:
hugin.info/134655/R/1658158/536510.pdf
Third Quarter Presentation 2012:
hugin.info/134655/R/1658158/536509.pdf
Third Quarter Report 2012:
hugin.info/134655/R/1658158/536507.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#1658158]
