Algeta results for the first half and second quarter 2012
(Thomson Reuters ONE) -
Not intended for US media
Oslo, Norway, 16 August 2012 - Algeta ASA (OSE: ALGETA), a company focused on
the development of novel targeted cancer therapeutics, announces its results for
the first half and second 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.
Commenting on the results, Andrew Kay, Algeta's President and CEO, said: "The
combination of our Board's decision to exercise Algeta's co-promotion option and
the successful fundraising during the first half of 2012 has enabled us to
optimise our commercial plans in the US. We have made great progress towards
establishing a high-quality US operation and continue to work hard to support
Bayer's plans to submit applications seeking marketing approval for Alpharadin
in the second half of 2012 in the US and Europe. We are also excited by Bayer's
plans for further studies with Alpharadin in earlier settings of prostate
cancer, including combination studies with other agents, as well as undertaking
studies in breast cancer and osteosarcoma. We believe that Alpharadin has the
potential to become a major new therapeutic option for cancer patients with bone
metastases and we, together with Bayer, are focused on making Alpharadin a
success."
Highlights of the first half and second quarter 2012:
* In April, Algeta announced that it had exercised its option to co-promote
Alpharadin (radium-223 dichloride) with Bayer in the US if Alpharadin
receives approval from the US Food & Drug Administration (FDA). Algeta will
recognize 50% of the profits and losses of commercializing Alpharadin in
this territory.
If approved, Bayer will market Alpharadin worldwide (except in the US, where
there will be 50/50 co-promotion), and Algeta will receive tiered double-digit
royalties and performance-related milestone payments based on non-US revenues.
Regulatory submissions seeking marketing approval in US and Europe are expected
in the second half of 2012.
* Algeta made good progress building its US commercial organization during the
first half of 2012. Algeta US has been established in Cambridge, MA and
experienced executives have been recruited to deliver a phased build up of
resources ahead of the planned launch of Alpharadin. Jeff Albers was
appointed as President, Algeta US in January. Mr. Albers was formerly Vice
President, US Hematology & Oncology Business, at Genzyme.
* The new Alpharadin commercial production facility has passed both
installation and operational qualification (IQ/OQ) protocols, has been
integrated into the IFE[1] infrastructure and has been authorized by the
NRPA[2]. Training and process qualification is ongoing, and according to
plan.
* An Expanded Access Program in the US was initiated in February by Bayer to
provide Alpharadin to castration-resistant prostate cancer (CRPC) patients
with symptomatic bone metastases through qualified clinical sites
participating in this program. A similar program has now been initiated in
Europe.
* Updated analyses of data from the phase III ALSYMPCA trial with Alpharadin
in CRPC patients with bone metastases demonstrated an improvement in overall
survival in the treatment arm vs. placebo compared with the interim analysis
from June 2011. These data were presented at the 48(th) Annual Meeting of
the American Society of Clinical Oncology (ASCO) in June.
The data also found that treatment with Alpharadin led to a statistically
significant delay in the time to first skeletal-related event. The overall
safety and tolerability profile for Alpharadin was consistent with previous
study results. These data were presented at ASCO's Genitourinary Cancers
Symposium in February and were updated at ASCO in June.
* In April, Algeta announced that its research collaboration with Sanofi
(previously Genzyme) has been extended for a further year. This
collaboration, which was originally announced in April 2011, is focused on
evaluating the potential of linking the alpha-emitter thorium-227 to a novel
and proprietary Sanofi antibody to create a potential tumor-targeting alpha-
pharmaceutical (also known as a Targeted Thorium Conjugate, or TTC).
During the second quarter 2012, Algeta initiated a new Thorium R&D program aimed
at investigating the effect of a novel TTC on hematological cancers. The program
will focus on the development of an undisclosed monoclonal antibody, which is
highly selective for a validated cell surface target on hematological cancer
cells, linked to Th-227. This represents Algeta's fourth TTC program.
Key financials
* Operating revenue for the second quarter 2012 amounted to NOK 55m compared
with NOK 59m in the second quarter in 2011. Operating revenue for the first
half of 2012 was NOK 128m compared with NOK 115m in the same period in
2011.
* Core operating expenses[3], which exclude currency effects, interest income
and costs directly related to preparation of commercial launch in the US, if
approved, for the second quarter 2012 amounted to NOK 80m, compared with
NOK 73m in the second quarter 2011. Core operating expenses for the first
half of 2012 were NOK 143m compared with NOK 135m in the same period in
2011.
* Liquid funds amounted to NOK 478m as of 30 June 2012, compared with NOK
527m at the end of March 2012.
The full Second 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: 856739#
----
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: 274103#
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(at)algeta.com
International media enquiries: +44 207 638 9571
Mark Swallow 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 (radium-223 dichloride) is being evaluated as a
potential new treatment for cancer patients with bone metastases. Alpharadin is
under clinical investigation in castration-resistant prostate cancer (CRPC)
patients with bone metastases. Submissions seeking marketing approval for this
indication are expected to be made in the second half of 2012 to regulatory
authorities in both the US and Europe; Alpharadin has Fast Track designation for
this indication in the US. Alpharadin, which is exclusively licensed to Bayer,
is not currently approved by the US Food & Drug Administration (FDA), the
European Medicines Agency (EMA) or any other health authority.
Alpharadin is also under clinical investigation in endocrine-refractory breast
cancer patients with bone metastases and is in a phase I/IIa trial in
combination with docetaxel chemotherapy in CRPC patients with bone metastases.
Alpharadin is being evaluated and will be commercialized, if approved, under a
global agreement with Bayer Pharma AG. If approved, Bayer will market Alpharadin
worldwide, and Algeta will co-promote Alpharadin with Bayer in the US.
Algeta is also evaluating 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 potential future pipeline of tumor-targeting alpha-
pharmaceutical candidates. Algeta has four TTC programs in place, including a
collaboration with Sanofi.
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 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, future
royalties and milestone payments 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 Alpharadin and our other products, the risk that costs associated
with the co-promotion of Alpharadin 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 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.
[1] IFE: Institute for Energy Technology
[2] NRPA: Norwegian Radiation Protection Authority
[3] 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
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/1634196/524626.pdf
Second Quarter Report 2012:
http://hugin.info/134655/R/1634196/524624.pdf
Second Quarter Presentation 2012:
http://hugin.info/134655/R/1634196/524625.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#1634196]
Unternehmensinformation / Kurzprofil:
Datum: 16.08.2012 - 07:00 Uhr
Sprache: Deutsch
News-ID 175204
Anzahl Zeichen: 14001
contact information:
Town:
Oslo
Kategorie:
Business News
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"Algeta results for the first half and second quarter 2012"
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