Not intended for US media
Oslo, Norway, 3 May 2012 - Algeta ASA (OSE: ALGETA), a company focused on the
development of novel targeted cancer therapeutics, announces its results for the
first 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: "It has
been an extremely productive first quarter of 2012 for Algeta. As a result, we
are now in a very strong position as we approach the first submissions for
marketing approval of Alpharadin, which we continue to expect Bayer to make in
mid 2012. Our key strategic objectives for the balance of 2012 are clear: to
support Bayer's filing for regulatory approval of Alpharadin and continue to
build a high quality US organization as we prepare, pending approval, for launch
and commercialization in the US. 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 quarter 2012:
* An updated analysis performed on data from all 921 castration-resistant
prostate cancer (CRPC) patients randomized into the pivotal phase III
ALSYMPCA study was announced. The analysis confirmed the results of the
interim analysis from June 2011 and showed an increase in median overall
survival of 3.6 months in the Alpharadin arm vs. the placebo arm. Compared
to the previously announced interim analysis, the hazard ratio was unchanged
and the p-value improved.
The updated survival analysis will be presented in the Late Breaker Abstract
oral presentation session at the upcoming American Society of Clinical Oncology
(ASCO) meeting in Chicago in early June 2012.
* Additional results from the ALSYMPCA phase III study were presented in
February at the 2012 Genitourinary Cancers Symposium. The results
highlighted the impact of Alpharadin on skeletal-related events (SREs)
associated with bone metastases in CRPC patients. Alpharadin treatment
delayed time to first SRE by 64% vs. placebo (13.5 months vs. 8.4 months for
placebo), as well as lengthening time to occurrence of three out of four SRE
components.
* An Expanded Access Program (EAP) was initiated in February by Bayer to
provide Alpharadin to CRPC patients with symptomatic bone metastases.
Alpharadin will be made available to patients through qualified clinical
sites in the US participating in this program.
* In January 2012, Jeff Albers was appointed as President, Algeta US. He was
formerly Vice President, US Hematology & Oncology Business, at Genzyme.
Algeta US subsequently hired Philina Lee, formerly Global Product Manager
for Jevtana(®) (cabazitaxel) at Sanofi, as Director of US Marketing. Algeta
US is now focused on building a field force including marketing and medical
affairs personnel ahead of the launch of Alpharadin.
* The building of the new commercial production facility, services and QC labs
have been completed, and the production line has been delivered, assembled
and installed. Algeta recognized a milestone payment of EUR 2.6m (NOK 20m)
from Bayer during 1Q 2012 in relation to progress. Product batches required
for regulatory submissions are on schedule to be produced in time to support
filing, around mid-year, for the marketing approval of Alpharadin.
* In February, Algeta raised NOK 271m (approximately USD 47m) in net proceeds
in a private placement and subsequent repair offering totalling 2.1 million
new shares. Algeta intends to use the proceeds to establish what it believes
would be an optimal level of commercial operations in the US in connection
with the launch of Alpharadin, pending approval. In addition, a substantial
proportion of the proceeds will be used to advance the research and
development of the TTC platform.
Post-period events
* In April, Algeta exercised its option in full to co-promote Alpharadin in
the US with Bayer upon approval by FDA. Algeta will now be eligible to
receive 50 percent of the profits related to sales of the drug in the US,
upon approval, and will be responsible for 50 percent of the costs of
commercializing Alpharadin in this territory.
* 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 antibody from Sanofi to create a potential tumor-targeting
alpha-pharmaceutical (also known as a Targeted Thorium Conjugate, or TTC).
Key financials
* Operating revenue for the first quarter 2012 amounted to NOK 73m, compared
with NOK 56m in the same period in 2011.
* Operating expenses[1] for the first quarter 2012 amounted to NOK 64m,
compared with NOK 63m in the same period in 2011.
* As of 31 March 2011, net cash and cash equivalents amounted to NOK 527m
compared to NOK 317m at the end of the fourth quarter 2011.
The full First 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: +44Â 203Â 147 4601
Norway: +47 21 01 09 30
Sweden: +46Â 850Â 559Â 840
Switzerland: +41Â 225Â 802Â 964
For other countries, please see the attached list of access numbers.
Participant pin code: 537060#
To access the replay, please dial:
SE: +46 (0)8Â 506Â 269 49
UK: +44 207Â 750 99 28
US: 18663056292
Conference reference: 266998#
A replay 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
International media enquiries: +44 207 638 9571
Mark Swallow 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 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 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 mid 2012 to regulatory authorities in both
the United States and Europe; Alpharadin has Fast Track designation for this
indication in the US. Alpharadin 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 CPRC 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.
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 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. Such forward-looking
statements reflect our current views and are based on the information currently
available to 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,
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
and alpha particle payloads, 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]Â The Group's operating expenses (defined as the sum of External R&D expenses,
Payroll and related costs, Depreciation and General and administrative expenses)
exclude currency effects and interest income
This information is subject of the disclosure requirements pursuant to section
5-12 of the Norwegian Securities Trading Act.
First Quarter Presentation 2012:
http://hugin.info/134655/R/1608209/510319.pdf
First Quarter Report 2012:
http://hugin.info/134655/R/1608209/510318.pdf
Press release:
http://hugin.info/134655/R/1608209/510320.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#1608209]