2013-02-28 07:05:25 -
Not Intended for US Media
Oslo, Norway, 28 February 2013 - Algeta ASA (OSE: ALGETA), a company focused on
the development of novel targeted cancer therapeutics, announces its results for
the fourth quarter and full year 2012.
A presentation of the results in Oslo will be webcast live from 10:00 CET and
can be accessed through www.algeta.com. An international conference call will
take place at 14:30 CET/08:30 EST (US). Details of both events are at the end of
this announcement.
"Algeta made significant achievements across its business in 2012, including
commercial preparations and expanding its manufacturing capabilities for radium-
223 dichloride (radium-223) as well as initiating further R&D collaborations for
the development of our Targeted Thorium Conjugate (TTC) pipeline.
This progress
means that Algeta entered 2013 well placed to deliver on its vision to be a
world-class oncology company bringing novel targeted medicines to cancer
patients through its leadership in alpha-pharmaceuticals," said Andrew Kay,
Algeta's President & CEO. "In parallel, we continue to make significant
investments in building our commercial operations for radium-223 in the US and
look forward, with Bayer and if approved, to co-promoting this novel product for
castration-resistant prostate cancer (CRPC) patients with bone metastases in the
world's largest pharmaceutical market."
Radium-223 is an investigational agent and is not approved by the European
Medicines Agency (EMA), the US Food and Drug Administration (FDA) or other
health authorities.
Highlights of the fourth quarter 2012:
* In December, Bayer submitted applications seeking marketing authorization to
the EMA and the FDA for radium-223 for the treatment of CRPC patients with
bone metastases. The first complete submission triggered a EUR 50m milestone
payment from Bayer to Algeta
* In November, Algeta and Bayer advanced the BC1-10 trial (radium-223 in
combination with docetaxel chemotherapy) into the phase IIa (expanded safety
cohort) portion of the study, based on the results of the dose escalation
(phase I) phase. Enrolment of approximately 45 CRPC patients with
symptomatic bone metastases has begun in eight centers across the US and
Europe.
* In November, Algeta entered a research collaboration with Ablynx to evaluate
a novel TTC based on combining Algeta's proprietary thorium-227 alpha-
pharmaceutical payload with tumor-targeting Nanobodies(®) generated by
Ablynx.
* 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.
Post-period events
* In February 2013, the FDA granted priority review of the NDA for radium-
223. The FDA grants priority review to medicines that offer major advances
in care or that provide a treatment where no adequate therapy exists. Under
the Prescription Drug User Fee Act (PDUFA), the FDA aims to complete its
review within eight months from the submission of the NDA, rather than the
standard 12-month review cycle.
* In February 2013, further results from the ALSYMPCA phase III study of
radium-223 were presented at the 2013 Genitourinary Cancers Symposium. Two
presentations were made, highlighting the beneficial impact of radium-223 on
the pain and analgesic use of CRPC patients, as well as providing further
analyses on the positive impact on skeletal-related events (SREs) associated
with bone metastases from castration-resistant prostate cancer.
* In January 2013, the US Nuclear Regulatory Commission (NRC) issued a
licensing decision on the medical use of radium-223, ruling that sites can
procure and administer radium-223 under the same framework as routinely-used
nuclear medicines. In addition, the NRC will not require additional
licensing to administer radium-223 for physicians who are already licensed
to dispense similar medications.
* In January 2013, Algeta initiated a new TTC research program using the anti-
CD22 monoclonal antibody (epratuzumab) developed by Immunomedics.
* In February 2013, and as part of the prioritization of the TTC portfolio,
Algeta deemed PDGFR-beta to be an unsuitable target for alpha-pharmaceutical
development. Accordingly, the decision has been taken to terminate this
element of the Affibody agreement.
Key financials
* Operating revenue for the fourth quarter and full year 2012 amounted to
NOK 440m and NOK 627m, respectively, compared with NOK 73m and NOK 250m in
the same periods in 2011.
* Core operating expenses[1], which exclude currency effects, interest income
and costs directly related to preparation of commercial launch in the US,
for the fourth quarter and full year 2012 amounted to NOK 99m and NOK 316m,
respectively, compared with NOK 84m and NOK 289m in the same periods in
2011.
* Algeta's recognized share of US co-promotion activity expenses for the
fourth quarter and full year 2012 was NOK 28m and NOK 72m. In 2011, the
activity had not yet commenced.
* Liquid funds amounted to NOK 369m as of the 31 December 2012, compared with
NOK 426m as of 30 September 2012, and NOK 317m at the end of December 2011.
The Fourth Quarter and Full Year 2012 Report and accompanying presentation will
be available through www.algeta.com 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 through
www.algeta.com. 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:
US: +1 877 423 0830
UK: +44 20 7153 9154
Norway: +47 21 06 61 13
Sweden: +46 8-506 443 86
Denmark: +45 32 71 42 62
Switzerland: +41 44 580 65 22
Participant pin code: 434633#
----
To access the replay, please dial:
US: +1 877 679 2989
UK: +44 20 3364 5196
Norway: +47 23 50 02 03
Sweden: +46 8-505 564 73
Conference reference: 345360#
A replay version of the conference call will also be available at
www.algeta.com.
###
About Radium-223 Dichloride
Radium-223 dichloride (radium-223), formerly referred to as Alpharadin, is a
therapeutic alpha particle-emitting pharmaceutical with targeted anti-tumor
effect on bone metastases in development for CRPC patients with bone metastases.
In September 2009, Algeta signed an agreement with Bayer Pharma AG (Berlin,
Germany) for the development and commercialization of radium-223. Under the
terms of the agreement, Bayer will develop, apply for global health authority
approvals, and commercialize radium-223 globally. Algeta will co-promote radium-
223 with Bayer in the US, and is eligible for milestones as well as royalties on
Bayer's sales outside the US. The ALSYMPCA trial was initiated by Algeta in June
2008.
For further information, please contact:
Mike Booth / Renate Birkeli +47 23 00 67 32
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 interactions with regulatory authorities, our
anticipated co-promotion of radium-223 in the US, additional clinical
development of radium-223 and our TTC program. 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, 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] Defined as the sum of External R&D expenses, Payroll and related costs,
Depreciation and General and Administrative expenses, excluding 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.
Fourth Quarter Presentation 2012:
hugin.info/134655/R/1681805/549906.pdf
Press release:
hugin.info/134655/R/1681805/549910.pdf
Annual report 2012:
hugin.info/134655/R/1681805/549918.pdf
Fourth Quarter Report 2012:
hugin.info/134655/R/1681805/549908.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#1681805]
