Algeta exercises option to co-promote Alpharadin in the United States
(Thomson Reuters ONE) -
Conference call will be held today at 1pm CET, 12pm UK & 7am Eastern
Oslo, Norway, 12 April 2012 - Algeta ASA (OSE: ALGETA), a company focused on the
development of novel targeted cancer therapeutics, announces that it has
exercised its option to co-promote Alpharadin for the treatment of cancer
patients with bone metastases in the United States.
Under the terms of the global development and commercialization agreement for
Alpharadin signed between Algeta and Bayer Pharma AG (Bayer) in 2009, Algeta
will now be eligible to receive 50 percent of the profits attributable to sales
of the drug in the US and will be responsible for 50 percent of the costs of
commercializing Alpharadin in this territory.
Alpharadin (radium-223 chloride), which is exclusively licensed to Bayer, is an
investigational agent and is not approved by either the US Food & Drug
Administration (FDA), the European Medicines Agency (EMA), or other health
authorities. The FDA has granted Fast Track Designation to Alpharadin in its
lead indication and regulatory filings by Bayer seeking marketing approval in
the US and Europe are expected in mid 2012.
Algeta has begun building its commercial operation in anticipation of the
approval and launch of Alpharadin in the US. To such an end, Algeta has
established a subsidiary in the US ("Algeta US") to carry out the co-promotion
of Alpharadin, pursuant to its 2009 agreement with Bayer. The headquarters of
this operation will be located in Cambridge, MA. In January 2012, Algeta US
hired Jeff Albers, formerly Vice President, US Hematology & Oncology Business,
at Genzyme as President. Algeta US has 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. This
process will be accelerated as a result of Algeta's successful fundraising in
February 2012.
Andrew Kay, Algeta's President and CEO, said: "We are delighted with the Board's
decision to exercise Algeta's co-promotion option, as we believe this to be in
the best interests of the Company and its shareholders. It will allow us to move
ahead rapidly with the building of a high-quality commercial operation in the
USA, the world's largest pharmaceutical market. We believe that Alpharadin has
the potential to bring a new therapeutic option to cancer patients with bone
metastases and we, together with Bayer, are focused on making Alpharadin a
success."
In September 2009, Bayer signed an agreement with Algeta for the development and
commercialization of Alpharadin. Under the terms of the agreement, Bayer will
develop, apply for global health authority approvals, and commercialize
Alpharadin globally, while Algeta retained an option for up to 50/50 co-
promotion and profit-sharing in the United States, which it has now exercised in
full.
Conference call
A conference call to discuss this decision and its implications will be held
today at 1pm CET, 12pm UK & 7am Eastern. To participate, please dial the
appropriate number below five minutes prior to the call:
* +47 23 18 45 55 (from Norway and abroad)
To access the replay, please dial +47 23 18 45 02. Enter account no. 1870
followed by #, then press 1, conference no. 870 followed by #. Press 1 to play.
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 chloride) is in development as a
potential new treatment for cancer patients with bone metastases. It is in pre-
registration for castration-resistant prostate cancer (CRPC) patients with bone
metastases, and filings are expected mid 2012 in the USA and Europe; Alpharadin
has Fast Track designation for this indication in the USA.
Alpharadin is also under clinical investigation in breast cancer patients with
bone metastases and in combination with docetaxel chemotherapy in CPRC patients
with bone metastases.
Alpharadin is being developed and will be commercialized, pending approval,
under a global agreement with Bayer Pharma AG.
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 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.
This information is subject of the disclosure requirements pursuant to section
5-12 of the Norwegian Securities Trading Act.
Algeta exercises option to co-promote Alpharadin in the United States:
http://hugin.info/134655/R/1601610/505766.pdf
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(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Algeta ASA via Thomson Reuters ONE
[HUG#1601610]
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Datum: 12.04.2012 - 08:01 Uhr
Sprache: Deutsch
News-ID 134202
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