OSLO, NORWAY--(Marketwired - June 20, 2013) - Intended for US media only
Algeta ASA (OSE: ALGETA), a company focused on the
development of cancer therapeutics, today celebrates the official opening
commercial production facility for Xofigo® (radium Ra 223
injection at the Institute for Energy Technology (IFE) in Kjeller, Norway.
Andrew Kay, Algeta's President & CEO, and senior management colleagues
joined by Trond Giske, the Norwegian Minister for Trade and Industry,
Dugstad, President of IFE and Andreas Fibig, President & Chairman of the
of Management, Bayer HealthCare Pharmaceuticals, and other distinguished
for an official ribbon cutting ceremony this afternoon.
Xofigo was approved by the US Food and Drug Administration (FDA) on 15
the treatment of patients with castration-resistant prostate cancer
symptomatic bone metastases and no known visceral metastatic disease. It
first alpha particle-emitting radioactive therapeutic agent approved by the
In September 2009, Algeta signed an agreement with Bayer for the
commercialization of Xofigo. Under the terms of the agreement, Bayer
develop, apply for health authority approvals worldwide and commercialize
globally. Algeta US, LLC and Bayer Healthcare are co-promoting the
the US. Xofigo has been launched in the US, triggering a EUR 50
milestone payment to Algeta from Bayer. Bayer Healthcare has licensed the
rights to Xofigo outside of the US.
Radium Ra 223 dichloride (radium 223) is currently not approved by the
Medicines Agency (EMA) or other authorities outside the US. Bayer
Marketing Authorisation Application to the EMA for radium 223 in December
Andrew Kay, Algeta's President & CEO, said: "The recent approval and
Xofigo in the US are momentous achievements for Algeta and put us firmly
path to deliver on our vision of becoming a world-class oncology
bringing medicines to cancer patients through our leadership in alpha
particle-emitting pharmaceuticals. IFE has been an important partner to
the clinical development of radium 223, and it has been instrumental in
us build a commercial production facility for the global supply of
are all extremely grateful for the expertise, dedication and support
has provided to Algeta on this journey and look forward to
"Today's opening of a new commercial production facility at IFE
Norwegian pharmaceutical industry's ability to develop products with
global potential. We are proud to have played an integral part in
development of Xofigo that has required quality manufacturing
path to market. The new facility which is being officially opened today has
designed according to highest quality standards - from raw material
the release of the final commercial product," said Eva S. Dugstad,
"On behalf of Bayer, I am proud and excited to be part of this
with our Norwegian partners, Algeta and IFE," said Andreas Fibig,
Chairman of the Board of Management, Bayer HealthCare Pharmaceuticals.
the time for the patients to gain from it. Our hope is that Xofigo can
castration-resistant prostate cancer patients with symptomatic bone
and no known visceral metastatic disease all over the world."
About Xofigo® (radium Ra 223 dichloride)
Xofigo is indicated for the treatment of patients with
castration-resistant prostate cancer, symptomatic bone metastases and no
known visceral metastatic
Xofigo is an alpha particle-emitting radioactive therapeutic agent with an
anti-tumor effect on bone metastases. The active ingredient in Xofigo is
particle-emitting isotope radium-223, which mimics calcium and forms
with the bone mineral hydroxyapatite at areas of increased bone turnover,
as bone metastases. The high linear energy transfer of radium-223 may cause
double-strand DNA breaks in adjacent cells, resulting in an anti-tumor
Important Safety Information for Xofigo (radium Ra 223 dichloride)
Xofigo is contraindicated in women who are or may become pregnant.
cause fetal harm when administered to a pregnant woman.
In the randomized trial, 2% of patients in the Xofigo arm experienced
marrow failure or ongoing pancytopenia, compared to no patients treated
placebo. There were two deaths due to bone marrow failure. For 7 of 13
treated with Xofigo bone marrow failure was ongoing at the time of death.
the 13 patients who experienced bone marrow failure, 54% required
transfusions. Four percent (4%) of patients in the Xofigo arm and 2%
placebo arm permanently discontinued therapy due to bone marrow
the randomized trial, deaths related to vascular hemorrhage in association
myelosuppression were observed in 1% of Xofigo-treated patients
0.3% of patients treated with placebo. The incidence of infection-related
(2%), serious infections (10%), and febrile neutropenia (less than
similar for patients treated with Xofigo and placebo. Myelosuppression -
thrombocytopenia, neutropenia, pancytopenia, and leukopenia - has been
in patients treated with Xofigo.
Monitor patients with evidence of compromised bone marrow reserve
provide supportive care measures when clinically indicated. Discontinue
in patients who experience life-threatening complications despite
care for bone marrow failure.
Monitor blood counts at baseline and prior to every dose of Xofigo.
first administering Xofigo, the absolute neutrophil count (ANC)
greater than to equal to 1.5 × 10(9)/L, the platelet count greater
than or equal
to 100 × 10(9)/L, and hemoglobin greater than or equal to 10
g/dL. Prior to
subsequent administrations, the ANC should be greater than or equal
to 1 ×
10(9)/L and the platelet count greater than or equal to 50 ×
Discontinue Xofigo if hematologic values do not recover within 6 to 8
after the last administration despite receiving supportive care.
Safety and efficacy of concomitant chemotherapy with Xofigo have not
established. Outside of a clinical trial, concomitant use of Xofigo in
on chemotherapy is not recommended due to the potential for
myelosuppression. If chemotherapy, other systemic radioisotopes, or
external radiotherapy are administered during the treatment period,
should be discontinued.
Xofigo should be received, used, and administered only by authorized
designated clinical settings. The administration of Xofigo is associated
potential risks to other persons from radiation or contamination from
bodily fluids such as urine, feces, or vomit. Therefore, radiation
precautions must be taken in accordance with national and local
The most common adverse reactions (greater than or equal to 10%) in
receiving Xofigo were nausea, diarrhea, vomiting, and peripheral edema.
and 4 adverse events were reported in 57% of Xofigo-treated patients and
placebo-treated patients. The most common hematologic laboratory
in Xofigo-treated patients (greater than or equal to 10%) were
lymphocytopenia, leukopenia, thrombocytopenia, and neutropenia.
For full prescribing information visit www.xofigo-us.com.
Xofigo® is a registered trademark of Bayer
Algeta is a company focused on developing novel targeted therapies for
with cancer based on its alpha-pharmaceutical platform. The
headquartered in Oslo, Norway, and has a US subsidiary, Algeta US, LLC,
Cambridge, MA performing commercial marketing operations in the US.
listed on the Oslo Stock Exchange (Ticker: ALGETA). For more information
This news release contains certain forward-looking statements that are
uncertainty, as they relate to events and depend on circumstances that
occur in the future and which, by their nature, may have an impact on
operations and the financial condition of Algeta. Such
forward-looking statements reflect our current views and are based on the
available to Algeta. Algeta cannot give any assurance as to whether such
looking statements will prove to be correct. These forward looking
include statements regarding our co-promotion of Xofigo in the US
ability to manufacture radium 223 on a global scale. There are a
factors that could cause actual results and developments to differ
from those expressed or implied by these forward-looking statements.
factors include, among other things, risks or uncertainties associated
ability to identify and hire a sufficient number of qualified employees
US, growth management, general economic and business conditions and the
environment, the impact of competition, the ability to
commercialize Xofigo, the risk that costs associated with the
co-promotion of Xofigo may be greater than anticipated, manufacturing
capacity, the risk of non-approval of patents not yet granted, risks in
obtaining additional regulatory
approvals for radium 223 and the other risks and uncertainties described
[i] XOFIGO Prescribing information. May 2013
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Source: Algeta ASA via Thomson Reuters ONE