Algeta ASA : Xofigo(R) (radium Ra 223 dichloride) injection granted Marketing Authorization in the European Union
(GlobeNewswire Via Acquire Media NewsEdge) OSLO, Norway, Nov. 15, 2013 (GLOBE NEWSWIRE) --
Intended for US media only
Oslo, Norway, 15 November 2013 - Algeta ASA (OSE: ALGETA) announces today that
Bayer has received marketing authorisation from the European Commission for
Xofigo® (radium Ra 223 dichloride) solution for injection for the treatment of
adults with castration-resistant prostate cancer, symptomatic bone metastases
and no known visceral metastases. The marketing authorization provides approval
for the commercialization of Xofigo in all 28 countries of the EU, and in
Norway, Iceland and Liechtenstein following national approval.
This decision follows a positive recommendation from the European Medicines
Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) in
September of this year.
Xofigo was approved by the US Food and Drug Administration in May 2013 for the
treatment of patients with castration-resistant prostate cancer, symptomatic
bone metastases and no known visceral metastatic disease and is now available in
the United States at licensed facilities. The approval of Xofigo is based on
data from the pivotal Phase III ALSYMPCA (ALpharadin in SYMptomatic Prostate
Andrew Kay, Algeta's President & CEO, said: "Today's decision by the European
Commission to approve Xofigo in the EU is another major milestone achieved for
Algeta. It marks the start of what we hope will become an important royalty
stream based on Bayer's ex-US sales, in addition to the 50% share of the profits
we expect to receive from the co-promotion of Xofigo in the US. More
importantly, Xofigo's approval in Europe highlights the need for new therapies
for castration-resistant prostate cancer patients with symptomatic bone
In September 2009, Algeta signed an agreement with Bayer for the development and
commercialization of Xofigo. Under the terms of this agreement, Bayer will
develop, apply for health authority approvals worldwide and commercialize Xofigo
globally. Algeta is eligible for royalties and milestones based on Bayer's sales
of Xofigo outside the US, and Algeta US, LLC is co-promoting Xofigo with Bayer
in the US.
The ALSYMPCA Trial and the Results
The European Marketing Authorization is based on data from ALSYMPCA, a phase
III, randomized, double-blind, placebo-controlled international study of Xofigo
plus best standard of care vs. placebo plus best standard of care in patients
with CRPC, symptomatic bone metastases and no known visceral metastatic disease.
The trial enrolled 921 patients in more than 100 centers in 19 countries.
Patients were stratified based on their baseline alkaline phosphatase (ALP)
level, current bisphosphonate use and whether or not they had received docetaxel
prior to study enrollment. The study treatment consisted of up to six
intravenous injections of Xofigo or placebo each separated by an interval of
The primary endpoint of the study was overall survival (OS). A key secondary
endpoint was time to first symptomatic skeletal event (SSE). SSE was defined as
first use of external beam radiation therapy to relieve skeletal pain, new
symptomatic pathologic bone fracture, occurrence of spinal cord compression or
tumor-related orthopedic surgical intervention. There were no scheduled
radiographic assessments performed on study.
Xofigo significantly improved OS in the overall study population at the pre-
specified interim analysis (HR=0.695, (95% CI 0.552-0.875), p=0.00185); median
OS was 14.0 months with Xofigo plus best standard of care (95% CI: 12.1-15.8)
vs. 11.2 months with placebo plus best standard of care (95% CI: 9.0-13.2).
These findings were supported by the exploratory analysis performed before
patient crossover with an additional 214 events in which Xofigo showed
improvement in OS (HR=0.695, (95% CI 0.581-0.832); median OS was 14.9 months in
the Xofigo arm (95% CI: 13.9-16.1) vs 11.3 months in the placebo arm (95% CI:
10.4-12.8). The survival results were supported by a delay in the time to first
SSE favoring the Xofigo arm. The majority of events consisted of external beam
radiotherapy to bone metastases.
In the ALSYMPCA trial the most common adverse drug reactions (greater than or
equal to 10 percent) in patients receiving Xofigo vs placebo, respectively, were
nausea (36% vs 35%), diarrhea (25% vs 15%), vomiting (19% vs 14%), and
peripheral edema (13% vs 10%). Grade 3 and 4 treatment-emergent adverse events
were reported among 57 percent of patients treated with Xofigo and 63 percent of
placebo-treated patients. The most common hematologic laboratory abnormalities
(greater than or equal to 10 percent) in patients receiving Xofigo vs placebo,
respectively, were anemia (93% vs 88%), lymphopenia (72% vs 53%), leukopenia
(35% vs. 10%), thrombocytopenia (31% vs 22%), and neutropenia (18% vs 5%).
In July 2013, complete results from the ALSYMPCA study were published in the New
England Journal of Medicine.
About Xofigo® (radium Ra 223 dichloride)
Xofigo® is approved in the United States and is indicated for the treatment of
patients with castration-resistant prostate cancer, symptomatic bone metastases
and no known visceral metastatic disease.
Xofigo is an alpha particle-emitting radioactive therapeutic agent with an anti-
tumor effect on bone metastases. The active ingredient in Xofigo is the alpha
particle-emitting isotope radium-223, which mimics calcium and forms complexes
with the bone mineral hydroxyapatite at areas of increased bone turnover, such
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 effect on
bone metastases. The alpha particle range from radium-223 is less than 100
micrometers which may limit the damage to the surrounding normal tissue[i].
Important Safety Information for Xofigo (radium Ra 223 dichloride) in the US
Xofigo is contraindicated in women who are or may become pregnant. Xofigo can
cause fetal harm when administered to a pregnant woman.
In the randomized trial, 2% of patients in the Xofigo arm experienced bone
marrow failure or ongoing pancytopenia, compared to no patients treated with
placebo. There were two deaths due to bone marrow failure. For 7 of 13 patients
treated with Xofigo bone marrow failure was ongoing at the time of death. Among
the 13 patients who experienced bone marrow failure, 54% required blood
transfusions. Four percent (4%) of patients in the Xofigo arm and 2% in the
placebo arm permanently discontinued therapy due to bone marrow suppression. In
the randomized trial, deaths related to vascular hemorrhage in association with
myelosuppression were observed in 1% of Xofigo-treated patients compared to
0.3% of patients treated with placebo. The incidence of infection-related deaths
(2%), serious infections (10%), and febrile neutropenia (less than 1%) was
similar for patients treated with Xofigo and placebo. Myelosuppression - notably
thrombocytopenia, neutropenia, pancytopenia, and leukopenia - has been reported
in patients treated with Xofigo.
Monitor patients with evidence of compromised bone marrow reserve closely and
provide supportive care measures when clinically indicated. Discontinue Xofigo
in patients who experience life-threatening complications despite supportive
care for bone marrow failure.
Monitor blood counts at baseline and prior to every dose of Xofigo. Prior to
first administering Xofigo, the absolute neutrophil count (ANC) should be
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 × 10(9)/L.
Discontinue Xofigo if hematologic values do not recover within 6 to 8 weeks
after the last administration despite receiving supportive care.
Safety and efficacy of concomitant chemotherapy with Xofigo have not been
established. Outside of a clinical trial, concomitant use of Xofigo in patients
on chemotherapy is not recommended due to the potential for additive
myelosuppression. If chemotherapy, other systemic radioisotopes, or hemibody
external radiotherapy are administered during the treatment period, Xofigo
should be discontinued.
Xofigo should be received, used, and administered only by authorized persons in
designated clinical settings. The administration of Xofigo is associated with
potential risks to other persons from radiation or contamination from spills of
bodily fluids such as urine, feces, or vomit. Therefore, radiation protection
precautions must be taken in accordance with national and local regulations.
The most common adverse reactions (greater than or equal to 10%) in the Xofigo
arm vs. the placebo arm, respectively, were nausea (36% vs 35%) diarrhea (25% vs
15%), vomiting (19% vs 14%), and peripheral edema (13% vs 10%). Grade 3 and 4
adverse events were reported in 57% of Xofigo-treated patients and 63% of
placebo-treated patients. The most common hematologic laboratory abnormalities
in the Xofigo arm (greater than or equal to 10%) vs the placebo arm,
respectively, were anemia (93% vs 88%), lymphocytopenia (72% vs.53%), leukopenia
(35% vs. 10%), thrombocytopenia (31% vs. 22%), and neutropenia (18% vs. 5%).
For full US prescribing information visit:
Xofigo® is a registered trademark of Bayer AG
For further information, please contact:
Mike Booth +1 646 410 1884
Communications & Corporate Affairs email@example.com
Mark Swallow +44 207 638 9571
Citigate Dewe Rogerson firstname.lastname@example.org
Kari Watson +1 781 235 3060
MacDougall Biomedical Communications email@example.com
Tricia Truehart +1 646 378 2953
The Trout Group firstname.lastname@example.org
Algeta is a company focused on developing, manufacturing and marketing novel
targeted therapies for patients with cancer. 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
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 our co-promotion of Xofigo in the US and Bayer's
promotion of Xofigo in Europe. 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, general economic and business conditions, the impact of competition, the
ability to successfully commercialize Xofigo, the risk that costs associated
with the co-promotion of Xofigo may be greater than anticipated, manufacturing
capacity, risks in obtaining additional regulatory approvals for radium 223 and
the other risks and uncertainties described in our annual report.
[i] XOFIGO Prescribing information. May 2013
Press release: http://hugin.info/134655/R/1743547/586534.pdf
Source: Algeta ASA
2013 GlobeNewswire, Inc.
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