Algeta ASA : Xofigo(r) (radium Ra 223 dichloride) Injection Recommended for
Approval in the European Union
Intended for US media only
OSLO, Norway, Sept. 20, 2013 (GLOBE NEWSWIRE) -- Algeta ASA (OSE: ALGETA),
announced today that Bayer has received a positive opinion from the European
Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP)
recommending approval of Xofigo^® (radium Ra 223 dichloride) in Europe. The
proposed indication is for the treatment of adults with castration-resistant
prostate cancer, symptomatic bone metastases and no known visceral metastases.
The decision of the European Commission (EC) on the approval is expected in
the fourth quarter of 2013.
Xofigo^® (radium Ra 223 dichloride) injection was approved by the US Food and
Drug Administration (FDA) in May 2013 for the treatment of patients with CRPC,
symptomatic bone metastases and no known visceral metastatic disease and is
now available in the United States at licensed facilities.
Andrew Kay, Algeta's President & CEO, said: "Today's positive opinion from the
CHMP marks an important step in the anticipated approval of Xofigo in Europe.
This recommendation, soon after Xofigo's US approval and launch, again
highlights the need for new therapeutic options that confer a survival
benefit. We are committed to working with Bayer to ensure patients and
physicians in Europe gain access to Xofigo as soon as possible."
In September 2009, Algeta signed an agreement with Bayer for the development
and commercialization of Xofigo. Under the terms of the 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 CHMP opinion is based on data from ALSYMPCA (ALpharadin in SYMptomatic
Prostate CAncer), 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 four weeks.
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.
Radium Ra 223 dichloride (radium 223) is currently not approved by the
European Medicines Agency (EMA) or other authorities outside the US. Bayer
submitted a Marketing Authorisation Application to the EMA for radium 223 in
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^.
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
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
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%
For full US prescribing information visit www.xofigo-us.com.
Xofigo^® is a registered trademark of Bayer
For further information, please contact:
Mike Booth +44 7866 490 850
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.
XOFIGO Prescribing information. May 2013
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