OSLO, Norway, Sept. 12, 2013 (GLOBE NEWSWIRE) --
Intended for US media only
Algeta ASA (OSE:ALGETA), announced today that
further analyses of data subsets from the phase III ALSYMPCA study of Xofigo(®)
(radium Ra 223 dichloride) injection will be presented at the 2013 European
Cancer Congress (ECCO/ESMO/ESTRO), 28 September- 1 October, in Amsterdam, The
Netherlands.
Xofigo(®) was approved by the US Food and Drug Administration (FDA) in May 2013
for the treatment of patients with castration-resistant prostate cancer (CRPC),
symptomatic bone metastases and no known visceral metastatic disease and is now
available in the United States at licensed facilities.
Dr Gillies O'Bryan-Tear, Algeta's Chief Medical Officer, said: "These data add
to the growing body of scientific knowledge of Xofigo, and also serve to
illustrate the depth and breadth of the ALSYMPCA phase III data set."
Abstract titles and session details
Time to first skeletal-related event (SRE) with radium-223 dichloride (Ra-223)
in patients with castration-resistant prostate cancer (CRPC) and bone
metastases: ALSYMPCA trial stratification factors analysis
* Abstract #2876, Poster Session: Genitourinary Malignancies - Prostate
Cancer
* Monday, 30 September, 9:30 AM-12:00 PM CEST, Hall 4
Hematologic safety of radium-223 dichloride (Ra-223) in the phase 3 ALSYMPCA
trial in castration-resistant prostate cancer (CRPC) patients with bone
metastases: baseline prognostic factor subgroup analysis
* Abstract #2877, Poster Session: Genitourinary Malignancies - Prostate
Cancer
* Monday, 30 September, 9:30 AM-12:00 PM CEST, Hall 4
Effects of radium-223 dichloride (Ra-223) on health-related quality of life
(QOL) outcomes in the phase 3 ALSYMPCA study in patients with castration-
resistant prostate cancer (CRPC) and bone metastases
* Abstract #2878, Poster Session: Genitourinary Malignancies - Prostate
Cancer
* Monday, 30 September, 9:30 AM-12:00 PM CEST, Hall 4
Radium-223 dichloride (Ra-223) efficacy and safety in patients with castration-
resistant prostate cancer (CRPC) with bone metastases: phase 3 ALSYMPCA study
findings stratified by age group
* Abstract #2883, Poster Session: Genitourinary Malignancies - Prostate
Cancer
* Monday, 30 September, 9:30 AM-12:00 PM CEST, Hall 4
About Xofigo (radium Ra 223 dichloride)
Radium-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 December 2012
and subsequently in other territories.
Radium 223 (as Xofigo(®) injection) is approved in the United States and is
indicated for the treatment of patients with castration-resistant prostate
cancer (CRPC), symptomatic bone metastases and no known visceral metastatic
disease.
Radium 223 is an alpha particle-emitting radioactive therapeutic agent with an
anti-tumor effect on bone metastases. The active ingredient in radium 223 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[1].
In September 2009, Algeta signed an agreement with Bayer for the development and
commercialization of radium 223. 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.
Important Safety Information for Xofigo (radium Ra 223 dichloride)
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 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 ir@algeta.com
Media enquiries:
Mark Swallow +44 207 638 9571
Citigate Dewe Rogerson mark.swallow@citigatedr.co.uk
Kari Watson +1 781 235 3060
MacDougall Biomedical Communications kwatson@macbiocom.com
Investor enquiries:
Tricia Truehart +1 646 378 2953
The Trout Group ttruehart@troutgroup.com
About Algeta
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
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 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.
[1] XOFIGO Prescribing information. May 2013
Press release: http://hugin.info/134655/R/1728821/577445.pdf
[HUG#1728821]