Algeta ASA: New data and analyses from clinical trials of Xofigo(R) (radium Ra 223 dichloride) to be presented at ASCO


OSLO, NORWAY--(Marketwired - May 16, 2013) - Intended for US Media only

Algeta ASA (OSE: ALGETA) announces that further analyses of data subsetsfrom the phase III ALSYMPCA study of the recently FDA-approved Xofigo®(radium Ra 223 dichloride, radium 223) will be presented at the 49(th)Annual Meeting of the American Society of Clinical Oncology (ASCO),31 May-4June, in Chicago, IL (USA).

Hematologic safety of Ra-223 dichloride (Ra-223) incastration-resistant prostate cancer (CRPC) patients with bone metastasesfrom the phase 3 ALSYMPCA trial

* Abstract #5060, General Poster Session: Genitourinary (Prostate) Cancer

* Monday, 3 June, 8:00am - 11:45am, S Hall A2

Efficacy and safety of radium-223 dichloride (Ra-223) incastration-resistant prostate cancer (CRPC) patients with bone metastaseswho did or did not receive prior docetaxel (D) in the phase 3 ALSYMPCAtrial

* Abstract #5068, General Poster Session: Genitourinary (Prostate) Cancer

* Monday, 3 June, 8:00am - 11:45am, S Hall A2

Pain analysis from the phase 3 randomized ALSYMPCA study withradium-223dichloride (Ra-223) in castration-resistant prostate cancer (CRPC) patientswithbone metastases

* Abstract #5038, General Poster Session: Genitourinary (Prostate) Cancer

* Monday, 3 June, 8:00am - 11:45am, S Hall A2

Correlation between baseline variables and survival in the radium-223dichloride(Ra-223) phase III ALSYMPCA trial with attention to total ALP changes

* Abstract #5080, General Poster Session: Genitourinary (Prostate) Cancer

* Monday, 3 June, 8:00am - 11:45am, S Hall A2

About Xofigo® (radium Ra 223 dichloride)

Xofigo is indicated for the treatment of patients withcastration-resistant prostate cancer, symptomatic bone metastases and noknown visceral metastatic disease.

Xofigo is an alpha particle-emitting radioactive therapeutic agent with ananti-tumor effect on bone metastases. The active ingredient in Xofigo isthe alphaparticle-emitting isotope radium 223, which mimics calcium and formscomplexeswith the bone mineral hydroxyapatite at areas of increased bone turnover,suchas bone metastases. The high linear energy transfer of Xofigo may causedouble-strand DNA breaks in adjacent cells, resulting in an anti-tumoreffect on bone metastases. The alpha particle range from radium 223dichloride is less than100 micrometers, which may limit the damage to the surrounding normaltissue(1).

In September 2009, Algeta signed an agreement with Bayer for thedevelopment andcommercialization of Xofigo. Under the terms of the agreement, Bayerwilldevelop, apply for health authority approvals worldwide and commercializeXofigoglobally. Algeta US, LLC will co-promote 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 cancause fetal harm when administered to a pregnant woman.

In the randomized trial, 2% of patients in the Xofigo arm experiencedbonemarrow failure or ongoing pancytopenia, compared to no patients treatedwithplacebo. There were two deaths due to bone marrow failure. For 7 of 13patientstreated with Xofigo bone marrow failure was ongoing at the time of death.Amongthe 13 patients who experienced bone marrow failure, 54% requiredbloodtransfusions. Four percent (4%) of patients in the Xofigo arm and 2%in theplacebo arm permanently discontinued therapy due to bone marrowsuppression. Inthe randomized trial, deaths related to vascular hemorrhage in associationwithmyelosuppression were observed in 1% of Xofigo-treated patientscompared to0.3% of patients treated with placebo. The incidence of infection-relateddeaths(2%), serious infections (10%), and febrile neutropenia (less than1%) wassimilar for patients treated with Xofigo and placebo. Myelosuppression -notablythrombocytopenia, neutropenia, pancytopenia, and leukopenia - has beenreportedin patients treated with Xofigo.

Monitor patients with evidence of compromised bone marrow reserveclosely andprovide supportive care measures when clinically indicated. DiscontinueXofigoin patients who experience life-threatening complications despitesupportivecare for bone marrow failure.

Monitor blood counts at baseline and prior to every dose of Xofigo.Prior tofirst administering Xofigo, the absolute neutrophil count (ANC)should begreater than to equal to 1.5 × 10(9)/L, the platelet count greaterthan or equalto 100 × 10(9)/L, and hemoglobin greater than or equal to 10g/dL. Prior tosubsequent administrations, the ANC should be greater than or equalto 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 8weeksafter the last administration despite receiving supportive care.

Safety and efficacy of concomitant chemotherapy with Xofigo have notbeenestablished. Outside of a clinical trial, concomitant use of Xofigo inpatientson chemotherapy is not recommended due to the potential foradditivemyelosuppression. If chemotherapy, other systemic radioisotopes, orhemibodyexternal radiotherapy are administered during the treatment period,Xofigoshould be discontinued.

Xofigo should be received, used, and administered only by authorizedpersons indesignated clinical settings. The administration of Xofigo is associatedwithpotential risks to other persons from radiation or contamination fromspills ofbodily fluids such as urine, feces, or vomit. Therefore, radiationprotectionprecautions must be taken in accordance with national and localregulations.

The most common adverse reactions (greater than or equal to 10%) inpatientsreceiving Xofigo were nausea, diarrhea, vomiting, and peripheral edema.Grade 3and 4 adverse events were reported in 57% of Xofigo-treated patients and63% ofplacebo-treated patients. The most common hematologic laboratoryabnormalitiesin Xofigo-treated patients (greater than or equal to 10%) wereanemia,lymphocytopenia, leukopenia, thrombocytopenia, and neutropenia.

For full prescribing information visit


Xofigo® is a registered trademark of Bayer.

About Algeta

Algeta is a company focused on developing novel targeted therapies forpatientswith cancer based on its alpha-pharmaceutical platform. TheCompany isheadquartered in Oslo, Norway, and has a US subsidiary, Algeta US, LLC,based inCambridge, MA performing commercial marketing operations in the US.Algeta islisted on the Oslo Stock Exchange (ALGETA.OL). For more informationpleasevisit

Forward-looking Statements

This news release contains certain forward-looking statements that arebased onuncertainty, as they relate to events and depend on circumstances thatwilloccur in the future and which, by their nature, may have an impact onresults ofoperations and the financial condition of Algeta. Suchforward-looking statements reflect our current views and are based on theinformation currently available to Algeta. Algeta cannot give any assuranceas to whether such forward looking statements will prove to be correct.These forward looking statements include statements regarding ouranticipated co-promotion of Xofigo in the US. There are a number offactors that could cause actual results and developments to differmaterially from those expressed or implied by these forward-lookingstatements. These factors include, among other things, risks oruncertainties associated with the ability to identify and hire asufficient number of qualified employees in the US, growth management,general economic and business conditions and the pricing environment, theimpact of competition, the ability to successfully commercialize Xofigo,the risk that costs associated with the co-promotion of Xofigo may begreater than anticipated, manufacturing capacity,the risk of non-approval of patents not yet granted, risks inobtainingadditional regulatory approvals for radium 223 and the other risksanduncertainties described in our annual report.


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