OSLO, NORWAY--(Marketwired - Jun 20, 2013) - Intended for US media only
Algeta ASA (
Andrew Kay, Algeta's President & CEO, and senior management colleagueswill bejoined by Trond Giske, the Norwegian Minister for Trade and Industry,Eva S.Dugstad, President of IFE and Andreas Fibig, President & Chairman of theBoardof Management, Bayer HealthCare Pharmaceuticals, and other distinguishedguestsfor an official ribbon cutting ceremony this afternoon.
Xofigo was approved by the US Food and Drug Administration (FDA) on 15May forthe treatment of patients with castration-resistant prostate cancer(CRPC),symptomatic bone metastases and no known visceral metastatic disease. Itis thefirst alpha particle-emitting radioactive therapeutic agent approved by theFDA.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 and Bayer Healthcare are co-promoting theproduct inthe US. Xofigo has been launched in the US, triggering a EUR 50millionmilestone payment to Algeta from Bayer. Bayer Healthcare has licensed thefullrights to Xofigo outside of the US.
Radium Ra 223 dichloride (radium 223) is currently not approved by theEuropeanMedicines Agency (EMA) or other authorities outside the US. Bayersubmitted aMarketing Authorisation Application to the EMA for radium 223 in December2012.
Andrew Kay, Algeta's President & CEO, said: "The recent approval andlaunch ofXofigo in the US are momentous achievements for Algeta and put us firmlyon thepath to deliver on our vision of becoming a world-class oncologycompanybringing medicines to cancer patients through our leadership in alphaparticle-emitting pharmaceuticals. IFE has been an important partner toAlgeta throughoutthe clinical development of radium 223, and it has been instrumental inhelpingus build a commercial production facility for the global supply ofXofigo. Weare all extremely grateful for the expertise, dedication and supportthat IFEhas provided to Algeta on this journey and look forward tocontinuing ourproductive partnership."
"Today's opening of a new commercial production facility at IFEunderlines theNorwegian pharmaceutical industry's ability to develop products withsignificantglobal potential. We are proud to have played an integral part inthedevelopment of Xofigo that has required quality manufacturingthroughout itspath to market. The new facility which is being officially opened today hasbeendesigned according to highest quality standards - from raw materialhandling tothe release of the final commercial product," said Eva S. Dugstad,President ofthe IFE.
"On behalf of Bayer, I am proud and excited to be part of thiscollaborationwith our Norwegian partners, Algeta and IFE," said Andreas Fibig,President &Chairman of the Board of Management, Bayer HealthCare Pharmaceuticals."Now isthe time for the patients to gain from it. Our hope is that Xofigo canhelpcastration-resistant prostate cancer patients with symptomatic bonemetastasesand no known visceral metastatic disease all over the world."
About Xofigo® (radium Ra 223 dichloride)
Xofigo is indicated for the treatment of patients withcastration-resistant prostate cancer, symptomatic bone metastases and noknown visceral metastaticdisease.
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 radium-223 may causedouble-strand DNA breaks in adjacent cells, resulting in an anti-tumoreffect onbone metastases[i].
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 www.xofigo-us.com.
Xofigo® is a registered trademark of Bayer
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 www.algeta.com.
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 currentlyavailable to Algeta. Algeta cannot give any assurance as to whether suchforwardlooking statements will prove to be correct. These forward lookingstatementsinclude statements regarding our co-promotion of Xofigo in the USand ourability to manufacture radium 223 on a global scale. There are anumber offactors that could cause actual results and developments to differmateriallyfrom those expressed or implied by these forward-looking statements.Thesefactors include, among other things, risks or uncertainties associatedwith theability to identify and hire a sufficient number of qualified employeesin theUS, growth management, general economic and business conditions and thepricingenvironment, the impact of competition, the ability tosuccessfullycommercialize Xofigo, the risk that costs associated with theco-promotion of Xofigo may be greater than anticipated, manufacturingcapacity, the risk of non-approval of patents not yet granted, risks inobtaining additional regulatoryapprovals for radium 223 and the other risks and uncertainties describedin ourannual report.
[i] XOFIGO Prescribing information. May 2013
This announcement is distributed by Thomson Reuters on behalf ofThomson Reuters clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and other applicable laws; and
(ii) they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Algeta ASA via Thomson Reuters ONE
- Health Care Industry
- radium 223
- bone metastases
- prostate cancer
Mike Booth / Renate Birkeli
+47 23 00 67 32
Communications & Corporate Affairs
+44 207 638 9571
Citigate Dewe Rogerson
+1 781 235 3060
MacDougall Biomedical Communications
US investor enquiries:
+1 646 378 2953
The Trout Group