Algeta Announces That Xofigo(R) (Radium Ra 223 Dichloride) Injection Has Been Approved by the US FDA as Treatment for Castration-Resistant Prostate Cancer With Bone Metastases


OSLO, NORWAY--(Marketwired - May 15, 2013) - Intended for US Media only

* Algeta to host international conference call scheduled fortomorrow at 08:00 CET, 02:00 Eastern time - details below

Oslo, Norway, 15 May 2013 - Algeta ASA (OSE: ALGETA) announces that Bayerhasreceived US Food and Drug Administration (FDA) approval for Xofigo(®)(radium Ra223 dichloride) injection for the treatment of patients with castration-resistant prostate cancer (CRPC), symptomatic bone metastases and no knownvisceral metastatic disease. Xofigo is the first alpha particle-emittingradioactive therapeutic agent approved by the FDA. It has demonstratedimprovement in overall survival (OS) and delay in time to first symptomaticskeletal event (SSE) compared to placebo in the pivotal phase III ALSYMPCAtrial[1].

The commercial production of Xofigo is underway, and first doses areexpected tobe ready for patient treatment within a few weeks. Bayer has worldwideexclusivemarketing rights for Xofigo. Algeta US, LLC and Bayer Healthcare will co-promotethe product in the US.

Andrew Kay, Algeta's President & CEO, said: "We are delighted that theFDA hastaken the decision to approve Xofigo so quickly. We are extremely pleasedto beable to make Xofigo available to US patients with castration-resistantprostatecancer, symptomatic bone metastases and no known visceral metastaticdisease. Wewill now finalize our launch preparations in the US, with theintention oflaunching Xofigo, with Bayer, as soon as possible. This approval is amajormilestone for Algeta and puts us firmly on the path to deliver on ourvision tobe a world-class oncology company bringing medicines to cancer patientsthroughour leadership in alpha particle-emitting pharmaceuticals."

"Most men with castration-resistant prostate cancer develop bonemetastases,which can decrease overall survival," said Oliver Sartor, MD, NorthAmericanPrincipal Investigator for the pivotal trial and medical director of theTulaneCancer Center (New Orleans, LA). "Xofigo has demonstrated an anti-tumoreffecton bone metastases and will be an important addition to the treatment ofthiscancer."

Bone is the most common site in the body to be affected by metastaticcancer,and bone metastases are particularly prevalent in patients with prostatecancer[2]. Approximately 90% of patients with metastatic prostate cancershowevidence of bone metastases[3](,)[4](,)[5](,)[6] Bone metastases can leadto anincrease in frequency of skeletal events[7] and are shown to be the maincauseof morbidity and death in patients with CRPC[8].

Jan Manarite, senior educational facilitator for the Prostate CancerResearchInstitute also added, "It is encouraging to have a new treatment for menwithcastration-resistant prostate cancer, who are dealing with bonemetastases.Xofigo provides another new option to treat this cancer using adifferentapproach."

Efficacy and Safety Data Supporting Xofigo(®) (radium Ra 223dichloride)Approval

The approval of Xofigo is based on data from the pivotal phase IIIALSYMPCA(ALpharadin in SYMptomatic Prostate CAncer) trial. At the interimanalysis,Xofigo significantly improved OS [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 vs. 11.2monthswith placebo plus best standard of care(1). Additionally, at theinterimanalysis there was a delay in the time to first symptomatic skeletal event(SSE)for patients treated with Xofigo vs. placebo(1).

An updated analysis, conducted after the study was unblinded, showedimprovementin overall survival with a median OS of 14.9 months vs. 11.3 months;HR=0.695(95% CI 0.581-0.832)(1).

The most common adverse reactions (greater than or equal to 10%) inpatientsreceiving Xofigo in the ALSYMPCA trial were nausea, diarrhea,vomiting andperipheral edema. The most common hematologic laboratory abnormalities(greaterthan or equal to 10%) were anemia, lymphocytopenia, leukopenia,thrombocytopeniaand neutropenia(1).

About Xofigo(®) (radium Ra 223 dichloride)

Xofigo is indicated for the treatment of patients with castration-resistantprostate cancer, symptomatic bone metastases and no known visceralmetastaticdisease.

Xofigo is an alpha particle-emitting radioactive therapeutic agent with ananti-tumor effect on bone metastases. The active ingredient in Xofigo is thealphaparticle-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-tumor effect onbonemetastases. The alpha particle range from radium-223 dichloride is lessthan100 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

About the ALSYMPCA Trial

The ALSYMPCA trial was a phase III, randomized, double-blind, placebo-controlledinternational study of Xofigo with best standard of care vs. placebo withbeststandard of care in symptomatic CRPC patients with bone metastases. Thetrialenrolled 921 patients in more than 100 centers in 19 countries. Thestudytreatment consisted of up to six intravenous injections of Xofigo orplaceboeach separated by an interval of four weeks.

The primary endpoint of the study was overall survival (OS). A keysecondaryendpoint was time to first symptomatic skeletal event (SSE), asdefined asexternal beam radiation therapy (EBRT) to relieve skeletalsymptoms, newsymptomatic pathologic bone fracture, occurrence of spinal cordcompression, ortumor-related orthopedic surgical intervention.

About CRPC and Bone Metastases

Prostate cancer is the most common cancer among men in the United States(otherthan skin cancer)[9]. Approximately 4% of prostate cancer cases areconsidereddistant, which means that the cancer has spread beyond the prostate todistantareas of the body (metastasized)[10]. If prostate cancer starts to spreadtoother areas of the body, it most commonly goes to the bones(7).About the Patient Assistance Program

Bayer and Algeta offer patient assistance through Xofigo AccessServices(SM)which will assist with obtaining coverage and patient support ofXofigo.Patients and providers may contact the program at 1-855-6XOFIGO (1-855-696-3446) for additional information.

Details of international conference call

A conference call for investors, analysts and the press, and hosted byAlgeta'ssenior management team, will take place tomorrow at 08:00 CET, 02:00Easterntime. To participate in the conference call, please dial the appropriatenumberbelow five minutes prior to the call:

US: +1 866 966 5335
UK: +44 20 3003 2666 (toll free 0808 109 0700)
Norway: +47 21 56 33 18 (toll free 800 19 457)

Password: Algeta


To access the replay (available for seven days), please dial:

US: +1 866 583 1035
UK: +44 20 8196 1998
Norway: toll free 800 19 101

Participant pin code: 9227182

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. Such forward-lookingstatements reflect our current views and are based on the informationcurrentlyavailable to Algeta. Algeta cannot give any assurance as to whether suchforwardlooking statements will prove to be correct. These forward lookingstatementsinclude statements regarding our anticipated co-promotion of Xofigo inthe US. There are a number of factors that could cause actual results anddevelopmentsto differ materially from those expressed or implied by these forward-lookingstatements. These factors include, among other things, risks oruncertaintiesassociated with the ability to identify and hire a sufficientnumber ofqualified employees in the US, growth management, general economic andbusinessconditions and the pricing environment, the impact of competition, theabilityto successfully commercialize Xofigo, the risk that costs associatedwith theco-promotion of Xofigo may be greater than anticipated, manufacturingcapacity,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.

Xofigo(®) is a registered trademark of Bayer.

Xofigo Access Services(SM) is a service mark of Bayer.

[1] XOFIGO Prescribing information. May 2013
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[3] Tannock IF, et al. Docetaxel plus prednisone or mitoxantrone plus
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[4] Petrylak DP, et al. Docetaxel and estramustine compared with
and prednisone for advanced refractory prostate cancer. N Engl J Med.
[5] Scher, HI, et al. Increased Survival with Enzalutamide in Prostate
after Chemotherapy. N Engl J Med. 2012;DOI10.1056
[6] Fizazi, K, et al. Abiraterone acetate for treatment of metastatic
castration-resistant prostate cancer: final overall survival analysis of
COU-AA-301 randomised, double-blind, placebo-controlled phase 3 study.
Oncol 2012; 13:983-92
[7] Saad, MD, et. al. "Guidelines for the management of castration-
prostate cancer." Can Urol Assoc 2010;4(6):380-4
[8] Lange PH, Vasella RL. "Mechanisms, hypotheses and questions regarding
prostate cancer metastatic to bone." Cancer & Metastasis
[9] American Cancer Society. Prostate Cancer: Detailed Guide. Available at:
[10] National Cancer Institute, Surveillance Epidemiology and End Results
(SEER). SEER Stat Facts: Prostate; Survival & Stage, 2002-2008

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Source: Algeta ASA via Thomson Reuters ONE



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