OSLO, NORWAY--(Marketwired - Aug 28, 2013) -
Intended for US media only
Algeta ASA (
A presentation of the results in Oslo will be webcast live from 10:00CET andcan be accessed through www.algeta.com. An international conference callwilltake place at 14:30 CET/ 08:30 EST (US). Details of both events are atthe endof this announcement.
"We were delighted that Xofigo(®) (radium Ra 223 dichloride)injection wasapproved and launched in the US in May. These major milestonesreflect thesignificant effort and commitment of everyone involved in the drug'sdevelopmentover the past decade and more," said Andrew Kay, Algeta President & CEO."WithBayer, we are now executing our launch strategy in the US and are pleasedwiththe progress being made."
Oystein Soug, Algeta's Chief Financial Officer, added, "Algeta hasreceivedEUR 100m in milestone payments from Bayer during 2013 which will enableus tofully invest in the US launch of Xofigo alongside Bayer. In additionto ourfinancial profile, our proven development expertise in oncology and ourgrowingcommercial experience and infrastructure provide us with the confidence toseekto build a broad portfolio of novel cancer therapeutics beyond Xofigo."
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 is eligible for royalties and milestones based on Bayer'ssalesof Xofigo outside the US, and Algeta US, LLC is co-promoting Xofigo withBayerin the US.
Highlights of the second quarter 2013:
Xofigo (radium Ra 223 dichloride) injection
* On 15 May 2013, the US Food and Drug Administration (FDA) approvedXofigo® (radium Ra 223 dichloride) injection for the treatment of patientswithcastration-resistant prostate cancer (CRPC), symptomatic bone metastasesandno known visceral metastatic disease.
* On 30 May, Algeta announced that Xofigo had been launched in the US andthefirst sale had been made, triggering a EUR 50m milestone payment toAlgetafrom Bayer. Algeta US, LLC and Bayer Healthcare are co-promoting Xofigointhe US.
* The launch of Xofigo is being executed by Algeta and Bayer to anagreedplan, and both companies are working in their respective territoriestoensure that physicians are aware of Xofigo and its approved label. Akeypart of the launch activities is to provide information and supporttoadministering centers to get licensed to procure and administer Xofigo.
* In June, Algeta celebrated the official opening of its commercialproductionfacility for Xofigo, located at the Institute for Energy Technology (IFE)inNorway. All material for commercial sale and for clinical trials world-wideis currently produced in this facility.
Targeted Thorium Conjugates (TTCs)
* In May, and to facilitate the conjugation of thorium-227 totargetingmolecules in its TTC research, Algeta announced the exercise of itsoptionto take an exclusive worldwide license to patented Lumi4(®) bi-functionalchelator technology from Lumiphore, Inc. and an extension ofthecollaboration to include additional chelator families.
* In June, Algeta announced a collaboration with Avipep Pty Ltd toevaluate anovel TTC that combines Algeta's thorium-227 payload with anAvibody™from Avipep that targets a number of different solid tumor types.
* Data from the phase III ALSYMPCA trial were published in the 18 July 2013issue of the New England Journal of Medicine.
* In August, Dr Andreas Menrad was appointed Chief ScientificOfficer,bringing more than 20 years of experience in oncology andtherapeuticantibody development. He was formerly CSO at Ablynx NV, andworkedpreviously at Genzyme (Sanofi) as General Manager and Vice PresidentofAntibody Therapeutics.
* Operating revenue for the second quarter 2013 amounted to NOK 444mcomparedwith NOK 55m in the same period in 2012. Revenues were NOK 515m in thefirsthalf of 2013 vs NOK 128m in same period in 2012.
* In the second quarter 2013, net sales of Xofigo in the US market(recognizedby Bayer) amounted to NOK 3m (USD 0.6m) compared to nil in the samequarterlast year.
* Algeta's recognized share of the net result of US co-promotionactivitiesfor the second quarter 2013 was an expense of NOK 70m, compared withanexpense of NOK 27m in the same period in 2012. Algeta recognizes 50% ofthenet result of Xofigo co-promotion activities in the US.
* Core operating expenses, which exclude currency effects, interestincomeand costs directly related to the commercial launch in the US, for thesecond quarter 2013 amounted to NOK 120m, compared with NOK 80m in the sameperiod in 2012.
* Net cash amounted to NOK 565m as at 30 June 2013 compared with NOK 369mas of the 31 December 2012.
The First Half and Second Quarter Report 2013 and accompanying presentationwillbe available through www.algeta.com from 07:00 CET today.
Details of presentation and webcast
A presentation by Algeta's executive management team to investors,analysts andthe press will take place in Oslo at 10:00 CET.
Haakon VIIs gate 9
The presentation will also be webcast live and can be accessedthroughwww.algeta.com. Questions can be submitted live during the webcast.
Details of international conference call
An international conference call will take place at 14:30 CET/ 08:30 EST(US).To participate in the conference call, please dial the appropriate numberbelowfive minutes prior to the call:
US: +1 877 423 0830
UK: +44 20 7153 9154
Norway: +47 21 06 61 13
Sweden: +46 8-506 443 86
Denmark: +45 32 71 42 62
Switzerland: +41 44 580 65 22
Participant pin code: 197187#
To access the replay, please dial:
US: +1 877 679 2989
UK: +44 20 3364 5200
Norway: +47 23 50 02 03
Sweden: +46 8-505 564 73
Conference reference: 348084#
A replay of the conference call will also be available at www.algeta.com.
About radium Ra 223 dichloride
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 December2012and subsequently in other territories.
Radium 223 (as Xofigo(®) injection) is approved in the UnitedStates and isindicated for the treatment of patients with castration-resistantprostatecancer (CRPC), symptomatic bone metastases and no known visceralmetastaticdisease.
Radium 223 is an alpha particle-emitting radioactive therapeutic agent withananti-tumor effect on bone metastases. The active ingredient in radium 223is thealpha particle-emitting isotope radium-223, which mimics calcium and formscomplexes with the bone mineral hydroxyapatite at areas of increased boneturnover, such as bone metastases. The high linear energy transfer ofradium-223 may cause double-strand DNA breaks in adjacent cells, resulting in ananti-tumor effect on bone metastases. The alpha particle range from radium-223isless than 100 micrometers which may limit the damage to the surroundingnormaltissue.
Important Safety Information for Xofigo (radium Ra 223 dichloride) in theUS
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%) in theXofigoarm vs. the placebo arm, respectively, were nausea (36% vs 35%) diarrhea(25% vs15%), vomiting (19% vs 14%), and peripheral edema (13% vs 10%). Grade 3and 4adverse events were reported in 57% of Xofigo-treated patients and63% ofplacebo-treated patients. The most common hematologic laboratoryabnormalitiesin the Xofigo arm (greater than or equal to 10%) vs the placeboarm,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.
Algeta is a company focused on developing, manufacturing and marketingnoveltargeted therapies for patients with cancer. The Company isheadquartered inOslo, Norway, and has a US subsidiary, Algeta US, LLC, based inCambridge, MAperforming commercial marketing operations in the US. Algeta is listedon theOslo Stock Exchange (ALGETA.OL). For more information pleasevisitwww.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. 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 co-promotion of Xofigo in the USand thedevelopment of our other product candidates. There are a number of factorsthatcould cause actual results and developments to differ materially fromthoseexpressed or implied by these forward-looking statements. These factorsinclude,among other things, general economic and business conditions, theimpact ofcompetition, the ability to successfully commercialize Xofigo, the riskthatcosts associated with the co-promotion of Xofigo may be greaterthananticipated, the risk that research & business development will notyield newproducts that achieve commercial success, manufacturing capacity, therisk ofnon-approval of patents not yet granted, risks in obtaining regulatoryapprovalsfor radium 223 and our other products and difficulties of obtainingrelevantgovernmental approvals for new products, and the other risks anduncertaintiesdescribed in our annual report.
Xofigo® is a registered trademark of Bayer
Lumi4® is a registered mark of Lumiphore, Inc.
 Alpha Emitter Radium-223 and Survival in Metastatic Prostate Cancer,Parker,C. et al. New England Journal of Medicine 2013; 369 (3) 213-223.
 Defined as the sum of External R&D expenses, Payroll and related costs,Depreciation (including change in inventory) and General and Administrativeexpenses. Core operating expenses do not include costs from co-promotionactivities.
 XOFIGO Prescribing information. May 2013
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Source: Algeta ASA via Thomson Reuters ONE
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