OSLO, NORWAY--(Marketwired - May 30, 2013) - Algeta ASA (
The first commercial sale of Xofigo triggers a EUR 50 million milestonepayment to Algeta from Bayer under the terms of the 2009 developmentand licensing agreement. Bayer has worldwide exclusive marketing rights forXofigo. Algeta US, LLC and Bayer Healthcare areco-promoting the product in the US.
Algeta's President & CEO, Andrew Kay, commented: "We are delighted toannounce the first sale of Xofigo, following its approval by the FDA forthe treatment of patients with castration-resistant prostate cancer,symptomatic bone metastases and no known visceral metastatic disease. Forthese patients, we anticipate that Xofigo will be an important and welcomenew addition to the treatment paradigm."
About Xofigo® (radium Ra 223 dichloride)
Xofigo is indicated for the treatment of patients withcastration-resistant prostate cancer, symptomatic bone metastases and no known 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 alpha particle-emitting isotope radium 223, which mimics calcium andforms complexes with the bone mineral hydroxyapatite at areas of increasedbone turnover, such as bone metastases. The high linear energy transfer ofXofigo may cause double-strand DNA breaks in adjacent cells, resulting inan anti-tumor effect on bone metastases. The alpha particle range fromradium 223 dichloride is less than 100 micrometers which may limit thedamage to the surrounding normal tissue[i].
In September 2009, Algeta signed an agreement with Bayer for thedevelopment and commercialization of Xofigo. Under the terms of theagreement, Bayer will develop, apply for health authority approvalsworldwide and commercialize Xofigo globally. Algeta US, LLC is co-promotingXofigo 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 experiencedbone marrow failure or ongoing pancytopenia, compared to no patientstreated with placebo. There were two deaths due to bone marrow failure.For 7 of 13 patients treated with Xofigo bone marrow failure was ongoingat the time of death. Among the 13 patients who experienced bonemarrow failure, 54% required blood transfusions. Four percent (4%) ofpatients in the Xofigo arm and 2% in theplacebo arm permanently discontinued therapy due to bone marrowsuppression. In the randomized trial, deaths related to vascularhemorrhage in association with myelosuppression were observed in 1% ofXofigo-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%) wassimilar for patients treated with Xofigo and placebo. Myelosuppression -notably thrombocytopenia, neutropenia, pancytopenia, and leukopenia - hasbeen reported in patients treated with Xofigo.
Monitor patients with evidence of compromised bone marrow reserveclosely and provide supportive care measures when clinically indicated.Discontinue Xofigo in patients who experience life-threateningcomplications 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 plateletcount greater than or equal to 100 × 10(9)/L, and hemoglobin greaterthan or equal to 10 g/dL. Prior to subsequent administrations, the ANCshould 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 within6 to 8 weeks after the last administration despite receiving supportivecare.
Safety and efficacy of concomitant chemotherapy with Xofigo have notbeen established. Outside of a clinical trial, concomitant use of Xofigoin patients on chemotherapy is not recommended due to thepotential for additive myelosuppression. If chemotherapy, othersystemic radioisotopes, or hemibody external radiotherapy areadministered during the treatment period, Xofigon should bediscontinued.
Xofigo should be received, used, and administered only by authorizedpersons in designated clinical settings. The administration of Xofigo isassociated with potential risks to other persons from radiation orcontamination from spills of bodily fluids such as urine, feces, orvomit. Therefore, radiation protection precautions must be taken inaccordance with national and local regulations.
The most common adverse reactions (greater than or equal to 10%) inpatients receiving Xofigo were nausea, diarrhea, vomiting, and peripheraledema. Grade 3 and 4 adverse events were reported in 57% of Xofigo-treatedpatients and 63% of placebo-treated patients. The most common hematologiclaboratory abnormalities in Xofigo-treated patients (greater than orequal to 10%) were anemia, 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 forpatients with cancer based on its alpha-pharmaceutical platform.The Company is headquartered in Oslo, Norway, and has a US subsidiary,Algeta US, LLC, based in Cambridge, MA performing commercial marketingoperations in the US. Algeta is listed on the Oslo Stock Exchange(ALGETA.OL). For more information please visit www.algeta.com.
This news release contains certain forward-looking statements that arebased on uncertainty, as they relate to events and depend oncircumstances that will occur in the future and which, by their nature, mayhave an impact on results of operations and the financial conditionof Algeta. Such forward-looking statements reflect our current viewsand are based on the information currently available to Algeta. Algetacannot give any assurance as to whether such forwardlooking statements will prove to be correct. These forward lookingstatements include statements regarding our co-promotion of Xofigo in theUS. There are a number of factors that could cause actual results anddevelopments to differ materially from those expressed or implied by theseforward-looking statements. These factors include, among other things,risks or uncertainties associated with the ability to identify and hire asufficient number of qualified employees in the US, growth management,general economic and business conditions and thepricing environment, the impact of competition, the ability tosuccessfully commercialize Xofigo, the risk that costs associated withthe co-promotion of Xofigo may be greater than anticipated, manufacturingcapacity, the risk of non-approval of patents not yet granted, risks in obtaining additional regulatory approvals for radium 223 and the otherrisks and uncertainties described in our annual report.
[i] XOFIGO Prescribing information. May 2013
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Source: Algeta ASA via Thomson Reuters ONE
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