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Algeta celebrates the official opening of its commercial production facility for Xofigo(R) (radium Ra 223 dichloride) injection

Algeta celebrates the official opening of its commercial production facility  for Xofigo(R) (radium Ra 223 dichloride) injection at the Institute for Energy Technology (IFE) in Norway  OSLO, NORWAY -- (Marketwired) -- 06/20/13 --  Intended for US media only  Algeta ASA (OSE: ALGETA), a company focused on the development of cancer therapeutics, today celebrates the official opening of its commercial   production   facility  for  Xofigo(R)  (radium  Ra  223 dichloride) injection at the Institute for Energy Technology (IFE) in Kjeller, Norway.  Andrew  Kay, Algeta's President & CEO,  and senior management colleagues will be joined  by Trond Giske,  the Norwegian Minister  for Trade and  Industry, Eva S. Dugstad,  President of IFE and Andreas Fibig,  President & Chairman of the Board of  Management, Bayer HealthCare Pharmaceuticals, and other distinguished guests for an official ribbon cutting ceremony this afternoon.  Xofigo  was approved by the US Food  and Drug Administration (FDA) on 15 May for the  treatment  of  patients  with  castration-resistant prostate cancer (CRPC), symptomatic  bone metastases and no known visceral metastatic disease. It is the first alpha particle-emitting radioactive therapeutic agent approved by the FDA. In September 2009, Algeta signed an agreement with Bayer for the development and commercialization  of  Xofigo.  Under  the  terms  of  the agreement, Bayer will develop, apply for health authority approvals worldwide and commercialize Xofigo globally.  Algeta US, LLC  and Bayer Healthcare  are co-promoting the product in the  US.   Xofigo  has  been  launched  in  the  US, triggering a EUR 50 million milestone  payment to Algeta from Bayer.  Bayer Healthcare has licensed the full rights to Xofigo outside of the US.  Radium  Ra 223 dichloride (radium 223) is currently not approved by the European Medicines  Agency (EMA) or  other authorities outside  the US. Bayer submitted a Marketing Authorisation Application to the EMA for radium 223 in December 2012.  Andrew  Kay, Algeta's President & CEO, said:  "The recent approval and launch of Xofigo  in the US are momentous achievements for Algeta and put us firmly on the path  to  deliver  on  our  vision  of  becoming  a world-class oncology company bringing  medicines to cancer patients through our leadership in alpha particle-emitting pharmaceuticals. IFE has been an important partner to Algeta throughout the  clinical development of radium 223, and it has been instrumental in helping us  build a commercial production  facility for the global  supply of Xofigo. We are  all extremely grateful  for the expertise,  dedication and support that IFE has  provided  to  Algeta  on  this  journey  and look forward to continuing our productive partnership."  "Today's  opening of a new commercial  production facility at IFE underlines the Norwegian pharmaceutical industry's ability to develop products with significant global  potential. We  are  proud  to  have  played  an  integral  part  in the development  of Xofigo  that has  required quality  manufacturing throughout its path to market. The new facility which is being officially opened today has been designed  according to highest quality standards - from raw material handling to the  release of the final commercial product," said Eva S. Dugstad, President of the IFE.  "On  behalf of Bayer,  I am proud  and excited to  be part of this collaboration with  our Norwegian partners,  Algeta and IFE,"  said Andreas Fibig, President & Chairman  of the Board of Management, Bayer HealthCare Pharmaceuticals. "Now is the  time for the  patients to gain  from it. Our  hope is that  Xofigo can help castration-resistant  prostate cancer patients  with symptomatic bone metastases and no known visceral metastatic disease all over the world."  About Xofigo(R) (radium Ra 223 dichloride)  Xofigo  is  indicated  for  the  treatment of patients with castration-resistant prostate  cancer, symptomatic bone  metastases and no known visceral metastatic disease.  Xofigo is an alpha particle-emitting radioactive therapeutic agent with an anti-tumor effect on bone metastases. The active ingredient in Xofigo is the alpha particle-emitting isotope radium-223, which mimics calcium and forms complexes with the bone mineral hydroxyapatite at areas of increased bone turnover, such as bone metastases. The high linear energy transfer of radium-223 may cause double-strand DNA breaks in adjacent cells, resulting in an anti-tumor effect on bone metastases[i].  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 experienced bone marrow  failure or  ongoing pancytopenia,  compared to  no patients treated with placebo.  There were two deaths due to bone marrow failure. For 7 of 13 patients treated  with Xofigo bone marrow failure was ongoing at the time of death. Among the   13 patients  who  experienced  bone  marrow  failure,  54% required blood transfusions.  Four percent  (4%) of  patients in  the Xofigo  arm and 2% in the placebo  arm permanently discontinued therapy due to bone marrow suppression. In the  randomized trial, deaths related to vascular hemorrhage in association with myelosuppression  were  observed  in  1% of  Xofigo-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%) was similar for patients treated with Xofigo and placebo. Myelosuppression - notably thrombocytopenia,  neutropenia, pancytopenia, and leukopenia - has been reported in patients treated with Xofigo.  Monitor  patients with evidence  of compromised bone  marrow reserve closely and provide  supportive care measures when  clinically indicated. Discontinue Xofigo in  patients  who  experience  life-threatening complications 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 x 10(9)/L, the platelet count greater than or equal to  100 x 10(9)/L, and  hemoglobin greater  than or  equal to  10 g/dL. Prior to subsequent  administrations,  the  ANC  should  be  greater than or equal to 1 x 10(9)/L and  the  platelet  count  greater  than  or  equal  to  50 x 10(9)/L. Discontinue  Xofigo if  hematologic values  do not  recover within  6 to 8 weeks after the last administration despite receiving supportive care.  Safety  and  efficacy  of  concomitant  chemotherapy  with  Xofigo have not been established.  Outside of a clinical trial, concomitant use of Xofigo in patients on   chemotherapy   is  not  recommended  due  to  the  potential  for additive myelosuppression.  If  chemotherapy,  other  systemic radioisotopes, or hemibody external  radiotherapy  are  administered  during  the  treatment period, Xofigo should be discontinued.  Xofigo  should be received, used, and administered only by authorized persons in designated  clinical settings. The  administration of Xofigo  is associated with potential  risks to other persons from radiation or contamination from spills of bodily  fluids such as  urine, feces, or  vomit. Therefore, radiation protection precautions must be taken in accordance with national and local regulations.  The  most common  adverse reactions  (greater than  or equal to 10%) in patients receiving Xofigo were nausea, diarrhea, vomiting, and peripheral edema. Grade 3 and  4 adverse events were reported in 57% of Xofigo-treated patients and 63% of placebo-treated  patients. The most  common hematologic laboratory abnormalities in   Xofigo-treated  patients  (greater  than  or  equal  to  10%) were anemia, lymphocytopenia, leukopenia, thrombocytopenia, and neutropenia.  For full prescribing information visit  Xofigo(R) is a registered trademark of Bayer  About Algeta  Algeta  is a company focused on developing novel targeted therapies for patients 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  marketing operations in  the US. Algeta is listed  on the Oslo Stock Exchange (Ticker: ALGETA). For more information please visit  Forward-looking Statements  This  news release contains certain forward-looking statements that are based on uncertainty,  as they  relate to  events and  depend on  circumstances that will occur in the future and which, by their nature, may have an impact on results of operations   and   the  financial  condition  of  Algeta.  Such forward-looking statements  reflect our current views and are based on the information currently available to Algeta. Algeta cannot give any assurance as to whether such forward looking  statements will prove  to be correct.  These forward looking statements include  statements  regarding  our  co-promotion  of  Xofigo  in the US and our ability  to manufacture  radium 223 on  a global  scale. There  are a number of factors  that could cause  actual results and  developments to differ materially from  those  expressed  or  implied  by  these forward-looking statements. These factors  include, among other things, risks or uncertainties associated with the ability  to identify and hire a sufficient  number of qualified employees in the US,  growth management, general economic and business conditions and the pricing environment,   the   impact   of   competition,   the  ability  to successfully commercialize  Xofigo, the risk  that costs associated  with the co-promotion of Xofigo may be greater than anticipated, manufacturing capacity, the risk of non-approval  of patents not  yet granted, risks  in obtaining additional regulatory approvals  for radium 223 and the other risks and uncertainties described in our annual report.  [i] XOFIGO Prescribing information. May 2013  Press release:  This announcement is distributed by Thomson Reuters on behalf of Thomson 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  [HUG#1710715]  For further information, please contact:  Mike Booth / Renate Birkeli +47 23 00 67 32 Communications & Corporate Affairs  Media enquiries:  Mark Swallow +44 207 638 9571 Citigate Dewe Rogerson  Kari Watson +1 781 235 3060 MacDougall Biomedical Communications  US investor enquiries:  Tricia Swanson +1 646 378 2953 The Trout Group    
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