Algeta Announces That Xofigo(R) (Radium Ra 223 Dichloride) Injection Has Been Approved by the US FDA as Treatment for Castration

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) -- 05/15/13 --  Intended for US Media only  * Algeta  to  host  international  conference  call  scheduled for tomorrow at     08:00 CET, 02:00 Eastern time - details below  Oslo, Norway, 15 May 2013 - Algeta ASA (OSE: ALGETA) announces that Bayer has received US Food and Drug Administration (FDA) approval for Xofigo((R)) (radium Ra 223 dichloride) injection for the treatment of patients with castration- resistant prostate cancer (CRPC), symptomatic bone metastases and no known visceral metastatic disease. Xofigo is the first alpha particle-emitting radioactive therapeutic agent approved by the FDA. It has demonstrated improvement in overall survival (OS) and delay in time to first symptomatic skeletal event (SSE) compared to placebo in the pivotal phase III ALSYMPCA trial[1].  The commercial production of Xofigo is underway, and first doses are expected to be ready for patient treatment within a few weeks. Bayer has worldwide exclusive marketing rights for Xofigo. Algeta US, LLC and Bayer Healthcare will co- promote the product in the US.  Andrew  Kay, Algeta's President & CEO, said:  "We are delighted that the FDA has taken  the decision to approve Xofigo so quickly. We are extremely pleased to be able  to make Xofigo available to US patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease. We will  now finalize  our launch  preparations in  the US,  with the intention of launching  Xofigo, with  Bayer, as  soon as  possible. This  approval is a major milestone  for Algeta and puts us firmly on the path to deliver on our vision to be  a world-class oncology company bringing medicines to cancer patients through our leadership in alpha particle-emitting pharmaceuticals."  "Most  men with  castration-resistant prostate  cancer develop  bone metastases, which  can decrease  overall survival,"  said Oliver  Sartor, MD, North American Principal  Investigator for the pivotal trial and medical director of the Tulane Cancer  Center (New Orleans, LA). "Xofigo  has demonstrated an anti-tumor effect on  b one metastases and will  be an important addition  to the treatment of this cancer."  Bone is the most common site in the body to be affected by metastatic cancer, and bone metastases are particularly prevalent in patients with prostate cancer[2]. Approximately 90% of patients with metastatic prostate cancer show evidence of bone metastases[3](,)[4](,)[5](,)[6] Bone metastases can lead to an increase in frequency of skeletal events[7] and are shown to be the main cause of morbidity and death in patients with CRPC[8].  Jan  Manarite, senior educational  facilitator for the  Prostate Cancer Research Institute  also added, "It is  encouraging to have a  new treatment for men with castration-resistant  prostate  cancer,  who  are  dealing with bone metastases. Xofigo  provides  another  new  option  to  treat  this cancer using a different approach."  Efficacy  and  Safety  Data  Supporting  Xofigo((R))  (radium  Ra  223 dichloride) Approval  The  approval of  Xofigo is  based on  data from  the pivotal phase III ALSYMPCA (ALpharadin  in  SYMptomatic  Prostate  CAncer)  trial. At the interim analysis, 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. 11.2 months with  placebo  plus  best  standard  of  care(1).  Additionally,  at the interim analysis 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, showed improvement in  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%) in patients receiving  Xofigo  in  the  ALSYMPCA  trial  were nausea, diarrhea, vomiting and peripheral  edema. The most common hematologic laboratory abnormalities (greater than or equal to 10%) were anemia, lymphocytopenia, leukopenia, thrombocytopenia and neutropenia(1).  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 Xofigo may cause double-strand  DNA breaks in adjacent cells, resulting  in an anti-tumor effect on bone metastases.  The alpha  particle range  from radium-223 dichloride  is less than 100 micrometers which may limit the damage to the surrounding normal tissue(1).  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 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 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 www.xofigo-us.com.  About the ALSYMPCA Trial  The ALSYMPCA trial was a phase III, randomized, double-blind, placebo- controlled international  study of Xofigo with best standard  of care vs. placebo with best standard  of care in  symptomatic CRPC patients  with bone metastases. The trial enrolled  921 patients  in  more  than  100 centers  in  19 countries. The study treatment  consisted of  up to  six intravenous  injections of Xofigo or placebo each separated by an interval of four weeks.  The  primary endpoint of  the study was  overall survival (OS).  A key secondary endpoint  was  time  to  first  symptomatic  skeletal event (SSE), as defined as external  beam  radiation  therapy  (EBRT)  to  relieve  skeletal symptoms, new symptomatic  pathologic bone fracture, occurrence of spinal cord compression, or tumor-related orthopedic surgical intervention.  About CRPC and Bone Metastases  Prostate cancer is the most common cancer among men in the United States (other than skin cancer)[9]. Approximately 4% of prostate cancer cases are considered distant, which means that the cancer has spread beyond the prostate to distant areas of the body (metastasized)[10]. If prostate cancer starts to spread to other 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 Access Services(SM) which  will  assist  with  obtaining  coverage  and  patient  support of Xofigo. 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 by Algeta's senior  management team,  will take  place tomorrow  at 08:00 CET, 02:00 Eastern time.  To participate in the conference call, please dial the appropriate number below 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 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 www.algeta.com.  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 anticipated co-promotion  of Xofigo in the US.  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.  Xofigo((R)) is a registered trademark of Bayer.  Xofigo Access Services(SM) is a service mark of Bayer.      [1] XOFIGO Prescribing information. May 2013 [2] Coleman R. Metastatic bone disease: clinical features, pathophysiology and treatment strategies. Cancer Treat Rev. 2001;27:165-176 [3] Tannock IF, et al. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med. 2004;351:1502-1512 [4] Petrylak DP, et al. Docetaxel and estramustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer. N Engl J Med. 2004;351:1513-1520 [5] Scher, HI, et al. Increased Survival with Enzalutamide in Prostate Cancer 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 the COU-AA-301 randomised, double-blind, placebo-controlled phase 3 study. Lancet Oncol 2012; 13:983-92 [7] Saad, MD, et. al. "Guidelines for the management of castration- resistant 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 Reviews.1999;17:331-336 [9] American Cancer Society. Prostate Cancer: Detailed Guide. Available at: http://www.cancer.org/acs/groups/cid/documents/webcontent/003134-pdf.pdf [10] National Cancer Institute, Surveillance Epidemiology and End Results (SEER). SEER Stat Facts: Prostate; Survival & Stage, 2002-2008    Press release: http://hugin.info/134655/ R/1702307/562444.pdf  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#1702307]  For further information, please contact: Mike Booth +47 2202 4510 Communications & Corporate Affairs ir@algeta.com  Media enquiries: Mark Swallow +44 207 638 9571 Citigate Dewe Rogerson mark.swallow@citigatedr.co.uk  Kari Watson +1 781 235 3060 MacDougall Biomedical Communications kwatson@macbiocom.com  US investor enquiries: Tricia Swanson +1 646 378 2953 The Trout Group tswanson@troutgroup.com    
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