Algeta ASA : US FDA Grants Priority Review to Bayer's NDA for Radium Ra 223 Dichloride for Castration-Resistant Prostate Cancer with Bone Metastases
February 13, 2013 - Oslo, Norway
Intended for US Media only
Algeta ASA (OSE: ALGETA) announces that Bayerhas received notification that the New Drug Application (NDA) fortheinvestigational compound Radium Ra 223 Dichloride (radium-223) has beenacceptedfor filing and granted priority review by the US Food and DrugAdministration(FDA). The application is currently under review for thetreatment ofcastration-resistant prostate cancer (CRPC) patients with bone metastases.
Andrew Kay, Algeta's President & CEO, said: "With the granting ofpriorityreview for the NDA for Radium Ra 223 dichloride (radium-223) in the US,there isrecognition that Radium Ra 223 dichloride (radium-223) has thepotential tooffer a treatment option for CRPC patients with bone metastases wherelittle orno therapy exists. While we await the final decision from the regulatorslaterthis year, and together with Bayer, we continue with ourcommercializationplanning and look forward to a potential approval, and to making thiscompoundavailable to patients."
The FDA grants priority review to medicines that provide a treatmentwherelittle or no adequate therapy exists. Under the Prescription Drug UserFee Act(PDUFA), the FDA aims to complete its review within six months of the60-dayfiling receipt of the NDA submission (eight months total), ratherthan thestandard 12-month review cycle.
In September 2009, Algeta signed an agreement with Bayer Pharma AG(Berlin,Germany) for the development and commercialization of radium-223.Under theterms of the agreement, Bayer will develop, apply for global healthauthorityapprovals, and commercialize radium-223 globally. Algeta will co-promoteradium-223 with Bayer in the US, and is eligible for milestones as well asroyalties onBayer's sales outside the US.
About Radium Ra 223 Dichloride
Radium Ra 223 Dichloride (radium-223), formerly referred to asradium-223chloride, is an investigational alpha particle-emittingpharmaceutical indevelopment for CRPC patients with bone metastases.
Radium-223 is an investigational agent and is not approved by theEuropeanMedicines Agency (EMA), the US Food and Drug Administration (FDA) orotherhealth authorities. Bayer submitted a Marketing Authorization Applicationto theEMA and a New Drug Application to the FDA for radium-223 in December2012 forthe treatment of CRPC patients with bone metastases.
In January 2013, the US Nuclear Regulatory Commission (NRC) issued alicensingdecision on the medical use of radium-223. The decision states that USmedicalsites can procure and administer radium-223 under 10 CFR Part 35,Subpart E,which includes 10 CFR § 35.300.
About CRPC and Bone Metastases
prostate cancer is the most common cancer among men in the United States(otherthan skin cancer).Approximately 16% of prostate cancer cases areconsideredregional or distant, which means that the cancer has spread beyond theprostateto nearby or distant areas of the body (metastasis).A majority of men with CRPC have radiological evidence of bonemetastases.Bone metastases secondary to prostate cancer typically target the lumbarspine,vertebrae and pelvis.In fact, bone metastases are the main cause ofmorbidityand death in patients with CRPC.
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 (Ticker: ALGETA). For more informationpleasevisit www.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. Suchforward-looking statements reflect our current views and are based on theinformation currentlyavailable to Algeta. Algeta cannot give any assurance as to whether suchforwardlooking statements will prove to be correct. These forward lookingstatementsinclude statements regarding the potential timeline of FDA approval ofradium-223 and our anticipated co-promotion ofradium-223 in the US. There are anumber of factors that could cause actual results and developments todiffermaterially from those expressed or implied by these forward-lookingstatements.These factors include, among other things, risks or uncertaintiesassociatedwith the ability to identify and hire a sufficient number of qualifiedemployeesfor the US field force, growth management, general economic andbusinessconditions and the pricing environment, the impact of competition, theabilityto successfully commercialize radium-223, the risk that costs associatedwiththe co-promotion of radium-223 may be greater than anticipated,manufacturingcapacity, the risk of non-approval of patents not yet granted,risks inobtaining regulatory approvals for radium-223 and the other risksanduncertainties described in our annual report.
 American Cancer Society. prostate cancer: Detailed Guide. October 26,2012.Available at:http://www.cancer.org/acs/groups/cid/documents/webcontent/003134-pdf.pdf.Accessed May 17, 2012
 National Cancer Institute, Surveillance Epidemiology and End Results(SEER).SEER Stat Facts: Prostate; Survival & Stage, 2002-2008
 Sartor, O. "Radiopharmaceutical and chemotherapy combinations inmetastaticcastrate-resistant prostate cancer: a new beginning."JCO. 2009;15:2417-2418
 Bone and Cancer Foundation. Questions & Answers about prostate cancerBoneMetastases and Treatment-Related Osteoporosis. Available at:http://www.boneandcancerfoundation.org/pdfs/prostate-cancer-qa.pdf.Accessed May17, 2012
 Lange PH, Vasella RL. "Mechanisms, hypotheses and questions regardingprostate cancer metastatic to bone." Cancer & MetastasisReviews.1999;17:331-336
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