Algeta ASA : Algeta ASA : US FDA Grants Priority Review to the New Drug Application for Radium-223 Dichloride for Castration-Resistant Prostate Cancer with Bone Metastases Not Intended for US Media Oslo, Norway, 13 February 2013 - Algeta ASA (OSE: ALGETA) announces that Bayer has received notification from the US Food and Drug Administration (FDA) granting priority review of the New Drug Application (NDA) filed in December 2012 for the investigational oncology compound radium-223 dichloride (radium-223). The application is under review for the treatment of castration-resistant prostate cancer (CRPC) patients with bone metastases. Andrew Kay, Algeta's President & CEO, said: "With the granting of priority review for the NDA for radium-223 in the US, there is recognition that radium-223 has the potential to offer a new treatment option for CRPC patients with bone metastases. While we await the final decision from the regulators later this year, we continue with our commercialization planning in the US and look forward, with Bayer and pending approval, to making this novel compound available to patients." The FDA grants priority review to medicines that offer major advances in care or that provide a treatment where no adequate therapy exists. Under the Prescription Drug User Fee Act (PDUFA), the FDA aims to complete its review within eight months from the submission of the NDA, rather than the standard 12-month review cycle. The submission was based on data from the pivotal Phase III ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) trial. In the study, radium-223 significantly increased overall survival by 44 percent (HR=0.695, p=0.00007), resulting in a 30.5 percent reduction in the risk of death compared to placebo. The median overall survival (OS) benefit in patients with radium-223 was 3.6 months, based on 14.9 months OS with radium-223 plus best standard of care (BSoC) vs. 11.3 months with placebo plus BSoC. These updated results were presented at the 48th Annual Meeting of the American Society of Clinical Oncology (ASCO) in June 2012. In January 2013, the US Nuclear Regulatory Commission (NRC) issued a licensing decision on the medical use of radium-223. The decision states that US medical sites can procure and administer radium-223 under 10 CFR Part 35, Subpart E, which includes 10 CFR § 35.300. About the ALSYMPCA Trial The ALSYMPCA trial was a Phase III, randomized, double-blind, placebo-controlled international study comparing radium-223 dichloride vs. placebo in symptomatic CRPC patients with bone metastases treated with BSoC compared with placebo plus BSoC. The trial enrolled 921 patients in more than 100 centers in 19 countries. The study treatment consisted of up to six intravenous administrations of radium-223 or placebo each separated by an interval of four weeks. The primary endpoint of the study was overall survival. Secondary endpoints included time to occurrence of skeletal related events (SRE), changes and time to progression in prostate-specific antigen (PSA) and alkaline phosphatase (ALP), safety, and impact on quality of life measures. About Radium-223 Dichloride Radium-223 dichloride (radium-223), formerly referred to as Alpharadin, is a therapeutic alpha particle-emitting pharmaceutical with targeted anti-tumor effect on bone metastases in development for CRPC patients with bone metastases. Radium-223 is an investigational agent and is not approved by the European Medicines Agency (EMA), the US Food and Drug Administration (FDA) or other health authorities. Bayer submitted a Marketing Authorization Application to the EMA and a New Drug Application to the FDA for radium-223 in December 2012 for the treatment of CRPC patients with bone metastases. In September 2009, Algeta signed an agreement with Bayer Pharma AG (Berlin, Germany) for the development and commercialization of radium-223. Under the terms of the agreement, Bayer will develop, apply for global health authority approvals, and commercialize radium-223 globally. Algeta will co-promote radium-223 with Bayer in the US, and is eligible for milestones as well as royalties on Bayer's sales outside the US. In terms of further development activities for radium-223, Bayer intends to conduct studies in earlier settings of prostate cancer, including combination studies with other agents, as well as exploratory studies in other tumors such as breast cancer and osteosarcoma. About CRPC and Bone Metastases Prostate cancer is the most common non-cutaneous malignancy in men worldwide. In 2008, an estimated 899,000 men were diagnosed with prostate cancer and 258,000 died from the disease worldwide. Prostate cancer is the sixth leading cause of death from cancer in men. A majority of men with CRPC have radiological evidence of bone metastases. Once the cancer cells settle in the bone, they interfere with bone strength, often leading to pain, fracture and other complications that can significantly impair a man's health. Bone metastases secondary to prostate cancer typically target the lumbar spine, vertebrae and pelvis. In fact, bone metastases are the main cause of morbidity and death in patients with CRPC. ### For further information, please contact: Mike Booth +47 2202 4510 Communications & Corporate Affairs email@example.com Media enquiries: Mark Swallow +44 207 638 9571 Citigate Dewe Rogerson firstname.lastname@example.org Knut Ekern +47 22 04 82 00 Gambit Hill & Knowlton email@example.com US investor enquiries: Tricia Swanson +1 646 378 2953 The Trout Group firstname.lastname@example.org 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 the potential timeline of FDA approval of radium-223 and our anticipated co-promotion of radium-223 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 for the US field force, growth management, general economic and business conditions and the pricing environment, the impact of competition, the ability to successfully commercialize radium-223, the risk that costs associated with the co-promotion of radium-223 may be greater than anticipated, manufacturing capacity, the risk of non-approval of patents not yet granted, risks in obtaining regulatory approvals for radium-223 and the other risks and uncertainties described in our annual report. This information is subject of the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act. 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#1677601
Algeta ASA : Algeta ASA : US FDA Grants Priority Review to the New Drug Application for Radium-223 Dichloride for Castration
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