Key Developments: Algeta ASA (ALGETA.OL)
209.00NOK
24 May 2013
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Latest Key Developments (Source: Significant Developments)
Algeta ASA Announces Exercise of Options and Issuance of Shares
Algeta ASA announced that following the FDA approval of Xofigo, the Company has decided to allow exercise of vested options held by employees and board members. To facilitate the exercise of the options, the Board of Directors of Algeta ASA resolved on May 16, 2013 in two separate resolutions to increase the Company's share capital in total by up to NOK 840,986.50 by issuance of up to 1,681,973 new shares, with a par value of NOK 0.50 per share equaling the current total number of vested options. Depending on the exercise of vested options the share capital may be increased from NOK 21,285,475.50 to a maximum of NOK 22,126,462. Exercise of the options will be completed in two tranches. Tranche 1 closed at 8.30 am on May 16, 2013, while Tranche 2 opens at 9 am and will close at 2.30 pm on May 16, 2013. A total of 1,200,491 vested options have been exercised and accordingly 1,200,491 shares each with a par value of NOK 0.50 were subscribed by employees and board members in Tranche 1. Following registration of the new shares to be issued in Tranche 1 the share capital in Algeta will be NOK 21,885,721 divided into 43,771,442 shares with a par value of NOK 0.50. A total of 481,482 vested options remain for potential exercise in Tranche 2. Option holders in Tranche 1 have transferred rights to receive a total of 1,191,779 of the shares issued through the exercise of options, to a third party which will sell the shares in the market. Full Article
United States FDA Approves Algeta ASA's Xofigo
Algeta ASA announced that the United States Food and Drug Administration (FDA) has approved Xofigo (radium-223 dichloride) injection for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease. Xofigo is the alpha particle-emitting radioactive therapeutic agent that has demonstrated improvement in overall survival (OS) and delay in time to first symptomatic skeletal event (SSE) compared to placebo, as shown in the pivotal phase III ALSYMPCA trial. 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 marketing rights for Xofigo. Algeta US, LLC and Bayer Healthcare will co-promote the product in the United States. The approval of Xofigo (radium-223 dichloride, radium-223) is based on data from the pivotal phase III ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) trial. At the interim analysis, radium-223 significantly improved OS; median OS was 14.0 months with radium-223 plus best standard of care vs. 11.2 months with placebo plus best standard of care. Additionally, at the interim analysis there was a delay in the time to first symptomatic skeletal event (SSE) for patients treated with radium-223 vs. placebo. An updated analysis, showed improvement in OS for patients treated with radium-223 vs. placebo, with a median OS of 14.9 months vs. 11.3 months; HR=0.695 (95% CI 0.581-0.832). Full Article
Algeta ASA Exercises Option and Signs Exclusive License Agreement with Lumiphore, Inc. for Lumi4 bi- Functional Chelator Technology
Algeta ASA announced that the Company has exercised its option to take an exclusive worldwide license to patented Lumi4 bi- functional chelator technology from Lumiphore, Inc. and has extended the collaboration to include additional chelator families. These technologies are being developed by Algeta to conjugate thorium-227 to tumor-targeting molecules to create Targeted Thorium Conjugates (TTCs). Lumiphore's Lumi4 technology is based on a class of bi-functional chelators[1] that forms a cage structure surrounding and tightly binding thorium-227, which can then be covalently attached to a range of tumor-targeting molecules, such as monoclonal antibodies, to create potential cancer therapeutics. Algeta originally signed an option/license agreement with Lumiphore around this technology in 2010 and subsequently extended it to enable further evaluation to be conducted. In parallel with this license agreement, Algeta has also been granted a license by Lumiphore covering a second class of bi-functional chelators that bind strongly to thorium-227, with the option of including a further selection of compounds within that license if future exploratory work confirms their promise. Under the terms of the agreements, Algeta will pay Lumiphore the option exercise fee for the Lumi4 chelators, and a signature and option fee for the second class of chelators, plus development and sales milestones and a royalty on product sales. Further financial details have not been disclosed. Full Article
Algeta ASA Increases Share Capital Related to Exercise of Employee Options
Algeta ASA announced that in order to facilitate the exercise of vested employee options in Algeta ASA, the Board of Directors of Algeta ASA, in accordance with the authorization granted by the Annual General Meeting on 19 April 2012, resolved on March 4, 2013 to increase the Company's share capital by up to NOK 705,619 by issuance of up to 1,411,238 new shares, with a par value of NOK 0.50 per share equaling the current total number of vested options. Depending on the exercise of vested options the share capital may be increased from NOK 21,263,625.50 to a maximum of NOK 21,969,244.50. The share capital increase will be registered in the Companies Register as soon as practically possible after the exact amount of the capital increase is determined. Full Article
Algeta ASA Presents Further Sub-Analyses of ALSYMPCA Phase III Study
Algeta ASA announced that further analyses of data subsets from the phase III ALSYMPCA study of radium-223 dichloride (radium-223) in castration-resistant prostate cancer (CRPC) patients have been presented at the 2013 Genitourinary Cancers Symposium. The additional analyses from ALSYMPCA demonstrate that, in addition to prolonging survival in CRPC patients with bone metastases, radium-223 also improves clinically relevant endpoints related to complications from bone metastases. Full Article
Algeta ASA's Radium-223 Dichloride in Cooperation with Bayer Receives Priority Review to the New Drug Application from FDA
Algeta ASA announced 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. Full Article
Algeta ASA and Immunomedics Inc Initiate New Oncology Research Program to Evaluate Potential of Targeted Thorium Conjugate (TTC) Based on Immunomedics' Anti-CD22 Monoclonal Antibody
Algeta ASA (Algeta) announced that it has initiated a new research program to evaluate a Targeted Thorium Conjugate (TTC) that combines Algeta's thorium-227 alpha-pharmaceutical payload with an anti-CD22 monoclonal antibody (epratuzumab) developed by Immunomedics Inc. (Immunomedics). Epratuzumab is a humanized monoclonal antibody (mAb) that binds to the CD22 glycoprotein on the surface of B cells. Epratuzumab has been evaluated for the treatment of a variety of hematological cancers and for autoimmune diseases such as systemic lupus erythematosus (SLE). Under the terms of this agreement, Immunomedics will provide clinical-grade antibody to Algeta, which has rights to evaluate the potential of a TTC, linking thorium-227 to epratuzumab, for the treatment of cancer. Algeta will fund all preclinical and clinical development costs up to the end of phase I testing. Upon successful completion of phase I testing, the parties shall negotiate terms for a license at Algeta's request according to certain parameters now agreed upon between the companies. Payments in the first year from Algeta to Immunomedics include a signature fee, an antibody delivery milestone and payments for cGMP antibody manufacture. No further details of the agreement are disclosed. Full Article
Algeta ASA Announces US Nuclear Regulatory Commission's Licensing Decision for Radium-223 Dichloride
Algeta ASA announced that the US (United States) Nuclear Regulatory Commission (NRC) has issued a licensing decision on the medical use of radium-223 dichloride (radium-223). The NRC licensing decision follows the recommendation from the Advisory Committee on the Medical Use of Isotopes (ACMUI) report, dated November 20, 2012. 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. The US NRC has ruled that sites can procure and administer radium-223 under 10 CFR Part 35, Subpart E, which includes 10 CFR § 35.300. It has also ruled that physicians authorized under 10 CFR § 35.390 or 10 CFR § 35.396 can be authorized for the medical use of radium-223. The US NRC has notified the Agreement States regarding their licensing decision on radium-223. Full Article
Algeta ASA's Partner Bayer Submits New Drug Application to FDA for Radium-223 Dichloride for Treatment of Castration-Resistant Prostate Cancer with Bone Metastases
Algeta ASA announced that its partner Bayer has submitted a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for radium-223 dichloride (radium-223) for the treatment of castration-resistant prostate cancer (CRPC) patients with bone metastases. Bayer submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) on December 12, 2012 for radium-223 for the treatment of castration-resistant prostate cancer (CRPC) patients with bone metastases. Under the terms of the 2009 agreement with Bayer, the first complete submission for marketing approval triggers a EUR50 million payment from Bayer to Algeta. The submission is based on data from the pivotal phase III ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) trial, which was conducted by Algeta. In the study, radium-223 significantly increased overall survival by 44% (HR=0.695, p=0.00007), resulting in a 30.5%-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. Full Article
Algeta ASA Announces its Partner Bayer Submits Radium-223 Dichloride for European Union Marketing Authorization for Treatment of Castration-Resistant Prostate Cancer with Bone Metastases
Algeta ASA (Algeta) announced that Bayer has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for radium-223 dichloride (radium-223) for the treatment of castration-resistant prostate cancer (CRPC) patients with bone metastases. The submission is based on data from the pivotal phase III ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) trial, which was conducted by Algeta. In the study, radium-223 increased overall survival by 44% (HR=0.695, p=0.00007), resulting in a 30.5% 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. Full Article
Bayer, Algeta win FDA approval for prostate cancer drug
FRANKFURT, May 15 - German drugmaker Bayer and its development partner Algeta won approval from U.S. regulators for a prostate cancer drug that could eventually generate more than 1 billion euros ($1.31 billion) in annual sales.
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