|By Marketwired .||
|February 13, 2013 01:17 AM EST||
OSLO, NORWAY -- (Marketwire) -- 02/13/13 --
Intended for US Media only
Algeta ASA (OSE: ALGETA) announces that Bayer has received notification that the New Drug Application (NDA) for the investigational compound Radium Ra 223 Dichloride (radium-223) has been accepted for filing and granted priority review by the US Food and Drug Administration (FDA). The application is currently 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 Ra 223 dichloride (radium-223) in the US, there is recognition that Radium Ra 223 dichloride (radium-223) has the potential to offer a treatment option for CRPC patients with bone metastases where little or no therapy exists. While we await the final decision from the regulators later this year, and together with Bayer, we continue with our commercialization planning and look forward to a potential approval, and to making this compound available to patients."
The FDA grants priority review to medicines that provide a treatment where little or no adequate therapy exists. Under the Prescription Drug User Fee Act (PDUFA), the FDA aims to complete its review within six months of the 60-day filing receipt of the NDA submission (eight months total), rather than the standard 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 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.
About Radium Ra 223 Dichloride
Radium Ra 223 Dichloride (radium-223), formerly referred to as radium-223 chloride, is an investigational alpha particle-emitting pharmaceutical 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 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 CRPC and Bone Metastases
Prostate cancer is the most common cancer among men in the United States (other than skin cancer).Approximately 16% of prostate cancer cases are considered regional or distant, which means that the cancer has spread beyond the prostate to nearby or distant areas of the body (metastasis). A majority of men with CRPC have radiological evidence of bone metastases. 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.
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.
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.
 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 in metastatic castrate-resistant prostate cancer: a new beginning." JCO. 2009;15:2417-2418
 Bone and Cancer Foundation. Questions & Answers about Prostate Cancer Bone Metastases and Treatment-Related Osteoporosis. Available at: http://www.boneandcancerfoundation.org/pdfs/prostate-cancer-qa.pdf. Accessed May 17, 2012
 Lange PH, Vasella RL. "Mechanisms, hypotheses and questions regarding prostate cancer metastatic to bone." Cancer & Metastasis Reviews.1999;17:331-336
Press release: http://hugin.info/134655/R/1677597/547152.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
For further information, please contact:
+47 2202 4510
Communications & Corporate Affairs
+44 207 638 9571
Citigate Dewe Rogerson
+1 781 235 3060
MacDougall Biomedical Communications
US investor enquiries:
+1 646 378 2953
The Trout Group
Machine Learning helps make complex systems more efficient. By applying advanced Machine Learning techniques such as Cognitive Fingerprinting, wind project operators can utilize these tools to learn from collected data, detect regular patterns, and optimize their own operations. In his session at 18th Cloud Expo, Stuart Gillen, Director of Business Development at SparkCognition, discussed how research has demonstrated the value of Machine Learning in delivering next generation analytics to impr...
Dec. 3, 2016 02:15 PM EST Reads: 6,943
Join Impiger for their featured webinar: ‘Cloud Computing: A Roadmap to Modern Software Delivery’ on November 10, 2016, at 12:00 pm CST. Very few companies have not experienced some impact to their IT delivery due to the evolution of cloud computing. This webinar is not about deciding whether you should entertain moving some or all of your IT to the cloud, but rather, a detailed look under the hood to help IT professionals understand how cloud adoption has evolved and what trends will impact th...
Dec. 3, 2016 02:00 PM EST Reads: 2,463
More and more brands have jumped on the IoT bandwagon. We have an excess of wearables – activity trackers, smartwatches, smart glasses and sneakers, and more that track seemingly endless datapoints. However, most consumers have no idea what “IoT” means. Creating more wearables that track data shouldn't be the aim of brands; delivering meaningful, tangible relevance to their users should be. We're in a period in which the IoT pendulum is still swinging. Initially, it swung toward "smart for smar...
Dec. 3, 2016 02:00 PM EST Reads: 438
20th Cloud Expo, taking place June 6-8, 2017, at the Javits Center in New York City, NY, will feature technical sessions from a rock star conference faculty and the leading industry players in the world. Cloud computing is now being embraced by a majority of enterprises of all sizes. Yesterday's debate about public vs. private has transformed into the reality of hybrid cloud: a recent survey shows that 74% of enterprises have a hybrid cloud strategy.
Dec. 3, 2016 01:30 PM EST Reads: 2,115
Businesses and business units of all sizes can benefit from cloud computing, but many don't want the cost, performance and security concerns of public cloud nor the complexity of building their own private clouds. Today, some cloud vendors are using artificial intelligence (AI) to simplify cloud deployment and management. In his session at 20th Cloud Expo, Ajay Gulati, Co-founder and CEO of ZeroStack, will discuss how AI can simplify cloud operations. He will cover the following topics: why clou...
Dec. 3, 2016 01:15 PM EST Reads: 581
Internet of @ThingsExpo, taking place June 6-8, 2017 at the Javits Center in New York City, New York, is co-located with the 20th International Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. @ThingsExpo New York Call for Papers is now open.
Dec. 3, 2016 01:00 PM EST Reads: 1,852
"ReadyTalk is an audio and web video conferencing provider. We've really come to embrace WebRTC as the platform for our future of technology," explained Dan Cunningham, CTO of ReadyTalk, in this SYS-CON.tv interview at WebRTC Summit at 19th Cloud Expo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 3, 2016 01:00 PM EST Reads: 284
When it comes to cloud computing, the ability to turn massive amounts of compute cores on and off on demand sounds attractive to IT staff, who need to manage peaks and valleys in user activity. With cloud bursting, the majority of the data can stay on premises while tapping into compute from public cloud providers, reducing risk and minimizing need to move large files. In his session at 18th Cloud Expo, Scott Jeschonek, Director of Product Management at Avere Systems, discussed the IT and busin...
Dec. 3, 2016 12:45 PM EST Reads: 3,763
Data is the fuel that drives the machine learning algorithmic engines and ultimately provides the business value. In his session at Cloud Expo, Ed Featherston, a director and senior enterprise architect at Collaborative Consulting, discussed the key considerations around quality, volume, timeliness, and pedigree that must be dealt with in order to properly fuel that engine.
Dec. 3, 2016 12:45 PM EST Reads: 1,942
Successful digital transformation requires new organizational competencies and capabilities. Research tells us that the biggest impediment to successful transformation is human; consequently, the biggest enabler is a properly skilled and empowered workforce. In the digital age, new individual and collective competencies are required. In his session at 19th Cloud Expo, Bob Newhouse, CEO and founder of Agilitiv, drew together recent research and lessons learned from emerging and established compa...
Dec. 3, 2016 12:45 PM EST Reads: 727
Everyone knows that truly innovative companies learn as they go along, pushing boundaries in response to market changes and demands. What's more of a mystery is how to balance innovation on a fresh platform built from scratch with the legacy tech stack, product suite and customers that continue to serve as the business' foundation. In his General Session at 19th Cloud Expo, Michael Chambliss, Head of Engineering at ReadyTalk, discussed why and how ReadyTalk diverted from healthy revenue and mor...
Dec. 3, 2016 12:15 PM EST Reads: 1,493
Effectively SMBs and government programs must address compounded regulatory compliance requirements. The most recent are Controlled Unclassified Information and the EU's GDPR have Board Level implications. Managing sensitive data protection will likely result in acquisition criteria, demonstration requests and new requirements. Developers, as part of the pre-planning process and the associated supply chain, could benefit from updating their code libraries and design by incorporating changes. In...
Dec. 3, 2016 12:00 PM EST Reads: 933
"Coalfire is a cyber-risk, security and compliance assessment and advisory services firm. We do a lot of work with the cloud service provider community," explained Ryan McGowan, Vice President, Sales (West) at Coalfire Systems, Inc., in this SYS-CON.tv interview at 19th Cloud Expo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 3, 2016 12:00 PM EST Reads: 724
CloudJumper, a Workspace as a Service (WaaS) platform innovator for agile business IT, has been recognized with the Customer Value Leadership Award for its nWorkSpace platform by Frost & Sullivan. The company was also featured in a new report(1) by the industry research firm titled, “Desktop-as-a-Service Buyer’s Guide, 2016,” which provides a comprehensive comparison of DaaS providers, including CloudJumper, Amazon, VMware, and Microsoft.
Dec. 3, 2016 11:45 AM EST Reads: 685
"We are an all-flash array storage provider but our focus has been on VM-aware storage specifically for virtualized applications," stated Dhiraj Sehgal of Tintri in this SYS-CON.tv interview at 19th Cloud Expo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 3, 2016 11:45 AM EST Reads: 450