Comments
yourfanat wrote: I am using another tool for Oracle developers - dbForge Studio for Oracle. This IDE has lots of usefull features, among them: oracle designer, code competion and formatter, query builder, debugger, profiler, erxport/import, reports and many others. The latest version supports Oracle 12C. More information here.
Cloud Expo on Google News
SYS-CON.TV
Cloud Expo & Virtualization 2009 East
PLATINUM SPONSORS:
IBM
Smarter Business Solutions Through Dynamic Infrastructure
IBM
Smarter Insights: How the CIO Becomes a Hero Again
Microsoft
Windows Azure
GOLD SPONSORS:
Appsense
Why VDI?
CA
Maximizing the Business Value of Virtualization in Enterprise and Cloud Computing Environments
ExactTarget
Messaging in the Cloud - Email, SMS and Voice
Freedom OSS
Stairway to the Cloud
Sun
Sun's Incubation Platform: Helping Startups Serve the Enterprise
POWER PANELS:
Cloud Computing & Enterprise IT: Cost & Operational Benefits
How and Why is a Flexible IT Infrastructure the Key To the Future?
Click For 2008 West
Event Webcasts
Algeta ASA : US FDA Grants Priority Review to Bayer's NDA for Radium Ra 223 Dichloride for Castration-Resistant Prostate Cancer with Bone Metastases

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)[1].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)[2]. A majority of men with CRPC have radiological evidence of bone metastases[3]. Bone metastases secondary to prostate cancer typically target the lumbar spine, vertebrae and pelvis[4].In fact, bone metastases are the main cause of morbidity and death in patients with CRPC[5].


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.


[1] 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

[2] National Cancer Institute, Surveillance Epidemiology and End Results (SEER). SEER Stat Facts: Prostate; Survival & Stage, 2002-2008

[3] Sartor, O. "Radiopharmaceutical and chemotherapy combinations in metastatic castrate-resistant prostate cancer: a new beginning." JCO. 2009;15:2417-2418

[4] 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

[5] 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

[HUG#1677597]

For further information, please contact:

Mike Booth
+47 2202 4510
Communications & Corporate Affairs
Email Contact

Media enquiries:

Mark Swallow
+44 207 638 9571
Citigate Dewe Rogerson
Email Contact

Kari Watson
+1 781 235 3060
MacDougall Biomedical Communications
Email Contact

US investor enquiries:

Tricia Swanson
+1 646 378 2953
The Trout Group
Email Contact

About Marketwired .
Copyright © 2009 Marketwired. All rights reserved. All the news releases provided by Marketwired are copyrighted. Any forms of copying other than an individual user's personal reference without express written permission is prohibited. Further distribution of these materials is strictly forbidden, including but not limited to, posting, emailing, faxing, archiving in a public database, redistributing via a computer network or in a printed form.

Latest Cloud Developer Stories
The widespread success of cloud computing is driving the DevOps revolution in enterprise IT. Now as never before, development teams must communicate and collaborate in a dynamic, 24/7/365 environment. There is no time to wait for long development cycles that produce software that...
Organizations today increasingly rely on Application Performance Management (APM) tools like New Relic to respond to end user complaints, and to track system latency and other key application metrics. With this data, users can often confirm if the application is running slowly an...
Racemi is announcing this update to its migration technology that makes the free online migrations to IBM SoftLayer easier than ever by adding a SoftLayer Object Storage image option for enhanced security and compliance.
Software AG helps organizations transform into Digital Enterprises, so they can differentiate from competitors and better engage customers, partners and employees. Using the Software AG Suite, companies can close the gap between business and IT to create digital systems of differ...
In this challenging environment, a combination of automated integration testing and test virtualization can enable test teams to improve software quality and keep up with the rate of change. This white paper helps address these needs by describing the benefits that can be gained ...
Subscribe to the World's Most Powerful Newsletters
Subscribe to Our Rss Feeds & Get Your SYS-CON News Live!
Click to Add our RSS Feeds to the Service of Your Choice:
Google Reader or Homepage Add to My Yahoo! Subscribe with Bloglines Subscribe in NewsGator Online
myFeedster Add to My AOL Subscribe in Rojo Add 'Hugg' to Newsburst from CNET News.com Kinja Digest View Additional SYS-CON Feeds
Publish Your Article! Please send it to editorial(at)sys-con.com!

Advertise on this site! Contact advertising(at)sys-con.com! 201 802-3021



SYS-CON Featured Whitepapers
ADS BY GOOGLE

Breaking Cloud Computing News

NEW YORK, Sept. 30, 2014 /PRNewswire/ -- ARK Investment Management (ARK) is pleased to announce t...