|By PR Newswire||
|December 30, 2013 03:00 AM EST||
HORSHOLM, Denmark, Dec. 30, 2013 /PRNewswire/ -- Veloxis Pharmaceuticals A/S (OMX: VELO), today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for the marketing and sale of Envarsus® (formerly LCP-Tacro™) for the prevention of organ rejection in kidney transplant recipients. The submission is based on the entire data set from the company's clinical development program that comprised 25 studies and enrolled over 1000 patients, including two pivotal clinical trials, studies 3001 and 3002. In the two pivotal trials, Envarsus® given once-daily met the primary endpoint of demonstrating comparable efficacy and safety compared to twice-daily tacrolimus (Prograf®, Astellas Pharma, Inc.). In the largest study, Study 3002, Envarsus® was shown to have a primary efficacy failure rate of 18.3% vs 19.6% with Prograf therapy. The differences between the treatments was well-within the pre-defined 10% non-inferiority margin. The study was conducted under a Special Protocol Agreement with the FDA. Envarsus® has been granted Orphan Drug status by the FDA for prophylaxis of rejection for kidney transplant recipients.
"The NDA filing marks another significant milestone for Veloxis as we move closer in bringing Envarsus® to patients in the U.S.," said William Polvino, M.D., president and chief executive officer of Veloxis. "Envarsus' once daily formulation provides an opportunity for an improved treatment experience for transplant patients while offering comparable efficacy and safety to the twice-daily tacrolimus, as was demonstrated most recently by our successful Phase 3 clinical trials, studies 3002 and 3001. Our commercial preparation activities in the U.S. are underway. We are planning to build a sales force for the marketing of Envarsus® in the U.S. and adequate financing is in place to support development, differentiation and commercialization activities through the initial launch of Envarsus®."
John Weinberg, M.D, chief commercial officer of Veloxis added, "The need for kidney transplants is significant with 17,000 kidney transplants performed annually in the U.S and about 180,000 kidney transplant recipients living in the US. Most patients are prescribed tacrolimus to prevent rejection of their transplanted kidney. Transplants are performed at approximately 250 highly specialized centers across the U.S. and Veloxis anticipates hiring a sales force of approximately 20 representatives to call on the key transplant centers. We look forward to the opportunity to bring this new treatment option to transplant patients and physicians once Envarsus® has been approved."
In May 2013, Veloxis received the acceptance of its European Marketing Authorisation Application Filing, based on the Phase I and II studies, as well as the pivotal trial, Study 3001. Outside the U.S., Veloxis plans to launch and commercialize Envarsus® through partnering arrangements. In Europe, Turkey and the CIS countries, Envarsus® will be commercialized by Veloxis' partner Chiesi Farmaceutici.
For more information, please contact:
Veloxis Pharmaceuticals A/S
John Weinberg, M.D.
EVP, Chief Commercial Officer
Phone: +1 732 321 3208
Email: [email protected]
EVP, Chief Financial Officer
Phone: +45 21 227 227
Email: [email protected]
About Envarsus® (formerly LCP-Tacro™) and tacrolimus
Tacrolimus is a leading immunosuppression drug used for the prevention of transplant allograft rejection after organ transplantation. Envarsus® is an investigational drug that is being developed as a once daily tablet version of tacrolimus, with improved bioavailability, consistent pharmacokinetic performance and reduced peak to trough variability when compared to currently approved tacrolimus products. Transplant patients need to maintain a minimum blood level of tacrolimus for the prevention of transplant allograft rejection, but excessive levels may increase the risk of serious side effects such as nephrotoxicity, tremor, diabetes, high blood pressure, and opportunistic infections. Therefore, tacrolimus levels need to be managed carefully, and transplant patients are typically obliged to make frequent visits to the hospital for monitoring and dose adjustments after receiving a new organ.
About Veloxis Pharmaceuticals
Based in Horsholm, Denmark, with an office in New Jersey, Veloxis Pharmaceuticals A/S, or Veloxis, is a specialty pharmaceutical company. The company's lead product candidate is Envarsus® for immunosuppression, specifically organ transplantation. Veloxis' unique, patented delivery technology, MeltDose®, can improve absorption and bioavailability at low scale up costs. Veloxis has a lipid lowering product, Fenoglide®, currently on the U.S. market that is commercialized through partner Santarus, Inc. Veloxis is listed on the NASDAQ OMX Copenhagen under the trading symbol OMX: VELO.
For further information, please visit www.veloxis.com.
SOURCE Veloxis Pharmaceuticals A/S
Cloud computing is being adopted in one form or another by 94% of enterprises today. Tens of billions of new devices are being connected to The Internet of Things. And Big Data is driving this bus. An exponential increase is expected in the amount of information being processed, managed, analyzed, and acted upon by enterprise IT. This amazing is not part of some distant future - it is happening today. One report shows a 650% increase in enterprise data by 2020. Other estimates are even higher....
Aug. 27, 2016 12:45 AM EDT Reads: 2,920
With over 720 million Internet users and 40–50% CAGR, the Chinese Cloud Computing market has been booming. When talking about cloud computing, what are the Chinese users of cloud thinking about? What is the most powerful force that can push them to make the buying decision? How to tap into them? In his session at 18th Cloud Expo, Yu Hao, CEO and co-founder of SpeedyCloud, answered these questions and discussed the results of SpeedyCloud’s survey.
Aug. 27, 2016 12:45 AM EDT Reads: 2,136
SYS-CON Events announced today that Isomorphic Software will exhibit at DevOps Summit at 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Isomorphic Software provides the SmartClient HTML5/AJAX platform, the most advanced technology for building rich, cutting-edge enterprise web applications for desktop and mobile. SmartClient combines the productivity and performance of traditional desktop software with the simp...
Aug. 27, 2016 12:15 AM EDT Reads: 2,250
Today we can collect lots and lots of performance data. We build beautiful dashboards and even have fancy query languages to access and transform the data. Still performance data is a secret language only a couple of people understand. The more business becomes digital the more stakeholders are interested in this data including how it relates to business. Some of these people have never used a monitoring tool before. They have a question on their mind like “How is my application doing” but no id...
Aug. 26, 2016 11:15 PM EDT Reads: 1,743
Actian Corporation has announced the latest version of the Actian Vector in Hadoop (VectorH) database, generally available at the end of July. VectorH is based on the same query engine that powers Actian Vector, which recently doubled the TPC-H benchmark record for non-clustered systems at the 3000GB scale factor (see tpc.org/3323). The ability to easily ingest information from different data sources and rapidly develop queries to make better business decisions is becoming increasingly importan...
Aug. 26, 2016 10:45 PM EDT Reads: 2,057
SYS-CON Events announced today that 910Telecom will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Housed in the classic Denver Gas & Electric Building, 910 15th St., 910Telecom is a carrier-neutral telecom hotel located in the heart of Denver. Adjacent to CenturyLink, AT&T, and Denver Main, 910Telecom offers connectivity to all major carriers, Internet service providers, Internet backbones and ...
Aug. 26, 2016 10:00 PM EDT Reads: 1,838
Kubernetes, Docker and containers are changing the world, and how companies are deploying their software and running their infrastructure. With the shift in how applications are built and deployed, new challenges must be solved. In his session at @DevOpsSummit at19th Cloud Expo, Sebastian Scheele, co-founder of Loodse, will discuss the implications of containerized applications/infrastructures and their impact on the enterprise. In a real world example based on Kubernetes, he will show how to ...
Aug. 26, 2016 09:15 PM EDT Reads: 1,425
Traditional on-premises data centers have long been the domain of modern data platforms like Apache Hadoop, meaning companies who build their business on public cloud were challenged to run Big Data processing and analytics at scale. But recent advancements in Hadoop performance, security, and most importantly cloud-native integrations, are giving organizations the ability to truly gain value from all their data. In his session at 19th Cloud Expo, David Tishgart, Director of Product Marketing ...
Aug. 26, 2016 07:15 PM EDT Reads: 396
SYS-CON Events announced today Telecom Reseller has been named “Media Sponsor” of SYS-CON's 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Telecom Reseller reports on Unified Communications, UCaaS, BPaaS for enterprise and SMBs. They report extensively on both customer premises based solutions such as IP-PBX as well as cloud based and hosted platforms.
Aug. 26, 2016 07:00 PM EDT Reads: 652
As the world moves toward more DevOps and Microservices, application deployment to the cloud ought to become a lot simpler. The Microservices architecture, which is the basis of many new age distributed systems such as OpenStack, NetFlix and so on, is at the heart of Cloud Foundry - a complete developer-oriented Platform as a Service (PaaS) that is IaaS agnostic and supports vCloud, OpenStack and AWS. Serverless computing is revolutionizing computing. In his session at 19th Cloud Expo, Raghav...
Aug. 26, 2016 07:00 PM EDT Reads: 698
Aspose.Total for .NET is the most complete package of all file format APIs for .NET as offered by Aspose. It empowers developers to create, edit, render, print and convert between a wide range of popular document formats within any .NET, C#, ASP.NET and VB.NET applications. Aspose compiles all .NET APIs on a daily basis to ensure that it contains the most up to date versions of each of Aspose .NET APIs. If a new .NET API or a new version of existing APIs is released during the subscription peri...
Aug. 26, 2016 06:00 PM EDT Reads: 1,925
SYS-CON Events announced today that StarNet Communications will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. StarNet Communications’ FastX is the industry first cloud-based remote X Windows emulator. Using standard Web browsers (FireFox, Chrome, Safari, etc.) users from around the world gain highly secure access to applications and data hosted on Linux-based servers in a central data center. ...
Aug. 26, 2016 05:00 PM EDT Reads: 668
Smart Cities are here to stay, but for their promise to be delivered, the data they produce must not be put in new siloes. In his session at @ThingsExpo, Mathias Herberts, Co-founder and CTO of Cityzen Data, will deep dive into best practices that will ensure a successful smart city journey.
Aug. 26, 2016 04:45 PM EDT Reads: 1,532
DevOps at Cloud Expo, taking place Nov 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with 19th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. 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 dev...
Aug. 26, 2016 04:30 PM EDT Reads: 2,309
The 19th International Cloud Expo has announced that its Call for Papers is open. Cloud Expo, to be held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, brings together Cloud Computing, Big Data, Internet of Things, DevOps, Digital Transformation, Microservices and WebRTC to one location. With cloud computing driving a higher percentage of enterprise IT budgets every year, it becomes increasingly important to plant your flag in this fast-expanding business opportuni...
Aug. 26, 2016 04:00 PM EDT Reads: 3,932