Welcome!

News Feed Item

Nexcyon Achieves European Regulatory Decision

MADISON, Wis., April 7, 2014 /PRNewswire/ -- The European Medicines Agency (EMA) has granted Minor Use Minor Species (MUMS) designation for Nexcyon's adrenocorticotropin (ACTH), a synthetic peptide for the diagnosis of hypoadrenocorticism in dogs.  Hypoadrenocorticism, also known as Addison's Disease, can be difficult to diagnose without the aid of an ACTH injection.  Nexcyon has developed a proprietary form of synthetic ACTH specifically formulated for use in dogs.  Presently, when veterinarians need to confirm the diagnosis of hypoadrenocorticism in dogs, extra-label use of human drugs or those compounded by pharmacists are utilized.  Once fully approved by EMA, Nexcyon's synthetic ACTH will be the first for use in veterinary medicine in all European Union (EU) countries, as well as Iceland, Liechtenstein, and Norway.  A MUMS designation is similar to an orphan drug designation in human health which allows for increased efficiency in the drug approval process.  An approval by EMA will grant 10 years of market exclusivity for Nexcyon. 

Nexcyon is also about to start phase 3 clinical trials in the USA to demonstrate the safety and effectiveness of synthetic ACTH in dogs.  Data will be submitted to the Food and Drug Administration (FDA) in order to seek approval of ACTH for use in dogs in the US market. 

Nexcyon is partnering with Johnson Bank to finance the final steps toward approval.  The partnership is designed to accelerate the development of innovative therapeutic medicines in underserved disease categories. Commercialization is planned for 2015.    

About the financial arrangement, Terrence Clark, D.V.M., Ph.D. and president of Nexcyon, said, "Through our relationship with Johnson Bank, we can focus on innovative research methods and processes as our primary objective.  As a result, we feel we can take complex programs with unique drug development challenges and submit cohesive data that demonstrates safety and effectiveness to regulatory bodies in an accelerated timeframe."

Nexcyon is presently seeking commercial partners to distribute ACTH in the EU and the USA when approved.  Synthetic ACTH will be Nexcyon's second approved drug.  The first drug that Nexcyon developed was approved by the EMA and FDA in 2011 and 2012, respectively.  Behind synthetic ACTH, Nexcyon is developing a number of other prescription medicines intended for use in dogs and cats. 

About Nexcyon

Nexcyon Pharmaceuticals, Inc. is a Madison, WI based privately held, veterinary pharmaceutical company.  Its European business is Nexcyon Pharmaceuticals, Ltd.  Nexcyon focuses on innovative, prescription medicines for regulatory approval and distribution around the world.  Nexcyon also partners with other companies to develop companion animal drugs from early stages through drug approval and commercialization.  Additional information about Nexcyon is available at www.nexcyon.com or email [email protected].

About Johnson Bank

Johnson Bank is a member of Johnson Financial Group, a premier financial services company offering comprehensive financial solutions in the areas of banking, trust, insurance, investment management and leasing.  The $3.9 billion financial services company has operating companies in Wisconsin and Arizona.  Principal owners of Johnson Financial Group are members of the Samuel C. Johnson family.  Helen Johnson-Leipold is Chairman of Johnson Financial Group and Chairman, Chief Executive Officer and Chairman of the Board of Johnson Outdoors Inc. in Racine, Wisconsin. For more information visit www.johnsonbank.com and www.johnsonins.com.

For more information, please contact:
Irene Clark
608-210-8060
[email protected]

SOURCE Nexcyon Pharmaceuticals, Inc.

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
In their general session at 16th Cloud Expo, Michael Piccininni, Global Account Manager - Cloud SP at EMC Corporation, and Mike Dietze, Regional Director at Windstream Hosted Solutions, reviewed next generation cloud services, including the Windstream-EMC Tier Storage solutions, and discussed how to increase efficiencies, improve service delivery and enhance corporate cloud solution development. Michael Piccininni is Global Account Manager – Cloud SP at EMC Corporation. He has been engaged in t...
The emerging Internet of Everything creates tremendous new opportunities for customer engagement and business model innovation. However, enterprises must overcome a number of critical challenges to bring these new solutions to market. In his session at @ThingsExpo, Michael Martin, CTO/CIO at nfrastructure, outlined these key challenges and recommended approaches for overcoming them to achieve speed and agility in the design, development and implementation of Internet of Everything solutions with...
Cloud Expo, Inc. has announced today that Andi Mann returns to 'DevOps at Cloud Expo 2017' as Conference Chair The @DevOpsSummit at Cloud Expo will take place on June 6-8, 2017, at the Javits Center in New York City, NY. "DevOps is set to be one of the most profound disruptions to hit IT in decades," said Andi Mann. "It is a natural extension of cloud computing, and I have seen both firsthand and in independent research the fantastic results DevOps delivers. So I am excited to help the great t...
Every successful software product evolves from an idea to an enterprise system. Notably, the same way is passed by the product owner's company. In his session at 20th Cloud Expo, Oleg Lola, CEO of MobiDev, will provide a generalized overview of the evolution of a software product, the product owner, the needs that arise at various stages of this process, and the value brought by a software development partner to the product owner as a response to these needs.
In 2014, Amazon announced a new form of compute called Lambda. We didn't know it at the time, but this represented a fundamental shift in what we expect from cloud computing. Now, all of the major cloud computing vendors want to take part in this disruptive technology. In his session at 20th Cloud Expo, John Jelinek IV, a web developer at Linux Academy, will discuss why major players like AWS, Microsoft Azure, IBM Bluemix, and Google Cloud Platform are all trying to sidestep VMs and containers...
SYS-CON Events announced today that MobiDev, a client-oriented software development company, will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place June 6-8, 2017, at the Javits Center in New York City, NY, and the 21st International Cloud Expo®, which will take place October 31-November 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. MobiDev is a software company that develops and delivers turn-key mobile apps, websites, web services, and complex softw...
SYS-CON Events announced today that Enzu will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY, and the 21st International Cloud Expo®, which will take place October 31-November 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Enzu’s mission is to be the leading provider of enterprise cloud solutions worldwide. Enzu enables online businesses to use its IT infrastructure to their competitive ad...
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, discussed the best practices that will ensure a successful smart city journey.
In his session at 19th Cloud Expo, Claude Remillard, Principal Program Manager in Developer Division at Microsoft, contrasted how his team used config as code and immutable patterns for continuous delivery of microservices and apps to the cloud. He showed how the immutable patterns helps developers do away with most of the complexity of config as code-enabling scenarios such as rollback, zero downtime upgrades with far greater simplicity. He also demoed building immutable pipelines in the cloud ...
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 ...
Choosing the right cloud for your workloads is a balancing act that can cost your organization time, money and aggravation - unless you get it right the first time. Economics, speed, performance, accessibility, administrative needs and security all play a vital role in dictating your approach to the cloud. Without knowing the right questions to ask, you could wind up paying for capacity you'll never need or underestimating the resources required to run your applications.
Technology vendors and analysts are eager to paint a rosy picture of how wonderful IoT is and why your deployment will be great with the use of their products and services. While it is easy to showcase successful IoT solutions, identifying IoT systems that missed the mark or failed can often provide more in the way of key lessons learned. In his session at @ThingsExpo, Peter Vanderminden, Principal Industry Analyst for IoT & Digital Supply Chain to Flatiron Strategies, will focus on how IoT depl...
Adding public cloud resources to an existing application can be a daunting process. The tools that you currently use to manage the software and hardware outside the cloud aren’t always the best tools to efficiently grow into the cloud. All of the major configuration management tools have cloud orchestration plugins that can be leveraged, but there are also cloud-native tools that can dramatically improve the efficiency of managing your application lifecycle. In his session at 18th Cloud Expo, ...
The pace of innovation, vendor lock-in, production sustainability, cost-effectiveness, and managing risk… In his session at 18th Cloud Expo, Dan Choquette, Founder of RackN, discussed how CIOs are challenged finding the balance of finding the right tools, technology and operational model that serves the business the best. He also discussed how clouds, open source software and infrastructure solutions have benefits but also drawbacks and how workload and operational portability between vendors an...
With the proliferation of both SQL and NoSQL databases, organizations can now target specific fit-for-purpose database tools for their different application needs regarding scalability, ease of use, ACID support, etc. Platform as a Service offerings make this even easier now, enabling developers to roll out their own database infrastructure in minutes with minimal management overhead. However, this same amount of flexibility also comes with the challenges of picking the right tool, on the right ...