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.
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 firstname.lastname@example.org.
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.
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SOURCE Nexcyon Pharmaceuticals, Inc.