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 ACTH formulated for use in dogs. Presently, when veterinarians need to confirm the diagnosis of hypoadrenocorticism in dogs, human or compounded drugs are used. Once fully approved by EMA, Nexcyon's 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 allows for increased efficiency in the drug approval process. An approval by EMA will grant 10 years of market exclusivity.
Nexcyon is to initiate phase 3 clinical trials in the USA to demonstrate the safety and effectiveness of synthetic ACTH in dogs. Data will be submitted to the FDA to seek approval 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 as our primary objective. As a result, 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 USA when approved. Synthetic ACTH will be Nexcyon's second approved drug. The first drug Nexcyon developed was approved by the EMA and FDA in 2011 and 2012, respectively. Nexcyon is developing a number of other prescription medicines intended for use in dogs and cats.
Nexcyon is a 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 is available at www.nexcyon.com
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SOURCE Nexcyon Pharmaceuticals, Inc.