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Pin to quick picksEco Animal Regulatory News (EAH)

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Regulatory Approval

31 Mar 2016 07:00

31 March 2016

ECO Animal Health Group plc

(AIM: EAH)

ECO RECEIVES MARKETING AUTHORISATION

FOR AIVLOSIN® IN THE USA

ECO is pleased to announce that it has been granted a marketing authorisation for Aivlosin® in the United States by the Center for Veterinary Medicine (CVM) of the Food and Drug Administration (FDA).

Aivlosin®, ECO’s patented antimicrobial, is used for the treatment of a variety of economically important respiratory and enteric (gut) diseases in pigs and poultry.

This authorisation is for a Type A Medicated Article (Premix) formulation for the treatment of ileitis (porcine proliferative enteropathy (PPE)), an enteric disease of swine. This new treatment meets all the guidelines for the responsible use of antimicrobials. Importantly, with global concerns about the use of antibiotics in food production animals, this treatment is under the control of veterinarians and has a low, highly effective therapeutic dose rate, short treatment duration and zero day drug withholding period.

This approval in the United States follows the recent successful Canadian launch of this formulation and marks a very important step in the Company’s continuing development of Aivlosin® as a global veterinary product. The product will be marketed through Pharmgate Animal Health LLC our well-established sales and marketing joint venture formed in 2010 with Pharmgate LLC, the majority-owned U.S. subsidiary of Jinhe Biotechnology Co. Ltd. in China.

Peter Lawrence, Chairman of ECO commented “We are delighted to receive this marketing authorisation in the United States. This key milestone follows many years of investment in product development and regulatory activity in North America. The USA represents more than one third of the world market for our products and this breakthrough will benefit our future profitable growth. It underlines ECO’s continued commitment to being a major force in the international market for veterinary pharmaceutical products”.

Contacts:

ECO Animal Health Group plc Peter Lawrence 020 8336 6190

Marc Loomes 020 8447 8899

Spiro Financial Anthony Spiro 020 8336 6196

Peel Hunt LLP Dan Webster 020 7418 8900

(Nominated Adviser)

ECO Animal Health Group plc is a leader in the development, registration and marketing of pharmaceutical products for animals. Our products for these global growth markets promote well-being. Our financial goals are achieved through the careful and responsible application of science to generate value for our shareholders.

View source version on businesswire.com: http://www.businesswire.com/news/home/20160330006019/en/

Copyright Business Wire 2016

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