Eco Animal Regulatory News (EAH)

10 Jul 2012 07:00

ECO Animal Health Group plc (ECO)

(AIM:EAH)

ECO RECEIVES FIRST MARKETING AUTHORISATION

FOR AIVLOSIN® IN THE USA

NOTIFICATION OF DATE OF RESULTS ANNOUNCEMENT

ECO is pleased to report that the Center for Veterinary Medicine (CVM) of the Federal Drug Administration (FDA) has granted ECO a marketing authorisation in the United States for Aivlosin® 625 mg/g water soluble granules for swine.

The FDA's approval is ECO's first in the United States and marks a very important step in the Company's continuing development of Aivlosin® as a global veterinary product. It follows the recent Canadian approval of this formulation and further extends the marketing reach of Aivlosin®, ECO's patented macrolide antibiotic, which is used for the treatment of respiratory and enteric (gut) diseases in pigs and poultry. ECO established a joint venture sales and marketing company, Pharmgate Animal Health LLC, in the USA in 2010 to prepare for the launch of Aivlosin®.

The authorised formulation of Aivlosin® will be marketed in the US for the treatment of ileitis (porcine proliferative enteropathy (PPE)), an enteric disease of swine. Aivlosin® water soluble granules dissolve readily in water providing a simple solution for the accurate and simultaneous treatment of large numbers of animals. Importantly, with global concerns about the use of antibiotics in production animals, this new treatment with its therapeutic dose rate, short treatment duration and zero day drug withholding period meets the current guidelines for the judicious use of antimicrobials.

Peter Lawrence, chairman of ECO said: "We are delighted to receive our first marketing authorisation in the United States. This key milestone follows some 12 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 is a significant milestone on the road to making ECO one of the most important global animal health companies".

The Company will announce its results for the year to 31 March 2012 on Friday 20 July 2012.

Contacts:

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.

Copyright Business Wire 2012