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Pin to quick picksEco Animal Regulatory News (EAH)

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Regulatory Approval

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:

Peter Lawrence 020 8336 6190
ECO Animal Health Group plc Marc Loomes 020 8447 8899
Spiro Financial Anthony Spiro 020 8336 6196
Cenkos Securities plc Stephen Keys 020 7397 8926
(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.

Copyright Business Wire 2012

Date   Source Headline
25th Apr 20247:00 amRNSTrading Update on year ended 31 March 2024
8th Apr 20247:00 amRNSHolding(s) in Company
4th Apr 20247:00 amRNSDisposal of non-core product line
22nd Mar 20247:00 amRNSShare Awards to Executive Directors
21st Mar 20249:13 amRNSReplacement: Trading Update
21st Mar 20247:00 amRNSTrading Update
19th Mar 20249:40 amRNSGeneral Meeting Result
27th Feb 20247:00 amRNSPublication of Notice of General Meeting
6th Feb 20247:00 amRNSTrademark Approval for ECOVAXXIN® family in the EU
8th Jan 20247:00 amRNSDisposal of Freehold Properties
5th Jan 20245:05 pmRNSHolding(s) in Company
5th Jan 20245:00 pmRNSHolding(s) in Company
22nd Dec 20237:00 amRNSDeferred Option Awards to Executive Directors
1st Dec 20237:00 amRNSDirector/PDMR Shareholding
27th Nov 202310:00 amRNSInvestor Presentation
27th Nov 20237:00 amRNSResults for the six months ended 30 September 2023
14th Nov 20233:00 pmRNSHolding(s) in Company
9th Nov 20237:00 amRNSCapital Markets Day Events
24th Oct 20237:00 amRNSNew USA and Canada label claim for Aivlosin®
28th Sep 20237:00 amRNSESG Rating
7th Sep 20232:57 pmRNSResult of AGM
10th Aug 20237:00 amRNSNotice of AGM
21st Jul 20234:25 pmRNSPosting of the Annual Report and Accounts
10th Jul 20237:00 amRNSFinal Results for the Year Ended 31 March 2023
5th Jul 20237:00 amRNSNotice of Results & Investor Presentation
6th Jun 20237:00 amRNSIssue of Equity and Total Voting Rights
18th May 20237:00 amRNSHolding(s) in Company
23rd Mar 20237:00 amRNSTrading Update
8th Mar 20237:00 amRNSAnimal Health Innovation Summit
27th Feb 202310:37 amRNSDirector/PDMR Shareholding
24th Feb 20233:19 pmRNSChange of Registered Address
17th Feb 20231:41 pmRNSHolding(s) in Company
13th Feb 20231:55 pmRNSHolding(s) in Company
9th Feb 20237:00 amRNSHolding(s) in Company
9th Feb 20237:00 amRNSHolding(s) in Company
8th Feb 20237:00 amRNSDirector/PDMR Shareholding
20th Jan 202312:14 pmRNSHolding(s) in Company
13th Dec 20223:50 pmRNSDeferred Share Option Awards
30th Nov 20223:01 pmRNSDirector/PDMR Shareholding
25th Nov 20221:37 pmRNSDirector/PDMR Shareholding
23rd Nov 20227:00 amRNSResults for the six months ended 30 September 2022
22nd Nov 20227:00 amRNSInvestor Presentation covering Interim Results
14th Nov 20227:00 amRNSChange of Auditor
31st Oct 20227:00 amRNSBlock listing Interim Review
24th Oct 20221:30 pmRNSHolding(s) in Company
24th Oct 20221:28 pmRNSHolding(s) in Company
26th Sep 20224:01 pmRNSResult of AGM
5th Sep 20221:00 pmRNSInvestor Presentation covering Full Year Results
2nd Sep 20227:00 amRNSPublication of Annual Report and Notice of AGM
31st Aug 20227:00 amRNSFinal Results for the Year Ended 31 March 2022

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