Positive Opinion from the EMA on BMK08

RNS Number : 6196Y

Benchmark Holdings PLC

10 September 2020

 

10 September 2020

Information within this announcement is deemed by the Company to constitute inside information under the Market Abuse Regulations (EU) No. 596/2014.

Benchmark Holdings plc

Important milestone reached towards commercialisation of BMK08 & CleanTreat ®

Positive Opinion from the European Medicine Agency on the safety of BMK08

Benchmark, the aquaculture biotechnology business, is pleased to announce that on 10 September 2020 the Committee for Medicinal Products for Veterinary Use ("CVMP"), a committee of the European Medicine Agency, adopted an opinion recommending the inclusion of BMK08's active pharmaceutical ingredient in fin fish as an allowed substance regarding maximum residue limits  in foodstuffs of animal origin (the "MRL opinion").

The MRL opinion is an important step towards the launch of BMK08 together with the Company's water purification system CleanTreat® in Q2 CY 2021. The MRL opinion is without prejudice to the European Commission's decision and ratification into EU law, which represents the next milestone for BMK08 together with CleanTreat®, and is a condition for obtaining Marketing Authorisation (MA) in Norway.

Trond Wiliksen, CEO commented:

"The MRL opinion is a significant stepping stone towards the launch of our novel sea lice treatment BMK08, together with CleanTreat® which purifies the treatment water. The positive opinion of the European Medicine Agency's experts in medicine safety is a critical step in a 10-year data collection and assessment process which ensures that the medicine is safe to use and safe for consumers."

"I congratulate our teams for getting us to this point and we look forward to making further progress towards a launch in Q2 CY 2021."

Enquiries

For further information, please contact:
Benchmark Holdings plc	Tel:  [phone]
Trond Williksen, CEO
Septima Maguire, CFO
Ivonne Cantu, Investor Relations
Numis (Broker and NOMAD)	Tel:  [phone]
James Black, Freddie Barnfield, Duncan Monteith MHP Communications	Tel:  [phone]

Katie Hunt, Reg Hoare, Alistair de Kare-Silver      [e-mail]

About Benchmark 

Benchmark's mission is to enable aquaculture producers to improve their sustainability and profitability.

We bring together biology and technology, to develop innovative products which improve yield, quality and animal health and welfare for our customers. We do this by improving the genetic make-up, health and nutrition of their stock - from broodstock and hatchery through to nursery and grow out.

Benchmark has a broad portfolio of products and solutions, including salmon eggs, live feed (Artemia), diets and probiotics and sea lice treatments. Find out more at www.benchmarkplc.com

 

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