New lice treatment wins Norway marketing authorisation
Aquaculture biotechnology company Benchmark today announced that is had received marketing authorisation from the Norwegian Medicines Agency (NoMA) for its novel lice treatment Ectosan Vet (BMK08) in Norway.
UK-based Benchmark said the final steps for commercialisation are the ratification of the maximum residue limit (MRL) into Norwegian regulation and the approval of product labels by the NoMA.
According to Benchmark, the MRL ratification into Norwegian regulation is a procedural step following EU legislation and is anticipated to complete in the next few weeks.
Filtration system
Ectosan Vet, which contains the neonicotinoid imidacloprid, is designed to be used on a wellboat and only in conjunction with Benchmark’s CleanTreat filtration system, which removes medicines residues and lice egg strings from treatment water.
Benchmark announced its first customer agreements for CleanTreat in March and said it has the infrastructure and operational capabilities in place to start delivery of Ectosan Vet and CleanTreat once the final steps are completed in the coming weeks.
Limited approval
“At this stage the marketing authorisation does not fully include all anticipated label claims on usage,” said Benchmark in a statement. “Benchmark will work closely with its customers as they develop their knowledge on the most effective usage of the product in the field. Benchmark will also continue to develop the optimal product usage in conjunction with NoMA through applications for field trials and variations to the marketing authorisation.
“Based on the market authorisation granted, Ectosan Vet and CleanTreat are expected to be profitable from the outset, with expectations for the Group’s performance in FY 2021 and potential market for the new sea lice solution unchanged, but with a slower ramp up. As previously communicated the initial launch will be with two vessels. Based on the current label claims, we expect to achieve an adjusted EBITDA margin of 25%-30% (excluding IFRS 16) for Ectosan Vet and CleanTreat which we anticipate will increase as new claims are granted.”
A major milestone
Benchmark chief executive Trond Williksen said the marketing authorisation from NoMA was a major milestone for the company.
“It is testament to the team of scientists at Benchmark that we are able to bring the first new sea lice veterinary medicinal treatment to the Norwegian salmon market in over a decade.
“We are excited to bring this much needed solution to the salmon industry, driving sustainability through improved animal welfare and yield while protecting the environment.
“We look forward to working with our customers as we roll-out Ectosan Vet and CleanTreat in the market.”
European Parliament resolution
The marketing authorisation has been given despite a June 9 vote by the European Parliament in favour of a resolution calling for the MRL for imidacloprid in fin fish to be changed to zero. It is up to the Commission to decide what to do next.
Referring to the vote, Benchmark stated: “As previously announced, the MRL was ratified as European law through a European Commission Implementing Regulation on 15th April 2021.
“The European Commission’s decision was taken following a rigorous programme of studies confirming the safety of BMK08 (imidacloprid), and a thorough assessment of robust scientific evidence by the European Medicines Agency Committee for Veterinary Medicinal Products, on 9 September 2020. Subsequently the Commission recommended on 26 February 2021 that a maximum residue limit in fin fish is established. This recommendation was confirmed on 20 March 2021 by the Commission’s Standing Committee on Veterinary Medicinal Products and adopted by the European Commission on 15 April 2021.
Confidence in science
“The Company has full confidence in the European Medicines Agency and European Commission’s scientific and regulatory process and is committed to working closely with professional scientists, marine experts and regulators to continue developing innovative products to help the aquaculture industry grow sustainably, in line with the UN's Sustainable Development Goals.
“The Company is monitoring any further decisions the Commission may or may not take following the adoption of the Resolution, and will update the market at such time.”
