The successful journey of Selektope: From lab to hull powered by entrepreneurial spirit and science

The beginning

Selektope began life in the Swedish Foundation for Strategic Environment Research (MISTRA) Programme for Marine Paint, a Swedish multidisciplinary research project at the University of Gothenburg and Chalmers University of Technology in the 1990s. The mission of this Marine Paint project was that it should not just generate fundamental research regarding antifouling substances, it should result in an actual product with the potential to reduce the environmental footprint of antifouling products on ships and leisure boats.

When studying a range of substances, scientists had an eureka moment with the substance medetomidine, a substance that is widely used for aesthetic effect in mammals.  When exposed to medetomidine, leaching out from a wet coating, the cyprid larvae of the species Balanus improvisus were repelled from the coated surface, without lethal effect.

I-Tech AB (Interface Technologies) was founded (in 2000) to hold the patents filed by the founding researchers. The company was initially hosted by the incubator-branch of Gothenburg University. Shortly after, funding via grants and business angels took place where the most emphasised public funding came from MISTRA.

The first ten years of development much of the focus was spent understanding medetomidine as an active substance. Large efforts were made to gain insight into the substance’s mode of action on barnacles, and at which concentrations the substance was most efficient. The leaching behaviour of Selektope in paint and possible environmental risks of using Selektope commercially was also examined in great depth.

We knew it worked. However, while work in the lab demonstrated the desired kicking behaviour, the next question was: how do you know it works on an industrial scale and on the side of a 200-metre ship? This process took another twelve years to complete.

Turning medetomidine into a product that could be used by paint manufacturers was a challenging process, particularly for the time needed to get the regulatory certifications and permissions in place. The strategic decision was made by I-Tech to achieve regulatory approval of Selektope under the, at the time, newly implemented biocides legislation in EU - the Biocidal Products Directive 98/8/EC (BPD).

The regulatory landscape for new biocidal substances is extremely complex due to their effect on living organisms. This makes the development and commercialisation of biocides a very tough, and expensive, road to travel. The BPD was established to regulate the use of biocides and avoid the situation of any substances which could pose a risk for humans, or the environment being placed on the market. As such, the requirements for an application dossier under the BPD are extensive. Overall, we spent six years just trying to get relevant study data to be able to do a risk assessment on the molecule, solely on the environmental and the human exposure side.

In total, I-Tech submitted a dossier containing approximately seventy original studies on Selektope in 2009. By the end of the evaluation the number of studies had increased to ninety.

Also, the cost to develop a dossier for an EU approval application containing all the required information is in the range of 5-10 million euros in investment. However, without EU approval a new biocide is likely to never reach the market at all.  However, we were lucky to have patient and strong owners supporting the company through the EU regulatory process. That, in combination with an existing toxicology data package from the substance approval as a pharmaceutical substance, made a large difference to the financial burden taken on by I-Tech.

In the end we made it through and that’s when the commercialisation of Selektope really began to speed up.