Key Milestone Achieved with EU Approval for Active Substances


Eden Research plc, the agrochemical and encapsulation development company, announced that the three active substances that are used in the company's lead product, 3AEY, have been approved for use in plant protection products by the European Commission under Regulation (EC) No. 1107/2009 within the European Union.
These approvals are the successful outcome of a process which has taken over seven years to complete and into which the company has invested considerable time and resources. This is the key regulatory milestone for the business and allows the actives to be used with Eden's encapsulation technology in any combination to create a range of agrochemical products for a variety of applications. These approvals will also trigger decisions by other regulators outside of the EU, particularly in Africa, who monitor European regulatory approvals and where sales are expected in a much shorter time frame.
In Europe, individual products, such as 3AEY, require separate national approvals. The company's lead agrochemical product, 3AEY, is a naturally derived "botryticide." Botrytis is a widespread fungal disease that causes gray mold on most fruits and vegetables, often leading to the rapid loss of commercially viable crops. The average losses from affected crops account for around 20 percent of the total harvest, costing in the region of 10 billion to 100 billion euros worldwide. The market size for botryticides is around $300 million per annum.
Clive Newitt, managing director of Eden, comments: "The regulatory process that exists for new actives in plant protection products is becoming increasingly onerous, and so to receive approval for three new actives is a great achievement.
"The inherent value of owning the registration for three actives is significant. It enables Eden to commercialize products in Europe and helps in the rest of the world as regulators in other continents, such as Africa, closely monitor what happens in Europe, where the regulatory framework is highly regarded.
"Now that we have passed this key milestone, we will be able to concentrate our efforts on getting products into the market and maximizing returns on the investment that we have made to date. I believe that this will not only be possible through the sale of agrochemicals using our actives, for which we will receive royalties, but also through sharing with third parties the wealth of data that we have generated for the approvals.
"Also, using our encapsulation technologies and know-how, we will now be able to expedite development and commercialization in non-agrochemical sectors, such as human and animal health, where we know there is demand for effective, environmentally friendly products backed up by sound intellectual property protection, such as ours."