Lipidor has signed a cooperation agreement with Aurena Laboratories.
Under the agreement, Aurena Laboratories will establish a production unit to meet the regulatory requirements for the manufacture of Lipidor's pharmaceutical products. This will enable Lipidor to offer potential licensees large-scale commercial production. This is an important step towards a licensing agreement for Lipidor drug candidates, AKP01 and AKP02, for the treatment of psoriasis.
Through the cooperation, the parties will jointly ensure that the production, which is already certified with the FDA, meets all requirements for registration application within the EU. The production unit is aiming to manufacture so-called stability batches for registration documentation during the first half of 2021. The collaboration aims to ensure processes and manufacturing otherwise meet current requirements for CMC (chemistry, manufacturing and Ccontrols) and GMP for commercial production of prescription drugs based on Lipidor's Akvano formulation platform.
"We look forward to further strengthening our cooperation with Aurena Laboratories. The new cooperation involves an intensive and increased transfer of knowledge between the companies, and the implementation of a development plan for the production facility. The goal is to facilitate the registration process and to be able to offer licensees the opportunity for a high-quality and large-scale manufacture of Lipidor's prescription drug candidates for upcoming commercialization,” said Ola Holmlund, CEO of Lipidor.
”Being able to demonstrate that the infrastructure is in place, that the production meets all regulatory requirements, and that the plant has capacity for commercial production are all strategically important for ongoing discussions with potential licensees.”
“We look forward to working side by side with Lipidor to be able to offer manufacturing to their future licensees. Aurena will invest in this project for several years and our view is that it is both commercially and strategically important,” said Magnus Hedman, Chairman of the Board, Aurena Laboratories.
Lipidor has already cooperated with Aurena regarding hand and skin disinfection sprays and veterinary care products.
