STOCKHOLM, Sweden, 16 December 2020 – Lipidor AB (Nasdaq First North:LIPI) announced today that the Company has signed a new cooperation agreement with Aurena Laboratories AB. Over a five-year period, Lipidor will invest up to SEK 15 million in the new collaboration. 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 the opportunity for 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.
Aurena Laboratories has already met the requirements of the U.S. Food and Drug Administration (FDA) for commercial drug production. Through the new cooperation, the parties will jointly ensure that the production meets all requirements for registration application within the EU. According to the first target milestone, the production unit shall be ready to manufacture so-called stability batches for registration documentation during the first half of 2021. This is followed by a number of activities and sub-milestones to ensure the unit's capacity up to full-scale commercial production. The collaboration will also ensure that the processes and manufacturing otherwise meet current requirements for CMC (Chemistry, Manufacturing and Controls) and GMP (Good Manufacturing Practices) for commercial production of prescription drugs based on Lipidor's formulation platform AKVANO®.
"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,” says 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,” says Magnus Hedman, Chairman of the Board, Aurena Laboratories.
Lipidor has already cooperated with the contract manufacturer Aurena Laboratories regarding hand and skin disinfection sprays and veterinary care products. Production takes place at Aurena Laboratories' production facility in Karlstad, Sweden and products are distributed from there to customers in Sweden and internationally. Aurena Laboratories is a leader in contract manufacturing of aerosol and spray products for the pharmaceutical industry and is one of Lipidor's two strong industrial principal owners. All in all, this contributes to Lipidor's ability to more rapidly develop and commercialize ever more competitive drug candidates.
This disclosure contains information that Lipidor is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication, through the agency of the contact person, on 16-12-2020 08:15 CET.