CDMO Famar and Active Biotech Ink Clinical Manufacturing Deal

Active Biotech AB has reached a manufacturing agreement with Famar Health Care Services Madrid SAU, a European provider of pharmaceutical manufacturing and development services. Famar will deliver clinical trial material of the newly developed eye-drop formulation of laquinimod.

The new formulation is developed by Active Biotech together with Leukocare AG, a biotechnology company from Munich, Germany, specialized in pharmaceutical formulation development. The formulation will be studied for the treatment of non-infectious non-anterior uveitis, which is an orphan disease and a serious, sight-threatening condition.

The agreement with Famar includes clinical trial material for dosing in clinical Phase I and II studies for the treatment of ophthalmic disorders. Famar R&D will provide process development, scale-up, supply of material for pre-clinical local tolerance studies and clinical grade material for use in the clinical studies.

The project has been initiated, and Active Biotech is aiming to start a clinical safety study in H2 2021. Active Biotech also plans to initiate a proof-of-principle study with oral laquinimod in uveitis patients in 2021.

“We are very excited with this collaboration with Famar, which makes it possible for us to start the first clinical safety study with this newly developed eye-drop formulation of laquinimod later this year,” said Helén Tuvesson, chief executive officer, Active Biotech.

Ian Cooper, chief executive officer, Famar, said, “We welcome this new collaboration with Active Biotech with excitement. Famar’s development service activity is a key element in Famar’s strategy to further develop and expand its health care services and customers’ portfolio.”