Novasep, a supplier of services and technologies for the life sciences industry, has entered into an agreement with Celladon, a clinical-stage biotechnology company. Novasep will prepare to supply the drug substance for Mydicar.

The EUR 4.7million deal covers scale-up and pre-validation studies. It includes the facility enhancement engineering Novasep will make at its Seneffe (Belgium) bioproduction plant to enable it to bring advanced heart failure drug Mydicar into commercial production. In addition, Novasep and Celladon have agreed to negotiate further terms for a commercial supply agreement until December 31, 2018. This is subject to the early termination of certain specified Mydicar regulatory and development outcomes, with extension options until 2020.

Mydicar is a genetically targeted enzyme replacement therapy for advanced heart failure based on AAV/SERCA2a, an Adeno-Associated Virus (AAV). Mydicar is currently undergoing several clinical phases, including a Phase IIb study in the US.

Source: Novasep