Novasep Selected for Commercial Biomanufacturing of Celladon’s Mydicar API

Novasep, a leading supplier of services and technologies for the life sciences industry, today announces that it has entered into an agreement with Celladon, a clinical-stage biotechnology company, to prepare the supply of the drug substance for MYDICAR®. The €4.7M deal covers scale-up and pre-validation studies as well as 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 an innovative, genetically-targeted enzyme replacement therapy for advanced heart failure based on AAV/SERCA2a, an Adeno-Associated Virus (AAV). It is currently undergoing several clinical phases including a phase 2b study in the USA.

“With this agreement, Novasep will support Celladon for its plans in producing MYDICAR on accelerated timelines,” said Alain Lamproye, President of Novasep Biopharma Business Unit. “We could leverage our over ten years ofexperience in developing and manufacturing viruses and viral vector productsto enable Celladon to meet its goal of bringing MYDICAR to the market as soon as possible. This contract clearly rewards our strategy to develop our custom manufacturing capabilities for novel virus and viral vector based therapies and we are delighted to have the opportunity to establish this partnership with Celladon to bring this potentially life changing therapy to patients sooner.”