The deal covers scale-up and pre-validation studies and also includes the facility enhancement engineering Novasep will make at its Seneffe, Belgium, bioproduction plant to enable it to bring Mydicar into commercial production.
Mydicar is currently undergoing several clinical phases, including a phase IIb study in the US.
“With this agreement, Novasep will support Celladon’s plans to produce Mydicar on accelerated timelines,” said Alain Lamproye, president of Novasep Biopharma. “We are leveraging over ten years’ experience in developing and manufacturing viruses and viral vector products to enable Celladon to meet its goal of bringing MYDICAR to the market as soon as possible. We consider this contract a reward for our strategy of developing custom manufacturing capabilities for novel virus and viral vector based therapies.”
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).
The deal to manufacture Mydicar follows the company’s decision to invest in ADC manufacturing at a French plant, as well as to reach double-digit growth last year.