Novasep to manufacture API for heart failure drug for Celladon


Signs a multi-million Euro deal with US firm

French contract manufacturer Novasep has agreed a €4.7m deal to supply a ingredient for a heart failure drug to US-based clinical stage biotechnology company Celladon.

The deal covers scale-up and pre-validation studies. Novasep will also make facility enhancements at its Seneffe (Belgium) bioproduction plant to enable it to bring Mydicar into commercial production.

The two companies have agreed to negotiate further terms for a commercial supply agreement until 31 December 2018. This is subject to the early termination of certain specified Mydicar regulatory and development outcomes, with extension options until 2020.

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

'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,' said Alain Lamproye, President of Novasep Biopharma BU.

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'We consider this contract a reward for our strategy of developing custom manufacturing capabilities for novel virus and viral vector based therapies.'