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Novasep to Manufacture Celladon's Mydicar API
PTSM: Pharmaceutical Technology Sourcing and Management
Novasep has entered into an agreement with Celladon to provide scale-up and pre-validation studies for the drug substance for MYDICAR.
Novasep has entered into an agreement with Celladon, a clinical-stage biotechnology company, to provide scale-up and pre-validation studies for the drug substance for MYDICAR.
The deal includes the facility enhancement engineering Novasep will make at its Seneffe, Belgium bioproduction plant to enable it to bring MYDICAR, a heart failure drug, 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). MYDICAR is currently undergoing several clinical phases, including a phase IIb study in the United States.
Source: Novasep