French active ingredients company Novasep and US biotech firm Celladon Corp (Nasdaq: CLDN), a clinical-stage cardiovascular gene therapy company, have signed a development, manufacturing and supply agreement under which, if supported by upcoming Mydicar clinical data, Novasep would manufacture Mydicar (AAV1/SERCA2a) drug substance through 2018 with extension options through 2020.
The contract follows an earlier letter agreement concerning the initial process transfer of Mydicar and pre-validation studies, which was signed in December 2014. The new agreement continues the work necessary for Novasep to achieve GMP production of Mydicar drug substance.
Second ingredient supplier
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