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Celladon announces Letter agreement with Novasep, Inc. for potential manufacture of MYDICAR

20 / 01 / 2015

 
 
  • As part of Celladon Corporation’s planning for the potential future dual source commercial supply of MYDICAR, the company entered into a Letter agreement with Novasep, Inc. pursuant to which the parties agreed to conduct the initial work necessary to prepare for the potential manufacture of MYDICAR drug substance (AAV1/SERCA2a) at Novasep Biopharma’s facilities in Europe.
    • In exchange for payments from the company to Novasep totaling up to 4,750,000 Euro, Novasep agreed to (i) conduct the engineering design work for facility modifications that would be necessary for the manufacture of MYDICAR, (ii) undertake initial process and analytical transfer and initial scale-up work in support of such potential future commercial manufacturing of MYDICAR, and (iii) allocate the resources and capacity necessary for the foregoing activities.
    • Under the terms of the Letter agreement, the parties agreed to negotiate in good faith the terms of a commercial supply agreement with a term through 31-Dec-18