Novasep, Celladon Sign API Supply PactBy
Novasep, a supplier of services and technologies for the life sciences and chemical industries, and Celladon Corporation, a clinical-stage cardiovascular gene therapy company, have signed a development, manufacturing, and supply agreement pursuant to which, if supported by upcoming Mydicar clinical data, Novasep would manufacture the Mydicar 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 the Mydicar drug substance.
Mydicar is a genetically targeted enzyme replacement therapy based on AAV1/SERCA2a that is being developed for advanced heart failure and has been granted Breakthrough Therapy Designation by the US Food and Drug Administration (FDA). Mydicar is currently being tested in human clinical trials, including a Phase IIb study in the US and Europe, the top-line results of the study (CUPID2), which are expected to be announced in late April 2015.
Under the terms of the agreement, Novasep and Celladon would conduct the process transfer, development, facility retrofitting, and scale-up activities necessary to carry out production of the the Mydicar drug substance in a 2000-L bioreactor at an enhanced bioproduction plant in Seneffe, Belgium. GMP operations are planned to start in the fourth quarter of 2016 and continue through 2018. An option to extend through 2020 will be determined based on Celladon's requirements for the the drug substance. Celladon has the right to terminate the agreement, exercisable for a specified period of time following the un-blinding of the data from the CUPID2 study, if Celladon concludes in good faith that the CUPID2 data is such that Celladon does not require production of the drug substance at the Novasep facility.