Novasep and Celladon Corporation have announced that they have signed a Development, Manufacturing and Supply Agreement pursuant to which, if supported by upcoming MYDICAR clinical data, Novasep would manufacture 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 MYDICAR drug substance.
MYDICAR is an innovative, 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 USA and Europe referred to as CUPID2, the top-line results of which are expected to be announced in late April 2015.
“We are very pleased to have the option to partner with Novasep to prepare for and commence commercial manufacturing of MYDICAR drug substance,” said Dr. Krisztina Zsebo, CEO of Celladon. “Novasep has demonstrated technical excellence and a real commitment to helping advance the MYDICAR program.”
“This agreement validates the trusted relationship Novasep has established with Celladon,” said Andrew Brennan, Novasep general manager, US Operations. “The relationship represents a partnership in every sense of the word and, I believe, is a model for future development and commercial supply agreements in the fast growing gene therapy space.”
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 MYDICAR drug substance in a 2000L bioreactor at an enhanced bioproduction plant in Seneffe, Belgium.
GMP operations are planned to start in Q4 2016 and continue through 2018. An option to extend through 2020 will be determined based on Celladon’s requirements for the MYDICAR 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 MYDICAR drug substance at the Novasep facility.
“Celladon has impressed us with their strategic approach in building a robust supply chain for a challenging biopharmaceutical. Celladon is preparing for potential fast track development, which makes Novasep’s technical expertise and dynamic business processes an excellent match,” said Michel Spagnol, Chairman of the Board and CEO of Novasep. “We are thrilled to be part of a team that is striving to enable the treatment of many patients suffering serious heart disease by Celladon’s innovative viral vector based therapy.”