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Novasep to Manufacture Mydicar API

To provide custom biomanufacturing for commercial production

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By: Kristin Brooks

Managing Editor, Contract Pharma

Novasep has entered an agreement with Celladon, a clinical-stage biotechnology company, to prepare and supply the API for Mydicar, in a deal valued at €4.7 million. MYDICAR is a genetically-targeted enzyme replacement therapy for advanced heart failure, and is currently in several Phases of development, including a Phase IIb study in the U.S.
 
Novasep will provide scale-up and pre-validation studies. The agreement also includes engineering enhancements Novasep will make at its Seneffe (Belgium) bioproduction plant in order to bring Mydicar into commercial production. Additionally, the companies have agreed to negotiate further terms for a commercial supply agreement until December 2018, with extension options until 2020.
 
“With this agreement, Novasep will support Celladon’s plans to produce MYDICAR on accelerated timelines,” said Alain Lamproye, president of Novasep Biopharma BU. “We are leveraging over ten years’ experience in developing and manufacturing viruses and viral vector products to enable Celladon to meet its goal of bringing MYDICAR to the market as soon as possible. We consider this contract a reward for our strategy of developing custom manufacturing capabilities for novel virus and viral vector based therapies. We are delighted to have the opportunity to establish this partnership with Celladon aimed at bringing this potentially life-changing therapy to patients sooner.”

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