Novasep Selected to Commercially Biomanufacture Mydicar API
Novasep recently announced it has entered into an agreement with Celladon to supply the drug substance for MYDICAR. The €4.7M deal covers scale-up and prevalidation studies. It includes the facility enhancement engineering Novasep will make at its Seneffe (Belgium) bioproduction plant to enable it to bring advanced heart failure drug MYDICAR into commercial production.
In addition, Novasep and Celladon have agreed to negotiate further terms for a commercial supply agreement until December 31, 2018. This is subject to the early termination of certain specified MYDICAR regulatory and development outcomes, with extension options until 2020.
MYDICAR is an innovative, genetically targeted enzyme replacement therapy for advanced heart failure based on AAV/SERCA2a, an Adeno-Associated Virus (AAV). MYDICAR is currently undergoing several clinical phases, including a Phase IIb study in the US.
“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 10 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.”
Novasep is a global provider of cost-effective and sustainable manufacturing solutions for life sciences molecules and fine chemicals. Novasep’s unique offering includes process development services, purification equipment, and turnkey processes, contract manufacturing services, and complex active molecules to serve pharmaceutical, biopharmaceutical, fine chemical, food and functional ingredients as well as fermentation and chemical commodities industries. For more information, visit www.novasep.com.
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