Date: 2015-02-17
Type of information: Production agreement
Compound: Mydicar®
Company: Celladon (USA - CA) Novasep (France)
Therapeutic area: Cardiovascular diseases
Type agreement: production manufacturing
Action mechanism: Mydicar® is a genetically targeted enzyme replacement therapy (ERT) intended to restore levels of SERCA2a, a regulator of calcium cycling in the heart and cardiac contractility. SERCA2a levels decline in all forms of late-stage Heart Failure resulting in deficient heart function. With Mydicar®, the SERCA2a gene is delivered using recombinant adeno-associated virus (AAV) as the vector. AAV is a naturally occurring virus not associated with any disease in humans. Mydicar® is delivered in a single dose directly to the heart during a routine outpatient cardiac catheterization procedure, similar to an angiogram.
Disease: advanced heart failure
Details: * On February 17, 2015, Novasep, a leading supplier of services and technologies for the life sciences industry, announced that it has entered into an agreement with Celladon, a clinical-stage biotechnology company. Novasep will prepare to supply the drug substance for Mydicar®. The €4.7M deal covers scale-up and pre-validation 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 currently undergoing several clinical phases, including a phase IIb study in the USA.
Financial terms:
Latest news:
