Celladon links with Lonza for commercial manufacturing of Mydicar

Swiss chemical supplier Lonza (SIX: LONN) and US biotech firm Celladon Corp (Nasdaq: CLDN) have entered into an agreement providing for the future commercial production of Mydicar (AAV1/SERCA2a).

Mydicar is Celladon’s enzyme replacement therapy for advanced heart failure that is currently in Phase IIb clinical development. The US Food and Drug Administration has granted its “breakthrough therapy” designation for this gene therapy treatment in mid-stage development by Celladon for patients with advanced heart failure.

This agreement with Lonza follows a successful multi-year clinical manufacturing relationship and provides for initiation of pre-construction activities and the reservation of Lonza resources giving Celladon an opportunity to trigger construction of the dedicated facility and secure a long term commercial supply arrangement. The establishment of this facility construction and commercial supply agreement provides Celladon with a strategic path to commercial supply, including plans for a dedicated cGMP production train within a new, state-of-the-art viral therapy facility.