Lonza, Celladon Enter Supply Agreement
Lonza and Celladon Corporation, a biopharmaceutical focused on cardiovascular gene therapy, entered into an agreement providing for the future commercial production of Mydicar (AAV1/SERCA2a), Celladon's enzyme-replacement therapy for advanced heart failure that is currently in Phase IIb clinical development.
This agreement 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.
In the near term, Lonza will complete a detailed engineering design for the facility to be located in Portsmouth, New Hampshire. The facility will be separate from Lonza's existing clinical and commercial mammalian operations facility also located in Portsmouth. In exchange for a reservation fee, Celladon has the option to trigger construction of the facility with a multi-year commitment to Lonza for the supply of Mydicar. Upon the trigger, Lonza will purchase from Celladon shares of Celladon common stock valued at $10 million.
Upon completion of the new manufacturing facility, Lonza is to transfer Celladon's 2000-liter commercial-scale process from Lonza's facility in Houston, Texas to the new facility in Portsmouth. Process validation is expected to be completed in the new Portsmouth facility.
Source: Lonza