Lonza, a global leader in the field of viral therapy and biologics manufacturing, and Celladon Corporation (NASDAQ: CLDN), a biotechnology industry leader in the field of cardiovascular gene therapy, announced today that they have 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 2b 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, NH (USA). 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, TX (USA) to the new facility in Portsmouth. Process validation is expected to be completed in the new Portsmouth facility.
“This strategic collaboration for Celladon’s cGMP production and future expansion of our viral therapy manufacturing capabilities is an exciting endeavor for Lonza,” said Marc Funk, COO, Lonza’s Pharma & Biotech segment. “This extended partnership continues to reflect Lonza’s track record as a trusted partner for the scale-up of emerging technologies in preparation for commercial launch. We are committed to the commercial manufacturing market and to the advancement of potentially life-saving treatments like MYDICAR®.”
“Our previous multi-year relationship with Lonza has helped us rapidly advance the clinical manufacture of MYDICAR,” said Krisztina Zsebo, PhD, Chief Executive Officer at Celladon. “As we continue to progress the development of MYDICAR®, we are pleased to announce this expansion of our partnership with Lonza in support of future commercial supply.”