Mesoblast’s lead candidate is remestemcel-L, which is a potential pediatric treatment for acute graft versus host disease following allogeneic bone marrow transplantation.
The company’s drug candidate is currently going through Phase III trials and Mesoblast expects to complete a biologics license application (BLA) to the US Food and Drug Administration (FDA) by the end of the year. If provided with priority review designation, the Australian company expects a US launch to occur next year.
Should it be approved, the candidate could become the first allogeneic cell therapy treatment to be available on the US market. Currently, there are just over half a dozen of allogeneic approvals worldwide but none in the US.
According to both companies, the signing of a commercial manufacture agreement allows an inventory of the potential product to be built up prior to any approval.
A spokesperson for Lonza stressed the importance of the long-term partnership the companies had agreed in order to reach this stage: “The key challenge for allogeneic cell therapy is developing a robust process in a reproducible format that can be transferred from the lab to the good manufacturing practice (GMP) and commercial setting. “
The spokesperson continued, “It needs to be addressed early to avoid finding one-self with a process in late stage that is not robust and having to back-track and potentially lose a significant amount of time and resources.”
The product will be manufactured at Lonza’s facility in Singapore and the contract manufacturing and development organization specified that the agreement between the two companies provides for an expansion of capacity for the product.
When asked for more detail, the Lonza spokesperson told us, “This will depend on the demand [of the product] for Mesoblast. Currently and in the foreseeable future, we are able to satisfy it with our existing setup, but should demand increase we will be ready to expand accordingly.”