Mesoblast signs manufacturing agreement with Lonza, prepares for US launch
Mesoblast and Lonza will manufacture Mesoblast’s lead allogeneic cell therapy product candidate, remestemcel-L, for pediatric steroid-refractory acute graft versus host disease.
Allogeneic cellular medicines company Mesoblast (ASX: MSB) is on track to commence manufacturing of its lead product candidate remestemcel-L courtesy of a manufacturing agreement with Swiss-listed chemicals and biotechnology company Lonza (SWX: LONN).
Remestemcel-L is being developed for the treatment of acute graft versus host disease (aGVHD) following an allogeneic bone marrow transplant (BMT).
In a statement to the market, Mesoblast said the agreement between the two companies will facilitate inventory build ahead of a planned US market launch of remestemcel-L and ongoing commercial supply to meet Mesoblast’s long-term market projections.
Mesoblast also revealed that it expects to complete filing of the rolling Biologics License Application (BLA) submission to the US Food and Drug Administration (FDA) by the end of this year.
If approved, the US launch of remestemcel-L is expected to occur in 2020.
From a funding perspective, Mesoblast says it is confident of achieving its market roll-out given the successful $75 million capital raising completed earlier this month.
Mesoblast completed a placement to investors and issued 37.5 million new shares with the raised capital to be directed at building product inventory and a targeted US-based sales force in preparation for the launch.
Moreover, proceeds will also be used to complete phase 3 trials for chronic low back pain and advanced heart failure.
Combating aGVHD
According to the Center for International Blood and Marrow Transplant Research, there are close to 30,000 allogeneic BMTs every year for diseases including hematological cancers, with 25% of all cases in the pediatric population. Furthermore, nearly 50% of all allogeneic BMT patients develop aGVHD.
Currently, there are no products currently approved in the US for treatment of steroid-refractory aGVHD in children under 12.
To further compound the problem for sufferers, off-label options have demonstrated mixed efficacy with high toxicity.
“We believe there is a significant need for effective treatment with a favourable risk/benefit profile,” the company said.
The deal announced today is a direct attempt at ensuring that Mesoblast’s lead product would meet demand with chief executive officer Dr Silviu Itescu declaring that this is only the first of the company’s allogeneic (off-the-shelf) cell therapies to be made available globally assisting people in need of life-saving and disease-modifying products.
“This agreement builds on the successful partnership and alliance between our two companies over the years,” said Alberto Santagostino, SVP Head of Cell & Gene Technologies at Lonza.
“As we also enter new partnerships with early-stage companies on one side, Mesoblast shows the path of success in reaching commercialisation on the other. We are committed for the long run with Mesoblast, to continue to grow and deliver cell therapies to all patients in need, together,” said Mr Santagostino.