Hi Fellow Mesoblasters, I pick this up on Facebook by Vince Dyer...

Hi Fellow Mesoblasters, I pick this up on Facebook by Vince Dyer / Nick Taylor and it sums up this current matter.

Nov 20th
Novartis licenses phase 3 COVID-19 cell therapy from Mesoblast
Novartis CEO Vas Narasimhan M.D. has secured a global license toMesoblast’s cell therapy remestemcel-L in the treatment of COVID-19.

The deal lands Mesoblast $50 million upfront and thesupport of a partner that could help address critical quality attributeconcerns raised by the FDA last month, the FDA rejected a filing for approvalof the cell therapy in children with steroid-resistant graft-versus-hostdisease (GvHD) by then Mesoblast hadalready begun testing the allogeneic cell therapy in COVID-19 patients withacute respiratory distress syndrome (ARDS) the phase 3 started in May and designedto validate signs of efficacy seen in a 12-patient compassionate use program.

Novartis has stepped in to help Mesoblast takeremestemcel-L forward in ARDS. In return for a $25 million upfront payment and$25 million investment, plus milestones and royalties, Mesoblast has givenNovartis a global license to develop and commercialize remestemcel-L in ARDS. Evidenceof the prospects of remestemcel-L, a mesenchymal stem cell therapy, inCOVID-19-related ARDS is set to arrive when the 300-patient phase 3 trial wrapsup early next year, If the trial is successful, Novartis plans to work withMesoblast to “develop appropriate critical quality attributes that meet [FDA]requirements for remestemcel-L.

The focus on critical quality attributes reflects theproblems Mesoblast encountered when it tried to win FDA approval forremestemcel-L in GvHD earlier this year, in its briefing document, the FDA saidthe attributes “do not have a demonstrated relationship to the clinicalperformance of specific [drug product] lots.

The advisory committee backed the drug, but the FDAissued a complete response letter.

Novartis, which has anapproved cell therapy, may have the expertise to ensure remestemcel-L faresbetter when up for review by the FDA as a treatment for ARDS in COVID-19patients.

Novartis will also provide “support to enablecommercial manufacturing scale-up.” Mesoblast has previously said it needed to“substantially scale up manufacturing” to serve the COVID-19 market.

The relationship between the companies extends beyondCOVID-19. Novartis plans to run a phase 3 trial in non-COVID-19 ARDS patients,setting it up to address the broader unmet medical need.

ARDS causes 40% mortality in the around 200,000 patientswho develop the condition in the U.S. annually. Novartis also has an option todistribute remestemcel-L outside of Japan in GvHD and to co-fund itsdevelopment and commercialization in other non-respiratory indications.
ST