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
- Forums
- ASX - By Stock
- MSB
- TYPE A OUTCOME AND NOVARTIS PARTNERSHIP
TYPE A OUTCOME AND NOVARTIS PARTNERSHIP, page-96
-
- There are more pages in this discussion • 16 more messages in this thread...
You’re viewing a single post only. To view the entire thread just sign in or Join Now (FREE)
Featured News
Add MSB (ASX) to my watchlist
(20min delay)
|
|||||
Last
91.5¢ |
Change
-0.010(1.08%) |
Mkt cap ! $1.050B |
Open | High | Low | Value | Volume |
92.0¢ | 92.5¢ | 91.5¢ | $449.8K | 489.2K |
Buyers (Bids)
No. | Vol. | Price($) |
---|---|---|
28 | 224760 | 91.5¢ |
Sellers (Offers)
Price($) | Vol. | No. |
---|---|---|
92.0¢ | 54871 | 31 |
View Market Depth
No. | Vol. | Price($) |
---|---|---|
28 | 224760 | 0.915 |
24 | 220412 | 0.910 |
9 | 49761 | 0.905 |
43 | 365236 | 0.900 |
9 | 388314 | 0.895 |
Price($) | Vol. | No. |
---|---|---|
0.920 | 54867 | 31 |
0.925 | 103327 | 18 |
0.930 | 89659 | 10 |
0.935 | 121086 | 5 |
0.940 | 16560 | 4 |
Last trade - 11.47am 18/09/2024 (20 minute delay) ? |
Featured News
MSB (ASX) Chart |