Novartis NVS announced that it has obtained exclusive rights for a potential acute respiratory distress syndrome cell therapy from Mesoblast Limited MESO.
Novartis entered into an exclusive worldwide license and collaboration agreement with Mesoblast for the development, commercialization and manufacturing of remestemcel-L for the treatment of acute respiratory distress syndrome (ARDS), including that associated with COVID-19.
Remestemcel-L will use mesenchymal stromal cells (MSCs), a cell-based platform technology, to treat this deadly condition and improve outcomes. The candidate is currently being evaluated in a phase III study (n=300) for COVID-19-related ARDS.
We remind investors that an open-label compassionate use program was conducted in March, which included 12 patients with COVID-19-related ARDS, who were being supported with mechanical ventilation. Treatment with remestemcel-L was associated with an 83% survival rate. Based on those results, remestemcel-L is now being studied in an ongoing 300-patient phase III study conducted in collaboration with the Cardiothoracic Surgical Network. The study is anticipated to be completed in early 2021.
Following the closure of the license agreement and the successful completion and outcome of this ongoing study, both companies will work together to develop appropriate critical quality attributes that meet FDA requirements for remestemcel-L in advance of the initiation of the phase III study in non-COVID-19-related ARDS.
Per the agreement, Novartis will acquire the exclusive worldwide rights to develop, commercialize and manufacture remestemcel-L for ARDS and obtain access to an innovative cell-therapy platform with a range of potential applications in severe respiratory conditions and beyond. In exchange, Novartis will make a $25-million upfront payment to and invest $25 million in Mesoblast equity with additional payments and royalties on achievement of agreed development, regulatory and commercial milestones. Additionally, the company will provide certain support to enable commercial manufacturing scale-up. Novartis has the option, if exercised, to distribute remestemcel-L for graft versus host disease (GVHD) (outside Japan). Both companies have rights to co-fund the development and commercialization for other non-respiratory indications.
The addition of remestemcel-L could expand Novartis’ respiratory portfolio by adding potential first-in-class ARDS therapy using innovative cell-based technology.
The stock has lost 7.9% in the year so far compared with the industry’s decline of 0.7%.
We remind investors that Incyte INCY is also conducting a phase III study in the United States to evaluate the efficacy and safety of ruxolitinib plus standard-of-care (SoC) compared to SoC therapy alone, in COVID-19 patients on mechanical ventilation and who have acute ARDS.
Novartis currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the healthcare space is Halozyme Therapeutics, Inc. HALO, which carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Halozyme’s earnings estimates have gained 14 cents in the past 30 days for 2020.
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