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Details:
Through the acquisition, Juvise Pharmaceuticals will leverage its expertise to commercialize and develop Ponvory(ponesimod), a first-line treatment option in active forms of relapsing multiple sclerosis, outside of the United States and Canada, with a focus on Europe.
Lead Product(s): Ponesimod
Therapeutic Area: Neurology Product Name: Ponvory
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Juvise Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition March 26, 2024
Details:
Through the acquisition, Vanda expands its commercial portfolio by including Ponvory (ponesimod), a daily oral selective sphingosine-1-phosphate receptor 1 (S1P1R) modulator, indicated to treat adults with relapsing forms of multiple sclerosis.
Lead Product(s): Ponesimod
Therapeutic Area: Neurology Product Name: Ponvory
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Vanda Pharmaceuticals
Deal Size: $100.0 million Upfront Cash: Undisclosed
Deal Type: Acquisition December 07, 2023
Details:
The trial was designed to evaluate the efficacy and safety of once daily oral ponesimod 20mg vs. once per day teriflunomide 14mg, an approved first-line oral treatment, in adult patients with RMS. In total, 1,133 adult patients were randomised at 162 sites in 28 countries.
Lead Product(s): Ponesimod
Therapeutic Area: Immunology Product Name: Ponvory
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 13, 2021
Details:
PONVORY™, a once-daily oral selective sphingosine-1-phosphate receptor 1 (S1P1) modulator, approved to treat adults with relapsing forms of MS in both the United States and European Union earlier this year.
Lead Product(s): Ponesimod
Therapeutic Area: Immunology Product Name: Ponvory
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 29, 2021
Details:
Within the OPTIMUM study, overall, the number of treatment-emergent adverse events reported was similar between the ponesimod and teriflunomide treated groups, and the majority were mild/moderate and did not warrant treatment discontinuation.
Lead Product(s): Ponesimod
Therapeutic Area: Immunology Product Name: Ponvory
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 24, 2021
Details:
Positive opinion is based on the pivotal Phase 3 OPTIMUM study evaluating the efficacy and safety of ponesimod vs. teriflunomide, an active comparator and oral standard of care treatment in adult patients with relapsing multiple sclerosis.
Lead Product(s): Ponesimod
Therapeutic Area: Neurology Product Name: Ponvory
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 26, 2021
Details:
Head-to-head pivotal clinical trial results showed PONVORY™ treatment led to nearly a third fewer annual relapses than teriflunomide. PONVORY™ is the first and only FDA-approved oral disease modifying therapy studied against an established oral comparator.
Lead Product(s): Ponesimod
Therapeutic Area: Neurology Product Name: Ponvory
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 19, 2021
Details:
Head-to-head OPTIMUM Phase 3 study showed superior efficacy of ponesimod 20 mg on the primary endpoint as well as most secondary endpoints, compared to Aubagio® (teriflunomide).
Lead Product(s): Ponesimod
Therapeutic Area: Neurology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 18, 2020
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