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[{"orgOrder":0,"company":"Johnson & Johnson Innovative Medicine","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Janssen Submits Ponesimod New Drug Application to the U.S. FDA for Treatment of Adults with Relapsing Multiple Sclerosis","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"March 2020","url1":"","url2":"","graph1":"Neurology","graph2":"Phase III"},{"orgOrder":0,"company":"Johnson & Johnson Innovative Medicine","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Janssen Announces U.S. FDA Approval of PONVORY, an Oral Treatment for Adults with Relapsing Multiple Sclerosis","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"March 2021","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"orgOrder":0,"company":"Johnson & Johnson Innovative Medicine","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Janssen Gets Positive CHMP Opinion for PONVORY for the Treatment of Relapsing MS With Active Disease Defined by Clinical or Imaging Features","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"March 2021","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"orgOrder":0,"company":"Centocor","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"EC Approves PONVORYTM for the Treatment of Adults with Relapsing Forms of Multiple Sclerosis","therapeuticArea":"Immunology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"May 2021","url1":"","url2":"","graph1":"Immunology","graph2":"Approved"},{"orgOrder":0,"company":"Johnson & Johnson Innovative Medicine","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Janssen Showcases Recent Data in Relapsing Multiple Sclerosis at the 2021 European Committee for Treatment and Research in Multiple Sclerosis Congress","therapeuticArea":"Immunology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"September 2021","url1":"","url2":"","graph1":"Immunology","graph2":"Approved"},{"orgOrder":0,"company":"Johnson & Johnson Innovative Medicine","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"New Subgroup Analysis of the Phase 3 OPTIMUM Study Demonstrates the Benefits of PONVORYTM\u25bc (Ponesimod) Over teriflunomide in Early Disease Multiple Sclerosis","therapeuticArea":"Immunology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"October 2021","url1":"","url2":"","graph1":"Immunology","graph2":"Approved"},{"orgOrder":0,"company":"Actelion Pharmaceuticals Ltd","sponsor":"Vanda Pharmaceuticals","pharmaFlowCategory":"D","amount":"$100.0 million","upfrontCash":"Undisclosed","newsHeadline":"Vanda Pharmaceuticals Acquires U.S. and Canadian Rights to PONVORY\u00ae (ponesimod), a Selective S1P1R Modulator Approved for Patients with Relapsing Multiple Sclerosis","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"SWITZERLAND","productType":"Small molecule","productStatus":"Approved","date":"December 2023","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"orgOrder":0,"company":"Actelion Pharmaceuticals Ltd","sponsor":"Juvise Pharmaceuticals","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Juvis\u00e9 Pharmaceuticals Acquires Multiple Sclerosis Drug PONVORY\u00ae (ex-US\/Canada) and Opens its Capital to Bpifrance and Pemberton","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"SWITZERLAND","productType":"Small molecule","productStatus":"Approved","date":"March 2024","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"}]

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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: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Juvise Pharmaceuticals

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Acquisition March 26, 2024

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            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: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Vanda Pharmaceuticals

            Deal Size: $100.0 million Upfront Cash: Undisclosed

            Deal Type: Acquisition December 07, 2023

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            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: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 13, 2021

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            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: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 29, 2021

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            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: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 24, 2021

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            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: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable March 26, 2021

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            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: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable March 19, 2021

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            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 III Product 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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