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Find Clinical Drug Pipeline Developments & Deals by Santhera Pharmaceuticals

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            Lead Product(s): Vamorolone

            Therapeutic Area: Genetic Disease Product Name: VBP15

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Highbridge Capital Management

            Deal Size: $16.5 million Upfront Cash: Undisclosed

            Deal Type: Financing November 02, 2020

            Details:

            Vamorolone, the only dissociative steroid in development, is currently in a pivotal Phase 2b study in DMD patients with a 6-month readout expected in the second quarter of 2021.

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            Lead Product(s): Idebenone

            Therapeutic Area: Genetic Disease Product Name: Puldysa

            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 October 06, 2020

            Details:

            Data from an interim analysis conducted by the independent Data and Safety Monitoring Board concluded that the Phase 3 SIDEROS study with Puldysa® (idebenone) was unlikely to meet its primary endpoint.

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            Lead Product(s): Idebenone

            Therapeutic Area: Genetic Disease Product Name: Puldysa

            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 October 06, 2020

            Details:

            Data from an interim analysis conducted by the (DSMB) concluded that the study was unlikely to meet its primary endpoint. Santhera will discontinue the study, withdraw the European marketing authorization application and end the global development program for Puldysa.

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            Lead Product(s): Vamorolone

            Therapeutic Area: Genetic Disease Product Name: VBP15

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: ReveraGen BioPharma

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 14, 2020

            Details:

            Data further show that vamorolone uniformly weakens co-activator associations, which leads to loss of gene transcriptional activities associated with safety concerns of corticosteroids.

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            Lead Product(s): Vamorolone

            Therapeutic Area: Genetic Disease Product Name: VBP15

            Highest Development Status: Phase II Product Type: Small molecule

            Recipient: Idorsia Pharmaceuticals

            Deal Size: $11.4 million Upfront Cash: Undisclosed

            Deal Type: Licensing Agreement September 02, 2020

            Details:

            Santhera has obtained an exclusive license from ReveraGen, the originator of vamorolone, for all indications worldwide. Vamorolone is currently being investigated in the pivotal Phase 2b VISION-DMD study in patients with Duchenne muscular dystrophy (DMD).

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            Lead Product(s): Idebenone

            Therapeutic Area: Genetic Disease Product Name: Puldysa

            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 June 23, 2020

            Details:

            Uk's Medicines and Healthcare products Regulatory Agency has renewed for a further year the Early Access to Medicines Scheme scientific opinion for idebenone for patients with Duchenne muscular dystrophy in respiratory function decline who are not taking glucocorticoids.

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            Lead Product(s): Idebenone

            Therapeutic Area: Genetic Disease Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Highbridge Capital Management

            Deal Size: $21.1 million Upfront Cash: Undisclosed

            Deal Type: Financing June 04, 2020

            Details:

            In combination with Santhera's existing cash and cash equivalents, this financing will provide the Company with sufficient funding to complete regulatory work for Puldysa®, including the CHMP review, and with the achievement of Company milestones.

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            Lead Product(s): Vamorolone

            Therapeutic Area: Genetic Disease Product Name: Undisclosed

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 02, 2020

            Details:

            Data from this VBP15-003 study in comparison to natural history study data demonstrated dose-dependent improvement in timed function tests. Vamorolone was reported to be safe and well tolerated up to the highest dose tested (6.0 mg/kg/day).

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            Lead Product(s): Idebenone

            Therapeutic Area: Genetic Disease 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 May 20, 2020

            Details:

            The large Phase 3 SIDEROS study was designed to confirm the efficacy of idebenone in patients with respiratory function decline who are concurrently taking glucocorticoids.

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            Lead Product(s): Lonodelestat

            Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Undisclosed

            Highest Development Status: Undisclosed Product Type: Undisclosed

            Partner/Sponsor/Collaborator: CSHL

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Collaboration April 27, 2020

            Details:

            Santhera will provide lonodelestat and intellectual support for the scientists at CSHL who will conduct the non-clinical research program.