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Find Clinical Drug Pipeline Developments & Deals by Aquestive Therapeutics

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            Lead Product(s): Apomorphine Hydrochloride

            Therapeutic Area: Neurology Product Name: Kynmobi

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Marathon Asset Management

            Deal Size: $125.0 million Upfront Cash: $40.0 million

            Deal Type: Agreement November 03, 2020

            Details:

            Marathon will receive all royalties and other payments due under Aquestive’s license agreement with Sunovion Pharmaceuticals as a result of commercialization of KYNMOBI™ sublingual film for acute, intermittent treatment of OFF episodes in patients with Parkinson’s disease.

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            Lead Product(s): Diazepam

            Therapeutic Area: Neurology Product Name: Libervant

            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 September 25, 2020

            Details:

            U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the New Drug Application (NDA) for Libervant™ (diazepam) Buccal Film for management of seizure clusters.

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            Lead Product(s): Epinephrine

            Therapeutic Area: Immunology Product Name: AQST-108

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 10, 2020

            Details:

            The FDA has granted the Aquestive's AQST-108 Fast Track designation, "first of its kind" oral sublingual film formulation that delivers systemic epinephrine to treat allergic reactions, including anaphylaxis, using the proprietary Aquestive PharmFilm ® technologies.

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            Lead Product(s): Epinephrine

            Therapeutic Area: Immunology Product Name: AQST-108

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 29, 2020

            Details:

            Aquestive plans to initiate its PK clinical trials of AQST-108 in a crossover study to compare the pharmacokinetics and pharmacodynamics of epinephrine administered as sublingual film to that of epinephrine administered as an injection.