Polpharma European CDMO Partner & API Manufacturer since 1951 Polpharma European CDMO Partner & API Manufacturer since 1951

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[{"orgOrder":0,"company":"KemPharm","sponsor":"Corium","pharmaFlowCategory":"D","amount":"$5.0 million","upfrontCash":"Not Applicable","newsHeadline":"KemPharm Eligible to Receive $5 Million Milestone Payment from Gurnet Point Capital After NDA Filing for Potential New ADHD Treatment","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"May 2020","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase III"},{"orgOrder":0,"company":"KemPharm","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"KemPharm Announces Issuance of Two Additional U.S. Patents Governing KP415 and KP484","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"July 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I"},{"orgOrder":0,"company":"KemPharm","sponsor":"Orphazyme","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"$12.8 million","newsHeadline":"KemPharm Announces Strategic Acquisition of Arimoclomol from Orphazyme, Expanding its Rare CNS Diseases Pipeline","therapeuticArea":"Rare Diseases and Disorders","highestDevelopmentStatus":"Phase II\/ Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"May 2022","url1":"","url2":"","graph1":"Rare Diseases and Disorders","graph2":"Phase II\/ Phase III"},{"orgOrder":0,"company":"KemPharm","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"KemPharm Receives FDA Orphan Drug Designation for Serdexmethylphenidate (SDX) for the Treatment of Idiopathic Hypersomnia (IH)","therapeuticArea":"Sleep","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Small molecule","productStatus":"New 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molecule","productStatus":"New Molecular Entity","date":"January 2023","url1":"","url2":"","graph1":"Sleep","graph2":"Phase II"}]

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            KP1077 is KemPharm’s lead clinical candidate being developed as a treatment for idiopathic hypersomnia (IH) and narcolepsy. KP1077 is comprised solely of serdexmethylphenidate (SDX), KemPharm’s proprietary prodrug of d-methylphenidate.

            Lead Product(s): Serdexmethylphenidate

            Therapeutic Area: Sleep Product Name: KP1077

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Hypersomnia Foundation

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Partnership January 18, 2023

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            Serdexmethylphenidate (SDX) is KemPharm’s proprietary prodrug of d-methylphenidate (d-MPH) and the sole active pharmaceutical ingredient (API) in KP1077, KemPharm’s lead clinical candidate being developed as a treatment for idiopathic hypersomnia (IH) and narcolepsy.

            Lead Product(s): Serdexmethylphenidate

            Therapeutic Area: Sleep Product Name: KP1077

            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 December 21, 2022

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            SDX is the sole active pharmaceutical ingredient (API) in KP1077, KemPharm’s lead clinical candidate being developed as a treatment for IH and narcolepsy.

            Lead Product(s): Serdexmethylphenidate

            Therapeutic Area: Sleep Product Name: KP1077

            Highest Development Status: IND Enabling Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable November 18, 2022

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            The acquisition of arimoclomol aligns perfectly with the strategy to build KemPharm’s value via the advancement and commercialization of novel treatments that address rare CNS conditions, including the lead clinical candidate, KP1077 in idiopathic hypersomnia.

            Lead Product(s): Arimoclomol

            Therapeutic Area: Rare Diseases and Disorders Product Name: Undisclosed

            Highest Development Status: Phase II/ Phase III Product Type: Small molecule

            Recipient: Orphazyme

            Deal Size: Undisclosed Upfront Cash: $12.8 million

            Deal Type: Acquisition May 15, 2022

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            The data suggest that KP1077 (serdexmethylphenidate) produces a smoother, more gradual release of d-MPH that may avoid the adverse events associated with large and rapid exposure fluctuations that may be experienced with other stimulant-based therapies.

            Lead Product(s): Serdexmethylphenidate

            Therapeutic Area: Sleep Product Name: KP1077

            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 May 05, 2022

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            Prodrug of d-methylphenidate, is sole API in KP1077, a potential first-ever therapeutic treatment for Idiopathic Hypersomnia, a neurological disorder marked by significant, detrimental effects on nighttime sleep as well as daytime sleepiness/wakefulness.

            Lead Product(s): Methylphenidate

            Therapeutic Area: Sleep Product Name: KP1077

            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 April 19, 2022

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            Data demonstrate higher doses of KP1077 (serdexmethylphenidate) prodrug of d-methylphenidate, were generally well-tolerated and produced targeted pharmacodynamic effects that may be beneficial for the treatment of idiopathic hypersomnia and other sleep disorders.

            Lead Product(s): Serdexmethylphenidate

            Therapeutic Area: Sleep Product Name: KP1077

            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 March 21, 2022

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            KemPharm is due to receive the fee, within 30 days following FDA approval of ADLARITY, pursuant to a master development services agreement entered into with Corium in July 2020, under which KemPharm provided development related to Corium’s resubmission of its NDA for ADLARITY.

            Lead Product(s): Donepezil

            Therapeutic Area: Neurology Product Name: Adlarity

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Corium

            Deal Size: $2.0 million Upfront Cash: Undisclosed

            Deal Type: Agreement March 16, 2022

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            The successful completion of the pre-IND meeting process with the FDA for KP1077 affirms company's plan to submit the IND application by mid-year 2022 and to initiate a Phase 2 trial of KP1077 for Idiopathic Hypersomnia.

            Lead Product(s): Dexmethylphenidate

            Therapeutic Area: Sleep Product Name: KP1077

            Highest Development Status: Preclinical Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable February 23, 2022

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            Details:

            AZSTARYS is a once-daily product for the treatment of ADHD in patients aged six years and older consisting of serdexmethylphenidate (SDX), KemPharm’s prodrug of d-methylphenidate (d-MPH), co-formulated with immediate-release d-MPH.

            Lead Product(s): Dexmethylphenidate,Serdexmethylphenidate

            Therapeutic Area: Psychiatry/Psychology Product Name: Azstarys

            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 27, 2021

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