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Find Clinical Drug Pipelines for Otolaryngology (Ear, Nose, Throat)

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            Lead Product(s): PIPE-505

            Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: PIPE-505

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

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable July 23, 2020

            Details:

            PIPE-505 is the first small molecule developed specifically for the treatment of sensorineural hearing loss (SNHL) associated with speech-in-noise impairment.

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            Lead Product(s): Fluticasone Propionate

            Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: Xhance

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Optinose

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Agreement July 08, 2020

            Details:

            Under the terms of the agreement, kaléo will promote XHANCE to an agreed-upon audience of office-based healthcare professionals, rapidly increasing promotional reach and frequency.

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            Lead Product(s): Gacyclidine

            Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: OTO-313

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

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable July 06, 2020

            Details:

            The trial achieved its objectives by demonstrating a positive clinical signal for OTO-313 based on a TFI responder analysis, with a favorable safety profile.

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            Lead Product(s): Dexamethasone

            Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: Otividex

            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 July 06, 2020

            Details:

            Management will review the OTIVIDEX statistical analysis plan update together with the positive top-line OTO-313 Phase 1/2 trial results during a conference.

            ALK

            • Deals

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            Lead Product(s): Ciprofloxacin

            Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: Otiprio

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Otonomy

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Agreement June 17, 2020

            Details:

            Under the terms of the agreement, ALK will have exclusive rights to promote OTIPRIO for AOE to office-based healthcare professionals in the U.S. including ENT physicians, pediatricians and select primary care physicians.

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            Lead Product(s): Dexamethasone

            Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: Otividex

            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 15, 2020

            Details:

            Results from Phase 3 trial of OTIVIDEX® in Ménière’s disease expected in first quarter of 2021, results from Phase 1/2 trial of OTO-313 in tinnitus expected in July 2020 and results of Phase 1/2 trial of OTO-413 in hearing loss expected in fourth quarter of 2020.

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            Lead Product(s): OTOF-GT

            Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: Undisclosed

            Highest Development Status: Preclinical Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 09, 2020

            Details:

            In vivo experiments conducted safely in non-human primates show promising preliminary data on inner ear tissue tropism and the achievement of a high transduction rate efficiency post Otoferlin Gene Therapy.

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            Lead Product(s): Ebselen

            Therapeutic Area: Otolaryngology (Ear, Nose, Throat) 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 June 08, 2020

            Details:

            SPI's clinical data from two completed multi-center, randomized, placebo-controlled studies (Phase 1b and Phase 2b clinical trials) showed that oral delivery of SPI-1005 for 21 or 28 days improved sensorineural hearing loss and tinnitus in patients affected by MD.

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            Lead Product(s): AK-OTOF

            Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: Undisclosed

            Highest Development Status: Preclinical Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: BofA Securities

            Deal Size: $100.0 million Upfront Cash: Undisclosed

            Deal Type: Public Offering June 05, 2020

            Details:

            Akouos' pipeline contains lead candidate AK-OTOF, a gene therapy for the treatment of hearing loss due to mutations in the otoferlin gene.

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            Lead Product(s): Colfosceril Palmitate,Cholesteryl Palmitate

            Therapeutic Area: Otolaryngology (Ear, Nose, Throat) 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 01, 2020

            Details:

            Although the study did not achieve statistical significance for the primary efficacy endpoints, But the statistical trend were encouraging that favored the OP0201 treatment group with regard to resolution of middle ear effusion.

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