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Find Clinical Drug Development Pipelines & Deals | PipelineProspector

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            Lead Product(s): Benralizumab,Mometasone Furoate

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

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 10, 2020

            Details:

            Fasenra showed a statistically significant improvement in the endoscopic total nasal polyp score and the nasal blockage score compared to placebo, in patients with severe bilateral nasal polyposis who were still symptomatic despite continued treatment with standard of care.

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            Lead Product(s): Sodium Thiosulfate

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

            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 August 11, 2020

            Details:

            After recent completion of a pre-approval inspection of the manufacturing facility of Fennec's drug product manufacturer, the FDA identified deficiencies resulting in a Form 483, which is a list of practices that are required to be resolved prior to the approval of PEDMARK™.

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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.

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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): 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): Sodium Thiosulfate

            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 April 13, 2020

            Details:

            Potential for PEDMARK to be the first product for the prevention of cisplatin-induced hearing loss in children.

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            Lead Product(s): Dexamethasone

            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 April 09, 2020

            Details:

            We are fortunate that the primary endpoint for OTIVIDEX® Phase 3 trial and key exploratory endpoints in OTO-313 Phase 2 trial are self-reported by the patient from home.

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            Lead Product(s): Mepolizumab

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

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable April 03, 2020

            Details:

            This is the first time an anti-IL5 biologic has reported positive phase 3 data in CRSwNP, and adds to the range of eosinophil-driven diseases in which Nucala has efficacious data.

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            Lead Product(s): Sodium Thiosulfate

            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 March 05, 2020

            Details:

            The patent captures the use of Fennec’s PEDMARK product to reduce the ototoxic effects of cisplatin in pediatric patients.