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Find Urology Clinical Drug Pipeline Developments & Deals

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            Lead Product(s): Vibegron

            Therapeutic Area: Urology Product Name: Gemtesa

            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 February 23, 2021

            Details:

            Vibegron is a beta-3 adrenergic receptor (β3) agonist, for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence (UUI), urgency, and urinary frequency in adults.

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            Lead Product(s): Mirabegron

            Therapeutic Area: Urology Product Name: Myrbetriq

            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 January 06, 2021

            Details:

            The NDA and sNDA were based on findings from a Phase 3 pivotal study that evaluated the efficacy, safety, tolerability and pharmacokinetics of mirabegron in children and adolescents with NDO and using clean intermittent catheterization.

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            Lead Product(s): Oxybutynin Chloride

            Therapeutic Area: Urology Product Name: Undisclosed

            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 December 18, 2020

            Details:

            Strides Pharma Global has received approval for Oxybutynin Chloride Tablets USP, 5 mg from the USFDA. Oxybutynin Chloride is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Ditropan Tablets, 5 mg, of Janssen Pharmaceuticals, Inc.

            BioSpecifics

            • Deals

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            Lead Product(s): Collagenase Clostridium Histolyticum

            Therapeutic Area: Urology Product Name: Xiaflex

            Highest Development Status: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Endo Pharm

            Deal Size: $540.0 million Upfront Cash: $540.0 million

            Deal Type: Acquisition December 02, 2020

            Details:

            BioSpecifics received a royalty stream from Endo related to Endo's collagenase-based therapies, which currently include XIAFLEX, marketed by Endo Pharmaceuticals.

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            Lead Product(s): Vibegron

            Therapeutic Area: Urology Product Name: KRP114V

            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 November 19, 2020

            Details:

            Results from the 40-week EMPOWUR extension to the 12-week EMPOWUR trial shows that 75 mg of vibegron was well tolerated over the total exposure of 52 weeks with numerically greater improvements from baseline, compared to tolterodine across QoL and responder efficacy endpoints.

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            Lead Product(s): Vibegron

            Therapeutic Area: Urology Product Name: RVT-901

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Sumitovant Biopharma

            Deal Size: $584.0 million Upfront Cash: Undisclosed

            Deal Type: Merger November 12, 2020

            Details:

            The merger may enable Urovant's team to fully concentrate on the important task of preparing for its potential commercial launch of vibegron, the first new branded prescription drug for the treatment of OAB in nearly a decade.

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            Lead Product(s): Tacrolimus

            Therapeutic Area: Urology Product Name: LP-10

            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 October 15, 2020

            Details:

            A multi-site, prospective, open-label, dose-escalation clinical trial assessing the safety and efficacy of LP-10 (liposomal tacrolimus) is now open for recruitment at several sites.

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            Lead Product(s): Vibegron

            Therapeutic Area: Urology Product Name: RVT-901

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Urovant Sciences

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Agreement October 07, 2020

            Details:

            Under the terms of the agreement, Sunovion will deploy its multi-specialty sales force to bring vibegron to primary care physicians (PCP). In support of this effort, Sunovion will provide sales and marketing activities targeting the PCP segment through March 31, 2026.

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            Lead Product(s): Desmopressin Acetate

            Therapeutic Area: Urology Product Name: Nocdurna

            Highest Development Status: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: ANTARES PHARMA INC

            Deal Size: $25.0 million Upfront Cash: $5.0 million

            Deal Type: Licensing Agreement October 01, 2020

            Details:

            This license agreement for NOCDURNA expands Antares Pharma's urology portfolio, which already includes XYOSTED, the best-selling branded testosterone replacement product in the United States.

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            Lead Product(s): OnabotulinumtoxinA

            Therapeutic Area: Urology Product Name: Botox

            Highest Development Status: Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 27, 2020

            Details:

            Phase 2 APOLLO clinical trial of a RTGel hydrogel formulation in combination with BOTOX® intravesical instillation in patients with overactive bladder (OAB) and urinary incontinence did not meet the primary endpoint of improvement of overactive bladder symptoms.

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