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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.
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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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