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Details:
Under the agreement,NovaBay will market Eyenovia’s clobetasol propionate ophthalmic suspension, a steroid indicated for the treatment of inflammation and pain following ocular surgery, through its U.S. physician-dispensed channel.
Lead Product(s): Clobetasol Propionate
Therapeutic Area: Immunology Product Name: APP13007
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Eyenovia
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement March 13, 2024
Details:
APP13007 (clobetasol propionate) is a nanoparticle formulation of a steroid in development for the treatment of inflammation and pain after cataract surgery. Sosei Heptares will receive undisclosed milestone payments based on progression of Activus' pipeline.
Lead Product(s): Clobetasol Propionate
Therapeutic Area: Immunology Product Name: APP13007
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Formosa Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement March 06, 2024
Details:
APP13007 (clobetasol propionate) is a nanoparticle ophthalmic formulation of a steroid. It is approved for the treatment of post-operative inflammation and pain following ocular surgery.
Lead Product(s): Clobetasol Propionate
Therapeutic Area: Neurology Product Name: APP13007
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: AimMax Therapeutics
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 04, 2024
Details:
Under the agreement, Cristália gets exclusive Brazilian rights for the commercialization of APP13007 (clobetasol propionate ophthalmic nanosuspension) for the treatment of inflammation and pain following ocular surgery.
Lead Product(s): Clobetasol Propionate
Therapeutic Area: Neurology Product Name: APP13007
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Cristália
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement January 26, 2024
Details:
The net proceeds will fund commercialization of a post-ophthalmic surgery product, APP13007 (clobetasol propionate), developed using Formosa’s proprietary APNT nanoparticle formulation platform, and for the manufacturing automation activities for the Optejet® device.
Lead Product(s): Clobetasol Propionate
Therapeutic Area: Neurology Product Name: APP13007
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: William Blair
Deal Size: $12.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering August 24, 2023
Details:
Through the acquisition, Eyenovia has gained the exclusive U.S. rights to distribute and sell APP13007 (clobetasol propionate ophthalmic nanosuspension), a potent steroid for reducing the inflammation and pain associated with ocular surgery, which is under review by FDA.
Lead Product(s): Clobetasol Propionate
Therapeutic Area: Neurology Product Name: APP13007
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Eyenovia
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition August 16, 2023
Details:
APP13007 (clobetasol propionate ophthalmic nanosuspension) is expected to provide ophthalmologists and ocular surgery patients with a compelling, rapid and sustained, and more convenient postoperative anti-inflammatory and pain relief solution.
Lead Product(s): Clobetasol Propionate
Therapeutic Area: Neurology Product Name: APP13007
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: AimMax Therapeutics
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 05, 2023
Details:
There were 26.5% of subjects who showed sustained anterior chamber cell (ACC) count = 0 (inflammation free) from post-operative day 8 (POD8) through POD15 in the APP13007 (clobetasol propionate) arm as compared to 5.1% in the placebo arm (p<0.001).
Lead Product(s): Clobetasol Propionate
Therapeutic Area: Neurology Product Name: APP13007
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: AimMax Therapeutics
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 12, 2022
Details:
Data showed statisticallly-significant and clinically-meaningful improvement of inflammation and pain with twice-daily APP13007 compared to matching placebo, a regimen that is being evaluated in ongoing Phase 3 studies.
Lead Product(s): Clobetasol Propionate
Therapeutic Area: Neurology Product Name: APP13007
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: AimMax Therapeutics
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 28, 2022
Details:
In this Phase 2 study investigating Rivelin-CLO across more than 20 clinical trial sites, a 20-µg dose resulted in a clinically significant reduction in OLP ulcer size, improvements in symptoms and quality of life, and a favorable safety profile compared to placebo.
Lead Product(s): Clobetasol Propionate
Therapeutic Area: Immunology Product Name: Rivelin-CLO
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 15, 2021
Details:
Rivelin-CLO is the first biodegradable oral adhesive patch designed for local delivery of clobetasol to treat symptomatic Oral Lichen Planus (OLP) lesions. First study to show the successful transmucosal delivery of a corticosteroid using electrospun patch technology.
Lead Product(s): Clobetasol Propionate
Therapeutic Area: Immunology Product Name: Rivelin-CLO
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 11, 2021
Details:
First patient is dosed in a 370-patient in Phase 3 trial of APP13007 in the US. Sosei Heptares will receive undisclosed milestone payments based on progression of Activus' pipeline and royalties from the commercialization of certain products should they reach the market.
Lead Product(s): Clobetasol Propionate
Therapeutic Area: Ophthalmology Product Name: APP13007
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Formosa Laboratories
Deal Size: $8.5 million Upfront Cash: Undisclosed
Deal Type: Agreement March 11, 2021
Details:
The approved ANDA is therapeutically equivalent to the reference listed drug product, Clobex Shampoo, of Galderma Laboratories, Clobetasol Propionate Shampoo is indicated for the treatment of moderate to severe forms of scalp psoriasis in subjects 18 years of age and older.
Lead Product(s): Clobetasol Propionate
Therapeutic Area: Dermatology Product Name: Clobetasol Propionate-Generic
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Aleor Dermaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 20, 2020
Details:
Study conducted in OLP patients with the 20?g dose of Rivelin-CLO demonstrated a statistically significant improvement in ulcer area, and continued to show improvement through the end of 4 weeks.
Lead Product(s): Clobetasol Propionate
Therapeutic Area: Immunology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 22, 2020
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