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Details:
Sofdra (sofpironium) works by inhibiting M3 muscarinic receptors in eccrine glands. It is approved for the treatment of primary axillary hyperhidrosis in patients ages 9 and older.
Lead Product(s): Sofpironium Bromide
Therapeutic Area: Dermatology Product Name: Sofdra
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 20, 2024
Details:
Under the agreement, Fresh Tracks provided consulting services as an independent contractor to Botanix in support of and through filing and approval of the U.S. new drug application for BBI-4000 (sofpironium bromide gel).
Lead Product(s): Sofpironium Bromide
Therapeutic Area: Dermatology Product Name: BBI-4000
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Botanix Pharma
Deal Size: $8.2 million Upfront Cash: $8.2 million
Deal Type: Agreement July 21, 2023
Details:
The results from the Cardigan I and Cardigan II studies, along with all previously completed clinical studies, will form the basis for a U.S. NDA for sofpironium bromide gel, 15%, which is expected to submit to the FDA in mid-2022.
Lead Product(s): Sofpironium Bromide
Therapeutic Area: Dermatology Product Name: BBI-4000
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 07, 2021
Details:
Sofpironium bromide is Brickell’s lead investigational product candidate and is a new chemical entity that belongs to a class of medications called anticholinergics.
Lead Product(s): Sofpironium Bromide
Therapeutic Area: Dermatology Product Name: BBI-4000
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: H.C. Wainwright & Co.
Deal Size: $8.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering July 22, 2021
Details:
Brickell Biotech completed patient enrollment in the Phase 3 pivotal Cardigan I study and that the Cardigan II study has surpassed 50% enrollment. Both studies are evaluating sofpironium bromide gel, 15% in patients with primary axillary (underarm) hyperhidrosis.
Lead Product(s): Sofpironium Bromide
Therapeutic Area: Dermatology Product Name: BBI-4000
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 27, 2021
Details:
The ARGYLE study assessed the long-term safety and efficacy of topical, once-daily treatment with sofpironium bromide gel, 5% and 15% for 48 weeks in patients nine years and older with primary axillary hyperhidrosis/excessive underarm sweating.
Lead Product(s): Sofpironium Bromide
Therapeutic Area: Dermatology Product Name: BBI-4000
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 23, 2021
Details:
First patient in its second U.S. pivotal Phase 3 clinical study (“Cardigan II study”) evaluating sofpironium bromide gel, 15% in approximately 350 subjects aged nine and older with primary axillary (underarm) hyperhidrosis.
Lead Product(s): Sofpironium Bromide
Therapeutic Area: Dermatology Product Name: Ecclock
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 07, 2020
Details:
The Cardigan I Study is a multicenter, randomized, double-blinded, vehicle (placebo)-controlled Phase 3 study to evaluate the safety and efficacy of topically applied sofpironium bromide gel, 15%.
Lead Product(s): Sofpironium Bromide
Therapeutic Area: Dermatology Product Name: BBI-4000
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 06, 2020
Details:
Sofpironium bromide gel was deemed to be safe and well tolerated in this study, as well as in the accompanying 52-week long-term safety extension study in Japan. Japan is the first country to approve sofpironium bromide with commercial launch expected later this year.
Lead Product(s): Sofpironium Bromide
Therapeutic Area: Dermatology Product Name: Ecclock
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Fresh Tracks Therapeutics
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 25, 2020
Details:
Brickell and Kaken Pharmaceutical were granted by the Japanese Patent Office a composition of matter patent with claims directed to the novel polymorphic, or crystalline, forms of sofpironium bromide, a retrometabolically designed new chemical entity.
Lead Product(s): Sofpironium Bromide
Therapeutic Area: Dermatology Product Name: BBI-4000
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Kaken Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 31, 2020
Details:
The Phase 3 pivotal study evaluated a total of 281 Japanese subjects randomized 1:1 to apply sofpironium bromide gel, or vehicle gel (placebo). All subjects scores ≥ 3 and ≥ 50 mg/5 min gravimetric sweat production (GSP) in each axilla at baseline.
Lead Product(s): Sofpironium Bromide
Therapeutic Area: Dermatology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 15, 2020
Details:
Presentation based on positive Phase 3 pivotal study results of Sofpironium Bromide in Japanese Patients with Primary Axillary Hyperhidrosis.
Lead Product(s): Sofpironium Bromide
Therapeutic Area: Dermatology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 04, 2020
Details:
In this Phase 2b dose-finding study, sofpironium bromide elicited clinically and statistically significant sustained reductions in sweating severity and was well tolerated.
Lead Product(s): Sofpironium Bromide
Therapeutic Area: Dermatology 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 February 20, 2020
Details:
The settlement resolves the previously disclosed dispute related to the sofpironium bromide license agreement allowing the Company to continue to produce sofpironium bromide to treat hyperhidrosis.
Lead Product(s): Sofpironium Bromide
Therapeutic Area: Dermatology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Fresh Tracks Therapeutics
Deal Size: $3.5 million Upfront Cash: $1.0 million
Deal Type: Licensing Agreement February 18, 2020
Details:
The application for sofpironium bromide in Japan involves data from the Phase 3 study in Japan, targeting patients with primary axillary hyperhidrosis, in which positive results were obtained.
Lead Product(s): Sofpironium Bromide
Therapeutic Area: Dermatology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 10, 2020
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