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Details:
Through the acquisition, LEO expand its pipeline by including TMB-001, an investigational topical reformulation of the active pharmaceutical ingredient, isotretinoin that today only exists in an oral formulation in the U.S.
Lead Product(s): Isotretinoin
Therapeutic Area: Dermatology Product Name: TMB-001
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Leo Pharma
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition January 23, 2024
Details:
Through the acquisition, LEO gains rights to establish TMB-001, topical isotretinoin in Timber's patented IPEG™ delivery system, as the standard of care in the treatment of congenital ichthyosis, a devastating, rare disease.
Lead Product(s): Isotretinoin
Therapeutic Area: Genetic Disease Product Name: TMB-001
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Leo Pharma
Deal Size: $36.0 million Upfront Cash: $14.0 million
Deal Type: Acquisition August 21, 2023
Details:
Isotretinoin capsule inhibits sebaceous gland function and keratinization at pharmacologic doses. It is being indicated for the treatment of severe recalcitrant nodular acne.
Lead Product(s): Isotretinoin
Therapeutic Area: Dermatology Product Name: Accutane-Generic
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 24, 2023
Details:
TMB-001 (isotretinoin) inhibits sebaceous gland function and keratinization at pharmacologic doses. It is being developed for the treatment of X-Linked recessive ichthyosis.
Lead Product(s): Isotretinoin
Therapeutic Area: Genetic Disease Product Name: TMB-001
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 February 24, 2023
Details:
TMB-001 is a topical isotretinoin, formulated using IPEG™ delivery system, in development for the treatment of moderate to severe forms of congenital ichthyosis.
Lead Product(s): Isotretinoin
Therapeutic Area: Genetic Disease Product Name: TMB-001
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 25, 2022
Details:
TMB-001 is a topical isotretinoin, formulated using the Company’s patented IPEG™ delivery system, in development for the treatment of moderate to severe forms of congenital ichthyosis (CI) including ARCI and X-linked recessive ichthyosis (XLRI).
Lead Product(s): Isotretinoin
Therapeutic Area: Genetic Disease Product Name: TMB-001
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 September 14, 2022
Details:
TMB-001 is a topical isotretinoin formulation in development based on the Company’s patented IPEG™ delivery system for the treatment of moderate to severe forms of congenital ichthyosis (CI).
Lead Product(s): Isotretinoin
Therapeutic Area: Genetic Disease Product Name: TMB-001
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 August 29, 2022
Details:
The Company intends to use the net proceeds from this offering for research and development, including clinical trials of TMB-001 having isotretinoin, working capital and general corporate purposes.
Lead Product(s): Isotretinoin
Therapeutic Area: Genetic Disease Product Name: TMB-001
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 August 08, 2022
Details:
TMB-001 0.05%, a topical isotretinoin formulated using patented IPEG™ delivery system, for treatment of moderate to severe forms of congenital ichthyosis.
Lead Product(s): Isotretinoin
Therapeutic Area: Genetic Disease Product Name: TMB-001
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 23, 2022
Details:
In the Phase 2b CONTROL study, treatment with TMB-001 (Isotretinoin) demonstrated a clinically meaningful reduction in targeted and overall severity of CI along with a favorable safety profile.
Lead Product(s): Isotretinoin
Therapeutic Area: Genetic Disease Product Name: TMB-001
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 May 31, 2022
Details:
TMB-001, a topical isotretinoin formulated using the company’s patented IPEG™ delivery system, for the treatment of X-linked recessive ichthyosis (XRI) and autosomal recessive congenital ichthyosis lamellar ichthyosis (ARCI-LI).
Lead Product(s): Isotretinoin
Therapeutic Area: Genetic Disease Product Name: TMB-001
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 28, 2022
Details:
Improvement of ≥2-grade IGA score was observed in all patients with XLRI who received TMB-001 0.05% compared to 25% receiving vehicle, and in all patients with ARCI-LI who received TMB-001 0.05% compared to no patients receiving vehicle.
Lead Product(s): Isotretinoin
Therapeutic Area: Genetic Disease Product Name: TMB-001
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 25, 2022
Details:
TMB-001, topical isotretinoin in Timber’s patented IPEG delivery system, is being developed for the treatment of moderate to severe subtypes of Congenital ichthyosis (CI).
Lead Product(s): Isotretinoin
Therapeutic Area: Genetic Disease Product Name: TMB-001
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 November 17, 2021
Details:
TMB-001, an investigational topical isotretinoin formulated using Timber’s patented IPEG™ delivery system, in patients with moderate to severe congenital ichthyosis (CI).
Lead Product(s): Isotretinoin
Therapeutic Area: Genetic Disease Product Name: TMB-001
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 October 07, 2021
Details:
Upsher-Smith’s product is AB2-rated to the branded product, Absorica® (isotretinoin) capsules in 10 mg, 20 mg, 30 mg and 40 mg strengths used to treat severe cystic acne.
Lead Product(s): Isotretinoin
Therapeutic Area: Dermatology Product Name: Isotretinoin-Generic
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Mayne Pharma
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 28, 2021
Details:
Upsher-Smith's product is AB2-rated to the branded product, Absorica® (isotretinoin) capsules. Isotretinoin capsules are a generic version of ABSORICA® indicated for the treatment of severe recalcitrant nodular acne.
Lead Product(s): Isotretinoin
Therapeutic Area: Dermatology Product Name: Isotretinoin-Generic
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Douglas CDMO
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 25, 2021
Details:
The Japanese Patent Office has decided to grant a patent for its lead asset, TMB-001, the Company’s topical pharmaceutical composition of isotretinoin that is currently being evaluated for the treatment of moderate to severe subtypes of congenital ichthyosis (CI).
Lead Product(s): Isotretinoin
Therapeutic Area: Genetic Disease Product Name: TMB-001
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 28, 2021
Details:
Journey Medical Corporation in-licensed and launched an oral isotretinoin under the brand name Accutane® (isotretinoin capsules USP) in the U.S. Accutane is an oral medication that is indicated for the treatment of severe recalcitrant nodular acne.
Lead Product(s): Isotretinoin
Therapeutic Area: Dermatology Product Name: Accutane
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Undisclosed
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership March 22, 2021
Details:
Timber Pharmaceuticals has received a formal notice of allowance from the U.S. Patent and Trademark Office (USPTO) for the Company’s patent application covering its pharmaceutical isotretinoin composition.
Lead Product(s): Isotretinoin
Therapeutic Area: Genetic Disease Product Name: TMB-001
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 December 15, 2020
Details:
U.S. and Australia participating in the Phase 2b CONTROL study evaluating TMB-001 (topical isotretinoin) are now initiated and patients with moderate to severe congenital ichthyosis (CI) are actively enrolling.
Lead Product(s): Isotretinoin
Therapeutic Area: Genetic Disease Product Name: TMB-001
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 July 01, 2020
Details:
The combined company will have a robust pipeline including Timber's two Phase 2b programs and a preclinical program targeting multiple niche orphan indications with no approved treatments as well as BioPharmX's two Phase 3-ready topical minocycline programs.
Lead Product(s): Isotretinoin
Therapeutic Area: Genetic Disease Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: BioPharmX
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Merger May 18, 2020
Details:
Funds support Phase 2b CONTROL Study of TMB-001 in congenital ichthyosis
Lead Product(s): Isotretinoin
Therapeutic Area: Genetic Disease Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: U.S. Food & Drug Administration
Deal Size: $1.5 million Upfront Cash: $0.5 million
Deal Type: Funding April 06, 2020
Details:
Under the terms of the merger agreement, a wholly-owned subsidiary of BioPharmX will be merged with and into Timber, with Timber surviving the merger as a wholly-owned subsidiary of BioPharmX.
Lead Product(s): Isotretinoin
Therapeutic Area: Genetic Disease Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Timber Pharmaceuticals
Deal Size: $20.0 million Upfront Cash: Undisclosed
Deal Type: Merger January 28, 2020
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