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Details:
The Company intends to use the proceeds to fund the ongoing activities related to expediting the development and approval of additional indications for the Company's lead product Ameluz (aminolevulinic acid hydrochloride), to treat mild to moderate actinic keratoses.
Lead Product(s): Aminolevulinic Acid HCl
Therapeutic Area: Dermatology Product Name: Ameluz
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Roth Capital Partners
Deal Size: $16.0 million Upfront Cash: Undisclosed
Deal Type: Private Placement January 23, 2024
Details:
SONALA-001 (aminolevulinic acid) is a porphyrin precursor and optical imaging agent. The mechanism of action of aminolevulinic acid is as a fluorescence contrast activity.
Lead Product(s): Aminolevulinic Acid HCl
Therapeutic Area: Oncology Product Name: SONALA-001
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 08, 2023
Details:
AMELUZ® (aminolevulinic acid hydrochloride) topical gel, 10%, a porphyrin precursor, in combination with photodynamic therapy using BF-RhodoLED® lamp, is indicated for lesion-directed and field-directed treatment of actinic keratoses.
Lead Product(s): Aminolevulinic Acid HCl
Therapeutic Area: Dermatology Product Name: Ameluz
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 21, 2022
Details:
AMELUZ (aminolevulinic acid hydrochloride) topical gel, 10%, a porphyrin precursor, in combination with photodynamic therapy using BF-RhodoLED® lamp, is indicated for the lesion-directed and field-directed treatment of actinic keratoses of mild-to-moderate severity.
Lead Product(s): Aminolevulinic Acid HCl
Therapeutic Area: Dermatology Product Name: Ameluz
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 06, 2022
Details:
Ameluz (Aminolevulinic Acid Hydrochloride) is utilized along with photodynamic therapy (PDT) provided by the Company’s proprietary lamp devices to form Ameluz®-PDT.
Lead Product(s): Aminolevulinic Acid HCl
Therapeutic Area: Dermatology Product Name: Ameluz
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 24, 2022
Details:
The new funds will aid to expand the market presence and strategic position. Together with broadening the product label through three clinical trials running in parallel with licensing partner, this will unravel the enormous market potential Ameluz® has long term.
Lead Product(s): Aminolevulinic Acid HCl
Therapeutic Area: Dermatology Product Name: Ameluz
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Roth Capital Partners
Deal Size: $9.4 million Upfront Cash: Undisclosed
Deal Type: Private Placement May 19, 2022
Details:
AMELUZ (aminolevulinic acid hydrochloride) topical gel, a porphyrin precursor, in combination with photodynamic therapy using BF-RhodoLED® lamp, is indicated for lesion-directed and field-directed treatment of actinic keratoses of mild-to-moderate severity on face and scalp.
Lead Product(s): Aminolevulinic Acid HCl
Therapeutic Area: Dermatology Product Name: Ameluz
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 21, 2022
Details:
Ameluz® is Biofrontera’s first FDA-approved flagship prescription drug is used in combination with the RhodoLED® lamp series for the treatment of Actinic Keratoses, and the topical antibiotic drug Xepi®.
Lead Product(s): Aminolevulinic Acid HCl
Therapeutic Area: Dermatology Product Name: Ameluz
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 17, 2022
Details:
Phase III clinical study for the treatment of superficial basal cell carcinoma with Ameluz photodynamic therapy (aminolevulinic acid hydrochloride) in combination with the BF-RhodoLED lamp enrolled 186 patient in the study is approved by FDA.
Lead Product(s): Aminolevulinic Acid HCl
Therapeutic Area: Oncology Product Name: Ameluz
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 01, 2022
Details:
Company commenced patient enrollment to its phase IIb study to evaluate the safety and efficacy of Ameluz (aminolevulinic acid hydrochloride) in combination with the red-light lamp BF-RhodoLED in the treatment of moderate to severe acne with photodynamic therapy (Ameluz®-PDT).
Lead Product(s): Aminolevulinic Acid HCl
Therapeutic Area: Dermatology Product Name: Ameluz
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 13, 2021
Details:
The non-randomized, open-label, multicenter study evaluates the safety and tolerability of Ameluz® in the treatment of AK located on the face and scalp with PDT together with the new BF-RhodoLED® XL lamp.
Lead Product(s): Aminolevulinic Acid HCl
Therapeutic Area: Dermatology Product Name: Ameluz
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 06, 2021
Details:
AMELUZ® (aminolevulinic acid hydrochloride) gel a porphyrin precursor, in combination with photodynamic therapy using BF-RhodoLED lamp, is indicated for the lesion-directed and field-directed treatment of actinic keratoses of mild-to-moderate severity on the face and scalp.
Lead Product(s): Aminolevulinic Acid HCl
Therapeutic Area: Dermatology Product Name: Ameluz
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Wellcome
Deal Size: $15.0 million Upfront Cash: Undisclosed
Deal Type: Private Placement December 02, 2021
Details:
Biofrontera will start a phase III trial for the treatment of actinic keratoses on the face and scalp with 3 tubes of Ameluz® and the RhodoLED® XL lamp involving the new protocol in 2022.
Lead Product(s): Aminolevulinic Acid HCl
Therapeutic Area: Dermatology Product Name: Ameluz
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 02, 2021
Details:
A multicenter, randomized, double-blind study with four arms is planned for conventional PDT with Ameluz® involving 126 patients aged 16 years and older.
Lead Product(s): Aminolevulinic Acid HCl
Therapeutic Area: Dermatology Product Name: Ameluz
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 22, 2021
Details:
The application is supported by a phase I pharmacokinetics (PK) study for the treatment of actinic keratoses with three tubes of Ameluz®.
Lead Product(s): Aminolevulinic Acid HCl
Therapeutic Area: Dermatology Product Name: Ameluz
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 24, 2021
Details:
The collaboration aims at conducting a first-in-human clinical trial in rGBM using SonALAsense's innovative Phase 0 approach to rapidly assess safety, and biological and clinical efficacy of aminolevulinic acid (ALA SDT).
Lead Product(s): Aminolevulinic Acid HCl
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: SonALAsense
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration December 14, 2020
Details:
Maruho will obtain exclusive development and commercialization rights including the right to sublicense for Ameluz® in Asia, Australia, New Zealand.
Lead Product(s): Aminolevulinic Acid HCl
Therapeutic Area: Dermatology Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Maruho Co, Ltd
Deal Size: Undisclosed Upfront Cash: $6.4 million
Deal Type: Licensing Agreement April 20, 2020
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