Benzinga | Nov 16, 2021 09:12AM EST

Biofrontera Kicks Off U.S. Clinical Study Program For Ameluz

Biofrontera Inc. (NASDAQ:BFRI) (the "Company"), a biopharmaceutical company specializing in the commercialization of dermatological products, announced today the start of a clinical study program focused on optimizing and expanding the market positioning of its in-licensed FDA-approved prescription drug Ameluz(r) for photodynamic therapy (PDT) in the United States. Site initiations for two upcoming studies are currently in progress with patient recruitment to start before the end of the year. The studies are being initiated and overseen by Biofrontera AG, an affiliate of the Company.



Within the scope of the license and supply agreement (LSA) between Biofrontera Inc. and Biofrontera AG and its Germany-based subsidiaries (together the "Licensor"), the Company holds the exclusive rights to market and sell Ameluz(r) and the PDT-lamps BF-RhodoLED(r) as well as its successor model BF-RhodoLED XL in the United States. Under the terms of the LSA, Biofrontera Inc. acquires Ameluz(r) from the Licensor for a transfer fee. In exchange for the transfer fee paid for the in-licensed products, the Licensor ensures the manufacturing and the supply of the products as well as responsibility for certain other aspects such as regulatory approvals and quality assurance. In addition, the LSA calls for the Licensor to perform and finance an extensive clinical study program to expand the FDA-approval of Ameluz(r) in the U.S. market.

Site initiations for two upcoming studies are currently in progress, seven sites for the phase IIb study for the treatment of moderate-to-severe acne in adults as well as eight sites for the phase I safety study evaluating the safety of PDT with the simultaneous application of three tubes of Ameluz(r). The latter trial comes on the back of a maximal-usage pharmacokinetics clinical study completed in early 2021. The results from that study were recently published on ClinicalTrials.gov and were presented to the FDA earlier this year. Following that meeting, the FDA requested another safety study focusing on transient application site effects before adding the use of three tubes in one session of PDT to the label. Along with an ongoing phase III study in the United States to evaluate Ameluz(r) in combination with PDT for the treatment of superficial basal cell carcinoma, which was initiated by the Licensor in 2018, the current site initiations mark the kick-off of the extensive study program under the terms of the LSA.

"We believe the clinical study program supporting the alignment of Ameluz(r) with the needs of patients and health care professionals is an important piece of the puzzle to reach our goal of establishing Ameluz(r) as the leading PDT drug for the treatment of actinic keratosis in the United States," states Erica Monaco, Chief Executive Officer of Biofrontera Inc. "The LSA is an important element of the interaction between Biofrontera Inc. and the Germany-based Biofrontera companies. It provides Biofrontera Inc. with the freedom to grow separately of the success of Biofrontera AG. The recent IPO of Biofrontera Inc. aims at separating Biofrontera Inc. from Biofrontera AG, allowing it to mature and grow according to the needs of a U.S. company active in the U.S. pharmaceutical marketplace."

The Licensor is in the process of preparing further clinical studies in the United States according to the development program that was agreed upon with Biofrontera Inc. Under the LSA, Biofrontera Inc. will benefit from these studies and consequent approval expansions without participating in the cost beyond the transfer fee paid for Ameluz(r) and BF-RhodoLED(r). Ameluz(r) gel in combination with PDT using BF-RhodoLED(r) lamp, is currently indicated by the FDA for the lesion-directed and field-directed treatment of actinic keratoses of mild-to-moderate severity on the face and scalp.