Benzinga | Dec 2, 2021 09:16AM EST

Biofrontera Announces Notice Of Allowance For U.S. Patent Titled 'Illumination for Photodynamic Therapy'

Biofrontera Inc. (NASDAQ:BFRI), a biopharmaceutical company specializing in the commercialization of dermatological products, announced today that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for the U.S. patent application number 17/234,490, titled "Illumination for Photodynamic Therapy," that covers an innovative, pain-reducing illumination protocol for photodynamic therapy (PDT).



"This patented illumination protocol demonstrates Biofrontera's commitment to the patients' need for innovative treatments. The patent also strengthens Biofrontera's competitiveness for our FDA-approved combination product, Ameluz(r) together with our PDT-lamp BF-RhodoLED(r) and its successor model RhodoLED(r) XL in the U.S. by providing an opportunity to pursue label expansion to include more patient-friendly protocols," stated Erica Monaco, Chief Executive Officer of Biofrontera Inc.

The patent application claims a method for photodynamic therapy in which a dynamic and innovative illumination protocol is implemented. This protocol consists of changing illumination intensities combined in a predefined order with interruptions of the illumination to specifically modulate and reduce pain perception to the patient. The new illumination protocol aims at combining the high efficacy of Ameluz(r) with the flexibility of BF-RhodoLED(r) to modulate light for pain reduction to ultimately become a new standard-of-care in PDT.

Implementation of the protocol to Biofrontera's medical devices requires a software installation and can be rolled-out to both the BF-RhodoLED(r) and BF-RhodoLED(r) XL lamps. To include this illumination protocol in the U.S. prescribing information, Biofrontera Group, in accordance with pipeline development under the license and supply agreement (LSA) between Biofrontera Inc. and Biofrontera AG, will start a Phase 3 trial for the treatment of actinic keratoses on the face and scalp with 3 tubes of Ameluz(r) and the RhodoLED(r) XL lamp involving the new protocol in 2022.

Within the scope of the LSA between Biofrontera Inc. and Biofrontera AG and its Germany-based subsidiaries (together the "Licensor"), Biofrontera Inc. holds the exclusive rights to market and sell Ameluz(r) and the PDT-lamps BF-RhodoLED(r) as well as the advanced BF-RhodoLED(r) XL in the United States. Under the LSA, the Licensor holds the patents for the licensed products.