Leverkusen, Germany (pta/02.12.2021/14:40 UTC+1)
Biofrontera AG (NASDAQ: BFRA; Frankfurt Stock Exchange: B8F) (the "Company"), an international biopharmaceutical company, announces that its wholly owned subsidiary Biofrontera Pharma GmbH has received a notice of allowance from the United States Patent and Trademark office (USPTO) with respect to the patent application "Illumination for Photodynamic Therapy" (US17/234,490), an innovative, pain-reducing illumination protocol for photodynamic therapy (PDT).
"This patented illumination protocol is an important part of Biofrontera's patent strategy to further protect our FDA-approved combination product, Ameluz® together with our PDT-lamp BF-RhodoLED® and its successor model RhodoLED® XL in the USA," states Hermann Lübbert, CEO of Biofrontera AG. "Patent protection on either part of the FDA-combination approval increases our competitive advantage and is likely to hinder generic competition in the US market."
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 for the patient. The new illumination protocol aims at combining the high efficacy of Ameluz® with a built-in-tool for pain reduction and could thus become a new standard-of-care in PDT.
As implementation of the patented invention to Biofrontera’s medical devices merely requires the installation of a software, it can potentially be rolled-out to both BF-RhodoLED® and BF-RhodoLED® XL. To include this illumination protocol in the US prescribing information, 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.
This application constitutes a continuation-in-part of the US nationalization application US17/056,170, which is based on the international application PCT/EP2019/064642, and thus claims the same priority date of June 5, 2019. The continuation-in-part had been filed as a fast-track application on 19 April 19, 2021 and an allowance was achieved in less than 8 months.
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