Biofrontera Inc. Announces Patent in Australia for Novel Illumination Protocols Granted to Biofrontera Bioscience GmbH

Patent Improves Differentiated Profile of Ameluz-PDT by Expected Reduced Pain Intensity while Maintaining Efficacy

WOBURN, Mass., Aug. 01, 2022 (GLOBE NEWSWIRE) -- Biofrontera Inc. (Nasdaq: BFRI), a biopharmaceutical company specializing in the commercialization of dermatological products, announced today that the Australian Patent Office (IP Australia) granted a notice of allowance to Biofrontera Bioscience GmbH for the patent "Photodynamic therapy comprising two light exposures at different wavelengths" (AU 2018/437303B2).

The patent protects a number of innovations related to new illumination protocols for the treatment of skin diseases with photodynamic therapy (PDT). It covers treatment protocols that are expected to combine the lower pain of daylight PDT with the higher cure rates and lower recurrence rates of conventional therapy. The patent also claims this illumination approach is linked to the performance of PDT with a drug containing a photosensitizer or its precursor. In this respect, the use of the illumination combinations protected in this patent also protects Biofrontera’s drug, Ameluz^®.

“The news of the patent allowance in Australia for our licensor Biofrontera Bioscience GmbH demonstrates the potential for continued innovation and further improvements in PDT therapy that our products are on the forefront of. By offering conventional therapy’s efficacy at a lower pain intensity and reduced patient presence in the doctor’s office, Biofrontera’s products and PDT in general have a strong competitive advantage. The patent strengthens the differentiated profile of the BF-RhodoLED^® and Ameluz combination, Ameluz-PDT, and provides a potential roadmap for similar patent extensions and further protection of Ameluz-PDT in other geographies, including the United States,” stated Hermann Luebbert, Executive Chairman of Biofrontera Inc.

The treatment method uses a photosensitizer in combination with two light exposures of different wavelengths and exposure durations. The application of a photosensitizer is followed first by a longer exposure to a broadband light (e.g., sunlight or light from an appropriate artificial light source) or blue light, followed by a subsequent, much shorter exposure to narrowband red light (e.g., light from Biofrontera's RhodoLED^® lamps).

About Biofrontera Inc.

Biofrontera Inc. is a U.S.-based biopharmaceutical company commercializing a portfolio of pharmaceutical products for the treatment of dermatological conditions with a focus on photodynamic therapy (PDT) and topical antibiotics. The Company’s licensed products are used for the treatment of actinic keratoses, which are pre-cancerous skin lesions, as well as impetigo, a bacterial skin infection. For more information, visit .

Forward-Looking Statements

Certain statements in this press release may constitute "forward-looking statements" within the meaning of the United States Private Securities Litigation Reform Act of 1995, as amended to date. These statements include, but are not limited to, statements relating to the Company’s business and marketing strategy, future operations and business, potential to expand the label of Ameluz^®, market presence and position of Ameluz^® and ongoing clinical trials conducted by our licensing partners and the future impact of such trials on the market for Ameluz^®. We have based these forward-looking statements on our current expectations and projections about future events, nevertheless, actual results or events could differ materially from the plans, intentions and expectations disclosed in, or implied by, the forward-looking statements we make. These risks and uncertainties, many of which are beyond our control, including, but not limited to, the impact of extraordinary external events, such as the current COVID-19 pandemic; any changes in the Company’s relationship with its licensors; the ability of the Company’s licensors to fulfill their obligations to the Company in a timely manner; the Company’s ability to achieve and sustain profitability; whether the current global disruptions in supply chains will impact the Company’s ability to obtain and distribute its licensed products; changes in the practices of healthcare providers, including any changes to the coverage, reimbursement and pricing for procedures using the Company’s licensed products; the uncertainties inherent in the initiation and conduct of clinical trials; availability and timing of data from clinical trials; whether results of earlier clinical trials or trials of Ameluz^® in combination with BF-RhodoLED^® in different disease indications or product applications will be indicative of the results of ongoing or future trials; uncertainties associated with regulatory review of clinical trials and applications for marketing approvals; whether the market opportunity for Ameluz^® in combination with BF-RhodoLED^® is consistent with the Company’s expectations; the Company’s ability to complete the transition to a public company; the Company’s ability to retain and hire key personnel; the sufficiency of cash resources and need for additional financing and other factors that may be disclosed in the Company’s filings with the SEC, which can be obtained on the SEC website at . Readers are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date on which they are made and reflect management's current estimates, projections, expectations and beliefs. The Company does not plan to update any such forward-looking statements and expressly disclaims any duty to update the information contained in this press release except as required by law.

Contacts

Biofrontera Inc.

Anke zur Mühlen

LHA Investor Relations

Tirth T. Patel

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