Biofrontera Inc. Announces Notice of Allowance for Nanoemulsion Composition-of-Matter U.S. Patent

Company also granted special designation that enables expedited review of a recent U.S. patent application relating to novel PDT illumination protocols

WOBURN, Mass., Sept. 06, 2022 (GLOBE NEWSWIRE) -- 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 granted a notice of allowance to Biofrontera Bioscience GmbH for patent application No. 12/520,759 (the ’759 patent), titled “Nanoemulsion Formulation with Improved Stability and Cell Penetration.” Biofrontera Inc. has an exclusive license to market and sell Ameluz®, an FDA-approved drug utilizing the technology covered by the patent, in the U.S.

The ’759 patent relates to the compositions of Biofrontera’s nanoemulsions and an active agent (such as in Ameluz®) and the preparation of the nanoemulsions or compositions, and describes its use in the treatment of dermatological, virus-associated and cell proliferation diseases, as well as in cosmetics. Biofrontera’s compositions of nanoemulsions overcome the disadvantages of other nanoemulsion formulations through a reduced particle size that contributes to improved stability, better penetration into cells and tissues and lower production costs. The notice of allowance precedes the granting of the patent by the USPTO, which typically follows soon after the patent holder pays the required fee.

“This new patent will further protect Biofrontera’s growing position in the dermatology market and our continued investment in the market. Compound-of-matter patents provide the strongest protection of all patent types. Our license agreement covers all combinations of the patented nanoemulsion technology with aminolevulinic acid, the active ingredient in Ameluz®. Together with Biofrontera Bioscience we are now even more strongly positioned to broaden the use of photodynamic therapy (PDT) in dermatology,” stated Hermann Lübbert, Executive Chairman of Biofrontera Inc.

“Utilizing nanoemulsion technology can help elevate PDT to the leading choice in treating actinic keratosis (AK). When formulated together with aminolevulinic acid, our nanoemulsion has demonstrated increased efficiency in cell uptake. This improves selectivity and also shortens the penetration period, or the time between applying the composition and irradiating the diseased tissue with light, providing a distinct relief for patients and process efficiency for offices. By enhancing penetration, we are able to treat diseases that reside more deeply in the skin,” stated Erica Monaco, Chief Executive Officer of Biofrontera Inc.

The Company also announces the granting of a special designation from the USPTO that enables expedited review of a recently submitted patent application relating to novel illumination protocols for the treatment of skin diseases with PDT. The patent, which was recently granted to Biofrontera Bioscience GmbH in Australia, covers treatment protocols that combine the lower pain of daylight PDT with the higher cure rates and lower recurrence rates of conventional therapy. The development of the illumination combinations protected by this patent will, once granted in the U.S., further protect Ameluz®-PDT.

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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