Novel Protocol is Expected to be Less Painful with Efficacy Similar to Conventional PDT

WOBURN, MA / ACCESSWIRE / May 15, 2023 / Biofrontera Inc. (Nasdaq:BFRI) (the "Company"), a biopharmaceutical company specializing in the commercialization of dermatologic products, announces that the U.S. Patent and Trademark Office (USPTO) has granted a new patent to Biofrontera Bioscience GmbH related to a photodynamic therapy (PDT) protocol that is expected to be less painful but similarly effective to conventional PDT. This new patent is exclusively licensed to Biofrontera Inc. and expires in April 2039, including a patent term adjustment (PTA) approved by the USPTO.

Titled "Photodynamic therapy comprising two light exposures at different wavelengths" (U.S. Patent No. 11,642,411 B2), the patent covers the use of a composition comprising a photosensitizer, a light-sensitive molecule activated by the absorption of light, that is used in PDT performed with illumination by two different photo-activating wavelengths of light.

"This is the fourth US patent recently issued to Biofrontera Bioscience GmbH and licensed exclusively to Biofrontera Inc. At the start of 2022 we had no protection for our intellectual property in the U.S., and since then we were granted protection for our product combination of Ameluz and the RhodoLED lamp series until 2040. Our growing licensed patent portfolio further establishes Biofrontera not only as a leader in PDT, but also in dermatologic innovation," said Hermann Lübbert, Executive Chairman of Biofrontera Inc. and the sole inventor on the patent. "This latest patent covers a protocol that supports further adoption of PDT. With an incubation between application of the gel with exposure to light with a wavelength spectrum similar to sunlight followed by 10 minutes of red-light illumination, this novel protocol is far more patient-friendly yet similarly effective to conventional PDT. It adds additional patient friendliness to another patent granted early in 2022, protecting red light application in defined ramps and pulses, expected to reduce PDT pain even further. Both patents add substance to our goal of providing doctors with data on patient-friendly PDT protocols to help them select the optimal risk-benefit ratio for their patients."

One of the four patents granted in 2022 is already listed in FDA's Orange Book, taking Ameluz/RhodoLED out of the list of products threatened by generic competition until 2040. To demonstrate proof-of-concept with the goal of expanding the FDA label for pain-reduced Ameluz^®-PDT, a Phase 3 study for almost pain-free PDT for the treatment of actinic keratoses on the face and scalp is currently designed, combining the new protocols for illumination with two wavelengths and light profiles. Light profiles are already applied in the ongoing Phase 3 trial investigating the treatment of actinic keratosis in the periphery with Ameluz and the RhodoLED^® XL lamp. The studies are performed in clinical centers throughout the U.S. and organized by Biofrontera Bioscience GmbH as part of the obligations financed by Biofrontera Inc. through the license and supply agreement for Ameluz and RhodoLED lamps.

About Biofrontera Inc.

Biofrontera Inc. is a U.S.-based biopharmaceutical company commercializing a portfolio of pharmaceutical products for the treatment of dermatologic 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 www.biofrontera-us.com and follow Biofrontera on LinkedIn and Twitter.

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 growth strategy for Biofrontera Inc.'s (the "Company") strategic plan, 2023 commercial goals and potential for growth, and the transition of responsibilities at the Company. 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 any extraordinary external events; 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 comply with public company requirements; the Company's ability to regain compliance with Nasdaq continued listing standards, 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 www.sec.gov. 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.

Contact:

LHA Investor Relations
Tirth T. Patel
212-201-6614
tpatel@lhai.com

SOURCE: Biofrontera Inc.