FDA Approves Use of Up to Three Tubes of Ameluz (aminolevulinic acid HCI) by Biofrontera Inc., 10% in One Treatment.

• The approval allows a larger field treatment of actinic keratosis (AK) on the face and skin with Ameluz.^®-PDT uses BF-RhodoLED or RhodoLED XL lamp

• Supplemental New Drug Application (sNDA) supported by two Phase 1 safety studies

• AK is the second most common test performed by dermatologists in the United States¹

• An estimated 13 million treatments are provided annually for AK in the US²

WOBURN, Mass., Oct. 07, 2024 (GLOBE NEWSWIRE) — Biofrontera Inc. (Nasdaq: BFRI) (“Biofrontera” or the “Company”)a biopharmaceutical company specializing in the commercialization of dermatologic products, today announced that the US Food and Drug Administration (FDA) has approved the Company’s sNDA to increase the approved dosage from one to three tubes of Ameluz.^® with treatment.

This approval allows health professionals to have more flexibility to handle large or multiple treatment areas for patients undergoing photodynamic therapy (PDT) for AK on the face and scalp, which which leads to greater convenience for health care providers and their patients.

“We are pleased with the FDA’s decision to approve the use of up to three tubes of Ameluz.^® per treatment,” said Dr. Hermann Luebbert, CEO and Chairman of Biofrontera Inc. “We are currently working with Medicare and commercial payers to obtain reimbursement for the label update and will notify consumers rightfully ours.”

The sNDA was supported by two Phase I safety studies in which three tubes of Ameluz^® were used in 116 patients. Studies have shown that the blood pressure of the active ingredient and metabolites were several orders of magnitude lower than those known to have side effects, and that the adverse events of the administration area and application were similar to those seen with a single tube of Ameluz.^®.

“Ameluz.”^® is the only PDT photosensitizer indicated by the FDA for the treatment of wound-driven and field-directed AKs. This approval will allow dermatologists to provide the full range of options they desire for their patients, while maintaining the proven efficacy and safety of Ameluz.^®. It is another important event for Biofrontera as we continue to demonstrate our commitment to PDT and our dedication to the development of this important treatment method,” explains Dr. Luebbert.

“Up to 60% of squamous cell carcinomas begin as AK lesions that cannot be treated, so it is important to be able to treat the entire affected area. I used Ameluz^® now for more than 7 years for the AK system because of the proven effectiveness and safety it provides. With the approval of the sNDA, I expect to be able to use about three tubes for patients who need them,” said Dr. Jonathan Weiss, researcher and co-managing partner of Georgia Dermatology Partners, Atlanta.

The story continues

About Actinic Keratosis

AK is a very common precancerous skin lesion caused by chronic sun exposure, which if left untreated, can develop into a life-threatening skin cancer called squamous cell carcinoma. AKs usually appear on sun-exposed areas such as the face, scalp, arms or back of the hands. In 2020, approximately 58 million people in the US were affected by AK and 13 million AK treatments were performed.³

1. Landis ET. and al. Dermatol Online J. 2014 Apr 16;20(4):22368.

2. Market data is available from CMS and IQVIA, 2021

3. www.skincancer.org/skin-cancer-information/actinic-keratosis/

Biofrontera Inc. Share Description

Biofrontera Inc. is a US-based biopharmaceutical company specializing in PDT-targeted skin conditions. The company sells a combination of the drug Ameluz® and RhodoLED^® light series for PDT of AK, precancerous skin lesions that may progress to invasive skin cancer. The company is conducting clinical trials to expand the product’s use in treating non-melanoma skin cancer and moderate to severe acne. 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. These statements include, but are not limited to, statements relating to Biofrontera’s business prospects and the commercial success of its licensed products. We have based these forward-looking statements on our current expectations and assumptions about future events. However, actual results or events may differ materially from the plans, intentions and expectations expressed in, or implied by, the forward-looking statements we make. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: the effect of any unusual external events; any changes in the Company’s relationships with 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 maintain profitability; whether current global supply chain disruptions will affect the Company’s ability to acquire and distribute its licensed products; changes in health care provider practices, including any changes in performance, reimbursement and pricing of procedures using the Company’s licensed products; uncertainties in the initiation and conduct of clinical trials; availability and timing of data from clinical trials; either the results of the first clinical trials or the Ameluz trials ^® in conjunction with BF-RhodoLED and/or RhodoLED XL in different disease indications or product applications will be indicative of the results of ongoing or future trials; uncertainties related to regulatory review of clinical trials and marketing authorization applications; whether the market potential of Ameluz together with BF-RhodoLED and/or RhodoLED XL is consistent with the Company’s expectations; the Company’s ability to retain and hire key personnel; adequacy of financial resources and the need for additional funds; and other information that may be disclosed in the Company’s filings with the Securities and Exchange Commission (“SEC”), which can be found on the SEC’s website at www.sec.gov. Readers are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they are made and reflect management’s current estimates, estimates, expectations and beliefs. The Company does not intend to update any such forward-looking statements and expressly disclaims any obligation to update the information contained in this press release except as required by law.

Contact:
Investor Relations
Andrew Barwicki
1-516-662-9461
ir@bfri.com