Biofrontera extends Ameluz patent to 2043 for acne treatment

WOBURN, Mass. - Biofrontera Inc. (NASDAQ:BFRI), a biopharmaceutical company, has announced the extension of patent protection for its Ameluz® formulation, now set to expire in December 2043. The company also reported the completion of patient enrollment for a Phase 2b clinical trial of Ameluz® for treating moderate to severe acne vulgaris. According to InvestingPro data, Biofrontera generated $37.32 million in revenue over the last twelve months, with a healthy gross profit margin of 50.14%.

The U.S. Food and Drug Administration (FDA) had previously accepted the revised formulation of Ameluz®, a nanoemulsion gel free of propylene glycol, and it has been in use since 2024. This development is expected to protect Ameluz® from generic competition for two additional decades.

The Phase 2b clinical trial, a multicenter, randomized, double-blind study, aims to evaluate the safety and efficacy of photodynamic therapy (PDT) using Ameluz® combined with the BF-RhodoLED® lamp. The study involved 120 patients who underwent up to three PDT sessions, with follow-up consultations planned for two months post-treatment. The company anticipates the last patient’s study exit in Q3 2025.

Dr. Mitchel P. Goldman, the coordinating investigator of the study, expressed optimism about the potential of Ameluz® PDT to treat acne, a condition that affects an estimated 50 million Americans annually. The U.S. acne treatment market, valued at $5.7 billion in 2024, is growing at a compound annual growth rate of 5.3%, driven by the increasing prevalence of adult acne and the demand for advanced therapies. With a current market capitalization of $6.2 million and revenue growth of 9.54%, Biofrontera appears undervalued according to InvestingPro analysis, which offers comprehensive research reports on over 1,400 US stocks.

Dr. Hermann Luebbert, CEO and Chairman of Biofrontera, highlighted the significance of this milestone in the clinical development of Ameluz®, which could expand its indications beyond the current approval for mild to moderate actinic keratosis on the face and scalp.

The information in this article is based on a press release statement from Biofrontera Inc.

In other recent news, Biofrontera Inc. reported a 9.5% increase in total revenue for 2024, reaching $37.3 million, with a notable 18.5% rise in fourth-quarter revenues. Despite this growth, the company faced a net loss of $17.8 million for the year. Benchmark analysts maintained their Buy rating for Biofrontera, setting a price target of $7, despite the company’s fourth-quarter revenue falling short of expectations. Biofrontera’s revenue of $12.6 million in the fourth quarter did not meet Benchmark’s projection of $13.9 million or the market consensus of $14.6 million. The company is optimistic about future growth, with new labeling allowing higher dosages of Ameluz and the introduction of new indications expected to boost revenue in the coming years.

Additionally, Biofrontera received a notification from Nasdaq regarding non-compliance with the minimum bid price requirement, granting the company a 180-day period to regain compliance. If necessary, the company may consider measures like a reverse stock split to meet the standards. Biofrontera also achieved significant preliminary results from a Phase 3 study of Ameluz for treating superficial Basal Cell Carcinoma, with plans to file a supplemental New Drug Application in the third quarter of 2025. The company has improved its cash position to $5.9 million by the end of 2024 and adjusted its EBITDA, reflecting progress in financial health.

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