The company will take control of all Ameluz® trials in the U.S. starting in June.

Biofrontera has announced a restructuring of agreements with its former parent company, Biofrontera AG, aimed at enhancing long-term profitability. As a result, the transfer price of its leading product, Ameluz, indicated for the treatment of actinic keratosis, will be slashed from 50% to 25% for all purchases throughout 2024 and 2025, according to a press release.

According to the manufacturer, beginning on January 1, 2026, and continuing until 2032, there will be gradual increases in the transfer price from 25% to 35% for sales related to actinic keratosis and potentially other approved indications such as basal cell carcinoma and squamous cell carcinoma. However, the transfer price for sales related to acne, currently in development, will remain at 25% indefinitely. This transfer price covers various expenses including the cost of goods, royalties, regulatory efforts, agency fees, pharmacovigilance, and patent administration.

Furthermore, effective June 1, the company will assume control over all clinical trials involving Ameluz in the US, allowing for more efficient cost management and direct oversight of trial efficiency. This strategic move, the company said, is facilitated by the reduced transfer price, which will enable the company to allocate resources towards research and development activities while maintaining its commercial growth trajectory.

 "This amendment provides significant value in both the short and long term. In the short term, we will be paying half of what we had paid in the past for product. In the long term, controlling US clinical trials will enable us to better manage costs and ensure efficiency, which we believe will lead to new indications in the label and increased revenue sooner," said Hermann Luebbert, CEO and Chairman of Biofrontera Inc., in a news release. “We believe that the renegotiated terms along with the capital committed in our simultaneous financing accelerate and could be sufficient for the company achieving profitability in 2025. This will be further supported by the potential label change of Ameluz for the use of up to three tubes per treatment currently under review by the FDA with a user fee goal of October 4, 2024.”