WOBURN, MA - Biofrontera Inc. (NASDAQ:BFRI), a U.S.-based biopharmaceutical company, announced a significant restructuring of its agreements with its former parent company, Biofrontera AG. The announcement, made today, details a substantial reduction in the transfer price of Ameluz®, a dermatological product, from 50% to 25% for purchases throughout 2024 and 2025.
This reduction will be followed by a gradual increase in the transfer price to 35% from January 1, 2026, to 2032 for sales related to actinic keratosis and potentially basal cell carcinoma and squamous cell carcinoma, pending FDA approval. However, the transfer price for Ameluz sales related to acne will remain at 25% indefinitely. The transfer price includes the cost of goods, royalties on sales, and services such as regulatory efforts, agency fees, pharmacovigilance, and patent administration.
Starting June 1, Biofrontera Inc. will also assume control of all U.S. clinical trials involving Ameluz®, positioning the company to manage costs and oversee trial efficiency directly. This strategic move is expected to finance research and development activities and support commercial growth.
Hermann Luebbert, CEO and Chairman of Biofrontera Inc., commented on the restructuring, highlighting the immediate financial benefits and the long-term advantages of conducting clinical trials in-house. Luebbert also mentioned that the renegotiated terms, coupled with capital from simultaneous financing, could potentially lead to profitability for the company by 2025. This expectation is further bolstered by a pending FDA review to potentially expand Ameluz's label to allow the use of up to three tubes per treatment, with a decision expected by October 4, 2024.
Actinic keratosis, the primary indication for Ameluz, is a common pre-cancerous skin lesion that can develop into squamous cell carcinoma if untreated. In 2020, approximately 58 million people in the U.S. were affected by actinic keratosis, with 13 million treatments performed.
Biofrontera Inc. specializes in the commercialization of products for dermatologic conditions, particularly photodynamic therapy and topical antibiotics. The company's portfolio addresses conditions such as actinic keratosis and impetigo.
The information in this article is based on a press release statement from Biofrontera Inc.
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