Pelthos Therapeutics acquires US rights to Xepi (ozenoxacin) cream, 1% to treat impetigo

Pelthos Therapeutics Inc.  announced it has acquired the U.S. marketing rights to Xepi (ozenoxacin) Cream, 1%, from Biofrontera Inc. and Ferrer Internacional S.A. (the Xepi is a non-fluorinated quinolone antimicrobial indicated for the topical treatment of impetigo due to Staphylococcus aureus or Streptococcus pyogenes in adult and pediatric patients two months of age and older.  Under the terms of the Acquisition agreement, Pelthos will pay Biofrontera $3.0 million and Ferrer $1.2 million upfront, with additional payments based on the availability of commercial quantities of Xepi and the achievement of sales-based milestones. Pelthos will pay royalties on U.S. net sales of Xepi to Ferrer and the Investors. Xepi was developed by Ferrer and Medimetriks Pharmaceuticals Inc. and approved by the FDA in 2017. At the time of approval, Xepi was the first new novel treatment for impetigo in more than 10 years. Biofrontera has owned the U.S. rights to Xepi since 2019 but has not been actively promoting the product. Pelthos intends to re-launch Xepi in late 2026.

“This acquisition represents an excellent investment opportunity and marks an exciting new chapter in the Pelthos growth story,” said Scott Plesha, CEO of Pelthos. “Xepi is well-positioned to address antimicrobial resistance in pediatric dermatology, and we believe it will provide physicians with an important alternative to first-line impetigo treatments. Offering another novel product to the pediatric and dermatology communities creates an increasingly favorable opportunity for Pelthos as it allows us to leverage our current commercial infrastructure to promote multiple innovative brands.”

“As bacterial resistance continues to rise, particularly to commonly used topical antibiotics like mupirocin, the need for effective alternatives in treating impetigo has never been greater,” said Dr. Lawrence A. Schachner,  Chairman and Professor Emeritus at the University of Miami Department of Dermatology. “Xepi is one of the few treatment options for children that can act against both methicillin-resistant and mupirocin-resistant Staphylococcus aureus. We believe it is a significant therapeutic advancement for clinicians and patients facing infections that no longer respond to traditional therapies.”