Pelthos Therapeutics Inc. has acquired the US commercialization rights to ozenoxacin cream, 1% (Xepi) from Biofrontera Inc. and Ferrer Internacional S.A.
Ozenoxacin cream 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 ozenoxacin cream aquisition 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 ozenoxacin cream and the achievement of sales-based milestones. Pelthos will pay royalties on U.S. net sales of ozenoxacin cream to Ferrer and the Investors. The company recently launched berdazimer topical gel, 10.3% (Zelsuvmi) for the treatment of molluscum contagiosum in adults and pediatric patients one year of age and older.
“This acquisition represents an excellent investment opportunity and marks an exciting new chapter in the Pelthos growth story,” says Scott Plesha, CEO of Pelthos, in a news release. “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.”
Ozenoxacin cream was developed by Ferrer and Medimetriks Pharmaceuticals, Inc., and approved by the U.S. Food and Drug Administration (FDA) in 2017. At that time, ozenoxacin cream was the first new novel treatment for impetigo in more than 10 years. Biofrontera has owned the US rights to the cream since 2019 but has not been actively promoting the product. Pelthos intends to re-launch ozenoxacin cream in late 2026.
“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,” says Lawrence A. Schachner, MD, Chair and Professor Emeritus at the University of Miami Department of Dermatology in Miami, FL. “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.”
Pelthos has also closed on an $18 million private convertible notes financing with existing investors, including Ligand Pharmaceuticals Incorporated and a group of investors led by Murchinson Ltd.
