Orchid Pharma and Libra (Libra) have signed a licensing and supply agreement covering Exblifep (cefepime/enmetazobactam) across nine Latin American markets. Exblifep is a novel antibiotic combination indicated for complicated urinary tract infections (cUTI) and hospital-acquired and ventilator-associated bacterial pneumonia (HAP/VAP) caused by Gram-negative pathogens. Commercialization in each market is subject to approval by the relevant national regulatory authority.
Designed as a carbapenem-sparing option, Exblifep targets serious hospital infections driven by ESBL-producing Gram-negative bacteria. It holds approvals from both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), features in the IDSA and EUCAST treatment guidelines, and is the first new chemical entity invented by an Indian pharmaceutical company to secure both approvals.
Libra receives exclusive rights to register, import, and market Exblifep in Chile, Costa Rica, Ecuador, EI Salvador, Guatemala, Honduras, Panama, Paraguay, and Uruguay, while the company manufactures and supplies the finished dosage form. Over the first 10 years, the partnership is expected to represent a potential commercial opportunity of around $80 million, based on projected demand across these markets.
Orchid Pharma, established as an export-oriented unit (EOU), is a vertically integrated company spanning the entire pharmaceutical value chain from discovery to delivery with established credentials in research, manufacturing and marketing.
