Orchid Pharma has signed a licensing and supply agreement with Laboratorio Libra to expand its novel antibiotic Exblifep across nine Latin American markets, with the partnership representing a potential commercial opportunity of approximately $80 million over 10 years.

 

Under the agreement, Libra will secure exclusive rights to register, import and market Exblifep (cefepime/enmetazobactam) in Chile, Costa Rica, Ecuador, El Salvador, Guatemala, Honduras, Panama, Paraguay and Uruguay. Orchid will manufacture and supply the finished dosage form.

 

Commercialisation in each market will be subject to approval by the respective national regulatory authority.

 

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. Designed as a carbapenem-sparing treatment option, the drug targets serious hospital infections driven by extended-spectrum beta-lactamase (ESBL)-producing Gram-negative bacteria.

 

The drug has secured approvals from both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), and features in treatment guidelines issued by the Infectious Diseases Society of America (IDSA) and the European Committee on Antimicrobial Susceptibility Testing (EUCAST).

 

Orchid said Exblifep is the first new chemical entity invented by an Indian pharmaceutical company to receive approvals from both US and European regulators, marking a significant milestone for the domestic pharmaceutical industry.

 

"Extending Exblifep into Latin America is a priority for Orchid, and Libra is well placed to lead its introduction across these markets. Together, we aim to give clinicians in the region a new option for treating serious Gram-negative hospital infections," said Manish Dhanuka, Managing Director, Orchid Pharma.

 

Libra said the partnership would help expand access to the antibiotic across the region while addressing the growing challenge of antimicrobial resistance.

 

"We are honoured to partner with Orchid Pharma to bring Exblifep to Latin America, expanding access to an innovative therapeutic option for patients across the region while contributing to the response to the growing challenge of antimicrobial resistance," said Carlos Scherschener, CEO, Laboratorio Libra.

 

The agreement strengthens Orchid's international expansion strategy, leveraging its integrated manufacturing capabilities and focus on complex injectable antibiotics to widen the global reach of its products.