Orchid Pharma Limited has signed a licensing and supply agreement with Uruguay-based Laboratorio Libra to introduce its antibiotic Exblifep® in nine Latin American markets. The agreement covers Chile, Costa Rica, Ecuador, El Salvador, Guatemala, Honduras, Panama, Paraguay and Uruguay.
Exblifep, a combination of cefepime and enmetazobactam, is indicated for complicated urinary tract infections (cUTI) and hospital-acquired and ventilator-associated bacterial pneumonia (HAP/VAP) caused by Gram-negative pathogens. Its commercial launch in each market will depend on approval from the relevant national regulatory authority.
Under the agreement, Libra will receive exclusive rights to register, import and market the antibiotic in the nine countries. Orchid Pharma will manufacture and supply the finished dosage form. The companies estimate that the partnership could represent a commercial opportunity of approximately US$80 million over the first 10 years, based on projected demand across the markets.
Exblifep is designed as a carbapenem-sparing treatment option for serious hospital infections caused by extended-spectrum beta-lactamase (ESBL)-producing Gram-negative bacteria. The product has received approval from both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), and is included in treatment guidelines issued by the Infectious Diseases Society of America (IDSA) and the European Committee on Antimicrobial Susceptibility Testing (EUCAST).
Orchid Pharma Managing Director Manish Dhanuka said expanding Exblifep into Latin America was a priority for the company. He said Libra’s regional presence and market capabilities would support the introduction of the antibiotic to healthcare providers treating serious Gram-negative infections.
Libra Chief Executive Officer Carlos Scherschener said the partnership would help expand access to the treatment across the region and contribute to efforts to address antimicrobial resistance. The agreement expands Orchid Pharma’s international commercial reach for Exblifep and gives Libra exclusive marketing rights in the covered markets, subject to regulatory approvals.
Orchid Pharma Limited is a vertically integrated pharmaceutical company with capabilities spanning key starting materials, active pharmaceutical ingredients and finished dosage forms. It focuses on complex injectable antibiotics and operates manufacturing facilities compliant with USFDA and European Union Good Manufacturing Practice standards. The company says it is the first Indian pharmaceutical company to invent a new chemical entity approved in both the United States and Europe, with the product commercially marketed in Europe and India.
Founded in Uruguay in 1961, Laboratorio Libra is a Latin American pharmaceutical company focused on specialised therapeutic areas, including infectious diseases, critical care, oncology, nutrition, HIV and rare diseases. It manufactures and commercialises its own products and represents international pharmaceutical companies through its regional offices and distribution network.
