Orchid Pharma Ltd, an Indian pharmaceutical company focused on complex antibiotics, has signed a licensing and supply agreement with Latin American pharmaceutical company Laboratorio Libra to commercialise its novel antibiotic Exblifep across nine Latin American markets, targeting a potential business opportunity of approximately $80 million over 10 years.
Under the agreement, Libra will receive exclusive rights to register, import and market Exblifep in Chile, Costa Rica, Ecuador, El Salvador, Guatemala, Honduras, Panama, Paraguay and Uruguay. Orchid Pharma will manufacture and supply the finished dosage form.
Commercialisation in each market will be subject to approval from the respective national regulatory authority.
Latin America expansion
The agreement marks an expansion of Orchid Pharma’s international footprint for Exblifep, a combination of cefepime and enmetazobactam developed to treat serious bacterial infections.
The antibiotic is indicated for complicated urinary tract infections (cUTI) and hospital-acquired and ventilator-associated bacterial pneumonia (HAP/VAP) caused by Gram-negative pathogens.
The partnership’s estimated $80 million commercial opportunity over the first 10 years is based on projected demand across the nine markets.
“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 Orchid Pharma Ltd Managing Director Manish Dhanuka.
Focus on antimicrobial resistance
Exblifep is designed as a carbapenem-sparing treatment option for serious hospital infections caused by extended-spectrum beta-lactamase (ESBL)-producing Gram-negative bacteria.
Carbapenems are a class of antibiotics used to treat severe bacterial infections. Treatment options that can help reduce reliance on these antibiotics are important in addressing antimicrobial resistance, a growing global healthcare challenge.
Exblifep has received approvals from the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). It is also included in treatment guidelines issued by the Infectious Diseases Society of America (IDSA) and the European Committee on Antimicrobial Susceptibility Testing (EUCAST).
Orchid Pharma said Exblifep is the first new chemical entity invented by an Indian pharmaceutical company to secure approvals from both US and European regulators.
“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 Laboratorio Libra SA, CEO,Carlos Scherschener.
Orchid strengthens global antibiotics business
Orchid Pharma operates an integrated manufacturing business spanning key starting materials, active pharmaceutical ingredients and finished dosage forms, with a focus on complex injectable antibiotics.
Its manufacturing facilities comply with US FDA and European Union Good Manufacturing Practice (EU-GMP) standards. The company markets its products in international markets, including Europe and India.
Founded in Uruguay in 1961, Laboratorio Libra specialises in therapeutic areas including infectious diseases, critical care, oncology, nutrition, HIV and rare diseases. It has an established presence across Latin America through its offices, regulatory capabilities and commercial distribution network.
The agreement provides Orchid with a route to expand Exblifep’s reach through a regional partner, while the timing of commercial launches will depend on regulatory approvals in the respective countries.