Agreement Details

Orchid Pharma Limited has entered into a licensing and supply agreement with Laboratorio Libra S.A. (Libra) covering Exblifep® (cefepime/enmetazobactam) across nine Latin American markets.

Product Information

Exblifep is a novel antibiotic combination indicated for:

  • Complicated urinary tract infections (cUTI)
  • Hospital-acquired and ventilator-associated bacterial pneumonia (HAP/VAP) caused by Gram-negative pathogens

Product is designed as a carbapenem-sparing option targeting 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), and features in the IDSA and EUCAST treatment guidelines.

Territory Coverage

The agreement covers nine Latin American markets:

  • Chile
  • Costa Rica
  • Ecuador
  • El Salvador
  • Guatemala
  • Honduras
  • Panama
  • Paraguay
  • Uruguay

Rights and Responsibilities

Libra receives exclusive rights to register, import, and market Exblifep in the specified territories.

Orchid Pharma will manufacture and supply the finished dosage form.

Financial Projections

Over the first 10 years, the partnership is expected to represent a potential commercial opportunity of approximately USD 80 million, based on projected demand across these markets.

Regulatory Condition

Commercialization in each market is subject to approval by the relevant national regulatory authority.

Management Commentary

Manish Dhanuka, Managing Director, Orchid Pharma Ltd.: "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."

Carlos Scherschener, CEO, Laboratorio Libra S.A.: "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."

Advisory Role

Sathguru Management Consultants acted as exclusive advisor to Orchid Pharma on the transaction.

Company Background

Orchid Pharma Limited is a fully vertically integrated pharmaceutical company with end-to-end capabilities from Key Starting Materials (KSMs) to Active Pharmaceutical Ingredients (APIs) and Finished Dosage Forms (FDFs), focused on complex injectable antibiotics. The company is the first Indian pharmaceutical company to invent a New Chemical Entity (NCE) approved in both the United States and Europe.