US-based integrated biopharmaceutical company Meitheal Pharmaceuticals has secured exclusive commercial rights to pneumonia antibiotic Xenleta (lefamulin acetate) in the US.
Xenleta is a pleuromutilin antibiotic originally discovered and developed by Ireland-based Nabriva Therapeutics to treat community-acquired bacterial pneumonia (CABP).
Meitheal secured exclusive US rights to the drug from Hong Kong King-Friend Industrial (HKF), which acquired global rights to Xenleta (except in Greater China) from Nabriva.
Through the licensing agreement for Xenleta, the US drugmaker adds a third branded biopharmaceutical and the first on-market branded product to its portfolio.
Meitheal recently added the first anti-infective to its portfolio through an exclusive commercialisation agreement with HKF-CONTEPO.
The company aims to use its new CONTEPO-aligned marketing, sales, and medical science liaison teams to support the launch of Xenleta, which shares similar hospital call points.
Meitheal CEO Tom Shea said: “The licensing of Xenleta bolsters our portfolio of novel antibiotics and reflects our focus on addressing the growing issue of antimicrobial resistance.
“As the first approved medicine of an entirely new class of antibiotics, Xenleta is an innovative therapeutic option that will be available to the patients affected by CABP and has been shown to be active against various bacterial strains.
“We look forward to leveraging our end-to-end expertise in biopharmaceutical development and commercialisation to bring this important therapeutic to patients in need.”
Xenleta is a semi-synthetic pleuromutilin antibiotic designed as a monotherapy to provide complete coverage against CABP pathogens and minimal risk for bacterial resistance.
The drug represents a key step in addressing antimicrobial resistance (AMR), a growing global public health issue, and supports the principles of antimicrobial stewardship.
The global regulatory approvals of Xenleta in CABP are based on the results of two global Phase 3 clinical trials, LEAP 1 and LEAP 2, in which Xenleta met all primary endpoints.
According to Meitheal, HKF and its related entities invested more than $300m in capital and research and development in recent years to support its supply across key focus areas.
Meitheal commercial operations senior vice president Brett Novak said: “Xenleta provides a unique and well-tolerated product profile for the more than five million annual cases of CABP in the US.
“We are pleased that this agreement will allow us to unlock synergies with our existing franchises and deliver critical medicines that address large gaps in the antibiotic treatment landscape.”
HKF president Eric Tang said: “We are pleased to have acquired the rights to Xenleta and look forward to supporting Meitheal as it delivers this important medication to patients in the US.
“We are committed to supporting Meitheal’s work to deliver accessible, sustainable, and innovative healthcare solutions and we remain focused on continuing to invest in the research, development, and commercialisation of branded pharmaceuticals to achieve this goal.”
