Meitheal Pharmaceuticals has gained exclusive US commercial rights for a first-in-class semi-synthetic pleuromutilin antibiotic, XENLETA (lefamulin acetate), to treat community-acquired bacterial pneumonia (CABP) in the adult population.
The rights were obtained through an exclusive licence and supply agreement with Hong Kong King-Friend Industrial (HKF), the parent company of Meitheal.
The licensing agreement marks the addition of a third branded biopharmaceutical to Meitheal鈥檚 portfolio and represents its first on-market branded product.
The therapy is approved in both intravenous and oral formulations in the US and several other countries. The acquisition of global rights to XENLETA, excluding Greater China, was completed by HKF from .
The acquisition includes all global assets related to therapy, such as development and regulatory activity outcomes.
XENLETA is considered an advance in combating the global public health crisis of antimicrobial resistance (AMR) and supports antimicrobial stewardship principles.
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By GlobalDataIt provides a complete spectrum of coverage against the main CABP pathogens, and has a low propensity for developing bacterial resistance.
Meitheal Pharmaceuticals CEO Tom Shea stated: 鈥淭he licensing of XENLETA bolsters our portfolio of novel antibiotics and reflects our focus on addressing the growing issue of antimicrobial resistance.
鈥淎s 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.鈥�
The global approvals of the therapy are grounded on the outcomes of two pivotal Phase III trials, LEAP 1 and LEAP 2, in which it achieved all primary endpoints.
Meitheal recently expanded its product range with the addition of its first anti-infective, CONTEPO, through an exclusive commercialisation agreement with HKF.
By utilising its marketing, sales and medical science liaison teams, which are aligned to CONTEPO, the company plans to support the launch of XENLETA.
