Allecra and Acino Sign Exclusive Licensing and Supply Deal for EXBLIFEP® in GCC and South Africa

Allecra Therapeutics and Acino have entered into an exclusive licensing agreement, granting Acino the commercial rights to Allecra’s antibiotic drug EXBLIFEP® (cefepime/enmetazobactam) in the Republic of South Africa and the member states of the Gulf Cooperation Council (GCC), which includes Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, and the United Arab Emirates. This agreement comes into effect on June 12, 2024. Additionally, Allecra will supply the cefepime/enmetazobactam finished product to these regions under a supply agreement.

EXBLIFEP® is a combination of cefepime, a fourth-generation cephalosporin, and enmetazobactam, an innovative extended-spectrum β-lactamase inhibitor. This drug aims to combat multi-drug resistant bacteria, including those producing extended-spectrum β-lactamases (ESBL) and resistant β-lactamase mutations like OXA-48 and AmpC. Enmetazobactam enhances the efficacy of cefepime against these resistant pathogens, addressing a significant global health issue.

The FDA approved EXBLIFEP® in February 2024 for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, for patients aged 18 and older. In March 2024, the European Commission (EC) granted marketing authorization for the drug, extending its approval for treating cUTI, hospital-acquired pneumonia (HAP), ventilator-associated pneumonia (VAP), and bacteraemia associated with these infections.

Allecra’s pivotal Phase III ALLIUM trial demonstrated the drug’s superior overall treatment success. The study compared 1034 randomized patients who received either cefepime/enmetazobactam or piperacillin/tazobactam. Conducted across 112 sites in nineteen countries, this trial's success was instrumental in gaining regulatory approvals.

Andreas Kranzusch, Chief Financial Officer and Managing Director at Allecra Therapeutics, emphasized the importance of this partnership with Acino, acknowledging Acino’s established presence in South Africa and the GCC region. He highlighted the need for new treatments to address antibiotic resistance and expressed optimism about the collaboration. Andrew Bird, CEO (ai) at Acino, shared Kranzusch’s enthusiasm, stating that the partnership aligns with Acino’s mission to provide innovative healthcare solutions. Bird underscored the company’s commitment to expediting the registration process to ensure hospitals can quickly access EXBLIFEP®.

Allecra Therapeutics, founded in 2013, focuses on developing therapies to combat antibiotic resistance. The company’s lead product, EXBLIFEP®, has undergone successful Phase III trials and received regulatory approvals in both the US and Europe. Allecra enjoys robust patent protection for enmetazobactam in major territories and counts several significant investors among its backers.

Acino is a Swiss pharmaceutical company based in Zurich, with a focus on markets in the Middle East, Africa, Ukraine, the CIS Region, and Latin America. The company aims to provide affordable healthcare through high-quality pharmaceuticals and leverages its manufacturing capabilities to supply other leading companies. Acino is part of Arcera, a global life sciences company headquartered in Abu Dhabi, established by ADQ, an investment and holding company. Arcera aims to position the UAE as a leader in science and technology.

The exclusive licensing and supply agreement between Allecra Therapeutics and Acino represents a significant step towards addressing the growing global challenge of antibiotic resistance. This partnership will ensure that innovative treatment options like EXBLIFEP® are accessible in key emerging markets, potentially extending to other regions in the future.