Acino Signs An Exclusive Licensing And Supply Agreement With Allecra Therapeutics In Gulf Cooperation Council Countries And South Africa

• The agreement focuses on the distribution of Allecra’s novel antibiotic drug EXBLIFEP (cefepime/enmetazobactam) within the Republic of South Africa and the member states of the GCC alliance, which includes Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, and the United Arab Emirates.
• Acino gains commercial rights for EXBLIFEP (cefepime/enmetazobactam) within the member states of the Gulf Cooperation Council (GCC) and South Africa.
• EXBLIFEP has been approved by the U.S. Food and Drug Administration (FDA) and the European Commission (EC) for the treatment of severe infections earlier in 2024.

Allecra Therapeutics (“Allecra”) and Acino today announced the signing of an exclusive licensing agreement under which Acino gains the rights to commercialise Allecra’s antibiotic drug EXBLIFEP (cefepime/enmetazobactam) within the Republic of South Africa and the member states of the GCC alliance, which includes Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, and the United Arab Emirates, effective from 12 June 2024. In addition, the companies have signed a supply agreement under which Allecra will supply the cefepime/enmetazobactam finished product in the above territories.

“Acino has established itself as a leader in South Africa and the GCC region. They are an ideal partner to support us as we build towards commercialisation of EXBLIFEP following our regulatory approvals in the US and EU,” stated Andreas Kranzusch, Chief Financial Officer and Managing Director at Allecra Therapeutics. “This agreement reflects the understanding that there remains a significant global need to address the dangerous increase of resistance to standard-of-care antibiotics, and we look forward to working with Acino to address this.”

“At Acino, we are dedicated to providing novel healthcare solutions to physicians and patients, aiming to alleviate the health burden in emerging markets. We are incredibly excited to partner with Allecra to offer access to this innovative product in two key geographic regions and, potentially, beyond,” said Andrew Bird, CEO (ai) at Acino. “We are committed to expediting the registration process in these designated markets to ensure hospitals’ swift access to EXBLIFEP as they continue to fight against high-risk infectious diseases in patients.”

About EXBLIFEP (cefepime/enmetazobactam)
EXBLIFEP is an intravenous antibiotic fixed-dose combination of enmetazobactam, a novel extended-spectrum β-lactamase inhibitor belonging to the penicillanic acid sulfone class, with the fourth-generation cephalosporin cefepime. Enmetazobactam has been shown to restore the efficacy of cefepime against some multi-drug resistant bacteria, including ESBL-producing pathogens alone or in combination with some resistant β-lactamase mutations as OXA-48 or AmpC, which are increasing in Europe and for which there are few therapeutic alternatives.

EXBLIFEP demonstrated statistically significant superior overall treatment success in Allecra’s pivotal Phase III ALLIUM trial, which compared 1034 randomized patients receiving either cefepime 2 g/enmetazobactam 0.5 g or piperacillin 4 g/tazobactam 0.5 g every 8 h as 2 h continuous intravenous infusion in a multi-centre, randomized, controlled, double-blind, global study in 112 sites within nineteen countries.

In February 2024, the U.S. Food and Drug Administration (FDA) approved EXBLIFEP as a treatment for complicated urinary tract infections (cUTI), including pyelonephritis, in patients 18 years and older. In March 2024 the European Commission (EC) granted marketing authorisation for EXBLIFEP for the treatment of adult patients with cUTI, including pyelonephritis; hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP); and bacteraemia that occurs in association with, or is suspected to be associated with any of the infections listed previously.

^1. Kaye KS, Belley A, Barth P et al. Cefepime-Enmetazobactam Demonstrates Superiority to Piperacillin-Tazobactam in a Subgroup of Patients with Complicated Urinary Tract Infections/Acute Pyelonephritis Caused by Extended Spectrum β-Lactamase-Producing Enterobacterales. IDWeek 2020; Oral presentation LB-4 – Late Breaking Abstracts October 24, 2020