Allecra Therapeutics and Acino Sign Exclusive Licensing and Supply Agreement for Allecra’s Novel Antibiotic EXBLIFEP® in Gulf Cooperation Council countries and South Africa

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.

About Allecra Therapeutics

Allecra Therapeutics, founded in 2013, is a private, clinical-stage biopharmaceutical company developing novel therapies to combat antibiotic resistance by overcoming emergent resistance mechanisms. Lead product candidate EXBLIFEP® (cefepime/enmetazobactam), has successfully completed a randomized, controlled, double-blind, global Phase 3 trial compared to standard of care in patients with complicated urinary tract infections (cUTIs). Based on these results, the company has received FDA marketing approval in the U.S. and announced approval in the European Union for EXBLIFEP® earlier this year.
Allecra has significant patent protection covering proprietary enmetazobactam in major territories. Allecra’s investors include Forbion, Andera Partners, Delos Capital, Xeraya Capital, EMBL Ventures, and BioMedPartners. Allecra’s wholly owned French subsidiary is a beneficiary of financial support from Bpifrance and the Région Alsace. Please visit www.allecra.com for further information.

About Acino

Acino is a Swiss pharmaceutical company headquartered in Zurich with a clear focus on selected markets in the Middle East, Africa, Ukraine, the CIS Region, and Latin America. We deliver quality pharmaceuticals to promote affordable healthcare in these emerging markets and leverage our high-quality pharmaceutical manufacturing capabilities and network to supply leading companies through contract manufacturing and out-licensing. For more information, please visit www.acino.swiss .
Acino is part of Arcera, a global company in the life sciences sector headquartered in Abu Dhabi, United Arab Emirates. Arcera was established by ADQ, an Abu Dhabi-based investment and holding company, to build a global life sciences powerhouse poised to make significant contributions to realising the UAE’s aspiration to emerge as a frontrunner in science and technology. To learn more about Arcera, please visit www.arceralifesciences.com

References:

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