Saint-Louis, France and Weil am Rhein, Germany and Zurich, Switzerland, June
24, 2024 (GLOBE NEWSWIRE) -- 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 ?-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 ?-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 Re?gion 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 (http://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
(http://www.arceralifesciences.com).
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