Allecra Therapeutics and Acino Sign Exclusive Licensing and Supply Agreement for Allecra’s Novel Antibiotic EXBLIFEP® in Gulf Cooperation Council countries and South Africa
June 24 2024 - 3:00AM
Allecra Therapeutics and Acino Sign Exclusive Licensing and Supply
Agreement for Allecra’s Novel Antibiotic EXBLIFEP® in Gulf
Cooperation Council countries and South Africa
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.
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.
- Allecra Therapeutics and Acino Sign Exclusive Licensing and
Supply Agreement for Allecra’s Novel Antibiotic EXBLIFEP® in Gulf
Cooperation Council countries and South Africa
- Acino and Allecra Therapeutics