- The European Commission (EC) granted marketing authorisation for EXBLIFEP®
- Developed by Allecra, EXBLIFEP® will be marketed in the European Union, the United Kingdom, Switzerland, and Norway by ADVANZ PHARMA under a license and supply agreement closed with Allecra in 2022
- ADVANZ PHARMA is committed to improving patients’ lives by providing potent therapeutic options in Europe in areas with high patient need
London, UK and SAINT-LOUIS, France and WEIL AM RHEIN, Germany – 27/03/2024: - ADVANZ PHARMA Holdco Limited (“ADVANZ PHARMA” or “the Company”), a UK headquartered global pharmaceutical company with a strategic focus on speciality, hospital, and rare disease medicines in Europe, Canada, and Australia, and Allecra Therapeutics (“Allecra”), a biopharmaceutical company developing novel therapies to combat antibiotic resistance, today announced that the EC granted a marketing authorization for EXBLIFEP®, an antibiotic fixed-dose combination of cefepime and enmetazobactam.
EXBLIFEP® is approved for the treatment of adult patients with complicated urinary tract infections (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.
ADVANZ PHARMA owns the rights to develop and commercialise Allecra’s antibiotic drug candidate, cefepime/enmetazobactam, within the European Union, the United Kingdom, Switzerland, and Norway.
About EXBLIFEP®
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 4th generation cephalosporin cefepime. Enmetazobactam has been shown to restore efficacy of cefepime against some multi-drug resistant bacteria, including ESBL-producing pathogens alone or in combination with some resistant beta-lactamase mutations as OXA-48 or AmpC, which are increasing in Europe and for which there are few therapeutic alternatives.
Allecra’s pivotal Phase III ALLIUM trial 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 19 countries.
EXBLIFEP® achieved its primary outcome measure, demonstrating statistically significant overall treatment success (clinical cure combined with microbiological eradication) at test-of-care visit compared with piperacillin/tazobactam in cUTI, including AP, caused by Gram-negative pathogens (79.1% vs. 58.9%). Statistically significantly superior results were also observed among patients with infections caused by ESBL-producing pathogens (73.7% vs. 51.5%, respectively).
EXBLIFEP® demonstrated a tolerable safety profile, comparable to piperacillin/tazobactam 19.8% vs 14.5%. Treatment-related SAEs were reported in 0.2% of patients treated with EXBLIFEP® vs. 0.6% of patients treated with piperacillin/tazobactam.
About complicated urinary tract infections (cUTI)
cUTIs are serious, potentially life-threatening infections accounting for 19% of all healthcare associated infections. The range of mortality rates of cUTI reported in the literature is very broad (2%–31%), as it is derived from the different compositions of included patients in terms of age, type of infection and comorbidities. cUTIs, including acute pyelonephritis, are defined as urinary tract infections ascending from the bladder accompanied by local and systemic signs and symptoms (ie. fever, chills, malaise, flank pain, back pain), that occur in the presence of a functional or anatomical abnormality of the urinary tract or in the presence of catheterization, with treatment typically initiated by IV therapy in a hospital setting.
About acute pyelonephritis (AP)
AP is a bacterial infection causing inflammation of the kidneys and is one of the most common diseases of the kidney. Pyelonephritis occurs as a complication of an ascending urinary tract infection (UTI) which spreads from the bladder to the kidneys and their collecting systems.
About hospital acquired pneumonia and ventilated acquired pneumonia
HAP/VAP is the second most common nosocomial infection (after cUTI) and a leading cause of death from nosocomial infections in critically ill patients. Hospital-acquired pneumonia (HAP) and ventilator-associated pneumonia (VAP) are lung infections caused by pathogens acquired during hospital stay, occurring ≥48 hours after hospital admission, and which were not incubating at the admission time. VAP is a subtype of HAP that develops in ICUs in patients who have been mechanically ventilated for ≥48 hours.
About ADVANZ PHARMA
Partner of choice in specialty, hospital, and rare disease medicines
ADVANZ PHARMA is a global pharmaceutical company with the purpose to improve patients’ lives by providing and enhancing the specialty, hospital, and rare disease medicines they depend on. Our headquarters are in London, UK. We have commercial sales in more than 90 countries globally and have a direct commercial presence in more than 20 countries, including key countries in Europe, the US, Canada, and Australia, a Centre of Excellence in Mumbai, India, as well as an established global distribution and commercialisation partner network. ADVANZ PHARMA’s product portfolio and pipeline comprises innovative medicines, specialty generics & biosimilars, and originator brands. Our products cover a broad range of therapeutic areas, including hepatology, gastroenterology, anti-infectives, critical care, endocrinology, oncology, CNS, and, more broadly, rare disease medicines. Our ambition is to be a partner of choice for the commercialisation of specialty, hospital, and rare disease medicines in Europe, Canada, and Australia. In line with our ambition, we are partnering with biopharma and development companies to bring medicines to patients. We can only achieve this due to our dedicated and highly qualified employees, acting in line with our company values of entrepreneurship, speed, and integrity.
For more information, please visit our Website or LinkedIn.
For media inquiries, please contact:
Courtney Baines
ADVANZ PHARMA
Tel: +44 7776 516979 Email: courtney.baines@advanzpharma.com
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. The proprietary beta lactamase inhibitor enmetazobactam was first discovered by scientists at Orchid Pharma in India. The 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 achieved FDA marketing approval in the U.S. and, together with its partner, ADVANZ PHARMA, have submitted for marketing approval in the EU. The company has significant patent protection covering the proprietary compound, 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 and follow us on LinkedIn.
Contact:
For Allecra Therapeutics GmbH:
Andreas Kranzusch, Chief Financial Officer, ir@allecra.com
For media:
Desmond James, Trophic Communications, +49 1516 7859086, allecra@trophic.eu
