Shanghai Haini Pharmaceutical Co. Ltd.

EXBLIFEP treatment is indicated for usage in patients aged 18 years and above with complicated urinary tract infections. Credit: Albina Gavrilovic / Shutterstock.com. The US Food and Drug Administration (FDA) has approved Allecra Therapeutics’ EXBLIFEP (cefepime/enmetazobactam) to treat complicated urinary tract infections (cUTIs) including pyelonephritis. EXBLIFEP is indicated for patients aged 18 years and above. The approval is accompanied by a five-year marketing exclusivity extension from the US regulator under the Generating Antibiotic Incentives Now (GAIN) Act. The GAIN Act offers incentives for developing new anti-infective drugs by granting benefits to qualified infectious disease product manufacturers. The FDA granted the approval based on comprehensive clinical data highlighting the effectiveness of EXBLIFEP against antimicrobial resistance in gram-negative bacteria, particularly resistance caused by extended spectrum beta lactamases and ampC enzymes. See Also: MHRA streamlines approval process for established medicines Beyond approval: Patients pursue alternate paths to get rare disease treatments The data included results from the Phase III ALLIUM clinical trial in which EXBLIFEP demonstrated superiority to piperacillin/tazobactam in clinical cure and microbiological eradication in cUTI patients. Allecra holds an extensive patent estate for the therapy in key markets, with the GAIN Act extending market exclusivity until 2032. Orchid Pharma discovered enmetazobactam, a component of EXBLIFEP, and assigned all rights outside India to Allecra Therapeutics in 2013. Since then, Allecra has been solely responsible for the global clinical and regulatory development of EXBLIFEP. The company has completed exclusive licensing agreements with Shanghai Haini Pharmaceutical in Greater China and ADVANZ PHARMA in Europe. In another global Phase III trial, EXBLIFEP was analysed against piperacillin / tazobactam, a standard cUTI care, showcasing its potential in a randomised, controlled, double-blind setting. Allecra’s commercial partner, Advanz Pharma, sought marketing authorisation for EXBLIFEP in Europe. Allecra Therapeutics supervisory board member Iain Buchanan said: “Receiving FDA approval is a tremendous achievement for Allecra and a testament to the hard work and dedication of a small yet highly focused team of individuals. “As we continue our discussions with strategic partners for product launch in the US, we value the FDA’s positive decision on EXBLIFEP’s ability to address a critical unmet medical need for patients.”

One antibiotic combo is up and another is down after the FDA approved Allecra's treatment for urinary tract infection while rejecting another brought by Venatorx and Melinta. Over the last few days, as the FDA rejected one antibiotic combination treatment for complicated urinary tract infections (cUTIs), it has approved another. The United States regulator has signed off on Allecra Therapeutics’ Exblifep (cefepime/enmatazobactam) as a treatment for cUTIs, including the severe kidney condition pyelonephritis, brought on by gram-negative bacteria. Meanwhile, the FDA handed out a rejection last week in the same indication for Venatorx Pharmaceuticals and Melinta Therapeutics’ antibiotic combo treatment cefepime/taniborbactam. As part of the approval, the FDA has extended Allecra five years of additional market exclusivity as part of the Generating Antibiotic Incentives Now (GAIN) Act. That exclusivity now will run through 2032, the company said. GAIN incentivizes the creation of new anti-infective therapeutics by providing benefits to manufacturers of qualified infectious disease products (QIDPs). Orchid Pharma, which discovered enmatazobactam, established Allecra in 2013 to take on development of the extended-spectrum beta-lactamase inhibitor (BLI) outside of India. Cefepime, which was developed by Bristol Myers Squibb and approved in 1994, is a beta-lactam antibiotic. Because of its increasing ineffectiveness, cefepime was removed from the World Health Organization’s list of essential medicines in 2019. “Receiving FDA approval is a tremendous achievement for Allecra and a testament to the hard work and dedication of a small, yet highly focused team of individuals,” Iain Buchanan, Allecra’s supervisory board member, said in a release. The approval was backed by a phase 3 trial which showed the superiority of cefepime/enmatazobactam to the standard of care, piperacillin/tazobactam, in clinical cure rates and microbiological eradication.    In January, Europe’s Committee of Medicinal Products for Human Use (CHMP) provided a positive opinion on cefepime/enmatazobactam. Additionally, the European Medicines Agency (EMA) said that the combo is eligible for approval for use in hospital-acquired ventilator-associated bacterial pneumonia. Allecra has signed license agreements for Exblifep with Advanz Pharma in Europe and with Shanghai Haini Pharmaceutical in China. The company is in “discussions with strategic partners” for launching Exblifep in the U.S., Buchanan said in a statement. As for the complete response letter (CRL) the FDA sent to Venatorx and Melinta, the regulator did not flag any clinical safety or efficacy problems but did identify a manufacturing issue. The companies' efforts with the combo are being funded by the National Institute of Allergy and Infectious Diseases, the National Institutes of Health, the Department of Health and Human Services and the Biomedical Advanced Research and Development Authority.

Company Receives Five-year Exclusivity Extension Through GAIN Act SAINT-LOUIS, France & WEILL AM RHEIN, Germany--(BUSINESS WIRE)-- Allecra Therapeutics (“Allecra”), a biopharmaceutical company developing novel therapies to combat antibiotic resistance, announced today that the U.S. Food and Drug Administration (FDA) has approved EXBLIFEP® (cefepime/enmetazobactam), as a treatment for complicated urinary tract infections (cUTIs), including pyelonephritis, in patients 18 years and older. Allecra has also received a five-year marketing exclusivity extension from the FDA as part of the Generating Antibiotic Incentives Now Act (GAIN Act). The GAIN Act, enacted by the U.S. Congress, incentivizes the creation of new anti-infective therapeutics by providing benefits to manufacturers of Qualified Infectious Disease Products (QIDPs). "Receiving FDA approval is a tremendous achievement for Allecra and a testament to the hard work and dedication of a small, yet highly focused team of individuals. I extend my sincere congratulations to my colleagues Omar Lahlou and Patrick Velicitat for their leadership and oversight throughout this whole process,” said Iain Buchanan, Supervisory Board Member of Allecra Therapeutics. “As we continue our discussions with strategic partners for product launch in the U.S., we value the FDA’s positive decision on EXBLIFEP®’s ability to address a critical unmet medical need for patients.” The FDA’s approval of EXBLIFEP® was supported by a totality of clinical data that demonstrated EXBLIFEP® effectiveness against antimicrobial resistance in gram-negative bacteria, especially resistance mediated by both ESBL (Extended Spectrum Beta Lactamases) and AmpC. This included results from Allecra’s Phase 3 ALLIUM trial, which met criteria for non-inferiority and superiority compared to piperacillin/tazobactam in the primary composite outcome of clinical cure and microbiological eradication in patients with cUTIs. Allecra is the sole holder of a significant patent estate covering EXBLIFEP® in major territories with the GAIN Act extending Allecra’s market exclusivity until 2032. Enmetazobactam was first discovered by Orchid Pharma and all rights outside India were assigned to Allecra Therapeutics in 2013. The company has since taken the sole responsibility for the international clinical and regulatory development of EXBLIFEP®. Allecra was founded through a strategic partnership formed by Nicholas Benedict, Stuart Shapiro and Edward Currie in conjunction with Orchid Chemicals and Pharmaceuticals Ltd. and Allecra lead investors, Andera Partners, Forbion and EMBL Ventures. The company has concluded exclusive license agreements for EXBLIFEP® with Shanghai Haini Pharmaceutical in Greater China and ADVANZ PHARMA in Europe. About EXBLIFEP® (cefepime/enmetazobactam) EXBLIFEP® (cefepime/enmetazobactam) has been investigated in patients with complicated urinary tract infections (cUTIs) compared to piperacillin/tazobactam, a current standard of care, in a randomized, controlled, double-blind, global Phase 3 trial. EXBLIFEP® has already been submitted for Marketing Authorization Approval in Europe by Allecra’s commercial partner, Advanz Pharma. The European Medicines Agency (EMA) has indicated that, in light of results obtained in an epithelial lining fluid penetration study, the company is eligible for approval of cefepime/enmetazobactam for use in hospital-acquired/ventilator-associated bacterial pneumonia. A positive opinion was received from the CHMP (The Committee for Medicinal Products for Human Use) in January 2024. 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 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 Region Alsace. Please visit for further information and follow us on LinkedIn. View source version on businesswire.com: Contacts For Allecra Therapeutics GmbH: Andreas Kranzusch, Chief Financial Officer, ir@allecra.com For media: Desmond James, Trophic Communications, +49 1516 7859086, allecra@trophic.eu Source: Allecra Therapeutics View this news release online at: