Associated tags: Cutis, Patient, Urinary tract infection, Standard of care, Therapy, Health, Clinical Trials, FDA, Pharmaceutical industry, Pharmaceutical, Biotechnology, Food, Esbly, Supervisory board, EU, United Kingdom, Piperacillin/tazobactam, Research, EMA, European Medicines Agency
Locations: EU
Retrieved on:
Tuesday, February 27, 2024
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Pharmaceutical industry 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.
Key Points:
- 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).
- "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.
- Enmetazobactam was first discovered by Orchid Pharma and all rights outside India were assigned to Allecra Therapeutics in 2013.
Biotechnology,
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Pharmaceutical industry Allecra Therapeutics (“Allecra”) announced today the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for cefepime/enmetazobactam, an antibiotic combination of the fourth generation cephalosporin cefepime with the proprietary beta lactamase inhibitor, enmetazobactam, for the treatment of complicated urinary tract infections (cUTIs).
Key Points:
- Allecra Therapeutics (“Allecra”) announced today the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for cefepime/enmetazobactam, an antibiotic combination of the fourth generation cephalosporin cefepime with the proprietary beta lactamase inhibitor, enmetazobactam, for the treatment of complicated urinary tract infections (cUTIs).
- Upon approval, the antibiotic combination will be marketed under the trademark name, EXBLIFEP®.
- EXBLIFEP® has been designed to combat anti-microbial resistance in gram-negative bacteria, especially resistance mediated by Extended Spectrum Beta Lactamases (or ESBLs).
- "This filing marks the culmination of a journey that began ten years ago with the formation of Allecra by a syndicate of European venture capital interests.
Retrieved on:
Wednesday, October 5, 2022
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EU The publication represents the first full analysis of the completed Phase 3 program, which showed that cefepime/enmetazobactam met criteria for non-inferiority and superiority compared to piperacillin/tazobactam in the primary outcome of clinical cure and microbiological eradication.
Key Points:
- The publication represents the first full analysis of the completed Phase 3 program, which showed that cefepime/enmetazobactam met criteria for non-inferiority and superiority compared to piperacillin/tazobactam in the primary outcome of clinical cure and microbiological eradication.
- Cefepime/enmetazobactam is a novel -lactam/-lactamase inhibitor combination for the treatment of resistant gram-negative infections mediated by Extended Spectrum Beta-Lactamases (ESBLs).
- Based on the positive data readout, Allecra expects to submit for marketing approval in the U.S. and EU.
- Allecra Therapeutics, founded in 2013, is a private, clinical-stage biopharmaceutical company developing novel therapies to combat antibiotic resistance by overcoming emergent resistance mechanisms.
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Thursday, January 13, 2022
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ADVANZ PHARMA,
CEFEPIME/ENMETAZOBACTAM,
ALLECRA THERAPEUTICS,
ADVANZ PHARMA ADVANZ PHARMA Corp. Limited ("ADVANZ PHARMA"), a specialty pharmaceutical company with a strategic focus on hospital medicines in Europe, and Allecra Therapeutics (Allecra) today announced that the companies have signed an exclusive license agreement under which ADVANZ PHARMA gains the rights to develop and commercialize Allecras antibiotic drug candidate cefepime/enmetazobactam within the European Union, the United Kingdom, Switzerland, and Norway.
Key Points:
- ADVANZ PHARMA Corp. Limited ("ADVANZ PHARMA"), a specialty pharmaceutical company with a strategic focus on hospital medicines in Europe, and Allecra Therapeutics (Allecra) today announced that the companies have signed an exclusive license agreement under which ADVANZ PHARMA gains the rights to develop and commercialize Allecras antibiotic drug candidate cefepime/enmetazobactam within the European Union, the United Kingdom, Switzerland, and Norway.
- In exchange for the exclusive license, Allecra will receive an upfront payment and development and sales milestones for cefepime/enmetazobactam, as well as double-digit tiered royalties.
- In addition, the two companies have signed a supply agreement under which Allecra will supply the cefepime/enmetazobactam finished product in the agreed upon territories.
- Allecra Therapeutics, founded in 2013, is a private, clinical-stage biopharmaceutical company developing novel therapies to combat antibiotic resistance by overcoming emergent resistance mechanisms.
Retrieved on:
Monday, December 21, 2020
Cities in China,
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Treaty of Nanking,
Wu,
Yangtze River Delta,
Cefepime,
Country subdivisions,
cefepime/enmetazobactam,
Allecra Therapeutics,
Shanghai Haini Mr. Iain Buchanan, on behalf of the Allecra Therapeutics board, said: "We are very pleased to sign this agreement with Shanghai Haini.
Key Points:
- Mr. Iain Buchanan, on behalf of the Allecra Therapeutics board, said: "We are very pleased to sign this agreement with Shanghai Haini.
- They are one of the top pharmaceutical firms in China and are considered a market leader in the antibiotics space.
- Mr. Tan Pengfei, the General Manager of Shanghai Haini, commented: "We are pleased to in-license cefepime/enmetazobactam and advance its development for Greater China.
- For more information, please visit our website, www.yangzijiang.com
Shanghai Haini Pharmaceutical Co., Ltd. (Shanghai Haini) was founded in 2001.
