Qpex Biopharma Announces Exercise of $20 Million Option by BARDA under its Other Transaction Authority (OTA) Agreement to Advance Multiple Products into Clinical Studies
SAN DIEGO, December 16, 2019 – Qpex Biopharma, Inc., a biopharmaceutical company dedicated to the discovery and development of innovative anti-infective therapies, today announced that the Biomedical Advanced Research and Development Authority (BARDA) has exercised its first agreement option, which will support advancing multiple programs into clinical studies. The option is for $20 million and is the second award under the company’s Other Transaction Authority (OTA) agreement for up to $132 million to develop a portfolio of antibiotics to address drug-resistant infections.
“We are grateful for our successful and longstanding partnership with BARDA, whose commitment to address the global and growing threat of antimicrobial resistance has been unparalleled,” said Michael Dudley, Pharm.D., President and CEO of Qpex Biopharma. “Our team has made rapid progress since forming the company just over a year ago, and the continued support from BARDA puts us in a strong position as we transition to a clinical-stage company.”
The BARDA agreement funds development of Qpex’s portfolio of products to comprehensively address patient needs associated with drug-resistant gram-negative infections:
ORAvanceTM: an orally-administered, beta-lactamase inhibitor (BLI) based product to treat infections that occur in the outpatient and community setting caused by drug-resistant gram- negative bacteria, including extended-spectrum beta-lactamase (ESBL)- and carbapenemase- producing Enterobacteriaceae
OMNIvanceTM: an IV-administered BLI-based product with best-in-class coverage of key pathogens, including carbapenem-resistant Acinetobacter, Enterobacteriaceae and Pseudomonas
QPX9003: a next-generation IV-administered polymyxin with an enhanced therapeutic profile designed to address highly drug-resistant infections caused by Pseudomonas and Acinetobacter.
OMNIvance and ORAvance use Qpex’s novel ultra-broad-spectrum BLI QPX7728 that inhibits both serine and metallo beta-lactamases, and restores the activity of multiple IV and oral beta-lactam antibiotics against many drug-resistant gram-negative pathogens.
In November 2019, the Center for Disease Control (CDC) updated figures on antibiotic resistance in the U.S., estimating that over 2.8 million antibiotic-resistant infections occur every year in the U.S. (nearly twice as many as previously reported in 2013). Among the most serious and difficult to treat infections are those caused by drug-resistant gram-negative bacteria, which are targeted by the Qpex-BARDA portfolio and considered by the CDC to be serious-to-urgent resistance threats. These include ESBL-producing bacteria which are widespread in the community as well as hospital settings, and carbapenem-resistant strains of Enterobacteriaceae (CRE), Acinetobacter, and Pseudomonas.
About Qpex Biopharma
Qpex Biopharma (www.qpexbio.com) is a San Diego-based biopharmaceutical company with a pipeline of best-in-class agents addressing critical needs for treatment of infectious diseases in the inpatient and outpatient settings. Qpex was launched in 2018 with investments from New Enterprise
Associates, Adams Street Partners, LYZZ Capital, Hatteras Venture Partners and Stanford University Draper Fund. The company’s scientists and clinicians have a record of deep expertise in the discovery and development of anti-infective agents, and an extensive record of working with public- private partnerships, including partnerships with the Biomedical Advanced Research and Development Authority (BARDA) that led to the first approved antimicrobial drug product under that program in 2017
Qpex’s partnership with BARDA is funded in whole or in part with federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under OTA number HHSO100201600026C. The agreement provides for up to $132 million in support for the development of a portfolio of new antibiotics to fight drug- resistant, gram-negative infections.
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