Melinta Therapeutics, LLC , a commercial-stage company providing innovative therapies for acute and life-threatening illnesses, announced today a partnership with the Biomedical Advanced Research and Development Authority (BARDA) to advance two antibiotics currently FDA-approved for adults, BAXDELA and VABOMERE , for use in pediatrics. In addition, Melinta and BARDA will partner on the development of BAXDELA® against biothreat pathogens. Under this contract, BARDA has awarded $20.5M for the base period, with the potential of additional funding of $121.4M, amounting to total funding up to $141.9M if all options are exercised. With this BARDA funding, Melinta aims to submit four supplemental New Drug Applications (sNDAs) for these new indications.
BARDA is part of the U.S. Department of Health and Human Services’ Administration for Strategic Preparedness and Response. This partnership may enable BAXDELA and VABOMERE to be integrated into national preparedness efforts as well as pediatric care for multi−drug-resistant bacterial infections, enhancing sustained availability of the products, increasing end-user familiarity, and striving for availability for the US pediatric population.
“I am thrilled and honored that BARDA and Melinta have agreed to partner for this important research marking a significant milestone in our journey toward becoming legendary for providing innovative therapies to people impacted by acute and life-threatening illnesses,” said Christine Miller, Melinta President and CEO. “This contract fuels our excitement to explore expanded applications of BAXDELA® and VABOMERE® through innovative research. We are poised to make a lasting impact in healthcare, unlocking new avenues for patient care and addressing unmet needs. We will drive progress and redefine what is possible, paving the way for a healthier future.”
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BAXDELA is a novel fluoroquinolone (FQ), approved for adults in IV and oral tablet formulations to treat acute bacterial skin and skin structure infection and community-acquired bacterial pneumonia (CABP). CABP remains a leading cause of pediatric hospitalization and mortality in the US, with the highest incidence and morbidity in children under 2 years of age. The partnership with BARDA will support the BAXDELA pediatric development plan to extend the adult CABP indication to children aged 2 months to less than 18 years.
In addition, Melinta aims to advance BAXDELA as a potential treatment option against biothreat pathogens for both adults and children. Given its broad spectrum of activity and availability in both IV and oral formulations, BAXDELA can provide flexibility for use following a biothreat public health emergency, in varied care settings and across spectrums of disease severity.
VABOMERE is an approved combination of the carbapenem, meropenem, and the novel ß-lactamase inhibitor (BLI), vaborbactam. VABOMERE® was specifically designed to address gram-negative bacteria that produce beta-lactamase enzymes, including strains producing the Klebsiella pneumoniae carbapenemase (KPC) enzyme, the predominant form of carbapenem-resistant Enterobacterales (CRE) in the US.
SOURCE: Businesswire