Meitheal Pharmaceuticals, Inc. (“Meitheal”), a fully integrated biopharmaceutical company based in Chicago and focused on the development and commercialization of generic injectables, fertility, biologic, and branded products, announced it has acquired North America rights to CONTEPO™ (fosfomycin for injection) from Nabriva Therapeutics. CONTEPO™ is a novel, intravenous (IV), broad spectrum antibiotic with demonstrated activity against most multi-drug resistant (MDR) strains that cause complicated urinary tract infections (cUTI).
“The strategic addition of CONTEPO™ to our robust product portfolio provides us with a novel therapeutic with the potential to address a significant unmet need around increasing antibiotic resistance,” said Tom Shea, Chief Executive Officer of Meitheal. “As a fully integrated biopharmaceutical company, Meitheal is uniquely positioned to advance CONTEPO™ through the final stages of the regulatory process and, if approved, deliver a consistent supply of this high-quality antibiotic to patients and providers in need of an innovative option for drug resistant urinary tract infections.”
Under the Asset Purchase Agreement, Meitheal acquires North America rights to CONTEPO™, including any results of development and regulatory activities, and all intellectual property (IP) rights, technology, and know-how related to CONTEPO™. In exchange, Nabriva will receive payment upon closing and a royalty on net U.S. sales of CONTEPO™.
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Fosfomycin for intravenous (IV) administration is marketed outside the U.S. where it has been approved across nine indications, including cUTI and other serious bacterial infections. CONTEPO™ utilizes a new dosing approach to optimize the compound’s pharmacokinetics and pharmacodynamics and has demonstrated efficacy by meeting the primary endpoint in the pivotal ZEUS™ trial for patients with cUTI, including acute pyelonephritis.
“The treatment paradigm for complicated infections in the U.S. is fragmented and inefficient with increasing antibiotic resistance rendering many traditional treatment options obsolete,” said Brett Novak, Meitheal Senior Vice President of Commercial Operations. “CONTEPO™, with demonstrated efficacy against most contemporary multi-drug resistant strains and a differentiated mechanism of action, has the potential to serve as the alternative antibiotic treatment of choice in appropriate patients, and provide them with the right spectrum of coverage for complicated UTIs.”
Nabriva submitted the New Drug Application (NDA) to the U.S. Food & Drug Administration (FDA) for the approval of CONTEPO™ (fosfomycin for injection) for the treatment of cUTI, including acute pyelonephritis. A decision is expected from the FDA later this year. In preparation for commercial launch, Meitheal will establish a full commercial marketing and sales organization in addition to a medical science liaison (MSL) team to support clinician needs.
Meitheal’s parent company, Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd. (NKF), has invested over $300 million in capital and research and development in recent years to support sustainable product supply across the Company’s focus areas including branded biopharmaceuticals.
SOURCE: Businesswire