Meitheal Pharmaceuticals Expands Its Specialty Biopharma Range by Acquiring CONTEPO™ (Fosfomycin for Injection) from Nabriva Therapeutics
Friday, July 19, 2024
Meitheal Pharmaceuticals, Inc., a biopharmaceutical company based in Chicago with a focus on generic injectables, fertility treatments, biologics, and branded products, has announced its acquisition of the North American rights to CONTEPO™ (fosfomycin for injection) from Nabriva Therapeutics. CONTEPO™ is an advanced intravenous antibiotic effective against many multi-drug resistant (MDR) strains responsible for complicated urinary tract infections (cUTI).
Tom Shea, Meitheal's CEO, stated, “Incorporating CONTEPO™ into our product line addresses a critical gap in the fight against rising antibiotic resistance. Our comprehensive capabilities enable us to push CONTEPO™ through the final regulatory phases and ensure a steady supply of this essential antibiotic for both patients and healthcare providers.”
Under the Asset Purchase Agreement, Meitheal gains North American rights to CONTEPO™, including development results, regulatory achievements, and related intellectual property. In return, Nabriva will receive an upfront payment and a royalty on net U.S. sales of CONTEPO™.
CONTEPO™ is already available outside the U.S., where it is approved for nine indications, including cUTI and other severe bacterial infections. It features a novel dosing approach to enhance its pharmacokinetics and pharmacodynamics and has proven effective in the pivotal ZEUS™ trial for cUTI and acute pyelonephritis.
Brett Novak, Meitheal’s Senior Vice President of Commercial Operations, remarked, “The current treatment options for complex infections in the U.S. are fragmented, and rising antibiotic resistance is rendering many traditional treatments ineffective. CONTEPO™, with its proven efficacy against modern MDR strains and its unique action mechanism, has the potential to become a preferred choice for treating complicated UTIs.”
Nabriva has filed a New Drug Application (NDA) with the U.S. FDA for CONTEPO™ for the treatment of cUTI and acute pyelonephritis, with a decision expected later this year. Meitheal is preparing for the product launch by establishing a comprehensive commercial marketing and sales team, as well as a medical science liaison (MSL) team to support healthcare professionals.
Meitheal’s parent company, Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd. (NKF), has invested over $300 million in recent years to ensure a reliable product supply across its focus areas, including branded biopharmaceuticals.
Complicated urinary tract infections (cUTI) are severe infections occurring in patients with abnormalities in the urinary tract or those using catheters, and include acute pyelonephritis. Approximately three million cases of Gram-negative cUTI are treated annually in U.S. hospitals, with about 40% attributed to resistant strains. Untreated cUTIs can lead to treatment failures, extended hospital stays, recurrences, re-hospitalizations, and higher mortality, creating significant economic and healthcare challenges.
CONTEPO™ (fosfomycin for injection) is an innovative intravenous antibiotic in the U.S., offering broad activity against both Gram-negative and Gram-positive bacteria, including most contemporary MDR strains like ESBL-producing Enterobacteriaceae. Although IV fosfomycin has been used internationally for over 45 years to treat various infections, CONTEPO™ represents a new therapeutic option for cUTI and other serious bacterial infections in the U.S.
Source: businesswire.com
