Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM), a biopharmaceutical company focused on the development and commercialization of novel therapies for debilitating liver diseases, today announced it has partnered with EVERSANA™, a leading provider of commercial services to the life science industry, to lead the U.S. market access, distribution and patient services for maralixibat.
Maralixibat is a novel, minimally absorbed, orally administered apical sodium dependent bile acid transporter inhibitor being evaluated for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS). Mirum initiated its rolling New Drug Application (NDA) to the U.S. Food and Drug Administration in August 2020, expects to complete the NDA submission in the first quarter of 2021, and is preparing for launch in the second half of 2021.
Mirum will utilize EVERSANA’s commercialization platform to provide integrated nationwide distribution, specialty pharmacy, patient services and Hub support for maralixibat, if approved.
“We are working diligently to prepare for the potential launch of maralixibat in the United States and one of the most important components is ensuring comprehensive support for patients and their families,” said Chris Peetz, president and chief executive officer at Mirum. “We are pleased to partner with EVERSANA and are confident in their ability to provide end-to-end services to ensure maralixibat will reach patients and their families efficiently and effectively once the medication is available for prescribing. In parallel, we are preparing to file a marketing authorization application for maralixibat in PFIC2 this year, and these programs will help to refine our strategies as we finalize launch plans in Europe.”
“Rare diseases like ALGS demand more than traditional patient support or distribution models. From day one, we knew that our partnership would focus entirely on individual patient’s needs at each step of their therapeutic and treatment journey. The platform is designed so that at launch, EVERSANA’s infrastructure and experts will be ready with the right services, and each action will be continually optimized through real-time analytics,” said Jim Lang, chief executive officer of EVERSANA. “Mirum’s patients will have access to comprehensive support delivered by Mirum and EVERSANA, two companies equally committed to the rare disease space.” – Business Wire