Mirum Pharmaceuticals Enters into $210 Million Funding Arrangement with Oberland Capital
December 9, 2020
Rare Daily Staff
Mirum Pharmaceuticals and Oberland Capital Management announced a $200 million capped, tiered, revenue-based funding agreement based on net revenues of maralixibat, as well as a $10 million equity investment agreement.
The funding will be used to support the commercialization of Mirum’s lead therapeutic maralixibat for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) in the United States and for patients with progressive familial intrahepatic cholestasis (PFIC2) in Europe, and for continued development of Mirum’s pipeline of treatments to address rare liver diseases in children and adults.
Under the agreement, Mirum will receive $60 million by the end of the year. That includes a $10 million equity investment; $65 million upon the U.S. Food and Drug Administration’s acceptance of Mirum’s New Drug Application for maralixibat for the treatment of cholestatic pruritis in patients with Alagille syndrome (ALGS); $35 million upon FDA approval of maralixibat for the treatment of cholestatic pruritis in patients with ALGS; and $50 million at the option of Oberland Capital, which may be funded to support in-licensing or acquisition of assets to further build upon Mirum’s development and commercialization pipeline in the pursuit of treatments for rare liver diseases.
ALGS is a rare, genetic disorder in which bile ducts are abnormally narrow, malformed, and reduced in number, leading to bile accumulation in the liver and ultimately progressive liver disease. The accumulation of bile acids prevents the liver from working properly to eliminate waste from the bloodstream and leads to progressive liver disease that may require liver transplantation. The severe itching, known as pruritus, that is experienced by patients with ALGS is among the most severe in any chronic liver disease and is present in most affected children by the third year of life.
Maralixibat is a novel, minimally absorbed, orally administered experimental drug being evaluated in several cholestatic liver diseases. Maralixibat inhibits the apical sodium-dependent bile acid transporter, resulting in more bile acids being excreted in the feces, leading to lower levels of bile acids systemically, thereby potentially reducing bile acid mediated liver damage and related effects and complications.
Mirum is submitting a rolling NDA to the FDA for maralixibat for the treatment of cholestatic pruritus in patients with ALGS, which it expects to complete in the first quarter of 2021, with launch planned in the second half of 2021. Mirum has also submitted a marketing authorization application to the European Medicines Agency (EMA) for maralixibat for the treatment of patients with progressive familial intrahepatic cholestasis type 2 (PFIC2), or bile salt export pump (BSEP) deficiency. The MAA was recently validated by the EMA and Mirum is preparing for launch in the European Union in the first quarter of 2022.
“The funding from Oberland Capital will enable us to invest in the launch and commercialization of maralixibat in the United States and Europe,” said Ian Clements, chief financial officer at Mirum. “The agreement with Oberland Capital provides us the support and flexibility to advance our pipeline focused on rare liver diseases for children and adults, an area where there is tremendous need.”
Photo: Ian Clements, chief financial officer at Mirum
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