RARE Daily

Mirum Acquires Satiogen

May 23, 2022

Mirum Pharmaceuticals said that it has acquired Satiogen Pharmaceuticals, an existing licensing partner for Livmarli and volixibat, a deal that gives Mirum all Satiogen licensing payments and Satiogen-owned intellectual property relating to the two drugs in development to treat rare liver diseases for up to $24 million in cash and stock.

Photo: Chris Peetz, president and CEO of Mirum.

“The acquisition of Satiogen is a strategic step that consolidates the economics of our commercial and pipeline programs,” said Chris Peetz, president and CEO of Mirum. “The Satiogen team laid some of the foundational groundwork for the potential for IBAT inhibitors in liver disease that is now translating to substantial benefits for patients and a successful launch of Livmarli in Alagille syndrome.”

The transaction will result in a reduction of total licensing royalty obligations for Livmarli and volixibat to high single digit to low teens. The total potential consideration for the acquisition consisted of a combination of 841,792 shares of common stock, 199,993 of which are subject to achievement of a milestone, and approximately $2.8 million in cash in respect of an equivalent amount of cash on the books of Satiogen acquired by Mirum at the closing. Mirum will wholly own the Satiogen subsidiary, which will receive a 2 percent royalty.

Livmarli oral solution is an orally administered, once-daily, ileal bile acid transporter (IBAT) inhibitor approved by the U.S. Food and Drug Administration for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) one year of age and older and is the only FDA-approved medication to treat cholestatic pruritus associated with Alagille syndrome.

Livmarli is currently being evaluated in late-stage clinical studies in other rare cholestatic liver diseases including progressive familial intrahepatic cholestasis (PFIC) and biliary atresia. Livmarli  has received Breakthrough Therapy designation for ALGS and PFIC type 2 and orphan designation for ALGS, PFIC, and biliary atresia.

Volixibat is an oral, minimally absorbed agent designed to selectively inhibit the ileal bile acid transporter (IBAT). Volixibat may offer a novel approach in the treatment of adult cholestatic diseases by blocking the recycling of bile acids, through inhibition of IBAT, thereby reducing bile acids systemically and in the liver. Phase 1 and phase 2 studies of volixibat demonstrated on-target fecal bile acid excretion, a pharmacodynamic marker of IBAT inhibition, in addition to decreases in LDL cholesterol and increases in 7αC4 which are markers of bile acid synthesis. Volixibat has been evaluated in more than 400 individuals across multiple clinical trials. The most common adverse events reported were mild to moderate gastrointestinal events observed in the volixibat groups.

Volixibat is currently being evaluated in phase 2b studies for primary sclerosing cholangitis, intrahepatic cholestasis of pregnancy, and primary biliary cholangitis.

Author: Rare Daily Staff

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