Transaction Details
Per the terms of the agreement, Mirum will acquire Travere’s rights to the bile acid product portfolio consisting of Cholbam® and Chenodal®. Travere will receive an upfront payment of $210 million and be eligible for up to $235 million in sales-based milestone payments based on annual net sales thresholds tiered from $125 to $500 million. Travere has also agreed to provide certain transitional services. The transaction is expected to close in the third quarter of 2023, subject to regulatory clearance and customary closing conditions.
Concurrent with entering into the definitive agreement to acquire Travere’s bile acid portfolio, Mirum has also entered into a definitive agreement for the sale of common stock in a private placement. The private placement was oversubscribed and is expected to result in gross proceeds to Mirum of approximately $210 million before deducting placement agent and other offering expenses. The proceeds from the private placement are intended to fund the up-front payment for the acquisition of Travere’s bile acid portfolio.
For Travere, Lazard is acting as financial advisor and Cooley is acting as legal advisor. For Mirum, Evercore is advising on the acquisition and Gibson, Dunn & Crutcher is acting as legal advisor. Morgan Stanley and Evercore are serving as placement agents on the accompanying equity financing, with Latham & Watkins advising the placement agents.
Mirum to Host Conference Call
Mirum will host a conference call today, July 17, 2023 at 8:30 a.m. ET/5:30 a.m. PT, to provide further details on the transaction. Join the call using the following information:
United States/Toll-free: 1-833-470-1428
International: 1-404-975-4839
Access code: 341495
You may also access the call via webcast by visiting the Events & Presentations section on Mirum’s website. A replay of this webcast will be available for 30 days.
About Cholbam® (cholic acid)
The FDA approved Cholbam® (cholic acid) capsules) in March 2015, the first FDA-approved treatment for pediatric and adult patients with bile acid synthesis disorders due to single enzyme defects, and for adjunctive treatment of patients with peroxisome biogenesis disorder-Zellweger spectrum disorder. The effectiveness of Cholbam® has been demonstrated in clinical trials for bile acid synthesis disorders and the adjunctive treatment of peroxisomal disorders. An estimated 200 to 300 patients are current candidates for therapy.
CHOLBAM® (cholic acid) Indication
Cholbam is a bile acid indicated for
| | • | | Treatment of bile acid synthesis disorders due to single enzyme defects. |
| | • | | Adjunctive treatment of peroxisomal disorders, including Zellweger spectrum disorders, in patients who exhibit manifestations of liver disease, steatorrhea, or complications from decreased fat-soluble vitamin absorption. |
LIMITATIONS OF USE
The safety and effectiveness of CHOLBAM on extrahepatic manifestations of bile acid synthesis disorders due to single enzyme defects or peroxisomal disorders, including Zellweger spectrum disorders, have not been established.
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS – Exacerbation of liver impairment
| | • | | Monitor liver function and discontinue CHOLBAM in patients who develop worsening of liver function while on treatment. |
| | • | | Concurrent elevations of serum gamma glutamyltransferase (GGT) and alanine aminotransferase (ALT) may indicate CHOLBAM overdose. |
| | • | | Discontinue treatment with CHOLBAM at any time if there are clinical or laboratory indicators of worsening liver function or cholestasis. |
ADVERSE REACTIONS
| | • | | The most common adverse reactions (≥1%) are diarrhea, reflux esophagitis, malaise, jaundice, skin lesion, nausea, abdominal pain, intestinal polyp, urinary tract infection, and peripheral neuropathy. |
DRUG INTERACTIONS
| | • | | Inhibitors of Bile Acid Transporters: Avoid concomitant use of inhibitors of the bile salt efflux pump (BSEP) such as cyclosporine. Concomitant medications that inhibit canalicular membrane bile acid transporters such as the BSEP may exacerbate accumulation of conjugated bile salts in the liver and result in clinical symptoms. If concomitant use is deemed necessary, monitoring of serum transaminases and bilirubin is recommended. |
| | • | | Bile Acid Binding Resins: Bile acid binding resins such as cholestyramine, colestipol, or colesevelam adsorb and reduce bile acid absorption and may reduce the efficacy of CHOLBAM. Take CHOLBAM at least 1 hour before or 4 to 6 hours (or at as great an interval as possible) after a bile acid binding resin. |
| | • | | Aluminum-based Antacids: Aluminum-based antacids have been shown to adsorb bile acids in vitro and can reduce the bioavailability of CHOLBAM. Take CHOLBAM at least 1 hour before or 4 to 6 hours (or at as great an interval as possible) after an aluminum-based antacid. |
PREGNANCY
No studies in pregnant women or animal reproduction studies have been conducted with CHOLBAM. Women who become pregnant during CHOLBAM treatment are encouraged to call 1-844-202-6262.
LACTATION
Endogenous cholic acid is present in human milk. Clinical lactation studies have not been conducted to assess the presence of CHOLBAM in human milk, the effects of CHOLBAM on the breastfed infant, or the effects of CHOLBAM on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for CHOLBAM and any potential adverse effects on the breastfed infant from CHOLBAM or from the underlying maternal condition.
GERIATRIC USE
It is not known if elderly patients respond differently from younger patients.
HEPATIC IMPAIRMENT
| | • | | Discontinue treatment with CHOLBAM if liver function does not improve within 3 months of the start of treatment. |
| | • | | Discontinue treatment with CHOLBAM at any time if there are clinical or laboratory indicators of worsening liver function or cholestasis. Continue to monitor laboratory parameters of liver function and consider restarting at a lower dose when the parameters return to baseline. |
OVERDOSAGE
Concurrent elevations of serum GGT and serum ALT may indicate CHOLBAM overdose. In the event of overdose, the patient should be monitored and treated symptomatically. Continue to monitor laboratory parameters of liver function and consider restarting at a lower dose when the parameters return to baseline.
Please see full Prescribing Information for additional Important Safety Information.
About Chenodal® (chenodiol)
Chenodal® is a synthetic oral form of chenodeoxycholic acid (“CDCA”), a naturally occurring primary bile acid synthesized from cholesterol in the liver. The FDA approved Chenodal for the treatment of people with radiolucent stones in the gallbladder. In 2010, Chenodal was granted orphan drug designation for the treatment of cerebrotendinous xanthomatosis (“CTX”), a rare autosomal recessive lipid storage disease.
While Chenodal® is not currently labeled for CTX, it received a medical necessity determination in the US by the FDA and has been used as the standard of care for more than three decades. Travere is working to obtain FDA approval of Chenodal for the treatment of CTX and initiated a Phase 3 clinical trial for this indication in January 2020. The prevalence of CTX is estimated in the literature to be as high as 1 in 70,000 in the overall population.
