Based on encouraging sales to date, Horizon Therapeutics (NASDAQ:HZNP) boosts its peak sales expectation for Krystexxa (pegloticase injection) to more than $1B from more than $750M. Sales growth in 2019 should be more than 25%.
Results from an open-label pilot study, MIRROR OL, evaluating the combination of Krystexxa and methotrexate in gout patients showed a 79% (n=11/14) complete response rate (patients achieving serum uric acid below 6 mg/dL at month 6). By comparison, the response rate was 42% in the Phase 3 program assessing Krystexxa alone.
A separate 135-subject study, MIRROR RCT, evaluating the combination in gout patients is in process with an estimated primary completion date in February 2021. The data will support a label update.
It is planning to evaluate a significantly shorter infusion duration (currently at least two hours) in a proof-of-concept study that should launch mid-year.
The company is also boosting its U.S. peak sales outlook for teprotumumab to more than a $1B from more than $750M. Its marketing application for thyroid eye disease is currently under FDA review with an action date of March 8. It plans to evaluate the IGF-1R inhibitor in diffuse cutaneous scleroderma.
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