The resurrection of LUM001: Mike Grey gets his drug back from Shire — along with $120M to gamble on PhIII trials
EXCLUSIVE: In drug development, failure isn’t always fatal. Just ask Mike Grey.
When Grey completed his deal to sell Lumena to Shire back in 2014 for $260 million-plus, Shire was left in full control of the charge to what it hoped would be a near-term approval for a drug designed to control excess bile acids and extreme itching.
A year later, though, the lead program for LUM001 was apparently in tatters, with an ugly mid-stage failure for rare cases of Alagille syndrome (ALGS) that appeared to wipe out the blockbuster value Shire CEO Flemming Ornskov had once envisioned when he did the deal. Then 2 years ago there was another critical trial breakdown for the drug, then known as SHP625, with no significant reduction from baseline in serum alkaline phosphatase or other liver parameters in patients with primary sclerosing cholangitis (PSC).
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