A few weeks after Seattle-based CTI Biopharma’s $CTIC troubled myelofibrosis drug pacritinib turned in some mixed late-stage data, Shire is preparing to punt its interest in the therapy.
Pacritinib was put on a full clinical hold by the FDA earlier in the year after investigators determined that patients in the drug arm were dying at a faster pace than the control group. That helped sink the biotech’s stock, which is now firmly entrenched in penny stock territory. The stock closed at 36 cents today.
According to an SEC filing, Shire — which inherited the licensing pact with its Baxalta buyout — told CTI a few days ago that it wanted to terminate the pact and hand back rights to the drug. They’re working out the final terms of the exit now.
CTI has already bagged plans for an NDA.
Baxter paid CTI $60 million upfront — with up to $112 million in milestones — to partner on the drug back in 2013, then handed the deal over to Baxalta in the spinout, which was followed closely by the Shire buyout. Shire gained a number of cancer drugs in the Baxalta deal, and has indicated its interest in continuing most of them.
Investigators pitted pacritinib, a JAK2/FLT3 treatment, against best available care among high-risk myelofibrosis patients. The preliminary results for PERSIST-2 demonstrated a “statistically significant response rate in spleen volume reduction in patients with myelofibrosis treated with pacritinib…. Although the PERSIST-2 trial did not meet the other co-primary endpoint of greater than 50 percent reduction in Total Symptom Score (TSS), the preliminary analysis approached marginal significance compared to BAT (p=0.0791).”
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