CTI BioPharma said today it has regained worldwide development and commercialization rights to the Phase III myelofibrosis drug candidate pacritinib from Baxalta—now a Shire subsidiary—after the two companies inked an asset return and termination agreement following the end of a collaboration that could have generated up to $172 million-plus for CTI.
CTI’s disclosure today comes more than a month after the company revealed on September 19 that it was negotiating a formal agreement ending the collaboration after receiving a termination notice from Shire, which acquired Baxalta for $32 billion in a deal completed June 3.
Under the termination agreement, Baxalta agreed to pay CTI a one-time cash payment of approximately $10.3 million “as reimbursement for certain expenses incurred or to be incurred,” CTI said.
In return, CTI agreed to pay Baxalta a one-time $10.3 million payment upon the first regulatory approval, or any pricing and reimbursement approvals, of a product containing pacritinib—a sum CTI said reflected amounts paid by Baxalta toward pacritinib program manufacturing efforts.
CTI also agreed not to transfer, license, sublicense, or otherwise grant rights with respect to intellectual property of pacritinib unless the transferee, licensee, or sublicensee agrees to abide by the termination agreement.
CTI—then called Cell Therapeutics Inc.—and Baxter International, from which Baxalta was later spun out, agreed to partner in commercializing pacritinib under an exclusive worldwide agreement valued at up to $172 million plus and signed in November 2013.
Pacritinib is an oral tyrosine kinase inhibitor with activity against Janus associated kinase 2 (JAK2) and FMS-like tyrosine kinase 3 (FLT3).
Pacritinib’s development suffered a setback in February, when the FDA imposed a full clinical hold on the candidate after the Phase III PERSIST-1 trial showed a higher number of deaths and adverse events in pacritinib-treated patients compared to the control arm. CTI withdrew its NDA for the candidate, saying it would conduct a review of safety and efficacy data from the PERSIST-2 Phase III trial before deciding next steps.
But PERSIST-2—which compared pacritinib against best available therapy (BAT), including ruxolitinib—generated mixed results. The company said August 29 that the candidate met one of the study’s co-primary endpoints by showing a statistically significant response rate in spleen volume reduction in patients with myelofibrosis treated with pacritinib compared to BAT, including the approved JAK2 inhibitor ruxolitinib.
However, pacritinib did not meet the other co-primary endpoint of greater than 50% reduction in Total Symptom Score.
In today’s regulatory filing, CTI also disclosed agreement by the company board’s compensation committee on a pay package for interim CEO and President Richard L. Love, who was appointed effective October 2—the day the company said his predecessor James A. Bianco, M.D., retired after 25 years at the company’s helm.