Shire ends pacritinib development deal with CTI post Baxalta merger

By Dan Stanton

- Last updated on GMT

Image: iStock/conejota
Image: iStock/conejota

Related tags Food and drug administration

Shire has abandoned its partnership on CTI BioPharma’s oral kinase inhibitor pacritinib seven months after deaths in a Phase III trial halted its clinical development.

In 2013,​ Baxter International penned a development and commercialisation agreement with CTI Biopharma for pactrinib, a kinase inhibitor intended to treat the blood cancer myelofibrosis.

The partnership continued with Baxalta – Baxter’s biopharma spin-off – taking the reins. But months after Baxalta was acquired for $32bn, its new owner Shire has abandoned the agreement, according to an SEC announcement filed by CTI yesterday.

“On September 13, 2016, the Company received a notice from Shire of Shire’s termination of the License Agreement,”​ CTI said.

“[CTI] and Shire currently intend to draft and negotiate a binding, definitive agreement,”​ it continued. “There can be no assurances that the Company and Shire will be able to finally negotiate and execute a definitive agreement.”

Kelly Schlemm, a spokesperson from Shire told this publication the move allows the firm to be "better able to strategically focus resources on the right opportunities for the business and the patients we serve."

She added: "The transfer of ongoing pacritinib activities from Shire to CTI will begin immediately and over the course of the next 30 days, as we work to finalise the asset return agreement."

In February, development of the candidate was stunted when patients died during a Phase III study – known as PERSIST-2 – examining whether once-daily or twice-daily pacritinib resulted in a greater proportion of patients with thrombocytopenia and myelofibrosis achieving ≥ 35% reduction in spleen volume from baseline.

This led to the US Food and Drug Administration (US FDA) placing the candidate on full clinical hold, which - as of late last month​ - is still ongoing.

When asked whether the decision to terminate the deal was a response to the clinical hold, Schlemm said it "was made in light of the risk-benefit profile for patients that we observed."

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