Baxter International will join Cell Therapeutics (CTI) in commercializing the Phase III myelofibrosis drug candidate pacritinib in the United States, while holding exclusive commercialization rights to the compound in the rest of the world, in a deal that could net Cell Therapeutics more than $172 million, the companies said today.
Under an exclusive worldwide licensing agreement, Baxter agreed to pay CTI $60 million up front—of which half will consist of a $30 million equity investment in CTI—and up to $112 million in payments tied to undisclosed clinical, regulatory, and commercial launch milestones. Nearly one-third of the milestone payments, $40 million, could be made in 2014 based on undisclosed clinical benchmarks.
In addition, CTI will receive royalties on net sales of pacritinib in markets outside the United States, with the companies sharing U.S. profits equally. Baxter will record a special pre-tax in-process research and development charge of about $30 million in the fourth quarter of this year.
Pacritinib is an oral tyrosine kinase inhibitor with dual activity against JAK2 and FLT3. Phase I and II studies showed encouraging results, including meaningful clinical benefits coupled with good tolerability among patients with advanced myelofibrosis. The drug candidate’s Phase III program consists of two clinical trials: PERSIST-1, which will study efficacy and safety in a broad set of patients with myelofibrosis without limitations on blood platelet counts, and PERSIST-2, which will evaluate efficacy and safety in patients with low platelet counts. PERSIST-2 is expected to begin by year’s end.
''The collaboration will complement Baxter’s existing oncology business and growing oncology pipeline, and will leverage our global commercialization capacity to extend the availability of pacritinib, which we believe has the potential to address a significant unmet medical need,'' Baxter BioScience president Ludwig Hantson, Ph.D., said in a statement.
CTI licenses pacritinib from Singapore-based S*BIO under a $30 million deal signed last year.
CTI hopes pacritinib will fare better in clinical trials than its tosedostat (IND 075503) program against blood-related cancers. The FDA placed a partial clinical hold earlier this year following the myocarditis death of a patient, the company disclosed in a June 23 regulatory filing.