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news.Helsinn has agreed to develop and commercialize MEI Pharma’s Pracinostat drug candidate for acute myeloid leukemia (AML) and other potential indications.
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The licensing, development and commercialization agreement is intended at rapidly advancing Pracinostat into phase III clinical development and expanding the treatment into further indications that include high-risk myelodysplastic syndrome (MDS).
The deal gives Helsinn exclusive global rights, including manufacturing and commercialization rights, to Pracinostat. The company will also be responsible for funding worldwide development of the candidate.
Helsinn has agreed to pay MEI Pharma $15m upfront, another $5m after dosing of the first patient in the upcoming Phase III study of Pracinostat in newly diagnosed AML patients unfit to receive induction therapy.
MEI Pharma will also be eligible to receive up to $444m in potential milestone payments as well as royalties on future sales.
In a related transaction, Helsinn will make a $5m equity investment in MEI Pharma.
The companies have also agreed to collaborate on exploring an optimal dosing regimen of Pracinostat in combination with azacitidine to treat high-risk MDS.
The combination will be the subject of a clinical study that is expected to start in the first half of 2017.
The US Food and Drug Administration recently granted breakthrough therapy designation for Pracinostat in combination with azacitidine to treat patients with newly diagnosed AML who are ≥75 years of age or unfit for intensive chemotherapy.
Image: Myeloblasts with Auer rods seen in acute myeloid leukemia. Photo: courtesy of Paulo Henrique Orlandi Mourao.