Swiss pharmaceutical group Helsinn has entered into an exclusive licensing, development and commercialisation agreement with US-based oncology company MEI Pharma for Pracinostat to treat acute myeloid leukaemia (AML).
Pracinostat is an oral histone deacetylase (HDAC) inhibitor that can be used to treat patients affected with AML and other potential indications.
Helsinn Group vice-chairman and CEO Riccardo Braglia said: “Helsinn is delighted to be entering into this agreement with MEI Pharma for the exclusive rights on Pracinostat, a promising late-stage novel asset.
“In the first instance we will target acute myeloid leukaemia (AML), an area of huge unmet medical need. As part of the development, we will also target additional indications.”
The two companies will work together to advance Pracinostat into Phase III clinical development as soon as possible, as well as expand into additional indications, such as high-risk myelodysplastic syndrome (MDS).
Under the deal, Helsinn will be responsible for providing funds for the development of Pracinostat worldwide.
The Swiss company will obtain exclusive global rights, along with manufacturing and commercialisation rights for the drug.
MEI Pharma, however, will receive near-term payments of $20m, of which $15m will come from upfront payment and $5m from payment upon dosing of the first patient in the Phase III study of Pracinostat.
Under the Phase III study, the dosing will be carried out in newly diagnosed AML patients who are not fit enough to receive induction therapy.
The company will additionally be eligible for receiving up to $444m in potential milestone payments and royalties on future sales.
As part of the agreement, Helsinn will also work in collaboration with MEI Pharma to study an optimal dosing regimen of Pracinostat in combination with azacitidine to treat patients with high-risk MDS.
MEI Pharma president and CEO Dr Daniel Gold said: “Including MDS along with AML in the development plans was a critical component to this deal, as it significantly increases the market opportunity for Pracinostat.
“With this agreement in place, we are now in a great position to move forward with the Phase III study in AML, optimise the development path in MDS, and maintain lucrative economics on future commercial success.”
The clinical study for MDS treatment is expected to begin in the first half of next year.
Image: Bone marrow aspirate showing acute myeloid leukaemia. Photo: courtesy of VashiDonsk.