Helsinn will develop and commercialize MEI Pharma’s Phase III-ready Pracinostat for acute myeloid leukemia (AML) and other potential indications under an agreement that could generate up to $469 million-plus for MEI Pharma.
The deal is aimed at rapidly advancing Pracinostat into Phase III clinical development and expanding the treatment into additional indications that include high-risk myelodysplastic syndrome (MDS), Helsinn and MEI Pharma 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,” MEI Pharma President and CEO Daniel P. Gold, Ph.D., said in a statement. “With this agreement in place, we are now in a great position to move forward with the Phase III study in AML, optimize the development path in MDS, and maintain lucrative economics on future commercial success.”
The exclusive licensing agreement gives Helsinn exclusive worldwide rights, including manufacturing and commercialization rights, to Pracinostat, with Helsinn responsible for funding global development of the candidate.
Helsinn has agreed to pay MEI Pharma $15 million upfront, another $5 million upon dosing of the first patient in the upcoming Phase III study of Pracinostat in newly diagnosed AML patients unfit to receive induction therapy, and up to $444 million in payments tied to achieving development, regulatory, and sales-based milestones. MEI is also eligible to receive additional tiered royalty payments in selected territories.
In a related transaction, Helsinn will make a $5 million equity investment in MEI Pharma.
Helsinn and MEI Pharma have also agreed to collaborate on exploring an optimal dosing regimen of Pracinostat in combination with azacitidine for the treatment of high-risk MDS. The combination will be the subject of a clinical study that is expected to commence in the first half of 2017.
“This agreement broadens our focus beyond cancer supportive care products and into the development of oncology therapeutics,” Riccardo Braglia, Helsinn group vice chairman and CEO, said in a statement. “Helsinn Therapeutics (HTU), our U.S. sales organization, will allow us to accelerate the development and commercialization of this product, once approved, as we will be able to leverage our clinical and regulatory expertise coupled with our existing oncology specialist sales organization.”
The boards of both companies have approved the agreement.