Date: 2016-08-08
Type of information: Licensing agreement
Compound: pracinostat
Company: Helsinn Group (Switzerland) MEI Pharma (USA - CA)
Therapeutic area: Cancer - Oncology
Type agreement: licensing development commercialisation
Action mechanism: histone deacetylase inhibitor. Pracinostat is an oral histone deacetylase (HDAC) inhibitor that has been tested in a number of Phase I and Phase II clinical trials in advanced hematologic disorders and solid tumor indications in both adult and pediatric patients. Pracinostat has been generally well tolerated in more than 300 patients to date, with manageable side effects that are often associated with drugs of this class, including fatigue, myelosuppresion and gastrointestinal toxicity. In a Phase I dose-escalation trial, Pracinostat demonstrated evidence of single-agent activity in elderly AML patients, including two out of 14 (14%) who achieved a CR, with durable responses persisting 206+ and 362 days, respectively. In addition, results from a pilot study of Pracinostat in combination with Vidaza in patients with advanced myelodysplastic syndrome (MDS) showed an overall response rate of 90% (nine out of 10), including eight patients who achieved either a CR or a CRi.
Disease: acute myeloid leukemia and other potential indications including myelodysplastic syndrome
Details: * On August 8, 2016, Helsinn and MEI Pharma announced that they have entered into an exclusive licensing, development and commercialization agreement for pracinostat, a Phase III-ready drug candidate for the treatment of acute myeloid leukemia (AML) and other potential indications. The deal provides the complementary resources from both organizations to rapidly advance pracinostat into Phase III clinical development and expand into additional indications, including high-risk myelodysplastic syndrome (MDS). As part of the development and commercialization agreement, Helsinn and MEI Pharma will also collaborate to explore an optimal dosing regimen of pracinostat in combination with azacitidine for the treatment of high-risk myelodysplastic syndrome. This clinical study is expected to commence in the first half of 2017. Riccardo Braglia, Helsinn Group Vice Chairman and CEO, 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 leukemia (AML), an area of huge unmet medical need. As part of the development, we will also target additional indications. Helsinn is committed to helping people to survive cancer and offer a better quality of living with cancer. This transaction has been approved by the boards of both companies. Destum Partners acted as an advisor to MEI Pharma on the transaction.
Financial terms: Under the terms of the agreement, Helsinn will get exclusive worldwide rights, including manufacturing and commercialization rights, and will be responsible for funding the global development of pracinostat. As compensation for such grant of rights, MEI Pharma will receive near-term payments of $20 million, comprised of a $15 million upfront payment and a $5 million payment upon dosing of the first patient in the upcoming Phase III study of pracinostat in newly diagnosed acute myeloid leukemia patients unfit to receive induction therapy. In addition, MEI Pharma will be eligible to receive up to $444 million in potential development, regulatory and sales-based milestone payments, along with additional tiered royalty payments in selected territories. In a related transaction, Helsinn will make a $5 million equity investment in MEI Pharma.
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