Helsinn Group and MEI Pharma to develop acute myeloid leukaemia treatment

MEI Pharma to receive $20m, plus up to $444m in potential milestone payments as well as sales royalties

Helsinn, a Swiss developer of cancer drugs has entered into an exclusive licensing agreement with Californian firm MEI Pharma.

The two cancer specialists will work together to develop Pracinostat, a Phase III-ready drug candidate for the treatment of acute myeloid leukaemia (AML) and other potential indications.

Under the terms, Helsinn gains exclusive worldwide rights, including manufacturing and commercialisation rights, and will be responsible for funding the global development of Pracinostat.

MEI Pharma will receive payments of $20m, comprising a $15m upfront payment and $5m upon dosing the first patient in the upcoming Phase III study.

In addition, MEI Pharma will be eligible to receive up to $444m in potential development, regulatory and sales-based milestones, along with tiered royalties in selected territories.

As part of the deal, the firms will also explore an optimal dosing regimen of Pracinostat in combination with azacitidine for the treatment of high-risk Myelodysplastic syndrome (MDS).

This clinical study is expected to start in the first half of next year.

This agreement broadens our focus beyond cancer supportive care products and into the development of oncology therapeutics

In a related deal, Helsinn will make a $5m equity investment in MEI Pharma.

Riccardo Braglia, Helsinn Group Vice Chairman and CEO, said: 'This agreement broadens our focus beyond cancer supportive care products and into the development of oncology therapeutics.

'Helsinn Therapeutics (HTU), our US sales organisation, will allow us to accelerate the development and commercialisation of this product, once approved.'

Daniel P. Gold, President and CEO of MEI Pharma, added: 'Helsinn is an ideal strategic partner to entrust the development of Pracinostat.

'Helsinn has a strong commercial presence in the US and, globally, has been able to create and coordinate a solid and significant network of 70 commercial partners in 90 countries.

'Helsinn's antiemetic, Aloxi, is a market leader and is often used by patients receiving azacitidine, so their commercial organisation is well positioned to market Pracinostat for the treatment of AML and MDS.'

The US FDA recently granted Breakthrough Therapy Designation for Pracinostat in combination with azacitidine for the treatment of patients with newly diagnosed acute myeloid leukemia (AML) who are over 75 or unfit for intensive chemotherapy.

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