Helsinn and MEI Pharma join forces to develop leukaemia drug Pracinostat
pharmafile | August 9, 2016 | News story | Manufacturing and Production, Research and Development | Helsinn, MEI Pharma, Pracinostat, chronic myeloid leukaemia
Swiss pharmaceutical group Helsinn has entered an agreement with MEI Pharma over the licensing, development and commercialisation of Pracinostat (SB939) as a treatment of acute myeloid leukaemia (AML) and other hematologic diseases.
The partnership allows the sharing of mutual resources to accelerate the Phase II-tested drug’s journey into Phase III clinical development and explore other treatment applications such as high-risk myelodysplastic syndrome (MDS).
Under the terms of the agreement, Helsinn possesses exclusive worldwide rights to the manufacture and commercialisation of Pracinostat in exchange for funding its global development. MEI Pharma will receive $20 million in near-term cash payments and up to $444 million in potential milestone payments, as well as tiered royalties on future sales in selected territories.
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 leukaemia (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 agreement broadens our focus beyond cancer supportive care products and into the development of oncology therapeutics,” Braglia continued. “Helsinn Therapeutics (HTU), our US sales organisation, will allow us to accelerate the development and commercialisation of this product, once approved, as we will be able to leverage our clinical and regulatory expertise coupled with our existing oncology specialist sales organisation.”
Pracinostat is an oral hisone deacetylase (HDAC) inhibitor, recently granted Breakthrough Therapy Designation by the FDA for treatment in combination with azacitidine. Phase II results taken from 50 participants showed a median overall survival of 19.1 months and a complete response (CR) rate of 42% for a combination of the two drugs, compared to a median overall survival of 10.4 months with azacitidine alone and a CR rate of 19.5%.
“Helsinn is an ideal strategic partner to entrust the development of Pracinostat,” said Daniel Gold, president and chief executive officer of MEI Pharma. “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.”
Matt Fellows
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