Endo Ventures Limited has entered into definitive agreements with Helsinn to register, commercialize, and distribute pracinostat on an exclusive basis in Canada.

Endo International plc and Helsinn, a Swiss pharmaceutical group focused on building quality cancer care products, are pleased to announce that Endo International plc's subsidiary Endo Ventures Limited has entered into definitive agreements with Helsinn to register, commercialize, and distribute Pracinostat on an exclusive basis in Canada upon receipt of the required regulatory approval.

Under the terms of the agreement, Paladin Labs Inc., an operating company of Endo, will be responsible for the registration, distribution, sales, marketing, medical affairs, pricing and reimbursement activities in connection with Pracinostat in Canada. Helsinn will be responsible for supplying the drug to Paladin and will retain all international development rights, including clinical development activities.

Pracinostat is a novel oral histone deacetylase (HDAC) inhibitor that is in a pivotal Phase III study in combination with azacitidine for the treatment of adults with newly diagnosed acute myeloid leukemia (AML) who are unfit for intensive chemotherapy. It is also being evaluated in a Phase II study in na�ve patients with high or very high-risk myelodysplastic syndrome (MDS). The FDA has granted Breakthrough Therapy Designation for Pracinostat in combination with azacitidine for the treatment of patients with newly diagnosed AML who are ?75 years of age or unfit for intensive chemotherapy.