Cell Therapeutics has signed a manufacturing agreement with NerPharMa DS (a pharmaceutical manufacturing company belonging to Nerviano Medical Sciences S.r.l. (“NerPharMa”), in Nerviano, Italy) for CTI’s drug candidate pixantrone. The five-year contract between CTI and NerPharMa provides for both the commercial and clinical supply of pixantrone. CTI is developing pixantrone as a treatment option for patients with relapsed or refractory aggressive non-Hodgkin’s lymphoma (“NHL”). CTI is currently preparing to submit a Marketing Authorization Application (“MAA”) in the European Union, and plans to initiate a Phase III trial of pixantrone in patients with relapsed or refractory aggressive NHL in the U.S. Both are planned for this year.
CTI announced on June 14, 2010 that the Italian Medicines Agency (AIFA), the national authority responsible for drug regulation in Italy, had approved the facility at NerPharMa for the production of pixantrone.
“We are pleased to have reached an agreement with NerPharMa for the long-term manufacture of pixantrone,” said Craig W. Philips, President of CTI. “Entering into this agreement puts us one step closer to fulfilling our mission of being able to provide pixantrone to patients with relapsed or refractory aggressive NHL, a setting for which there are currently no approved treatment options.”
