Recently, Cell Therapeutics, Inc. (CTIC: 0.4243 -0.0057 -1.33%) inked a five-year manufacturing deal with Italian pharmaceutical manufacturing company NerPharMa, S.r.l. for Cell Therapeutics’ candidate pixantrone. The candidate is being developed for the treatment of relapsed or refractory aggressive non-Hodgkin’s lymphoma (NHL) in patients who have not responded to other treatment options.NerPharMa belongs to Nerviano Medical Sciences S.r.l. of Italy. Nerviano is the largest facility for research and development in Italy. The deal, whose financial clauses were not disclosed, takes care of both the commercial and clinical supply of pixantrone.
Last month the company reported that the Italian Medicines Agency (AIFA) has approved the facility at NerPharMa for producing pixantrone. AIFA is the drug regulatory authority in Italy. Cell Therapeutics intends to initiate a late-stage study in the US of pixantrone for the same indication later in the year.
Recently, Cell Therapeutics submitted an expanded Pediatric Investigation Plan (PIP) to the European Medicines Agency (EMEA) for pixantrone. The PIP provides the outline of the process the company intends to follow to study the drug in children. The pediatric program intends to evaluate the safety and efficacy of pixantrone compared to chemotherapy drug doxorubicin in children (aged between 6 months and 18 years). The company intends to submit a Marketing Authorization Application (MAA) seeking marketing approval for pixantrone in the EU later in the year.
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