Recently, Cell Therapeutics, Inc. (CTIC) 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.
We remind investors that Cell Therapeutics originally submitted the PIP in September 2009. However, pixantrone’s potential but unconfirmed benefit to children in reducing long-term cardiotoxicity in combination with current medications prompted the pediatric committee of the EMEA to ask for an expanded PIP in April 2010. Earlier in the year, pixantrone was denied approval by the US Food and Drug Administration (FDA) on account of insufficient clinical data.
Our Recommendation
Cell Therapeutics is a Zacks #3 Rank (Hold) stock, which indicates that it is expected to perform in line with the overall US equity market for the next 1 to 3 months. Our long-term Neutral stance on the company indicates that the stock is expected to replicate its short-term performance over the next 6 to 12 months. Consequently, we advise investors to retain the stock over the time period.
Our short-term as well as long-term recommendation on the stock is supported by the lack of estimates revisions by the analysts covering Cell Therapeutics over the last thirty days. This indicates a lack of directional pressure on the stock.
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