Read Zacks_Analysts' blog in RSS
August 24, 2011
Share This
Cell Therapeutics Inc. (CTIC) recently announced that it has moved a step closer to getting its lead pipeline candidate pixantrone approved in the European Union. Cell Therapeutics submitted a response to the Day 120 List of Outstanding Issues to the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) relating to the Marketing Authorization Application (MAA) filed for pixantrone.
Cell Therapeutics is looking to get pixantrone approved for the treatment of relapsed, aggressive non-Hodgkin's lymphoma (NHL) in patients who have not responded to other treatment options.
Cell Therapeutics is expecting to get an opinion from CHMP regarding approval of pixantrone in the first quarter of 2012. Approval of the drug in Europe will boost Cell Therapeutics’ top line and provide it with some much needed funds.
In the US, Cell Therapeutics has been allowed to re-submit its new drug application (NDA) to the US Food and Drug Administration (FDA) after being denied approval on the basis of the first NDA filing. In December 2010, Cell Therapeutics filed an appeal against the regulatory body’s decision to deny approval to pixantrone due to concerns that the late stage trial PIX301 (which formed the basis of the NDA filing) had not sufficiently proved the effectiveness of the drug.
The FDA asked Cell Therapeutics to conduct an additional trial to determine the safety and efficacy of pixantrone. Cell Therapeutics met with the FDA Office of New Drugs (OND) in May 2011 which allowed it to re-submit the NDA for pixantrone without the need for an additional trial.
The OND recommended Cell Therapeutics will have to conduct an additional independent radiologic review utilizing a new independent panel of radiologists of the PIX301 trial to determine the soundness of the primary endpoint. The company will also submit new information regarding circumstances of stopping the PIX 301 trial early.
In June 2011, the company received guidance on how to proceed with the resubmission from the Division of Oncology Drug Products (DODP). The DODP focused on the information which the company proposes to submit and on the composition of the new radiology expert panel. The DODP will review the NDA within 6 months of the resubmission. Cell Therapeutics will re-submit the NDA in the fourth quarter of 2011 and anticipates receiving approval in April 2012.
The decision from the OND has removed a major overhang for Cell Therapeutics and revived the prospects of pixantrone. The company has been saved two to three years of time by getting the opportunity to file on the basis of the original completed trial PIX301 instead of the new trial PIX306 which the company began in March 2011.
Our Recommendation
We currently have a Neutral recommendation on Cell Therapeutics. The stock carries a Zacks #3 Rank (short Hold rating).
We believe the uncertainty surrounding the approval of pixantrone, for aggressive NHL, in the US has eased following the opportunity given by the FDA to resubmit the NDA. Moreover, the drug is also under review in Europe and progressing well.
Cell Therapeutics’ other pipeline drugs Opaxio and tosedostat, also studied for different types of cancers, create synergies with pixantrone. We nevertheless prefer to remain on the sidelines as Cell Therapeutics is heavily dependent on the approval of pixantrone.
Therefore, any delay in gaining approval would be a major blow for the company. Even if pixantrone gains approval it is sure to face tough competition from several established products in the market.
Read the full analyst report on "CTIC"
Zacks Investment Research