CEPH Cephalon (MM)

Cell Therapeutics (CTIC) recently met with the Division of Oncology Drug Products (the DODP) of the US Food and Drug Administration (FDA) and received guidance for resubmission of the new drug application (NDA) for its lead pipeline candidate pixantrone. Pixantrone has been developed for the treatment of relapsed or refractory aggressive non-Hodgkin’s lymphoma (NHL) in patients who have not responded to other treatment options. The company is also looking for accelerated approval of the NDA based on data from the PIX301 study.

The meeting follows the early May decision of the Office of New Drugs (OND) of the FDA allowing the company to re-submit the NDA for pixantrone for review without the need for an additional trial. The OND recommended Cell Therapeutics to conduct an additional independent radiologic review utilizing a new independent panel of radiologists of the PIX301 trial (which formed the basis of the original NDA) to determine the soundness of the primary endpoint. The company is also required to submit new information regarding circumstances of stopping trial early. The DODP focused on the information that Cell Therapeutics proposes to submit and on the composition of the new radiology expert panel. Cell Therapeutics also aims to address items noted in the complete response letter (CRL) issued by the FDA in April 2010.

The CRL for pixantrone was issued due to concerns that PIX301 has 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. Although the company began an additional trial for pixantrone (PIX306) in March 2011, Cell Therapeutics appealed to the OND in December to reverse the FDA’s decision to deny approval of pixantrone. Cell Therapeutics met with the FDA OND and presented documents supporting the efficacy of pixantrone for the desired indication.

The DODP will review the NDA within 6 months of the resubmission. Cell Therapeutics will resubmit the NDA later in 2011 and anticipates receiving approval in the first half of 2012.

The decision of OND has removed a major overhang for the company and revived the prospects of pixantrone. The company has been saved 2-3 years time by getting the opportunity to file on the basis of the original completed trial PIX301 instead of the new trail PIX306.

Our Recommendation

We currently have a Neutral recommendation on Cell Therapeutics.

We believe the uncertainty surrounding the approval of Cell Therapeutics’ lead pipeline candidate 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 is expected to be approved in 2011. However, we prefer to remain on the sidelines since 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 will face tough competition from several established products in the market. One of the top-selling drugs for the treatment of NHL is Biogen/Roche’s (BIIB/RHHBY) Rituxan. Other competing products include Sanofi Aventis’ (SNY) Campath, Takeda’s Velcade and Cephalon's (CEPH) Treanda.

 
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