Last Wednesday, Cell Therapeutics (Nasdaq: CTIC ) announced that it had finally signed a manufacturing agreement with NerPharMa DS, an Italian company, for its potential drug pixantrone. That's good news for the beleaguered company.
Cell Therapeutics is developing the drug to treat patients with a certain type of aggressive non-Hodgkin's lymphoma, or NHL. Craig Philips, company president, has said, "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."
In the meantime, Cell Therapeutics has submitted a pediatric investigation plan to the European Medicines Agency (EMEA) to try to get marketing authorization. The company plans on submitting its application later this year. Here in the U.S., it plans on starting a late-phase clinical trial after the Food and Drug Administration told the company that there were concerns about the study and safety of the drug.
Too many hurdles?
Shares of the biotech, which is based in Seattle, are actually down about 5% since the announcement. However, even if pixantrone overcomes all its hurdles, it faces some stiff competition in the NHL space. Biogen Idec (Nasdaq: BIIB ) has the top-selling NHL drug, Rituxan (it recorded sales of $1.1 billion in 2009); in addition, there's Cephalon's (Nasdaq: CEPH ) Treanda. Last but not least, there's Zevalin, made by Spectrum Pharmaceuticals (Nasdaq: SPPI ) ; Cell Therapeutics used to hold a 50% stake in the company but had to sell to raise cash for operating purposes.
Just shy of 90% of those rating the company from among the 165,000-plus members of our Motley Fool CAPS community think that Cell Therapeutics will outpace the market going forward. There's no doubt that pixantrone would play a big part in the success. What do you think? How likely is Cell Therapeutics to effectively manage the last parts of the development of this new drug, and more importantly, can it survive to do so?
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