Cephalon's Date With the FDA

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In what may be an attempt to square everything away before its New Year's partying begins, Cephalon (Nasdaq: CEPH) announced today that it had submitted another New Drug Application (NDA) for oncology treatment Treanda.

Treanda is Cephalon's most advanced pipeline candidate, acquired back in 2005, when the company bought Salmedix. European drugmaker Astellas developed the drug, and retains rights to sell it on the Continent. Today's marketing application proposed Treanda as a treatment following Biogen Idec's (Nasdaq: BIIB) Rituxan for late-stage non-Hodgkin's lymphoma (NHL), a rare blood disorder.

Cephalon already submitted a marketing application for Treanda to the FDA for treating chronic lymphocytic leukemia (CLL) in September. If approved, Treanda would be used as a front-line agent prior to drugs like Celgene's (Nasdaq: CELG) Revlimid, which are sometimes used off-label to treat CLL.

Cephalon is best known for its wakefulness drug Provigil, which provided the majority of its $1.7 billion in sales last year. It does have a small European oncology drug pipeline,  acquired via its acquisition of Zeneus Holdings in late 2005, and also the rights to Cell Therapeutics' (Nasdaq: CTIC) former leukemia drug Trisenox. Trisenox has never been much of a hit for Cephalon, with its sales getting lumped into the "other" category of the company's quarterly drug sales breakdown.

Treanda will provide a huge boost to Cephalon's oncology assets, provided it can get approved. Approximately 15,000 people are unfortunately diagnosed with CLL in the U.S. every year, and 30,000 patients exhibit the subtype of NHL targeted by this most recent Treanda marketing application.

Cephalon will likely receive a priority review for this marketing application, since it tackles a life-threatening condition. This means that we'll likely hear back from the FDA within six months from Cephalon's application date for each proposal, putting both NDA approval decisions before the middle of 2008.

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