- $29m Zevalin sales in 2010- still won't give guidance for 2011. Q on Q growth rate decreased in the 4th quarter from the 3rd quarter- of course management says this is a bad metric to evaluate sales...
- Management hopes that Zevalin will "one day" have sales between $100-300m
- Zevalin is a medical not prescription reimbursement, so no need to establish which "tier" of reimbursement/copays, etc
- $104m cash on hand at year-end 2010, 7m warrants expired unexercised during 2010
- SPPI estimates that >30,000 US colorectal cancer patients treated with Fusilev during leucovorin shortage
- Fusilev is not currently being promoted- but if approved for CRC, could promote with existing Zevalin team- no need to expand sales force
- SPPI now has multiple manufacturers in place for Fusilev
- Application for oral fusilev is under FDA review, but stuck in backlog
- Rondman and Renshaw analyst stated info he had heard that Barr and Teva had indicated that they would have leucovorin manufacturing shortage resolved by April
- Apaziquone- have been discussing additional trial protocol with FDA for initiation in 2h2011 with Allergan. THis multiple instillation trial will be in a different population than previously though- will be in higher risk non-superficial bladder (vs a trial in BCG failure pts). They now have an SPA in place for the new trial
- Asian apaziquone partners are rapidly enrolling PK bridging studies and are discussing ways to bridge these partners/regions to the newly contemplated bladder cancer trial
- Belinostat- last patient evaluation in the PTCL trial will occur in December 2011, causing the NDA filing to slip into 2012 (had been stated to be 2011 ever since in-licensing from TopoTarget)
- Expect an update soon on plans for Belinostat in NSCLC.
- Belinostat CUP trial enrollment complete in December 2010, most of the pts relapse within 6 months, this trial is controlled by TopoTarget, expect results in 2011
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