Here are my notes from the SUPG presentation at the Roth conference on 3/1/11
- Dacogen guidance for 2011 is $52-55m (slide typo says up to 52m), admits this is conservative, especially as regards progress in ROW
- Still saying that Eisai and JNJ will file the US/EU elderly AML for Dacogen this year. He did not repeat his line about Eisai filing by the end of their fiscal year by 3/31/11- and I repeat my skepticism that either of these filings actually take place
- Worldwide hypomethylator market was >$900m in 2010 (Dacogen plus Vidaza)
- Though elderly AML trial missed primary endpoint of OS, he said there was a "significant trend" towards survival improvement (which of course is a poor choice of words because the whole point was that there was no significance to the result)
- Complete p3 data will be presented around mid-year 2011
- GSK deal now describing as seeking "third-generation" hypomethylators" (dacogen/vidaza are 1st, sgi-110 is 2nd gen)
- GSK- has been 1.5 yrs, have not announced any milestones for selecting leads, but they will announce these events when they occur
- Amuvantinib- slide still says p2 trial will initiate 1h11, verbally said "shortly"- will be 21 pts at first in 10 centers (a couple could be in EU), with stringent response requirement to then enroll 29 more pts
- Over 180 pts dosed already with amuvatinib, wanted to be able to carefully choose indication and see which other drugs it works well with
- Phase 1 results in SCLC and neuroendocrine tumors- 6/13 pts had PRs, 6 more had SD
- Unlike Dacogen and Vidaza which don't accumulate in solid tumors, SGI-110 has the potential to find application in solid tumors in the longer term. COM patent expires 4/2030
- Dose expansion portion of p1/2 SGI-110 trial would be allowed to enroll treatment-naive MDS and elderly AML pts
- Data for both SGI-110 and amuvatinib phase 2 portions would read out in 2012
- PIM kinase program- working on backup compound and next generation series
- Reiterated that will not raise money in 2011
- Question asked about using cash hoard to in-license more assets led to statement that SUPG evaluated 94 asset opportunities over the past year or so, and considered 2 of them of interest. The first was a potential JV with a Japanese company that decided to not partner the asset. The second asset was one in which SUPG was outbid by a larger pharmaceutical company.
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