- Spectrum Pharma presented a webcast at the Jefferies conference on 6/7/11. Click here for more info on the SPPI research page.
- Here are my notes:
- Company's strength is in clinical development - both early and late stage. Do not hire contract research organizations (CROs), only use SPPI employees to run trials.
- Employees- about 75 in sales/marketing, all with at least 10 yrs oncology experience. 75 in regulatory/clinical affairs. Plus a few for HR/finance functions
- Core risk mitigating strategy- no drug discovery. Goal is to reduce the time to market. SPPI acquires drugs in various stages of development, each with existing human data
- 1q2011 did $40m product revenue, expect well over $100m in revenue for 2011 (note that the company later released an SEC form 8-k to make sure we know that this was just the CEO Raj running his mouth and in no way represents actual guidance - click here for link)
- belinostat and apaziquone NDA planned for 2012 (Belinostat had been forcast for 2011 upon licensing from TopoTarget)
- Broad pipeline behind two marketed and two advanced candidates, but not talk about today (Or ever...They never talk about other candidates and has been no progress of news since they killed the BPH drug licensed from AEZS, except for the collaboration for biosimilar Rituxan)
- Fusilev: in a year or two should be cruising with $180-200m per year (another non-guidance statement of course...depends heavily on competition between Fusilev and generic leuocovorin)
- New comment re submission for removal of Zevalin bioscan requirement: Submitted data on 8000 that pts got bioscan, 6 were abnormal. All 6 of these still got zevalin, and all showed durable efficacy (ie, a partial response PR or complete response CR), no new side effects
- Clinical trial in Rochester, MN compared Zevalin head to head vs rituxan- better outcome on all endpoints (didn't say if were statistically significant or how big the trial was - anyone have a link to the publication if there is one?): Overall Response Rate (ORR) 83% vs 55%; CR 38% vs 18%, Time to Progression (TTP) 12.1 vs 10.1 months
- Merck $MRK obtained good efficacy data with combination of carboplatin/paclitaxel plus histone deacetylase (HDAC) inhibitor- but their HDACi was too toxic so abandoned- belinostat is less toxic becaue is bone marrowing sparing-rationale for the ongoing combo studies
- pivotal trial in PTCL needs 100 pts (no comment on enrollment timeline).
- CUP results by end of 2011
- trial starting in NSCLC (not sure when...)
- apaziquone- bladder cancer is an ignored disease, despite being 5th highest cancer killer
- Phase 3 program with 1600 patients, partnered with Allergan $AGN, last pt observation will occur 12/2011, top line data early 2012, NDA would be in 2012
- Trial design- put ("instill") drug into bladder for 60 min after surgery
- 50/50 split of US rights, allergan has EU rights. SPPI still retains rights for india and some other countries (two separate Asian deals in place - see SPPI research page for details)
- webcast cut off mid sentence...but sounds like he was wrapping up...
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