- BPAX webcast a presentation in London at the UBS Specialty Pharma conference - see the Upcoming Events page for the webcast link
- Click here for a PDF file of the slide deck (nothing really new)
- Here are my notes:
- Elestrin was approved by FDA one day before PDUFA date (same Division as will handle Libigel)
- None of the $140m Elestrin milestones will occur in next year or two
- Following lawsuit by ABT, Teva is working to ensure that Bio-T-Gel PDUFA date stays the same (huh?)
- Safety study has enrolled 3500 pts, have 3600 pts years so far. 1400 women on drug >1 yr, 700-800 >2 yrs, 40 >3 yrs
- Would reach 4000 pts in July or August
- Hopeful could be told to stop enrollment early (at meeting by end of May or at next meeting about a month later)...but criteria to stop enrollment is more stringent than needed for FDA approval
- No new safety update (should come soon though), still saying 17 CV events and 8 breast cancers, both below expected rates
- Composite safety endpoint is similar to that used for some diabetes drugs
- Expect top-line safety data "summer" / 3q2012 (this is a timeline slip), file NDA by end of 2012
- Burning ~$4m per month now, will reduce to $3m late 2011 into 2012
- "No intention or need to raise money in 2011" (this recent rally to $3 may test that conviction!...could pay off their debt)
- Expect efficacy data Oct-Nov 2011
- Q&A session:
- Testosterone and Estrogen products will never be available OTC
- Male testosterone products cost $11-12 per day, estimate Libigel price as $8-10 per day
- Estimate Libigel co-pay ($30-50 per month) will be less than cost of compounded prescriptions ($50-80 per month)
- Efficacy trials have upper BMI limit on obesity, safety study has no limit
- Androgel ($900m US sales 2010) has been on marktet 13 yrs w/ no generic, Testin 8 yrs
- All 3 gels (Androgel, Testin, Libigel) have composition of matter (COM) patents covering their formulation components...no patents on testosterone itself
3 Comments
Dan
5/24/2011 01:24:49 am
This is excellent. Thank you for the thoughtful analysis and relevant data. I can't help but notice that among all the meaningless stock tweets on BPAX (e.g. $BPAX NICE, $BPAX VOLUME, $BPAX Breakout!, $BPAX Wants 52 wk high) you are the only one making substantial, helpful, and sometimes critical statements. Keep it up.
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James
5/26/2011 06:28:46 am
Great website and notes! I also took notes but didn't look at yours first in case I might've been biased. It's always good to compare to see what I missed :).
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bill
5/26/2011 10:39:55 am
I was reading through some abstracts presented at a recent meeting at the American Urologic Association in Washington DC from this week. I'm not sure if you can get access to it.
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