Biosante Pharma $BPAX JMP Securities webcast notes 5/9/2011

• Here are my notes from the presentation last night. New updates are in bold.
• Libigel FDA filing will be same division that approved elestrin
• submit libigel NDA in 2012
• male testosterone gel market in 2010: 2 products combined for $1.1b sales
• Abbott Labs $ABT quickly filed patent infringement suit, Teva asserted non infringement in NDA (this confirms that the ABT lawsuit was regarding BioTGel rather than some other Teva generic testosterone product filed via ANDA pathway)
• 3400 women randomized to date in Libigel safety study. >3600 women yrs exposure (this is a new update. reach 4000 no later than july or august. hopeful that could stop early and be sure of statistics for endpt. >1300 pts on tx over 1 yr. >700 over 2 yr, 10-12 >3yrs
• coprimary endpoints in efficacy trials are SSE and change in "mean desire" score
• Sought SPA to make sure FDA was on board with concept and what BPAX was doing for FSD
• p2 2.5 SSE during baseline 4 wks, at month 3 was 7.5 sse. placebo only increased to 4.1 (3.4 difference with Libigel)
• On safety study, 65% of pts have high BP and cholesterol. 4-5% have prior CV event
• both efficacy trials covered by SPA
• next safety update by end of May 2011
• 2009- 4m offlabel rx written for testosterone (includes both male products or compounding). no 2010 #s yet
• two papers published (JAMA and NEJM) showed 43% rate of FSD/low desire in female population (higher rate than males)
• 30% of women that complain  about low desire/sevual dysfunction to their OB/GYN are currently treated with off label products
• cancer vaccines- 15 p1 and 2 trials ongoing at no cost
• melanoma and prostate clinical trials will start this year
• think that the later they partner libigel, the better the transaction will be for stockholders
• effiacy data early 4th qtr in October -November timeframe (this is another slight slip)
• topline saefty data 3q12
• Additional pill plus  data 2011 (oral use)
• cash well into 2nd or 3rd qtr 2012
• q&a session:
• Will they get any efficacy data from safety trial? Safety trial has broader population (surgically and naturally menopausal women) But will collect/obtain minimal efficacy information
• ovaries produce 50% of woman's testosterone (hence efficacy trials are in surgically menopausal women)
• how does teva plan to position biotgel upon approval? we dont know yet- Teva hasn't told us. Reiterated that BioTGel was filed as NDA not ANDA
• Warner Chilcott not doing safety study for Intrinssa despite supposedly huge market-- do they know something bpax doesn't?  W-C doesn't really fund much r&d. They made the acquisition to get PG's currently marketed products. Not want to fund $100-150m safety study. BPAX believes "other people should be in this mkt" but no one else is.
• male testosterone market was only $25m in 1995.