- BioSante presented 9/27 at the JMP Securities conference - click here for full biotech webcast calendar and links to my notes.
- Complete background info on LibiGel can be found on the BPAX research page.
- Keep reading for my complete notes from the presentation (new updates/info are in bold):
- last patient, last visit for second trial is this week..so trials will be complete this week
- "by definition" teva did not infringe ABT patents because they filed ANDA not NDA [this is questionable logic to me...]
- Teva believes they'll straighten out the legal issues well before 11/14/2011 PDUFA date [this hasn't been said before, and isn't really clear what is meant by this statement exactly]
- last woman in LibiGel safety trial was enrolled june 2, 2011 - so 6/2/2012 safety data analysis can begin
- 2000 patients on safety trial over 1year, 744 over 2 years, >300 over 3 yrs on therapy
- Following trials closing, data clean up/queries, then hope to release data around Thanksgiving-December 1 plus or minus a few days
- It's a matter of being sure that data pristine before breaking the blind
- 7th unblinded safety review (cardiovascular, breast cancer, all other safety events) will be in the first or second week or October, then we will announce their recommendation
- at break of blind, safety trial average exposure will be 20-24 months, some patients will have been on drug over 4 years
- safety committee mainly composed of cardiologists and endocrinologists
- women are more willing to report sexual dysfunction and more likely to seek treatment compared to men
- We have raised $125m in last 15 months, $90-95m of this spent on libigel
- We are now 60-75 days away from efficacy data
- NDA filing November or December 2012. We expect priority review
- Clarification...this week - second trial complete? yes
- data release for the two efficacy trials together or alone? It is making more sense now to release both at same time
- CV risk- the risk is FDA will want more data. Is there any reason to believe it would take more or less than a year of testosterone therapy to start seeing risk? There is no correlation between time on treatment and occurence of events. 4 of the CV events came during screening (ie, before randomization or any treatment)
- when do you see the efficacy effect? Testosterone reaches steady state concentration within 2-3 days. We saw statistical difference around month 3. Maximum effect at months 4-5, then plateau...advice to women and doctors should be to stay on therapy 2-3 months to see if effect is real. Mood improvements and other benefits are seen initially while waiting for sexual benefits
- what is a successful efficacy outcome? 2 coprimary and secondary outcomes. # of Satisfying Sexual Events (SSE) - we will announce difference from baseline and difference from placebo. An FDA advisory committee voted that an increase of 0.9-1 event is clinically meaningful. Anything more than that doesn't matter to doctor if drug is FDA approved, as they know each woman will respond differently.
- margins? owe small royalty? Libigel will enjoy typical old time pharma margins (90% or better, including the 4.5% royalty to AIS). We surveyed payors covering 80-90% of patient lives. They are ambivalent to cost....no impact of $3,4,7,10 or per day. We would charge $10/day to maximize revenue. Compare this to cost of male testosterone at $12-14 per day. Viagra etc cost $15 each, so monthly cost depends of frequency of use. Research shows LibiGel would be reimbursed at same rate as ED.
- According to aesthetics companies, self pay has not suffered in this market...we are beginning to think that the self pay market is larger than we had anticipated.
- Cancer vaccines- 15 trials ongoing. We only spend money on patent maintenance.
- PK data - hope to present at medical meeting 1q2012. Observed no build up of testosterone. No effect of oral or transdermal estrogen. No conversion of testosterone to estradiol. Testosterone levels drop back to baseline after cessation of therapy. Blood levels very similar to Libigel phase 2 and Intrinsa phase 3 data