- Quick notes from 10/26/2011 presentation by BPAX (click for full research page) at BIO Investor Forum (click for complete webcast calendar) --
- Pill Plus contraceptive release of additional phase 2 data: slide now says 2011/2012 not 2011 as in previous webcasts
- Simes: "BPAX is the 3rd company i've been CEO of, last 2 were sold to larger players"
- LibiGel business development strategy: "our intention is to license the product"
- ABT acquired androgel (male testosterone gel) via Solvay acquisition
- men and women both produce maximum testosterone levels in their 20-30s, and levels decrease by a couple % per year after that
- Libigel efficacy phase 3 program included 135 US sites, 6 canada
- Libigel safety trial update: >2000 women on study for over 1 yr, 744 >2 yrs, almost 400 >3 yrs. Average exposure is almost 16 months. When we break blind Summer 2012, we will be at ~24 month average exposure
- Warner Chilcott (bought pharma division from Proctor and Gamble PG) has refused, for cost reasons primarily, to do a cardiovascular safety trial for the Intrinsa testosterone patch (which is marketed in Europe)
- Company is now focused on safety study and NDA preperation
- We have enough cash to get beyond NDA submission and maybe even to FDA approval
- Efficacy data is being gathered for data lock and announcement later this quarter
- Efficacy data will be in the time period of "early to mid December" [has slipped slightly again from "late November or early December"]
- Safety topline data: need 60-75 days of info gathering after 6/2 last patient last visit, so will occur sometime in the "Summer 2012"
- Potential approval and launch mid-2013 [this would required priority review, which the company insists is likely but many other are skeptical]
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