Libigel - competition and market exclusivity
- Boehringer Ingelheim (B-I) had flibanserin antidepressant drug in trials for premenopausal HSDD (data 11/2009- 4 p3 trials, not all of which hit primary endpt- click here for press release, high dropout, sexual data was comparable to P&G patch, much worse than libigel p2-have initiated more trials)--negative FDA panel 6/2010 (click here for slide deck ... click here for committee questions ... click here for company report ... click here for FDA briefing document) and discontinued 9/2010.
- 11/3/10 webcast: B-I failed to convince FDA to allow monthly rather than daily diary of SSE's
- P&G (since sold to Warner Chilcott) has run 5 efficacy but not enough safety studies (14-3 effective, 0-17 safe vote) for competing Intrinsa testosterone patch [30-50% site irritation],
- Intrinsa is sold in EU (France, Italy, Spain, U.K., Germany and others) but 9/2010 withdrew application for extension of indication to menopausal women. Current Warner Chilcott 10k says will not develop the product further (3/15/11 webcast)
- 4/15/11 webcast: Intrinsa 74% increase SSE rated as clinically meaningful by FDA advisory committee- same 300 ug dose as libigel trials. 33% irritation rate seen for patch. Since has been discontinued from active US development
- 5/9/11 webcast question: Warner Chilcott is not doing safety study for Intrinssa despite supposedly huge market-- do they know something BPAX doesn't? Answer: W-C doesn't really fund much r&d. They made the acquisition to get PG's currently marketed products. They do not want to fund $100-150m safety study. BPAX believes "other people should be in this mkt" but no one else is at the present time
- 2010 10K: there are no approved products for the indication and none in phase 3 development for the US market. 4/15/11 webcast- know of no competitors even in phase 2
- Would be eligible for 3 yrs Hatch-Waxman market exclusivity and 6 month pediatric extension, estimate that it would take anyone else 5-6 yrs to get approvals.
- Formulation patent expires 6/2022 and one pending for low dose in bottle for this indication that would expire later than 2022. There is no patent protection on testosterone...Libigel, like Androgel and Testin, have formulation patents covering the other components of the gel...male products have achieved 8-13 yrs market exclusivity so far w/o generic competition (5/24/11 webcast)
Guidance on Libigel clinical trial progress, regulatory timeline, and costs
- Note: I've maintained the history of all of the stated timelines and updates so you can visualize the evolving statements from BPAX management
- NDA submission: Prior guidance had been for NDA 2h2011 (6-12 months after last woman enrolled). Expected submission in late 2011 or early 2012 (2/14/11 webcast). Expected submission 1q2012 or 2q2012 (3/15/11 webcast). Expect submission for product approval in 2012 (2010 10k)...aka by mid-year 2012 based on priority review expectation). Expect submission in 2012 (4/15/11, 5/9/11, and 5/24/11 webcasts, 6/6/11 PR said by the end of 2012....see how fast this timeline has slid backwards!)
- Safety enrollment: Estimated would reach 4000 pt mark in early 2011 (10/2010). Estimated would complete Dec 2010-Feb 2011 (11/3/2010 webcast). Would reach maximum 4000 pt enrollment in ~ August 2011 (2/14/11 webcast). Completed enrollment in June 2011 of ~3550 pts.
- Efficacy enrollment: Estimated completion of enrollment "summer" 2010 (then radio silence for awhile). Hope to "begin to announce enrollment completion 1q2011" (2/14/11 webcast). Will announce completion of enrollment by end of March 2011 (3/15/11 webcast). Enrollment was completed in March 2011 (see below)
- Efficacy top-line data readout: Expected ~September 2011 (2/14/11 webcast). Expected October 2011 or earlier (3/15/11 webcast). Expect 10/1/2011 plus or minus 2 weeks (4/15/11 webcast). Expect in October or November 2011 (5/24/11 webcast, 5/9/11 webcast says 4q2011)
- Safety top-line data readout: Expected first or 2nd quarter 2012 (3/15/11 and 4/15/11 webcasts). Expected 3q2012 (5/9/2011 webcast)
- Cash burn: About $3m per month (late 2010). About $3.5-4m per month (2/14/11 webcast). About $4.5m per month (4/15/11 webcast). About $4m per month (5/24/11 webcast)
- Cash Runway: "well into 2q2012 or 3q2012" (5/9/11 webcast)
Guidance- Libigel business development
- Would need at least 100-200 reps, so will not attempt to market this product themselves- want large company who can "do justice" to libigel.
- Previous statement: probably partner before NDA (catalyst would be completion of enrollment), definitely before aproval, or sale of entire company
- Late 2010: partner in "next 6-12 months"
- 2/14/11 and 3/15/11 webcasts: Plan to develop Libigel as long as possible before partnering to maximize value to shareholders
- 3/15/11 webcast: want $50 to $100m upfront with significant milestones, royalties of 20-30%- typical for phase 3 or NDA stage program (very odd of CEO to state demands so explicitly in public forum)