- Biosante presented 9/12/11 at Rodman and Renshaw conference, along with most of the stocks I cover - click here for full schedule of biotech webcasts and links to my notes.
- Find more detailed info on Libigel on the BPAX research page.
- Keep reading for my complete webcast notes - new info is bolded:
- All current spending and focus at company is on LibiGel
- Safety trial - average exposure is now almost 14 months. By the time we submit NDA, we will have average exposure of 24 months
- same overview of libigel safety/efficacy as always...available on BPAX research page if you're new to the stock
- Phase 2 trail: 3.4 event increase at 3 months. 6 month phase 3 studies are powered to detect one event increase
- 597 and 575 patients were enrolled in the 2 efficacy trials
- No correlation between length of therapy and CV events in safety trial
- 7th safety look will be in October.
- We have also done extensive research among payers...we will get the same coverage as currently given to male ED products. 40% of Viagra/Levitra/Cialis use is reimbused ...and we forecast Libigel could be a >$1b product based on this
- patent until 2022, others pending, hope to have USPTO office action even this year
- We applied for and received 4 orphan drug designations for cancer vaccine program since acquisition of Cell Genesys $CEGE...our intention is to monetize. We may be able to get orphan grant funding
- LibiGel topline efficacy data 4q2011
- $73.3m cash as of 8/31/11, enough to last well into 2013
- last patient's last visit will be complete this month for both efficacy trials. Then data readout within weeks - 2 months. November into early December would be our target.
- Next steps: data cleanup, close dataset, inquiries to investigator sites, check forms by data management company, then analysis begins.
- Safety - must follow last woman enrolled for 12 months until june 2012 then have same data process before topline data in 3q2012
- Plan to submit NDA by ye2012
- what is relationship with AIS? They are licensor for LibiGel and owed 4.5% royalty [Simes didn't mention the 25% cut of all licensing payments], they get access to data for use in their territories, including Europe
- what are plans for commercialization? Ideal option would be a marketing partner. We have begun discussions, there are peple doing due diligence under confidentiality agreements. We think efficacy data will be catayst. We have enough cash so we won't take a deal that does not maximize shareholder value
- We desire 25-30% royalty and significant milestones and we are quite optimistic we'll get something done
- is it uncommon for FDA to approve based on opinion data? Categorically no. Examples include Elestrin (daily diary of # and severity of hot flashes). FDA has guidance for validation of patient-reported outcomes issued in 2006 and 2009. Also pain studies are often reported by patient. Our daily diary and monthly questionnaire meets both guidelines.
- Will efficacy data be per protocol vs ITT analysis? Analysis is ITT (Click for definition). Dropout rate in efficacy trials is 10-12%..we predicted 15%, and we made up for these in enrolling extra patients (hence the 575-597 enrollment numbers above, greater than the 500x quoted in protocol design). We will also do responder analysis of course.
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