- Biosante presented at the Stifel Nicolaus Healthcare conference on 9/7/11 - click here for full schedule of presentations and links to all of my notes.
- Click here for detailed notes about LibiGel and the rest of BPAX pipeline.
- See below for my complete notes from the webcast:
- Elestrin - $140m in sales milestones are far off in distance
- P+E birth control down-regulates testosterone (paradoxical effect on sex drive, hence attempt to develop Pill Plus).
- Pill Plus needs multiple phase 2 trials, design would be 1/2 patients on birth control, half on birth control plus DHEA (androgen)...look for increased sexual activity [and presumably no loss of birth control activity]
- Bio-T-Gel: would stand to receive 5-7.5% royalties from Teva [don't recall actual numerical range being disclosed before]
- Abbott filed patent infringement claim...but Teva made 505b2 NDA filing (not ANDA), Teva feels strongly that product does not infringe. They have filed court document, hope judge throws out case.
- Efficacy trials both completed enrollment in march. [Not technically true since the first 'enrollment is complete' PR came out in late February]
- LibiGel efficacy trials are diary studies - record sexual events for 8 weeks before randomized to product or placebo. Add up that total for 8 weeks and divide by 2 to get 4 week baseline, then randomize equally. Keep the diary for 6 months, the add up number of events in last 4 weeks of 6 month period and compare that total to baseline.
- Safety study: 3656 pts randomized, over 4500 woman-years of treatment now. 1700 pts on drug <1 year, 1200 >1 year, almost 500 >2 years, 263 >3 yrs...so we won't have problem of lack of long term safety data for potential FDA advisory committee (compare to experience of obesity products recently...)
- May 2011 data committee ran algorithm - instructed them to stop enrollment, based on reaching 90% probability of success to show noninferiority at 12 months.
- "Mean desire" - daily diary 0-4 scale, coprimary endpoint along with "number if satisfying sexual events"
- Testosterone patch data - 1 event inccrease on placebo at 6 months vs 2 for patch. This 1 event delta was used to power libigel trials.
- Libigel phase 2 baseline rate was ~2.5 (intrinsa was ~3)
- P&G trials - increase in SSE w/ patch plateaued at month 4-5. (phase 2 Libigel data went up thru 3 months)
- Safety summary: 9 breast cancers (0.24% rate vs 0.35-0.39% expected) and 22 cardiovascular events (0.58% vs 2% expected rate)
- Safety: last woman enrolled 6/2011, will follow her until 6/2012.
- cancer vaccines - 15 phase 1/2 trials paid for by Johns Hopkins, NCI, or foundations. We are spending little or no money or time but own commercial rights. We will share clinical data over next 12-18 months and hopefully monetize indivdual or portfolio
- 2 pancreatic cancer trials, prostate, melanoma trials to start 2011
- Cash burn drops to $3m per month in 2012
- Now have cash thru projected FDA approval (expecting 6 month review clock, approval by mid-2013) [Note for those of you who believe this means they won't (or are promising not to) sell stock before mid-2013. That is not what this means. No biotech burns their cash down to zero. BPAX has been a serial diluter. And if they don't sign a partnership in early 2012 - after efficacy data but before safety data - I would assume that they will raise money in that time frame]
Question and answer session:
--SPA covers efficacy trials, can't get SPAs for safety studies, but have written agreement that closely mirrors the SPA.
--Women with sex hormone binding globulin (SHBG) levels >160 were non-responders to patch, so in phase 3 trial ( butnot phase 2), we excluded those women
--"we have a great relationship with the FDA" and think they have an open mind about the product. There is a big difference between 2004 and 2012/13. Our confidence comes from the design of our program
--We have 60-65 employees in Illinois..most work on conduct of LibiGel program [will they lay off these people in late 2012?], no CRO in place, but contractors handles certain aspects like statistics and assays...we oversee the program ourselves.
--We have no sales/marketing infrastructure, therefore there are 3 alternatives:
1) "Auxilium plan": There are 14,000 high volume prescribing gynecologists, would require sales force of 150-200 reps. We are not going to take the dilution to hire that staff with a stock price at $2.5-3.00 - but would consider if stock price moves up on efficacy trial results [That they even mention this possibility is a concern to me...the prospect of selling product themselves used to be off the table. I would want no part of the stock if they announced plans to go it alone]
2) M&A alternative [aka, selling the company]: This is also not so likely. If we had $5m in the bank vs $75m than maybe... we have already taken the dilution hit. We can go to or thru FDA approval. Our board would lean against this.
3) Licensing deal: We would seek 25-30% royalties. Milestone on approval and lucrative, large, sales based milestones - back end loaded is fine with us because we believe in the product [He didn't repeat his request for $50-100m upfront this time]. A large royalty makes sense because we've taken the product almost all the way. Good efficacy data will be a catalyst for additional interest.
--We have a 2nd SPA for naturally menopausal - only one phase 3 efficacy trial would be needed because safety study umbrellas for both populations.
--LibGel product label will read "for surgically menopausal women with HSDD" but below that will be safety data covering both populations.
--600k oopherectomy procedures per year. not sure of total population size
--SPA covers efficacy trials, can't get SPAs for safety studies, but have written agreement that closely mirrors the SPA.
--Women with sex hormone binding globulin (SHBG) levels >160 were non-responders to patch, so in phase 3 trial ( butnot phase 2), we excluded those women
--"we have a great relationship with the FDA" and think they have an open mind about the product. There is a big difference between 2004 and 2012/13. Our confidence comes from the design of our program
--We have 60-65 employees in Illinois..most work on conduct of LibiGel program [will they lay off these people in late 2012?], no CRO in place, but contractors handles certain aspects like statistics and assays...we oversee the program ourselves.
--We have no sales/marketing infrastructure, therefore there are 3 alternatives:
1) "Auxilium plan": There are 14,000 high volume prescribing gynecologists, would require sales force of 150-200 reps. We are not going to take the dilution to hire that staff with a stock price at $2.5-3.00 - but would consider if stock price moves up on efficacy trial results [That they even mention this possibility is a concern to me...the prospect of selling product themselves used to be off the table. I would want no part of the stock if they announced plans to go it alone]
2) M&A alternative [aka, selling the company]: This is also not so likely. If we had $5m in the bank vs $75m than maybe... we have already taken the dilution hit. We can go to or thru FDA approval. Our board would lean against this.
3) Licensing deal: We would seek 25-30% royalties. Milestone on approval and lucrative, large, sales based milestones - back end loaded is fine with us because we believe in the product [He didn't repeat his request for $50-100m upfront this time]. A large royalty makes sense because we've taken the product almost all the way. Good efficacy data will be a catalyst for additional interest.
--We have a 2nd SPA for naturally menopausal - only one phase 3 efficacy trial would be needed because safety study umbrellas for both populations.
--LibGel product label will read "for surgically menopausal women with HSDD" but below that will be safety data covering both populations.
--600k oopherectomy procedures per year. not sure of total population size
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