Here is the link from yesterday:http://finance.yahoo.com/news/BioSante-Pharmaceuticals-bw-381121180.html?x=0&.v=1
So after five Data Safety Committee meetings to look at unblinded data, here is where the trial stands:
So this is clearly good news in the big picture. Libigel is safe, these women are not having CV events more so that placebo patients. The data safety group has now five times looked at the number of events in Libigel and control arm of the study and determined that the balance does not indicate an unacceptable risk (ie, 7 vs 10, 8 vs 9, 9 vs 8, 10 vs 7 events). Any durable trend against Libigel would cause the immediate halting of the trial and the death of BPAX for all intents and purposes.
However, the low event rate is a double edged sword- it make it more difficult to prove statistically that the Libigel arm is not getting more CV events than placebo. This is why the estimated trial size was already increased once (from a range of 2400-3100 to a range of 2500 to 4000). And of course, the longer the enrollment needs to proceed, the longer it takes to get that number of women on drug for an average of 12 months, and the later the NDA for Libigel can be filed.
If you've followed BPAX for awhile, you know that the estimated date of NDA filing has constantly slipped backward. This weekend's press release buries the latest delay in the midst of the good safety news. No longer do they say the NDA will be filed in 2011. Now BPAX says the NDA will be filed for a product launch in 2012. Since BPAX has stated that they expect a 6 month priority review from the FDA, this clearly allows for the NDA to be filed in 2012.
I am as confident as ever that Libigel works and is safe, and will get approved. However, each delay in the completion of the safety trial has meant another 5-10 million shares sold, each time with millions of five-year warrants. These financings substantially dilute the value per share of Libigel on a fully diluted basis, severely limiting shareholders upside upon a partnering event or sale of the company. BPAX has stated they are burning $3-4 million per month, so any delay adds up quickly in the amount they need to raise. There are already 81m shares outstanding and 19m warrants that are in the money or nearly so. This has a big impact on the fully-diluted value of the company as a whole or Libigel specifically. Also note there is $22m of debt on the books from the CEGE merger ta
Barring a catastrophe in the safety trial, BPAX will partner Libigel, or sell the company outright. They have made this very clear on numerous occasions and will not try to go it alone. Also, keep in mind that Antares Pharma (AIS) receives 25% of any upfront license fees and/or equity premiums, as well as mid-single digit royalties and maintains manufacturing rights which would bring in more revenue to AIS. AIS also owns the ex-US rights to the product and could stand to gain a substantial payday for a European marketing deal.
So after five Data Safety Committee meetings to look at unblinded data, here is where the trial stands:
- 2,869 women enrolled (>1000 for more than 1 year, >550 for two years)
- 17 cardiovascular events (0.57% event rate) and 8 breast cancers (0.27% event rate)
- 3000 women-years of exposure, and average enrollment period of 12.5 months
So this is clearly good news in the big picture. Libigel is safe, these women are not having CV events more so that placebo patients. The data safety group has now five times looked at the number of events in Libigel and control arm of the study and determined that the balance does not indicate an unacceptable risk (ie, 7 vs 10, 8 vs 9, 9 vs 8, 10 vs 7 events). Any durable trend against Libigel would cause the immediate halting of the trial and the death of BPAX for all intents and purposes.
However, the low event rate is a double edged sword- it make it more difficult to prove statistically that the Libigel arm is not getting more CV events than placebo. This is why the estimated trial size was already increased once (from a range of 2400-3100 to a range of 2500 to 4000). And of course, the longer the enrollment needs to proceed, the longer it takes to get that number of women on drug for an average of 12 months, and the later the NDA for Libigel can be filed.
If you've followed BPAX for awhile, you know that the estimated date of NDA filing has constantly slipped backward. This weekend's press release buries the latest delay in the midst of the good safety news. No longer do they say the NDA will be filed in 2011. Now BPAX says the NDA will be filed for a product launch in 2012. Since BPAX has stated that they expect a 6 month priority review from the FDA, this clearly allows for the NDA to be filed in 2012.
I am as confident as ever that Libigel works and is safe, and will get approved. However, each delay in the completion of the safety trial has meant another 5-10 million shares sold, each time with millions of five-year warrants. These financings substantially dilute the value per share of Libigel on a fully diluted basis, severely limiting shareholders upside upon a partnering event or sale of the company. BPAX has stated they are burning $3-4 million per month, so any delay adds up quickly in the amount they need to raise. There are already 81m shares outstanding and 19m warrants that are in the money or nearly so. This has a big impact on the fully-diluted value of the company as a whole or Libigel specifically. Also note there is $22m of debt on the books from the CEGE merger ta
Barring a catastrophe in the safety trial, BPAX will partner Libigel, or sell the company outright. They have made this very clear on numerous occasions and will not try to go it alone. Also, keep in mind that Antares Pharma (AIS) receives 25% of any upfront license fees and/or equity premiums, as well as mid-single digit royalties and maintains manufacturing rights which would bring in more revenue to AIS. AIS also owns the ex-US rights to the product and could stand to gain a substantial payday for a European marketing deal.
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