Leerink Swann Downgrades BioSante Pharmaceuticals (BPAX) to Market Perform; Pivotal BLOOM Trials Surprisingly Disappoint
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Price: $1.09 --0%
Rating Summary:
0 Buy, 4 Hold, 0 Sell
Rating Trend: = Flat
Today's Overall Ratings:
Up: 8 | Down: 5 | New: 26
Rating Summary:
0 Buy, 4 Hold, 0 Sell
Rating Trend: = Flat
Today's Overall Ratings:
Up: 8 | Down: 5 | New: 26
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Leerink Swann downgraded BioSante Pharmaceuticals (NASDAQ: BPAX) to Market Perform, price target dropped from $2.00 to $0.11.
Leerink analyst says, "We are downgrading BPAX after both Phase III studies, BLOOM-1 and -2, failed to show a statistically significant separation from placebo in terms of their co-primary endpoints. It is surprising that similar plasma levels of low dose testosterone therapy were unable to replicate positive Intrinsa (P&G patch) results. Both studies showed an improvement from baseline that was greatly offset by a higher-than-expected placebo effect, which may have been inflated by the use of a daily diary."
"BPAX has been burning $12.5MM per quarter and does not expect that to change much in 2012. The cost for the outcomes trial alone is $1.5-2MM per month and shutting down the trial at this point would not result in significant cost savings. BPAX has rights to receive 5-7% royalties on TEVA's (Nasdaq: TEVA) sales of Bio-T-Gel for male hormone replacement therapy if it is approved on 2/14/12; however this would be the fifth entrant to an already crowded market and Abbott (NYSE: ABT) has sued TEVA on the basis of AndroGel patent infringement so this is not in BPAX management expectations."
For an analyst ratings summary and ratings history on BioSante Pharmaceuticals click here. For more ratings news on BioSante Pharmaceuticals click here.
Shares of BioSante Pharmaceuticals closed at $2.12 yesterday.
Leerink analyst says, "We are downgrading BPAX after both Phase III studies, BLOOM-1 and -2, failed to show a statistically significant separation from placebo in terms of their co-primary endpoints. It is surprising that similar plasma levels of low dose testosterone therapy were unable to replicate positive Intrinsa (P&G patch) results. Both studies showed an improvement from baseline that was greatly offset by a higher-than-expected placebo effect, which may have been inflated by the use of a daily diary."
"BPAX has been burning $12.5MM per quarter and does not expect that to change much in 2012. The cost for the outcomes trial alone is $1.5-2MM per month and shutting down the trial at this point would not result in significant cost savings. BPAX has rights to receive 5-7% royalties on TEVA's (Nasdaq: TEVA) sales of Bio-T-Gel for male hormone replacement therapy if it is approved on 2/14/12; however this would be the fifth entrant to an already crowded market and Abbott (NYSE: ABT) has sued TEVA on the basis of AndroGel patent infringement so this is not in BPAX management expectations."
For an analyst ratings summary and ratings history on BioSante Pharmaceuticals click here. For more ratings news on BioSante Pharmaceuticals click here.
Shares of BioSante Pharmaceuticals closed at $2.12 yesterday.
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