BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) said today that it failed its two pivotal Phase 3 LibiGel efficacy trials and did not meet the co-primary or secondary endpoints. In the first trial, called BLOOM-1, patients who received LibiGel showed an increase of 1.47 days with a satisfying sexual event compared with 1.26 days for those who received the placebo gel, with p=0.463. The total number of satisfying sexual events of 3.87 was recorded in the LibiGel group while 3.52 satisfying sexual events was recorded in the placebo group, with p=0.698. In the second trial p value of 0.214 was recorded. Subjects in BLOOM-1 showed an increase in mean sexual desire of 0.03 over placebo, p=0.672, while those in BLOOM-2 demonstrated an increase in mean sexual desire of 0.03 compared to placebo, p=0.48. It noted that the LibiGel Phase 3 cardiovascular and breast cancer safety study will continue but will evaluate the value of continuing the trial.
Cerus Corporation (NASDAQ:CERS) filed a mixed shelf enabling it to issue stock and warrants to the value of $150m from time to time.
ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced that it has commenced an underwritten public offering of shares of its common stock. The size of the offering was not released.
Orexigen Therapeutics, Inc. (Nasdaq: OREX) also said it intends to offer stock and warrants in an underwritten public offering. The size of the offering was not released.
Anthera Pharmaceuticals, Inc. (Nasdaq: ANTH) today announced that the VISTA-16 Data Safety Monitoring Board (DSMB) recommended the Phase 3 trial continue without change. The interim efficacy analysis of the primary endpoint is scheduled to occur after 50% of the primary endpoint events in the VISTA-16 clinical study have been collected. It mentioned last month that it expected the interim efficacy analysis to take place this quarter.