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Shares of BioSante ($BPAX) shot up more than 20% this morning after the developer heralded data showing improved survival rates in an early trial of GVAX for pancreatic cancer. The data is from a trial that recruited 30 patients. Story
Jan
31
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BioSante Pharmaceuticals ($BPAX) alerted investors this morning to its plan to move forward after the colossal failure of its late-stage trials for its female libido gel last month. To save cash, the company said it's cutting 21 full-time employees or contractors, about a quarter of its total workforce, and is hunting for in-licensing, merger and acquisition deals.
The Lincolnshire, IL-based drug developer has seen about three quarters of its stock value wiped away after a pair of Phase III studies failed to show that its experimental LibiGel product could beat placebo in treating female sexual dysfunction, for which there are no FDA-approved treatments. The company plans to meet with the FDA to discuss the program and decide within the next three months whether to continue a safety study for LibiGel.
The company's market share stood at a lowly $71.5 million and its stock at 65 cents per share this morning, according to Google Finance.
With the blockbuster hopes for LibiGel all but dashed, BioSante faces questions about what other pipeline contenders can renew faith in the company. Its experimental testosterone gel, licensed to Teva Pharmaceuticals ($TEVA), is under FDA review and the agency is expected to decide whether to approved the treatment by Feb. 14. BioSante also has been studying cancer vaccines in early- and midstage studies for a variety of tumors.
BioSante CEO Stephen Simes has put on a brave face after the LibiGel setback. "Although we are disappointed about the recently reported LibiGel clinical efficacy results, " he said in a statement today. "We are optimistic about the future of BioSante."
Investors don't seem so confident, but we'll see how well Simes can navigate the headwinds that his BioSante faces and renew faith in the company.
- here's the release
Related Articles:
BioSante shares nosedive after libido gel flunks pivotal studies
BioSante's female sexual dysfunction drug draws partnering interest
BioSante's LibiGel passes safety hurdle
Dec
15
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BioSante ($BPAX) shares went into a meltdown this morning after the company announced that its experimental female libido gel failed to outperform a placebo in a pair of big pivotal trials. The stock nosedived, plunging 74%--to 56 cents--as investors digested the news about the blockbuster hopeful, which BioSante execs blamed on an unusually high placebo response.
LibiGel failed co-primary as well as secondary endpoints in the studies. And analysts quickly raised some big questions about the company's next move.
"The magnitude of the miss on the efficacy data is what is surprising everybody," Jefferies' Graig Suvannavejh told Bloomberg. "People had a view that the bigger concern might have been safety, and efficacy was a layup of sorts. The big question isn't what happens with LibiGel going forward, but what's next for the company."
Investigators reported that the women recruited for the study didn't experience a significant increase in either sexual desire or sexual encounters after using LibiGel, compared to the placebo arm. Researchers recruited 1,172 women for the studies.
"LibiGel did exactly what we wanted it to do, and in a very safe manner," BioSante CEO Stephen Simes noted to reporters. "If the placebo would have acted like previous placebo or what would have been predicted, we would have won with flying colors. It's not that LibiGel did not work. The problem is that both arms worked equally well." And BioSante isn't ready to give up on the program yet.
"We will be looking to see if there are certain subsets of the data ... whether there is an age of patients who are responding or more likely to respond and so on," the company told analysts in a call.
- here's the press release
- read the Reuters story
- get the report from Bloomberg
Related Articles:
BioSante's female sexual dysfunction drug draws partnering interest
BioSante's LibiGel passes safety hurdle