A gel developed by Antares (AMEX:AIS) and licensed to BioSante Pharmaceuticals (NASDAQ:BPAX) to treat female sexual dysfunction failed two phase 3 clinical trials testing efficacy, according to a statement from BioSante.
Initial analysis of the data from the trials showed that the tests “did not meet the co-primary or secondary endpoints,” the statement said. LibiGel is being developed to treat hypoactive sexual desire disorder in postmenopausal women, for which there is currently no U.S. Food and Drug Administration-approved treatment.
The randomized, double-blind, placebo-controlled trials enrolled 597 and 575 surgically menopausal women, respectively, for six months of therapy.
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Prior to the announcements of the results, some analysts were optimistic:
“I estimate that the product will be licensed to a larger company in the U.S. and that marketing will begin in 2014. There is a large U.S. addressable market in the billions of dollars for LibiGel. However, I am projecting a modest takeoff in sales in the 2014 and 2015 period. My sales estimates are $20 million for 2014 and $40 million for 2015.”
BioSante CEO Stephen M. Simes said: “We obviously are very disappointed by the phase 3 LibiGel efficacy trial results. We have been committed to LibiGel for many years and we are committed to determining the future of LibiGel. …We will continue to analyze the efficacy trial data fully and determine plans for our next steps in the LibiGel development plan, and provide an update at a later time.”
Simes said it still intends to go ahead with the LibiGel phase 3 cardiovascular and breast cancer safety study, but it “will be analyzing the best path forward for the study given the results reported today.”
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Traders did not take the news well and Antares’ stock price had fallen 8 percent when trading closed at 4 p.m.
The news creates some uncertainty on projected revenue for Ewing, New Jersey-based Antares, and was something of a setback to a company riding high from the FDA approval for its overactive bladder drug last week. The company is also focused on developing its self-injectable drug-delivery technology.
