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BioSante Tries Again to Show Female Libido Drug Works


The drug LibiGel failed in a study last year but CEO Stephen Simes wants investors to dismiss those results. Investors react with a yawn.

MINYANVILLE ORIGINAL After its libido-boosting drug for women failed to work in a company study, BioSante (BPAX) says it is going to try again.

The news is a head scratcher considering that the drug, a testosterone gel called LibiGel, was less effective than a placebo in the prior clinical trial. That failure, announced in December, obliterated the company's stock. (See "Female Viagra" Drug Failure Causes BioSante Shares to Plunge 77%)

Now BioSante CEO Stephen Simes is moving ahead with new studies, saying that his management team and board gave great thought to how to proceed. After considering other strategic options, including merging with another company or buying someone else's drug, Simes says he wants to show that the problem with LibiGel is not a lack of effectiveness but, rather, that placebo works too well in helping women with low sex drives.

In the earlier trial, LibiGel was upstaged by a "placebo phenomenon," Simes told analysts on a conference call Monday morning.

"LibiGel really did perform as we predicted and as well as we could have expected," Simes says. "However, the placebo responders performed as well."

So, the next study -- two clinical trials gauging effectiveness -- will try to reduce the chance of a placebo working its wonders. BioSante will ask the Food and Drug Administration to sign off on the study design. It hopes to start enrolling post-menopausal women by next year.

Simes estimates the studies will cost as much $36 million to complete. BioSante reported having cash of more than $49 million as of March 31, after a follow-on stock offering last year.

Simes argues that there's a need for LibiGel to treat a condition known as hypoactive sexual desire disorder. He's said women deserve treatment options for low sex drive and estimated the market at $2 billion a year in sales. That figure comes from an estimate of the erectile dysfunction market dominated for years by Pfizer's (PFE) Viagra. Though it was nicknamed a female Viagra, LibiGel is merely a low-dose testosterone gel. Some doctors already prescribe testosterone for women with low sex drives even though its not approved for that use, Simes has said.

A safety study started earlier that evaluates LibiGel's cardiovascular risk will continue as well. That trial was never stopped despite the failure of the efficacy trial late last year. A safety analysis of the drug is expected in the second half of this year.

The news didn't generate a lot of investor excitement. Shares of the company rose less than 1% to $2.57 in Monday morning trading. The stock is down 15% this year.

Publicly traded since 2000, BioSante lost more than $217 million in total through the end of 2011. Simes, who owns more than 1% of the company, was paid a base salary of almost $500,000 last year, according to a securities filing. The directors and executives as a whole own 4.6% of the common stock. One director, Louis Sullivan, owns almost 26% of a special class of stock. Sullivan is the former secretary of the US Department of Health and Human Services.

Twitter: @brettchase

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