INTERVIEW-BioSante CEO keeps eye on elusive prize

By Bill Berkrot

NEW YORK, Jan 17 (Reuters) - In a space littered with failure, tiny BioSante Pharmaceuticals Inc (BPAX.O) believes it can succeed in finally bringing a treatment for female sexual dysfunction to the U.S. market.

The search for a so-called female Viagra has proved to be difficult and frustrating both for potential patients and drugmakers, with Viagra itself a high-profile failure.

"Today in the U.S. there is no FDA approved product for the treatment of women. We believe LibiGel can be first and will be an important product," BioSante Chief Executive Stephen Simes said in an interview about the product intended to restore loss of sexual desire in women.

Analysts have said any therapy that proves effective in treating sexual dysfunction in women -- whether it addresses physical arousal problems or loss of desire -- could garner annual sales in excess of $1 billion.

And LibiGel, which is just beginning a major safety study, is on a timeline -- with a projected 2011 launch -- that could prove extremely tempting to big drugmakers.

Several of the world's most lucrative prescription drugs are facing patent expirations between 2010 and 2012 and companies facing precipitous sales declines are scrambling to fill gaping holes in their development pipelines.

With only a $100 million market cap, BioSante could be a bargain, although prices for partnership deals or acquisition will likely rise as LibiGel moves closer to approval.

"We believe it will take about 12 months to fully enroll the (safety) trial and then 12 months on therapy, so 2010 is the pivotal year for an NDA submission," Simes said.

LibiGel is no groundbreaking new entity. It is testosterone in gel form intended to replace the natural hormone in post-menopausal women who are distressed by their loss of sexual desire.

Procter & Gamble CO's (PG.N) testosterone patch Intrinsa, intended for a similar patient population, appeared headed for the U.S. market in late 2004 only to be shot down when the Food and Drug Administration insisted on extensive safety data.

Intrinsa is available in some European markets, but its U.S. prospects have been in limbo and remain uncertain.

The rejection came shortly after Merck & Co Inc (MRK.N) pulled its blockbuster pain drug Vioxx off the market, an event that Simes believes set off a more conservative, safety conscious climate at the FDA that continues today.

"Merck and Vioxx really changed the complexion of the industry," Simes said.

Since then other small companies have abandoned their female sexual dysfunction programs.

But after intensive discussions with the FDA, BioSante has initiated a large, late-stage heart risk study it believes will satisfy regulators. The placebo-controlled trial will look at the impact on cardiac deaths, heart attacks and strokes.

"We now have clear definition and agreement with the FDA of what is required," said Simes, who is celebrating 10 years with the company that recently moved from the American Stock Exchange to trading on the more high profile Nasdaq.

Convinced that the efficacy of testosterone in restoring lost libido has already been proven, Simes believes demonstrating heart safety to the FDA's satisfaction remains the final hurdle to a big payoff.

"We believe that LibiGel has the potential to be a $500 million or a $1 billion product going with the supposition that the market for women is at least as big as the erectile dysfunction market. This is a very, very big market," he said.

Simes said in 2006 that 1.4 million off-label prescriptions were written for testosterone for women, according to data compiled by IMS Health Inc (RX.N).

LibiGel, which is rubbed onto the upper arm once a day, is expected to cost about $100 per month.

BioSante's share price has fallen some 40 percent to about $3.50 since late October. Simes argues that there is good reason to stick with the company as the industry's big players with deep pockets begin to take notice.

"We have a potential blockbuster product. We think we're alone and, even if we're not, it's a big market," Simes said. "And it's what every company dreams of having -- a product for a true unmet, unserved market."

(Reporting by Bill Berkrot;Editing by Andre Grenon)

((bill.berkrot@reuters.com +1 646 223 6030; Reuters Messaging: bill.berkrot.reuters.com@reuters.net)) Keywords: BIOSANTE/

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