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BioSante Rising as Female Libido Drug Moves Foward


Despite skepticism about the condition LibiGel is aimed at treating, the company plans to apply for US approval next year.

There's skepticism about whether a dysfunction called hypoactive sexual disorder in women is a real condition.

BioSante Pharmaceuticals (BPAX) CEO Stephen Simes has heard the critics and he maintains that the dysfunction is very real. Simes hopes to prove the skeptics wrong sometime this quarter when BioSante discloses detailed study data that shows its experimental product LibiGel increases sexual desire in menopausal women. Last week, the company noted its trials to show the drug's effectiveness were wrapping up. Today, the company said ongoing research showed the product was safe.

The company's shares traded up on both bits of news. The stock rose 2% to $2.38 in midday trading and is up 46% this year. Since its public debut in early 2000, the company's shares have lost almost three-fourths of their value.

It's indeed been a long journey for Simes, who hopes to apply for US approval for LibiGel in about a year. He's seen potential competitors drop out of the race. A year ago, German drug maker Boehringer Ingelheim announced it was scrapping plans to develop its female libido drug because of safety concerns. Procter & Gamble (PG) ran into similar government concerns last decade over its testosterone patch.

LibiGel has been nicknamed the female Viagra but it works much differently than the blockbuster erectile dysfunction drug. Pfizer's (PFE) Viagra is a pill that increases blood flow to the penis. Like the P&G patch, LibiGel is testosterone in cream form. There's no US approved use for testosterone in treating low sexual desire in women but there's believed to be considerable "off-label" use to perk up female sex drives. According to BioSante, there were 4 million testosterone prescriptions written for women with low sex drives. The company predicts it would capture 90% of those prescriptions, converting patients to LibiGel.

Simes has said the market for LibiGel may be at least $2 billion -- the estimate for erectile dysfunction drugs. That market has drawn a lot of interest from big pharma. In addition to Viagra, Eli Lilly (LLY) sells Cialis and Bayer sells Levitra and licenses Staxyn to Merck (MRK) and GlaxoSmithKline (GSK).

BioSante, which has partners for other experimental drugs, is going solo as it develops LibiGel.

Obviously, BioSante has a number of believers. Though even bulls doubt the company will capture anywhere near $2 billion in sales.

Rodman & Renshaw analyst Elemer Piros recommends buying the stock and has a 12-month price target of $5 a share. Piros predicts a 2013 launch of the drug and estimates peak sales of $500 million a year by 2021.

Twitter: @brettchase

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