BioSante CEO: Company in good financial condition with $12 million in bank, declining cash burn rate

By Ronda Fears

Nashville, Aug. 25 - BioSante Pharmaceuticals Inc. is in good financial condition with $12 million in the bank and a declining cash burn rate as it stands on the threshold of bringing two drugs onto the market, said chief executive Stephen Simes at an industry conference Thursday.

"We feel like we're in good financial condition for this time," Simes said at the Informed Investors Forum conference, which focused on the biotech industry.

In addition to a cash balance of $12 million at June 30, he said the company expects its burn rate to decrease to $750,000 a month for the remainder of 2005 from $850,000 a month.

The company does not have any licensing partners, thus will not have to share revenues from its two hormone therapy products in late-stage development. The company has been open to discussions with partners, Simes has said in the past, but currently does not have any deal in the works.

Its two lead candidates focus on women's hormone therapy, poised to break into the U.S. market for estrogen and testosterone products that is estimated at more than $2.5 billion a year.

Hormone therapies coming up

Out front is Bio-E-Gel, a topical application of estrogen used to reduce menopause symptoms, with a New Drug Application filing targeted by the end of September or October with launch in mid to late 2006.

Next comes LibiGel, a topical application of testosterone used to treat female sexual dysfunction, with phase III trials expected to begin by year-end with an NDA application anticipated in late 2007.

"Pfizer spent 10 years trying to find a Viagra for women. They discontinued that a year ago," Simes said.

BioSante's biggest competitor in this area now, he said, is Proctor & Gamble, with a patch expected to produce a new NDA late this year. But he said BioSante believes trial data for its gel show it to be superior to the patch.

With the aging Baby Boomer population entering menopause, he said the market for hormone therapy is expected to multiply in years to come.

In addition to the hormone therapy products, BioSante also is developing calcium phosphate nanotechnology for novel vaccines, including biodefense vaccines for toxins such as anthrax and ricin, and drug delivery systems for proteins such as insulin.

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