BioWorld Today Contributing Writer

A $45 million public offering by BioSante Pharmaceuticals Inc., of Lincolnshire, Ill., will help float the company through Phase III Libigel trials. Libigel is a transdermal testosterone gel that BioSante is developing for female sexual dysfunction.

The offering of 16 million shares of common stock will be priced at $3 per share, and is expected to close on Aug. 2.

BioSante completed its enrollment of 3,557 women in a Phase III safety trial in May, based on a recommendation by a data monitoring committee showing that sample size was sufficient, and had achieved a minimum 90 percent predictive probability of success.

The unblinded data showed that the rate of cardiovascular events was lower than anticipated, at about 0.58 percent. The rate of breast cancer was also lower than expected at 0.24 percent.

The Phase III LibiGel safety study will continue for five years, but data will be rolled into a new drug application after the last subject has completed 12 months of therapy.

The overall objective of the study is to compare safety of testosterone to placebo with respect to a set of specific cardiovascular events, including death, myocardial infarction and stroke.

Expectations are high that LibiGel will be approved and successful at the market. "Every woman over age 49 would be a candidate for LibiGel making the market bigger than that for male T products, which address around 40 percent of men over 60," wrote Leerink Swann's Joseph Schwartz.

Getting it across the finish line takes funding, however. The current $45 million public offering follows two registered direct offerings in December 2010 and March 2011 for $18 million and $25.1 million, respectively, for an aggregate of nearly $90 million raised in the past year. (See BioWorld Today, March 7, 2011.)

BioSante markets an FDA-approved product, Elestrin, for hot flashes of menopause, with Azur Pharma Ltd. Under a 2009 licensing agreement, BioSante is entitled to receive up to $140 million in sales-based milestone payments for Elestrin.

Also in development, BioSante has Bio-T-Gel for hypogonadism in men, the Pill Plus triple component contraceptive and a cancer vaccine technology being investigated by various partner institutions. All of those products are in Phase II trials. Bio-T-Gel has been assigned a PDUFA date of Nov. 14.

Prior to the offering, BioSante had 93,590,612 shares of common stock outstanding. The offering's underwriters have a 30-day option to purchase up to 2.4 million additional shares to cover overallotments.

Shares in the company (NASDAQ:BPAX) lost 10 cents, to close at $3 Friday.