POINT ROBERTS, WA and LINCOLNSHIRE, IL--(Marketwire - Jun 8, 2011) - Investorideas.com, an investor research portal covering leading sectors including biotech and pharma stocks, features an exclusive Q&A interview and update with Mr. Stephen M. Simes, president and chief executive officer of BioSante Pharmaceuticals (
LibiGel is a testosterone gel in Phase III clinical development for the treatment of women who suffer from female sexual dysfunction (FSD).
BioSante Pharmaceuticals Interview Excerpt
Q: Investorideas.com
Stephen, the company has announced completion of the enrollment in its ongoing LibiGel (testosterone gel) Phase III cardiovascular and breast cancer safety study. Can you explain to investors how it was determined that the current enrollment is sufficient?
A: Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals
Yes, based on the last unblinded statistical analysis by the independent statistician of the Data Monitoring Committee, it was determined that according to the FDA-agreed sample size analysis enrollment should stop, based on meeting a minimum 90 percent predictive probability of success of the safety study to show the safety of LibiGel at the primary data analysis. As per the protocol, the safety study will continue for 12 months of therapy from the last subject enrolled before the primary analysis will be conducted by BioSante, which will provide the data for BioSante's new drug application (NDA) submission anticipated to be made in 2012. The study will continue for five years.
Full Q&A: http://www.investorideas.com/news/2011/main/06073.asp
About BioSante Pharmaceuticals, Inc.
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante's lead products include LibiGel® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD) which is in Phase III clinical development under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment (SPA). BioSante's first FDA-approved product is Elestrin™ (estradiol gel) indicated for the treatment of hot flashes associated with menopause, marketed in the U.S. by Azur Pharma, BioSante's licensee. BioSante also is developing a portfolio of cancer vaccines, four of which have been granted Orphan Drug designation, and are currently in several Phase II clinical trials. Other BioSante products are Bio-T-Gel™, a testosterone gel for male hypogonadism, for which an NDA is pending, licensed to Teva Pharmaceuticals, and an oral contraceptive in Phase II clinical development using BioSante patented technology. Additional information is available online at: www.biosantepharma.com
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