|Keeping an eye on both BPAX and AIS|
|Wednesday, 16 November 2011 09:53|
BioSante Pharmaceuticals, Inc. (NASDAQ:BPAX) has just shared some additional data from its principal LibiGel (testosterone gel) pharmacokinetic (pK) study. Will that be enough to break shares away from down-trending resistance levels?
Top line data from this particular study were announced in late September and they indicate that LibiGel increases levels of free testosterone (the active testosterone component) in the serum of postmenopausal women to within the normal ranges for younger, premenopausal women. LibiGel is in development for the treatment of female sexual dysfunction (FSD), specifically, hypoactive sexual desire disorder (HSDD) in postmenopausal women, for which there is no FDA-approved product.
LibiGel is a testosterone gel in Phase III clinical development for the treatment of women who suffer from female sexual dysfunction (FSD), specifically hypoactive sexual desire disorder (HSDD). The completed Phase III efficacy trials are double-blind, placebo-controlled trials that enrolled over 500 surgically menopausal women each for six-months of therapy, approximately half of whom were taking concomitant estrogen therapy and half of whom took no concomitant estrogen therapy. The completed efficacy trials were conducted according to an FDA-agreed special protocol assessment (SPA) agreement. LibiGel is absorbed quickly through the skin after applying a once-daily pea-sized topical application on the upper arm that delivers testosterone to the bloodstream evenly over time.
As we told our readers back in February, there are actually two companies in prime position to benefit from good news associated with clinical information about the LibiGel program: BioSante and their partner, Antares Pharma, Inc. (AMEX: AIS).
Both companies have a large stake in LibiGel and while BioSante has been pushing the product through development, many investors may not be aware that a patented FDA approved technology developed by Antares is a critical component in Libigel. The company’s Advanced Transdermal Delivery (ATD) Gel System offerd BioSante an ideal means to deliver testosterone in a controlled and reproducible way with a convenient to use dosage form.