BioSante Pharmaceuticals, Inc. (Public, NASDAQ:BPAX)

[Michael Scally MD]

BioSante Pharmaceuticals, Inc. (Public, NASDAQ:BPAX) BioSante Pharmaceuticals - Improving health for life
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2011 10-2Q: http://www.sec.gov/Archives/edgar/data/1023024/000110465911044302/a11-14113_110q.htm

2010 10-K: http://www.sec.gov/Archives/edgar/data/1023024/000110465911014913/a11-7481_110k.htm


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.


LibiGel is a testosterone gel in Phase III clinical development for the treatment of women who suffer from female sexual dysfunction (FSD). The on-going Phase III efficacy trials are double-blind, placebo-controlled trials that have enrolled over 500 surgically menopausal women each for a six-month clinical trial. The efficacy trials, which have completed enrollment, are being conducted under an FDA-approved 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.

In a Phase II trial, LibiGel significantly increased the number of satisfying sexual events in surgically menopausal women suffering from FSD by 238 percent versus baseline (p<0.0001); this increase also was significant versus placebo (p<0.05). In this study, the effective dose of LibiGel produced testosterone blood levels within the normal range for pre-menopausal women and had a safety profile similar to that observed in the placebo group. In addition, no serious adverse events and no discontinuations due to adverse events occurred in any subject receiving LibiGel. The Phase II clinical trial was a double-blind, placebo-controlled trial, conducted in the United States, in surgically menopausal women distressed by their low sexual desire and activity.

 

[Michael Scally MD]

BioSante Pharmaceuticals Successfully Completes LibiGel(R) Pharmacokinetic Study
http://www.marketwatch.com/story/biosante-pharmaceuticals-successfully-completes-libigelr-pharmacokinetic-study-2011-09-12

LINCOLNSHIRE, Ill., Sep 12, 2011 (BUSINESS WIRE) -- BioSante Pharmaceuticals, Inc. BPAX +2.18% , today announced successful completion of its principal LibiGel (testosterone gel) pharmacokinetic (PK) study. The top-line results indicate that LibiGel increases levels of free testosterone, bioavailable testosterone and total testosterone 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.

The LibiGel PK study was conducted as part of the required studies to be submitted in the LibiGel new drug application (NDA), which is anticipated by the fourth quarter of 2012. The PK study was conducted in 24 postmenopausal subjects for a total of 63 days, in the absence of estrogen therapy, as well as in the same women when treated with a transdermal estradiol patch and subsequently oral estrogen. There were no differences in blood levels of testosterone regardless of the absence or presence of estrogen therapy, whether transdermal or oral.

The data from the PK study showed that testosterone blood levels were similar on days 14, 21, 42 and 63 of the study, indicating that there was no buildup of testosterone blood levels with daily LibiGel treatment. Additionally, free and bioavailable testosterone returned to baseline levels within 36-48 hours after the last dose of LibiGel, indicating effective elimination after dosing is discontinued. The testosterone blood levels produced in this study were very similar to those seen in the BioSante LibiGel Phase II efficacy trial reported previously, and they were very similar to blood levels observed in transdermal testosterone patch studies, which also demonstrated efficacy in the treatment of HSDD. Importantly, in the LibiGel PK study, there were no measurable increases in blood levels of the most active estrogen, estradiol, which could have occurred as a result of the conversion of testosterone to estradiol. BioSante plans to present the full PK study results at an upcoming medical meeting.

"Significantly, none of the subjects in the LibiGel PK study had average testosterone concentrations above the normal range for younger, premenopausal women, a finding that may be a key component in the safety evaluation of LibiGel by FDA," noted Michael C. Snabes, M.D., Ph.D., senior vice president of medical affairs at BioSante. "This finding adds to our confidence that the results of our ongoing, long-term safety study of LibiGel will be favorable."

 

[CubbieBlue]

BioSante Pharmaceuticals Successfully Completes LibiGel(R) Pharmacokinetic Study
http://www.marketwatch.com/story/biosante-pharmaceuticals-successfully-completes-libigelr-pharmacokinetic-study-2011-09-12

LINCOLNSHIRE, Ill., Sep 12, 2011 (BUSINESS WIRE) -- BioSante Pharmaceuticals, Inc. BPAX +2.18% , today announced successful completion of its principal LibiGel (testosterone gel) pharmacokinetic (PK) study. The top-line results indicate that LibiGel increases levels of free testosterone, bioavailable testosterone and total testosterone 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.

The LibiGel PK study was conducted as part of the required studies to be submitted in the LibiGel new drug application (NDA), which is anticipated by the fourth quarter of 2012. The PK study was conducted in 24 postmenopausal subjects for a total of 63 days, in the absence of estrogen therapy, as well as in the same women when treated with a transdermal estradiol patch and subsequently oral estrogen. There were no differences in blood levels of testosterone regardless of the absence or presence of estrogen therapy, whether transdermal or oral.

The data from the PK study showed that testosterone blood levels were similar on days 14, 21, 42 and 63 of the study, indicating that there was no buildup of testosterone blood levels with daily LibiGel treatment. Additionally, free and bioavailable testosterone returned to baseline levels within 36-48 hours after the last dose of LibiGel, indicating effective elimination after dosing is discontinued. The testosterone blood levels produced in this study were very similar to those seen in the BioSante LibiGel Phase II efficacy trial reported previously, and they were very similar to blood levels observed in transdermal testosterone patch studies, which also demonstrated efficacy in the treatment of HSDD. Importantly, in the LibiGel PK study, there were no measurable increases in blood levels of the most active estrogen, estradiol, which could have occurred as a result of the conversion of testosterone to estradiol. BioSante plans to present the full PK study results at an upcoming medical meeting.

"Significantly, none of the subjects in the LibiGel PK study had average testosterone concentrations above the normal range for younger, premenopausal women, a finding that may be a key component in the safety evaluation of LibiGel by FDA," noted Michael C. Snabes, M.D., Ph.D., senior vice president of medical affairs at BioSante. "This finding adds to our confidence that the results of our ongoing, long-term safety study of LibiGel will be favorable."

Is there really any difference between this stuff and Androgel except it is at a lesser concentration?

 

[Michael Scally MD]

Is there really any difference between this stuff and Androgel except it is at a lesser concentration?

Pretty much! I am NOT in this company. Too risky.