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."
About LibiGel®
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 two on-going Phase III efficacy trials are double-blind, placebo-controlled trials that have each enrolled over 500 surgically menopausal women for a six-month clinical trial. The efficacy trials, which completed enrollment in the first quarter 2011, 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 HSDD 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
In addition, BioSante is conducting a Phase III LibiGel safety study, which is a randomized, double-blind, placebo-controlled, multi-center, cardiovascular (CV) events and breast cancer study that completed enrollment of 3,656 women on June 2, 2011 and has accrued over 4,500 women-years of exposure. The safety study will continue for a total of five years, however, BioSante will use the safety study data as part of an NDA submission after the last subject enrolled has completed 12 months of exposure to LibiGel or placebo.
The LibiGel safety study is tracking a predefined list of CV events, in agreement with the FDA, including CV death, myocardial infarction and stroke in women 50 years of age or older and suffering from at least two CV risk factors including hypertension and diabetes. The objective of the safety study is to show the relative safety of testosterone compared to placebo in the number of CV events. The incidence of breast cancer also is being tracked over the course of the study. The study represents the largest data base of the safety of testosterone in women.
Upon completion of the statistical analyses of the safety study and efficacy trials, BioSante intends to submit an NDA to the FDA, requesting approval to market LibiGel for the treatment of HSDD in menopausal women. The NDA submission is targeted for the fourth quarter of 2012.
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. 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 products in development are Bio-T-Gel™, a testosterone gel for male hypogonadism licensed to Teva Pharmaceuticals and an oral contraceptive in Phase II clinical development using BioSante patented technology. The company also is seeking opportunities for its other technologies. Additional information is available online at: www.biosantepharma.com.
Forward-Looking Statements
To the extent any statements made in this news release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about BioSante's plans, objectives, expectations and intentions with respect to future operations and products, the timing of anticipated regulatory submissions and other statements identified by words such as "will," "continue," "could," "believe," "intends," "continue," "expects," "anticipates," "estimates," "may," other words of similar meaning, derivations of such words or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause BioSante's actual results to be materially different than those expressed in or implied by BioSante's forward-looking statements. For BioSante, particular uncertainties and risks include, among others, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the marketing success of BioSante's licensees or sublicensees; the success of clinical testing; and BioSante's need for and ability to obtain additional financing. More detailed information on these and additional factors that could affect BioSante's actual results are described in BioSante's filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K and subsequent quarterly report on Form 10-Q. All forward-looking statements in this news release speak only as of the date of this news release. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Contact:
BioSante Pharmaceuticals
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
or
For Media:
McKinney/Chicago
Alan Zachary
(312) 944-6784 ext. 316
azachary@mckinneychicago.com
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