The Company reported news earlier this month of positive LibiGel® safety data review in the Phase III program. Mr. Simes explains the significance of the data and what's next to take
LibiGel (testosterone gel) to market for the millions of women anxiously awaiting an approved FDA solution for female sexual dysfunction.
BioSante Pharmaceuticals Interview
Q: Investorideas.com
In the Company's last release, it was reported that "The DMC once again has recommended that the safety study continue as per the FDA-agreed protocol, without modification as there were no general or specific safety issues based on their unblinded review of adverse events."
Based on competitors dropping out of the market due to lack of sufficient safety data how significant is it that BioSante has reached this stage?
A: Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals
Very significant. BioSante is conducting the largest safety study ever undertaken for a drug in the treatment of female sexual dysfunction. We are in the fourth year of a cardiovascular event and breast cancer safety study having completed enrollment at 3,656 women equally randomized to LibiGel or placebo. The Independent data monitoring committee has recommended continuing the study as per FDA-agreed protocol based on their seventh unblinded review of all safety data. We expect to be able to demonstrate the safety of LibiGel for the treatment of female sexual dysfunction.
Q: Investorideas.com
Can you explain to investors the next steps prior to filing an NDA in 2012?
A: Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals
We now have completed two LibiGel Phase III efficacy trials of over 500 women each. We expect to announce top-line efficacy data in December of this year. The LibiGel safety study will undergo its primary safety analysis next summer which will put us in position to submit the new drug application (NDA) by the end of 2012. Bases on positive safety and efficacy data we hope to receive FDA approval by mid-2013.
Q: Investorideas.com
LibiGel is currently the only product in Phase III clinical development for the treatment of female sexual dysfunction (FSD), specifically hypoactive sexual desire disorder (HSDD), with an estimated market of $2 billion. How does the Company see the revenue stream following FDA approval?
A: Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals
We expect that the market for the treatment of female sexual dysfunction will be over $2 billion, which is the size of the erectile dysfunction market in the U.S. Based on published reports we believe the market for FSD will be at least that large. In addition, in 2010, there were about four million testosterone prescriptions written off-label for women, and in primary research doctors tell us they will switch over 90 percent of the off-label use to an FDA approved product.
Q: Investorideas.com
Several analysts including Rodman & Renshaw have a 12- month price target of $5.00 or more on the stock. The stock has had a 52-wwek high of just over $4.00 and has fallen back… What do you say to that?
A: Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals
These are very difficult times in the market and in the economy. We believe our stock price is not reflecting accurately our true value. As we continue to make progress we would expect our stock price to reflect our true value. Happily we are in a very solid cash position with over $73 million in cash as of August 31, 2010 with an approximate $4 million/month burn rate which should decrease to about $3 million/month in 2012.
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 completed Phase III efficacy trials are double-blind, placebo-controlled trials that enrolled over 500 surgically menopausal women each for six-months of 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.
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
About BioSante Pharmaceuticals, Inc. (NASDAQ:BPAX)
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), specifically hypoactive sexual desire disorder (HSDD), which is in Phase III clinical development according to 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. Additional information is available online at: www.biosantepharma.com.
Forward-Looking Statements
or revise any forward-looking statement, whether as a result of new information, future events or otherwise. 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 its future operations and products, the timing of anticipated clinical development milestones and regulatory submissions and other statements identified by words such as "will," "could," "believes," "intends," "continue," "plans," "expects," "anticipates," "may," other words of similar meaning, derivatives of such words and 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 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 reports 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
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About the LibiGel Phase III Cardiovascular and Breast Cancer Safety Study