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Tuesday, November 2, 2010 - Q&A Interview with BioSante Pharmaceuticals (NASDAQ: BPAX), Update on LibiGel® (testosterone gel) for the treatment of female sexual dysfunction and its Pancreatic Cancer Vaccine - Q&A Interview with BioSante Pharmaceuticals (NASDAQ: BPAX), Update on LibiGel® (testosterone gel) for the treatment of female sexual dysfunction and its Pancreatic Cancer Vaccine

Stephen M. Simes, President and CEO Discusses LibiGel (testosterone gel) in Phase III and GVAX Pancreas Vaccine in Phase II

November 2, 2010 - ( newswire,, an investor research portal covering leading sectors including biotech stocks and pharma stocks, presents the second in a series of Q&A interviews with BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX).

The first introductory Q&A can be found here:

In this follow up, Stephen M. Simes, president and chief executive officer of BioSante Pharmaceuticals discusses recent developments with its lead product in Phase III, LibiGel (testosterone gel) in addition to GVAX Pancreas Vaccine in Phase 2.

Your company just recently announced that the Phase III LibiGel (testosterone gel) cardiovascular and breast cancer safety study will continue without modifications and will continue to enroll new subjects as a result of the fourth unblinded review of adverse events by its independent Data Monitoring Committee (DMC). Can you give investors insight into the study, the subjects and the type of data collected?

A: Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals
Yes. We currently are conducting three Phase III LibiGel clinical studies, one of which is a very important cardiovascular events and breast cancer safety study to which you refer. We now have enrolled over 2,500 women into this study and to date the safety of LibiGel looks excellent. The rate of cardiovascular events that have been reported in the study is significantly lower than was predicted for this population of women, and the rate of breast cancer reported is close to predicted. Our objective is to show the safety of LibiGel in the treatment of female sexual dysfunction for which there is no FDA approved product today. We believe we are doing that.

According to your press release, A new drug application (NDA) can be submitted after an average of 12 months of exposure with subjects followed for five years in total, including after NDA submission and potential FDA approval. BioSante’s objective is to submit the LibiGel NDA in 2011. The average time for FDA approval is six months to a year. Once approved by FDA, the drug becomes available for physicians to prescribe for patients- so the company is looking at 2012 for LibiGel to be available?

A: Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals
Our objective is to submit the new drug application (NDA) in 2011 for a potential approval and launch in 2012. We belive LibiGel will be the first product to enter this market, notwithstanding the fact that Viagra was approved for men over 12 years ago. The time for women to have a product to trat their sexual issues has come!


You recently stated , “With this most recent favorable DMC recommendation, we continue to believe that LibiGel will be the first product approved by the FDA to treat HSDD in menopausal women, also referred to as FSD”- for investors looking at potential revenue for this product , what does this represent for the company?

A: Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals
The forecast for the size of the potential market for female sexual dysfunction products varies from $2 billion up to $5 billion. The market for erectile dysfunction products like Viagra is over $2 billion just in the U.S. We believe LibiGel alone has the potential to be a $1 billion per year product.


In a recent article on Seeking Alpha, discussing pancreatic cancer, your company is featured in the section “Select Pancreatic Products in Active Clinical Development”. Can you give us an overview and update on the GVAX Pancreas Vaccine, Phase 2.
Article source for reference:

A: Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals
We have a full pipeline of cancer vaccines in clinic al trials. In fact there are 12 ongoing clinical trials in pancreatic cancer and breast cancer among other cancer types. Cancer vaccines represent the next wave in potential therapies for cancer patients and we hope to contribute to that wave. Data to date have been excellent.

About LibiGel®

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 will enroll up to approximately 500 surgically menopausal women each for a six-month clinical trial. The efficacy trials 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.

About BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX)
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 (GVAX), three 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 developing its calcium phosphate technology (CaP) for aesthetic medicine (BioLook™), among other uses, as well as seeking opportunities for its 2A/Furin and other technologies. Additional information is available online at:

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Forward-Looking Statements
This news release may contain forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include statements about BioSante’s plans, objectives, expectations and intentions with respect to future operations and products, future market acceptance, size and potential of LibiGel and other statements identified by words such as “will,” “potential,” “could,” “would,” “can,” “believe,” “intends,” “continue,” “plans,” “expects,” “anticipates,” “estimates,” “may,” other words of similar meaning 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 reports on Form 10-Q. All forward-looking statements in this presentation speak only as of the date of this presentation. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
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