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Wednesday, February 23, 2011

Q&A Interview with BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX); Update on LibiGel Phase III Clinical Development Program

February 23, 2011 - (, an investor research portal covering leading sectors including biotech stocks and pharma stocks, presents the fourth in a series of Q&A interviews with Stephen M. Simes, President and CEO of BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX). Mr. Simes updates the investment community on recent milestones for its leading product in development, LibiGel (testosterone gel).
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 LibiGel (testosterone gel).
Stephen, can you give us a quick summary of some of the company's recent milestones?
A: Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals
The most recent milestone regarding LibiGel is a very positive LibiGel safety data update. We reported that the safety study's independent Data Monitoring Committee (DMC) took its fifth unblinded look at adverse events reported in the LibiGel safety study. For the fifth time, the DMC recommended continuing the LibiGel safety study as per FDA-agreed protocol without modification. This is a positive outcome since the DMC did not express to us any concern to date about the safety of LibiGel.
Your company just recently announced t hat there has been positive safety data in your ongoing LibiGel Phase III clinical trials. Your news release states "with 2,869 women enrolled and over 3,000 women-years of exposure in its LibiGel Phase III cardiovascular and breast cancer safety study, there have been 17 adjudicated cardiovascular (CV) events, with a lower than anticipated event rate of approximately 0.57 percent. There have been eight breast cancers reported, a rate of approximately 0.27 percent." With those positive safety results how much closer to FDA approval does that make LibiGel?
A: Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals
We are making excellent progress toward FDA approval in that our three LibiGel Phase III clinical studies are proceeding as per our plan. Our hope is to submit a new drug application (NDA) to the FDA for a LibiGel approval and launch in 2012. This is on the near-term horizon for us.
Your company recently presented data at an International conference showing Female Sexual Dysfunction is a significant unmet medical need. Can you give us a summary of some the physician stats to back that up?
A: Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals
To start, it is important to point out that there is no FDA-approved pharmaceutical product for the treatment of female sexual dysfunction (FSD), specifically hypoactive sexual desire disorder (HSDD). Well over 80 percent of surveyed physicians told us that there is a need or a great need for an FDA-approved product for the treatment of female sexual dysfunction, a full 13 years after Viagra was approved for men. In fact, over 90 percent of surveyed physicians report that they currently prescribe products off-label (that is, products not FDA-approved) for the treatment of FSD. Interestingly the average gynecologist hears 37 non-solicited complaints about FSD per month. The unmet medical need is dramatic.
You recently stated. "LibiGel remains the only product in the world in Phase III clinical development for the treatment of HSDD". Can you comment in more detail on the significance of that?
A: Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals
As I mentioned, there is no FDA-approved pharmaceutical product for the treatment of HSDD. LibiGel is the only product in the world in Phase III clinical development for this indication. Therefore, we expect to be the first product to be FDA approved for HSDD!
As the biotech sector is heating up again for investors, your company has received substantial media attention recently, in particular following your company reporting positive safety data from your late-stage study. The company plans to submit an application for LibiGel's approval to the Food and Drug Administration in 2012 - so what key developments are in the pipeline for investors and media to watch for from now to then?
A: Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals
In the very near-term, we hope to announce completion of enrollment in our LibiGel efficacy trials. In addition, we will continue to report on data from our LibiGel safety study, even though we remain blinded to which therapy, LibiGel or placebo, the women in the study are taking. LibiGel is the main driver of value for BioSante in 2011, however, we also expect to update the public about our other products in development including Bio-T-Gel, our male testosterone gel, already licensed to TEVA, as well as our cancer vaccines in development.
About LibiGel®
LibiGel® is a gel formulation of testosterone in development that is quickly absorbed through the skin after a once-daily application of a pea-sized dose of gel on the upper arm, delivering testosterone to the bloodstream evenly over time and in a non-invasive and painless manner. Though generally characterized as a male hormone, testosterone also is present in women and its deficiency has been found to decrease libido or sex drive. In addition, studies have shown that testosterone therapy can increase bone density, raise energy levels and improve mood, in addition to boosting sexual desire and activity.
Currently, BioSante is conducting three Phase III clinical studies to demonstrate the safety and efficacy of LibiGel to increase sexual desire and satisfying sexual events and to decrease distress associated with the decreased desire. Two Phase III safety and efficacy trials that are underway are randomized, doubleblind, placebo-controlled trials which will enroll approximately 500 surgically menopausal women each for six-months of treatment. BioSante is conducting these trials under an FDA agreed special protocol assessment (SPA). In addition, BioSante has another SPA agreement with the FDA related to treatment of naturally menopausal women. The SPA process and agreement confirms the FDA's position that FSD and HSDD are true conditions that women experience, with measurable endpoints, that can be evaluated and which deserve therapeutic options. It also affirms that the FDA agrees that the LibiGel Phase III safety and efficacy clinical trial design, clinical endpoints, sample size, planned conduct and statistical analyses are acceptable to support regulatory approval. Further, it provides assurance that these agreed measures will serve as the basis for regulatory review and the decision by the FDA to approve an NDA for LibiGel.
About BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX)
BioSante (NASDAQ: BPAX) 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:
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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," "potential," "could," "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 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.
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