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Q&A with Stephen M. Simes, President and CEO of BioSante Pharmaceuticals (NASDAQ: BPAX); Update on LibiGel®, Pipeline and Recent Research Report

|Includes: ANI Pharmaceuticals, Inc. (ANIP)
Q&A with Stephen M. Simes, President and CEO of BioSante Pharmaceuticals (NASDAQ: BPAX); Update on LibiGel®, Pipeline and Recent Research Report  
How a Specialty Pharmaceutical Company Leads the Way; Phase III Clinicals for the Only Product Currently Addressing Female Sexual Dysfunction
March 28 , 2011 - (, an investor research portal covering leading sectors including biotech stocks and pharma stocks, features an exclusive Q&A interview and update with Mr. Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals.
Stephen M. Simes, discusses how specializing in a product for female sexual dysfunction and leading in development with LibiGel® in Phase III clinicals, makes BioSante Pharmaceuticals (NASDAQ: BPAX) a company to watch.
JMP Securities released a report this month with a price target of $5.00. Mr. Simes gives his insight as the company’s leader as to why the future looks so bright.
BioSante Pharmaceuticals Interview
As you move forward with development of LibiGel®  and other products in the pipeline, is your company able to execute in terms of funding and cash available ? – and up to what time period?  
A: Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals
It is quite interesting that a full 13 years after Viagra was approved for treating men’s sexual issues, women still do not have an approved product to treat their sexual health. Today, BioSante is the only company in the world in Phase III clinical development for the treatment of women’s sexual dysfunction, specifically hypoactive sexual desire disorder. This represents a major opportunity for BioSante and women since we expect to be first to market with our LibiGel which is in several Phase III studies.
JMP Securities recently released research on your company as an “underfollowed and undervalued microcap company” and has placed a $5.00 target price. They note “Our $5 price target is derived by applying a 5x multiple to our base case projection for LibiGel sales of $422MM in 2016, discounted by 30% per year. “ Can you comment on their revenue projections ?
A: Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals
We believe the market potential for products like LibiGel is over $1 billion. This is derived from many factors including the fact that the erectile dysfunction market in the U.S. alone is over $2 billion and the market for male testosterone products is over $1 billion.
The Company recently reported financial results and a pipeline update . Can you give us a summary of what the pipeline looks like outside of LibiGel® ?
A: Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals
Yes, we have a full pipeline of products. Elestrin is our already approved estrogen product for the treatment of hot flashes in menopausal women and Bio-T-Gel is our male testosterone product. We hope to announce an FDA submission of Bio-T-Gel in the near future.   In addition, we have a full portfolio of cancer vaccines in clinical trials.
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, double-blind, 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 (NYSE: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 (NYSE:FSD) which is in Phase III clinical development under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment. 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 products 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. Additional information is available online at:
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Recent Research
JMP Securities
We are initiating coverage on BioSante Pharmaceuticals with a Market Outperform rating
and price target of $5. We view BioSante as an underfollowed and undervalued microcap
company with a late-stage development asset that has better than average clinical risk. BioSante's lead product candidate is LibiGel, a proprietary formulation of testosterone delivered through the skin being developed for the treatment of female sexual dysfunction, for which there is currently no approved therapy. We believe that with clarity emerging on timelines for key value-driving LibiGel catalysts, institutional interest will increase and the market inefficiency in the current valuation can begin to resolve. Our $5 price target is derived by applying a 5x multiple to our base case projection for LibiGel sales of $422MM in 2016, discounted by 30% per year.
Full report :
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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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