Point Roberts, WA, LINCOLNSHIRE, Ill – July 15, 2011 –(Investorideas.com newswire.com) Investorideas.com, an investor research portal covering leading sectors including biotech and pharma stocks, features an exclusive Q&A interview with Mr. Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals, as industry buzz builds on talk of partners or acquisition with value up to $1 Billion.
As BioSante's lead product LibiGel ® (transdermal testosterone gel), for the treatment of female sexual dysfunction gets closer to market, the company is now on the radar as a biotech company to watch.
BioSante Pharmaceuticals Interview
Q: Investorideas.com
Stephen, there is an old saying in the market, that the trading tells the story. The activity and interest in your stock is building from both analysts and retail investors. Can you give us some insight to the key points of the recent analyst coverage and what the industry is saying about your company?
A: Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals
We have been in development of LibiGel for quite a number of years. Finally the finish line is in site. We have completed enrollment of women into our three LibiGel Phase III clinical studies and efficacy data should be available in the fourth quarter of this year. Safety data should be available in the third quarter of 2012 and our objective is to submit the LibiGel new drug application (NDA) to the FDA in the fourth quarter of 2012. All of these dates are near-term opportunities in the biotech/pharma world. Analysts and investors are taking note of the progress we have made with LibiGel.
Q: Investorideas.com
Can you discuss the potential dollar value for a female sexual dysfunction drug hitting the market?
A: Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals
We believe the market for a drug for female sexual dysfunction is potentially bigger than the market for erectile dysfunction drugs, a $2 billion market if the U.S., and male testosterone, a $1.3 billion market in the U.S. Our belief is based on current off-label use of products to treat female sexual dysfunction as well as publications that indicate the potential size of the market for treatment of female sexual dysfunction. It has been over 13 years since Viagra was approved and we believe strongly that women deserve an FDA-approved therapeutic choice for their sexual health issues.
Q: Investorideas.com
With LibiGel ® getting closer to market, how will the process of potential partners or acquisition play out in the pharma industry?
A: Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals
Our focus is on completing the LibiGel Phase III clinical work and submitting an NDA in 2012. Our LibiGel partnering strategy from the beginning has been and remains to develop LibiGel as far as we can since we believe the best way to maximize our stockholder value is to bring LibiGel to the latest stage of product development and regulatory status possible. Although we would entertain a license/partnership at this time, we believe the value of LibiGel will increase as new efficacy and safety data become available and these data will be available beginning in the coming months.
Q: Investorideas.com
With other players abandoning the female sexual dysfunction market, your company stayed through the long process and is now postured to be first to market. How significant is it that you have no current competition?
A: Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals
As stated before we believe the market for female sexual dysfunction is significant and we would welcome other companies to develop product for this market. Having said that, today LibiGel is the only product in Phase III clinical development in the world. Assuming positive safety and efficacy data, we believe LibiGel will be the first product approved by the FDA for the treatment of female sexual dysfunction, specifically hypoactive sexual desire disorder. In our primary market research with prescribing physicians, they tell us that there is a great need for an FDA-approved product and that they are dissatisfied with their choices for off-label use. If and when LibiGel is approved we believe it will be a very successful product and result in a very attractive choice for prescribers and women in need, and continued increasing value for our stockholders.
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 have enrolled over 500 surgically menopausal women each for a six-month clinical trial. The efficacy trials, which have completed enrollment, 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.
In addition, BioSante is conducting the Phase III LibiGel safety study, a randomized, double-blind, placebo-controlled, multi-center, cardiovascular (CV) events and breast cancer study that has completed enrollment of 3,656 women and has accrued 4,000 women-years of exposure. The 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 second half 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 (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 using BioSante patented technology. 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.
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
For Media:
McKinney/Chicago
Alan Zachary
(312) 506-5220
azachary@mckinneychicago.com
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