Point Roberts, WA, LINCOLNSHIRE, Ill - May 12, 2011 – Investorideas.com, a leader in sector stock research for independent investors, releases the following updates for featured showcase biotech/pharma stock BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX). The company’s President and CEO, Mr. Stephen Simes, was recently interviewed by CEOCFOinterviews.com.
The interview and article entitled , With An Eye on Women's Sexual Health, BioSante Pharmaceuticals, Inc. is Developing their LibiGel® for the Treatment of Female Sexual Dysfunction for which there is No Approved Product in the United States, provides investors insight into the current status of LibiGel®, clinical data, market opportunities and the significance of being first to market with a product for women's sexual health.
In a quote from his Q&A with Ceocfointerviews.com, Mr. Simes explains; "BioSante is a very interesting opportunity and is a company on the leading edge of a very important unmet medical need. Female sexual dysfunction is a very critical issue and again I will repeat, thirteen years after Viagra was approved for men, women still don't have an option for their sexual health. To the extent that women want to be treated, we think a product should be available. It is all about choice for women. We are developing LibiGel, which is in late stage, Phase III clinical development with an approval on the horizon. We believe the upside for our stockholders is dramatic. We have the money in the bank to implement the plan… as well as the people to take this product through to an FDA approval…In summary, we believe BioSante is well positioned for increasing value for our stockholders.”
"From the beginning, we have had our eye on women's sexual health…We believe this represents a blockbuster opportunity.”- Stephen M. Simes, President and CEO
CEOCFO: How does LibiGel work?
Mr. Simes: LibiGel is a testosterone gel. As we age, both men's and women's testosterone levels decline. Although it is not well known, a normal pre-menopausal woman actually has more testosterone flowing in her blood than she has estrogen. As women get older, their testosterone levels go down, and with the declining testosterone levels often their sexual desire and sexual activity decline. What LibiGel aims to do is bring those testosterone levels back to where they used to be and to restore sexual desire and sexual activity.
CEOCFO : Has testosterone been tried before; in what way is LibiGel different?
Mr. Simes: As I mentioned there is no product FDA-approved for the treatment of female sexual dysfunction, specifically hypoactive sexual desire disorder, so nobody has been successful at providing to the FDA the safety and efficacy data required to get approval for a product.
There are two issues of critical importance: one is the efficacy of a product, and the FDA end points are an increase in sexual desire and an increase in the number of satisfying sexual events. We are measuring those using validated instruments in two LibiGel Phase III efficacy trials.
The other critical issue is the safety of a product. We have known for many years that testosterone can increase desire and sexual activity; what has not been produced yet are the safety data that will convince the FDA that it is safe to use testosterone in women. We are working to provide these data by conducting the very large LibiGel Phase III safety study now in its fourth year. We are planning to submit our new drug application requesting approval in 2012.
About BioSante Pharmaceuticals, Inc: 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'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 with a PDUFA date of November 14, 2011, 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.
This article 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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