Point Roberts WA, LINCOLNSHIRE, Ill. May 3, 2011 - (Investorideas.com newswire.com) Investorideas.com, an investor research portal covering leading sectors including biotech stocks and pharma stocks, features an exclusive discussion with Mr. Stephen M. Simes, president and chief executive officer of specialty pharmaceutical company, BioSante Pharmaceuticals ( NASDAQ: BPAX ) . Mr. Simes discusses how their product LibiGel ®, (testosterone gel) for the treatment of female sexual dysfunction, paves the way for women's equality in the sexual dysfunction market, currently dominated by male products.
In an interesting perspective from a male CEO bringing his product to market for women, Mr. Simes passionately explains the problem and the solution (LibiGel ®) that is coming to market in the not so distant future. Interestingly, BioSante's vice president of clinical development in charge of LibiGel's clinical studies is a woman!
Sexual Equality for Women!
Why is there no biotech or pharmaceutical product for the treatment of female sexual dysfunction?
By Stephen M. Simes
BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX)
Men have enjoyed access to Viagra and other erectile drugs for over 13 years.
For women, specifically women suffering from hypoactive sexual desire disorder (HSDD), product development has been notably lacking. Today in the United States there is no FDA approved pharmaceutical product for the treatment of HSDD.
Yet HSDD - lack of sexual desire - affects an untold number of women. It is more common than erectile dysfunction in men - which is a $2 billion a year prescription business in the US.
In a study by investigators the University of Chicago, of 1,400 men and 1,700 women between the ages of 18 and 59, 43% of women said they have experienced some degree of sexual dysfunction, compared with just 31% of men. Among the women surveyed, 32% lacked interest in sex. Another study by the same group at the University also found that 43% of American women between the ages of 57 and 85 (about 40 million) experience some degree of low sexual desire.
The majority of women with female sexual dysfunction (FSD) are postmenopausal, experiencing FSD due to hormonal changes following menopause, whether natural or surgical.
Today, there is only one company in the world in active clinical development of a product for this true unmet medical need in women. The company in development of a product is BioSante Pharmaceuticals Inc., in Lincolnshire, Illinois. The product is a transdermal testosterone gel (LibiGel ®). LibiGel currently is in Phase III clinical studies for the treatment of HSDD in post-menopausal women. The LibiGel Phase III clinical development program includes two traditional pivotal Phase III randomized, placebo-controlled, multi-center, safety and efficacy trials, both of which are covered by an FDA SPA (special protocol assessment).
In addition, BioSante is conducting a LibiGel Phase III randomized, placebo controlled, multi-center, cardiovascular event and breast cancer safety study. Over 3,000 of a potential 4,000 women have been enrolled in the study and randomized to LibiGel or placebo. This LibiGel safety study represents the largest database of the safety of testosterone in women ever. To date, the cardiovascular event and breast cancer event rates in the study are lower than predicted. BioSante plans on submitting a new drug application (NDA) to FDA seeking approval for LibiGel by the end of 2012.
LibiGel is absorbed quickly through the skin after a once-daily pea-sized application on the upper arm, delivering testosterone to the bloodstream evenly over time and in a non-invasive and painless manner.
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.
BioSante is committed to the success of LibiGel and to women's health. The time for equal treatment of men's and women's sexuality is here. Practitioners and women are waiting for solutions.
- Stephen M. Simes is president and CEO of BioSante Pharmaceuticals Inc. (http://www.biosantepharma.com), Lincolnshire, IL.
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.
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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 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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