Point Roberts, WA, LINCOLNSHIRE, Ill - November 9, 2010 (Investorideas.com Newswire) Investor ideas and its biotech portal present a company and product spotlight for B ioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) lead product LibiGel®.
Highlights from the LibiGel Brochure:
Read the Full Brochure at: http://www.investorideas.com/CO/BPAX/news/LibiGel-Brochure-102910.pdf
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 will enroll up to approximately 500 surgically menopausal women each for a six-month clinical trial. The efficacy trials 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.
Hypoactive Sexual Desire Disorder (HSDD) � lack of sexual desire � affects millions of women in the U.S., especially those past menopause, whether natural or surgical. Studies find it is more common than erectile dysfunction � which is a $2 billion a year prescription business in the U.S. A University of Chicago study of 1,700 men and 1,700 women between the ages of 18 and 59 published in JAMA, found that 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. Further, according to a study published in the NEJM, 43% of women between the ages of 57 and 85 experience some degree of low sexual desire. The majority of women with FSD are postmenopausal, experiencing FSD due to hormonal changes following menopause, whether natural or surgical. In 2009, there were over 4.0 million testosterone prescriptions written off-label for the treatment of HSDD. Over 90% of women using testosterone off-label would be switched to LibiGel® once approved, according to surveyed physicians.
Unmet Clinical Need / Market Opportunity
The goal of testosterone treatment of women experiencing Hypoactive Sexual Desire Disorder (HSDD) is to increase the serum testosterone towards the normal range of premenopausal women in an effort to alleviate the symptoms of this disorder....
This market has wide potential with predictions ranging from about $2.0 billion up to $5 billion. The $2.0 billion potential is the size of the male market if one considers only the current erectile dysfunction products. The current market for testosterone products for men is approximately $1 billion and growing.
Results of Phase II for LibiGel Testing:
Specifically to testosterone and LibiGel in the treatment of female sexual dysfunction, there is little question that testosterone can increase the number of satisfying sexual events, the FDA�s primary endpoint for approval of a drug for this indication. Both BioSante and Proctor & Gamble (for their testosterone patch, Intrinsa, which is not currently in active clinical development and now owned by Warner Chilcott) have completed clinical trials showing the efficacy of testosterone to statistically and clinically significantly increase the number of satisfying sexual events.
Progress and Plans in Phase III:
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....
In addition to the two Phase III safety and efficacy trials covered by the SPA, BioSante is conducting one Phase III cardiovascular and breast cancer safety study of LibiGel, which also is underway....
- BioSante�s objective is to submit the LibiGel NDA in 2011 for a potential FDA approval in 2012.Recent News for LibiGel Product:
BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) reports recent news; “BioSante Pharmaceuticals Reports Positive LibiGel ® Data Monitoring Committee Recommendation
Recent Q&A featuring LibiGel®
Q&A Interview with BioSante Pharmaceuticals (NASDAQ: BPAX), Update on LibiGel® (testosterone gel) for the treatment of female sexual dysfunction and its Pancreatic Cancer Vaccine
Stephen M. Simes, President and CEO Discusses LibiGel (testosterone gel) in Phase III and GVAX Pancreas Vaccine in Phase II
Full interview � read here: http://www.investorideas.com/CO/BPAX/news/11021.asp
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, and Elestrin™ (estradiol gel) for the treatment of moderate-to-severe vasomotor symptoms associated with menopause, which is marketed in the U.S. by Azur Pharma, BioSante's licensee. BioSante also is developing a portfolio of cancer vaccines (GVAX), three 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 developing its calcium phosphate technology (CaP) for aesthetic medicine (BioLook™), among other uses, as well as seeking opportunities for its 2A/Furin and other technologies. Additional information is available online at: www.biosantepharma.com.
This e-mail 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.
The Trout Group LLC
(312) 944-6784 ext. 316
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