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Tuesday, June 7, 2011

Biotech Q&A; BioSante Announces Completion of Enrollment in LibiGel Safety Study

Point Roberts, WA, LINCOLNSHIRE, Ill - June 7, 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 and update with Mr. Stephen M. Simes, president and chief executive officer of BioSante Pharmaceuticals. Mr. Simes discusses the significance of the Company’s completion of enrollment in its ongoing LibiGel (testosterone gel) Phase III cardiovascular and breast cancer safety study.
LibiGel is a testosterone gel in Phase III clinical development for the treatment of women who suffer from female sexual dysfunction (FSD).
BioSante Pharmaceuticals Interview
Q: Investorideas.com
Stephen, the company has announced completion of the enrollment in its ongoing LibiGel (testosterone gel) Phase III cardiovascular and breast cancer safety study. Can you explain to investors how it was determined that the current enrollment is sufficient?
A: Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals
Yes, based on the last unblinded statistical analysis by the independent statistician of the Data Monitoring Committee, it was determined that according to the FDA-agreed sample size analysis enrollment should stop, based on meeting a minimum 90 percent predictive probability of success of the safety study to show the safety of LibiGel at the primary data analysis. As per the protocol, the safety study will continue for 12 months of therapy from the last subject enrolled before the primary analysis will be conducted by BioSante, which will provide the data for BioSante's new drug application (NDA) submission anticipated to be made in 2012. The study will continue for five years.
Q: Investorideas.com
How does this impact the timeline for a new drug application (NDA) submission?
A: Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals
Our projected timeline is to submit an NDA to the FDA seeking approval to market LibiGel by the end of 2012.
Q: Investorideas.com
Can you explain to investors the timelines and the next stages of the Phase III LibiGel safety study?
Based on the LibiGel safety study protocol, the primary analysis of data will be conducted in 12 months. This will put us in a position to submit the NDA by the end of 2012.
A: Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals
Q: Investorideas.com
LibiGel is currently the only product in the world in Phase III clinical development for the treatment of HSDD- Can you explain to new investors the significance of being first to market?
A: Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals
We believe the potential market for products to treat women's sexual health is well over $1 billion in the U.S. alone. We also believe that LibiGel will be the first product approved for the treatment of menopausal women in this indication. Being first to market will result in gaining the majority of the available market.
Related News Release:
Pharma News; BioSante Pharmaceuticals (NASDAQ: BPAX) Completes Enrollment in LibiGel® Phase III Safety Study
May 31, 2011 (Investorideas.com newswire) - BioSante Pharmaceuticals, Inc. (NASDAQ:BPAX), today announced completion of enrollment in its ongoing LibiGel (testosterone gel) Phase III cardiovascular and breast cancer safety study. LibiGel is in development for the treatment of female sexual dysfunction (FSD), specifically, hypoactive sexual desire disorder (HSDD) in menopausal women, for which there is no FDA-approved product.
BioSante has been informed by the LibiGel safety study independent Executive Committee regarding the outcome of the sample size analysis that determines the number of subjects to be enrolled in the LibiGel Phase III safety study. The FDA-agreed sample size analysis indicates that enrollment should stop, based on meeting a minimum 90 percent predictive probability of success of the safety study to show the safety of LibiGel at the primary data analysis. As per the protocol, the safety study will continue for 12 months of therapy from the last subject enrolled before the primary analysis will be conducted by BioSante, which will provide the data for BioSante's new drug application (NDA) submission anticipated to be made in 2012. The study will continue for five years.
Full News at: http://www.investorideas.com/CO/BPAX/news/2011/05311.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 (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 more information, please contact:
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953; tswanson@troutgroup.com azachary@mckinneychicago.com
For Media:
McKinney/Chicago
Alan Zachary
312-506-5220; azachary@mckinneychicago.com
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