News Excerpt: Mr. Stephen M. Simes, President and CEO of BioSante Pharmaceuticals (NASDAQ: BPAX), Discusses the Future of LibiGel® Following Closing of $48 Million Offering
“ BioSante plans to use the net proceeds from the offering for general corporate purposes, including funding the ongoing Phase III clinical study program for LibiGel® for the treatment of female sexual dysfunction (FSD), specifically hypoactive sexual desire disorder (HSDD), which is in development under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment (SPA).
BioSante Pharmaceuticals Interview
Mr. Simes, following the closing of the $48 Million offering, you report use of proceeds will include ongoing Phase III clinical study program for LibiGel® for the treatment of female sexual dysfunction (FSD). How far will this take you into the study and what does this mean for investor confidence in taking this product to market?
A: Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals
The proceeds of the $48 million underwritten financing together with the cash we had before the transaction results in almost $80 million in cash. This cash balance is sufficient to fund the LibiGel program and BioSante through our anticipated LibiGel new drug application (NDA) submission by the end of 2012, and in fact all the way through a potential FDA approval which could come in mid-2013. This long runway was one of the key reasons for executing the transaction at this time. Another reason for executing the transaction at this time was so that in the fourth quarter of this year when we announce LibiGel efficacy data investors can concentrate on the quality of the data versus being concerned that we would need to raise money.”
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), specifically hypoactive sexual desire disorder (HSDD), 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.
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.
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