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Thursday, April 28, 2011

Q&A With Stephen M. Simes, President and CEO of BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) Discussing BioSante's Pipeline into 2012

Point Roberts WA, LINCOLNSHIRE, Ill. April 28, 2011 - (, an investor research portal covering leading sectors including biotech stocks and pharma stocks, features an exclusive Q&A interview with Mr. Stephen M. Simes, President and Chief Executive Officer of specialty pharmaceutical company, BioSante Pharmaceuticals. Mr Simes discusses the current product line of LibiGel�, Bio-T-Gel� and Elestrin� into 2012.
Postured to be the first-to-market with an FDA approved product for the treatment of female sexual dysfunction with LibiGel ®, Mr. Simes lays out the roadmap as the company heads into 2012.
BioSante Pharmaceuticals Interview
Mr. Simes, can you give investors an overview of your first FDA-approved product Elestrin™?
A: Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals
Elestrin is FDA-approved for the treatment of hot flashes in menopausal women, an over $1.5 billion market in the U.S. alone. Significantly, the product development team at BioSante developed Elestrin from just a product formulation through clinical trials, a new drug application submitted to the FDA, and a full non-conditional FDA-approval. It is this same BioSante team that is working on our much bigger potential product, LibiGel.
Your leading product, LibiGel ® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD) currently in Phase III clinical development, will bring BioSante to market first in this category - can you give us insight as to the significance of what this represents?
A: Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals
LibiGel is the only product in the world in clinical development for the treatment of female sexual dysfunction, specifically, hypoactive sexual desire disorder, for which there is no FDA-Approved product, a full 13 years after Viagra was approved for men. It is time that women had a choice for treatment of their sexual health. We believe LibiGel will be the first product to be FDA-approved for this exciting indication, estimated to be a multi-billion market. Importantly, there were 4 million testosterone prescriptions written off-label for women in the U.S. in 2009. Physicians surveyed commented that they will switch 96% of their patients over to the FDA-approved, precise metered dose alternative when it becomes available.
Bio-T-Gel™, a testosterone gel for male hypogonadism, has a pending NDA; can you give us a brief overview of the status and predicted timelines for this product?
A: Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals
Bio-T-Gel is our male testosterone product already licensed to TEVA (NASDAQ: TEVA) for marketing in the U.S. The current market for male testosterone products in the U.S. is over $1.2 billion and growing. TEVA is a dynamic sales and marketing company and we are confident they can capture a significant share of market. BioSante will be paid a royalty on TEVA sales of Bio-T-Gel. The FDA's assigned target (PDUFA date) to complete their review of the Bio-T-Gel NDA is November 14, 2011. Therefore, Bio-T-Gel could be launched late this year or early next.
Can you give investors a brief overview of the company's financial status?
A: Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals
At March 31, 2011, we had approximately $51.3 million in cash. This cash balance is sufficient to take us well into 2012 without any need to raise additional capital. We believe we have removed the financing risk from BioSante for the foreseeable future.
About BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX)
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 has been filed 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:
For info about BioSante Pharmaceuticals, Inc
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(646) 378-2953
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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 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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