Investor FAQs and Facts for BioSante Pharmaceuticals, Inc: (NASDAQ: BPAX)
POINT ROBERTS, August 24, 2001 - www.InvestorIdeas.com, a global investor research portal for independent investors features an investor FAQ and Fact Sheet for specialty pharmaceutical company, BioSante Pharmaceuticals, Inc: (NASDAQ: BPAX).
BioSante’s (NASDAQ: BPAX) stock has built a significant retail investor following as well as over 40% institutional ownership and has had extensive media coverage as its key product, LibiGel®, gets closer to market as the first FDA-approved drug for female sexual dysfunction. The following FAQs and Facts can serve as an important stage of due diligence for investors and media following the company’s progress.
BioSante FAQs (Frequently asked Questions)
1) In the correct market environment cash is king. How long will your cash last?
A: BioSante is well funded and has the financial resources to continue our corporate strategy well into 2013, with a current burn rate averaging $4 Million per month which will decrease to approximately $3 million per month in 2012. As of August 2, 2011 we had about $79 million in cash.
2) What is the timeline for LibiGel clinical development?
A: LibiGel is in three pivotal Phase III clinical studies at this time. The first two trials are set to be completed in September 2011 with top-line efficacy data reported in the fourth quarter 2011. Top-line data from the third study, a safety study, will be reported in the third quarter 2012.A new drug application (NDA) is targeted to be submitted in 2012 and a potential FDA approval could come in mid-2013.
3) Other companies have tried to develop products for the treatment of female sexual dysfunction. Why is BioSante the only company active in Phase III clinical development for this indication today?
A: As stated before we believe the market for female sexual dysfunction is significant and we would welcome other companies to develop product for this market. Having said that, today LibiGel is the only product in Phase III clinical development in the world. Previous companies have failed in their development either because their efficacy data were not adequate or they did not prove the safety of their products to FDA’s satisfaction. We believe the LibiGel Phase III clinical program will show both the efficacy and the safety of LibiGel in the treatment of female sexual dysfunction, specifically hypoactive sexual desire disorder, a significant unmet medical need among women.
4) How big is the market for FSD?
A: The current market for testosterone and estrogen products is over $2.5 billion dollars in the U.S. alone, with estimates for female sexual dysfunction (FSD) potentially adding more than $2.0 billion. Unfortunately a full 13 years after Viagra was approved for men’s sexual health there still is no FDA-approved product for the treatment of women’s sexual health.
5) How will LibiGel be marketed?
A: According to IMS and primary research, in 2010, over four million “off label” testosterone prescriptions were written for women in the U.S. According to survey data, clinicians indicated that they would prefer to prescribe an FDA approved product that has been clinically tested and proven to be safe and effective for the treatment of HSDD, and they would switch over 90% of their patients using testosterone to LibiGel®. In addition, the physicians indicated the number of women using testosterone for HSDD would more than double given an FDA approved product. Our objective is to license LibiGel to a larger company to market it once approved.
6) Does BioSante have a pipeline beyond LibiGel?
A: Yes, BioSante has a long list of products in clinical development as well as pending FDA approval. Clearly, LibiGel represents our biggest and best near-term opportunity. In addition, our male testosterone product, Bio-T-Gel™ has an NDA pending and has been licensed to Teva for marketing in the U.S. In addition we have a portfolio of cancer vaccine currently in 15 Phase I and Phase II studies. Importantly, these studies are funded by others and therefore BioSante has no cost, but significant potential upside. Investors should visit our website, www.biosantepharma.com, to review our full product portfolio as well as review our public filings for the most information about our company.
What investors need to know about BioSante
• Financial resources to continue corporate strategy well into 2013
• Late stage pharmaceutical product portfolio with significant growth potential
• LibiGel in three ongoing Phase III safety and efficacy clinical studies
• Elestrin is FDA approved and marketed in the U.S.
• Bio-T-Gel™ has NDA pending
• Proprietary cancer vaccines in Phase II clinical trials
• Focused growth strategy
• Management’s proven ability to gain FDA approval, implement plans and increase stockholder value
• At August 2, 2011, BioSante had approximately $79M in cash
• Monthly burn rate of approximately $4.0M
LibiGel® — In development under an SPA for treatment of female sexual dysfunction. Three Phase III safety and efficacy clinical studies are ongoing.
ElestrinTM — FDA approved transdermal gel for treatment of hot flashes; currently
marketed in the U.S. by Azur Pharma.
Bio-T-GelTM — An NDA has been filed byTeva USA for the treatment of hypogonadism
The Pill-PlusTM — Triple component contraceptive in Phase II clinical development
combining oral contraceptive and androgen. Licensed to and being developed
by Pantarhei Bioscience for oral uses.
Cancer Vaccines — A portfolio of cancer vaccines in Phase II clinical trials for various
cancer types, conducted at Johns Hopkins Cancer Center.
Read the August 2011 Fact Sheet in Full
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.
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:
The Trout Group LLC
(646) 378-2953; [email protected]
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