BioSante Pharmaceuticals, Inc. (BPAX)

[Just the facts maam]

Libigel’s Testosterone Play?

Firstly, I want to thank those who welcomed me to the board.

I have also found the following information for your consideration.

Most of you are aware of the results released December 14th, 2011 The result of the testosterone were never in doubt as shown below.

BioSante Pharmaceuticals Announces Results from LibiGel® Efficacy Trials

Excerpt from above article

Importantly, and as seen in previous pharmacokinetic data, the LibiGel groups in both trials showed an increase in free testosterone levels compared to baseline and placebo. In BLOOM-1 mean free testosterone at baseline was approximately 1.19 pg/ml and 1.10 pg/ml in the placebo and LibiGel groups, respectively. In month six of the trial, free testosterone levels were approximately 1.35 pg/ml and 4.01 pg/ml in the placebo and LibiGel groups, respectively. In BLOOM-2 mean free testosterone at baseline was approximately 1.06 pg/ml and 1.19 pg/ml in the placebo and LibiGel group, respectively. In month six of the trial, free testosterone levels were approximately 1.09 pg/ml and 3.70 pg/ml in the placebo and LibiGel groups, respectively.

The trials demonstrated that LibiGel was generally well tolerated with a safety profile that appears to be comparable to the placebo. Remember the Bloom 1 and 2 trials increased sexual satisfaction was subjective and recorded in a diary allowing greater chance of a placebo effect. The testosterone levels are clinical and concrete.

Interview conducted by: Lynn Fosse, Senior Editor, CEOCFOinterviews.com, Published - March 11, 2011

Excerpt from above article

CEOCFO: What is the market opportunity for LibiGel?

Mr. Simes: There are different ways to look at the market. The erectile dysfunction market in the U.S., which is the market for Viagra, Levitra, and Cialis, is about $2 billion a year. Based on publications on women’s self-reporting of how many women suffer from low sexual desire, or low sexual activity, we believe the market for women is at least $2 billion. However, there is another very important consideration. Last year in the U.S., there were 4 million testosterone prescriptions, written off-label by physicians for women. That is, they are using men’s testosterone or they are using other products that are not FDA-approved to treat the condition. In any event, doctors already are prescribing and women already are using testosterone for this indication, and the 4 million depending on the pricing would result in a $1 to $2 billion potential for LibiGel. Now the question is why do we need LibiGel? Those other products are not FDA-approved or clinically tested, so the safety has not been proven and most importantly there is no way of knowing what the effective dose is. Therefore, in our primary research, doctors tell us that, if and when LibiGel is approved, they will switch about 96% of those women using testosterone today to LibiGel. That represents well over a $1 billion opportunity for us.

CEOCFO: In closing, why should potential investors choose BioSante Pharmaceuticals?

Mr. Simes: BioSante is a very interesting opportunity and is a company on the leading edge of a very important unmet medical need. Female sexual dysfunction is a very critical issue and again I will repeat, thirteen years after Viagra was approved for men, women still don’t have an option for their sexual health. To the extent that women want to be treated, we think a product should be available. It is all about choice for women. We are developing LibiGel, which is in late stage, Phase III clinical development with an approval on the horizon. We believe the upside for our stockholders is dramatic. We have the money in the bank to implement the plan as I have described, as well as the people to take this product through to an FDA approval. They have a proven track record as evidenced by our Elestrin approval. LibiGel is being dealt with by the same division at the FDA, The Division of Reproductive and Urologic Products, as was Elestrin. In summary, we believe BioSante is well positioned for increasing value for our stockholders.


Menopause and Testosterone
Excerpt from above article
Testosterone is an important factor in women's health before and after menopause. Testosterone provides several benefits to women:
• improves relief of vasomotor symptoms of menopause
• increases energy levels
• enhances of feelings of well-being
• decreases breast tenderness
• improves sexual desire
• increases sexual sensitivity
• increases the frequency of coitus
• enhances orgasm

Conclusion:
Biosante Plan B is going from "Viagra for women" to a testosterone designed for women which has been clinically tested and FDA with reduced side effects. Not the home run of Female Viagra but a solid double. Patent until 2022 with potentially 4 + million prescriptions per year (US only) and an aging population = potential > $8 billion in sales up to 2022.