BioSante Pharmaceuticals, Inc. (BPAX)

[Just the facts maam]

BPAX Future Revenue Potential

Biosante focuses on unmet needs which is research intense but highly lucrative when successful.

Cancer - $78 billion

Global cancer therapy estimated at over $78 billion for 2012

Biosante with over 17 (looking to expand) cancer treatments in either phase I or II trials, arguably the largest cancer treatment portfolio in existence. Through the Hussman Foundation (Sidney Kimmel Cancer Centrte – Johns Hopkins University) BioSante also will receive between 15 and 33 percent of any sublicense payments made to the Foundation depending on the timing of a sublicense to a corporate partner.

Externally
Biosante has 19.9% ownership of Cold Genesys who in April 2012 will start an Integrated Phase II/III, Open Label, Randomized and Controlled Study of the Safety and Efficacy of CG0070 in Patients With Non-Muscle Invasive Bladder Cancer Who Have Failed BCG

Cold Genesys Clinical trial

BioSante is poised to benefit from Faster Access to Specialized Treatments (FAST) Act

Libigel Markets HSDD ($4-$9 Billion annually in an exclusive market) Cardiovascular (up to $50 billion in a non-exclusive market) in US

Libigel apparently has identified three potential uses and is in different stages of testing for HSDD, Cardiovascular Diseases and Cognitive Function (Alzheimer’s Disease)

HSDD
Phase III HSDD efficacy issues with placebo not the drug. Libigel acted as expected. Management believes they have found the problem with the elevated placebo in the daily and monthly journals entries. Biosante is in discussions with FDA on this matter.

Target audience for HSDD is 4 million off script testosterone user. To which a survey indicated approx. 96 % of physicians would switch to an approved Libigel Drug. Additionally it is estimated that approx 5 million go untreated as there is no proven safe drug for HSDD. 4 to 9 million potential clients estimated cost of prescription ranges between $80 to $144/mo. For the sake of arguments using the lower number and rounding to $1000/yr per client that equates to between $4 and $9 billion/yr

Cardiovascular
Safety trial which equals over 5000 person years of treatment uncovered unexpected benefit of reducing the risk of cardiovascular events by over 70%. As a result Biosante submitted 2 patent applications addressing the cardiovascular benefit. Libigel has just cleared the 8th safety review by the independent Data Monitoring Committee (DMC) with no modifications and has one more safety review. Subject to passing the next DMC review Biosante is in a position to make an NDA application whether it is for the HSDD and/or Cardiovascular is yet to determined.

Heart Disease is the number one cause of death in post menopausal women.

More than 42 million women currently living with or at risk for heart disease in the United States.

35.3% of deaths in American women over the age of 20, or more than 432,000, are caused by cardiovascular disease each year .You know a large percentage of these women are post menopausal.
More than 200,000 women die each year from heart attacks- nearly five times as many women as breast cancer. (imagine potentially saving 140,000 lives per year)

There are presently 50 million menopausal women in the US alone they will spend over 1/3 of their life beyond menopause

Due to the lives that can be save from the Cardiovascular benefit, BioSante can benefit from Faster Access to Specialized Treatments (FAST) Act and get Libigel to market quicker.

This translates to a $50 billion market in the US alone.

Women Heart Disease

Post-Menopause info

Cognitive Function
Libigel is presently being tested for it’s cognitive benefits. Monash University research shows that testosterone treatment improves brain function in healthy postmenopausal women

Testosterone cognitive benefit article

Cognitive Study

The Pill Plus - $4.5 billion market in US

The Pill Plus (oral administration) is looking to start a phase 3 trial and is sublicensed to Pantarie Bioscience. This market is a $4.5 Billion market in the US. Biosante still owns the trans-dermal rights

Biosante has brought two drugs to FDA approval though not financially lucrative to date they provided the experience required to get FDA approvals.

Elestrin (FDA Approved) - Up to $140 million in milestone payments
Marketed by Jazz pharmaceuticals who have marketed it as their lead drug in their Women’s Health Division. Though it had slower start greater acceptance has caused Jazz to dedicate 25 % of its sales force to market Elestrin

Biosante still owns global right outside the US

Bio-t-gel (FDA Approved) $1.6 billion market in US

Teva will be marketing Bio-T-Gel but has entered into an undisclosed agreement with Abott to settle a lawsuit. Once marketed Biosante will receive royalties of between 5% and 10 %

Biosante still owns global right to Bio-t-gel outside the US.

Combine all of this with the fact that Biosante was listed by the Patent Board scorecard in February 2012 as the benchmark in research intensity and rates highly in the quality of the science.

Honestly, how many stocks under a $1 give you this type of potential?