ANI Pharmaceuticals 8K Regulation FD Disclosure | ANIP 7 Nov 06

To the extent any statements made in this presentation deal with information that is not historical, these are necessarily forward-looking. As such, they are subject to the occurrence of many events outside of BioSante’s control and are subject to various risk factors that could cause BioSante’s results to differ materially from those expressed in any forward-looking statement. The risk factors include, without limitation, the inherent risk of competition in the marketplace, clinical outcomes in drug development programs, regulatory risks related to proprietary rights and market acceptance. cause such material differences are identified and discussed from time to time in BioSante’s filings with the Securities and Exchange Commission, including those factors discussed in BioSante’s most recent Forms 10-K and 10Q, which discussion also is incorporated herein by reference. Bio-E-Gel nor LibiGel will be approved by the FDA, that LibiGel clinical development will not be successful or will be discontinued, that safety and efficacy protocols will not be finalized and Phase III will not be started in a timely manner or at all the first product in its category to be approved by the FDA. forward-looking statements speak only as of the date of this presentation. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

Mission

Increase stockholder value by developing and commercializing BioSante’s near and long-term product pipeline

hormone therapy products,

nanotechnology

vaccines, and

protein delivery

Investment Highlights

Hormone therapy (HT) gel portfolio

Bio-E-Gel^® for reduction of hot flashes

LibiGel^®for female sexual dysfunction

Bio-E+P-Gel™ for reduction of hot flashes

Bio-T-Gel™ for male hypogonadism

Calcium phosphate nanotechnology (CAP)

Vaccines

Bio-defense vaccines, e.g., anthrax

Adjuvanted avian flu vaccine

Drug delivery for proteins and peptides (non-injected)

Management’s proven ability to increase stockholder value

HT Product Portfolio

Bio-E-Gel^® (estradiol gel)

Market Size:

Once daily transdermal gel for treatment of menopausal women

Indication:

Hot flashes, vaginal atrophy, decreased libido and osteoporosis

Symptoms:

Data from IMS Health [U.S. only 2005)]:

- Estrogentherapy(ET)market: $1.3 billion

- Transdermal segment: about $250 million

- Estimated to reach $400million in 2008

NDA submitted Q1 2006

- Significant reduction in frequency and severity of hot flashes

- Three effective doses shown

- Lowest effective dose identified

- 50% lower E than currently on market

- Launch in 2007

Status:

* Statistically significant from placebo p<0.0001 through Week 12 (p=.0002 for Low Dose at Weeks 5 and 6).

Baseline moderate-to-severe hot flash rates ranged from 12.9 – 13.5 across treatment groups.

Mean Change From Baseline in Daily Moderate-to-Severe

Hot Flash Rate by Bio-E-Gel^® Dosage

Severity scale: 1=mild, 2=moderate, 3=severe.

Baseline hot flash rates Severity ranged from 2.3 – 2.4 across treatment groups.
* Statistically significant from placebo p<0.0001, p<0.001 or p<0.01 through Week 12.

Mean Change From Baseline in Severity of

Hot Flashes by Bio-E-Gel^® Dosage

Bio-E-Gel^® Marketing Strategy

Expect launch in 2007

•

–

small surface area (upper arm)

–

fast drying (one to two minutes)

–

no residue or evidence of use

Target audience: the 14,000 high volume prescribing Ob/Gyns in the U.S. who prescribe about 70% of the $1.3 billion market for estrogen
therapy

•

Can be launched with approximately 50 sales representatives

•

Seeking sales/marketing partner to launch Bio-E-Gel®

LibiGel^® (testosterone gel for women)

Indication: Female sexual dysfunction (FSD)

Symptoms: Lack of sexual desire, arousal or pleasure

Market Size: - 43% of women experience FSD

- Lack of sexual desire is largest segment

- P&G’s Intrinsa “patch”

● approved in Europe; planning launch

● reportedly on hold in U.S.

● P & G “considering options” in U.S

- Estimate U.S. market above $2 billion

Phase II clinical trial completed - statistical increase in satisfying sexual events

Phase III safety and efficacy protocols to be finalized with FDA

Status:

Phase III to start in late 2006/early 2007 LibiGel potentially

could be the first FSD Rx product to market in U.S.

Objective:

Study Design	3 month Phase II 150 mcg/day N=46 SM	6 month Phase III 300 mcg/day N=562 SM	6 month Phase III 300 mcg/day N=533 SM
% increase in sexual events from baseline	238%*	74%*	51%*
# increase active v. pbo	5.0 v. 1.6*	2.13 v. 0.98*	1.56 v. 0.73*
Application site reactions	rare	~ 30%	~ 30%

BioSante/
LibiGel^®

P&G/

Intrinsa

P&G/

Intrinsa

*Statistically significant versus baseline and placebo, respectively

SM = surgically menopausal

Comparative Results

Pipeline Potential

The $2.5 billion U.S. hormone therapy market is poised for growth based on demographics of aging (e.g., menopause)

Female sexual dysfunction could add $2.0 to $4.0 billion

BioSante’s Product Pipeline

BioSante Pharmaceuticals, Inc.

Corporate Summary

Trading Data

American Stock Exchange (Amex)

Common stock outstanding

23.0 million

Warrants ($2.15, $2.75 and $7.00)

3.0 million

Employee options (average exercise price of $3.61)

1.0 million

Fully diluted shares

27.0 million

BPA

Financial Highlights

Cash at September 30, 2006

Approximately $10.3 million

Burn rate for third quarter 2006

Approximately $600,000-$650,000/month

No long-term debt

Key Product Development Milestones

•

Bio-E-Gel^®

NDA submitted in Q1-2006

three effective doses shown

lowest effective dose identified

launch estimated in 2007

•

LibiGel^®

initiate Phase III clinical studies in female sexual dysfunction in 2006/early 2007

•

CaP Bio-Vant™ vaccine adjuvant

pursue continued development of biodefense and avian flu vaccines

ANI Pharmaceuticals (ANIP) 8-KRegulation FD Disclosure