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BioSante Pharmaceuticals (AMEX: BPA)

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Symbol: AMEX: BPA

Address:
BioSante Pharmaceuticals
Corporate Headquarters
111 Barclay Boulevard
Lincolnshire, IL 60069
(847) 478-0500

www.biosantepharma.com

Top Investment Highlights

• BioSante is a pharmaceutical company developing a pipeline of hormone therapy products to treat both men and women.
• The company has a late stage product portfolio with significant growth potential, and its lead product is FDA approved.
• The company's next product in development is for the treatment of female sexual dysfunction (FSD), a condition for which there is currently no FDA approved pharmaceutical products.
• BioSante has no long-term debt and a low current monthly burn rate of approximately $750,000.
• The company has an aggressive business strategy and management has proven its ability to implement plans, reach milestones and increase stockholder value.

Company Overview

BioSante is developing a pipeline of hormone therapy products to treat both men and women. Its hormone therapy products are gel formulations for transdermal administration that deliver bioidentical estradiol (estrogen) and testosterone. Symptoms treated with hormone therapy in men include impotence, diminished sex drive and muscle weakness. Symptoms in menopausal women include hot flashes and female sexual dysfunction (FSD). The estrogen and testosterone markets in the United States alone account for over $2.5 billion in annual sales. The company also is developing its proprietary calcium phosphate nanotechnology (CaP) for novel vaccines, including bird flu and biodefense vaccines for toxins such as anthrax, and drug delivery systems.

Product Pipeline

The company's lead products are gel formulations of testosterone and estradiol, as well as combinations of estradiol with testosterone and estradiol with progestin. These formulations deliver bioidentical hormones similar to those that occur naturally in men and women, and the products have been designed to be effective and convenient for the user. The gels allow for fast-drying, painless, non-invasive application to the upper arm, and absorb evenly into the bloodstream with no physical presence and without leaving residue.

BioSante's lead product, Elestrin™, is an FDA approved bioidentical estradiol gel designed to reduce the frequency and severity of hot flashes in menopausal women. The product has been approved in doses of 12.5 micrograms and 37.5 micrograms per day, and a Phase III clinical trial comprised of 484 postmenopausal women showed both doses of Elestrin to be effective. BioSante signed an exclusive marketing agreement with Bradley Pharmaceuticals (NYSE: BDY), which resulted in an upfront payment of $2.625 million and already triggered milestones of $7.9 million. In addition, BioSante could receive salesbased milestone payments up to $30.0 million plus royalties on the sales of Elestrin. The company's next product in development is LibiGel. Also designed in a transdermal gel form, LibiGel is bioidentical testosterone for the treatment of FSD. A Phase II clinical trial has shown excellent results, reporting a 238% increase in the total number of satisfying sexual events. There are currently no pharmaceutical products approved for the treatment of FSD in the United States. The company began its Phase III clinical development program in December of 2006 by launching the first of two Phase III safety and efficacy trials. The company believes that these two trials, along with one year of data from a separate safety trial, will be what are required to submit to the FDA a New Drug Application (NDA) for approval.

The company also is developing nanotechnology formulations, including vaccines and protein delivery technology. Most vaccines are injected and require the use of adjuvants (agents that modify the effect of other agents) to generate protective immunity for the prevention or treatment of diseases. When BioSante's nanotechnology-based BioVant™ vaccine adjuvant is combined with vaccines in animal studies, it has shown a higher immune response than non-adjuvanted vaccines, and left no site specific irritation. BioVant adjuvanted vaccines have also been shown to induce a higher immune response when delivered intranasally and via other noninjected routes. The company has also developed what it believes to be formulations for the oral, buccal or inhaled delivery of proteins (e.g., insulin). The company is focused primarily on its hormone therapy products and relies on external funding for the development of its nanotechnology formulations.

Hormone Therapy: A Multi-Billion Dollar Industry

The market for hormone therapy products (testosterone, estrogen and progestogen) is approximately $2.5 billion in the U.S. alone. Specifically, the estrogen market for the treatment of hot flashes was a $1.3 billion market in 2006 and is expected to grow based on the aging of the baby-boom generation. Approximately 6,000 women become menopausal every day and two-thirds of menopausal women suffer from hot flashes.

Business Strategy

The company plans to pursue its mission through the following strategies:

• Launch Elestrin in 2007 through Bradley Pharmaceuticals, Inc.,
• Accelerate the development of BioSante's hormone therapy products, focusing on LibiGel for female sexual dysfunction,
• Continue development and partnering of nanoparticulate-based technology,
• In-license additional products that add value to the product portfolio,
• Implement business collaborations with other pharmaceutical/biotechnology companies, as appropriate.

Management

Stephen M. Simes, President and CEO
Prior to joining BioSante in 1998, Mr. Simes was President, Chief Executive Officer and a Director of Unimed Pharmaceuticals, Inc., a company with a product focus on infectious diseases, AIDS, endocrinology and oncology. From 1989 to 1993, he was Chairman, President and Chief Executive Officer of Gynex Pharmaceuticals, Inc., a company which concentrated on the AIDS, endocrinology, urology and growth disorders markets.

Phillip B. Donenberg, CPA Chief Financial Officer, Treasurer and Secretary
Phillip B. Donenberg, CPA has served as the company's Chief Financial Officer, Treasurer and Secretary since July 1998. Previously, he was Controller of Unimed Pharmaceuticals and Molecular Geriatrics Corporation, a biotechnology corporation.

Louis W. Sullivan, M.D., Chairman of the Board
The Honorable Louis W. Sullivan, M.D. has been BioSante's Chairman of the Board of Directors since March 1998 and has been a director of the company since its formation. Dr. Sullivan served as Secretary of Health and Human Services in the cabinet of President George H.W. Bush from 1989 to 1993. Since retiring from the Bush Administration, Dr. Sullivan has been President Emeritus of the Morehouse School of Medicine in Atlanta, Georgia. Dr. Sullivan serves on the board of directors of Henry Schein Inc., United Therapeutics Corporation, Emergent BioSolutions and Inhibitex, Inc.

This corporate profile is based upon information provided by management of BioSante Pharmaceuticals. The information is not intended to be and shall not constitute, an offer to sell or solicitation of any offer to buy any security. It is intended for information only and to increase awareness of BioSante Pharmaceuticals' services. Safe Harbor Statement: The statements in this document relating to future product availability, collaboration and partnership and positive direction are forward- looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Some or all of the aspects anticipated by these forward-looking statements may not, in fact, occur. Factors that could cause or contribute to such differences include, but are not limited to, contractual difficulties, demand for BioSante Pharmaceuticals' products, the future market price of BioSante Pharmaceuticals common stock and the Company's ability to obtain necessary future financing. EQUITIES Magazine was paid by BioSante Pharmaceuticals to write and print this profile. Before investing in any security, you are strongly advised to review all public filings of the issuer of such security, which can be found at www.sec.gov, as well as the warnings published by the Securities and Exchange Commission at http://www.sec.gov/investor.shtml.