The Only Pharmaceutical Company with A Product In Active Phase III Development for Menopausal Women Experiencing Sexual Dysfunction
A $2-4 Billion Potential Market With No Approved Rx Product in the U.S.
A Late Stage Specialty Pharmaceutical Company Focused on Developing Products for the Underserved Female Sexual Health Market
Lincolnshire, Illinois (October 22, 2008) – BioSante Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on developing products for female sexual health, menopause, contraception, and male hypogonadism. BioSante’s lead product, LibiGel® (transdermal testosterone gel) is currently in Phase III clinical development under a U.S. Food and Drug Administration SPA (Special Protocol Assessment) for the treatment of female sexual dysfunction. Based on sales data for male sexual dysfunction products as well as independent market research, the estimated market for an FDA approved female sexual dysfunction product would reach $2.0 billion. Currently there are no Rx products approved for the treatment of female sexual dysfunction in the U.S., although there are several options available for male sexual dysfunction, including Viagra, which was commercially launched ten years ago.
LibiGel® is designed to restore testosterone levels in post-menopausal women to levels that are considered normal to maintain a healthy libido. A pea- sized amount of gel is applied once a day to the upper arm via a metered dose bottle. Safety and efficacy Phase III trials currently are underway throughout the country in more than one hundred test sites. Phase II clinical trials at seventeen sites showed use of LibiGel® led to a 238% increase in satisfying sexual events for women taking the drug. When these safety and efficacy studies are completed, and if the FDA approves the drug, LibiGel® may become the first FDA approved treatment specifically indicated for Hypoactive Sexual Desire Disorder in menopausal women.
BioSante also has a marketed product, Elestrin™ (estradiol gel), which is FDA approved to reduce hot flashes in menopausal women. BioSante received an unconditional FDA approval for two doses of Elestrin™ in December 2006 and the product was launched commercially in June 2007. Elestrin™ currently is marketed in the U.S. and competes in the $1.4 billion estrogen product market for the treatment of hot flashes.
BioSante’s Key Products
*Primary Focus is on LibiGel® and Elestrin™
LibiGel® – In Phase III Development for Female Sexual Dysfunction
- Phase II clinical trial demonstrated excellent results with a significant 238% increase in the total number of satisfying sexual events, which is a primary endpoint for FDA approval
- Three Phase III clinical trials are ongoing
- The Phase III safety and efficacy trials are being conducted under an SPA agreement with the FDA
- Each efficacy trial will enroll approximately five hundred surgically menopausal women for six-months of treatment
- A LibiGel® new drug application (NDA) submission is planned for 2010 with a potential commercial launch in 2011
Elestrin™ – FDA Approved Transdermal Gel for Treatment of Hot Flashes
- Elestrin™ was launched commercially in June 2007
- Received an unconditional FDA approval for two doses in December 2006
- Elestrin™ competes in the $1.4 billion U.S. estrogen market for the treatment of hot flashes
The Pill-Plus™ – Triple Hormone Contraceptive
- Restores sexual desire and activity to women taking hormonal contraception
- Oral use licensed to and being developed by Pantarhei Bioscience; BioSante maintains transdermal route of administration
- Completed Phase II clinical trial with positive results
Bio-T-Gel™ – In Development for Treatment of Testosterone Deficiency in Men
- Licensed to and being developed by Teva Pharmaceuticals (NASDAQ: TEVA)
BioLook™ – A Development Stage Facial Line Filler in the Area of Aesthetic Medicine
- Licensed to and being developed by Medical Aesthetics Technology Corp.
Multi-Billion Dollar Potential in an Underserved Market
- The current market for testosterone and estrogen products is approximately $2.5 billion dollars in the U.S. alone, with estimates for female sexual dysfunction potentially adding more than $2 billion
- There currently are no pharmaceutical products approved for the treatment of female sexual dysfunction in the U.S., however, according to IMS, two million testosterone prescriptions were written off-label for women by U.S. physicians in 2007
- Although Viagra has been on the market for over ten years, to date, there has been no pharmaceutical product approved in the U.S. for female sexual dysfunction
- BioSante is a specialty pharmaceutical development company with a late stage product portfolio with significant growth potential
- The Company’s key product, LibiGel®, is in active Phase III clinical development to treat female sexual dysfunction with an NDA submission planned for 2010
- Another important BioSante product, Elestrin™, is FDA approved and currently marketed in the U.S.
- BioSante’s proprietary CaP technology has aesthetic medicine potential
- Management has the proven ability to gain FDA approval, implement plans, and increase stockholder value
Recent Price (10/21/2008): $3.44
Market Cap: $94.4M
Average Volume: 78,311
Common Shares Outstanding: 27.0M
52-Week Range: $2.05-$6.05
Fiscal Year Ends: December 31
Cash Balance: $22.8M (6/30/2008)
Stephen M. Simes
Vice Chairman, President and CEO
Phillip B. Donenberg, CPA
CFO, Treasurer and Secretary
Michael C. Snabes, M.D., Ph.D.
VP, Clinical Development
VP, Corporate Development
111 Barclay Boulevard
Lincolnshire, IL 60069
Tel.: (847) 478-0500
The Investor Relations Group