FDA Approves Bio-T-Gel

BioSante Pharmaceuticals Announces FDA Approval for Bio-T-Gel

LINCOLNSHIRE, Ill.--(BUSINESS WIRE)--Feb 15, 2012 - BioSante Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved Bio-T-Gel, which is licensed by BioSante to Teva Pharmaceuticals USA, Inc. Bio-T-Gel is a testosterone gel for the treatment of male hypogonadism or low testosterone levels. Male hypogonadism is generally characterized by impotence, a lack of sex drive, muscle weakness and osteoporosis.

Bio-T-Gel was initially developed by BioSante, and then it was licensed to Teva for late stage clinical development. Teva is responsible for all Bio-T-Gel regulatory and marketing activities. BioSante will receive royalties and may receive certain milestone payments upon commercialization of Bio-T-Gel. The current U.S. market for male testosterone products is estimated at over $1.6 billion.

“We are pleased that Bio-T-Gel will provide another treatment option to men suffering from low testosterone levels,” said Stephen M. Simes, BioSante's president & CEO. “We are confident that Teva has the commercialization and marketing expertise to implement a successful launch, and we look forward to Bio-T-Gel reaching the market.”

About Male Hypogonadism

Typically, a man's testosterone level is considered low if it's below a level of approximately 300 ng/dL. Low testosterone affects 4 to 5 million men over the age of 39 and is associated with a multitude of symptoms including loss of libido and sexual function, decreased energy, increased body fat, osteoporosis, reduced muscle mass, and loss of body hair. There is no cure for hypogonadism. It is a medical condition that usually requires ongoing treatment.

About BioSante Pharmaceuticals, Inc.

BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante's products include LibiGel® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD), specifically hypoactive sexual desire disorder (HSDD), which is in Phase III clinical development. BioSante also is developing a portfolio of cancer vaccines, with 17 Phase I and Phase II clinical trials currently on-going. Four of these vaccines have been granted Orphan Drug designation by the U.S. Food and Drug Administration (FDA). BioSante's other products include Bio-T-Gel™, a testosterone gel for male hypogonadism, for which a New Drug Application (NDA) was just approved by the FDA, which is licensed to Teva Pharmaceuticals, and the Pill-Plus™, an oral contraceptive in Phase II clinical development by Pantarhei Bioscience B.V. BioSante's first FDA-approved product is Elestrin™ (estradiol gel) indicated for the treatment of hot flashes associated with menopause, marketed in the U.S. by Jazz Pharmaceuticals, BioSante's licensee. Additional information is available online at: www.biosantepharma.com.

Forward-Looking Statements

To the extent any statements made in this news release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about BioSante's plans, objectives, expectations and intentions with respect to its future operations and products, Teva's plans with respect to Bio-T-Gel and the estimated market for Bio-T-Gel and other statements identified by words such as “will,” “potential,” “could,” “can,” “believe,” “intends,” “continue,” “plans,” “expects,” “anticipates,” “estimates,” “may,” other words of similar meaning or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause BioSante's actual results to be materially different than those expressed in or implied by BioSante's forward-looking statements. For BioSante, particular uncertainties and risks include, among others, the timing of a commercial launch of Bio-T-Gel, market acceptance of Bio-T-Gel and its future sales and BioSante's future revenues as a result of such sales; the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the success of BioSante's licensees or sublicensees to develop and market BioSante's products; the success of clinical testing; and BioSante's need for and ability to obtain additional financing. More detailed information on these and additional factors that could affect BioSante's actual results are described in BioSante's filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. All forward-looking statements in this news release speak only as of the date of this news release. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

Contact: For Investors:
The Trout Group LLC
Tricia Swanson, 646-378-2953
tswanson@troutgroup.com
or
For Media:
Harris D. McKinney, Inc.
Alan Zachary, 312-506-5220
azachary@harrisdmckinney.com

Posted: February 2012

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Bio-T-Gel (testosterone) FDA Approval History

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