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BioSante Pharmaceuticals Reports LibiGel[R] Status and Financial Results for 2008.


LINCOLNSHIRE, Ill. -- BioSante Pharmaceuticals, Inc. (NASDAQ NASDAQ
 in full National Association of Securities Dealers Automated Quotations

U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on
: BPAX) today announced the status of LibiGel in development for the treatment of female sexual dysfunction sexual dysfunction

Inability to experience arousal or achieve sexual satisfaction under ordinary circumstances, as a result of psychological or physiological problems.
 and financial results for the year ended December 31, 2008.

"BioSante had an excellent year in 2008. Our new product development was led by the initiation of three LibiGel Phase III clinical trials," said Stephen M. Simes, BioSante's president and chief executive officer. "These clinical trials continue to enroll subjects and make progress. LibiGel is BioSante's transdermal testosterone gel in late-stage development for the treatment of female sexual dysfunction (FSD FSD Female Sexual Dysfunction
FSD File System Driver
FSD Family Support Division
FSD Fire Services Department (Hong Kong)
FSD Full Scale Development
FSD Full Scale Deflection
FSD Federal Systems Division
) in menopausal women. LibiGel's development continues under a Special Protocol Assessment (SPA). The SPA affirms that BioSante's clinical trial design, endpoints, sample size, planned conduct and statistical analyses are acceptable to support regulatory approval. BioSante's objective continues to be to submit a new drug application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) for LibiGel by the end of 2010."

Financial Results for 2008

The company's net loss was approximately $17.4 million or $(0.64) per basic and diluted share for the year ended December 31, 2008, compared to a net loss of $7.6 million or $(0.30) per basic and diluted share for the same period in 2007. This increase in net loss was due primarily to increased spending on the company's Phase III Noun 1. phase III - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA  LibiGel clinical trial program. As of December 31, 2008, BioSante's cash, cash equivalents and short-term investments were approximately $14.8 million as compared to $30.7 million at December 31, 2007.

About BioSante Pharmaceuticals, Inc.

BioSante is a specialty pharmaceutical company focused on developing products for female sexual health, menopause, contraception and male hypogonadism Noun 1. male hypogonadism - the state of being a eunuch (either because of lacking testicles or because they failed to develop)
eunuchoidism

hypogonadism - incompetence of the gonads (especially in the male with low testosterone); results in deficient
. BioSante's lead products include LibiGel([R]) (transdermal testosterone gel) in Phase III clinical development by BioSante under a U.S. Food and Drug Administration (FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
) SPA (Special Protocol Assessment) for the treatment of female sexual dysfunction (FSD), and Elestrin[TM] (estradiol gel) developed through FDA approval by BioSante, indicated for the treatment of moderate-to-severe vasomotor vasomotor /vaso·mo·tor/ (-mo´tor)
1. affecting the caliber of blood vessels.

2. a vasomotor agent or nerve.


va·so·mo·tor
adj.
 symptoms associated with menopause, currently marketed in the U.S. Also in development are Bio-T-Gel[TM], a testosterone gel for male hypogonadism, and an oral contraceptive oral contraceptive
n.
A pill, typically containing estrogen or progesterone, that prevents conception or pregnancy. Also called birth control pill.
 in Phase II/III clinical development using BioSante patented technology. The current market in the U.S. for estrogen and testosterone products is approximately $2.5 billion and for oral contraceptives Oral Contraceptives Definition

Oral contraceptives are medicines taken by mouth to help prevent pregnancy. They are also known as the Pill, OCs, or birth control pills.
 approximately $3 billion. The company also is developing its calcium phosphate technology (CaP) for novel vaccines, drug delivery and aesthetic medicine (BioLook[TM]). Additional information is available online at: www.biosantepharma.com.

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  of 1995. The statements regarding BioSante contained in this news release that are not historical in nature, particularly those that utilize terminology such as "will," "potential", "could," "can," "believe," "intends," "continue," "plans," "expects," "estimates" or comparable terminology, are forward-looking statements. Forward-looking statements are based on current expectations and assumptions, and entail various risks and uncertainties that could cause actual results to differ materially from those expressed in such forward-looking statements. Important factors known to BioSante that could cause actual results to differ materially from those expressed in such forward-looking statements include BioSante's need for and ability to obtain additional financing, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the marketing success of BioSante's licensees or sublicensees; the success of clinical testing, and other factors 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 annual report on Form 10-K Form 10-K

A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information.


Form 10-K

See 10-K.
,which discussions also are incorporated herein by reference. All forward-looking statements 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.
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Publication:Business Wire
Article Type:Financial report
Date:Mar 16, 2009
Words:629
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