UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C.  20549

FORM 8-K

Current Report

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported):

November 9, 2011

BIOSANTE PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

(847) 478-0500

(Registrant’s Telephone Number, Including Area Code)

N/A

(Former Name or Former Address, If Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

o            Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

o            Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

o            Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

o            Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Section 2 – Financial Information

Item 2.02. Results of Operations and Financial Condition.

On November 9, 2011, BioSante Pharmaceuticals, Inc. publicly announced its financial results for the third quarter ended September 30, 2011.  For further information, please refer to the news release attached hereto as Exhibit 99.1, which is incorporated by reference herein.

The information contained in this Item 2.02 and Exhibit 99.1 hereto shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that section, and shall not be incorporated by reference into any filings made by BioSante Pharmaceuticals, Inc. under the Securities Act of 1933, as amended, or the Exchange Act, except as may be expressly set forth by specific reference in such filing.

Section 9 – Financial Statements and Exhibits

Item 9.01. Financial Statements and Exhibits.

(d)   Exhibits.

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SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

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BIOSANTE PHARMACEUTICALS, INC.

FORM 8-K

Exhibit Index

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Exhibit 99.1

BioSante Pharmaceuticals Reports Financial Results for Third Quarter 2011

and Pipeline Update

Lincolnshire, Illinois – November 9, 2011 – BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) today announced financial results for the third quarter ended September 30, 2011 and provided an update on the Company’s pipeline.

As of September 30, 2011, BioSante’s cash and cash equivalents were approximately $69.6 million, compared to $38.2 million at December 31, 2010.  BioSante’s net loss was $12.7 million or $(0.12) per share for the third quarter of 2011, compared to a net loss of $11.6 million or $(0.16) per share for the third quarter 2010. This increase in net loss was due primarily to increased LibiGel® (testosterone gel) clinical development expenses during the third quarter of 2011.

Pipeline Update

On October 4, 2011, BioSante announced the completion of its two pivotal LibiGel Phase III efficacy trials.  Trial data are being collected from the 141 investigative sites in the U.S. and Canada that participated in the trials and the Company remains blinded to the results.  BioSante expects to announce top-line LibiGel efficacy results from both trials in December 2011.

The LibiGel clinical development program also includes the ongoing LibiGel Phase III cardiovascular event and breast cancer safety study, which completed enrollment of 3,656 subjects in June 2011. On October 11, the Company announced that an independent Data Monitoring Committee completed its seventh unblinded safety review and recommended that the study continue as per the FDA-agreed protocol, without modifications.  The primary analysis of safety data is targeted for the third quarter of 2012. The LibiGel New Drug Application (NDA) submission will include data from the two efficacy trials as well as the safety study, and is targeted for the fourth quarter of 2012.

In addition, BioSante’s Bio-T-Gel™, a testosterone gel for male hypogonadism licensed to Teva Pharmaceuticals, has been assigned a new PDUFA date of February 14, 2012. Teva is responsible for all regulatory and marketing activities for Bio-T-Gel.

About BioSante Pharmaceuticals, Inc.

BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante’s lead 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 according to a U.S. Food and Drug Administration (FDA) Special Protocol Assessment (SPA). 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 Azur Pharma, BioSante’s licensee. BioSante also is developing a portfolio of cancer vaccines, four of which have been granted Orphan Drug designation, and are currently in several Phase II clinical trials. Other BioSante products are Bio-T-Gel™, a testosterone gel for male hypogonadism, for which an NDA is pending, licensed to Teva Pharmaceuticals, and an oral contraceptive in Phase II clinical development. Additional information is available online at: www.biosantepharma.com.

BioSante Pharmaceuticals, Inc.

Selected Statements of Operations Data

BioSante Pharmaceuticals, Inc.

Selected Balance Sheet Data