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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):
August
11, 2008
BIOSANTE
PHARMACEUTICALS, INC.
(Exact
name of registrant as specified in its charter)
|
Delaware
|
001-31812
|
58-2301143
|
|
(State
or Other Jurisdiction of Incorporation)
|
(Commission
File Number)
|
(I.R.S.
Employer Identification Number)
|
|
111
Barclay Boulevard
Lincolnshire,
Illinois
|
60069
|
|
(Address
of Principal Executive Offices)
|
(Zip
Code)
|
(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:
|
£
|
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
|
|
£
|
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
|
|
£
|
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
|
|
£
|
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 August
11, 2008, BioSante Pharmaceuticals, Inc. publicly announced its financial
results for the second quarter ended June 30, 2008. For further
information, please refer to the press 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.
(c) Exhibits.
|
Exhibit
No.
|
Description
|
|
99.1
|
Press
Release issued August 11, 2008
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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.
BIOSANTE
PHARMACEUTICALS, INC.
By: /s/ Phillip B.
Donenberg
Phillip
B. Donenberg
Chief
Financial Officer, Treasurer and Secretary
Dated: August 11,
2008
BIOSANTE
PHARMACEUTICALS, INC.
FORM
8-K
Exhibit
Index
|
Exhibit
No.
|
Description
|
Method
of Filing
|
|
99.1
|
Press
Release issued August 11, 2008
|
Furnished
herewith
|
BioSante
Pharmaceuticals, Inc.
111
Barclay Boulevard
Lincolnshire,
Illinois 60069
www.biosantepharma.com
FOR
IMMEDIATE RELEASE
NASDAQ:
BPAX
BioSante
Pharmaceuticals Reports
Second
Quarter 2008 Developments and Financial Results
LINCOLNSHIRE, Illinois - (August 11, 2008) --- BioSante
Pharmaceuticals, Inc. (NASDAQ: BPAX) today reported its recent developments and
financial results for the second quarter and six months ended June 30, 2008, and
its cash balance as of June 30, 2008.
Significant
Recently Announced Developments:
|
·
|
The Reacquisition of Elestrin™:
BioSante reacquired Elestrin (estradiol gel), U.S. Food and Drug
Administration (FDA) approved for the treatment of menopausal hot flashes,
from Nycomed US Inc., and will assume all manufacturing, distribution and
marketing responsibilities for the product. Nycomed originally acquired
the product from BioSante in November 2006 for $14 million. Under terms of
the reacquisition agreement, BioSante will pay Nycomed $100,000 for the
transfer and Nycomed will continue to inventory the product in its
facilities for up to one year to provide for a smooth
transition. BioSante does not have to return any of the $14
million and will move forward to maximize the value of Elestrin to
BioSante.
|
|
·
|
BioSante Receives a
Second Special
Protocol Assessment (SPA) Agreement with
FDA for
LibiGel®: BioSante reached an
agreement with the FDA for a new SPA for the additional indication for
LibiGel to include “naturally” menopausal women. Previously,
BioSante had an SPA for only “surgically” menopausal
women. This significantly increases the potential market
opportunity for LibiGel, a transdermal testosterone gel in Phase III
clinical development for the treatment of female sexual dysfunction, which
could be the first product approved for this treatment in the U.S for
menopausal women.
|
|
·
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BioSante
Engages Deutsche Bank Securities
Inc.: BioSante engaged Deutsche
Bank as its advisor in connection with BioSante’s ongoing process to
explore strategic alternatives in order to maximize value to its
stockholders.
|
Second
Quarter Results:
BioSante
incurred a net loss of approximately $6.0 million or ($0.22) per share for the
quarter ended June 30, 2008 and $9.7 million or ($0.36) per share for the six
months ended June 30, 2008, compared to a net loss of $2.4 million or
($0.10) per share and $4.2 million or ($0.18) per share for the same respective
periods in 2007. The increased net loss was due primarily to
anticipated increased expenses relating to BioSante’s three ongoing LibiGel®
(testosterone gel) Phase III clinical studies to support submission and approval
of a new drug application (NDA) with the FDA. The LibiGel Phase III
safety and efficacy studies are being conducted under an FDA approved
SPA.
The Company’s cash, cash equivalents and short-term investments as of June 30, 2008 were approximately $22.8 million, as compared to approximately $30.7 million as of 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. BioSante's lead
products include LibiGel®
(transdermal testosterone gel) in Phase III clinical development by BioSante
under a U.S. Food and Drug Administration (FDA) SPA (Special Protocol
Assessment) for the treatment of female sexual dysfunction (FSD), and Elestrin™
(estradiol gel) developed through FDA approval by BioSante, indicated for the
treatment of moderate-to-severe vasomotor symptoms associated with menopause,
currently marketed in the U.S. Also in development are Bio-T-Gel™, a
testosterone gel for male hypogonadism, and an oral contraceptive in Phase II
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 approximately $3 billion. The company also is
developing its calcium phosphate technology (CaP) for novel vaccines, drug
delivery and aesthetic medicine (BioLook™). Additional information is
available online at: www.biosantepharma.com.
For more information, please contact:
McKinney/Chicago
Alan
Zachary
(312)
944-6784 ext. 316; azachary@mckinneychicago.com;
Investor
Relations:
The
Investor Relations Group
Investors:
Adam S.
Holdsworth / Erica Ruderman
212-825-3210
or
Media:
Laura
Colontrelle /Janet Vasquez
212-825-3210