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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):
May 12,
2006
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
May
12, 2006, BioSante Pharmaceuticals, Inc. publicly announced its financial
results for the quarter ended March 31, 2006. 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 report and the exhibit hereto shall
not
be deemed to be “filed” for purposes of Section 18 of the Securities Exchange
Act of 1934, as amended, 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
Securities Exchange Act of 1934, as amended, 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 May
12, 2006
|
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: May
12,
2006
BIOSANTE
PHARMACEUTICALS, INC.
FORM
8-K
Exhibit
Index
|
Exhibit
No.
|
Description
|
Method
of Filing
|
|
99.1
|
Press
Release issued May
12, 2006
|
Furnished
herewith
|
BioSante
Pharmaceuticals, Inc.
FOR
IMMEDIATE RELEASE
Amex: BPA
BioSante
Pharmaceuticals Reports Product Development Highlights
and
First Quarter 2006 Financial Results
LINCOLNSHIRE,
Illinois - (May 12, 2006)
---
BioSante Pharmaceuticals (AMEX: BPA) today reported product development
highlights and financial results for the first quarter ended March 31, 2006.
“We
were
pleased to start the year by submitting our new drug application for
Bio-E-Gel®,
which
we believe, if and when approved, may offer the lowest effective dose of
estrogen on the market for the treatment of hot flashes,” said Stephen M. Simes,
BioSante’s president and chief executive officer. “Also in the first quarter,
positive data from pre-clinical trials with BioVant™,
our
calcium phosphate nanoparticle technology, demonstrated its effectiveness as
an
adjuvant for flu vaccines, including bird flu. Looking to the remainder of
2006,
we aim to continue our success by initiating Phase III clinical studies of
LibiGel®
in
female sexual dysfunction.”
Product
Development Highlights
—
BioSante
submitted a new drug application (NDA) to the U.S. Food and Drug Administration
(FDA) for Bio-E-Gel (transdermal
estradiol gel) to treat moderate to severe hot flashes in menopausal women.
The
NDA includes data from a 12-week pivotal Phase III, randomized, double-blind,
placebo controlled study of 484 symptomatic women, as well as data from a
transfer study, a sunscreen study, and a pharmacokinetic study. Low, mid, and
high doses of Bio-E-Gel were tested. We believe the lowest effective dose was
identified and all three dosages showed a significant reduction in the number
and severity of hot flashes compared to placebo.
—
BioSante announced positive results from three pre-clinical studies,
demonstrating that BioVant (calcium phosphate nanoparticle technology, or CaP)
may serve as an adjuvant for the development of vaccines for M1 protein, H3N1
and H5N1 (bird flu) flu virus strains. Results of the studies show that BioVant
can enhance flu-specific immunity, elicit high titers of bird flu-specific
antibodies, and potentially serve as a good adjuvant for an H5N1 vaccine.
—
BioSante signed an exclusive option and license agreement with Medical
Aesthetics Technology Corporation for the use of CaP technology in the field
of
aesthetic medicine.
—
BioSante was awarded a subcontract by the University of Nebraska-Lincoln valued
at $250,000 for the development of recombinant Factor IX formulations using
CaP
technology for alternate routes of administration. The current subcontract
is
for the first year of the University’s grant and, if warranted, BioSante can
apply to renew the subcontract with a total possible value of $1.25 million
over
five years.
First
Quarter 2006 Financial Overview
BioSante
incurred a net loss of approximately $3.2 million or ($0.17) per share for
the
quarter ended March 31, 2006, compared to a net loss of $2.8 million or ($0.14)
per share for the same period in 2005. This increase was due primarily to the
impact of BioSante adopting SFAS No. 123(R) “Share-Based Payment” and increases
in general and administrative expenses, partially offset by reductions in
research and development expense and an increase in licensing and grant revenue.
The
Company’s cash, cash equivalents and short-term investments as of March 31, 2006
were approximately $7.1 million, as compared to approximately $9.1 million
on
December 31, 2005. The Company’s cash burn rate for the first quarter of 2006
was approximately $2 million, slightly lower than the projected burn rate
mentioned in BioSante’s announcement regarding its 2005 financial results. We
remain confident that our cash balance is sufficient to allow for the initiation
of LibiGel Phase III clinical development in 2006.
About
BioSante Pharmaceuticals, Inc.
BioSante
is developing a pipeline of hormone therapy products to treat both men and
women. These hormone therapy products are gel formulations for transdermal
administration that deliver bioidentical estradiol and testosterone. BioSante's
lead products include Bio-E-Gel (transdermal estradiol gel) for the treatment
of
women with menopausal symptoms, and LibiGel (transdermal testosterone gel)
for
the treatment of female sexual dysfunction (FSD). A Bio-E-Gel New Drug
Application was submitted to the FDA in the first quarter of 2006. The current
market in the U.S. for estrogen and testosterone products is approximately
$2.5
billion. The transdermal gel formulations used in the women's gel products
are
licensed by BioSante from Antares Pharma Inc. BioSante also is developing its
calcium phosphate nanotechnology (CaP) for novel vaccines, including avian
flu
and biodefense vaccines for toxins such as anthrax and ricin, and drug delivery
systems. 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 of 1995. The statements regarding
BioSante contained in this news release that are not historical in nature,
particularly those that utilize terminology such as "may," "will," "should,"
"likely," "expects," "anticipates," "estimates," "believes,” "plans,” "hopes,”
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 cause actual results to differ materially from those expressed
in such forward-looking statements are the difficulty of developing
pharmaceutical products, obtaining regulatory and other approvals and achieving
market acceptance, and other factors identified and discussed from time to
time
in BioSante's filings with the Securities and Exchange Commission, including
those factors discussed on pages 22 to 34 in BioSante's most recent Form 10-K,
which discussion also is incorporated herein by reference. Additional risk
factors include the risk that the FDA will not approve Bio-E-Gel for marketing
or that if approved, Bio-E-Gel may not achieve commercial success. 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.
For
more information, please contact:
Phillip
Donenberg, BioSante Pharmaceuticals, Inc.; (847) 478-0500;
donenber@biosantepharma.com
Lauren
Glaser, The Trout Group LLC; (415) 392-3310; lglaser@troutgroup.com
Daniel
Budwick, BMC Communications; (212) 477-9007 ext 14; dbudwick@bmccommunications.com