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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
1, 2007
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 1,
2007, BioSante Pharmaceuticals, Inc. publicly announced its financial results
for the first quarter ended March 31, 2007. 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 May 1, 2007
|
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
1,
2007
BIOSANTE
PHARMACEUTICALS, INC.
FORM
8-K
Exhibit
Index
|
Exhibit
No.
|
Description
|
Method
of Filing
|
|
99.1
|
Press
Release issued May 1, 2007
|
Furnished
herewith
|
FOR
IMMEDIATE RELEASE
Amex: BPA
BioSante
Pharmaceuticals Reports
First
Quarter 2007 Financial Results
LINCOLNSHIRE,
Illinois - (May 1, 2007)
---
BioSante Pharmaceuticals, Inc. (AMEX: BPA) today reported its March 31, 2007
cash balance and its financial results for the first quarter ended March
31,
2007.
The
Company’s cash, cash equivalents and short-term investments as of March 31, 2007
were approximately $15.1 million, as compared to approximately $11.5 million
on
December 31, 2006. The Company’s cash burn rate in
the
second quarter of 2007 is expected to be approximately $750,000 per month.
BioSante
incurred a net loss of approximately $1.8 million or ($0.08) per share
for the
quarter ended March 31, 2007, compared to a net loss of $3.2 million or
($0.17)
per share for the same period in 2006. This decrease was due primarily
to a
reduction in business development costs and legal expenses and a decrease
in
non-cash stock-based
compensation
expense.
Recent
Product Developments and Corporate Highlights
As
previously announced,
the
Company in
December 2006 received its first U.S. Food and Drug Administration (FDA)
approval for Elestrin™ (estradiol gel) in the treatment of hot flashes. The
lower of the two Elestrin doses approved is the lowest dose of estradiol
approved for the treatment of hot flashes. In November 2006, the Company
bolstered its cash position and realized another milestone in the
commercialization of Elestrin by signing an exclusive agreement with Bradley
Pharmaceuticals, Inc.
(NYSE:
BDY) for the marketing of Elestrin in the United States. Upon execution of
the
agreement, BioSante received $3.5 million. The December FDA approval triggered
a
payment of $10.5 million to BioSante. In March 2007, the Company received
$7.0
million of this payment and the rest is to be received by year-end 2007.
Sales-based milestone payments could bring payments from Bradley to BioSante
up
to an additional $40 million over several years. In addition, Bradley has
agreed
to pay to BioSante royalties on sales of Elestrin. Bradley is planning a
mid-2007 launch of the product.
In
December 2006, the Company announced that it initiated
a Phase III safety and efficacy trial of LibiGel®
(transdermal testosterone gel) in the treatment of female sexual dysfunction
(FSD). The double-blind, placebo-controlled Phase III trial will enroll
surgically menopausal women for a six-month clinical trial, conducted under
a
Phase III protocol reviewed by and on file with the FDA.
In
February 2007, the Company announced that a new patent was issued covering
the
formulations used in Elestrin (estradiol gel), BioSante’s newly approved
treatment for moderate to severe vasomotor symptoms associated with menopause
and LibiGel®
(transdermal testosterone gel), which recently moved into Phase III clinical
development for the treatment of female sexual dysfunction. The patent, which
was issued on April 3, 2007 covering both Elestrin and LibiGel, will expire
on
June 25, 2022.
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 bio-identical estradiol and testosterone. BioSante's
lead products include Elestrin™ (estradiol gel), developed through FDA approval
by BioSante, indicated for the treatment of moderate-to-severe vasomotor
symptoms associated with menopause, and LibiGel®
(transdermal testosterone gel) in Phase III development for the treatment
of
female sexual dysfunction (FSD). 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, which receives a portion of milestone payments and royalties
on
such products. The company also is developing its calcium phosphate
nanotechnology (CaP) for novel vaccines, including hepatitis B, avian flu
and
biodefense vaccines for toxins such as anthrax, as well as a system for
delivering drugs via alternative routes of administration. 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, the success of clinical testing, 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 in
BioSante's most recent Forms 10-K and 10-Q, which discussion also is
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.
For
more information, please contact:
Phillip
Donenberg, BioSante Pharmaceuticals, Inc.; (847) 478-0500;
donenber@biosantepharma.com