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
7, 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))
|
Item
7.01. Regulation
FD Disclosure.
Representatives
of BioSante Pharmaceuticals, Inc. (“BioSante”) intend to make presentations at
investor conferences and in other forums using slides containing the information
attached to this Current Report on Form 8-K as Exhibit 99.1. BioSante is
furnishing the text of these slides pursuant to the Securities and Exchange
Commission’s Regulation FD. This information is furnished pursuant to
Item 7.01 of Form 8-K and shall not be deemed to be “filed” for the
purposes of Section 18 of the Securities Exchange Act of 1934 (the
“Exchange Act”), or otherwise subject to the liabilities of that section, nor
shall it be deemed to be incorporated by reference in any filing under the
Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act,
except as expressly set forth by specific reference in such filing. BioSante
expects to use these slides, in whole or in part, and possibly with
modifications, in connection with presentations to investors, analysts and
others during the remainder of 2006.
By
filing
this Current Report on Form 8-K and furnishing this information, BioSante makes
no admission as to the materiality of any information in this report that is
required to be disclosed solely by reason of Regulation FD.
The
information contained in the slides is summary information that is intended
to
be considered in the context of BioSante’s Securities and Exchange Commission
(“SEC”) filings and other public announcements that BioSante may make, by press
release or otherwise, from time to time. BioSante undertakes no duty or
obligation to publicly update or revise the information contained in this
report, although it may do so from time to time as its management believes
is
warranted. Any such updating may be made through the filing of other reports
or
documents with the SEC, through press releases or through other public
disclosure.
When
included in this Current Report on Form 8-K, the words “expects,” “intends,”
“anticipates,” “believes,” “estimates,” and analogous expressions are intended
to identify forward-looking statements as defined within the Private Securities
Litigation Reform Act of 1995. Such forward-looking statements are subject
to
risks and uncertainties that could cause actual results to differ materially
from those projected or implied. Such potential risks and uncertainties relate,
but are not limited, to, in no particular order: the difficulty of developing
pharmaceutical products, obtaining regulatory and other approvals and achieving
market acceptance. More detailed information on these and additional factors
which could affect BioSante’s operating and financial results are described in
BioSante’s filings with the Securities and Exchange Commission, including its
most recent annual report on Form 10-K. BioSante urges all interested parties
to
read these reports to gain a better understanding of the many business and
other
risks that the company faces. Additionally, BioSante undertakes no obligation
to
publicly release the results of any revisions to these forward-looking
statements, which may be made to reflect events or circumstances occurring
after
the date hereof or to reflect the occurrence of unanticipated events.
Item
9.01 Financial
Statements and Exhibits.
(d) Exhibits.
|
Exhibit
No.
|
Description
|
|
99.1
|
BioSante
Pharmaceuticals, Inc. Investor Presentation (furnished
herewith)
|
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/
Stephen M. Simes
Stephen
M. Simes
President
and Chief Executive Officer
Dated:
November 7, 2006
BIOSANTE
PHARMACEUTICALS, INC.
CURRENT
REPORT ON FORM 8-K
EXHIBIT
INDEX
|
Exhibit
No.
|
Description
|
Method
of Filing
|
|
99.1
|
BioSante
Pharmaceuticals, Inc. Investor Presentation
|
Furnished
herewith
|
To
the extent any statements made in this presentation deal with information
that
is not historical, these are necessarily forward-looking. As such, they
are
subject to the occurrence of many events outside of BioSante’s control and are
subject to various risk factors that could cause BioSante’s results to differ
materially from those expressed in any forward-looking statement. The
risk
factors include, without limitation, the inherent risk of competition
in the
marketplace, clinical outcomes in drug development programs, regulatory
risks
related to proprietary rights and market acceptance. cause such material
differences are 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 10Q, which discussion also is
incorporated herein by reference. Bio-E-Gel nor LibiGel will be approved by
the FDA, that LibiGel clinical development will not be successful or
will be
discontinued, that safety and efficacy protocols will not be finalized
and Phase
III will not be started in a timely manner or at all the first product in
its category to be approved by the FDA. forward-looking statements
speak only as of the date of this presentation. BioSante undertakes no
obligation to update or revise any forward-looking statement, whether
as a
result of new information, future events or otherwise.
Mission
Increase
stockholder value by developing and commercializing BioSante’s near and
long-term product pipeline
Ø
hormone
therapy products,
Ø
nanotechnology
ü
vaccines,
and
ü
protein
delivery
Investment
Highlights
Ø
Hormone
therapy (HT) gel portfolio
§
Bio-E-Gel® for
reduction of hot flashes
§
LibiGel®
for
female sexual dysfunction
§
Bio-E+P-Gel™
for reduction of hot flashes
§
Bio-T-Gel™
for male hypogonadism
Ø
Calcium
phosphate nanotechnology (CAP)
§
Vaccines
ü
Bio-defense
vaccines, e.g., anthrax
ü
Adjuvanted
avian flu vaccine
§
Drug
delivery for proteins and peptides (non-injected)
Ø
Management’s
proven ability to increase stockholder
value
HT
Product Portfolio
Bio-E-Gel® (estradiol
gel)
Market Size:
Once
daily transdermal gel for treatment of menopausal
women
Indication:
Hot
flashes, vaginal atrophy, decreased libido and osteoporosis
Symptoms:
Data
from IMS Health [U.S. only 2005)]:
-
Estrogentherapy(ET)market:
$1.3 billion
-
Transdermal segment: about $250 million
-
Estimated to reach $400million
in
2008
NDA
submitted Q1 2006
-
Significant reduction in frequency and severity of hot
flashes
-
Three effective doses shown
- Lowest effective dose identified
- 50% lower E than currently on market
-
Launch in 2007
Status:
*
Statistically significant from placebo p<0.0001 through Week 12 (p=.0002 for
Low Dose at Weeks 5 and 6).
Baseline
moderate-to-severe hot flash rates ranged from 12.9 – 13.5 across
treatment groups.
Mean
Change From Baseline in Daily Moderate-to-Severe
Hot
Flash Rate by Bio-E-Gel®
Dosage
Severity
scale: 1=mild, 2=moderate, 3=severe.
Baseline
hot flash rates Severity ranged from 2.3 – 2.4 across treatment groups.
* Statistically significant from placebo p<0.0001, p<0.001 or p<0.01 through Week 12.
* Statistically significant from placebo p<0.0001, p<0.001 or p<0.01 through Week 12.
Mean
Change From Baseline in Severity of
Hot
Flashes by
Bio-E-Gel® Dosage
Bio-E-Gel® Marketing
Strategy
Expect
launch in 2007
•
–
small
surface area (upper arm)
–
fast
drying (one to two minutes)
–
no
residue or evidence of use
Target
audience: the 14,000 high volume prescribing
Ob/Gyns in the U.S. who prescribe about 70% of the $1.3 billion market
for
estrogen
therapy
therapy
•
Can
be launched with approximately 50 sales
representatives
•
•
Seeking
sales/marketing partner to launch
Bio-E-Gel®
LibiGel®
(testosterone
gel for women)
Indication:
Female sexual dysfunction (FSD)
Symptoms: Lack
of
sexual
desire, arousal or pleasure
Market
Size: - 43%
of women experience FSD
- Lack
of sexual desire is largest segment
-
P&G’s Intrinsa “patch”
●
approved
in
Europe; planning launch
● reportedly
on hold in U.S.
● P
& G “considering options” in U.S
- Estimate
U.S. market above $2 billion
Phase
II clinical trial completed - statistical increase in satisfying sexual
events
Phase
III safety and efficacy protocols to be finalized with
FDA
Status:
Phase
III
to start in late 2006/early 2007 LibiGel potentially
could
be
the first FSD Rx product to market in U.S.
Objective:
|
Study
Design
|
3
month
Phase
II
150
mcg/day
N=46
SM
|
6
month
Phase
III
300
mcg/day
N=562
SM
|
6
month
Phase
III
300
mcg/day
N=533
SM
|
|
%
increase in
sexual
events
from baseline |
238%*
|
74%*
|
51%*
|
|
#
increase
active
v. pbo
|
5.0
v. 1.6*
|
2.13
v. 0.98*
|
1.56
v. 0.73*
|
|
Application
site
reactions
|
rare
|
~
30%
|
~
30%
|
BioSante/
LibiGel®
LibiGel®
P&G/
Intrinsa
P&G/
Intrinsa
*Statistically
significant versus baseline and placebo, respectively
SM
= surgically menopausal
Comparative
Results
Pipeline
Potential
The
$2.5 billion U.S. hormone therapy market is poised for growth based on
demographics of aging (e.g., menopause)
Female
sexual dysfunction could add $2.0 to $4.0
billion
BioSante’s
Product Pipeline
BioSante
Pharmaceuticals, Inc.
Corporate
Summary
Trading
Data
Ø
American
Stock Exchange (Amex)
Ø
Common
stock outstanding
23.0
million
Ø
Warrants
($2.15,
$2.75 and $7.00)
3.0
million
Ø
Employee
options
(average
exercise price of $3.61)
1.0
million
Ø
Fully
diluted shares
27.0
million
BPA
Financial
Highlights
Ø
Cash
at September 30, 2006
Approximately
$10.3 million
Ø
Burn
rate for
third quarter 2006
Approximately
$600,000-$650,000/month
Ø
No
long-term debt
Key
Product Development Milestones
•
Bio-E-Gel®
ü
NDA
submitted in Q1-2006
ü
three
effective doses shown
ü
lowest
effective dose identified
ü
launch
estimated in 2007
•
LibiGel®
ü
initiate
Phase III clinical studies in female
sexual dysfunction in 2006/early 2007
•
CaP
Bio-Vant™ vaccine
adjuvant
ü
pursue
continued development of biodefense and avian flu
vaccines
