STEPHEN M. SIMES - BIOSANTE PHARMACEUTICALS, INC. (BPA)
CEO Interview - published 01/08/2007

STEPHEN M. SIMES HAS BEEN VICE CHAIRMAN, PRESIDENT AND CEO OF BIOSANTE 
Pharmaceuticals, Inc., since January 1998. Prior to BioSante, Mr. Simes was 
President and CEO of Unimed Pharmaceuticals, Inc., and Gynex Pharmaceuticals, 
Inc., both of which were sold to bigger companies; Unimed to Solvay and Gynex to 
Bio-Technology General Corp. (now Savient Pharmaceuticals, Inc.). Mr. Simes 
started his career in the pharmaceutical industry with G.D. Searle & Co. in 
1974. Since 1984, Mr. Simes has specialized in emerging companies, building 
product portfolios in endocrinology, urology, hormones and drug delivery 
systems, among other areas. Mr. Simes holds a BS in Chemistry from Brooklyn 
College of the City University of New York and an MBA from New York University.

TWST: Please begin with a brief historical sketch of the company, and a picture 
of the things you are doing at the present time.

Mr. Simes: BioSante Pharmaceuticals has been a US publicly traded company since 
2000, and our focus today is in hormone therapy products. We recently received 
FDA approval of our first product, Elestrin(tm), which is an estrogen gel 
approved for the treatment of hot flashes in menopausal women. Also, we have 
initiated a Phase III clinical trial of LibiGel(r), our testosterone gel for the 
treatment of female sexual dysfunction in women. In addition, we are working on 
our calcium phosphate-based nanotechnology in the area of improved vaccines and 
protein delivery.

TWST: Is there an underlying science for all three of these?

Mr. Simes: The underlying science for our hormone therapy products are 
transdermal gels, that is, these products are applied to a small area on the 
upper arm by women. These are gel products for transdermal delivery. Separately 
and quite apart from the gels is our calcium phosphate nanotechnology. The term 
nanotechnology describes the size of the particles being used. These are very 
small particles for improved delivery, efficacy, and safety of vaccines and for 
the delivery of proteins that now must be injected.

TWST: would you tell us about each product and about the timeline for each?

Mr. Simes: First, as I mentioned, is our Elestrin, which was recently approved 
by the Food and Drug Administration (FDA). We submitted the NDA (New Drug 
Application) for Elestrin in February 2006. For the better part of 2006, the NDA 
was under active FDA review, and we received approval in December 2006.  We are 
looking forward to launching Elestrin in 2007. Elestrin is bioidentical 
estradiol in the form of a gel for transdermal administration for the treatment 
of hot flashes. Our Phase III trial, which is one of the biggest hot flash 
studies ever done, showed that Elestrin statistically significantly reduced the 
frequency and severity of hot flashes versus placebo and we are greatly 
anticipating its introduction in 2007. In November 2006, we announced a 
marketing agreement signed with Bradley Pharmaceuticals (NYSE: BDY). a Big Board 
listed company, for marketing of Elestrin. That is, BioSante itself will not be 
marketing Elestrin, but Bradley Pharmaceuticals will be introducing Elestrin in 
2007. We look forward to this launch. From a marketing point of view and a 
safety point of view, we've identified the lowest effective dose of estradiol to 
reduce hot flashes. In fact, that dose is 50% lower than the next lowest dose on 
the market. Importantly, the North American Menopause Society (NAMS), the 
American College of Obstetricians and Gynecologists, and the FDA all recommend 
women use the lowest effective dose of estradiol for the shortest period of 
time.

The next product in line is our LibiGel, which is our transdermal testosterone 
gel for the treatment of female sexual dysfunction. This is a very exciting 
market in that today in the US there is no pharmaceutical product approved for 
the treatment of female sexual dysfunction. Estimates are that this market could 
be well over $2 billion in size; that is, at least as big as the erectile 
dysfunction market. We hope to be able to provide a product for women. We had 
very good Phase II clinical data increasing the number of satisfying sexual 
events by 238% and we initiated a Phase III clinical trial of LibiGel in 
December 2006. 

Lastly is our calcium phosphate nanotechnology for improved vaccines and protein 
delivery. What calcium phosphate does is act as a vaccine adjuvant - that is, an 
additive to a vaccine that makes it more effective. We believe we can do this in 
an effective, safer fashion than other adjuvants in development, and we are 
working with a variety of different vaccines and many different companies. 
Furthermore, we are collaborating with the US government on certain biodefense 
vaccines as well as an internally funded project in the area of bird flu. 

An overview of our portfolio of products reflects that we have a near-term 
opportunity in Elestrin, which we believe will be launched in 2007; our LibiGel, 
which has moved into Phase III clinical trials in the last month; and our 
calcium phosphate, which in vaccines and protein delivery is a longer-term 
opportunity,  and one with great upside.

TWST: How extensive is the hot flash problem?

Mr. Simes: It's mostly suffered by women going through menopause, and the 
average age of menopause in the US is about 51 years old. In the US this year, 
the estrogen market for hot flashes is about $1.3 billion, and it turns out that 
about 70% or 80% of women going through menopause suffer from hot flashes.

TWST: Regarding female sexual dysfunction, is it a more widespread problem than 
male sexual dysfunction?

Mr. Simes: The University of Chicago did a survey several years ago, which was 
published in the Journal of the American Medical Association. Approximately 43% 
of women reported some degree of female sexual dysfunction. In the same study, 
only 31% of men reported sexual dysfunction. So the hypothesis is that this 
market in women is at least as big as the erectile dysfunction market and that's 
why we believe this market will be at least $2 billion or even larger.

TWST: What about competing products? I think Procter & Gamble has some things 
that are similar or is addressing some of the same issues.

Mr. Simes: That's correct. In the area of female sexual dysfunction, Procter & 
Gamble has a transdermal testosterone patch. It turns out that testosterone 
cannot be taken orally and that's why we are developing a gel product. Procter & 
Gamble has been developing a transdermal testosterone patch whereas ours is a 
gel, so LibiGel, our testosterone gel, is perfectly differentiated, in fact, 
currently, gels are preferred for delivery of testosterone. Procter & Gamble 
recently received approval for their Intrinsa testosterone patch in Europe and 
we believe that they are planning their launch in Europe at this time; we hope 
to see that launch and successful European rollout in 2007. In terms of the US, 
they have been silent about what they are doing with the patch. We understand 
they are considering their different options for how to best approach the US 
market. As sated we are proceeding with Phase III development of LibiGel in the 
U.S. So certainly there is competition, especially when markets get so big. For 
estrogen products and Elestrin, the market is a $1.3 billion. Wyeth, with their 
oral product Premarin, is the major player. Of the $1.3 billion market, $250 
million already is in transdermal therapies, primarily patches. We hope to 
compete in this whole estrogen market when Bradley Pharmaceuticals introduces 
Elestrin in 2007. Versus the patch, our Elestrin compares quite nicely as there 
is no physical presence of the gel as there is with the patch, there is little 
or no site application irritation with the gel as there is with the patch and 
finally, the gel cannot "fall off" but the patch can.  Perhaps most important, 
Elestrin will be the lowest dose of estradiol on the market for hot flashes.

TWST: What do you expect to do regarding partnerships, alliances, joint 
ventures, etc., as you move forward?

Mr. Simes: As I've mentioned, Elestrin, our estrogen gel, which is closest to 
market, already is licensed in the US to Bradley Pharmaceuticals. This is a 
marketing arrangement. We've already received $2.6 million upfront. And over the 
life of this arrangement, further milestone payments, both regulatory payments 
and sales-based milestones, we can get an additional $40 million for BioSante, 
as well as royalties on the product. The FDA approval of Elestrin triggers 
$7.875 million in payments to BioSante. In terms of LibiGel, we have moved into 
Phase III clinical trials and at some point over the next 12 to 18 months we 
will consider a licensee for that product as well because the development cost 
is high. The female sexual dysfunction market is very exciting and we would like 
to be able to maximize sales and earnings for our stockholders. In addition, we 
have the licensing rights to these two products in various countries outside of 
the US.

TWST: What do you worry about?

Mr. Simes: I worry about the state of the economy, the state of the market, 
normal worries of the CEO of a company. We've been very successful at raising 
money to allow funding for our projects. We are in good financial shape right 
now, and with the FDA approval of Elestrin, our cash balance will go up once 
again. So I worry about the normal things including moving into clinical trials, 
but I know that we have a plan, we will be implementing that plan and we are 
continuing on the road to success.

TWST: Is there anything else that you would like to say about your agenda for 
the next few years?

Mr. Simes: I think in the near term we will have a sales-based product in 
Elestrin. We hope to collect sales-based milestones and royalties. Then, LibiGel 
development is very exciting, because, as I mentioned, there is no 
pharmaceutical product approved in the US for the treatment of female sexual 
dysfunction. It turns out that we are considered an early-stage or an emerging 
company from a Wall Street point of view. On the other hand, our products really 
are late stage in their development, with one approved product, and once Wall 
Street and investors gain a better understanding of that, I think that value 
will follow for our stockholders.

TWST: What is the picture that you would reasonably hope to see in about three 
years?

Mr. Simes: In three years, we would hope that Elestrin is well established in 
the market through Bradley Pharmaceuticals' marketing of the product, and 
LibiGel has completed its Phase III clinical trials with an NDA  for a very, 
very exciting product.

TWST: Would you tell us about the backgrounds and the expertise of yourself and 
one of your key colleagues?

Mr. Simes: I've been with BioSante since 1998, having started in the 
pharmaceutical industry in 1974 with G.D. Searle & Co. I was with Searle for 10 
years, and then for the last 20 years I have been with small emerging companies 
like BioSante. The last two companies were sold to bigger players and our 
stockholders did very well. Our plan would be to repeat that performance here at 
BioSante. Phil Donenberg, who is our CFO and is a CPA, and I have worked 
together since 1990 at several different companies. We are a team that I think 
works well together and is able to implement our plan, and our objective is to 
maximize value for our stockholders.

TWST: What occupies your own attention most, day by day?

Mr. Simes: I am focused on many different aspects of the company. Obviously, our 
cash balance is a focus, and I am happy to say that we are in good shape as far 
as that's concerned. We are working with Bradley on the launch in 2007 of 
Elestrin, and being sure to have our team focused on the Phase III clinical 
trials of LibiGel.

TWST: How many employees does the company have?

Mr. Simes: We now have about 14 people working on projects. Only eight of those 
are full-time employees and the rest are on a consulting basis. We find this a 
good way to keep our burn rate low and manageable. In fact, our burn rate for 
the last several months and going into 2007 is only about $600,000 or $650,000 a 
month, which allows us to maintain a good cash balance and yet get a lot of work 
done.

TWST: Do you see any need at all to enhance your capital structure in any way?

Mr. Simes: Our capital structure is solid and simple and our balance sheet is 
quite clean. We've issued only common stock and warrants associated with our 
private placements and we have no bonds, no preferred stock, no convertibles; 
nothing that would concern investors, and we have no short-term or long-term 
debt. We are in very good financial shape and right now we don't see a change in 
the capital structure.

TWST: Would you tell us what you do to communicate with investors?

Mr. Simes: Through interviews just like this, we hope to keep in touch with 
investors. Of course, when we have something significant or material to say, we 
put out news releases. For example, we announced recently that we will be 
participating in a couple of upcoming healthcare conferences and we announced 
the FDA approval of Elestrin as well as the initiation of the LibiGel Phase III 
clinical trial. In addition, we are always available for stockholders either by 
e-mail or telephone. We have a very pro-stockholder bias because we know in 
fact, that we work for the stockholders and our mission is to maximize 
stockholder value.

TWST: What would be the two or three best reasons for the long-term investor to 
take a very good look at BioSante?

Mr. Simes: I think the long-term investor should take a look at the very short-
term opportunity here at BioSante, and that is launch of Elestrin for the 
treatment of hot flashes; having moved into Phase III clinical trials for 
LibiGel in the treatment of female sexual dysfunction in what we believe is a 
huge, untapped area; and the potential upside of our calcium phosphate 
nanotechnology in the area of vaccines and drug delivery. We are focused on 
avian flu and biodefense vaccines in addition to working in hepatitis B. 
BioSante hopes to make a contribution in this field.

TWST: Is there anything further you can say about the calcium phosphate 
nanotechnology?

Mr. Simes: We are internally funding our own project, looking at the best 
formulations for a calcium phosphate bird flu vaccine and trying to create the 
most effective and safest bird flu vaccine. In addition, we are working on 
anthrax and hepatitis B, as well as certain drug delivery projects. 

TWST: Regarding female sexual dysfunction, is it thought that women will respond 
to a product the way men have responded to Viagra and other such things?

Mr. Simes: I believe the thought is absolutely yes. As I mentioned, there are 
43% of women who report sexual dysfunction. We now have the benefit of our Phase 
II data and the Procter & Gamble Phase III data testing transdermal 
testosterone, and the response has been very, very good. In fact, in our 
clinical trial of LibiGel, we showed a 238% increase in the number of satisfying 
sexual events reported by women. We hope to repeat these results in the current 
LibiGel Phase III trial.

TWST: Are there many smaller companies that are very similar to BioSante?

Mr. Simes: In the case of Elestrin, although the estrogen market is a very large 
market, there is not much in the way of competition. There is one company that 
controls the oral estrogen market and that is Wyeth. There is one company that 
controls about 50% of the transdermal patches and that's a company by the name 
of Noven. We believe we are in the lead in new development and we believe that 
Elestrin will be well received in the market, most especially because our low 
dose regimen and the strong suggestion by FDA and professional groups for women 
to be started with the lowest dose possible to treat their hot flashes. Elestrin 
will be the lowest dose estradiol on the market for hot flashes. In the case of 
LibiGel, Procter & Gamble really is the only other player that is active in 
developing a testosterone product for female sexual dysfunction., and we believe 
we have a preferred product.

TWST: Is there anything you would like to add to what we've talked about, 
especially regarding strategies and long-term objectives?

Mr. Simes: Our strategy is to focus on the business plan. The business plan 
right now is to introduce our transdermal estradiol gel, Elestrin, through 
Bradley Pharmaceuticals, and conduct the Phase III clinical trials of LibiGel 
for the treatment of female sexual dysfunction in order to submit a new drug 
application. One of the key parts of operating a small company like ours is 
focus, and this is our focus and that's why I've repeated so often that Elestrin 
is about to be commercialized, LibiGel has entered Phase III, and we have an 
additional activity in our calcium phosphate nanotechnology, especially in 
vaccines and protein delivery. We are committed to our mission, which is to 
maximize stockholder value.

TWST: Thank you. (

STEPHEN M. SIMES
Vice Chairman, President & CEO
BioSante Pharmaceuticals, Inc.
111 Barclay Boulevard
Lincolnshire, IL 60069
(847) 478-0500
(847) 478-9152 - FAX
www.biosantepharma.com

This interview contains forward-looking statements within the meaning of the 
Private Securities Litigation Reform Act of 1995. The statements regarding 
BioSante contained in this interview 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 in BioSante's most recent Forms 10-K and 10-Q, which 
discussion also is incorporated herein by reference. Additional risk factors 
include the risk that Elestrin may not be successfully marketed and that 
LibiGel(R) may not be successfully developed. All forward-looking statements 
speak only as of the date of this interview. 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; (847) 478-0500

___

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