How a Specialty Pharmaceutical Company Leads the Way; Phase III Clinicals for the Only
Product Currently Addressing Female Sexual Dysfunction
March 28 , 2011 - (Investorideas.com newswire.com) Investorideas.com, an investor research
portal covering leading sectors including biotech stocks and pharma stocks, features an exclusive
Q&A interview and update with Mr. Stephen M. Simes, President and Chief Executive Officer of
BioSante Pharmaceuticals.
Stephen M. Simes, discusses how specializing in a product for female sexual dysfunction and
leading in development with LibiGel® in Phase III clinicals, makes BioSante Pharmaceuticals
(NASDAQ: BPAX) a company to watch.
JMP Securities released a report this month with a price target of $5.00. Mr. Simes gives his
insight as the company’s leader as to why the future looks so bright.
BioSante Pharmaceuticals Interview
Q: Investorideas.com
As you move forward with development of LibiGel® and other products in the pipeline, is your
company able to execute in terms of funding and cash available ? – and up to what time period?
A: Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals
It is quite interesting that a full 13 years after Viagra was approved for treating men’s
sexual issues, women still do not have an approved product to treat their sexual health.
Today, BioSante is the only company in the world in Phase III clinical development for the
treatment of women’s sexual dysfunction, specifically hypoactive sexual desire disorder.
This represents a major opportunity for BioSante and women since we expect to be first to
market with our LibiGel which is in several Phase III studies.
Q: Investorideas.com
JMP Securities recently released research on your company as an “underfollowed and
undervalued microcap company” and has placed a $5.00 target price. They note “Our $5
price target is derived by applying a 5x multiple to our base case projection for LibiGel sales
of $422MM in 2016, discounted by 30% per year. “ Can you comment on their revenue
projections ?
A: Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals
We believe the market potential for products like LibiGel is over $1 billion. This is derived
from many factors including the fact that the erectile dysfunction market in the U.S. alone
is over $2 billion and the market for male testosterone products is over $1 billion.
Q: Investorideas.com
The Company recently reported financial results and a pipeline update . Can you give us a
summary of what the pipeline looks like outside of LibiGel® ?
A: Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals
Yes, we have a full pipeline of products. Elestrin is our already approved estrogen product for the
treatment of hot flashes in menopausal women and Bio-T-Gel is our male testosterone product.
We hope to announce an FDA submission of Bio-T-Gel in the near future. In addition, we have a
full portfolio of cancer vaccines in clinical trials.
About LibiGel® LibiGel® is a gel formulation of testosterone in development that is quickly
absorbed through the skin after a once-daily application of a pea-sized dose of gel on the upper
arm, delivering testosterone to the bloodstream evenly over time and in a non-invasive and
painless manner. Though generally characterized as a male hormone, testosterone also is
present in women and its deficiency has been found to decrease libido or sex drive. In addition,
studies have shown that testosterone therapy can increase bone density, raise energy levels and
improve mood, in addition to boosting sexual desire and activity.
Currently, BioSante is conducting three Phase III clinical studies to demonstrate the safety
and efficacy of LibiGel to increase sexual desire and satisfying sexual events and to decrease
distress associated with the decreased desire. Two Phase III safety and efficacy trials that are
underway are randomized, double-blind, placebo-controlled trials which will enroll approximately
500 surgically menopausal women each for six-months of treatment. BioSante is conducting
these trials under an FDA agreed special protocol assessment (SPA). In addition, BioSante has
another SPA agreement with the FDA related to treatment of naturally menopausal women.
The SPA process and agreement confirms the FDA’s position that FSD and HSDD are true
conditions that women experience, with measurable endpoints, that can be evaluated and which
deserve therapeutic options. It also affirms that the FDA agrees that the LibiGel Phase III safety
and efficacy clinical trial design, clinical endpoints, sample size, planned conduct and statistical
analyses are acceptable to support regulatory approval. Further, it provides assurance that these
agreed measures will serve as the basis for regulatory review and the decision by the FDA to
approve an NDA for LibiGel.
About BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX)
BioSante (NASDAQ: BPAX) is a specialty pharmaceutical company focused on developing
products for female sexual health and oncology. BioSante’s lead products include LibiGel®
(transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD) which is
in Phase III clinical development under a U.S. Food and Drug Administration (FDA) Special
Protocol Assessment. BioSante’s first FDA-approved product is Elestrin™ (estradiol gel)
indicated for the treatment of hot flashes associated with menopause, marketed in the U.S.
by Azur Pharma, BioSante’s licensee. BioSante also is developing a portfolio of cancer
vaccines, four of which have been granted Orphan Drug designation, and are currently in
several Phase II clinical trials. Other products are Bio-T-Gel™, a testosterone gel for male
hypogonadism licensed to Teva Pharmaceuticals and an oral contraceptive in Phase II clinical
development using BioSante patented technology. Additional information is available online at:
www.biosantepharma.com.
Visit the company profile on Investorideas.com: http://www.investorideas.com/CO/BPAX/
Or the company website www.biosantepharma.com to learn more about BioSante.
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Recent Research
JMP Securities
We are initiating coverage on BioSante Pharmaceuticals with a Market Outperform rating
and price target of $5. We view BioSante as an underfollowed and undervalued microcap
company with a late-stage development asset that has better than average clinical risk.
BioSante's lead product candidate is LibiGel, a proprietary formulation of testosterone delivered
through the skin being developed for the treatment of female sexual dysfunction, for which there
is currently no approved therapy. We believe that with clarity emerging on timelines for key value-
driving LibiGel catalysts, institutional interest will increase and the market inefficiency in the
current valuation can begin to resolve. Our $5 price target is derived by applying a 5x multiple to
our base case projection for LibiGel sales of $422MM in 2016, discounted by 30% per year.
Full report :
http://www.investorideas.com/CO/BPAX/news/Initiating-Coverage-031611.pdf
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Forward-Looking Statements
To the extent any statements made in this news release deal with information that is not historical, these are forward-
looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are
not limited to, statements about BioSante's plans, objectives, expectations and intentions with respect to future
operations and products, the timing of anticipated regulatory submissions and other statements identified by words such
as "will," "potential," "could," "can," "believe," "intends," "continue," "plans," "expects," "anticipates," "estimates," "may,"
other words of similar meaning or the use of future dates. Forward-looking statements by their nature address matters that
are, to different degrees, uncertain. Uncertainties and risks may cause BioSante's actual results to be materially different
than those expressed in or implied by BioSante's forward-looking statements. For BioSante, particular uncertainties
and risks include, among others, the difficulty of developing pharmaceutical products, obtaining regulatory and other
approvals and achieving market acceptance; the marketing success of BioSante's licensees or sublicensees; the success
of clinical testing; and BioSante's need for and ability to obtain additional financing. More detailed information on these
and additional factors that could affect BioSante's actual results are described in BioSante's filings with the Securities
and Exchange Commission, including its most recent annual report on Form 10-K and subsequent quarterly reports on
Form 10-Q. All forward-looking statements in this news release 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 info about BioSante Pharmaceuticals, Inc
Contact:
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953; tswanson@troutgroup.com
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C Van Zant: 800-665-0411 – cvanzant@investorideas.com
Source – Investorideas.com
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