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发帖数: 5516 | 1 重要的时间点和market 都能在这篇文章里找到。
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http://www.investorideas.com/CO/BPAX/news/2011/07151.asp
Mr. Stephen M. Simes, President and CEO of BioSante Pharmaceuticals, Inc. (
NASDAQ: BPAX), Discusses the Potential of Future Partners or Acquisition
Point Roberts, WA, LINCOLNSHIRE, Ill – July 15, 2011 –(Investorideas.com
newswire.com) Investorideas.com, an investor research portal covering
leading sectors including biotech and pharma stocks, features an exclusive Q
&A interview with Mr. Stephen M. Simes, President and Chief Executive
Officer of BioSante Pharmaceuticals, as industry buzz builds on talk of
partners or acquisition with value up to $1 Billion.
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As BioSante's lead product LibiGel ® (transdermal testosterone gel),
for the treatment of female sexual dysfunction gets closer to market, the
company is now on the radar as a biotech company to watch.
BioSante Pharmaceuticals Interview
Q: Investorideas.com
Stephen, there is an old saying in the market, that the trading tells the
story. The activity and interest in your stock is building from both
analysts and retail investors. Can you give us some insight to the key
points of the recent analyst coverage and what the industry is saying about
your company?
A: Stephen M. Simes, President and Chief Executive Officer of BioSante
Pharmaceuticals
We have been in development of LibiGel for quite a number of years. Finally
the finish line is in site. We have completed enrollment of women into our
three LibiGel Phase III clinical studies and efficacy data should be
available in the fourth quarter of this year. Safety data should be
available in the third quarter of 2012 and our objective is to submit the
LibiGel new drug application (NDA) to the FDA in the fourth quarter of 2012.
All of these dates are near-term opportunities in the biotech/pharma world.
Analysts and investors are taking note of the progress we have made with
LibiGel.
Q: Investorideas.com
Can you discuss the potential dollar value for a female sexual dysfunction
drug hitting the market?
A: Stephen M. Simes, President and Chief Executive Officer of BioSante
Pharmaceuticals
We believe the market for a drug for female sexual dysfunction is
potentially bigger than the market for erectile dysfunction drugs, a $2
billion market if the U.S., and male testosterone, a $1.3 billion market in
the U.S. Our belief is based on current off-label use of products to treat
female sexual dysfunction as well as publications that indicate the
potential size of the market for treatment of female sexual dysfunction. It
has been over 13 years since Viagra was approved and we believe strongly
that women deserve an FDA-approved therapeutic choice for their sexual
health issues.
Q: Investorideas.com
With LibiGel ® getting closer to market, how will the process of
potential partners or acquisition play out in the pharma industry?
A: Stephen M. Simes, President and Chief Executive Officer of BioSante
Pharmaceuticals
Our focus is on completing the LibiGel Phase III clinical work and
submitting an NDA in 2012. Our LibiGel partnering strategy from the
beginning has been and remains to develop LibiGel as far as we can since we
believe the best way to maximize our stockholder value is to bring LibiGel
to the latest stage of product development and regulatory status possible.
Although we would entertain a license/partnership at this time, we believe
the value of LibiGel will increase as new efficacy and safety data become
available and these data will be available beginning in the coming months.
Q: Investorideas.com
With other players abandoning the female sexual dysfunction market, your
company stayed through the long process and is now postured to be first to
market. How significant is it that you have no current competition?
A: Stephen M. Simes, President and Chief Executive Officer of BioSante
Pharmaceuticals
As stated before we believe the market for female sexual dysfunction is
significant and we would welcome other companies to develop product for this
market. Having said that, today LibiGel is the only product in Phase III
clinical development in the world. Assuming positive safety and efficacy
data, we believe LibiGel will be the first product approved by the FDA for
the treatment of female sexual dysfunction, specifically hypoactive sexual
desire disorder. In our primary market research with prescribing physicians,
they tell us that there is a great need for an FDA-approved product and
that they are dissatisfied with their choices for off-label use. If and when
LibiGel is approved we believe it will be a very successful product and
result in a very attractive choice for prescribers and women in need, and
continued increasing value for our stockholders.
About LibiGel ®
LibiGel is a testosterone gel in Phase III clinical development for the
treatment of women who suffer from female sexual dysfunction (FSD). The on-
going Phase III efficacy trials are double-blind, placebo-controlled trials
that have enrolled over 500 surgically menopausal women each for a six-month
clinical trial. The efficacy trials, which have completed enrollment, are
being conducted under an FDA-approved special protocol assessment (SPA)
agreement. LibiGel is absorbed quickly through the skin after applying a
once-daily pea-sized topical application on the upper arm that delivers
testosterone to the bloodstream evenly over time.
In a Phase II trial, LibiGel significantly increased the number of
satisfying sexual events in surgically menopausal women suffering from FSD
by 238 percent versus baseline (p<0.0001); this increase also was
significant versus placebo (p<0.05). In this study, the effective dose of
LibiGel produced testosterone blood levels within the normal range for pre-
menopausal women and had a safety profile similar to that observed in the
placebo group. In addition, no serious adverse events and no
discontinuations due to adverse events occurred in any subject receiving
LibiGel. The Phase II clinical trial was a double-blind, placebo-controlled
trial, conducted in the United States, in surgically menopausal women
distressed by their low sexual desire and activity.
In addition, BioSante is conducting the Phase III LibiGel safety study, a
randomized, double-blind, placebo-controlled, multi-center, cardiovascular (
CV) events and breast cancer study that has completed enrollment of 3,656
women and has accrued 4,000 women-years of exposure. The study will continue
for a total of five years, however, BioSante will use the safety study data
as part of an NDA submission after the last subject enrolled has completed
12 months of exposure to LibiGel or placebo.
The LibiGel safety study is tracking a predefined list of CV events, in
agreement with the FDA, including CV death, myocardial infarction and stroke
in women 50 years of age or older and suffering from at least two CV risk
factors including hypertension and diabetes. The objective of the safety
study is to show the relative safety of testosterone compared to placebo in
the number of CV events. The incidence of breast cancer also is being
tracked over the course of the study. The study represents the largest data
base of the safety of testosterone in women.
Upon completion of the statistical analyses of the safety study and efficacy
trials, BioSante intends to submit an NDA to the FDA, requesting approval
to market LibiGel for the treatment of HSDD in menopausal women. The NDA
submission is targeted for the second half of 2012. | g*****s
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