 BioSante Pharmaceuticals is a specialty pharmaceutical company
which specialises in developing innovative testosterone and oestrogen
products for female sexual health, menopause, contraception and male
hypogonadism. BioSante'sPresident and Chief Executive Officer, Mr.
Stephen M. Simes, comments: "Women should have the same options
as men do when they want to treat sexual dysfunction."
Mr. Simes joined BioSante, which
was founded in 1996, eleven years
ago. The company's main products
today are LibiGel, which is in Phase III
clinical trial for the treatment of female
sexual dysfunction and Elestrin, which
is FDA approved for the treatment of
hot flashes in menopausal women.
BioSante is publicly traded on the
NASDAQ (BPAX), and currently employs
22 people.
 According to Mr. Simes, the market
for oestrogen is about 1.4 billiondollars in the United States. Premarin,
marketed by Wyeth, has most of
that market. BioSante has chosen to
focus on the transdermal segment,
a portential growth market, through
Elestrin, which is a transdermal gel.
It is applied to a woman's upper arm
once a day, delivering 0.0125 mg
of oestrogen to a woman's system
daily. The product is marketed in the
United States by Azur Pharma, an
Irish pharmaceutical company with a
sales force in the United States. One
of the key benefits of Elestrin is that
it's one of the two lowest doses of
oestrogen approved by the FDA for
the treatment of hot flashes. "From
an efficacy point of view, we're at
least as good as the other products
and from a safety point of view we're
better," Mr. Simes states.
On the subject of LibiGel, he points
out that there is no pharmaceutical
product approved for women suffering
from female sexual dysfunction,
whereas men have had this for
over ten years. The biggest sexual
dysfunction women suffer from is low
sexual desire. LibiGel was designed
to help increase a women's sexual
desire and her sexual activity. "In our
clinical trials we're measuring the
level of sexual desire as well as the
number of satisfying sexual events as
reported by the women. The results
from phase II, a placebo controlled
clinical trial, were very promising:
We showed that we're able toincrease the number of satisfying
sexual events by 238 percent."
BioSante recently merged with Cell
Genesys (NASDAQ: CEGE); the
combined entity will operate under the
BioSante name. "Combined we should
have enough cash to continue our
programs and improve and increase our
product portfolio," states Mr. Simes.
The next couple of years will be
very important for BioSante. "LibiGel
is the key candidate in our pipeline.
We hope to complete phase III of
clinical trials by the end of 2010, and
launch the product by the end of 2011,"
Mr. Simes says.
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