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BioSante
is a product development company. From the beginning, we have had our eye on
women’s sexual health. Right now, we are developing a product, LibiGel®, for
the treatment of female sexual dysfunction for which there is no product
approved in the United States. We believe this represents a blockbuster
opportunity. - Stephen M. Simes (BPAX)
(Interview published March 11, 2011) |
CEOCFO-
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BioSante Pharmaceuticals
Reports
First Quarter Financial Results and Recent Developments
LINCOLNSHIRE, Illinois
(May 10, 2011) -- BioSante Pharmaceuticals, Inc. (NASDAQ:
BPAX) today reported on its financial results for the first quarter,
cash balance as of March 31, 2011 and recent developments.
First Quarter 2011 Financial Results
BioSante's cash balance as of March 31, 2011 was approximately $51.3
million, compared to a cash balance of approximately $38.2 million
on December 31, 2010.
BioSante incurred a net loss of approximately $17.3 million or
$(0.20) per share for the quarter ended March 31, 2011, compared to
a net loss of $10.5 million or $(0.19) per share for the same period
in 2010. This expected increase in net loss was due primarily to the
conduct of the three ongoing LibiGel® (testosterone gel) Phase III
clinical studies to support submission of a
new drug application (NDA)
for U.S. Food and Drug Administration (FDA) approval.
Recent BioSante Developments
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LibiGel®
Phase III Efficacy Trials Enrollment Completed:
BioSante completed enrollment of subjects in its two pivotal
Phase III LibiGel (testosterone gel) efficacy trials in the
first quarter. The efficacy trials are being conducted under an
FDA-approved special protocol assessment (SPA) agreement.
LibiGel is in development for the treatment of female sexual
dysfunction (FSD), specifically, hypoactive sexual desire
disorder (HSDD) in menopausal women, for which there is no
FDA-approved product.
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LibiGel
Phase III Safety Study Continues:
For the fifth time, unblinded safety data were reviewed by the
independent Data Monitoring Committee (DMC) of the LibiGel
Cardiovascular and
Breast Cancer Safety
Study. As per DMC recommendation, the LibiGel safety study
continues, with no modifications.
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Bio-T-Gel™
New Drug Application (NDA) Filed by BioSante Licensee, Teva
Pharmaceuticals:
An NDA for Bio-T-Gel (testosterone gel) for the treatment of
male hypogonadism, was accepted for filing by the
FDA
following submission by a subsidiary of
Teva Pharmaceutical Industries Ltd.
(NASDAQ: TEVA). The FDA has assigned a
PDUFA date of
November 14, 2011. The
PDUFA date is the target date for the FDA to complete its review
of the NDA.
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Pancreas Cancer Vaccine
Positive Clinical Results and Melanoma
Orphan Drug
Designation:
BioSante reported positive Phase II clinical results for its
Pancreas Cancer Vaccine. The vaccine increased the median
survival of resected
pancreatic cancer patients
from 15 to 20 months, as reported in published data, to 24.8
months, an increase of more than 25 percent. In addition, the
vaccine demonstrated a 35 percent increase in one year survival,
from 63 percent to 85 percent. BioSante also received Orphan
Drug designation from the FDA's Office of Orphan Products
Development for its
Melanoma Cancer Vaccine.
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Closed $25.1
million Registered Direct Financing:
BioSante closed a registered direct offering in March 2011,
bringing its March 31, 2011 cash balance to approximately $51.3
million. BioSante's management believes this cash balance will
be sufficient to finance operations and LibiGel clinical
development well into 2012, without the need for additional
funds.
About BioSante Pharmaceuticals, Inc.
BioSante
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
BioSante products are Bio-T-Gel™, a testosterone gel for male
hypogonadism, for which an NDA is pending with a PDUFA date of
November 14, 2011, licensed to Teva Pharmaceuticals, and an oral
contraceptive in Phase II clinical development using BioSante
patented technology. Additional information is available online at:
http://www.biosantepharma.com
For more information, please contact:
For Media:
McKinney
Chicago
Alan Zachary
phone:
(312) 506-5220
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For Investors:
The Trout Group LLC
Tricia Swanson
E-Mail:
tswanson@troutgroup.com
Phone:
(646) 378-2953
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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 how long BioSante's cash balance should last,
BioSante's plans, objectives, expectations and intentions with
respect to future operations and products 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 burn
rate, 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
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