BioSante’s Prostate Cancer Vaccine Resulted In Stable Disease In Over 50% Of Patients In Newly Published Study
About BioSante Pharmaceuticals, Inc.
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante's products include LibiGel ® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD), specifically hypoactive sexual desire disorder (HSDD), which is in Phase III clinical development. BioSante also is developing a portfolio of cancer vaccines, with 17 Phase I and Phase II clinical trials currently on-going. Four of these vaccines have been granted Orphan Drug designation by the U.S. Food and Drug Administration (FDA). BioSante’s other products include a testosterone gel for male hypogonadism, for which a New Drug Application (NDA) was approved by the FDA on February 14, 2012, which is licensed to Teva Pharmaceuticals USA, Inc., and the Pill-Plus™, an oral contraceptive in Phase II clinical development by Pantarhei Bioscience B.V. 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 Jazz Pharmaceuticals, BioSante's licensee. Additional information is available online at: www.biosantepharma.com.
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 the timing
of a Phase II GVAX Prostate clinical trial and the potential for GVAX
cancer vaccines, and other statements identified by words such as
“anticipates,” “will,” “continue,” “could,”
“believe,” “intends,”
“expects,” “plans,” “may,” “potential,” other words of similar meaning,
derivations of such words and 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, uncertainties
regarding clinical testing, the difficulty of developing pharmaceutical
products, obtaining regulatory and other approvals and achieving market
acceptance; the marketing and other success of BioSante's licensees or
sublicensees and BioSante’s future revenues, if any, from its licensees
and sublicensees; uncertainties relating to the future and costs of
BioSante’s product development programs and BioSante’s need for and
ability to obtain additional financing if needed. 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 and are based on BioSante’s current beliefs
and expectations.
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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