Biosante Pharma (AMEX:BPA)
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BioSante Pharmaceuticals, Inc. (AMEX:BPA) today
announced that BioSante has been awarded a subcontract valued at
$250,000 for the development of recombinant Factor IX (FIX)
formulations for delivery via alternative routes of administration.
The subcontract was awarded to BioSante by the University of
Nebraska-Lincoln as part of their five year $10M grant entitled "cGMP
Recombinant FIX for IV and Oral Hemophilia B Therapy" from the
National Institutes of Health (NIH).
This subcontract leverages BioSante's expertise in alternative
routes of drug administration, specifically oral, buccal, and
pulmonary administration using its proprietary CaP BioOral(TM) and
BioAir(TM) technologies. The University of Nebraska-Lincoln has
received approval for a five year grant totaling $10M. The current
subcontract with BioSante is for the first year of the grant, and if
warranted, BioSante can apply to renew the subcontract in subsequent
years with a total possible value to BioSante of $1.25M over five
years. "This subcontract is further validation for our CaP program,
and allows us another avenue to use CaP to develop alternative
treatment options for a life-threatening disease" said Stephen M.
Simes president and chief executive officer of BioSante.
Hemophilia B (Christmas disease) is a rare, potentially life
threatening, congenital bleeding disorder resulting from a defect or
deficiency in blood coagulation factor IX. Currently the only way to
administer FIX is through intravenous injection. "We are looking
forward to working with the University of Nebraska-Lincoln to find a
more convenient and accessible therapy for people with this disease,
and hope to continue with the University for years to come" said Mr.
Simes.
About BioSante Pharmaceuticals, Inc.
BioSante is developing a pipeline of hormone therapy products to
treat both men and women. These hormone therapy products are gel
formulations for transdermal administration that deliver bioidentical
estradiol and testosterone. BioSante's lead products include
Bio-E-Gel(TM) (bioidentical estradiol gel) for the treatment of women
with menopausal symptoms, and LibiGel(TM) (bioidentical testosterone
gel) for the treatment of female sexual dysfunction (FSD). The current
market in the U.S. for estrogen and testosterone products is
approximately $2.5 billion. The transdermal gel formulations used in
the women's gel products are licensed by BioSante from Antares Pharma
Inc. BioSante also is developing its calcium phosphate nanotechnology
(CaP) for novel vaccines, including biodefense vaccines for toxins
such as anthrax and ricin, and drug delivery systems. Additional
information is available online at: www.biosantepharma.com.
About the University of Nebraska
Founded in 1869, the University of Nebraska-Lincoln is the state's
land-grant university and the only comprehensive university in
Nebraska. Through its three primary missions of learning, discovery
and engagement, UNL is Nebraska's intellectual center. UNL is one of a
select group of research universities that holds membership in the
Association of American Universities - a distinction granted in 1909.
Nebraska was the first university west of the Mississippi to establish
a graduate college; today, UNL is one of the top 50 American
universities in the number of doctoral degrees granted annually.
UNL's project team is led by chemical engineer William Velander,
and includes scientists from three universities and two private
entities. Velander is a professor and chairman of the department of
chemical engineering at UNL and holds the Donald R. Voelte Jr. and
Nancy A. Keegan Endowed Chair in Engineering. He has been working on
safer and more abundant sources of plasma-derived medicines since
1987, when disease contamination of blood supply medicines by HIV and
Hepatitis B and C reached a worldwide epidemic. Velander's work on
using this technology to promote hemophilia treatment in developing
countries in Latin America has been embraced by the World Federation
of Hemophilia, an international nonprofit organization. His work with
transgenic animals has earned worldwide acclaim.
This news release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995. The
statements regarding BioSante contained in this press release that are
not historical in nature, particularly those that utilize terminology
such as "may," "will," "should," "likely," "expects," "anticipates,"
"estimates," "believes" or "plans," or comparable terminology, are
forward-looking statements. Forward-looking statements are based on
current expectations and assumptions, and entail various risks and
uncertainties that could cause actual results to differ materially
from those expressed in such forward-looking statements. Important
factors known to BioSante that cause actual results to differ
materially from those expressed in such forward-looking statements are
the difficulty of developing pharmaceutical products, obtaining
regulatory and other approvals and achieving market acceptance, and
other factors identified and discussed from time to time in BioSante's
filings with the Securities and Exchange Commission, including those
factors discussed on pages 22 to 34 of BioSante's most recent Form
10-Q, which discussion also is incorporated herein by reference. All
forward-looking statements 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.