BioSante Pharmaceuticals Announces Subcontract with the University of Nebraska-Lincoln Using its Proprietary CaP(TM) Drug Delive
07 February 2006 - 12:00AM
Business Wire
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.
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