BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) and Cell Genesys,
Inc. (NASDAQ: CEGE), today announced the successful completion of
their previously announced merger of Cell Genesys with and into
BioSante, with BioSante as the surviving company, under which
BioSante now has acquired all of the outstanding shares of Cell
Genesys common stock.
BioSante intends to focus primarily on LibiGel, BioSante’s
testosterone gel in Phase III clinical development under a U.S.
Food and Drug Administration (FDA) agreed Special Protocol
Assessment (SPA) for the treatment of female sexual dysfunction
(FSD). BioSante also intends to seek future development
opportunities for GVAX Immunotherapies including combinations with
BioVant™, BioSante’s vaccine adjuvant, and possible external
collaborations, and also will seek to outlicense other former Cell
Genesys technologies. In addition, BioSante now owns a 16 percent
equity ownership position in Ceregene, Inc., a former subsidiary of
Cell Genesys which is developing gene therapies for
neurodegenerative disorders.
“Closing the merger today is a very exciting development for
BioSante. We now have accomplished our objective of having enough
cash on hand to complete the LibiGel clinical development program
to and through submission of a new drug application (NDA) in the
first half of 2011,” said Stephen M. Simes, president and CEO of
BioSante. “The merger follows our successful registered direct
financing closed on August 13, 2009 and our recent announcement of
continued safety of LibiGel in our Phase III clinical studies. We
now will accelerate completion of the LibiGel clinical development
program to be in a position to submit the NDA in a timely fashion.
We also will work to maximize the value of our newly acquired GVAX
immunotherapies.”
“The successful closing of our merger with BioSante provides an
impressive array of opportunities to create value from the assets
of the combined company,” said Stephen A. Sherwin, M.D., the former
chairman and CEO of Cell Genesys, and as a result of the merger, a
new director of BioSante. “I am very pleased to have the
opportunity to serve as a director of BioSante and look forward to
working with the BioSante team.”
The combined company’s ownership composition consists of
approximately 62% from BioSante stockholders and 38% from the
former Cell Genesys stockholders. BioSante stockholders approved
the merger on September 30, 2009, and the former Cell Genesys
stockholders approved the merger agreement and the transactions
contemplated thereby at a special meeting of stockholders held
today. Well over 90 percent of shares voted were voted in favor of
the merger. Effective at the close of business today, trading in
Cell Genesys common stock will be discontinued. All remaining Cell
Genesys employees and management were terminated effective
today.
In addition to Dr. Sherwin, John T. Potts, Jr., M.D., a former
Cell Genesys director, also now serves as a director of BioSante as
a result of the merger. Stephen M. Simes, president and CEO of
BioSante, and Phillip B. Donenberg, CFO of BioSante, continue to
serve in those positions, and Dr. Louis W. Sullivan, chairman of
the board of BioSante, continues in that position.
Pursuant to the merger, the payment obligations of Cell Genesys
under its 3.125% convertible senior notes due 2011 and 2013,
respectively, were assumed by BioSante. Prior to the merger, the
2011 and 2013 notes were convertible into common stock of Cell
Genesys at a conversion price of $9.10 and $0.68, respectively, and
upon the merger, pursuant to the indentures governing those notes,
the 2011 and 2013 notes became convertible into common stock of
BioSante at a conversion price of $49.78 and $3.72,
respectively.
About LibiGel®
LibiGel is a gel formulation of testosterone designed to be
quickly absorbed through the skin after application of a pea-sized
dose of gel on the upper arm, delivering testosterone to the
bloodstream evenly over time and in a non-invasive and painless
manner. Though generally characterized as a male hormone,
testosterone also is present in women and its deficiency has been
found to decrease libido or sex drive. In addition, studies have
shown that testosterone therapy can increase bone density, raise
energy levels and improve mood, in addition to boosting sexual
desire and activity. According to a study published in the Journal
of the American Medical Association, 43 percent of American women
(about 40 million) experience some degree of impaired sexual
function. Among the more than 1,400 women surveyed, 32 percent
lacked interest in sex. According to IMS data, 2.0 million
testosterone prescriptions were written off-label for women by U.S.
physicians in 2007. The majority of women with FSD are
postmenopausal, experiencing FSD due to hormonal changes following
menopause, whether natural or surgical.
About GVAX Immunotherapies
GVAX cancer immunotherapies are non patient-specific therapies
comprised of whole tumor cells that have been modified to secrete
GM-CSF (granulocyte-macrophage colony-stimulating factor), an
immune stimulatory cytokine, and then irradiated for safety. GVAX
is administered via intradermal injections on an outpatient basis.
To date, over 1000 patients have been treated in clinical trials
with different GVAX cancer immunotherapies for various types of
cancer. Although phase III trials in prostate cancer were
discontinued in 2008, phase II trials under physician investigator
sponsored-INDs are ongoing at the Sidney Kimmel Cancer Center at
Johns Hopkins Hospital in pancreatic cancer, leukemia and breast
cancer.
About BioSante Pharmaceuticals, Inc.
BioSante is a specialty pharmaceutical company focused on
developing products for female sexual health, menopause,
contraception and male hypogonadism. BioSante’s lead products
include LibiGel® (transdermal testosterone gel) in Phase III
clinical development by BioSante under a U.S. Food and Drug
Administration (FDA) SPA (Special Protocol Assessment) for the
treatment of female sexual dysfunction (FSD), and Elestrin™
(estradiol gel) developed through FDA approval by BioSante,
indicated for the treatment of moderate-to-severe vasomotor
symptoms associated with menopause, currently marketed in the U.S.
Also in development are Bio-T-Gel™, a testosterone gel for male
hypogonadism, and an oral contraceptive in Phase II clinical
development using BioSante patented technology. The current market
in the U.S. for estrogen and testosterone products is approximately
$2.5 billion and for oral contraceptives approximately $3 billion.
The company also is developing its calcium phosphate technology
(CaP) for aesthetic medicine (BioLook™), as a vaccine adjuvant,
including for an H1N1 (swine flu) vaccine, and drug delivery. In
addition, BioSante will seek opportunities for its GVAX cancer
immunotherapies, which BioSante acquired from Cell Genesys, Inc.
and are non patient-specific therapies comprised of whole tumor
cells that have been modified to secrete GM-CSF
(granulocyte-macrophage colony-stimulating factor), an immune
stimulatory cytokine, and then irradiated for safety and are
administered via intradermal injections on an outpatient basis.
Additional information is available online at:
www.biosantepharma.com.
Forward-Looking Statements
This news release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995.
Such statements include, but are not limited to, statements about
BioSante’s plans, objectives, expectations and intentions with
respect to future operations and products, the timing of regulatory
submissions, the availability of sufficient financing through the
submission of an NDA for LibiGel and other statements that are not
historical in nature, particularly those that utilize terminology
such as "will," "potential," "could," "can," "believe," "intends,"
"continue," "plans," "expects," "estimates" or comparable
terminology. Forward-looking statements are based on current
expectations and assumptions, and entail various known and unknown
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 could cause actual results
to differ materially from those expressed in such forward-looking
statements include general business and economic conditions; the
failure to realize the anticipated benefits from the recently
completed merger with Cell Genesys; the businesses of BioSante and
Cell Genesys may not be combined successfully, or such combination
may take longer, be more difficult, time-consuming or costly to
accomplish than expected; operating costs and business disruption
following the merger; BioSante's need for and ability to obtain
additional financing; the difficulty of developing pharmaceutical
products, obtaining regulatory and other approvals and achieving
market acceptance; the marketing success of BioSante's licensees or
sublicensees and the success of clinical testing. Additional
factors that could cause BioSante's results to differ materially
from those described in the forward-looking statements can be found
in BioSante's recent registration statement on Form S-4 and
BioSante's most recent annual report on Form 10-K and subsequent
quarterly reports on Form 10-Q and other filings with the
Securities and Exchange Commission, which are filed with the SEC
and available at the SEC's web site at www.sec.gov and which
discussions also are incorporated herein by reference. The
information set forth herein speaks only as of the date hereof, and
BioSante disclaims any intention and does not assume any obligation
to update or revise any forward looking statement, whether as a
result of new information, future events or otherwise.
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