LINCOLNSHIRE, Ill.–(Business Wire)–
BioSante Pharmaceuticals, Inc. (NASDAQ:BPAX) today announced the receipt of
Orphan Drug designation for GVAX CML Vaccine in the treatment of chronic myeloid
leukemia (CML) from the FDA`s Office of Orphan Products Development. Orphan drug
designation, as granted by the U.S. Orphan Drug Act, is for a product to treat a
rare disease or condition that affects fewer than 200,000 people in the U.S.
Orphan drug designation qualifies the sponsor of the product for tax credits and
seven years of marketing exclusivity, among other benefits.

The orphan drug designation for the GVAX CML Vaccine resulted from BioSante`s
third GVAX regulatory submission since acquiring this portfolio of cancer
vaccines in October 2009. This is the third orphan drug designation for
BioSante; the company also has received orphan drug designations for its
vaccines to treat pancreatic cancer and acute myeloid leukemia.

“We continue to develop our vaccine portfolio in cooperation with the Johns
Hopkins Sidney Kimmel Comprehensive Cancer Center,” said Stephen M. Simes,
president and chief executive officer of BioSante. “Clinical trials of GVAX
cancer vaccines are being conducted to treat leukemia, pancreatic cancer and
breast cancer, among other cancer types. In addition, we recently announced
reinitiation of the GVAX Prostate cancer vaccine program.”

As previously reported, in a clinical study, the GVAX CML vaccine was
administered to 19 CML patients with measurable cancer cells, despite taking
Gleevec® for at least one year (range of 13-53 months). Each patient was given a
series of four vaccines administered in three-week intervals while remaining on
a stable dose of Gleevec. After a median of 72 months of follow-up, the number
of remaining cancer cells declined in 13 patients, eight of whom had increasing
disease burden before vaccination. Twelve patients reached their lowest levels
of residual cancer cells to date following vaccination. Seven CML patients had
complete remission. Patients receiving the GVAX CML vaccine experienced
relatively few side effects that included injection site pain and swelling,
occasional muscle aches and mild fevers.

The study was conducted by researchers at the Johns Hopkins Kimmel Cancer Center
in Baltimore, Maryland, led by Hyam Levitsky, M.D., professor of oncology,
medicine and urology at the Cancer Center. The research was funded by the
National Institutes of Health.

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, and Elestrin (estradiol gel)
for the treatment of moderate-to-severe vasomotor symptoms associated with
menopause, which is marketed in the U.S. by Azur Pharma, BioSante`s licensee.
BioSante also is developing a portfolio of cancer vaccines (GVAX), three of
which have been granted orphan drug designation, and are currently in several
Phase II clinical trials. Other products in development are Bio-T-Gel, a
testosterone gel for male hypogonadism, licensed to Teva Pharmaceuticals and an
oral contraceptive in Phase II clinical development using BioSante patented
technology. 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 as well as seeking opportunities for
its 2A/Furin and other technologies. 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 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 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 releasespeak 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.

Gleevec® (imatinib mesylate) is marketed in the U.S. by and is a trademark of
Novartis Pharmaceuticals Corporation.

For more information, please contact:
For Media:
McKinney/Chicago
Alan Zachary, 312-944-6784 ext. 316
azachary@mckinneychicago.com
or
For Investors:
The Trout Group LLC
Tricia Swanson, 617-583-1306
tswanson@troutgroup.com

Copyright Business Wire 2010