BioSante Pharmaceuticals Receives Milestone Payment from Bradley Pharmaceuticals
26 Mars 2007 - 1:30PM
Business Wire
BioSante Pharmaceuticals, Inc. (Amex:BPA) today announced receipt
of a $7.0 million milestone payment under the terms of its
Elestrin� (estradiol gel) licensing agreement with Bradley
Pharmaceuticals, Inc. (NYSE:BDY). The payment is the first of two
triggered by the December 2006 FDA approval of Elestrin. BioSante
is entitled to receive an additional payment for this milestone in
the amount of $3.5 million in December 2007. The net amount of the
current milestone received by BioSante after payment to its
licensor was $5.25 million. The net amount to BioSante of the
December 2007 payment will be $2.625 million. BioSante received
approval from the FDA for the marketing of Elestrin in the United
States on December 15, 2006. The FDA approved two doses of
Elestrin, 12.5 micrograms per day and 37.5 micrograms per day in a
non-conditional full approval. Elestrin 12.5 micrograms per day is
the lowest dose of estradiol approved by the FDA for the treatment
of moderate-to-severe vasomotor symptoms, and is 50% lower than the
next lowest dose currently approved and marketed for the treatment
of hot flashes. In November 2006, BioSante signed an agreement with
Bradley Pharmaceuticals, Inc. for the marketing of Elestrin in the
United States, through Bradley�s Kenwood Therapeutics division.
Under the terms of the agreement, BioSante received an initial net
payment of $2.625 million in 2006 based on a total licensing
payment of $3.5 million. Bradley expects to launch Elestrin in
mid-2007 into the $1.3 billion estrogen therapy market with a sales
force of at least 50 sales representatives. BioSante has the right
under the agreement to receive up to an additional $40 million ($30
million net after payments to its licensor) upon the achievement of
certain sales-based milestones plus royalties upon sales of the
product. �We are pleased with the progress Bradley is making toward
the marketing of Elestrin. We look forward to a mid-year 2007
launch,� said Stephen M. Simes, BioSante�s president and chief
executive officer. �With about $15.0 million in cash, we are
actively working on our recently begun LibiGel Phase III
development program,� Simes continued. 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 bio-identical estradiol and testosterone. BioSante's lead
products include Elestrin� (estradiol gel), developed through FDA
approval by BioSante, indicated for the treatment of
moderate-to-severe vasomotor symptoms associated with menopause,
and LibiGel� (transdermal testosterone gel) in Phase III
development 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. The company also is developing its
calcium phosphate nanotechnology (CaP) for novel vaccines,
including hepatitis B, avian flu and biodefense vaccines for toxins
such as anthrax, as well as a system for delivering drugs via
alternative routes of administration. Additional information is
available online at: www.biosantepharma.com. About Estrogens
Estrogen products today are approved for the treatment of
menopausal symptoms, including hot flashes. Estrogen products are
not approved for and should not be used for the treatment or
prevention of heart disease, breast cancer or dementia. The Women's
Health Initiative (WHI) study reported increased risk of stroke and
deep vein thrombosis in postmenopausal women (50 to 79 years of
age) during 6.8 years of treatment with 0.625 mg of oral conjugated
equine estrogens alone per day, relative to placebo. The WHI study
reported increased risk of myocardial infarction, stroke, invasive
breast cancer, pulmonary emboli and deep vein thrombosis in
postmenopausal women during five years of daily treatment with
0.625 mg of oral conjugated equine estrogens combined with 2.5 mg
of medroxyprogesterone acetate per day. Although studies involving
hormone use and breast cancer risk have produced varied results,
newly reported estrogen-only data provide strong evidence that
estrogen alone does not increase the risk of breast cancer, and in
fact may decrease the risk and that transdermal estrogen may be
safer than oral estrogen. The North American Menopause Society, the
American College of Obstetricians and Gynecologists and the FDA all
recommend women use the lowest effective dose of estrogen for the
shortest period of time. 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 news release that are not historical in nature, particularly
those that utilize terminology such as �may,� �will,� �should,�
�likely,� �expects,� �anticipates,� �estimates,� �believes,�
�plans,� �hopes,� 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, the
success of clinical testing, 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 in BioSante's most recent Forms 10-K and 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.
Biosante Pharma (AMEX:BPA)
Graphique Historique de l'Action
De Mai 2024 à Juin 2024
Biosante Pharma (AMEX:BPA)
Graphique Historique de l'Action
De Juin 2023 à Juin 2024