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Data Suggest Estrogen-Alone Therapy May Decrease Incidence of
Breast Cancer for Some Women
BioSante Pharmaceuticals, Inc. (Amex:BPA) today offered comment
on new data from the Women's Health Initiative (WHI) study, published
in the April 12, 2006 issue of the Journal of the American Medical
Association (JAMA), demonstrating that estrogen-alone therapy did not
increase breast cancer incidence in postmenopausal women after an
average of 7.1 years.
The authors also suggest a possible protective effect of
estrogen-alone therapy against breast cancer incidence among study
participants in the following risk categories: women with a low
five-year estimated risk of developing breast cancer as measured by
the Gail Risk Score, women with no first-degree relatives with breast
cancer, and women with no prior history of benign breast disease.
Additionally, women in the study who adhered strictly to
estrogen-alone dosing schedules had a statistically significant
decrease in breast cancer risk (Hazard Ratio (HR) 0.67; 95% confidence
interval (CI); 0.47-0.97; P=.03), compared to women taking placebo.
When compared with data from an earlier WHI analysis, the new results
also suggest that progestin, a hormone often used in combination with
estrogen, may contribute to increased breast cancer risk.
An additional article was published recently in the Archives of
Internal Medicine, summarizing venous thrombosis (VT) data from the
WHI estrogen-alone study (Archives of Internal Medicine. 2006;
166:772-780). This report of increased risk of VT is consistent with
data from other studies and with information in the current product
labeling for estrogen products. The findings of this study showed that
women treated with estrogen-alone had a 30 percent increased chance of
a VT compared to women who did not receive estrogen. This is well
known, but in this same study it also was noted that women treated
with estrogen plus progestin in combination had a rate of VT that was
significantly higher than those treated with estrogen-alone (P = .03),
even after adjusting for VT risk factors.
"Although studies involving hormone use and breast cancer risk
have produced varied results, these newly reported WHI data provide
strong evidence that estrogen-alone does not increase the risk of
breast cancer, and in fact may decrease the risk," said Stephen M.
Simes, president and chief executive officer of BioSante. "In
addition, the results from analyses of the VT data in WHI have shown
again that treatment with estrogen-alone has less risk than estrogen
plus progestin in combination."
"With our New Drug Application for Bio-E-Gel(R) (transdermal
estrogen gel) recently submitted to the U.S. Food and Drug
Administration, we are pleased that these newly reported results, in
addition to recent WHI data on cardiovascular disease, may further
help women and their doctors assess how estrogen-alone therapy may
provide a benefit for the treatment of menopausal symptoms in
appropriate women."
The full JAMA article is available at
http://jama.ama-assn.org/cgi/content/full/295/14/1647 .
About the Women's Health Initiative
Sponsored by the National Institutes of Health, the Women's Health
Initiative (WHI) was designed to evaluate hormone therapy, dietary
modification, calcium and vitamin D as preventative therapies for post
menopausal women. Between 1993 and 1998, the WHI enrolled approximated
27,000 women into two hormone therapy sub-studies designed to assess
the long-term risks and benefits of estrogen-alone (conjugated equine
estrogen (CEE)) and estrogen-plus-progestin (CEE / medroxyprogesterone
combination).
The estrogen-alone arm of WHI was a randomized, placebo-controlled
evaluation of 10,738 women between the ages of 50 and 79 at baseline,
all of whom had previously undergone a hysterectomy. All study
participants received mammography screenings and clinical breast
examinations at baseline and then annually for the trial's duration.
Main outcome measures included breast cancer incidence, tumor
characteristics and mammogram findings. To provide a measurement of
breast cancer risk, the Gail Risk Score incorporates age, history of
benign breast disease, age at menarche, age at first live birth,
race/ethnicity, and number of sisters or a mother with breast cancer.
The primary efficacy endpoint of the WHI study was the prevention
of coronary heart disease, and the primary safety endpoint was the
risk of breast cancer. Secondary endpoints included hip fracture,
colorectal cancer, stroke, pulmonary embolism and death from other
causes. The estrogen-plus-progestin arm concluded in July 2002; the
estrogen-alone arm concluded in March 2004.
For additional information on the Women's Health Initiative, visit
http://www.nhlbi.nih.gov/whi/ .
About Bio-E-Gel(R)
Bio-E-Gel(R) is a transdermal gel formulation of estradiol
(bioidentical human estrogen) designed to be quickly absorbed through
the skin after topical application on the upper arm, delivering
estradiol to the bloodstream evenly over time at minimal dosage and in
a quick-drying, non-invasive, painless manner.
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 WHI study reported
increased risks of stroke and deep vein thrombosis in postmenopausal
women (50 to 79 years of age) during 6.8 years of treatment with oral
conjugated equine estrogens (CEE 0.625 mg) alone per day, relative to
placebo. The WHI study reported increased risk of myocardial
infarction, stroke, invasive breast cancer, and pulmonary emboli in
postmenopausal women during 5 years of treatment with CEE 0.635 mg
combined with medroxyprogesterone acetate (MPA 2.5 mg) per day.
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(R) (transdermal estradiol gel) for the treatment of women
with menopausal symptoms, and LibiGel(R) (transdermal testosterone
gel) for the treatment of female sexual dysfunction (FSD). A Bio-E-Gel
New Drug Application (NDA) was submitted to the FDA in the first
quarter of 2006. 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. The company also is developing its
calcium phosphate nanotechnology (CaP) for novel vaccines, including
avian flu and biodefense vaccines for toxins such as anthrax and
ricin, and drug delivery systems. Additional information is available
online at: www.biosantepharma.com.
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, 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 in BioSante's most recent Form
10-K, which discussion also is incorporated herein by reference.
Additional risk factors include the risk that the FDA will not accept
the Bio-E-Gel NDA for filing and that future studies may result in
additional risk factors inherent in the use of estrogen products. 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.