Healthcare Industry News: transdermal gel
News Release - October 12, 2006
BioSante Pharmaceuticals Presents Bio-E-Gel(R) Woman-to-Partner Transfer Study at Menopause Society MeetingBio-E-Gel does not transfer from woman to partner
LINCOLNSHIRE, Ill.--(HSMN NewsFeed)--BioSante Pharmaceuticals, Inc. (Amex:BPA ) announced today that it will present new study results from the Bio-E-GelŪ (transdermal estradiol gel) development program at the annual meeting of the North American Menopause Society (NAMS) in Nashville October 11-14, 2006. Bio-E-Gel is an innovative low-dose topical estrogen therapy intended to treat moderate-to-severe hot flashes in menopausal women. Bio-E-Gel has been shown to be effective at a daily dose that is 50 percent lower than the lowest dose of estradiol currently available for the treatment of hot flashes. The current study investigated if Bio-E-Gel could be "transferred" to a partner after skin contact.
"In addition to demonstrating the significant efficacy of Bio-E-Gel in reducing hot flashes, we have shown that estradiol is not transferred from women using Bio-E-Gel to their partners," said Stephen Simes, president and chief executive officer of BioSante. "These results underscore Bio-E-Gel's greater convenience and comfort compared to a pill or a patch. This is important because we believe that the lowest effective dose of Bio-E-Gel was identified in the Phase III clinical study at levels that are one-half the lowest dose of estradiol therapy currently available for treatment of hot flashes. In fact, the lowest dose of Bio-E-Gel delivers approximately 12.5 micrograms of estradiol per day, whereas the lowest dose currently on the market for hot flashes delivers approximately 25 micrograms per day. If and when approved, Bio-E-Gel will become the lowest dose of estradiol available to treat hot flashes, making it an attractive alternative to therapeutic options currently on the market."
Bio-E-Gel is a fast-drying gel formulation of estradiol, the same estrogen produced naturally in women. Bio-E-Gel was developed to be absorbed through the skin after topical application on the upper arm, and delivers estradiol to the bloodstream evenly over time in a non-irritating, painless manner. Bio-E-Gel is administered using a metered dose applicator that delivers 0.87 g of gel per actuation, thereby allowing for precise titration from dose to dose. The gel dries quickly in one to two minutes.
The Bio-E-Gel transfer study was conducted in accordance with U.S. Food & Drug Administration (FDA) guidance. In the study, women applied Bio-E-Gel to their upper arm. Then, the women had five minutes of vigorous arm-to-arm contact with their male partners at the application site either two hours or eight hours after application. Blood levels of estradiol were then measured in the men over a 48-hour period. Estradiol levels in the men showed no change after skin contact indicating that Bio-E-Gel is not transferred by vigorous skin-to-skin contact.
In another part of this same study, the amount of Bio-E-Gel remaining on a woman's arm was measured two hours and eight hours after application. Results showed only a small fraction, 4.6 percent and 7.8 percent of the applied dose remaining on the application site two hours and eight hours after application, respectively. In the final part of the study, when the application site was washed with soap and water eight hours after application of Bio-E-Gel the small fraction of estradiol remaining on the arm was further reduced to about 1 percent of the original dose.
"Bio-E-Gel offers key safety potential over oral estrogen products by delivering bio-identical estrogen that is not subject to first-pass liver metabolism, thus avoiding side effects associated with oral administration of conjugated estrogen," Simes noted. "It is also less conspicuous than wearing a patch, with less potential for irritation, and both of these advantages are possible with minimal risk of person-to-person transfer of Bio-E-Gel."
According to NAMS, more than two-thirds of North American women have hot flashes during menopause. At present, oral conjugated estrogen is the primary treatment for this menopausal symptom. The U.S. estrogen therapy market is currently estimated at approximately $1.3 billion in annual sales, of which the transdermal segment, mostly patches, is about $250 million.
The NDA for Bio-E-Gel currently is undergoing FDA review and includes data from the pivotal Phase III clinical trial of Bio-E-Gel and data from three additional clinical trials; a transfer study, a sunscreen study and a pharmacokinetic study.
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 (50 to 79 years of age) 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.
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 Bio-E-Gel (transdermal estradiol gel) for the treatment of women with menopausal symptoms and LibiGelŪ (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD). A Bio-E-Gel NDA was submitted to the FDA in the first quarter 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 in BioSante's most recent Forms 10-K and 10-Q, which discussion also is incorporated herein by reference. Additional risk factors include the risk that Bio-E-Gel may not be approved by the FDA or that Bio-E-Gel may not be successfully marketed. 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.
Source: BioSante Pharmaceuticals
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