BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX), PHARMACEUTICAL company to professions was focused in product development for feminine sexual health, menopause, contraceptions, and male hypogonadism, commented today in new publication, reporting on efficiency on processing the Feminine Sexual Dysfunction (FSD), specifically hypoactive sexual disorder of the desire (HSDD) in menopausal woman. On paper named, “Testosteron for Low-level Libido in Woman Postmenopausal Not Taking Estrogen,” authors indicate that therapy provides modest but significant advantage in processing HSDD in postmenopausal woman and that as it is reported in preceding blind study, 85 percents of that womans, reporting that profit wants to continue the processing. The Authors also indicate that, “Additional given - it is necessary to value long-term safety in woman with estrogen depletion.” The Paper came up for November 6, 2008, issue New England Journal Medicine.
BioSante CURRENTLY has two clinical tests Phase III in progress covered MIN. (the Special Estimation of the Protocol) with to demonstrate safety and efficiency LibiGel (the gel on processing HSDD. In addition to two LibiGel Phase III safe and test to efficiency, BioSante enrolls the woman in Phase III cardiovascular and study breast cancer safe LibiGel. In accordance with written consents with And this safe analysis will serve as bases to safety both for surgical and naturally menopausal womans. The Safe analysis is mixed, double-blind, operated much-centre, event operated by study between 2,400 and 3,100 womans subjected to LibiGel or during twelve months. At the end twelve months, BioSante is intended present New Exhibit a Medicine LibiGel (NDA) for review and possible approval. BioSante will REMAIN to follow the woman enrolled in safety to prepare to additional year after subservience NDA and possible approval LibiGel.
BioSante KEEPS two RESORTS with mineral water for LibiGel for processing FSD; for “surgical” and for “naturally” menopausal womans. “RESORTS with mineral water BioSante’s confirm the position that FSD and HSDD - diagnosable condition of the truth that women(woman) feel, with measured endpoints, which can be evaluated and, which deserves the therapeutic options. Comparatively LibiGel specifically, we are made happy that RESORTS with mineral water confirm that our clinical experienced project, endpoints, sample size, scheduled behaviour and statistical analysis acceptable to support the plenipotentiary approval,” said Stephen M. Simes, president BioSante’s & GL.UPR.DELAMI. “Us have clear determined, reasonable and feasible way of the development LibiGel, which can conduct to approval LibiGel to provide the potential profit for broad population menopausal womans.”
“No pharmaceutical product is approved for processing FSD or HSDD in USA. LibiGel IF it is approved by And was addressed truly unserved medical need. BioSante TODAY - a single company actively in product development for processing FSD in menopausal woman and - a single company, which entered the long-term safe analysis to define safety on this instruction. BioSante is ACCEPTED obligation about development LibiGel, what finally could be a pharmaceutical product of the first prescription approved by And for this processing in USA.” Though Proctor & Gamble have conducted several clinical trials of its patch Intrinsa, P & G did not enter the long-term safe analysis which is a critical requirement And for possible approval of the product for processing FSD.
As is it previously declared BioSante, processing with LibiGel in clinical test the Phase II vastly raised satisfying sexual events in surgical menopausal woman, sufferring from FSD. The Experienced results of the Phase II shown LibiGel vastly raised amount satisfactory sexual event 238 percents against baseline (p<0.0001); this increase also was significant against (p<0.05). In this analysis, the efficient dose LibiGel produced the blood is justified within normal for pre-menopausal womans and had a safe profile similar to which existed in group Besides, no serious disadvantage events and no cessation because of disadvantage event did not occur on any subject, getting LibiGel. Clinical test the Phase II was double-blind, operated by test called on in United Staff, in surgical menopausal woman worried their low sexual desire and activity.
About LibiGel
LibiGel - a wording helium designed, which it is necessary be quickly absorbed through skin after application measured pea dose gel on upper lever (the hand), delivering in bloodstream evenly time and in non-invasive and painless way. All- usually characterized as male hormone, also is present in woman and defect turns out to be reduces libido or sexual of the drive. Besides, studies have shown that therapy can enlarge bone density, raise the energy level and perfect the mood, in addition to raised sexual desire and activity.
According to analysis published in Journal of the American Medical Assotiation, 43 percents of the American womans (beside 40 million) feel certain degree to spoiled sexual function. Amongst more, than 1,400 womans 32 percents lacked interest in sex and 26 percents could not feel orgasm. According to given IMS, 2.0 millionth prescriptions were recorded-label for womans physician USA in 2007. The Majority of the womans with FSD - postmenopausal, feelling FSD because of hormonal change, the following for menopause, independently natural or surgical.
About BioSante Pharmaceuticals, Inc.
BioSante - a pharmaceutical company to professions focused in product development for feminine sexual health, menopause, contraceptions and male hypogonadism. THE LEADEN products BioSante's include LibiGel (transdermal gel in clinical development Phase III BioSante under USA. Food and Administration Medicine And MIN.VOD (the Special Estimation of the Protocol) for processing the feminine sexual dysfunction (FSD), and estradiol helium). The External reference" target="_blank">Elestrin (estradiol gel) designed through approval And BioSante, specified for processing moderate-serious vasomotor bound menopause, currently marketed in USA. Also in development, - Bio-T-Gel , gel for male hypogonadism, and spoken contraceptive in clinical development Phase II, used BioSante patented technology. The Current market in USA for estrogen and products - aproximately $2.5 and for spoken contraceptive aproximately $3 The Company also develops its calcium technology of the phosphate (CaP) for new vaccines, supply medicine and aesthetic medicine (BioLook ). Additional information - available online in: http://www.biosantepharma.com.
This version of the news contains forward to look statement within importance of the Reform of the Suit Quotient Actions of the Securities from 1995. Statement comparatively BioSante contents in these news release that not history in nature, particularly that which use the terminology such as, “will,” “potential”, “could,” “can,” “expects,” “continue,” “plans,” “expects” or terminology, - forward to look statement. The Examples are forward to look statement in this versions of the news include statement comparatively expected synchronizing to initiations of the clinical test and subservience of plenipotentiary applications. Forward to look statement are founded in the current waiting and suggestions and are attracted for itself different risk and uncertainty, which could force the results to differ vastly from that expressed in such forward to look statement. The Important factors heard on BioSante, which could force the results to differ vastly from that expressed in such forward to look statement to include the difficulty of the development of the pharmaceutical products, getting plenipotentiary and the other approvals and market acceptance to reach, success of the clinical test, and the other factors identified and were discussed now and then in sawdust BioSante’s with Commission of the Securities And exchange, including that factors was discussed in BioSante’s the most last report in the Form 10-K and the following quarterly reportings about the Form 10-Q, what debates are also included above by reference. All are forward to look statement speaks according to date of this versions of the news only. BioSante does NOT R the obligation to correct or check any forward to look statement, as a result of new information independently, future event or otherwise.
