BioSante Pharmaceuticals to Present LibiGel(R) at International Society for the Study of Women's Sexual Health (ISSWSH) Annual Meeting.LINCOLNSHIRE, Ill. -- BioSante Pharmaceuticals, Inc. (Amex: BPA BPA British Paediatric Association. ) announced today that it has been granted a presentation at the International Society for the Study of Women's Sexual Health (ISSWSH ISSWSH International Society for the Study of Women's Sexual Health ) Annual Meeting. The ISSWSH meeting is being held from February 22-25 in Orlando, Florida The city of Orlando is a major city in central Florida and is the county seat of Orange County, Florida. According to the 2000 census, the city population was 185,951. A 2006 U.S. . BioSante will present information regarding Phase II study results and the initiation of a Phase III Noun 1. phase III - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA safety and efficacy study of LibiGel([R]) (transdermal testosterone gel) in the treatment of female sexual dysfunction sexual dysfunction Inability to experience arousal or achieve sexual satisfaction under ordinary circumstances, as a result of psychological or physiological problems. (FSD FSD Female Sexual Dysfunction FSD File System Driver FSD Family Support Division FSD Fire Services Department (Hong Kong) FSD Full Scale Development FSD Full Scale Deflection FSD Federal Systems Division ). The six-month, double-blind, placebo-controlled Phase III study is planned to enroll approximately 360 surgically menopausal women and is being conducted under a Phase III protocol and investigational new drug application (IND) reviewed by and on file with the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ). In the Phase II study, LibiGel([R])significantly increased satisfying sexual events in surgically menopausal women suffering from FSD. The Phase II study results showed LibiGel significantly increased the number of satisfying sexual events by 238 percent versus baseline (p<0.0001); this increase also was significant versus placebo (p<0.05). In this study, the effective dose of LibiGel produced testosterone blood levels within the normal range for pre-menopausal women and had a safety profile similar to that observed in the placebo group. In addition, no serious adverse events and no discontinuations due to adverse events occurred in any subject receiving LibiGel. The Phase II study was a double-blind, placebo-controlled study, conducted in the United States, in surgically menopausal women distressed by their low sexual desire and activity. "We are pleased to be in a position to present and discuss LibiGel at the ISSWSH meeting. ISSWSH is a key professional organization for women's sexual health. We have initiated our first Phase III study of LibiGel in the large potential FSD market and look forward to speaking with ISSWSH practitioners about our LibiGel efficacy data and new Phase III study," said Stephen M. Simes, president and chief executive officer of BioSante. "We have moved our LibiGel into Phase III clinical development and are excited to be developing a treatment for female sexual dysfunction which is underserved by the pharmaceutical industry today. LibiGel may help address this unmet medical need. We believe two Phase III safety and efficacy studies plus one year of safety study data are the essential requirements for submission and approval by the FDA of a new drug application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any )," Simes continued. "With the initiation of this Phase III LibiGel study and our recent FDA approval of Elestrin[TM] (estradiol gel), this is a very exciting time for BioSante," he added. About LibiGel([R]) LibiGel is a gel formulation of bioidentical testosterone designed to be quickly absorbed through the skin after application on the upper arm, delivering testosterone to the bloodstream evenly over time and in a non-invasive and painless manner. Though generally characterized as a male hormone, testosterone also is present in women and its deficiency has been found to decrease libido libido (lĭbē`dō, –bī`–) [Lat.,=lust], psychoanalytic term used by Sigmund Freud to identify instinctive energy with the sex instinct. or sex drive. In addition, studies have shown that testosterone therapy can increase bone density, raise energy levels and improve mood, in addition to boosting sexual desire and activity. According to a study published in the Journal of the American Medical Association JAMA: The Journal of the American Medical Association is an international peer-reviewed general medical journal, published 48 times per year by the American Medical Association. JAMA is the most widely circulated medical journal in the world. , 43 percent of American women (about 40 million) experience some degree of impaired sexual function. Among the more than 1,400 women surveyed, 32 percent lacked interest in sex and 26 percent could not experience orgasm. BioSante's hormone product portfolio In addition to LibiGel, BioSante recently received FDA approval for Elestrin[TM] (estradiol gel), a fast-drying gel formulation of bio-identical estradiol, in the treatment of moderate to severe vasomotor vasomotor /vaso·mo·tor/ (-mo´tor) 1. affecting the caliber of blood vessels. 2. a vasomotor agent or nerve. va·so·mo·tor adj. symptoms (hot flashes hot flashes Hot flush Gynecology A symptom afflicting 80-85% of middle-aged ♀, first occurring during the perimenopause, continuing with ↓ intensity for yrs, manifesting itself as transient waves of erythema and uncomfortable warmth beginning in the ) in menopausal women. Elestrin is 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. Elestrin is administered using a metered dose applicator ap·pli·ca·tor n. An instrument for applying something, such as a medication. applicator, n a device for applying medication; usually a slender rod of glass or wood, used with a pledget of cotton on the end. that delivers 0.87 g of gel per actuation, thereby allowing for precise titration titration (tītrā`shən), gradual addition of an acidic solution to a basic solution or vice versa (see acids and bases); titrations are used to determine the concentration of acids or bases in solution. from dose to dose. The gel dries quickly in one to two minutes. Elestrin will be launched in mid-2007 by Bradley Pharmaceuticals, Inc., under a marketing agreement between BioSante and Bradley. About ISSWSH The International Society for the Study of Women's Sexual Health is an international, multidisciplinary, academic, clinical and scientific organization whose purposes are : (1) to provide opportunities for communication among scholars, researchers and practitioners about women's sexual health, (2) to support the highest standards of ethics and professionalism in research, education and clinical practice of women's sexual health, and (3) to provide the public with accurate information about female women's sexual health. About BioSante Pharmaceuticals, Inc. BioSante is developing a pipeline of hormone therapy Hormone therapy Treating cancers by changing the hormone balance of the body, instead of by using cell-killing drugs. Mentioned in: Breast Cancer, Thyroid Cancer 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[TM] (estradiol gel), developed through FDA approval by BioSante, indicated for the treatment of moderate-to-severe vasomotor symptoms associated with menopause, and LibiGel([R]) (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 Hepatitis B Definition Hepatitis B is a potentially serious form of liver inflammation due to infection by the hepatitis B virus (HBV). It occurs in both rapidly developing (acute) and long-lasting (chronic) forms, and is one of the most common chronic , avian flu and biodefense vaccines for toxins such as anthrax anthrax (ăn`thrăks), acute infectious disease of animals that can be secondarily transmitted to humans. It is caused by a bacterium (Bacillus anthracis , as well as a system for delivering drugs via alternative routes of administration. 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 The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and 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. |
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