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Zestra(TM) Female Arousal Fluid Provides Solution For Many Female Sexual Problems; Pfizer Inc. (PFE) Ends Research Of Viagra(R) For Women


10/19/2005 5:10:21 PM

CHARLESTON, S.C., March 9 /PRNewswire/ -- The only clinically-proven topical Female Arousal Fluid Zestra(TM) has received "Notice of Allowance" from the United States Patent and Trademark Office just as Pfizer announced its decision to end Viagra(R) research in women. QualiLife Pharmaceuticals, Inc., a privately-held consumer products company focused on Women's Health, has been developing Zestra since 1997.

(Photo: http://www.newscom.com/cgi-bin/prnh/20040309/CLTUFNS1 )

The non-prescription Zestra patent is titled "Compositions and Method for Enhancing or Treating Female Sexual Response". Zestra from QualiLife Pharmaceuticals has demonstrated robust increases in female sexual arousal, pleasure and satisfaction in a well-designed, well-controlled clinical study conducted by several leading independent sexual medicine experts and scientists. The randomized, double-blind, placebo-controlled, crossover clinical study results are published in numerous respected medical journals. See: http://www.zestraforwomen.com/

"The approval of the Zestra patent is another milestone in QualiLife's strategy of utilizing safe, effective bioactives from scientifically researched botanicals to provide clinically proven solutions for women", says pharmaceutical scientist and sexual medicine expert, Martin G. Crosby, R.Ph., its inventor. International patents are pending.

Of the three highly-effective oral "prescription-only" male erectile dysfunction (ED) drugs; Viagra(R), Levitra(R) and Cialis(R), and the other prescription-based products that are presently in clinical trials intended for women's sexual complaints -- all were originally designed for use in men. Since 1996, several pharmaceutical companies have tried to adapt the "male" prescription ED drugs for use in female sexual complaints, but have met with little to no success in women since their pharmacologic mechanism of action (PDE-V inhibition) solely involves increasing genital blood flow.

"It is surprising that it took Pfizer eight years and 3,000 women to finally announce their decision last week," says Zestra's inventor. "Our research team knew in 1997 that the pharmaceutical companies were headed in the wrong direction for women with testing of any PDE-V inhibitor used alone". Instead, we focused our pharmacologic and natural product expertise on the desired goal of increasing female sexual pleasure and satisfaction which required a novel and more complex approach".

Published Clinical Study

Clinical study results for Zestra were first reported in Boston at the prestigious International Society for the Study of Women's Sexual Health (ISSWSH) and results are published in several respected medical journals -- The Journal of Sex & Marital Therapy, Drugs, National Association of Nurse Practitioners in Women's Health (NPWH) -- Women's Health Care: A Practical Journal for Nurse Practitioners, and WebMD Medical News. http://www.zestraforwomen.com/aboutzestra/publications.html

Zestra Female Arousal Fluid will be available in retail pharmacies nationwide in May 2004 and easily located in the "Family Planning" sections and/or 'Women's Personal Care' sections. It is already available by purchasing online at the "Official Zestra for Women Website": http://www.zestraforwomen.com/ or by calling (1-877-4-ZESTRA)(1-877-493-7872) Monday - Friday from 9am to 5pm Eastern Time.

The Zestra Advantage

Only Zestra was designed by pharmaceutical scientists and women's sexual health experts to effectively address the sexual pleasure pathways that are specific to women, says Crosby. "Non-prescription Zestra is the natural solution for most women who experience sexual problems such as difficulty with arousal, lubrication, sensation, pleasure, orgasm and satisfaction".

Women without sexual difficulties are embracing Zestra as the ultimate "Women's Lifestyle Product" for seeking sexual satisfaction. No other women's product has been proven to be more effective at increasing sexual pleasure, Crosby says. Applied during foreplay, the gentle application of Zestra combined with tender massage also helps to lubricate and arouse delicate tissue.

Prescription drugs using the nitric oxide pathway alone (Viagra(R), Levitra(R) and Cialis(R)) all work well in men with ED, but increased genital blood flow by itself, does not correlate well with increased female sexual pleasure as it (nitric oxide) is not involved in sexual sensation. "Accordingly, the inconclusive results obtained from studies of Viagra(R)-type drugs by pharmaceutical companies attempting to develop a potential "FDA- approved treatment for female sexual arousal disorder (FSAD), a common type of female sexual dysfunction (FSD)" has confounded many sexual medicine researchers over the years -- but QualiLife's scientists knew the solution for women was not going to be that simple" says Crosby.

Women Are Much More Complex

While Pfizer started the ED sexual revolution, with its Viagra(R) product for men, they recently suspended Viagra(R) research on the female sexual dysfunction market, as studies on women proved inconclusive. There are still no prescription drugs that are FDA-approved to treat any form of Female Sexual Dysfunction (FSD) or help with female sexual pleasure and sexual satisfaction. Non-prescription Zestra(TM) is the only clinically proven solution for women seeking an effective product that lubricates while safely increasing female arousal and sexual pleasure.

Competitive Landscape

Topical: While other non-prescription topical products may claim to increase female pleasure -- none are supported by a well-designed, well-controlled clinical study that has been conducted by independent recognized sexual medicine experts. None of those products are published in the medical or scientific literature. Other topical products on the market simply use known "chemical irritants" to produce sensation by irritating delicate clitoral and vaginal tissue. (examples are -- menthol, orange oil, peppermint oil, etc). Unfortunately, most of those products also contain L-Arginine, which can re-activate an outbreak of genital herpes.

Oral: One widely marketed herbal pill, Avlimil(R), has as its primary listed ingredient Salvia. Numerous Safety Warnings concerning Avlimil(R) have been published in physician, pharmacy and nursing journals advising healthcare professionals about the known neurotoxins in Salvia which can cause systemic side effects such as nausea, vomiting & hallucinations due to its thujone and isothujone content. Informed healthcare professionals are aware of these potentially serious risks and are advising their patients not to take that product.

QualiLife's Strategic Focus

QualiLife is a Specialty Consumer Products company focused on satisfying large unmet needs by leveraging its proprietary research platform combined with pharmaceutical expertise in natural flavinoid technologies, biological precursor technologies, together with incorporation of highly-researched botanical bioactives having scientifically established activities and well-documented favorable safety profiles. While Zestra is QualiLife's flagship product, the Company has additional promising consumer products in late-stage development that address other large unmet needs in Women's Health. QualiLife's proprietary targeted female libido solution is expected to join Zestra in the Company's consumer product line in October 2004. The Company continues to remain focused in Women's Health and will seek commercialization partners while exploring financing and/or merger options to maximize the Zestra and other pipeline opportunities.

MEDIA CONTACT: CORPORATE CONTACT: Judith Lederman Martin G. Crosby, R.Ph JSL Publicity & Marketing President & CEO 914-472-9072 (phone) QualiLife Pharmaceuticals, Inc. 914-472-9073 (fax) 843.402.0901 (phone) JudySL@aol.com (email) 843.402.0919 (fax) http://www.jslpublicity.com/http://www.zestraforwomen.com/

Photo: NewsCom: http://www.newscom.com/cgi-bin/prnh/20040309/CLTUFNS1AP Archive: http://photoarchive.ap.org/PRN Photo Desk, photodesk@prnewswire.comQualiLife Pharmaceuticals, Inc.

CONTACT: Judith Lederman of JSL Publicity & Marketing, +1-914-472-9072,or fax, +1-914-472-9073, JudySL@aol.com, for QualiLife Pharmaceuticals, Inc.;or Martin G. Crosby, R.Ph, President & CEO of QualiLife Pharmaceuticals, Inc.,+1-843-402-0901, or fax, +1-843-402-0919


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