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FemmePharma Global Healthcare, Inc. Announces the Divestiture of its Product for the Treatment of Endometriosis to KV Pharmaceutical Company

PRODUCT SHOWS PROMISING RESULTS IN PHASE 2 CLINICAL TRIALS

WAYNE, PA, June 15, 2005 – FemmePharma Holding Company, Inc. parent of FemmePharma Global Healthcare, Inc. announced that effective May 4, 2005 it entered into an agreement with KV Pharmaceutical Company to divest its product FP 1096 which treats the painful symptoms of endometriosis for an undisclosed amount that resulted in a significant return to its shareholders. 

FemmePharma developed FP1096 using its proprietary PARDEL® technology which allows for the local regional delivery of the active ingredient directly to the region affected by endometriosis, thus minimizing the systemic exposure to the active ingredient. In the Phase 2 clinical trials conducted by FemmePharma, FP1096 demonstrated a reduction of pain associated with endometriosis and at the same time showed minimal side effects. The clinical trial results demonstrate the positive impact of FP1096 on the quality of life for women with endometriosis.

“We are eager to see this important treatment option enter the market to help alleviate the pain that endometriosis inflicts on millions of women each and every day”, commented Gerianne Tringali DiPiano, President and CEO of FemmePharma Global Healthcare, Inc.

Endometriosis is a painful chronic disease that affects 89 million women worldwide. The endometriosis market in the United States has been estimated to be $2.5 billion. The disease occurs when endometrial tissue, or tissue resembling the lining of the uterus, develops in the pelvic region, which can cause severe pain during each menstrual cycle. The cause of endometriosis is not known and morbidity associated with this women’s disease can be considerable. Pain can be debilitating and result in loss of school and work days. Endometriosis is also the leading cause of infertility among women of reproductive age, accounting for an estimated 25% to 30% of unexplained infertility.

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FEMMEPHARMA, INC. CREATES NEW HOLDING COMPANY AND SUBSIDIARY 

EXPANDING ROLE OF COMPANY PARALLELS GROWING NEEDS OF GLOBAL FEMALE MARKET

WAYNE, PA, January 18, 2005 – FemmePharma, Inc. is pleased to announce two significant changes to its corporate structure that will enable it to effectively play an expanded role in the growing worldwide market for woman-focused pharmaceutical products. 

The first major shift includes the formation of FemmePharma Holding Company, Inc. to house the FemmePharma operating companies and their expanding intellectual property estate. The second change is the creation of a new subsidiary, FemmePharma Global Healthcare, Inc., to support the company’s mission of developing drugs for diseases and disorders disproportionately affecting women throughout the world. 

“These changes are important because they emphasize the growing global market for treatments that specifically target women and the diseases that disproportionately affect them,” explains FemmePharma Inc. President & CEO Gerianne Tringali DiPiano. “We are committed to developing and expanding the drugs in our pharmaceutical pipeline, quite simply, because women throughout the world need them, and these changes in our structure will allow us to smoothly transition into a company that can meet these global needs.” 

Ms. Tringali DiPiano explained that FemmePharma Holding Company will oversee clinical and pharmaceutical development across the company’s product lines here in the U.S. and globally. She noted the company will continue to create specialty subsidiaries for its areas of therapeutic focus.

FemmePharma Global Healthcare is engaged in the ongoing development of products in the therapeutic areas of endometriosis, urinary incontinence and mastalgia in other parts of the world. 

About FemmePharma, Inc.
FemmePharma was founded by Gerianne Tringali DiPiano in 1996 to target needs within the estimated $70 billion women’s healthcare pharmaceutical market. FemmePharma is devoted to developing safe and effective drugs that minimize or eliminate unpleasant side effects associated with many medications by designing them in a manner that is specifically suited to a woman’s physiology, with an eye toward the changing needs of women throughout their lives. The company has a number of drugs in development based on its proprietary technologies, including new therapeutic options for urinary incontinence and mastalgia. For more information about FemmePharma, please visit its website at www.fpghc.com.

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FEMMEPHARMA NAMED “COMPANY TO WATCH” BY EASTERN TECHNOLOGY COUNCIL

WAYNE, PA, November 10, 2004 – FemmePharma, Inc. , a specialty pharmaceutical company in late stages of development for the treatment of diseases and disorders disproportionately affecting women, has been named a “Company to Watch” by the Eastern Technology Council, Greater Philadelphia’s premier organization for technology leaders and companies.

“Companies to Watch” represents companies that have accomplished tremendous objectives, but the objectives may not be reflected in revenues at this stage in their growth. FemmePharma, as a development stage company, epitomizes the meaning of the category,” said Dianne Strunk, CEO of the Eastern Technology Council.

Focusing entirely on women’s health, FemmePharma has products in late stages of development for the treatment of endometriosis, urinary incontinence and mastalgia. Recent Phase 2 clinical trials for the Company’s endometriosis product yielded a significant reduction of the pain associated with the disease and an absence of systemic side effects for those who participated in the trial.

FemmePharma will be honored at the upcoming 12th Annual Enterprise Awards on Thursday, November 11, 2004 at the Pennsylvania Convention Center.

About FemmePharma, Inc.
FemmePharma was founded by Gerianne Tringali DiPiano in 1996 to target needs within the estimated $70 billion women’s healthcare pharmaceutical market. The Company is in a Phase III trial for FP1096, a new investigational treatment for endometriosis, and is preparing for its Phase II trial for its drug to treat female urinary incontinence. 

FemmePharma is devoted to developing safe and effective drugs that minimize or eliminate unpleasant side effects associated with many medications by designing them in a manner that is specifically suited to a woman’s physiology, with an eye toward the changing needs of women throughout their lives. The company has a number of drugs in development based on its proprietary technologies, including a new therapeutic option for mastalgia. For more information about FemmePharma, please visit its website at www.fpghc.com.

About the Enterprise Awards
With sponsors such as ATX Communications, Comerica Bank, PricewaterhouseCoopers, PECO, Cephalon, Inc., Innovation Philadelphia, Garfield Group, KPMG, Ben Franklin Technology Partners, SunGard SCT and Woodcock Washburn, the Enterprise Awards are presented on an annual basis by the Eastern Technology Council to technology companies and individuals that contribute to the Region’s high-tech reputation.

About the Eastern Technology Council:
The Eastern Technology Council, an association representing approximately 800 technology-oriented companies, helps entrepreneurs raise capital, attract employees, gain customers, find information and garner publicity. The Council provides customized events and innovative financial services as well as a broad variety of publications and cost-saving discounts on retirement benefits, medical plans and healthcare. For more information, visit the Eastern Technology Council website at www.techcouncil.org.

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FEMMEPHARMA CEO TO BE HONORED AT 4TH ANNUAL REGIONAL BIOTECH COUNCIL CONFERENCE

WAYNE, PA, September 20, 2004 – The Regional Biotech Council established in rural Bucks County in 2000 will hold its 4th Annual Regional Biotech Council Conference at the Pinecrest Country Club in Lansdale, PA on Friday, September 24, 2004. Co-hosted by Senator Joe Conti, Majority Policy Chairman and State Senator for the 10th Senatorial District, the event’s theme is “Taking small and emerging biotechs through clinical trials and the complex of regulatory requirements – a risky and expensive endeavor for all parties involved.”

Gerianne Tringali DiPiano is being honored for leading her company, FemmePharma, Inc., through the rigors of drug development in the arena of women’s health. 

“Gerianne’s story is that of an entrepreneur who stayed the course and achieved success. She is a strong example to showcase for the Conference,” said Carolyn d’Arville, Ph.D., Associate Director of the Council. “I am truly honored by this recognition and I look forward to sharing my story and experience in the hopes it will help other entrepreneurs in the region,” stated Ms. Tringali DiPiano.

Focusing entirely on women’s health, FemmePharma has products in late stages of development for the treatment of endometriosis, urinary incontinence and mastalgia. Recent Phase 2 clinical trials for FemmePharma’s endometriosis product yielded a significant decrease in the reduction of pain associated with the disease and an absence of systemic side effects for those who participated in the trial. 

About FemmePharma, Inc.
FemmePharma was founded by Gerianne Tringali DiPiano in 1996 to target needs within the estimated $70 billion women’s healthcare pharmaceutical market. The Company is in a Phase III trial for FP1096, a new investigational treatment for endometriosis, and is preparing for its Phase II trial for its drug to treat female urinary incontinence. 

FemmePharma is devoted to developing safe and effective drugs that minimize or eliminate unpleasant side effects associated with many medications by designing them in a manner that is specifically suited to a woman’s physiology, with an eye toward the changing needs of women throughout their lives. The company has a number of drugs in development based on its proprietary technologies, including a new therapeutic option for mastalgia. For more information about FemmePharma, please visit its website at www.fpghc.com.

About Regional Biotech Council
The mission of The Regional Biotech Council, established in rural Bucks County in 2000, is to provide a networking environment, with a regional emphasis, for biotech entrepreneurs as well as small and emerging biotech companies to support their concerns on organizational and strategic issues, thereby helping the biotechnology community leverage bargaining power, and become stakeholders in their own future in Southeastern Pennsylvania. The Council, which serves the five counties: Chester, Montgomery, Delaware, Philadelphia and Bucks, welcomes the more established companies to meetings, where a wealth of experience in biotech can be shared and strategic networking relationships can be fostered and maintained.

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FEMMEPHARMA, INC. APPOINTS ERNST & YOUNG AS COMPANY’S INDEPENDENT AUDITORS

WAYNE, PA, July 30, 2004 –FemmePharma, Inc. announced today its Board of Directors has approved the selection of Ernst & Young as the Company’s independent auditors. “After reviewing several firms, we are confident the world-wide experience and reputation Ernst & Young brings will provide FemmePharma with an excellent partner as it continues to execute its business strategy,” said Kevin Flanagan, a Director of the Company and Chairman of its Audit Committee. 

About FemmePharma, Inc.
FemmePharma was founded by Gerianne Tringali DiPiano in 1996 to target needs within the estimated $70 billion women’s healthcare pharmaceutical market. The Company is in a Phase III trial for FP1096, a new investigational treatment for endometriosis, and is preparing for its Phase II trial for its drug to treat female urinary incontinence. 

FemmePharma is devoted to developing safe and effective drugs that minimize or eliminate unpleasant side effects associated with many medications by designing them in a manner that is specifically suited to a woman’s physiology, with an eye toward the changing needs of women throughout their lives. The company has a number of drugs in development based on its proprietary technologies, including a new therapeutic option for mastalgia. For more information about FemmePharma, please visit its website at www.fpghc.com.

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Gerianne Triangli DiPiano, President & CEO of FemmePharma, Inc., Named Finalist For Ernst & Young Entrepreneur Of The Year® 2004 Award 

June 1, 2004 – PHILADELPHIA, PA – Gerianne Tringali DiPiano, President & CEO of FemmePharma, Inc., was named a finalist by professional services firm Ernst & Young LLP for the Ernst & Young Entrepreneur Of The Year 2004 Awards in Greater Philadelphia & Central-Eastern Pennsylvania. FemmePharma was selected from nominations in Greater Philadelphia & Central-Eastern Pennsylvania by a panel of judges comprised of local community and business leaders. Award recipients will be selected in a number of award categories announced at an awards banquet on June 18, 2004 at the Philadelphia Marriott.

After an established career in senior executive positions for such international pharmaceutical companies as Baxter Healthcare, Bristol-Myers Squibb, Sterling-Winthrop and Wyeth-Ayerst, Tringali DiPiano founded FemmePharma in 1996. The Company is a specialty pharmaceutical company in late stages of development of products for the treatment of diseases and disorders disproportionately affecting women. The Company is in a Phase III trial for FP1096, a new investigational treatment for endometriosis, and is preparing for a Phase II trial for its drug to treat female urinary incontinence. FemmePharma is devoted to developing safe and effective drugs that minimize or eliminate unpleasant side effects associated with many medications by designing them in a manner that is specifically suited to a woman’s physiology, with an eye toward the changing needs of women throughout their lives. The Company has a number of drugs in development based on its proprietary technologies, including a new therapeutic option for fibrocystic breast disease.

Currently, Tringali DiPiano serves on the Board of Trustees for Drexel University and the Corporate Advisory Board of the Society for Gynecologic Investigation. She has been a Finalist in the Ernst and Young Entrepreneur of the Year for the Greater Philadelphia Region in 2002 and 2003 and has been recognized in “People to Watch in 2004” by Philadelphia Magazine. She is the 2004 recipient of the Iris Newman Award sponsored by the Ben Franklin Technology Partners of Southeastern Pennsylvania and the Purple Aster Award from the Grand Lodge of Pennsylvania Order, Sons of Italy in America. 

Greater Philadelphia & Central-Eastern Pennsylvania winners will be eligible for consideration for the Entrepreneur Of The Year 2004 national program. Winners in several national categories, as well as the overall national Ernst & Young Entrepreneur Of The Year, will be announced at the annual awards gala in Palm Springs, Calif., in November 2004. 

The Ernst & Young Entrepreneur Of The Year Greater Philadelphia & Central-Eastern Pennsylvania Program is sponsored nationally by Microsoft®, Kauffman Foundation and locally by Wachovia, Marsh USA, Philadelphia Business Journal, Eastern Pennsylvania Business Journal, and Harrisburg Patriot-News and the Technology Council of Central Pennsylvania. For more information about the awards program, visit www.ey.com/us/eoy.

About The Ernst & Young Entrepreneur Of The Year® Awards Program
The Entrepreneur Of The Year awards program was created and is produced by professional services firm Ernst & Young LLP. As the first award of its kind, Ernst & Young Entrepreneur Of The Year recognizes outstanding entrepreneurs who are building and leading dynamic and growing businesses. The program honors entrepreneurs through regional, national and global award programs in over 100 cities and 35 countries.

About Ernst & Young
Ernst & Young, a global leader in professional services, is committed to restoring the public’s trust in professional services firms and in the quality of financial reporting. Its 103,000 people in more than 140 countries around the globe pursue the highest levels of integrity, quality, and professionalism to provide clients with solutions based on financial, transactional, and risk-management knowledge in Ernst & Young's core services of audit, tax, and transaction services. Further information about Ernst & Young and its approach to a variety of business issues can be found at www.ey.com/perspectives. Ernst & Young refers to all the members of the global Ernst & Young organization.

About FemmePharma
FemmePharma was founded by Gerianne Tringali DiPiano in 1996 to target needs within the estimated $35 billion women’s healthcare pharmaceutical market. The company is in a Phase III trial for its first drug, a new treatment for endometriosis, and is preparing for its Phase II trial for its drug to treat female urinary incontinence. FemmePharma is devoted to developing safe and effective drugs that minimize or eliminate unpleasant side effects associated with many medications by designing them in a manner that is specifically suited to a woman’s physiology, with an eye toward the changing needs of women throughout their lives. The Company has a number of drugs in development based on its proprietary technologies, including new therapeutic options for fibrocystic breast disease. For more information about FemmePharma, please visit its website at www.fpghc.com.

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FEMMEPHARMA, INC. PRESENTS PHASE II CLINCIAL RESULTS OF AN INVESTIGATIONAL TREATMENT FOR ENDOMETRIOSIS AT THE ANNUAL CLINICAL MEETING OF THE AMERICAN COLLEGE OF OBSTETRICIANS AND GYNECOLOGISTS

PHILADELPHIA, PA, May 5, 2004 – An investigational treatment for endometriosis, FP1096, reduced the painful symptoms of endometriosis in trial subjects with minimal side effects, according to Phase II clinical study results presented this week at the 52nd Annual Clinical Meeting of The American College of Obstetricians and Gynecologists (ACOG). FP1096 is being developed by FemmePharma, a late stage specialty pharmaceutical company dedicated to developing drugs for diseases and disorders disproportionately affecting women. Drs. W. Paul Dmowski and Tom Janicki, investigators in the study and members of FemmePharma’s Scientific Advisory Board, co-authored the abstract that was published in the April edition of Obstetrics and Gynecology.

This was a multicenter, prospective, open-label study conducted in the U.S. Approximately 30 subjects were recruited from four centers across the U.S.; each of these subjects had endometriosis which had been surgically diagnosed within three years of enrollment. Subjects were screened to assess their suitability and to ensure that they had moderate-to-severe endometriosis. Severities of symptoms associated with endometriosis (i.e., dysmenorrhea, dyspareunia, pelvic pain, pelvic tenderness, induration) were assessed using the Biberoglu and Behrman Symptom Score (BBSS). Change from baseline to the end of treatment in BBSS was the primary efficacy endpoint. Additionally, secondary efficacy endpoints, including a pain assessment questionnaire, a quality of life measure and a daily diary assessment, were also collected.

The primary efficacy endpoint demonstrated a statistically significant decrease indicating the subjects had a diminishment in the symptoms associated with endometriosis. The secondary efficacy endpoints supported and corroborated the observation that FP1096 reduced the pain associated with endometriosis. 

Endometriosis is the leading cause of infertility among reproductive age women and the most common non-malignant gynecological disorder in the U.S. The disease affects 89 million women in the worldwide. Traditional treatments include oral medications or surgery. Today’s approved treatments for endometriosis can carry significant systemic side effects – either menopausal (bone loss, mood swings, hot flashes) or androgenic (acne, facial hair growth, deepening of voice and reduction of breast size). 

FP1096 is an investigational drug delivered intravaginally directly to the targeted region of the disease. Through local delivery of FP1096, FemmePharma hopes to reduce or avoid the unwanted systemic side effects.

“FemmePharma welcomed the opportunity to review our Phase II study results with the ACOG community. We viewed it as a venue to share the study’s outcomes and to create dialogue for the future. FemmePharma is looking forward to continuing the clinical development of FP1096 and ultimately bringing it to OB/GYN market,” said the Company’s President and CEO, Gerianne Tringali DiPiano

About FemmePharma, Inc.
FemmePharma was founded by Gerianne Tringali DiPiano in 1996 to target needs within the estimated $70 billion women’s healthcare pharmaceutical market. The company is in a Phase III trial for FP1096, a new investigational treatment for endometriosis, and is preparing for its Phase II trial for its drug to treat female urinary incontinence. 

FemmePharma is devoted to developing safe and effective drugs that minimize or eliminate unpleasant side effects associated with many medications by designing them in a manner that is specifically suited to a woman’s physiology, with an eye toward the changing needs of women throughout their lives. The company has a number of drugs in development based on its proprietary technologies, including a new therapeutic option for fibrocystic breast disease. For more information about FemmePharma, please visit its website at www.fpghc.com.

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FEMMEPHARMA, INC. CEO, GERIANNE TRINGALI DIPIANO, RECIPIENT OF PURPLE ASTER AWARD FROM SONS OF ITALY

WAYNE, PA, May 17, 2004 – FemmePharma, Inc. President and CEO, Gerianne Tringali DiPiano, was honored by the Grand Lodge of Pennsylvania Order, Sons of Italy in America as a recipient of the Purple Aster Award at the 21st Annual Purple Aster Awards Ball on May 15, 2004 at the Hyatt Regency, Penns Landing. Recipients are members of the Italian community and recognized for their business achievements as well as their civic contributions. 

Ms. Tringlai DiPiano is the daughter of Joseph and Connie Tringali of Clarksville, Maryland. Her maternal and paternal grandparent emigrated from Sicily in the 1920’s. They raised families in the United States and built successful businesses in Maryland. “My grandparents are the true honorees; they sacrificed and struggled to create an opportunity for future generations. This honor belongs to them,” said Tringali DiPiano.

After an established career in senior executive positions for such international pharmaceutical companies as Baxter Healthcare, Bristol-Myers Squibb, Sterling-Winthrop and Wyeth-Ayerst, Tringali DiPiano founded FemmePharma in 1996. The Company is a specialty pharmaceutical company in late stages of development of products for the treatment of diseases and disorders disproportionately affecting women. The company is in a Phase III trial for FP1096, a new investigational treatment for endometriosis, and is preparing for a Phase II trial for its drug to treat female urinary incontinence. FemmePharma is devoted to developing safe and effective drugs that minimize or eliminate unpleasant side effects associated with many medications by designing them in a manner that is specifically suited to a woman’s physiology, with an eye toward the changing needs of women throughout their lives. The Company has a number of drugs in development based on its proprietary technologies, including a new therapeutic option for fibrocystic breast disease.

Currently, Tringali DiPiano serves on the Board of Trustees for Drexel University and the Corporate Advisory Board of the Society for Gynecologic Investigation. She has been a Finalist in the Ernst and Young Entrepreneur of the Year for the Greater Philadelphia Region in 2002 and 2003 and has been recognized in “People to Watch in 2004” by Philadelphia Magazine. She is the 2004 recipient of the Iris Newman Award sponsored by the Ben Franklin Technology Partners of Southeastern Pennsylvania. 

Proceeds from the event benefited the Order’s Charitable Education Trust. Other recipients honored were Gabriel L. I. Bevilacqua, Esq., Chancellor, Philadelphia Bar Association and Lisa Isgro Binder, Group Executive Vice President, Citizens Bank.…..

For more information about FemmePharma, please visit the Company’s website at www.fpghc.com.

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FEMMEPHARMA'S CEO WINS IRIS NEWMAN AWARD AT 2004 BEN FRANKLIN EMERGING BUSINESS AWARDS

Philadelphia, PA - March 16, 2004- Five companies and one individual were honored recently for their extraordinary achievements at the 10th Annual Ben Franklin Emerging Business Awards, affectionately known as The Bennies. The accomplishments of Acuity Pharmaceuticals, Collages.net, IPR International Inc., Morphotek Inc., Rajant Corporation, and Gerianne Tringali DiPiano, CEO of FemmePharma Inc., were all celebrated at the event held on March 11.

The Bennies, founded in 1994 by The Entrepreneurs' Forum of Greater Philadelphia and Ben Franklin Technology Partners of Southeastern Pennsylvania, promotes area companies in recognition of their breakthrough technologies, product innovations and management excellence. Each winner received a $1,000 cash prize. This year's Bennies event also included a special Alumni Award, presented to a regional enterprise that has achieved significant growth milestones since winning its emerging business award.

The winners of the 2004 Ben Franklin Emerging Business Awards are:

  • Most Innovative Product Award: Rajant Corporation's BreadCrumb® Wireless LAN is a tactical, self-healing, self-meshing battery powered broadband wireless IP/digital device for deployment in situational areas by first responders, security and military personnel.
  • Most Innovative Service Award: Collages.net uses proprietary, patent pending technology to automate online marketing, resale of photographs, and reprint fulfillment for professional photographers and commercial color labs.
  • Best Management Team: IPR International is a leader in data protection and recovery for small-to-midsize and enterprise-level organizations, offering solutions that ensure instant data backup, recovery, archiving, and retrieval, no matter where the data resides.
  • Biotech Company of the Year: Acuity Pharmaceuticals Inc. is an emerging ophthalmic pharmaceutical company applying its proprietary technology to the treatment and prevention of ophthalmic disease, focusing on the exciting new field of RNA interference (RNAi).
  • Iris Newman Award: Named in honor of the co-founder of the Women's Investment Network, the award was presented to Gerianne Tringali DiPiano, CEO of FemmePharma Inc., in recognition of her support for and work with women-owned and women-led businesses.
  • Alumni Award: Morphotek Inc. is a biopharmaceutical company focused on the discovery and co-development of monoclonal antibodies for treatment of cancer, autoimmune disorders, and other serious diseases. Morphotek won the Biotech Company of the Year award at the 2002 Bennies.

BDO Seidman LLP, Blank Rome LLP, and S.R.One, Limited were the premier sponsors of the event.

Since 1982, Ben Franklin Technology Partners of Southeastern Pennsylvania (BFTP/SEP) has helped grow the region through science, technology and entrepreneurship. BFTP/SEP provides entrepreneurs and established businesses the capital, talent, and expertise they need to compete in the global marketplace. Like its namesake, Ben Franklin invests in, builds upon and delivers solutions that grow communities and create wealth by supporting today's technological ideas and tomorrow's scientific discovery.
www.sep.benfranklin.org

Contact:
BFTP/SEP
Kimberly Everett
Director of Public Relations
215-972-6700 x3989
kim@sep.benfranklin.org

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FEMMEPHARMA, INC. and EMORY UNIVERSITY TEAM TO IDENTIFY TOPICAL MICROBICIDES FOR DRUG DEVELOPMENT

February 9, 2004 - WAYNE, PA - FemmePharma, Inc., a prescription pharmaceutical company dedicated to developing drugs for diseases and disorders disproportionately affecting women, has initiated a collaboration with Emory University to study a library of molecules and their respective activity against HIV and other sexually transmitted diseases (STDs). The intention of the collaboration is to identify lead candidates for the drug development process. 

"This new collaboration with FemmePharma is of critical importance in developing these microbicides as products for protection against HIV," said Richard W. Compans, Ph.D., principal investigator of the Emory topical microbicide program project grant from NIH, and Professor and Chair of the department of Microbiology and Immunology.

A collaborative group including researchers from Emory, Georgia State University, and Louisiana State University has been studying the ability of porphyrins and related compounds to inhibit infection by HIV since 1999. This project has been supported by NIH for the last four years, and the group has shown that several of the compounds tested are indeed virucidal, i.e., they inactivate infectivity of cell-free HIV virions. This virucidal activity is at least in part due to interactions with the HIV envelope protein, which is responsible for initiating viral infection. The new collaboration with FemmePharma will advance these active compounds to clinical trials. Compounds will first be synthesized, purified, and characterized in biological studies, and the activity of the lead compounds against infectious HIV-1 virions will be determined. Effective compounds will be screened using animal models prior to formulation and human testing by FemmePharma.

Topical vaginal microbicides to decrease the transmission of HIV infection are an important adjuvant in the arsenal to reduce heterosexual transmission of HIV. According to the Center for Disease Control and Prevention (CDC), approximately 65 million people worldwide have been infected with HIV since the start of the global epidemic. At the end of 2002, approximately 42 million were living with HIV/AIDs. Women's rate of infection of HIV is on the rise, according to the CDC. At the end of 2002, women made up approximately half of the worldwide population living with HIV/AIDs.

Correct use of a condom during sexual intercourse is a major means of prevention of the HIV virus and other STDs. Women, however, often lack other options when it comes to their protection against STDs. Personal, social and cultural factors can and do interfere with a woman's ability to have her partner use a condom. A safe and effective vaginal microbicide will give a woman the control she needs over her health - with or without the consent or knowledge of her partner.

"FemmePharma is proud to be working with Emory University and these other outstanding organizations in this critical arena of vaginal microbicides. We look forward to the development process and hope to ultimately deliver a difference to women as they face choices regarding protection against HIV and STDs," said Gerianne Tringali DiPiano, President and CEO of FemmePharma, Inc.

About FemmePharma

FemmePharma was founded by Gerianne Tringali DiPiano in 1996 to target needs within the estimated $35 billion women's healthcare pharmaceutical market. The company is in a Phase III trial for its first drug, a new treatment for endometriosis, and is preparing for its Phase II trial for its drug to treat female urinary incontinence. FemmePharma is devoted to developing safe and effective drugs that minimize or eliminate unpleasant side effects associated with many medications by designing them in a manner that is specifically suited to a woman's physiology, with an eye toward the changing needs of women throughout their lives. The company has a number of drugs in development based on its proprietary technologies, including new therapeutic options for fibrocystic breast disease. For more information about FemmePharma, please visit its website at www.fpghc.com.

About Emory University

Emory's Robert W. Woodruff Health Sciences Center (WHSC) encompasses those components of Emory University responsible for education of health professionals, research affecting health and illness, patient care, and policies for prevention and treatment of disease. The WHSC's namesake, the legendary leader of The Coca-Cola Company, was a man whose vision and generosity left a lasting imprint on Emory and the city of Atlanta. In addition to the Woodruff Health Sciences Center and its components, including the School of Medicine, Emory University includes Emory College, Oxford College, a graduate school of arts and sciences, and professional schools of business, law, and theology. 

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FEMMEPHARMA, INC. ANNOUNCES PROMISING RESULTS OF PHASE 2 CLINICAL TRIAL FOR FP1096, A NEW INVESTIGATIONAL TREATMENT FOR ENDOMETRIOSIS

January 19, 2004 WAYNE, PA - FemmePharma, Inc., a prescription pharmaceutical company dedicated to developing drugs for diseases and disorders disproportionately affecting women, announced today the results from its Phase 2 study of FP1096, its investigational treatment for endometriosis. The results demonstrated that FP1096 reduced the painful symptoms of endometriosis in trial subjects with very minimal side effects. 

This was a multicenter, prospective, open-label study conducted in the United States. Approximately 30 subjects were recruited from 4 centers across the U.S.; each of these subjects had endometriosis which had been surgically diagnosed within three years of enrollment. Subjects were screened to assess their suitability and to ensure that they had moderate-to-severe endometriosis. Severities of symptoms associated with endometriosis (i.e., dysmenorrhea, dyspareunia, pelvic pain, pelvic tenderness, induration) were assessed using the Biberoglu and Behrman Symptom Score (BBSS). Change from baseline to the end of treatment in BBSS was the primary efficacy endpoint. Additionally, secondary efficacy endpoints, including a pain assessment questionnaire, a quality of life measure and a daily diary assessment, were also collected.

The primary efficacy endpoint demonstrated a statistically significant decrease indicating the subjects had a diminishment in the symptoms associated with endometriosis. The secondary efficacy endpoints supported and corroborated the observation that FP1096 reduced the pain associated with endometriosis. 

Dr. Tom Janicki, a practitioner at Green Road Obstetrics and Gynecology and a Scientific Advisory Board member for FemmePharma, commented, "FP1096 appears to have been well tolerated by the patients participating in the study and results of this trial indicate that the pain associated with the disease was relieved. Development of this drug may benefit women suffering from endometriosis in the future."

About Endometriosis

Endometriosis is a disease in which endometrial tissue or the tissue resembling the lining of the uterus is found in the pelvic region. Active and fibrotic endometrial tissue can cause severe pain during each menstrual cycle. Symptoms include painful menstruation, abnormal bleeding during menstruation, pain that surfaces during or after intercourse, fatigue, painful urination or bowel movements during periods and gastrointestinal upsets. The disease affects 11 million women in the U.S. alone. It is the leading cause of infertility among reproductive age women and the most common non-malignant gynecological disorder in the U.S. Traditional treatments include oral medications or surgery.

Today's approved treatments for endometriosis can carry significant systemic side effects - either menopausal (bone loss, mood swings, hot flashes) or androgenic (acne, facial hair growth, deepening of voice and reduction of breast size). These side effects are the outcome of delivering the drug systemically and often result in a discontinuation of treatment. 

About FP1096

FP1096 is an investigational drug delivered intravaginally directly to the targeted region of the disease. Through local delivery of FP1096, FemmePharma hopes to reduce or avoid the unwanted systemic side effects.

"In this early trial, FP1096 has shown a positive impact on the quality of life for women affected with endometriosis. Our investigational drug has significantly reduced the pain associated with endometriosis and at the same time has shown minimal systemic side effects. FemmePharma is looking forward to continuing the clinical development of FP1096 and ultimately bringing it to market," said Gerianne Tringali DiPiano, FemmePharma's President and CEO.

About FemmePharma, Inc.

FemmePharma was founded by Gerianne Tringali DiPiano in 1996 to target needs within the estimated $35 billion women's healthcare pharmaceutical market. The company is in a Phase III trial for FP1096, a new investigational treatment for endometriosis, and is preparing for its Phase II trial for its drug to treat female urinary incontinence. FemmePharma is devoted to developing safe and effective drugs that minimize or eliminate unpleasant side effects associated with many medications by designing them in a manner that is specifically suited to a woman's physiology, with an eye toward the changing needs of women throughout their lives. The company has a number of drugs in development based on its proprietary technologies, including new therapeutic options for fibrocystic breast disease. For more information about FemmePharma, please visit its website at www.fpghc.com.

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FEMMEPHARMA, INC. ADDS CAROLYN d’ARVILLE, MS, Ph.D. and LISA RARICK, MD, FACOG TO SCIENTIFIC ADVISORY BOARD

November 10, 2003 WAYNE, PA – FemmePharma, Inc., a prescription pharmaceutical company dedicated to developing drugs for diseases and disorders disproportionately affecting women, proudly announces the recent addition of two new Scientific Advisory Board (SAB) members who are considered leaders in their respective fields – Drs. Carolyn d’Arville and Lisa Rarick. 

“FemmePharma is pleased to have these two outstanding women join our SAB. We look forward to their guidance, expertise and contributions as we continue our pipeline development and corporate growth,” said Gerianne Tringali DiPiano, the Company’s President and CEO.

Dr. d’Arville is Associate Director of the Jefferson Center, Thomas Jefferson University Medical School, where she also coordinates the activities of the Ben Franklin Innovation Center. She is co-founder of the Regional Biotechnology Council serving early-stage and emerging biotech in the South Eastern Pennsylvania region. In addition, as President/Founder of Competitive Edge Technologies Inc, she combines her scientific expertise and academic knowledge to the assessment and management of companies’ life science portfolios, particularly those in women’s reproductive health. Previously, she joined Johnson & Johnson, Inc. where she initiated, developed and managed several feasibility projects and early stage research efforts in various arenas. Educated in the UK, Dr. d’Arville attained her MS in Virology at the University of Reading and her Ph.D. in Reproductive Endocrinology at the Welsh National School of Medicine, Wales. Her postdoctoral research included gynecologic oncology, cell and molecular biology programs.

Dr. d’Arville champions the entrepreneurial spirit embodied by FemmePharma.

“That is why FemmePharma is so intriguing to me. I admire Gerianne’s tenacity – recognizing a need in women’s healthcare – and doing something about it!” she said. “I look forward to contributing to FemmePharma’s future and to keeping the company at the forefront of women’s healthcare.”

Tringali DiPiano is also pleased to have Dr. d’Arville join her team.

“We are excited about having Carolyn’s expertise on our SAB, particularly as we explore and develop new technologies for treatment and drug delivery,” said Tringali DiPiano. 

Dr. Lisa Rarick is the former Medical Officer in the U.S. Food and Drug Administration Office of Women’s Health (OWH). Dr. Rarick worked in the Center for Drug Evaluation and Research (CDER), where she reviewed and had responsibility for the management of products for a wide variety of reproductive and urologic health issues including contraception, hormone therapy in both men and women, infertility and endometriosis. Dr. Rarick received her M.D. degree from the Loma Linda University School of Medicine. She completed her residency at Georgetown University School of Medicine, Department of Obstetrics and Gynecology.

“I look forward to working with the team members at FemmePharma as they move their products through clinical development toward product launch,” said Dr. Rarick. 

Tringali DiPiano believes Dr. Rarick’s knowledge will benefit FemmePharma.

“With her strong background in women’s health and her experience with the FDA, Lisa will provide FemmePharma with a valuable resource in accomplishing key milestones, such as the launch of our products to women who suffer from these diseases,” Tringali-DiPiano stated.

Drs. d’Arville and Rarick join FemmePharma’s current SAB members, who include Dr. Paul Dmowski, Dr. Tom Janicki, Dr. Sheldon Segal and Dr. Jerome Strauss, who serves as Chairperson.

About FemmePharma
FemmePharma was founded by Gerianne Tringali-DiPiano in 1996 to target needs within the estimated $35 billion women’s healthcare pharmaceutical market. The company is preparing for its Phase III trial for its first drug, a new treatment for endometriosis, and its Phase II trial for its drug to treat female urinary incontinence. FemmePharma is devoted to developing safe and effective drugs that minimize or eliminate unpleasant side effects associated with many medications by designing them in a manner that is specifically suited to a woman’s physiology, with an eye toward the changing needs of women throughout their lives. The company has a number of drugs in development based on its proprietary technologies, including new therapeutic options for fibrocystic breast disease and the prevention of HIV/STD transmission. For more information about FemmePharma, please visit its website at www.fpghc.com.

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FemmePharma Invited to Present at Venture Fair for East Coast's Leading Biotechnology Companies

Pharmaceutical Company Chosen Through Competitive Process to Speak at BIO VentureForum East in Philadelphia, Nov. 17-19 

October 6, WAYNE, PA - FemmePharma, Inc., a late stage prescription pharmaceutical company focused solely on the diseases and disorders disproportionately affecting women, has been chosen to be a Presenting Company at this year's BIO VentureForum East 2003 to be held at the Philadelphia Convention Center Nov. 17-19. 

"BIO VentureForum East 2003 is the premier venture fair on the East Coast for life science, biotechnology and heathcare companies. Due to the competitiveness of the application process, we are grateful for and excited about the opportunity to share FemmePharma's achievements and objectives with this audience," said Gerianne Tringali DiPiano, the company's President & CEO.

FemmePharma is seeking up to $10 million in investment capital in order to complete development of its urinary incontinence product and its fibrocystic breast disease product. Working capital is also being sought so FemmePharma can expand its commercial operations. The Company will open a Phase IIa human clinical trial for its urinary incontinence drug in early 2004. This is FemmePharma's second product to enter human clinical trials. Its first product, a drug for endometriosis, is preparing to enter Phase III.

BIO VentureForum East 2003 is sponsored by the Biotechnology Industry Organization (BIO). The venture fair features the most promising seed, early and late stage biotechnology and healthcare companies. An international audience of the most prestigious life science venture capital firms will be in attendance. This year, BIO is collaborating with the Greater Philadelphia Venture Group to produce the BIO VentureForum East 2003 concurrently with the Mid-Atlantic Venture Fair, a premier East Coast event for entrepreneurs and financiers.

About FemmePharma, Inc.
FemmePharma was founded by Gerianne Tringali-DiPiano in 1996 to target needs within the estimated $35 billion women's healthcare pharmaceutical market. The company is preparing for its Phase III trial for its first drug, a new treatment for endometriosis, and its Phase II trial for its drug to treat female urinary incontinence. FemmePharma is devoted to developing safe and effective drugs that minimize or eliminate unpleasant side effects associated with many medications by designing them in a manner that is specifically suited to a woman's physiology, with an eye toward the changing needs of women throughout their lives. The company has a number of drugs in development based on its proprietary technologies, including new therapeutic options for fibrocystic breast disease and the prevention of HIV/STD transmission. For more information about FemmePharma, please visit its website at www.fpghc.com.

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FemmePharma Receives U.S. Ind Approval for its New Therapeutic Option for Female Urinary Incontinence

September 15, WAYNE, PA - FemmePharma, Inc., a late stage pharmaceutical company solely focused on developing drugs for the diseases and disorders disproportionately affecting women, announced today the FDA has permitted the Company to open an IND (Investigational New Drug) application for FP1097, a new therapeutic treatment option for female urinary incontinence. The Company will open a Phase IIa human clinical trial. This is FemmePharma's second product to enter human clinical trials. Its first product, an drug for endometriosis, will enter Phase III.

"FemmePharma is pleased to have reached this significant milestone. We look forward to moving FP1097 through the clinical development process," stressed FemmePharma President Gerianne Tringali-DiPiano. "This is an important step toward providing women who suffer from urinary incontinence an effective therapeutic option with fewer of the systemic side effects seen from the products currently available in the market."

About Female Urinary Incontinence and FP1097
Urinary incontinence is defined as the unwanted loss or leakage of urine at an unacceptable place and time. Of the 13 million Americans suffering from this disorder, 80 percent are women. Many sufferers incorrectly believe urinary incontinence is an inevitable part of aging. In fact, 25 percent of women between the ages of 30 and 59 has experienced urinary leakage, according to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Many suffer with Urinary Incontinence in silence, too embarrassed to confide in friends or healthcare professionals. They feel isolated and withdraw from family, friends and social contact. Daily routines focus around immediate access to bathrooms.

A variety of treatment and management options are available in today's market. Adult diapers and sanitary napkins, while protecting against the "accident," are not treating the disorder. Behavioral techniques such as bladder training and Kegel exercises are often viewed as first-line therapies and can be effective in the mild to moderate cases of the disorder. Surgery and medical insert devices can be expensive, may require hospitalization, and are generally seen as options for the most severe cases.

FemmePharma's research has shown that women prefer to explore non-surgical treatment options when given the choice. Today, the market contains effective pharmacologic treatment options for urinary incontinence. However, women are finding that while these medications are effective in treating the incontinence, the drugs can carry significant systemic side effects, such as dry mouth, sensitivity to bright light, blurred vision, dry eyes, nausea, drowsiness and cardiac manifestations.

Delivered locally, FemmePharma's new drug, FP1097, will have high bioavailability within the pelvic region and affect the local bladder receptors. Regional administration should result in lower systemic side effects. This treatment option should be a viable alternative to women who cannot tolerate currently available pharmacologic treatment options.

About FemmePharma, Inc.
FemmePharma was founded by Gerianne Tringali-DiPiano in 1996 to target identifiable unmet needs within the estimated $35 billion women's healthcare pharmaceutical market. The company is preparing for its Phase III trial for its first drug, a new treatment for endometriosis. It is devoted to developing safe and effective drugs that minimize or eliminate unpleasant side effects associated with many medications by designing them in a manner that is specifically suited to a woman's physiology, with an eye toward the changing needs of women throughout their lives. FemmePharma's mission is to create value by developing innovative "woman-friendly" products in identified areas of highly-unmet needs, low market penetration by existing therapeutic options and high commercial and clinical value. The company has a number of drugs in development based on its proprietary technologies, including new therapeutic options for fibrocystic breast disease and the prevention of HIV/STD transmission. For more information about FemmePharma, please visit its website at www.fpghc.com.

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FemmePharma, Inc. Announces New 
Appointment and Promotions
August 25, 2003

WAYNE, Pa…. FemmePharma, Inc., a pharmaceutical company dedicated to treating disorders disproportionately affecting women, is pleased to announce the hiring of Jessica A. Donahue as Director, Clinical Operations for the company.

Ms. Donahue brings a wealth of experience to the FemmePharma team. She has over eight years of experience in clinical research, with expertise in project management, design of investigational plans and implantation and management of clinical studies. She has worked with Advanced Clinical Epidemiological Research, Inc. and Quintiles, Inc., advancing to positions of increasing responsibility and authority in both instances. Most recently Ms. Donahue worked as an independent consultant. As Director, Clinical Operations, she will lead FemmePharma's clinical development from protocol coordination and development through study completion.

Ms. Donahue holds a B.S. from Dickinson College and an M.P.H. from Johns Hopkins University School of Hygiene and Public Health.

FemmePharma is also happy to announce the promotion of two members of its management team.

Peter K. Mays, Ph. D. was promoted to Vice President, Pharmaceutical Development. Dr. Mays has been with the organization for the past year and has led the Phase II pharmaceutical development for FemmePharma's endometriosis product. He has also led the upcoming urinary incontinence and fibrocystic breast disease products through pre-clinical development.

Kim Groff has been promoted to Assistant Vice President, Corporate Communications/Investor Relations. Ms. Groff has led the public relations strategy of the organization, as well as its fund raising efforts. She has been with the organization since 2000.

"The combined skills of these dynamic members of our management team will play an iintegral role in supporting FemmePharma's efforts as we move forward with our product development and product launch plans," emphasized Gerianne Tringali-DiPiano, president of FemmePharma.

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FemmePharma, Inc. Secures Round of Financing
July 7, 2003

WAYNE, PA - FemmePharma, Inc. a women’s prescription pharmaceutical company, recently announced the completion of a round of financing. Wynnefield Capital Advisors, one of FemmePharma’s existing investors, provided the capital. The financing will facilitate clinical development of FemmePharma’s upcoming urinary incontinence product and pharmaceutical development for its fibrocystic breast disease product, as well provide working capital for the organization. Details of the raise were not disclosed.

“FemmePharma is pleased by Wynnefield’s continued support. This recent investment will allow us to accelerate the development of products in our pipeline, ultimately to product launch. We aim to bring valuable products in women’s healthcare to women in need of therapy; we are closer to that objective today,” said Gerianne Tringali DiPiano, President & CEO of FemmePharma. 

Andrea McFadden, a partner at Wynnefield Capital Advisors and a board member of FemmePharma, said, “We continue to be excited about being a part of FemmePharma’s team. Women’s healthcare is an emerging market, and FemmePharma has been especially intelligent in taking a product design approach that is specifically geared to a woman’s physiology. We think they will prove to be uniquely positioned to develop this underserved market.” 

About FemmePharma
FemmePharma was founded by Gerianne Tringali-DiPiano in 1996 to target identifiable unmet needs within the estimated $35 billion women’s healthcare pharmaceutical market. The company is concluding Phase 2 clinical trials for its first drug, a new treatment for endometriosis. It is devoted to developing safe and effective drugs that minimize or eliminate unpleasant side effects associated with many drugs by designing them in a manner that is specifically suited to a woman’s physiology, with an eye toward the changing needs of women throughout their lives. FemmePharma’s mission is to create value by developing innovative “woman-friendly” products in identified areas of high-unmet need, low market penetration by existing therapeutic options and high commercial and clinical value. The company has a number of drugs in development based on its proprietary PARDEL™ technology. 

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FEMMEPHARMA, INC. JOINS CORPORATE ADVISORY BOARD OF THE SOCIETY FOR GYNECOLOGIC INVESTIGATION
June 17, 2003

WAYNE, PA - FemmePharma has recently accepted an invitation to join the Corporate Advisory Board of the Society for Gynecologic Investigation (SGI). The mission of SGI is to establish a scientific basis for gynecology, obstetrics and related disciplines by providing and promoting the following:

  • Leadership and excellence in research;
  • International forums for scientific exchange;
  • Mentoring, career development and education;
  • Advocacy for research in women's health and reproductive science; and
  • Collaboration with academia, government and industry. 

Jerome F. Strauss, III, MD, Ph.D. serves as the President of SGI. He is Associate Chairman of Obstetrics and Gynecology at the University of Pennsylvania and is the Director of the Institute for the Study of Women. He is internationally recognized for his work in reproductive endocrinology and has published extensively in the area of control of the reproductive cycle. 

FemmePharma was formed by Gerianne Tringali-DiPiano in 1996 to target identifiable unmet needs within the estimated $35 billion women's healthcare pharmaceutical market. The company has a number of drugs in development based on its proprietary PARDEL™ technology. The founding of FemmePharma by Tringali-DiPiano followed her extensive experience in key positions with several large women's healthcare pharmaceutical companies. 

For more information on FemmePharma, call Kim Groff at (610) 995-0801 or visit www.fpghc.com.

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LIFE FOR URINARY INCONTINENCE SUFFERERS MAY IMPROVE WITH NEW TREATMENT BEING DEVELOPED BY FEMMEPHARMA, INC.
March 20, 2003

WAYNE – When Royersford, Pa. resident Lori Kline first started noticing the signs of urinary incontinence, she was just 23 years old.

As a college student driving home to work weekends, she began to notice that she stopped more often to use the restroom. Even with those frequent pit stops, she still had to run to the bathroom as soon as she got home. She tried experimenting by not drinking any liquids before her trip, but that didn’t seem to help.

The disorder became more problematic when she began her first job out of college. Because she worked with handicapped people, she could not leave them alone if she needed to use the bathroom. Trying to control her urge caused Lori to tremble and experience abdominal pain. Sometimes, she couldn’t make it to the bathroom in time.

“It’s the most embarrassing when you’re in a work environment,” said Lori. “People don’t understand. Urinary incontinence makes you seem like you don’t have control over your body.”

Even when the doctor prescribed drugs such as Ditropan and Detrol to control the condition, Lori suffered from side effects such as dry mouth and constipation. The dry mouth would make her drink more water, which in turn would lead her to urinate more often. 

So she made a decision to live with the disorder rather than take medicine. Upbeat and optimistic, the vibrant 33-year-old was not about to let her condition stand in the way of her active lifestyle. Now she plans road trips with rest stops in mind and brings a change of clothes with her in case she has an accident. 

“It could be a lot worse. I just have to think ahead,” she said. 

Lori is not alone. Thirteen million Americans suffer from this disorder, and 80 percent of them are women. Many of them suffer in silence, too embarrassed to admit their problem. Some sufferers incorrectly believe urinary incontinence is an inevitable part of aging, but 25 percent of women between the ages of 30 and 59 have experienced urinary leakage, according to the National Institute of Diabetes and Digestive and Kidney Diseases. 

Fortunately for women like Lori, living with urinary incontinence may soon be much easier thanks to FemmePharma, Inc. The Wayne-based pharmaceutical company is exploring a new way to treat urinary incontinence that will help limit the side effects associated with current treatments.

FemmePharma’s treatment differs from others in that it would be delivered locally to the affected area – the local bladder receptors. Because the drug would not have to travel through the entire bloodstream to reach the affected area, fewer side effects would result.

FemmePharma is devoted to developing safe and effective drugs that minimize or eliminate side effects associated with many drugs by designing them in a way to suit the female anatomy. The Wayne-based company was founded in 1996 by Gerianne Tringali DiPiano.

After more than 15 years in the pharmaceutical industry, Tringali DiPiano saw a glaring need for a pharmaceutical company dedicated just to women, and formed FemmePharma to meet that need. She believes that a female-focused pharmaceutical company will allow for unprecedented opportunities to focus on the physiological differences between the sexes and improve the quality of life for women. 

In addition to exploring treatment for urinary incontinence, FemmePharma is also currently investigating a new way to treat endometriosis, a painful condition that affects millions. Similar to the treatment for urinary incontinence, an investigational drug is delivered locally to reduce side effects associated with other types of treatment. Phase II clinical trials are being conducted in the Philadelphia, Cleveland and Chicago areas.

For more information on FemmePharma, call Kim Groff at (610) 995-0801 or visit www.fpghc.com.

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WAYNE PHARMACEUTICAL COMPANY EXPLORES NEW TREATMENT FOR FEMALE URINARY INCONTINENCE
February 7, 2003

WAYNE, PA - New help is on the way for the millions of women who suffer with urinary incontinence.

FemmePharma, a Wayne-based pharmaceutical company, is studying a new treatment option for treating urinary incontinence in women.

Urinary incontinence is defined as the unwanted loss or leakage of urine at an unacceptable place and time. Of the 13 million Americans suffering from this disorder, 80% are women. Many sufferers incorrectly believe urinary incontinence is an inevitable part of aging. In fact, 25% of women between the ages of 30 and 59 has experienced urinary leakage, the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) says. Many suffer with Urinary Incontinence in silence, too embarrassed to confide in friends or healthcare professionals. They feel isolated and withdraw from family, friends and social contact. Daily routines focus around immediate access to bathrooms.

Urinary Incontinence is not just an outcome of childbirth, menopause or aging, although they can be contributing factors. The primary causes for urinary incontinence are:

  • Bladder related; caused by the bladder's failure to store and/or empty; and
  • Sphincter related; caused by poor position of the bladder neck in women, uncoordinated bladder sphincter, sphincter damage or weakness or outlet obstruction.

There are several different types of incontinence which include:

  • Stress incontinence - This loss of urine occurs when pressure is exerted on the bladder through actions such as laughing, coughing, sneezing or exercising. It's estimated that 65 percent of the women with urinary incontinence suffer from this form.
  • Urge incontinence - This loss of urine happens when the urge to urinate is so strong and sudden that the woman is not able to reach the bathroom in time. About 28 percent of the women with urinary incontinence suffer from this form.
  • Overflow incontinence - This loss of urine happens because the woman is not able to completely empty her bladder. This could be due to an obstruction in the bladder or the tube leading from the bladder to the outside of the body. About 7 percent of the women with urinary incontinence suffer from this form.

A variety of treatment and management options are available in today's market. Adult diapers and sanitary napkins, while protecting against the "accident," are not treating the disorder. Behavioral techniques such as bladder training and Kegel exercises are often viewed as first-line therapies and can be effective in the mild to moderate cases of the disorder. Surgery and medical insert devices can be expensive, may require hospitalization and are generally seen as options for the most severe cases.

FemmePharma's research has shown that women prefer to explore non-surgical treatment options when given the choice. Today, the market contains effective pharmacologic treatment options for urinary incontinence. However, women are finding that while these medications are effective in treating the incontinence, the drugs can carry significant systemic side effects, such as dry mouth, sensitivity to bright light, blurred vision, dry eyes, nausea, drowsiness and cardiac manifestations.

Thus, women suffering from incontinence are forced to make a difficult decision - treat the disorder and live with side effects, explore surgical options or live with the disorder untreated.

That is where FemmePharma will be different. Delivered locally, FemmePharma's new drug will have high bioavailability within the pelvic region and affect the local bladder receptors. Regional administration should result in lower systemic side effects. This treatment option should be a viable alternative to women who cannot tolerate currently available pharmacologic treatment options.

FemmePharma is devoted to developing safe and effective drugs that minimize or eliminate side effects associated with many drugs by designing them in a way to suit the female anatomy. Clinical trials to test a new treatment for endometriosis are already under way in the Philadelphia, Chicago and Cleveland areas. Founded in 1996, by Gerianne Tringali DiPiano, the company's long-term vision is to develop products targeting life-cycle management of diseases and disorders that disproportionately affect women.

For more information on FemmePharma's clinical trials, call Kim Groff at (610) 995-0801.

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