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.femmepharmainc.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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Top
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.femmepharmainc.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.femmepharmainc.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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