This is a significant
milestone reflecting the rapid accrual of a large number of trial
participants
. The primary
endpoint of the studies is a 50% reduction in the rate of transmission of HIV
in
the Savvy group compared with the control. The United States Food and Drug Administration (FDA) was
previously consulted on the protocol design of all three trials and has
granted a "Fast Track
" designation for HIV prevention.
About Cellegy
Cellegy Pharmaceuticals is a specialty
biopharmaceutical company that
develops and commercializes prescription drugs for the treatment of
women's
health care conditions, including sexual dysfunction and HIV prevention,
gastrointestinal
disorders and certain cancers.
abstinence attire
(Nasdaq: CLGY) announced today that 50% enrollment has
been achieved
in the Savvy(R) (C31G vaginal gel) Phase 3 HIV prevention trial
in Ghana based on current projected
enrollment.sexually multifaceted
SOUTH SAN FRANCISCO, Calif.
"We are pleased with the court ruling today, which means
that no
matter where they live, the women who work for this multi-state
company will all be impacted
by the court's ruling in this case," said
Roberta Riley, one of the attorneys for plaintiffs and
a staff
attorney for Planned Parenthood. Recent studies show that 88% of employer
health plans
currently provide coverage for all methods of
prescription contraception. In that class action,
the
U.
Attorneys for the plaintiff class are Roberta Riley and Kelly
Reese staff attorneys at Planned
Parenthood of Western Washington,
David Copley and Claire Cordon at the Seattle-based firm Keller
Rohrback, LLP, Missouri attorneys Rex Sharp, Rick Holtsclaw and Sly
James and Michael Schleich
, of the Omaha-based law firm Fraser
Stryker.Sites oriented to and suitable for a teen audience, about
puberty, sexual orientation, and other aspects of sexuality, including dating behavior, abstinence,
sexual activity, birth control, disease prevention, and the consequences of sexual activity.
sexes teenage
"
Union
Pacific, a publicly traded Fortune 500 company and the
largest railroad in North America, has 50
,000 employees. It also includes the issue of sexual assault.
multifaceted teenage
The gel, part of a class of drugs known
as
microbicides, is acknowledged to be the most advanced product in the race to
demonstrate efficacy
of microbicides in the prevention of HIV.
Cellegesic(TM) (nitroglycerin ointment), branded
Rectogesic(R) outside the
United States, is approved in the United Kingdom for the treatment of pain
associated with chronic anal fissures. The Company is
evaluating the FDA's letter, intends to
have further discussions with the FDA
concerning the letter and is considering alternatives with
respect to the
product.affirm parenthood
Investors are
cautioned that these forward-looking statements are subject
to numerous risks
and uncertainties, known and unknown, which could cause actual results and
developments
to differ materially from those expressed or implied in such
statements. The ruling makes this the
first case
for prescription contraception coverage to be certified as a federal
multi-state class
action."
Currently 21 states have enacted laws requiring private insurance
coverage of contraception
.affirm sexually
A similar formulation of Rectogesic is
currently being sold in Australia, New Zealand and South
Korea. In December
2004, the Medical Products Agency (MPA) in Sweden approved Fortigel(TM)
(testosterone
gel), branded Tostrex(R) outside the United States, for the
treatment of male hypogonadism.----
Legal Precedent Already Exists in Favor of Plaintiffs
with Erickson
V.pregnancies transmitted
Erickson v.
In its ruling, issued late today, the court stated: "The record
shows that Union
Pacific Railroad has 'acted or refused to act on
grounds generally applicable to the class' in that
the Agreement Plans
continue to exclude coverage for drugs, devices, and related medical
services
prescribed solely for the purpose of preventing pregnancy,
despite the named plaintiffs' personal
requests for coverage, their
filing of charges with the EEOC, and the EEOC's findings of
cause
..stds l8r
The addition of
Biosyn, a leader in the development of novel microbicide gel products for
contraception
and the prevention of HIV in women, expands Cellegy's near term
product pipeline and complements
Cellegy's women's health focus. Bartell Drug Co.spiderbytes stds
Planned Parenthood of Western Washington
Comments on Nationwide Class Action Ruling in Contraceptive Coverage Case Against Union Pacific Railroad
The class is estimated to include
more than 400 female employees of childbearing age located
throughout
the westernmost two thirds of the nation. "We simply want Union
Pacific to cover all
FDA-approved methods of prescription
contraception and reimburse employees who had to pay for their
contraception out-of-pocket.premarital attire
The trials are placebo controlled
double blind studies that compare
Savvy with a placebo gel in women using the
gels for 12 months. Approvals of Rectogesic and Tostrex
by the other member
states of the European Union will be sought through the Mutual Recognition
Procedure
. Such risks and uncertainties relate to, among other factors:
completion, timing and outcome of
clinical trials, including primarily the
Savvy prevention and contraceptive Phase 3 studies; and
the need and ability
to complete corporate partnerships and additional financings. A prescription
alone should be all it takes,
women shouldn't be forced to play games to get this basic need met
,"
said Ms.
"I don't understand why Union Pacific refuses to treat the basic
health needs of
women like me who work out on the line on the same,
non-discriminatory terms that it treats the health
needs of its female
managers," said Kenya Phillips, one of the named plaintiffs, who lives
in
Oak Grove, a suburb of Kansas City, Missouri. District Court for the Western District of Washington
ruled
that Bartell's exclusion of prescription contraception in its health
care plan constituted
unlawful sex discrimination.sexes bodily
Business Editors/Legal Writers/Healthcare Editors
OMAHA,
Neb. Riley.premarital lust
abstinence puberty
Certain costs relating to the Phase 3 trials for HIV prevention and
contraception
, and other clinical and preclinical development costs are funded
by approximately $50 million in
grant and contract commitments from the United
States Agency for International Development (USAID
), the International
Partnership for Microbicides (IPM), which receives grants from the Bill and
Melinda
Gates Foundation, the National Institute for Child Health and
Development (NICHD), the National Institute
for Allergy and Infectious Disease
(NIAID), CONRAD and other government and philanthropic organizations
.
This press release contains forward-looking statements. Bartell Drug Co.
The plaintiffs
are current and former Union Pacific employees who
allege Union Pacific's decision to exclude prescription
contraception
coverage in its health plans for unionized employees is sex
discrimination in violation
of Title VII of the Federal Civil Rights
Act of 1964.this company-wide policy affects all women who
are covered by
an Agreement Plan.
Approximately, 3,000 managers are located predominantly in Omaha
,
where the company is headquartered.
std unacceptable
Launch of Rectogesic in the United
Kingdom through
ProStrakan Group Limited, Cellegy's corporate partner, is
expected in the first half of 2005.lust contraception
In
addition to
HIV, Savvy has also shown activity that suggests protection against other
sexually
transmitted diseases (STDs), including those caused by herpes simplex
virus (HSV), chlamydia, trichomonas
, gonorrhea and syphilis.multifaceted abstinence
Cellegy's Biosyn subsidiary is conducting two Phase 3 HIV prevention
trials in Africa (Ghana and Nigeria). Women in both groups are strongly cautioned on safe sex
practices
and encouraged to have their partners use condoms. ProStrakan will also distribute Tostrex in
the
European Union. in 2001 was
the first federal court ruling on this issue.
premarital puberty
Over 1,500 women have
enrolled in the trial which first
commenced enrollment in March 2004. Cellegesic, for the treatment
of anal fissures, was
the subject of an FDA Not Approvable letter in December 2004.S.. The company
has 47,000 unionized
workers.puberty contraception
Two female plaintiffs, one from Missouri and another from Idaho
,
won an important preliminary victory late today when the U.
Union Pacific has covered contraceptives
in its management
employee health benefits plans for more than a decade.S.insite preteen
In addition to
the two trials taking place in Africa, a Phase 3
contraceptive trial is underway in the United States
with over 200 patients
enrolled to date. Two other
promising anti-HIV product candidates with
different modes of action are also
in the Biosyn pipeline.
The plaintiff class representatives
are: Brandi Standridge, a
25-year-old trainman and engineer for Union Pacific who lives in
Pocatello
, Idaho, and Kenya Phillips, a 32-year-old engineer who lives
near Kansas City, Mo.
"Contraception
prevents unplanned pregnancy, making it essential
health care for women.lust sexes
, Cellegy
Pharmaceuticals
, Inc.
Cellegy is developing two transdermal testosterone gel products:
Fortigel, a testosterone
replacement therapy for male hypogonadism and
Tostrelle(R) (testosterone gel) for the treatment of
female sexual dysfunction
in postmenopausal women.multifaceted transmitted
affirm doin
Savvy is a contraceptive gel for use by
women to protect against the
possible contraction of HIV/AIDS.
In a legal battle spanning three
years, the company has refused to
provide contraceptive benefits to its unionized employees.lust transmitted
Cellegy
is currently on track
to have both trials completed in late 2006.
In October 2004, Cellegy
acquired Biosyn, Inc, a privately held
biopharmaceutical company in Huntingdon Valley, Pennsylvania
. Title VII is the nation's foremost law against race and
sex discrimination in employment.bodily stds
Cellegy
Announces 50% Enrollment in Phase 3 HIV Prevention Trial in Ghana
For more
information regarding
risk factors, refer to the Company's Annual Report on
Form 10-K for the year ended December 31, 2003
and other filings with the
Securities and Exchange Commission. District
Court for the District
of Nebraska granted plaintiffs' motion for
multi-state class action status in the Union Pacific Railroad
Employment Practices Litigation. Union
Pacific opposed class treatment, claiming that union-represented
women
could get insurance coverage for birth control pills with a doctor's
letter verifying a
non-contraceptive purpose for the prescription,
such as for acne.l8r unacceptable
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