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.3 percent of pregnant women ages 15 to 44 used an illicit drug in the
past month compared to 10.8
percent ).

SAMHSA, a public health agency within the U.

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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.6 percent) than pregnant women ages 26 to 44 (10.
Information on fetal alcohol syndrome is available at
http://fascenter.

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"These health ramifications are
preventable .4 percent of non pregnant women in this age group.gov.

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Two other
promising anti-HIV product candidates with different modes of action are also
in the Biosyn pipeline. 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.
Pregnant women ages 15 to 25 were more likely to have used an illicit drug
(8.

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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 . WASHINGTON, Over four percent of pregnant women
ages 15 to 44 used illicit drugs during the past month, according to new data
released today by the Substance Abuse and Mental Health Services
Administration (SAMHSA).

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0 percent) than those ages 26 to 44 (1.samhsa.

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A similar formulation of Rectogesic is
currently being sold in Australia, New Zealand and South Korea.

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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.oas.

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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.

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Savvy is a contraceptive gel for use by women to protect against the
possible contraction of HIV/AIDS. Cellegesic, for the treatment of anal fissures, was
the subject of an FDA Not Approvable letter in December 2004.

This press release contains forward-looking statements.

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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.

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SOUTH SAN FRANCISCO, Calif . Over 1,500 women have enrolled in the trial which first
commenced enrollment in March 2004. The trials are placebo controlled
double blind studies that compare Savvy with a placebo gel in women using the
gels for 12 months.

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, Cellegy
Pharmaceuticals, Inc. (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. 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.

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.

Over Four Percent of Pregnant Women Used Illicit Drugs in Past Month

The data show that pregnant women ages 15 to 25 were
more likely to use illicit drugs than pregnant women ages 26 to 44."
The report, "Substance Use During Pregnancy: 2002 and 2003 Update," found
that 4.7 percent) than pregnant women (18 percent).
The report is available on the web at http://www.

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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.
SAMHSA extracted the data from the National Surveys on Drug Use and
Health, 2002 and 2003.1 percent reported binge alcohol use; and less than
one percent reported heavy alcohol use (five or more drinks on one occasion
five or more times in a month).

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Women in both groups are strongly cautioned on safe sex
practices and encouraged to have their partners use condoms.

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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. These data also show that over four percent of
pregnant women reported binge alcohol use and 18 percent reported smoking
cigarettes.
"We know that substance use by pregnant women is a leading cause of
mental, physical and psychological problems in infants and children," SAMHSA
Administrator Charles Curie noted.

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ProStrakan will also distribute Tostrex in
the European Union .



Among pregnant women ages 15 to 44, 9.

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SAMHSA is working to get the word out that women who are pregnant
or plan to become pregnant should not use illicit drugs, alcohol or
cigarettes .8 percent reported drinking alcohol
during the past month; 4. The data suggest that women ages 15 to 44 increased their
substance use during the year after giving birth, but not to the level of non
pregnant women who were not recent mothers.

Sites relating to physical and mental health, disabilities and diseases which affect women.

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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. Binge alcohol use is defined as drinking five or more drinks on
the same occasion on at least one day in the past month.

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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. Cigarette use was higher among non pregnant
women ages 15 to 44 (30.
Substance use rates were lower for recent mothers than for women who were
not recent mothers.
S.

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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.6 percent).

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Cellegy's Biosyn subsidiary is conducting two Phase 3 HIV prevention
trials in Africa (Ghana and Nigeria). Launch of Rectogesic in the United
Kingdom through ProStrakan Group Limited, Cellegy's corporate partner, is
expected in the first half of 2005. Pregnant
women ages 15 to 25 were more than twice as likely to have smoked cigarettes
during the past month (27.


sexually affect

Cellegy Announces 50% Enrollment in Phase 3 HIV Prevention Trial in Ghana

This is a significant
milestone reflecting the rapid accrual of a large number of trial
participants. Approvals of Rectogesic and Tostrex by the other member
states of the European Union will be sought through the Mutual Recognition
Procedure.samhsa.

affect obstacles


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. 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.gov or by calling SAMHSA's clearinghouse at 1-800-729-
6686. Department of Health and
Human Services, is the lead federal agency for improving the quality and
availability of substance abuse prevention, addiction treatment and mental
health services in the United States .

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