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2013

Cellegy Issued Patent for Treatment of Female Sexual Dysfunction

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    SOUTH SAN FRANCISCO, Calif., Aug. 28 /PRNewswire-FirstCall/ -- Cellegy
 Pharmaceuticals, Inc. (Nasdaq:   CLGY) announced today that the United States
 Patent and Trademark Office (USPTO) has issued patent number 6,610,652
 entitled "Microdose Therapy."
     This patent delineates methods of treating urogenital disorders in
 females, using a nitric oxide (NO) donor or a phosphodiesterase (PDE)
 inhibitor. Such urogenital disorders include pain during intercourse
 (dyspareunia), decreased vaginal lubrication, and decreased vaginal
 engorgement. Commonly known NO donor compounds include nitroglycerin and
 sodium nitroprusside; PDE inhibitors include sildenafil (Viagra(TM), Pfizer),
 vardenafil (Levitra(TM), Bayer) and tadalafil (Cialis(TM), Lilly/ICOS). This
 patent increases the Company's intellectual property portfolio to 5 issued
 United States patents and over 20 pending United States and foreign patent
 applications for the treatment of urogenital disorders and female sexual
 dysfunctions using NO donors and related compounds.
     Dyspareunia is characterized by difficult or painful sexual intercourse
 afflicting approximately 5 million women in the United States.  Treating
 dyspareunia with a nitric oxide donor could potentially provide significant
 benefits to patients who are poorly served by currently available treatments,
 such as lubricants.  The utility of nitroglycerin ointment in the treatment of
 vaginal pain was previously demonstrated in a pilot study conducted by Dr.
 Jennifer Berman at UCLA Medical Center.
     "Cellegy is pleased to add this issued patent to the Company's expanding
 intellectual property portfolio for the treatment of urogenital disorders and
 female sexual dysfunctions using nitric oxide donor compounds," said David A.
 Karlin, M.D., Cellegy's Vice President, Clinical Development.  "We plan to
 initiate a confirmatory dose ranging clinical study using nitroglycerin for
 the treatment of dyspareunia before the end of this year."
 
     Cellegy Pharmaceuticals is a specialty biopharmaceutical company engaged
 in the development and marketing of prescription drugs for the treatment of
 gastroenterology disorders, sexual dysfunction in men and women, and the use
 of nitric oxide donors for the treatment of certain cancers. The Company is
 progressing a Phase 3 clinical study for Cellegesic(TM)(nitroglycerin
 ointment) for the treatment of chronic anal fissure pain.  It is also
 developing Cellegesic for hemorrhoids and dyspareunia.
 Tostrelle(TM)(testosterone gel) 0.5%, is undergoing a Phase 2 clinical trial
 for the treatment of sexual dysfunction (decline in libido) in women.  Cellegy
 currently is assessing what additional data will be required by the FDA in
 order to gain approval of Fortigel(TM)(testosterone gel) 2.0 for the treatment
 of male hypogonadism.  Other nitric oxide donor products in early stage
 development include treatments for prostate cancer, Raynaud's Disease,
 Restless Leg Syndrome and erectile dysfunction.
 
     This press release contains forward-looking statements.  Actual results,
 particularly with regard to the outcome of clinical trials and discussions
 with regulatory authorities, may differ materially from those discussed above.
 There can be no assurance that the Company's issued patents will provide
 commercial protection against competitive products or technologies.  For more
 information regarding risk factors, refer to the Company's Annual Report on
 Form 10-K for the year ended December 31, 2002.
 
 

SOURCE Cellegy Pharmaceuticals, Inc.

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