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Urigen Announces US Patent Office Notice of Allowance of Claims for URG101

Friday, April 25, 2008

Burlingame, CA -- Urigen Pharmaceuticals, Inc. (OTCBB: URGP), announced that the U.S. Patent and Trademark Office issued a notice of allowance for claims for the first patent application for URG101, an investigational, bladder instillation for the treatment of Painful Bladder Syndrome/Interstitial Cystitis (PBS). These claims broadly cover URG101 and its use in the treatment of PBS by administering a glycosaminoglycan (such as heparin) and a local anesthetic.

Urigen recently closed a Phase II study of URG101 due to positive, statistically significant results at interim analysis with 50 percent patient enrollment. The Phase II study was a multi-center, double-blind, placebo-controlled, crossover designed clinical trial of URG101 in patients with PBS.

Findings from the study included:

  • Primary Endpoint - Improvement in Average Daytime Pain (p=0.03).
  • Secondary Endpoints - Improvement in Daytime Urgency (p=0.03) and Total Symptom Score (p=0.03). In addition, patients reported improved symptom relief with URG101 as measured by PORIS (p=0.01).

Based on these results, Urigen plans to advance the project into late-stage clinical development.

"We are pleased the U.S. Patent Office allowed important patent claims for URG101," said William J. Garner, MD, Urigen’s President and CEO. "They will establish the cornerstone for our intellectual property base to protect URG101 in the commercial marketplace and to increase Urigen’s shareholder value. Additionally, URG101 offers the potential to bring standardization to the treatment of PBS with the first FDA-approved product in a market conservatively estimated at $300-400 million annually in the US."

About URG101

URG101 is a pharmaceutical treatment for Painful Bladder Syndrome/Interstitial Cystitis that is instilled into the bladder. URG101 works with lidocaine, reducing the sensations of pain, urge and muscle spasms, and heparin, a glycosaminoglycan, coating the bladder wall and thus augmenting the natural heparinoids.

About Painful Bladder Syndrome/Interstitial Cystitis (PBS)

Painful Bladder Syndrome/Interstitial Cystitis is a recognized medical condition with increased frequency of diagnosis. PBS/IC is characterized by bladder pain, urinary urgency and nocturia; few IC treatments exist, and no approved therapies are available for PBS. Today, there are an estimated 10.5 million women and men in North America who suffer from PBS/IC.

About Urigen Pharmaceuticals, Inc.

Urigen Pharmaceuticals is a specialty pharmaceutical company dedicated to the development and commercialization of therapeutic products for urological disorders. Urigen's product development programs target significant unmet medical needs and major market opportunities in urology. URG101 targets painful bladder syndrome/interstitial cystitis, which affects approximately 10.5 million men and women in North America. URG301 targets urethritis and acute urgency in patients diagnosed with an overactive bladder. For further information, please visit Urigen's website at

Forward-Looking Statement

This press release may contain forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as "may," "will," "should," "expect," "plan," "anticipate," "believe," "estimate," "predict," "potential" or "continue," the negative of such terms, or other comparable terminology. These statements are only predictions. Although we believe that the expectations reflected in the forward-looking statements are reasonable, such statements should not be regarded as a representation by the Company, or any other person, that such forward-looking statements will be achieved. We undertake no duty to update any of the forward-looking statements, whether as a result of new information, future events, or otherwise. In light of the foregoing, readers are cautioned not to place undue reliance on such forward-looking statements. For further risk factors associated with our Company, please review our SEC filings.

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