Urigen Files Request for FDA Meeting
SAN FRANCISCO, Apr 23, 2010 (BUSINESS WIRE) --Urigen Pharmaceuticals, Inc. (OTCBB:URGP), a specialty pharmaceutical company focused on the development of treatments for urological disorders and pain, announced today that it has filed a request for an FDA meeting to advance the URG101 clinical program and mutually agreed with Oceana Therapeutics, Inc. to terminate their Consulting Agreement effective immediately.
"Urigen's request to meet with the US Food and Drug Administration was filed yesterday. We look forward to working with the FDA as we move our URG101 program forward for Painful Bladder Syndrome/Interstitial Cystitis," said William J. Garner, MD, CEO.
"Ending our contractual obligation to Oceana enables us to pursue several additional commercial opportunities in the US and the EU more aggressively," stated, Edward R. Teitel, MD, JD, Chairman of Urigen.
Prof. Lowell Parsons, MD said, "After 30 years, in my opinion, from my clinical experience with URG101, it is the most significant advance in treating interstitial cystitis/painful bladder syndrome that has yet been developed and will greatly improve the quality of patients' lives."
URG101 is a patent-protected, regional therapy for Painful Bladder Syndrome/Interstitial Cystitis which afflicts millions of women and men. Urigen has previously announced positive results from a Phase 2 study of URG101. The study was a multi-center, double-blind, placebo-controlled, crossover trial. 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).
About Urigen Pharmaceuticals, Inc.
Urigen Pharmaceuticals, Inc. is a specialty pharmaceutical company dedicated to the development and commercialization of therapeutic products for urological disorders. Urigen's two lead programs target significant unmet medical needs and major market opportunities in urology. Urigen's URG101, a proprietary combination of approved drugs that is instilled into the bladder, targets painful bladder syndrome, which affects approximately 10.5 million men and women in North America. Urigen's URG301, a proprietary dosage form of an approved drug that is locally delivered to control urinary urgency, targets acute urgency in females diagnosed with an overactive bladder, another major unmet need that is insufficiently managed by presently available overactive bladder drugs. For further information, please visit Urigen's website at http://www.urigen.com.
This press release may contain forward-looking statements. These statements may be identified by the use of forward-looking terminology such as "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "might," "plan," "potential," "predict," "should," or "will," or the negative thereof or other variations thereon or comparable terminology. Urigen has based these forward-looking statements on current expectations, assumptions, estimates and projections. While Urigen believes that these expectations, assumptions, estimates and projections are reasonable, such forward-looking statements are only predictions and involve known and unknown risks and uncertainties, many of which are beyond its control. Given these risks and uncertainties, investors and security holders are cautioned not to place undue reliance on such forward-looking statements. Urigen does not undertake any obligation to update any such statements or to publicly announce the results of any revisions to any such statements to reflect future events or developments.
SOURCE: Urigen Pharmaceuticals, Inc.
Urigen Pharmaceuticals, Inc.William J. Garner, MD, 415-781-0350Chief Executive Officerhttp://www.urigen.com