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8/11/2010 8:12:25 AM
SAN FRANCISCO, CA--(Marketwire - 08/11/10) - Urigen Pharmaceuticals, Inc. (Pinksheets:URGP - News), a specialty pharmaceutical company focused on the development of treatments for urological disorders and pain, announced it has formally requested a Phase II Type C discussion with the FDA for its URG101 program for Painful Bladder Syndrome/Interstitial Cystitis.
This interaction with the FDA is important for any new applicant regarding the development or review of a new product by the FDA and is expected to occur within 75 days. The Company continues to believe that additional successful double blinded placebo controlled studies may provide sufficient evidence of safety and efficacy to form the clinical basis of an NDA submission.
William J. Garner, MD, CEO of Urigen Pharmaceuticals commented, "As promised we have continued our efforts with the FDA and are pleased to have prepared the Company for this formal request to advance our regulatory requirements." Dr. Garner concluded, "The urgency to meet with the FDA has increased in recent weeks as Pfizer announced it has suspended its recent Tanezumab osteoarthritis clinical trial and related studies, including those associated with Interstitial Cystitis."
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.