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
"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, 415-781-0350
Chief Executive Officer