BURLINGAME, Calif.--(Business Wire)--
Urigen Pharmaceuticals, Inc. (OTCBB: URGP), http://www.urigen.com
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
http://www.urigen.com.
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.
Urigen Pharmaceuticals, Inc.
Martin E. Shmagin, 650-259-0239
Chief Financial Officer
www.urigen.com
or
Redington, Inc.
Thomas Redington, 203-222-7399 or 212-926-1733
www.redingtoninc.com
Copyright Business Wire 2008
