Replies to post #202 on Urigen Pharmaceuticals fka URGP

[Apophis]

Clinical Trial Status

Urigen filed an IND in 2005 to initiate a Phase IIb multi-center, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of intravesical alkalinized lidocaine-heparin for the symptoms of pelvic pain and urgency of bladder origin. A Phase I study was not required because the components of URG101 are FDA-approved for other uses. The study enrolled 90 subjects randomized to drug vs. placebo in a 1:1 ratio. The study included a clinically relevant three-week treatment phase to evaluate the safety and efficacy of URG101 for the treatment of pelvic pain and/or urgency of bladder origin. While URG101 did not meet the primary endpoint in the study, the trial provided information necessary to proceed with development of the product. According to press releases issued by Acordia Therapeutics, Inc. in 2004 and 2006, there are other examples of clinical trials not achieving primary endpoints, but there are lessons learned in the study that can lead to success in Phase III trials. The rationale for continued development of URG101 was several-fold: the largest and most experienced clinical trial site met both the primary (70% drug response versus 17% placebo) and secondary endpoints of the study. Additionally, the study achieved a high level of statistical significance on improvement in urgency with just one dose over placebo and trended toward improvement in pain with just one dose. These results indicated that, in a controlled clinical trial, subjects receiving study drug experienced meaningful symptom improvement in both urgency and bladder pain over placebo.

In a subsequent Phase II multi-center, double-blind, randomized, placebo-controlled, cross-over study comparing URG101 to placebo an interim analysis of 21 completed patients demonstrated that URG101 primary and secondary efficacy measurements in the study were significantly better than placebo. Top line data analysis findings 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).

[Apophis]

FDA Meeting

Urigen continues to prepare for the upcoming FDA type C meeting and has made progress in preparing questions and meeting materials. Dan Vickery, PhD, said, "We have crystallized our thinking about the regulatory strategy and pivotal study designs for the URG101 NDA, which we believe can be filed using the 505(b)(2) pathway."

Debt Restructuring

In preparation for the FDA meeting, Urigen has raised additional funding from Platinum-Montaur Life Sciences, LLC who restructured $461K of debt into a Senior Unsecured Promissory Note in the amount of $611K which included a new Senior Unsecured Promissory Note in the amount of $150K.

Management

Urigen is clarifying the press release of July 6, 2010 in which the Company announced that Lowell Parsons, MD, was appointed Chief Medical Officer; Dr. Parsons has never signed an employment agreement with Urigen and is not an officer of the company. While Dr. Parsons acts in the capacity of Chief Medical Officer, Urigen is clarifying that the position is honorary, and he has not been compensated. The board thanks him for his time and effort to move URG-101 forward in development. Going forward, Dr. Parsons intends to enter into a consulting agreement with the company for the provision of research and development services.