Urigen specializes in the design and implementation of innovative products for patients with urological ailments including, specifically, the development of innovative products for amelioration of Painful Bladder Syndrome (PBS), Urethritis, Nocturia and Over Active Bladder (OAB).

Urology represents a specialty pharmaceutical market of approximately 12,000 physicians in North America. Urologists treat a variety of ailments of the urinary tract including urinary tract infections, bladder cancer, overactive bladder, urgency and incontinence and interstitial cystitis, a subset of PBS. Many of these indications represent significant, underserved therapeutic market opportunities.

Over the next several years a number of key demographic and technological factors should accelerate growth in the market for medical therapies to treat urological disorders, particularly in our product categories. These factors include the following:

• Aging population. The incidence of urological disorders increases with age. The over-40 age group in the United States is growing almost twice as fast as the overall population. Accordingly, the number of individuals developing urological disorders is expected to increase significantly as the population ages and as life expectancies continue to rise.
• Increased consumer awareness. In recent years, the publicity associated with new technological advances and new drug therapies has increased the number of patients visiting their urologists to seek treatment for urological disorders.

C. Lowell Parsons, M.D., a director and Chief Medical Officer of Urigen, is a leader in medical research into the causes and treatment of interstitial cystitis, which is a painful bladder syndrome with typical cystoscopic and/or histological features in the absence of infection or other pathology, and has published over 200 scientific articles and book chapters in this area describing his work. Dr. Parsons received his M.D. degree from the Yale University School of Medicine in New Haven, CT, in 1970. After completing his medical internship at Yale in 1971, Dr. Parsons spent two years as a staff associate in the Laboratory of Microbiology at the National Institutes of Health in Bethesda, Maryland. He then completed his urology residency training at the Hospital of the University of Pennsylvania in Philadelphia, Pennsylvania, in 1977. Dr. Parsons joined the Division of Urology faculty at the University of California, San Diego, or UCSD, in 1977 as assistant professor. He served as Chief of Urology at the UCSD-affiliated Veterans Affairs Medical Center in La Jolla from 1977 to 1985. Since 1988, he has been Professor of Surgery/Urology.

Edward R. Teitel, M.D., J.D., M.B.A. currently serves as the President and Chief Executive Officer of ThromboVision, Inc. Prior to founding ThromboVision in 2005, Dr. Teitel served as Senior Vice President and Chief Medical Officer at MicroMed Technology, Inc. (now MicroMed Cardiovascular, Inc.). As a part of senior management at MicroMed, Dr. Teitel participated in all aspects of clinical trials and regulatory matters, business scope and fund raising activities, as well as legal matters. As chief medical officer for the DeBakey Left Ventricular Assist Device at MicroMed, Dr. Teitel acquired extensive experience in platelet function and anti-platelet therapy, especially relating to artificial surface devices.

Jeffrey G. Proctor, M.D., is Chairman of Urigen's Scientific Advisory Board. Dr. Proctor is Director of Interstitial Cystitis at GA Urology, PA in Riverdale, Georgia where he has practiced since November 1997. Dr. Proctor completed his Doctor of Medicine and his Residency in Urology at New York Medical College, Westchester County Medical Center, Valhalla, New York. Dr. Proctor's areas of urologic expertise are Interstitial Cystitis, Overactive Bladder, and Interstim Therapy. Dr. Proctor served as Lieutenant Commander in the Navy at the Naval Hospital Pensacola, where he served as Chief of Urology. Dr. Proctor is board-certified by the American Board of Urology and is a member of American Urological Association, Southeastern Section American Urological Association, Society of Infections and Inflammation in Urology and GAG Society.

C. Lowell Parsons, M.D., a director and Chief Medical Officer of Urigen, is a leader in medical research into the causes and treatment of interstitial cystitis, which is a painful bladder syndrome with typical cystoscopic and/or histological features in the absence of infection or other pathology, and has published over 200 scientific articles and book chapters in this area describing his work. Dr. Parsons received his M.D. degree from the Yale University School of Medicine in New Haven, CT, in 1970. After completing his medical internship at Yale in 1971, Dr. Parsons spent two years as a staff associate in the Laboratory of Microbiology at the National Institutes of Health in Bethesda, Maryland. He then completed his urology residency training at the Hospital of the University of Pennsylvania in Philadelphia, Pennsylvania, in 1977. Dr. Parsons joined the Division of Urology faculty at the University of California, San Diego, or UCSD, in 1977 as assistant professor. He served as Chief of Urology at the UCSD-affiliated Veterans Affairs Medical Center in La Jolla from 1977 to 1985. Since 1988, he has been Professor of Surgery/Urology.

Research and Development

Market Opportunity for Treatment of PBS

Presently, no approved products exist for treating painful bladder syndrome and those that have been approved for interstitial cystitis, a subset of PBS, are based on clinical studies which have shown the drugs to be marginally effective. Consequently, there remains a significant need for new therapeutic interventions such as URG101 that can address the underlying disease process while also providing acute symptom relief. PBS is a chronic disease characterized by moderate to severe pelvic pain, urgency, urinary frequency, dyspareunia (painful intercourse) with symptoms originating from the bladder. Current epidemiology data shows that PBS may be much more prevalent than previously thought.

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.

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).

Market Opportunity for Treatment of Radiation Cystitis

Urigen estimates that the incidence of radiation cystitis in the United States is more than 34,000 cases per year. Although the symptoms of radiation cystitis are similar to those of interstitial cystitis, they can be differentiated based on medical history. In fact, clinical studies of products in development for interstitial cystitis typically exclude patients suffering from radiation cystitis. Currently, there are no approved treatments of these symptoms that are caused by pelvic irradiation.

Clinical Trial Status

Clinical experience with URG101 has demonstrated benefit in interstitial cystitis patients with a similar constellation of symptoms to Radiation Cystitis. Based on these observations, Urigen has expanded its IND to include the evaluation of URG101 in a Phase II multi-center, randomized, double-blind, placebo-controlled crossover to open-label study to evaluate the safety and efficacy of URG101 in patients exhibiting symptoms of pelvic pain of bladder origin secondary to pelvic irradiation.

Market Opportunity for Treatment of Dyspareunia

Dyspareunia is sexual dysfunction manifested as painful or difficult sexual intercourse. The disorder is recurrent and associated with a disruption of normal functioning. Dyspareunia is most frequently in females; however, incidence has also been reported among males.

Clinical Trial Status

An unpublished clinical study demonstrates that administration of URG101 relieves symptoms of dyspareunia in women suffering from the disorder. Based on these anecdotal results, Urigen is collaborating with a leading academic center to explore the potential of URG101 to effectively treat women diagnosed with dyspareunia.

Dan Vickery
Phone: +1.925.280.2861
Fax: +1.925.280.2861 Email: dan@urigen.com

Urigen is seeking development partners for URG1101 in the EU, Japan, Latin America and Asia. For the US Urigen is seeking strategic partnerships and development funding.

May 29-Jun 3 2010 - San Francisco, California Urigen will be attending the American Urological Association (AUA) 2010 Annual Meeting Click here.

Corporate Office

Urigen Pharmaceuticals, Inc.
1700 North Broadway, Suite 330
Walnut Creek, CA 94596
USA
Phone: +1.925.280.2861
Fax: +1.925.280.2861
info@urigen.com

Anyone with a concern regarding accounting, internal accounting controls, or auditing matters may send an anonymous and confidential letter to the following address:

The Audit Committee of the Board of Directors
Urigen Pharmaceuticals, Inc.
1700 North Broadway, Suite 330
Walnut Creek, CA 94596

  

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Share Structure

Market Value1	$1,634,514	a/o Aug 17, 2011
Shares Outstanding	11,930,756	a/o Jun 28, 2011
Float	4,472,370	a/o Jun 28, 2011
Authorized Shares	25,000,000	a/o Jun 28, 2011
Par Value	0.001

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