Urigen Pharmaceuticals, Inc.
27 Maiden Lane, Suite 595, San Francisco, CA 94108
415 781-0350 www.urigen.com
Safe Harbor Statement Under the Private Securities Litigation Act of 1995 -- With the exception of historical information, the matters discussed herein are forward-looking statements that involve a number of risks and uncertainties. The actual future results of Urigen could differ significantly from those statements. Factors that could cause actual results to differ materially include risks and uncertainties such as the inability to finance the company's operations or expansion, inability to hire and retain qualified personnel, changes in the general economic climate, including rising interest rate and unanticipated events such as terrorist activities. As with any new pharmaceutical product, there are significant risks in development, regulatory approval and commercialization of Urigen’s products. There are no guarantees that future clinical studies will confirm the preliminary results discussed in this document or that URG101 or URG301or any other Urigen product will receive regulatory approval for any medical condition. Further, even if Urigen were to receive regulatory approval for a product, there can be no assurance that such a product would prove to be commercially successful.
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 see the risk factors associated with our Company, please review our SEC filings.
Inventor of URG101
Inventor of Elmiron ®
#1 in license revenue for UCSD
Sole Inventor on patent
The standard of care
About 250 publications
Over 30 years of PBS/IC research
Former Chair of Urology at UCSD, Currently Full Professor
Residency at Penn and Scientific Training at the NIH
M.D., Yale University School of Medicine
Clinical-stage urology products
No new chemical entity (NCE) risk
Substantial markets for unmet medical needs
URG101 - Painful Bladder
Syndrome/Interstitial Cystitis
URG301 - Urethritis, Nocturia
Experienced team
Strong and expanding IP
URG101 –
Painful Bladder
URG301 – Urethritis
Painful Bladder Syndrome/Interstitial Cystitis
1 . Urine Contains Toxins, Electrolytes (Including K + )
Can damage exposed urothelium & activate nerves
2. Mucin Protects Urothelium
Loss of sulfated polysaccharide mucin layer results in damage to urothelium and loss of protection to bladder detrusor and nerves
3. Muscle Tissue
– Effects Urination
Detrusor muscle spasms. Frequent urination
4. Sensory Neurons – Monitor Bladder Status
Pain, urinary urgency and muscle spasms occur via electrolytes and toxins
Urigen Pharmaceuticals, Inc.
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PBS/IC often misdiagnosed as other disorders e.g. OAB, UTIs, endometriosis, prostatitis
Overactive Bladder (OAB) - US Market ~17-33M
Urinary Tract Infections (UTI) - 8M visits annually
Endometriosis – US Women ~5.5M
Significant Growth Prospects in an Underserved Market
*Wu et al.,(2006) A retrospective claims database analysis to assess patterns of interstitial cystitis diagnosis
Allergan AGN203818
NIDDK/Roche Cellcept
®
MediciNova MN001
Astellas IPD1151D
Pfizer PF04383119
Pfizer PD0299685
Plethora PSD597
Suspended in Phase II
Terminated
Suspended in Phase II/III
Phase II US & EU
Phase II US – injectable anti-NGF Ab
Phase II US – oral (pregabalin)
Phase II US – instilled anesthetic only
Urigen Pharmaceuticals, Inc.
Lidocaine and heparin
Product Advantages
Rapid Pain Relief
Easily assimilated into office practice
Existing CPT Reimbursement
Code
Generation of significant extra income for Urologists and Gynecologists
URG101 Double blind, placebo-controlled Phase II Study in
Painful Bladder Syndrome/Interstitial Cystitis
All End Points hit statistical significance
Key Patent Issued 2008 (US Patent Protection to 2026)
Extensive Safety Data
Existing CPT Reimbursement Code
Life Science Strategy Group surveyed urologists and payors
Urologists “Very Likely” to prescribe URG101 for:
PBS/IC Flares
“Diagnostic” – Determines that Pain is from Bladder with first treatment
Rapid adoption of URG101 expected within 7 months
Payors Interviewed view URG101 favorably and will reimburse 100%
Normal Bladder PBS/IC Bladder with visible damage
Bladder Pain with Urgency &
Frequency
Urine leaks through bladder wall triggering pain & urgency
No marketed product available for breakthrough symptoms
~10.5M US & Canada
PBS/IC Market Poised For Growth
’09 RAND Interstitial Cystitis Epidemiology study prevalence ~3-8M US women with IC
<50,000 Elmiron ® scripts, but growing
Last drug approved in 1997
URG101 Comparison to Market Leader
Elmiron
®
(J&J)
3-6 Months for Effect
Three times per day
Oral capsules
Artificial heparinoid
URG101
Effect within Minutes
Two/three per Flare
Instillation (MD Revenue)
Heparin-lidocaine formulation
URG101 for Painful Bladder Syndrome
Completed Positive Phase II study
Filed for FDA Meeting on April 22, 2010
~$10M - $12M cost to NDA filing
Existing reimbursement code (CPT)
Peak sales est. $500M*
US Patent protection to 2026
*
Life Science Strategy Group
URG101-104
% Change in Pain over Time
0
-10
-20
50%
-30
-40
11%
-50
0 1 2 3 4 5 6 7 8 9 10 11 12
Time (hours) n = 18
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Endpoint
Primary Endpoint
Symptom P Value
% Improvement Ave Daytime Pain
Secondary Endpoints
PORIS Question 3 (0.5hr)
% Improvement Ave Daytime Urge
% Improvement Ave Total Symptom
Score
Pain 0.036
Pain/Urgency 0.014
Urgency 0.033
Pain/Urgency 0.032
Many patients experienced > 24hr symptom relief following only one dose.
Significant reduction of daytime symptoms
Many patients experienced fewer night time voiding episodes.
1. Patent licensed from UCSD
U.S. Patent 7,414,039 covering the use of the composition of a local anesthetic, heparinoid and buffer for the treatment of symptoms of interstitial cystitis
Coverage to 2026
2. Urigen patent application
Improved compositions for treatments
Pending in US, EU, other jurisdictions
URG301: buffered lidocaine urethral suppository
Occupies ~ 65% of the female urethra
Melts promptly upon insertion
Distributes the drug to the urethral and bladder tissues
Achieves rapid anesthetic effect
Calms pain and urgency
Two issued patents
URG301
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Unsatisfied Market
Afflicts at least 16 million American women*
Under-reported, under-treated
4 million ‘drop outs’ in 2006: 90% at 11 months**
Characterized By:
Relentless urge and frequency to ‘go’
Reduced social mobility/sleep interruption
Current Medications
Reduce frequency by ‘one’ event in 24 hours
Significant frequency of bothersome side effects
None provide sleep or social relief
*Mayo Clin Proc 2001; 76:358-363; **IMS 2006 Prescription Data
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Healthy Volunteers
Pain scale endpoints
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C. Lowell Parsons, MD – Inventor of URG101 & Elmiron ®
($170M Urology Drug)
Michael M. Goldberg, MD – Platinum-Montaur Life Sciences,
LLC
William J. Garner, MD – President & CEO
Martin E. Shmagin – Chief Financial Officer
Edward R. Teitel, MD,JD,MBA – CEO, ThromboVision, Inc.
Dan B. Vickery, Ph.D. – President, BioEnsemble, Ltd.
Robert J. Watkins, RJ Watkins & Company – ex-J&J
$450,000,000
$400,000,000
$350,000,000
$300,000,000
Gynecologists
Urologists
$250,000,000
$200,000,000
$150,000,000
$100,000,000
$50,000,000
$0
Year 1 Year 2 Year 3 Year 4 Year 5 Year 6 Year 7
Gynecologists $74,846,247 $129,933,666 $181,207,059 $233,056,318 $281,274,121 $355,551,551 $425,980,304
Urologists $28,523,398 $42,211,465 $54,830,598 $67,465,033 $79,035,930 $98,468,800 $117,004,847
Urigen Pharmaceuticals, Inc.
Source: Physician interviews; Navigant Consulting, Inc. 2006
OTC BB: URGP
151,535 Average Daily Volume
$0.19 52 week high
$0.05 52 week low
$12.96M Market Cap
*88,733,194 common shares outstanding
210 convertible preferred shares outstanding that convert to 21,000,000 common shares
17,260,790 warrants that convert at $0.125
5,524,410 convertible preferred shares outstanding that convert to
5,529,410
33.19% Insider ownership
*Includes 2.5M to be issued
Urigen Pharmaceuticals, Inc.
URG101 FDA meeting filed April 22, 2010 (Phase
II met all endpoints)
Strengthen Balance Sheet For Tier 1 Partnerships
URG301 Phase I Tolerability Study
Urigen Pharmaceuticals, Inc.
27 Maiden Lane, #595, San Francisco, CA 94108
(415) 781-0350 www.urigen.com
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