URG101 – Substantial Market & Paradigm Shift in Diagnosis

advertisement

Corporate Presentation

April 23, 2010

URGP.OB

Urigen Pharmaceuticals, Inc.

27 Maiden Lane, Suite 595, San Francisco, CA 94108

415 781-0350 www.urigen.com

Forward-Looking

Statement

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.

Lowell Parsons, MD

 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

Urigen - a Specialty

Urology Company

 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.

5

URG101 – Substantial

Market & Paradigm Shift in

Diagnosis & Therapy of

PBS/IC

 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

PBS/IC Market Gaining

Pharma Attention

Trial

Allergan AGN203818

NIDDK/Roche Cellcept

®

MediciNova MN001

Astellas IPD1151D

Pfizer PF04383119

Pfizer PD0299685

Plethora PSD597

Status

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.

URG101 Product for the

Treatment of PBS/IC

 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

Investor Attributes

 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

Market Research Confirms

PBS/IC Market Need

 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%

Painful Bladder Syndrome -

Interstitial Cystitis Market

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

URG101 Provides Rapid

Relief for Symptom Flares

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

Partnering Opportunity

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

Pharmacodynamic Study

Time Course of

Symptom Relief with

One Dose

% 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

Urigen Pharmaceuticals, Inc.

15

URG101-104 Study Met

All Endpoints

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

Key Summary Findings

Immediate relief with first URG101 dose

 Many patients experienced > 24hr symptom relief following only one dose.

 Significant reduction of daytime symptoms

 Many patients experienced fewer night time voiding episodes.

URG101 Intellectual

Property

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

Overactive Bladder

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

Urigen Pharmaceuticals, Inc.

19

Overactive Bladder

Market Overview

 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

Urigen Pharmaceuticals, Inc.

20

Overactive Bladder

Program

Lidocaine female urethral suppository

Phase I Tolerability Targeted for Q4 2010

 Healthy Volunteers

 Pain scale endpoints

Urigen Pharmaceuticals, Inc.

21

Board of Directors

 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

URG101 Revenue

Projection

$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

Capital Structure

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.

Current Status

 URG101 FDA meeting filed April 22, 2010 (Phase

II met all endpoints)

 Strengthen Balance Sheet For Tier 1 Partnerships

 URG301 Phase I Tolerability Study

URGP.OB

Urigen Pharmaceuticals, Inc.

27 Maiden Lane, #595, San Francisco, CA 94108

(415) 781-0350 www.urigen.com

26

Download