Filed by Corgentech Inc. Pursuant to Rule 425
Under the Securities Act of 1933
And Deemed Filed Pursuant to Rule 14a-12
Under the Securities Exchange Act of 1934
Subject Company: AlgoRx Pharmaceuticals, Inc.
Commission File No. of Subject Company: 000-51146
*** *** ***
The following is a slide presentation used at investor meetings on October 13, 2005.
ALGORX
Pharmaceuticals, Inc.
Corgentech
Creating a Late-Stage Company Focused on Pain Management and Inflammation
October 13, 2005
Filed by Corgentech Inc. Pursuant to Rule 425
Under the Securities Act of 1933
And Deemed Filed Pursuant to Rule 14a-12
Under the Securities Exchange Act of 1934
Subject Company: AlgoRx Pharmaceuticals, Inc.
Commission File No. of Subject Company: 000-51146
*** *** ***
The following is a slide presentation used at investor meetings on October 13, 2005.
FORWARD LOOKING STATEMENTS
This presentation includes “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Words such as “expect,” “estimate,” “project,” “budget,” “forecast,” “anticipate,” “intend,” “plan,” “may,” “will,” “could,” “should,” “believes,” “predicts,” “potential,” “continue,” and similar expressions are intended to identify such forward-looking statements. Forward-looking statements in this presentation include, without limitation, forecasts of product development, FDA filings, benefits of the proposed merger, and other matters that involve known and unknown risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to differ materially from results expressed or implied in this presentation. Such risk factors include, among others: difficulties encountered in integrating merged businesses; uncertainties as to the timing of the merger; approval of the transaction by the stockholders of the companies; the satisfaction of closing conditions to the transaction, including the receipt of regulatory approvals; whether certain market segments grow as anticipated; the competitive environment in the biotechnology industry; and whether the companies can successfully develop new products and the degree to which these gain market acceptance. Actual results may differ materially from those contained in the forward-looking statements in this presentation. Additional information concerning these and other risk factors is contained in Corgentech’s Form 10-K/A for the year ended December 31, 2004 and most recently filed Form10-Q.
Corgentech and AlgoRx undertake no obligation and do not intend to update these forward-looking statements to reflect events or circumstances occurring after this press release. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this presentation. All forward-looking statements are qualified in their entirety by this cautionary statement.
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FORWARD LOOKING STATEMENTS (2)
Additional Information and Where to Find It
Corgentech Inc. intends to file a registration statement on Form S-4, and Corgentech and AlgoRx Pharmaceuticals, Inc. intend to file a related joint proxy statement/prospectus, in connection with the merger transaction involving Corgentech and AlgoRx. Investors and security holders are urged to read the registration statement on Form S-4 and the related joint proxy/prospectus when they become available because they will contain important information about the merger transaction. Investors and security holders may obtain free copies of these documents (when they are available) and other documents filed with the SEC at the SEC’s web site at www.sec.gov. In addition, investors and security holders may obtain free copies of the documents filed with the SEC by contacting Corgentech Investor Relations at the email address: investors@corgentech.com.
Corgentech, AlgoRx and their directors and executive officers may be deemed to be participants in the solicitation of proxies from the stockholders of Corgentech and AlgoRx in connection with the merger transaction. Information regarding the special interests of these directors and executive officers in the merger transaction will be included in the joint proxy statement/prospectus of AlgoRx and Corgentech described above. Additional information regarding the directors and executive officers of Corgentech is also included in Corgentech’s proxy statement for its 2005 Annual Meeting of Stockholders, which was filed with the SEC on April 27, 2005. This document is available free of charge at the SEC’s web site at www.sec.gov and from Investor Relations at Corgentech as described above.
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COMBINED COMPANY
Pain Management and Inflammation
Sizable Patient Populations
Unmet or Underserved Medical Needs Differentiated Products with Clear Advantages over Current Therapies Substantial Body of Preclinical and Clinical Data
Faster, Cheaper Trials
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CREATING LATE-STAGE COMPANY
Four product development programs focused on significant clinical problems with attractive market potential
Each drug has unique mechanism of action offering risk diversification Each drug has potential for approval in multiple indications Each drug can be commercialized with specialty sales force All discovery and development programs 100% owned
Phase 3 program ALGRX 3268 for the treatment of venipuncture
Statistically significantly less pain in first Phase 3 trial Second Phase 3 trial data expected within two months Expect to file NDA in 1H06 Expect product approval in 1H07
Development and commercial expertise in critical areas
Marketing, commercialization, regulatory affairs, manufacturing and clinical trials management
Financial strength and flexibility
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MERGER AGREEMENT
Stock Transaction
Corgentech to issue sufficient shares such that AlgoRx shareholders would own, in a tax-free exchange, 62% and Corgentech shareholders 38% of company, respectively
Combined management team will work to integrate the companies and to identify synergies and redundancies Board and Management
Richard Brewer, Dr. Charles Cohen, Thomas Colligan, Carter Eckert, Dr. Rodney Ferguson, John McLaughlin, Dr. Arnold Oronsky and Dr. Michael Powell Management
John McLaughlin as CEO
Dr. Ronald Burch, current AlgoRx CEO, to serve as VP of Development Richard Powers to remain as CFO
James Huang newly elected as president with responsibility for commercial and other operations Secaucus and South San Francisco facilities to remain open Headquarters: South San Francisco
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PRODUCT PIPELINE
ALGRX 3268
Pre-procedural analgesia (003) Pre-procedural analgesia (004)
ALGRX 4975 *
Post-surgical pain Morton’s neuroma Tendonitis
NF- kB Decoy *
Atopic dermatitis (eczema)
ALGRX 1207 *
Cutaneous neuropathic pain
PRECLINICAL
PHASE 1
PHASE 2
PHASE 3
* |
| Does not reflect comprehensive list of trials currently underway |
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ALGRX 3268-
TOPICAL LOCAL ANESTHESIA
Indication
Reduction of pain associated with venipunctures and intravenous line placements
Two Phase 3 trials being conducted Key desirable product attributes
Sterile, pre-filled, needle-free disposable delivery system (Powderject®) Rapid onset of action
Within 1 minute with duration of about 10 minutes
No vasoconstriction with good dermal tolerability Ease of use with no dressings
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ALGRX 3268
Reduction in Pain from Venipuncture after Administration
EMLA
Package Insert for EMLA
10
0
-10
-20
-30
VAS, mm
3 |
|
60
Time after administration, minutes
ALGRX 3268
Data from Phase 1 trial in 272 adults
10
0
-10
-20
-30
VAS, mm
1 |
|
3 |
|
5 |
|
Time after administration, minutes
ALGRX 3268 has an onset within one minute, whereas EMLA is labeled for a pretreatment period of at least one hour
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ALGRX 3268 DEVELOPMENT
Total
Protocol Age Group Phase Patients Primary Endpoint Status
Primary Endpoint
Antecubital Fossa Adults 1 272 Safety and Efficacy
Achieved
Primary Endpoint
Back of Hand Adults 1 183 Safety and Efficacy
Achieved
Evaluate Circulating Primary Endpoint
Pharmacokinetics Adults 1 38
Lidocaine Achieved
Primary Endpoint
Antecubital Fossa Children 2 195 Safety and Efficacy
Achieved
Primary Endpoint
Back of Hand Children 2 145 Safety and Efficacy
Achieved
Primary Endpoint
Back of Hand Children 2 306 Safety and Efficacy
Achieved
Antecubital Fossa and Primary Endpoint
Children 3 574 Safety and Efficacy
Back of Hand Achieved
Antecubital Fossa and
Children 3 500 Safety and Efficacy Enrollment Completed
Back of Hand
2,213
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PHASE 3’s: 003 AND 004
IDENTICAL PROTOCOLS
Design
U.S. multicenter, randomized, double-blind, placebo-controlled
Number of subjects
500-600 subjects in each study
Population
Pediatric subjects of either gender (ages 3-18)
Objectives
Confirm efficacy, safety and tolerability of ALGRX 3268 vs. placebo administered on back of hand and antecubital fossa
Primary endpoint
Assessment of pain on venipuncture or peripheral venous cannulation performed 1-3 minutes after ALGRX 3268 or placebo in total population (3-18 yrs.) using FACES rating scale
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PHASE 3 RESULTS (003)
Primary endpoint achieved (p=0.007)
Statistically significantly less pain on needle insertion in treated group compared to placebo group assessed using FACES rating scale
574 patients at six U.S. clinical trial sites
ALGRX 3268 group = 289 patients (ages 3-18) Placebo = 285 patients (ages 3-18)
No significant safety issues
Well tolerated
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PROJECTED TIMELINE FOR ALGRX 3268
Clinical
Data from second Phase 3 trial (004) expected within two months
Regulatory
Reviewed as a drug by the FDA Analgesics and Acute Care Division
Registration
File NDA in 1H06 Product approval in 1H07
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ALGRX 4975 – VR1 ANESTHETIC
Capsaicin Overview
Administered locally at the site of pain Single administration may provide analgesia for weeks to months Non-opioid based Only reduces long-term noxious pain associated with C-neurons Does not affect other nerve fibers important for motor skills
Activates the VR1 channel; expressed by pain receptor C-fibers
Blocks noxious pain with long duration
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ALGRX 4975 DEVELOPMENT
Total |
|
Protocol |
| Phase Patients Primary Endpoint Status |
Postsurgical |
| Pain |
Bunion |
| Removal Surgery 2 40 Time to Rescue Medication Primary Endpoint Achieved |
Bunion |
| Removal Surgery 2 182 Magnitude of Pain Relief Primary Endpoint Achieved |
Hernia |
| Repair 2 48 Magnitude and Duration of Pain Relief Ongoing |
Total |
| Knee Replacement 2 60 Dosing Study Ongoing |
Cholecystectomy |
| 2 40 Magnitude of Pain Relief Ongoing |
Neuropathic |
| Pain |
Morton’s |
| Neuroma 2 60 Magnitude and Duration of Pain Relief Ongoing |
Musculoskeletal |
| Pain |
End-Stage |
| Osteoarthritis 1 16 Safety Primary Endpoint Achieved |
End-Stage |
| Osteoarthritis 2 12 Magnitude and Duration of Pain Relief Primary Endpoint Achieved |
Osteoarthritis |
| of the Knee 2 52 Magnitude and Duration of Pain Relief Primary Endpoint Missed |
Tendonitis |
| 2 40 Magnitude and Duration of Pain Relief Achieved 30 Day Endpoint; |
Ongoing
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COMMON, CHRONIC PROBLEM
Eczema (Atopic Dermatitis)
Red, cracked, and unbearably itchy skin caused by excess inflammation in the skin Makes the person more susceptible to infection
90% of people with AD have staph bacteria on their skin compared to <5% of people without AD
Affects about 15 million people in the United States
Affects about 10-20% of infants
Very common in all parts of the world
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ECZEMA: LARGE UNMET NEED
Unmet medical need
Existing therapies are not satisfactory (steroids and calcineurin inhibitors)
Safety issues with long-term application of steroids, especially in children, and black box warning for cancer risk on calcineurin inhibitors
Strong preclinical data with NF- kB Decoy showing effective treatment for eczema Good drug delivery to the dermis and epidermis with simple formulation Validated, accepted clinical endpoints
Shorter time to proof of concept
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DRUG COMPARISON
Topical |
|
NF- |
| kB Decoy Steroids Calcineurin Inhibitors |
Agents |
|
Efficacy |
| +++ +++ ++ |
Twice a day
Once |
| a day or Once/twice a day |
Dosing |
| Short-term/ intermittent |
less |
| Short-term |
long-term
Skin-thinning |
| None Limits use None |
Onset |
| of |
+++ |
| +++ ++ |
action |
|
Systemic |
| May cause significant Black box warning for |
Limited |
|
exposure |
| side effects cancer risk |
Rebound |
| None Frequent Occasional |
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NF-kB DECOY FOR ECZEMA
Two Phase 1/2 trials underway Clinical data expected in 1Q/06 Adults with mild-moderate eczema Endpoints
Safety, tolerability and PK
Multiple endpoints to assess preliminary efficacy
Physician and patient assessments of target area (signs and symptoms)
US Trial (75 patients)
Four cohorts
0.25% |
| 20 patients |
0.50% |
| 20 patients |
1.00% |
| 20 patients |
Placebo |
| 15 patients |
21 days of treatment and 28 days of follow-up
Ex-US Trial (120 patients)
Three cohorts
1.0% |
| daily 40 patients |
1.0% |
| 2x day 40 patients |
Placebo |
| 40 patients |
28 days of treatment and 14 days of follow-up
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ALGRX 1207
IND-enabling studies underway
New chemical class of local anesthetic for topical analgesia
Deep, rapid penetration of the skin and long duration of action Addresses a wide variety of procedures including:
Neuropathic pain Dermatological surgery Surgical incisions
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ALGRX 1207
New local anesthetic allowing rapid and complete topical anesthesia without exotic delivery
100 80 60 40 20 0
Percent complete anesthesia
-120 -110 -100 -90
Time, minutes
Percent complete anesthesia
100 80 60 40 20 0
-120 -60 0 60 120 180 240 300 360 420
Time, minutes
Lidocaine
ALGRX 1207
Unique non-clinical results in relevant models
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PREVALANCE OF PAIN IN SEVEN MAJOR COUNTRIES
PATIENT NUMBERS
Prevalence of post-operative pain 75,068,000
Prevalence of back pain 208,996,000
Prevalence of HIV and AIDS pain 847,000
Prevalence of diabetic neuropathy pain 13,243,000
Prevalence of osteoarthritic pain 46,610,000
Above indications are all targets of Corgentech pipeline
Source: Datamonitor
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3268: TOPICAL LOCAL
ANESTHESIA MARKET DYNAMICS
Strong focus of pain management including treatment protocols and guidelines Increase in dedicated pediatric hospitals and specialized pediatric departments in larger general hospitals Continuing pressure on cost reduction and patient through-put in hospitals Fundamental market need for easy to use, fast onset topical local anesthetic
Current market dynamics provide an excellent opportunity for a fast acting, easy to use topical local anesthetic product like ALGRX 3268
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UNDERSERVED MARKET
Target market
Only 2.1MM out of 18MM venipuncture procedures in children’s hospitals and large academic institutions utilize a topical local anesthetic today
Low utilization of topical local anesthetics (12% of pediatric procedures) due to slow onset of action lack of promotion of currently available drugs
Faster onset of action, needleless injection and promotion will allow significant penetration and growth into target market of 18MM pediatric procedures
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3268: PHASED MARKETING APPROACH
Physician Offices, Labs, Blood Donation Centers
Hemodialysis Centers
In-hospital Adult (ER)
In-hospital Pediatric
18M
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ALGRX 4975: POST-OPERATIVE PAIN MARKET
US post-operative pain market: $1.7 billion Virtually all patients experience some level of pain post operatively
50% indicate lack of adequate pain control Patients’ post-surgical pain experiences between 1993 and 1999 have not improved Europe also under treats post-operative pain
Pain in hospital associated with increased length of stay, longer recovery times, poorer patient outcomes
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CURRENT POST-OP PAIN MEDICATIONS VS. ALGRX 4975
Epidurals
Use declining significantly due to contra-indication in combination use with anticoagulants
Opioids
Nausea, vomiting, respiratory depression and constipation Sedation may limit the ability of the patient to ambulate and prolong time to discharge
Decreased bowel function can lead to an ileus which causes morbidity and prolongs hospitalization
Concern about addiction leads to insufficient pain relief which has physiologic consequences
Non-narcotics
Unacceptable anesthesia for moderate to severe pain
ALGRX 4975
Unlikely to be contra-indicated for use in conjunction with anticoagulants Site-specific with limited systemic exposure and unlikely to cause nausea, vomiting, respiratory depression or sedation No addiction potential Long-acting with single administration and ideal for moderate to severe pain
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NF-kB DECOY: ECZEMA MARKET
Eczema market is comprised of mild, moderate and severe patient segments within the pediatric and adult patient populations
Patient Population Segmented by Mild, Moderate and Severe (US, EU, Japan)
Severe 10%
15.6M
5.2M
31.1M
Moderate 30%
Mild 60%
Sources:
1. International Consensus Conference on Atopic Dermatitis II: clinical update and current treatment strategies, BJD, 2003; 148 (Suppl. 63): 3-10
2. Prevalence of Atopic Dermatitis in Japanese Adults, Muto T, Hsieh SD et al., BJD, 2003 Jan; 148(1): 117-21
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NF-kB DECOY: Rx SALES (U.S.)
Total Dollars (millions) $900 $800 $700 $600 $500 $400 $300 $200 $100 $0
1999 2000 2001 2002 2003 2004
Corticosteroids Protopic Elidel
Source: IMS Health, 2004
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ALGRX1207: TARGET MARKET
Deep, rapid penetration of the skin Long duration of action Addresses neuropathic pain market Non-exotic delivery
Lidoderm® (Endo Pharmaceuticals) Postherpetic Neuralgia Indication
($ in millions) $45 $107 $215 $300 $400
2001 2002 2003 2004E 2005E (IMS) (IMS) (IMS) (Endo) (Endo)
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DEAL TIMELINE
Merger requires stockholder approval
Both boards have approved merger
Merger documents to be filed shortly
S-4 and related joint Proxy Statement
Shareholder vote expected to occur in late 2005 / early 2006
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WHY THIS MERGER MAKES SENSE
Four product development programs focused on significant clinical problems with attractive market potential
Each drug has unique mechanism of action offering risk diversification Each drug has potential for approval in multiple indications Each drug can be commercialized with specialty sales force All discovery and development programs 100% owned
Phase 3 program ALGRX 3268 for the treatment of venipuncture
Statistically significantly less pain in first Phase 3 trial Second Phase 3 trial data expected within two months Expect to file NDA in 1H06 Expect product approval in 1H07
Development and commercial expertise in critical areas
Marketing, commercialization, regulatory affairs, manufacturing and clinical trials management
Financial strength and flexibility
32