425 1 d425.htm FILED PURSUANT TO RULE 425 Filed pursuant to Rule 425

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.

 

LOGO

 

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.


LOGO

 

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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LOGO

 

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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LOGO

 

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

5

 


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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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LOGO

 

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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LOGO

 

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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LOGO

 

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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LOGO

 

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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LOGO

 

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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LOGO

 

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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LOGO

 

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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LOGO

 

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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LOGO

 

3268: PHASED MARKETING APPROACH

Physician Offices, Labs, Blood Donation Centers

Hemodialysis Centers

In-hospital Adult (ER)

In-hospital Pediatric

18M

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LOGO

 

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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LOGO

 

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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LOGO

 

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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LOGO

 

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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LOGO

 

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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LOGO

 

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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LOGO

 

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