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0000950135-06-003916.txt : 200606130000950135-06-003916.hdr.sgml : 2006061320060613172051ACCESSION NUMBER:0000950135-06-003916CONFORMED SUBMISSION TYPE:425PUBLIC DOCUMENT COUNT:34FILED AS OF DATE:20060613DATE AS OF CHANGE:20060613

SUBJECT COMPANY:

COMPANY DATA:COMPANY CONFORMED NAME:PREDIX PHARMACEUTICALS HOLDINGS INCCENTRAL INDEX KEY:0001044487STANDARD INDUSTRIAL CLASSIFICATION:PHARMACEUTICAL PREPARATIONS [2834]IRS NUMBER:133795882

FILING VALUES:FORM TYPE:425SEC ACT:1934 ActSEC FILE NUMBER:000-51551FILM NUMBER:06902967

BUSINESS ADDRESS:STREET 1:4 MAGUIRE ROADCITY:LEXINGTONSTATE:MAZIP:02421BUSINESS PHONE:781-372-3260

MAIL ADDRESS:STREET 1:4 MAGUIRE ROADCITY:LEXINGTONSTATE:MAZIP:02421

FILED BY:

COMPANY DATA:COMPANY CONFORMED NAME:EPIX Pharmaceuticals, Inc.CENTRAL INDEX KEY:0001027702STANDARD INDUSTRIAL CLASSIFICATION:IN VITRO & IN VIVO DIAGNOSTIC SUBSTANCES [2835]IRS NUMBER:043030815FISCAL YEAR END:1231

FILING VALUES:FORM TYPE:425

BUSINESS ADDRESS:STREET 1:71 ROGERS STCITY:CAMBRIDGESTATE:MAZIP:02142-1118BUSINESS PHONE:6172506000

MAIL ADDRESS:STREET 1:71 ROGERS STCITY:CAMBRIDGESTATE:MAZIP:02142-1118

FORMER COMPANY:FORMER CONFORMED NAME:EPIX MEDICAL INCDATE OF NAME CHANGE:19961129

4251b61217e5e425.htmEPIX PHARMACEUTICALS FORM 425

e425

Filed by EPIX Pharmaceuticals, Inc.
Pursuant to Rule425 under the Securities Act of 1933, as amended
Subject Company: Predix Pharmaceuticals Holdings, Inc.
Commission File Number: 333-133513

The following communications contain forward-looking statements within the meaning of the PrivateSecurities Litigation Reform Act of 1995 and Section27A of the Securities Act of 1933, as amended,and Section21E of the Securities Exchange Act of 1934, as amended, that are based on currentexpectations of the management of EPIX Pharmaceuticals, Inc. ("EPIX"). These statements are neither promises nor guarantees,but are subject to a variety of risks and uncertainties, many of which are beyond the control ofEPIX, and which could cause actual results to differ materially fromthose contemplated in these forward-looking statements. Such forward-looking statements includestatements regarding: The approximate value of the merger transaction and net debt to be assumedat the closing; the approximate percent of the combined company that EPIX stockholders will ownupon closing of the merger; the expectation that Chris Gabrieli will remain Chairman of the Boardof Directors of the combined company; the expectation that EPIX will appeal the FDAs approvableletters of January and November2005 relating to Vasovist; the expectation that PRX-00023 willenter Phase II for depression in 2007; the expectation that PRX-03140 will enter Phase IIa forAlzheimers disease later this year; the expectation that PRX-08066 will enter Phase IIa forpulmonary hypertension (associated with COPD) later this year; the expectation that PRX-07034 willbe developed for obesity and cognitive impairment; the anticipated timing and structure ofpartnering strategies; the expectation that the full results of EP-2104Rs Phase IIa trial will beavailable in the second half of 2006; the expectation that the results from PRX-00023s first PhaseIII trial in GAD will be available in the second half of 2006; the expectation to finalize apartnership with a pharmaceutical/biotech partner(s) to license select drug candidate(s) in thesecond half of 2006 or first quarter of 2007; the expectation to advance at least one candidateinto the clinic annually; the goal of completing the first of at least two pivotal Phase III trialsfor PRX-00023 for the treatment of anxiety; the expected receipt of $200,000 $800,000 inVasovist royalty revenue in 2006 and its anticipated growth for the rest of the decade; theexpectation that there will be no additional registration trial(s) pending the appeal to the FDArelating to Vasovist; the anticipated focus of EP-2104R on the evaluation of patients at risk ofstroke; the expected notification by Schering AG of its decision to exercise its option of EP-2104Rin the second half of 2006; the belief that Predix will be achieving significant clinical andcorporate milestones ahead; the belief in PRX-00023s potential to meet unmet needs including animproved tolerability and side effect profile, to drive long-term compliance and to capture marketshare and its potential profile including efficacy compared to SSRIs, once-daily dosing, no sexualdysfunction, no effect on sleep or appetite, no withdrawal symptoms and no expected black boxwarning; the belief that the aging of baby boomers will have a large impact on the Alzheimersdisease market size in the U.S. as the population of people aged 65 and over is expected toincrease as well as the prevalence of Alzheimers disease in that population; the expectation thatPRX-08066 will provide symptomatic relief through selective vasodilation and slow diseaseprogression by blocking signaling pathways; the belief that PRX-00023 for the treatment of GAD hasthe potential to meet the significant unmet medical need for a once-daily treatment to relieveanxiety without the troublesome side effects associated with many of the other drugs used to treatthis disorder and that its indicated well tolerability will be an important differentiator forPRX-00023 in this therapeutic area; and the efficacy of PRX-00023s design to have minimal affinityfor the GPCRs believed to be associated with the side effects of 5-HT1A agonists that are in theazapirone chemical class, and to have a more convenient dosing profile than azapirones. Thefollowing factors, among others, could cause actual results to differ materially from thosedescribed in the forward-looking

statements: costs related to the merger, failure of EPIXs or Predixs stockholders to approve themerger, EPIXs or Predixs inability to satisfy the conditions of the merger, the risk that EPIXsand Predixs businesses will not be integrated successfully, the combined companys inability tofurther identify, develop and achieve commercial success for new products and technologies, thepossibility of delays in the research and development necessary to select drug developmentcandidates and delays in clinical trials, the risk that clinical trials may not result inmarketable products, the risk that the combined company may be unable to successfully secureregulatory approval of and market its drug candidates, the risks associated with reliance onoutside financing to meet capital requirements, risks associated with Predixs new and uncertaintechnology, the development of competing systems, the combined companys ability to protect itsproprietary technologies, patent-infringement claims, risks of new, changing and competitivetechnologies and regulations in the U.S. and internationally. You are urged to consider statementsthat include the words may, will, would, could, should, believes, estimates,projects, potential, expects, plans, anticipates, intends, continues, forecast,designed, goal, or the negative of those words or other comparable words to be uncertain andforward-looking. These factors and others are more fully discussed in EPIXs periodic reports andother filings with the Securities and Exchange Commission.

EPIX undertakes no obligation and does not intend to update these forward-looking statements toreflect events or circumstances occurring after the date of these communications. You are cautionednot to place undue reliance on these forward-looking statements, which speak only as of the date ofthese communications. All forward-looking statements are qualified in their entirety by thiscautionary statement.

*********************

THE FOLLOWING IS THE TEXT OF SLIDES FROM A SLIDESHOW PRESENTATION PRESENTED BY EPIX TO
INVESTORS AND OTHERS ON JUNE 13, 2006

Pacific Growth Equities Life Sciences Growth Conference

June 13, 2006

Andrew C.G. Uprichard, M.D., President andCOO, EPIX

Michael G. Kauffman, M.D., Ph.D., Presidentand CEO, Predix

Forward-looking Statements

the expected timing, progress and success of our current andanticipated clinical trials and preclinical research programs;

the anticipated efficacy of our drug/imaging candidates;

the expected benefits of our drug candidates over other therapies;

statistical information concerning the markets in which we expect ourproduct candidates to compete, if approved; and

estimates of our future financial performance.

While management make their best efforts to be accurate in makingforward-looking statements, forward-looking statements reflect ourcurrent assumptions and views with respect to future events and aresubject to risks and uncertainties that could cause actual results to varymaterially from those described in the forward-looking statements.

The following presentation contains forward-looking statements aboutPredix Pharmaceuticals Holdings, Inc., and EPIX Pharmaceuticals,Inc., including, but not limited to, statements about:

Additional Information About the Merger

And Where To Find It

EPIX has filed a registration statement on Form S-4 with the Securities and ExchangeCommission containing a joint proxy statement/prospectus in connection with the proposed merger.Investors and security holders are advised to read the joint proxy statement/prospectus (includingany amendments or supplements thereto) regarding the proposed merger because it containsimportant information about EPIX, Predix and the proposed transaction and other related matters.The joint proxy statement/prospectus will be sent to stockholders of EPIX and Predix seeking theirapproval of the proposed transaction. Investors and security holders may obtain a free copy of thejoint proxy statement/prospectus and any amendments or supplements thereto (when they areavailable) and other documents filed by EPIX at the Securities and Exchange Commission's website at www.sec.gov. The joint proxy statement/prospectus and such other documents may also beobtained for free by directing such request to EPIX Pharmaceuticals, Inc. 161 First Street,Cambridge, Massachusetts, Attn: Investor Relations, tel: (617) 250-6000; e-mail:ahedison@epixpharma.com or Predix Pharmaceuticals Holdings, Inc., 4 Maguire Road, Lexington,Massachusetts 02421, Attn: Investor Relations, tel: (781) 372-3260; e-mail:investors@predixpharm.com.

EPIX and Predix and their respective directors, executive officers and other members ofmanagement and employees may be deemed to be participants in the solicitation of proxies withrespect to the adoption of the merger agreement and the transactions associated with the merger.A description of any interests that EPIX and Predix directors and executive officers have in themerger is included in the registration statement containing the proxy statement/prospectus that hasbeen filed with the Securities and Exchange Commission and available free of charge as indicatedabove. You can obtain free copies of these documents using the contact information above.

Transaction Summary

Transaction value ~ $90 million

Net debt assumption ~ $7.8 million at closing

Additional milestone payment of $35 million

Stock, cash or combination

Achievement of certain clinical milestones or a strategic alliance

EPIX stockholders will own ~ 53% of combined companyupon closing

Chris Gabrieli to remain Chairman of the Board of thecombined company

Major Predix shareholders and Gabrieli subject to lock-upsranging from 90 days - 180 days

The New Epix Pharmaceuticals

Broad pipeline

Vasovist(tm), EPIX's novel blood pool imaging agent, which is marketed in Europeby Schering AG and will be the subject of an Appeal of the FDA's ApprovableLetters of January and November 2005

PRX-00023 in Phase III for anxiety, and expected to enter Phase II fordepression in 2007

EP-2104R has completed Phase IIa for imaging arterial and venous blood clots

PRX-03140 has completed Phase Ib trials and is expected to enter Phase IIafor Alzheimer's disease later this year

PRX-08066 has completed Phase Ib trials and will enter Phase IIa forpulmonary hypertension (associated with COPD) later this year

PRX-07034 has entered a Phase I clinical trial and is expected to be developedfor obesity and cognitive impairment

a portfolio of several pre-clinical product candidates

Critical mass, stable management and development expertise for multi-product pipeline

Approximately $125 million in cash and marketable securities - 1Q06

Robust Pipeline

Robust Pipeline

*Clinical development of PRX-00023 for a depression indication has not been initiated.

Commercialization Strategy

Partner programs from our pipeline when we believe wecan create the greatest value for our shareholders

Prioritize later stage clinical compounds for partnershipsfocusing on primary care marketing sales forces

Discovery stage partnerships only in selected cases; notplatform or technology transfers

A combination of the above

Milestone Timing Presentation of data at upcoming scientific & business meetings Ongoing Appeal filing for Vasovist(tm) Mid 2006 Full Results of Phase IIa EP2104R 2H06 Initiate Phase IIa Trial in PH/COPD 2H06 Initiate Phase IIa Trial in Alzheimer's 2H06 Results from first Phase III Trial in GAD 2H06 Finalize partnership with pharmaceutical/biotech partner(s) to license select drug candidate(s) 2H06/1H07 Advance at least one candidate into the clinic Annually

Near-term Value Drivers

Management Team

Michael Kauffman, MD, PhD

CEO

Andrew Uprichard,

MD

President

Kim Drapkin, CPA

Chief Financial Officer

Brenda Sousa

Vice President of

Human Resources

Chen Schor, MBA,CPA

Chief Business Officer

Steve Donahue, MD

Vice President of

Clinical & RegulatoryAffairs

Israel Site

Oren Becker, PhD

CSO

Silvi Noiman, PhD, MBA

SVP, GM

Strong Development/Approval Track Record

Michael G. Kauffman, MD, PhD

Velcade(r) Development/Approval (Millennium Pharmaceuticals)

Melastatin(r) Diagnostic Development (Millennium Pharmaceuticals)

Inlicensing/development of CVT-124 (Biogen Idec)

Development of Anti-CD40L (Biogen Idec)

Andrew Uprichard, MB, MD (PhD)

Over 18 years' experience in drug discovery/development

Warner Lambert, Pfizer and others

Lipitor(r), Lopid(r), Accupril(r), Omnicef(r), NitroStat(r)

Stephen Donahue, MD

Vytorin(r) Development/Approval (Merck)

Metabolic Portfolio / Development (Bristol Myers Squibb)

Priorities

File Vasovist(tm) Appeal asking the FDA for approval, requestingAdvisory Committee.

Complete the first of at least two pivotal Phase III trials for PRX-00023 for the treatment of anxiety to advance this novel drugcandidate toward regulatory submission.

Continue to progress the lead product candidates for Alzheimer'sdisease and two types of Pulmonary Hypertension.

Advance our partnering discussions on our lead product candidateswith the goal of maximizing the value of these proprietary assets forour shareholders.

EPIX - Vasovist(tm) Image

Vasovist(tm)

First blood pool agent developed for MR angiography

One injection provides an imaging window of ~60 minutes

Enables imaging of multiple vascular beds

Reduces technical challenges of shorter duration agents (~90 sec window)

Achieved primary endpoints in all four pivotal Phase III trials (two aorto-iliac, one renal, one pedal)

EU and Swiss approvals in Q4 2005 (Schering AG markets)

Selling in Netherlands, Norway, Sweden, Denmark, UK, Germany andAustria

EPIX expects royalty revenue of $200,000 - $800,000 in 2006, thenanticipates growth for rest of decade

Two approvable letters January and November 2005 requestingadditional clinical trial(s); Epix to appeal the Approvable Letters

Met with FDA in early April to discuss draft protocol - no conclusion

Requesting an Advisory Committee as part of the Appeal

No additional registration trial(s) currently planned pending Appeal

EP-2104R

Proprietary fibrin-binding imaging agent used to identify blood clots

Open-label Phase IIa completed 1H 2006

Encouraging images seen identifying clots in different vessel beds; mostlikely focus of development is evaluation of patients at risk of stroke

$5 million milestone payment associated with exercise of Schering AGoption

Notification expected in 2H 2006

Predix Overview

Pharmaceutical company focused on validated targets fordrug discovery and development:

Effective discovery and optimization engine

4 internally discovered drug candidates in clinical trials in less than 4years

Highly selective small-molecule drugs for G-protein-coupledreceptors (GPCR) and ion channels

Retained all worldwide rights

Commercialization strategy includes partnering in large,PCP-driven markets

Significant clinical and corporate milestones ahead

GPCRs and Ion Channels -

Proven Drug Targets

GPCRs and ion channels (IC)

Embedded proteins in surface membraneof all cells

Mediate biological signaling in health /disease

Clinically and commercially validatedtargets:

40% of top selling drugs target GPCR/IC

Despite commercial success, side effectsand administration (ADME) issues remainproblematic

Opportunity for Predix

Market Overview - Anxiety and Depression

Sources: U.S. National Institute of Mental Health; European Study of Epidemiology of Mental Disorders (Acta Psychiatr Scand 2004); Kawakami et al., PsychiatryRes 2004; Ayuso-Mateos et al., Br J Psych 2001; Global Industry Analysts Antidepressants Report, October 2004

Market value of more than $15.9 billion worldwide in 2004(Espicom)

Mechanism of PRX-00023

Potential to meet unmet needs:

Improved tolerability and sideeffect profile

Drive long-term compliance

Capture market share

PRX-00023

Potential profile:

Efficacy comparable to SSRIs

Once-daily dosing

No sexual dysfunction

No effect on sleep or appetite

No withdrawal symptoms

Do not expect black box warning

PRX-00023 - Anxiety and Depression

Highly selective, once daily, long acting, small-molecule drug candidatefor the 5-HT1A receptor

Well tolerated in >200 humans to date

Dose dependent increase in brain-derived biomarker at doses 30 mg andhigher in Phase I

Well tolerated with titration up to 150 mg daily (no DLT)

Target dose based on biomarker in 100% of patients is 40 mg qd x 3 days,then 80 mg qd thereafter

Four-week Phase II GAD study in 20 patients

Significant improvement in symptoms with 32% remissions

Well tolerated up to 120 mg/day (mild nausea, no HA or dizziness)

Initiated pivotal Phase III in GAD in August 2005

Enrollment completed Q2 2006

Dose Selection - Phase I Results

Biomarker Induction

Max Transient Prolactin Change from Baseline

0

5

10

15

20

25

30

0

10

30

40

60

90

120

150

Dose in mg

Prolactin Max Change, ng/mL

Study -002

Study -003

PRX-00023 Phase III Pivotal Trial

Initiated under a Special Protocol Assessment with FDA

310 patients with moderate-to-severe GAD; US only

Randomized, double-blind, placebo-controlled, multi-center

Primary: HAM-A change from baseline to week 8 vs. placebo

Secondary: CGI-Improvement, sexual dysfunction, withdrawal, MADRS

Enrollment completed in Q2 2006; data expected 2H 2006

Sources: Espicom report, "CNS Drug Discoveries: What the Future Holds (Neurodegenerative)", June 2005; U.S. Census Internet Release, January 2004; Hebertet al., Neurology 2004; Company Reports

Market Overview - Alzheimer's Disease

Significant unmet need fortherapy that will improvesymptoms and slow diseaseprogression

Aging of baby boomers will havelarge impact on market size inUS

Aged 65+ will double over thenext 25 yrs to > 70M

44% increase predicted inAlzheimer's prevalence

by 2025

CNS Active 5-HT4 Agonist Potential

Stimulates brainACh productionor release forsymptomaticimprovement

Synergy withcholinesteraseinhibitors

PRX-03140 - Alzheimer's Disease

Well tolerated in >100 healthy volunteers in single dose andmultiple dose Phase I trials

Biomarker demonstrates hitting target in humans

Placebo-controlled Phase Ib in 12 patients with

Alzheimer's Disease

Dose 50 mg qd well tolerated for 2 weeks in 8 patients

Statistically significant changes in EEG within 2 weeks consistentwith effects seen with approved drugs

Demonstrated synergy with cholinesterase inhibitors inpreclinical models

Phase IIa trial alone or with cholinesterase inhibitor plannedfor second half of 2006

PRX-03140 is Synergistic

With a Cholinesterase Inhibitor

Vehicle

PRX-03140 0.03

mg/kg

Galanthamine 0.3

Mg/kg

Gal 0.3+PRX-

01340 0.03

PRX-03140 1

mg/kg

Galanthamine 2.5

mg/kg

Percent Alternation (mean +- SEM)

*

**

**

Synergism Between PRX-03140 and Galantamine in the SpontaneousAlternation Test in Rats

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