e425
Filed by EPIX Pharmaceuticals, Inc.
Pursuant to Rule 425 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 Private
Securities Litigation Reform Act of 1995 and Section 27A of the Securities Act of 1933, as amended,
and Section 21E of the Securities Exchange Act of 1934, as amended, that are based on current
expectations 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 of
EPIX, and which could cause actual results to differ materially from
those contemplated in these forward-looking statements. Such forward-looking statements include
statements regarding: The approximate value of the merger transaction and net debt to be assumed
at the closing; the approximate percent of the combined company that EPIX stockholders will own
upon closing of the merger; the expectation that Chris Gabrieli will remain Chairman of the Board
of Directors of the combined company; the expectation that EPIX will appeal the FDAs approvable
letters of January and November 2005 relating to Vasovist; the expectation that PRX-00023 will
enter Phase II for depression in 2007; the expectation that PRX-03140 will enter Phase IIa for
Alzheimers disease later this year; the expectation that PRX-08066 will enter Phase IIa for
pulmonary hypertension (associated with COPD) later this year; the expectation that PRX-07034 will
be developed for obesity and cognitive impairment; the anticipated timing and structure of
partnering strategies; the expectation that the full results of EP-2104Rs Phase IIa trial will be
available in the second half of 2006; the expectation that the results from PRX-00023s first Phase
III trial in GAD will be available in the second half of 2006; the expectation to finalize a
partnership with a pharmaceutical/biotech partner(s) to license select drug candidate(s) in the
second half of 2006 or first quarter of 2007; the expectation to advance at least one candidate
into the clinic annually; the goal of completing the first of at least two pivotal Phase III trials
for PRX-00023 for the treatment of anxiety; the expected receipt of $200,000 $800,000 in
Vasovist royalty revenue in 2006 and its anticipated growth for the rest of the decade; the
expectation that there will be no additional registration trial(s) pending the appeal to the FDA
relating to Vasovist; the anticipated focus of EP-2104R on the evaluation of patients at risk of
stroke; the expected notification by Schering AG of its decision to exercise its option of EP-2104R
in the second half of 2006; the belief that Predix will be achieving significant clinical and
corporate milestones ahead; the belief in PRX-00023s potential to meet unmet needs including an
improved tolerability and side effect profile, to drive long-term compliance and to capture market
share and its potential profile including efficacy compared to SSRIs, once-daily dosing, no sexual
dysfunction, no effect on sleep or appetite, no withdrawal symptoms and no expected black box
warning; the belief that the aging of baby boomers will have a large impact on the Alzheimers
disease market size in the U.S. as the population of people aged 65 and over is expected to
increase as well as the prevalence of Alzheimers disease in that population; the expectation that
PRX-08066 will provide symptomatic relief through selective vasodilation and slow disease
progression by blocking signaling pathways; the belief that PRX-00023 for the treatment of GAD has
the potential to meet the significant unmet medical need for a once-daily treatment to relieve
anxiety without the troublesome side effects associated with many of the other drugs used to treat
this disorder and that its indicated well tolerability will be an important differentiator for
PRX-00023 in this therapeutic area; and the efficacy of PRX-00023s
design to have minimal affinity
for the GPCRs believed to be associated with the side effects of 5-HT1A agonists that are in the
azapirone chemical class, and to have a more convenient dosing profile than azapirones. The
following factors, among others, could cause actual results to differ materially from those
described in the forward-looking
statements: costs related to the merger, failure of EPIXs or Predixs stockholders to approve the
merger, EPIXs or Predixs inability to satisfy the conditions of the merger, the risk that EPIXs
and Predixs businesses will not be integrated successfully, the combined companys inability to
further identify, develop and achieve commercial success for new products and technologies, the
possibility of delays in the research and development necessary to select drug development
candidates and delays in clinical trials, the risk that clinical trials may not result in
marketable products, the risk that the combined company may be unable to successfully secure
regulatory approval of and market its drug candidates, the risks associated with reliance on
outside financing to meet capital requirements, risks associated with Predixs new and uncertain
technology, the development of competing systems, the combined companys ability to protect its
proprietary technologies, patent-infringement claims, risks of new, changing and competitive
technologies and regulations in the U.S. and internationally. You are urged to consider statements
that 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 and
forward-looking. These factors and others are more fully discussed in EPIXs periodic reports and
other filings with the Securities and Exchange Commission.
EPIX undertakes no obligation and does not intend to update these forward-looking statements to
reflect events or circumstances occurring after the date of these communications. You are cautioned
not to place undue reliance on these forward-looking statements, which speak only as of the date of
these communications. All forward-looking statements are qualified in their entirety by this
cautionary statement.
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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 and
COO, EPIX
Michael G. Kauffman, M.D., Ph.D., President
and CEO, Predix
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Forward-looking Statements
the expected timing, progress and success of our current and
anticipated 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 our
product candidates to compete, if approved; and
estimates of our future financial performance.
While management make their best efforts to be accurate in making
forward-looking statements, forward-looking statements reflect our
current assumptions and views with respect to future events and are
subject to risks and uncertainties that could cause actual results to vary
materially from those described in the forward-looking statements.
The following presentation contains forward-looking statements about
Predix Pharmaceuticals Holdings, Inc., and EPIX Pharmaceuticals,
Inc., including, but not limited to, statements about:
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Additional Information About the Merger
And Where To Find It
EPIX has filed a registration statement on Form S-4 with the Securities and Exchange
Commission 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 (including
any amendments or supplements thereto) regarding the proposed merger because it contains
important 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 their
approval of the proposed transaction. Investors and security holders may obtain a free copy of the
joint proxy statement/prospectus and any amendments or supplements thereto (when they are
available) and other documents filed by EPIX at the Securities and Exchange Commission's web
site at www.sec.gov. The joint proxy statement/prospectus and such other documents may also be
obtained 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 of
management and employees may be deemed to be participants in the solicitation of proxies with
respect 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 the
merger is included in the registration statement containing the proxy statement/prospectus that has
been filed with the Securities and Exchange Commission and available free of charge as indicated
above. You can obtain free copies of these documents using the contact information above.
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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 company
upon closing
Chris Gabrieli to remain Chairman of the Board of the
combined company
Major Predix shareholders and Gabrieli subject to lock-ups
ranging from 90 days - 180 days
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The New Epix Pharmaceuticals
Broad pipeline
Vasovist(tm), EPIX's novel blood pool imaging agent, which is marketed in Europe
by Schering AG and will be the subject of an Appeal of the FDA's Approvable
Letters of January and November 2005
PRX-00023 in Phase III for anxiety, and expected to enter Phase II for
depression 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 IIa
for Alzheimer's disease later this year
PRX-08066 has completed Phase Ib trials and will enter Phase IIa for
pulmonary hypertension (associated with COPD) later this year
PRX-07034 has entered a Phase I clinical trial and is expected to be developed
for 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
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Robust Pipeline
Robust Pipeline
*Clinical development of PRX-00023 for a depression indication has not been initiated.
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Commercialization Strategy
Partner programs from our pipeline when we believe we
can create the greatest value for our shareholders
Prioritize later stage clinical compounds for partnerships
focusing on primary care marketing sales forces
Discovery stage partnerships only in selected cases; not
platform or technology transfers
A combination of the above
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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
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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 & Regulatory
Affairs
Israel Site
Oren Becker, PhD
CSO
Silvi Noiman, PhD, MBA
SVP, GM
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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)
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Priorities
File Vasovist(tm) Appeal asking the FDA for approval, requesting
Advisory Committee.
Complete the first of at least two pivotal Phase III trials for PRX-
00023 for the treatment of anxiety to advance this novel drug
candidate toward regulatory submission.
Continue to progress the lead product candidates for Alzheimer's
disease and two types of Pulmonary Hypertension.
Advance our partnering discussions on our lead product candidates
with the goal of maximizing the value of these proprietary assets for
our shareholders.
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EPIX - Vasovist(tm) Image
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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 and
Austria
EPIX expects royalty revenue of $200,000 - $800,000 in 2006, then
anticipates growth for rest of decade
Two approvable letters January and November 2005 requesting
additional 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
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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; most
likely focus of development is evaluation of patients at risk of stroke
$5 million milestone payment associated with exercise of Schering AG
option
Notification expected in 2H 2006
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Predix Overview
Pharmaceutical company focused on validated targets for
drug discovery and development:
Effective discovery and optimization engine
4 internally discovered drug candidates in clinical trials in less than 4
years
Highly selective small-molecule drugs for G-protein-coupled
receptors (GPCR) and ion channels
Retained all worldwide rights
Commercialization strategy includes partnering in large,
PCP-driven markets
Significant clinical and corporate milestones ahead
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GPCRs and Ion Channels -
Proven Drug Targets
GPCRs and ion channels (IC)
Embedded proteins in surface membrane
of all cells
Mediate biological signaling in health /
disease
Clinically and commercially validated
targets:
40% of top selling drugs target GPCR/IC
Despite commercial success, side effects
and administration (ADME) issues remain
problematic
Opportunity for Predix
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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., Psychiatry
Res 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)
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Mechanism of PRX-00023
Potential to meet unmet needs:
Improved tolerability and side
effect 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
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PRX-00023 - Anxiety and Depression
Highly selective, once daily, long acting, small-molecule drug candidate
for the 5-HT1A receptor
Well tolerated in >200 humans to date
Dose dependent increase in brain-derived biomarker at doses 30 mg and
higher 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
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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
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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
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Sources: Espicom report, "CNS Drug Discoveries: What the Future Holds (Neurodegenerative)", June 2005; U.S. Census Internet Release, January 2004; Hebert
et al., Neurology 2004; Company Reports
Market Overview - Alzheimer's Disease
Significant unmet need for
therapy that will improve
symptoms and slow disease
progression
Aging of baby boomers will have
large impact on market size in
US
Aged 65+ will double over the
next 25 yrs to > 70M
44% increase predicted in
Alzheimer's prevalence
by 2025
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CNS Active 5-HT4 Agonist Potential
Stimulates brain
ACh production
or release for
symptomatic
improvement
Synergy with
cholinesterase
inhibitors
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PRX-03140 - Alzheimer's Disease
Well tolerated in >100 healthy volunteers in single dose and
multiple 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 consistent
with effects seen with approved drugs
Demonstrated synergy with cholinesterase inhibitors in
preclinical models
Phase IIa trial alone or with cholinesterase inhibitor planned
for second half of 2006
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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 Spontaneous
Alternation Test in Rats
**p<0.01
* p<0.05
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Overall mean placebo-adjusted alpha: theta ratio increased by ~ 0.3 on day 2 and 0.7 on day 10
PRX-03140 decrease in theta power in consistent with changes observed with effective doses of Aricept (Kogan et
al. Neural Transm. 2001. 108: 1167) and Exelon (Adler G, Brassen S. Neuropsychobiol 2001: 43: 273)
Previously, AD patients that were tacrine responders had an overall mean placebo-adjusted alpha:theta ratio increase of ~
0.3 with tacrine 40 mg (Almkvist et al., Demnt Geriatr Cogn Disord,2001)
Increase in Placebo-Adjusted Right Frontal Alpha: Theta Ratio
PRX-03140 Produces Desirable
Changes in qEEG in Alzheimer's Patients
P=0.04 for
difference in
medians (treatment
vs. placebo
control)
*
ns
0
0.05
0.1
0.15
0.2
0.25
0.3
Day 2
Day 10
R Frontal Alpha:
Theta Median Change From Baseline
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Pulmonary Hypertension (PH) Associated with
Chronic Obstructive Pulmonary Disease (COPD)
COPD is a slowly progressive disease of the airways
characterized by a gradual loss of lung function
PH develops in a subset of patients with moderate to severe COPD
Estimated to affect ~ 5 million people worldwide
Exercise and activities of daily living are significantly impaired
There are currently no approved drugs for PH associated
with COPD and current treatment options are limited
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Key Role of 5-HT2B in Lung
From Farber and Loscalzo. 2004. New England Journal of Medicine. 351:1655
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PRX-08066 - PH Associated with COPD
Highly selective, oral, small-molecule antagonist drug
targeting the 5-HT2B receptor
First-in-class for PH
Intended to:
Provide symptomatic relief through selective vasodilation
Slow disease progression by blocking signaling pathways
Phase I trial completed; excellent PK and tolerability profile
Phase Ib trial in hypoxia-induced PH (athletes) completed
Positive, preliminary results announced on April 20, 2006
Phase IIa trial in PH associated with COPD planned for
second half of 2006
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PRX-08066 Reduces Pulmonary Artery Pressure (PAP) During
Hypoxic Exercise in Conditioned Athletes
Phase Ib trial in 15 adults conditioned to exercise at high altitudes, with elevated pulmonary BP induced by hypoxia.
Ten of the 15 subjects completed all testing and were included in the current analysis.
At 200 mg bid (twice-daily), PRX-08066 caused a statistically significant, 40% reduction in the hypoxia-induced
increase in pulmonary systolic BP compared to placebo during hypoxia exercise (pooled data from days 1 and 3)
Effect of PRX-08066 during hypoxic exercise was similar to that seen in a clinical trial with Revatio(r) (Ghofrani et al.,
Ann Intern Med, 2004), a drug approved for PAH
Mean Changes in Systolic Pulmonary BP From Baseline During Hypoxic Exercise
P<0.05 for difference in
means (200mg bid vs.
placebo control)
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The New EPIX Pharmaceuticals
Poised for Growth & Opportunity
Expands addressable market
High-margin, growth-oriented pipeline focused on large markets like
cardiovascular disease, anxiety & depression, Alzheimer's disease
Seasoned, stable management team
Proven track record in multiple therapeutic areas, including:
Velcade(r), Vytorin(r), Accupril(r), Omnicef(r) and NitroStat(r)
Late-stage therapeutic and imaging product candidates
Excellent patent life
All product candidates internally-discovered
Value-enhancing partnerships
Significant discovery pipeline of proprietary product candidates
Near, mid and long-term value drivers
Approximately $125 million in cash and marketable securities at the end
of the first quarter
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EPIX/Predix:
Shaping a Future of Growth & Opportunity
June 2006
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THE FOLLOWING IS THE PRESS RELEASE ISSUED BY PREDIX ON JUNE 13, 2006
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NEWS RELEASE |
FOR IMMEDIATE RELEASE
CONTACT:
Sheryl Seapy, Pure Communications
949-608-0841
PHASE II CLINICAL DATA FOR PREDIXS LEAD DRUG CANDIDATE SHOW POSITIVE RESULTS IN GENERALIZED ANXIETY DISORDER
Results Presented at 46th Annual New Clinical Drug Evaluation Unit Meeting Show Efficacy in Anxiety Patients with Minimal Side Effects
LEXINGTON, Mass., June 13, 2006 Predix Pharmaceuticals, which recently announced a definitive
agreement to merge with EPIX Pharmaceuticals (Nasdaq:EPIX), announced today that a Phase II
clinical trial of its lead drug candidate, PRX-00023, showed significantly reduced symptoms and was
well-tolerated in the 21 patients with generalized anxiety disorder (GAD) participating in the
four-week, open-label study. The results are being presented at the 46th Annual New
Clinical Drug Evaluation Unit (NCDEU) meeting in Boca Raton, Fla.
Lead investigator Sanjay J. Mathew, M.D., Assistant Professor of Psychiatry at the Mount Sinai
School of Medicine, commented, The Phase II data suggest that PRX-00023 has the potential to meet
the significant unmet medical need for a once-daily treatment to relieve anxiety without the
troublesome side effects associated with many of the other drugs used to treat this disorder. A
Phase III clinical trial is ongoing with PRX-00023, and the results from that study will provide
further clinical insight into the efficacy and tolerability of this drug candidate in generalized
anxiety.
The Phase II data, which were reported by the Company last year, showed that the GAD patients
enrolled in the study had significantly reduced GAD symptoms from day 1, including the Hamilton
Anxiety Rating Scale (HAM-A). Six of the 19 patients (32%) with week 4 evaluations achieved
remission criteria based on the HAM-A, and 52% had a 50% or greater reduction in the HAM-A total
scale. Patients had a diagnosis of GAD, HAM-A screening scores of 20 or greater when they entered
the study, and had stopped taking other medicines for the treatment of anxiety.
Investigators noted a particularly low drop-out rate for this study in comparison to other studies
in generalized anxiety, which may indicate that PRX-00023 is well tolerated, stated Michael G.
Kauffman, president and CEO of Predix. GAD is a chronic illness, and if we continue to see
excellent tolerability in our Phase III studies, then we believe this will be an important
differentiator for PRX-00023 in this therapeutic area.
During the trial, patients initially received placebo for one week, and then were given PRX-00023,
a novel non-azapirone 5-HT1A selective agonist. PRX-00023 was administered once daily at 40 mg per
day for days 1 through 4, 80 mg for days 5 through 14, and 120 mg for days 15 through 28, and then
drug was stopped. There were no serious adverse events reported, no discontinuations due to
adverse events, no withdrawal symptoms following the 28 days of dosing, and no reports of ataxia,
dizziness, insomnia or sexual dysfunction. Additionally, no significant clinical laboratory, vital
sign, or ECG effects were observed.
PRX-00023 is currently being studied in patients with GAD in a Phase III clinical trial.. The
Phase III trial is an eight-week, double-blind, placebo-controlled, multi-center study. The trial
includes 25 sites in the United States and has enrolled approximately 310 patients with
moderate-to-severe GAD randomized equally into one of two arms: a placebo arm or a PRX-00023
treatment arm, in which patients receive a dose of 40 mg once daily for three days followed by 80
mg once daily for the remainder of the study. The primary objectives in this trial are to evaluate
the efficacy of PRX-00023 in GAD as measured by the change from baseline in the HAM-A scale, and to
assess the safety and tolerability of PRX-00023 during treatment of patients with GAD. The HAM-A
scale is the FDA-accepted standard for the evaluation of anti-anxiety activity, and it is used in
all pivotal trials of drug candidates for the treatment of GAD. This trial will be the first of at
least two pivotal trials with PRX-00023 for the treatment of GAD.
About PRX-00023
PRX-00023 is Predixs lead drug candidate and represents a novel, highly selective, non-azapirone
class of 5-HT1A agonists discovered using the companys proprietary G-Protein Coupled Receptors
(GPCR) modeling, screening and lead optimization technology. Buspirone is currently the only 5-HT1A
agonist approved in the United States for the treatment of anxiety, but is taken three times a day,
requires approximately three to four weeks of dose adjustment to reach therapeutic levels, and may
cause lightheadedness, nausea, headache and restlessness. Several other 5-HT1A agonists have shown
efficacy in Phase II and III clinical trials in depression. However, most of these drugs belong to
a chemical class of drugs called azapirones, and their development has been hindered by poor
tolerability at therapeutic doses, need for dosing up to three times daily, and by the requirement
of gradual dose escalation to effective doses because of side effects such as nausea, dizziness,
and restlessness which are thought to be caused by azapirones binding to non-5-HT1A GPCRs.
In contrast, PRX-00023 is designed to have minimal affinity for the GPCRs believed to be associated
with the side effects of 5-HT1A agonists that are in the azapirone chemical class, and to have a
more convenient dosing profile than azapirones. PRX-00023 has a half-life of 12 hours, allowing it
to be administered once daily.
The Journal of Medicinal Chemistry, the official peer-reviewed journal of the American Chemical
Society, recently published a paper highlighting PRX-00023s novel discovery process as
illustrative of a new paradigm in drug discovery utilizing in silico methods together with
medicinal chemistry that resulted in a substantially reduced discovery timeline for this drug
candidate.
About Predix Pharmaceuticals Holdings, Inc.
Predix, based in Lexington, MA, is a pharmaceutical company focused on the discovery and
development of novel, highly selective, small-molecule drugs that target G-Protein Coupled
Receptors (GPCRs) and ion channels. Using its proprietary drug discovery technology and approach,
Predix has advanced four internally-discovered drug candidates into clinical trials and has five
additional programs in preclinical development and discovery. Predix is expected to complete the
first of at least two pivotal Phase III clinical trials for generalized anxiety disorder for its
lead drug candidate, PRX-00023, in the second half of 2006. In addition to PRX-00023, Predix has
three other clinical-stage drug candidates: PRX-03140 for the treatment of Alzheimers disease,
which is expected to enter Phase IIa later this year; PRX-08066 for the treatment of pulmonary
hypertension (PH) and PH associated with chronic obstructive pulmonary disease, which recently
completed a Phase Ib trial and is expected to enter Phase IIa in mid-2006; and, PRX-07034, which
recently entered a Phase I trial and is expected to be developed for the treatment of obesity and
also cognitive impairment associated with Alzheimers disease or schizophrenia. Additional
information about Predix can be found on the companys website at www.predixpharm.com.
Additional Information About the Merger And Where To Find It
EPIX has filed a registration statement on Form S-4 with the Securities and Exchange Commission
containing a joint proxy statement/prospectus in connection with the proposed merger with Predix.
Investors and security holders are advised to read the joint proxy statement/prospectus (including
any amendments or supplements thereto) regarding the proposed merger because it contains important
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 their approval
of the proposed transaction. Investors and security holders may obtain a free copy of the joint
proxy statement/prospectus and any amendments or supplements thereto and other documents filed by
EPIX at the Securities and Exchange Commissions web site at www.sec.gov. The joint proxy
statement/prospectus and such other documents may also be obtained 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 of management
and employees may be deemed to be participants in the solicitation of proxies with respect 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 the merger is included in the registration statement containing the
proxy statement/prospectus that has been filed with the Securities and Exchange Commission and is
available free of charge as indicated above.
Safe Harbor Statement
Certain statements in this news release concerning Predixs business are considered
forward-looking statements within the meaning of the Private Securities Litigation Reform Act of
1995. These statements include, but are not limited to, those relating to the timing and results of
future clinical development of PRX-00023, the potential efficacy of PRX-00023 and the expected
safety and tolerability of PRX-00023 as compared to other drugs treating anxiety. Any or all of
the forward-looking statements in this press release can be affected by inaccurate assumptions
Predix might make or by known or unknown risks and uncertainties, including, but not limited to:
the early stage of product development; uncertainties as to the future success of ongoing and
planned clinical trials; and the unproven safety and efficacy of products under development.
Consequently, no forward-looking statement can be guaranteed, and actual results may vary
materially. Predix undertakes no obligation to publicly update forward-looking statements, whether
because of new information, future events or otherwise, except as required by applicable law.
###
EPIX has filed a registration statement on Form S-4 with the Securities and Exchange Commission
containing a joint proxy statement/prospectus in connection with the proposed merger with Predix
Pharmaceuticals. Investors and security holders are advised to read the joint proxy
statement/prospectus (including any amendments or supplements thereto) regarding the proposed
merger because it contains important 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 their approval of the proposed transaction. Investors and security holders
may obtain a free copy of the joint proxy statement/prospectus and any amendments or supplements
thereto (when they are available) and other documents filed by EPIX at the Securities and Exchange
Commissions web site at www.sec.gov. The joint proxy statement/prospectus and such other documents
may also be obtained 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 of management
and employees may be deemed to be participants in the solicitation of proxies with respect 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 the merger is included
in the registration statement containing the joint proxy statement/prospectus filed with the
Securities and Exchange Commission and available free of charge as indicated above. Information
regarding EPIXs executive officers and directors is also available in EPIXs Form 10-K, as
amended, for the year ended December 31, 2005, which was filed with the Securities and Exchange
Commission on March 1, 2006 and amended on April 28, 2006. You can obtain free copies of these
documents using the contact information above.