UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d)
of
the Securities Exchange Act of 1934
Date
of Report (Date of earliest event reported): May 15, 2006
ALTEON
INC.
(Exact
name of registrant as specified in its charter)
|
Delaware
|
001-16043
|
13-3304550
|
||
|
(State
or other jurisdiction
of
incorporation)
|
(Commission
File Number)
|
(IRS
Employer
Identification
No.)
|
6
Campus Drive
Parsippany,
New Jersey 07054
(Address
of principal executive offices and zip code)
Registrant’s
telephone number, including area code: (201) 934-5000
Check
the
appropriate box below if the Form 8-K filing is intended to simultaneously
satisfy the filing obligation of the registrant under any of the following
provisions:
[X]
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
[X]
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
o
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange
Act
(17 CFR 240.14d-2(b))
o
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange
Act
(17 CFR 240.13e-4(c))
Kenneth
I. Moch, President and Chief Executive Officer of Alteon Inc. (“Alteon”), will
participate in the Rodman & Renshaw 3rd Annual Global Healthcare Conference
in Monaco on Monday, May 15, 2006 at 5:35 pm (11:35 am, ET), as previously
announced on May 3, 2006. In addition, Noah Berkowitz, M.D., Ph.D., President
and Chief Executive Officer of HaptoGuard, Inc. (“HaptoGuard”), who is expected
to become President and CEO of Alteon upon the closing of a previously-announced
merger between the two companies, will review Alteon and HaptoGuard’s clinical
programs. The previously-announced merger is subject to approval of Alteon
and
HaptoGuard stockholders and is expected to close in the third quarter of
2006.
The presentation will be webcast and accessible at Alteon's website,
www.alteon.com.
The
presentation is attached hereto as Exhibit 99.1 and incorporated herein by
reference.
Participants
in the Solicitation
In
connection with the proposed merger, Alteon Inc. and HaptoGuard, Inc. will
be
filing a joint proxy statement with the Securities and Exchange Commission.
Investors and security holders of Alteon Inc. and HaptoGuard, Inc. are
advised
to read the joint proxy statement regarding the proposed merger referred
to in
this communication when it becomes available because it will contain important
information. Alteon Inc. and HaptoGuard, Inc. expect to mail the joint
proxy
statement about the proposed merger to their respective stockholders. In
addition to the proxy statement, Alteon Inc. files annual, quarterly, and
special reports, proxy statements and other information with the Securities
and
Exchange Commission. Investors and security holders may obtain a free copy
of
the proxy statement and any other documents filed by Alteon Inc. at http://www.sec.gov
and
directly from Alteon Inc.
Alteon
Inc. and its officers and directors may be deemed to be participants in
the
solicitation of proxies from stockholders of Alteon Inc. with respect to
the
proposed merger. Information regarding such officers and directors is included
in Alteon Inc.’s Annual Report on Form 10-K for the fiscal year ended
December 31, 2005 and in its proxy statement for the 2006 annual meeting,
which will be filed with the Securities and Exchange Commission. Once filed,
these documents are available free of charge at the Securities and Exchange
Commission’s website at http://www.sec.gov
and
directly from Alteon Inc.
HaptoGuard,
Inc. and its officers and directors may be deemed to be participants in
the
solicitation of proxies from stockholders of HaptoGuard, Inc. HaptoGuard,
Inc.
is a private company and does not file annual or quarterly reports with
the SEC.
(d)
Exhibit.
99.1 Presentation.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant
has
duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
| ALTEON INC. | ||
| |
|
|
|
Dated:
May 15, 2006
|
By: | /s/ Kenneth I. Moch |
|
Kenneth
I. Moch
President
and Chief Executive
Officer
|
||
This
presentation is copyright ©2006
by Alteon Inc.
Any
duplication, use or distribution of this presentation is strictly prohibited
without prior written authorization from Alteon
Inc.
This
presentation is copyright ©2006
by
Alteon Inc.
Any
duplication, use or distribution of this presentation is strictly prohibited
without prior written authorization from Alteon
Inc.
ALTEON
“The
Anti-A.G.E.ing Company”
Breakthrough
Medicines For Cardiovascular Aging and
Diabetic Complications
Diabetic Complications
Rodman
&
Renshaw 3rd
Annual
Global Healthcare Conference
May
15, 2006
Kenneth
I.
Moch
President
& CEO
Alteon
Inc.
Noah
Berkowitz, M.D., Ph.D.
President
& CEO
HaptoGuard,
Inc.
Safe
Harbor
Statement
Certain
statements
made in the course of this presentation may be forward-looking and involve
a
number of risks and uncertainties, including, but not limited to:
number of risks and uncertainties, including, but not limited to:
Our
technology and
product development efforts (including the possibility that early clinical
trial
results
may not be predictive of results that will be obtained in large-scale testing or the possibility that any
clinical trials may not demonstrate sufficient safety and efficacy to obtain requisite approvals or result
in marketable products)
may not be predictive of results that will be obtained in large-scale testing or the possibility that any
clinical trials may not demonstrate sufficient safety and efficacy to obtain requisite approvals or result
in marketable products)
Anticipated
operating losses and capital
Anticipated
regulatory filing dates and clinical trial initiation dates
Our
estimates
regarding our capital requirements and our needs for additional financing
Our
ability to
obtain sufficient additional financing in near term
Uncertainties
associated with obtaining and enforcing our patents and with the patent rights
of others
Our
selection and
licensing of product candidates
Technological
change
and competition
Our
ability to
attract collaborative partners and other third parties with acceptable
development,
regulatory and commercialization expertise
regulatory and commercialization expertise
Our
ability to form
and maintain collaborative relationships, including those relating to the
development
and
commercialization of our product candidates
Other
risks
identified in Alteon’s filings with the Securities and Exchange Commission
Actual
results,
events or performance may differ materially. Alteon undertakes no
obligation to publicly
release the result of any revision to these forward-looking statements that may be made to reflect events
or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
release the result of any revision to these forward-looking statements that may be made to reflect events
or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
Diabetes
and
Cardiovascular Synergy:
Merging Alteon and HaptoGuard
Merging Alteon and HaptoGuard
Deal
Parameters
Technology
Synergies
New Management Team
New Members of the
Board
Renegotiated
Agreement and Rights Granted to
Genentech
Small Transitional
Financing
Detailed
View of the
Post-Merger Cardiovascular Product Pipeline
New Eyes on
Alteon’s Alagebrium: CHF Patients With
Diastolic
Dysfunction (Chronic)
Introducing
HaptoGuard’s ALT-2074: A Pharmacogenomic
Approach
to Post-MI
M/M Reduction (Acute)
Diabetes
and
Cardiovascular Synergy
Alteon
HaptoGuard
Focus
on
novel
therapeutics
for
cardiovascular
aging
and
diabetic
complications
Focus
on
novel
therapeutics
for
inflammation
in
cardiovascular
disease
and
diabetes
Alteon/HaptoGuard: Synergistic
Technologies
With Two Phase 2 Compounds
With Two Phase 2 Compounds
A
new company with a
promising product pipeline focused on:
ALT-2074,
HaptoGuard’s lead compound, a glutathione
peroxidase mimetic in development for reduction of mortality
in post-myocardial infarction patients with diabetes.
peroxidase mimetic in development for reduction of mortality
in post-myocardial infarction patients with diabetes.
Alagebrium
chloride
(formally ALT-711), Alteon’s lead
compound, an Advanced Glycation End-product Crosslink
Breaker being developed for heart failure in diabetics with
compound, an Advanced Glycation End-product Crosslink
Breaker being developed for heart failure in diabetics with
diastolic
dysfunction.
Alteon/HaptoGuard:
A “Transforming Transaction”
A
acquires all
outstanding
H
equity
H
receives $5.3m
A
common shares
(~22.5m)
G
receives milestones
and royalties on
and royalties on
alagebrium
G
receives ~13.5m
A
common shares
upon
conversion of
A
preferred
stock
G
returns remaining
preferred
stock,
which
is
cancelled
A
H
G
A
sells 10.3 million
units
of common
stock
and
warrants for
~$2.5m
G
receives right of
1st
negotiation
to
H
lead
compound
H
receives
A
preferred
stock
held by
G
valued
at
$3.5m (= ~14.9m
A
common
shares)
Alteon/HaptoGuard:
“The Deal”
A
acquires all
outstanding
H
equity
H
receives $5.3m
A
common shares
(~22.5m)
A
H
G
A
sells 10.3 million
units
of common
stock
and
warrants for
~$2.5m
G
receives right of
1st
negotiation
to
H
lead
compound
H
receives
A
preferred
stock
held by
G
valued
at
$3.5m (= ~14.9m
A
common
shares)
G
receives milestones
and royalties on
and royalties on
alagebrium
G
receives ~13.5m
A
common shares
upon
conversion of
A
preferred
stock
G
returns remaining
preferred
stock,
which
is
cancelled
Post-Merger
Management Team
Upon
shareholder
approval, Alteon’s new management team will be as
follows:
follows:
Kenneth
I.
Moch, Chairman
Currently Chairman, President & CEO of Alteon
Noah
Berkowitz, M.D., Ph.D., President
& CEO
Currently
President & CEO of HaptoGuard
Malcolm
MacNab, M.D., Ph.D., Vice
President of Clinical Development
Currently
Chief
Medical Officer of HaptoGuard
Howard
B.
Haimes, Ph.D, Executive
Director, Preclinical Science
Currently Executive Director, Preclinical Science of
Alteon
Post-Merger
Board of Directors
From
Alteon’s
Current Board:
Kenneth
I. Moch, Chairman
- Director
of Alteon since December 1998
President
& CEO, Alteon; President & CEO, Biocyte Corporation; Mng.General
Partner, Catalyst Ventures; VP,
The Liposome Company
The Liposome Company
Marilyn
G. Breslow
- Director
of Alteon since June 1988
Former
President/Analyst, W.P. Stewart; General Partner, Concord Partners; VP, Dillon,
Read & Co.; Polaroid
Corp.; Peat Marwick
Corp.; Peat Marwick
Thomas
A. Moore
- Director
of Alteon since October 2001
Former
President & CEO, Biopure; President & CEO, Nelson Communications;
President, Procter & Gamble’s
Worldwide Prescription and OTC Healthcare Products
Worldwide Prescription and OTC Healthcare Products
George
M. Naimark, Ph.D
- Director
of Alteon since June 1999
President,
Naimark & Barba; President, Naimark & Associates
From
HaptoGuard’s
Current Board:
Noah
Berkowitz, M.D., Ph.D.
- Director
of HaptoGuard since November 2003
President &
CEO, HaptoGuard; VP Clinical Development, IMPATH; Founder, Physician Choice
Mary
Tanner
- Director
of HaptoGuard since January 2004
Principal and
Founder, Life Sciences Partners; Senior Managing Director, Bear Stearns;
Managing Director,
Lehman Brothers
Lehman Brothers
Wayne
P. Yetter
- Director
of HaptoGuard since August 2004
CEO Verispan;
President and CEO, Odyssey Pharmaceuticals; Chairman & CEO, Synavant; CEO
Astra
Merck; Executive at Pfizer, Merck, Novartis, IMS
Merck; Executive at Pfizer, Merck, Novartis, IMS
Alteon
Pro-forma Capitalization
Current
Alteon Shares Outstanding
(including
4/06 Financing) 68.3
Genentech
Common Shares upon
partial
preferred stock conversion 13.5
HaptoGuard
Shares
From
Genentech (=$3.5 million) 14.9
From
Alteon (=$5.3 million) 22.5
Total
Shares
Outstanding 119.2
Current
Warrants and Options 11.5
New
Financing Warrants 10.3
Fully
Diluted Shares 141.0
Shares
(Millions)
The
Post-Transaction Alteon
Multi-product
cardiovascular pipeline with focus
on
patients with
diabetes
Two
distinct NCE’s
in Phase 2 clinical trials
Additional
management with highly complementary
cardiovascular/diabetes
expertise
New
Board members
with extensive pharma and financing
expertise
Genentech
overhang
eliminated
New
financing
bridging towards shareholder vote
Proposed
Transaction Calendar
Financing Mid-April
2006
Complete
Proxy
Filed May
2006
SEC
Review May-June
2006
Shareholder 3Q
2006
Vote
Post-Transaction
Development Pipeline: Two Phase 2
Cardiovascular Compounds Plus Pipeline
Cardiovascular Compounds Plus Pipeline
Preclinical
Phase
1
Phase
2
Phase
3
NDA
Development
Drugs/Indications
Alagebrium
Alagebrium
Alagebrium
ALT-2074
AGE
Breakers
GPx
Mimetics
Discovery
2nd
Generation
Chronic
Heart Failure
Nephropathy
Retinopathy
Acute
Coronary Syndrome
Other
*
*
*Based
on outcome of
preclinical studies, may go directly to Phase 2
Segmenting
Large Markets:
Cardiovascular Complications of Diabetes
Cardiovascular Complications of Diabetes
--
Addressing Multi-billion Dollar Markets --
25-
44%
of
Diabetic
Patients
Prevalence:
~5
Million
(U.S.)
20-30%
Diabetic
Patients
Prevalence:
~13.9
Million (U.S.)
>
$5
BILLION/YEAR
(Worldwide
Estimate)
Sources:
AHA;
National Quality Measures Clearing House; Analyst Estimates
Alagebrium
Chronic
Heart Failure
ALT-2074
Acute
Coronary Syndrome
>
$10
BILLION/YEAR
(Worldwide
Estimate)
Mechanism
Markets
Management
Deal
Synergy
“The
possibility of widespread coronary inflammation has
important implications for research and therapy. It
challenges the widely accepted hypothesis that a single
vulnerable plaque is responsible for the development of
coronary instability.”
important implications for research and therapy. It
challenges the widely accepted hypothesis that a single
vulnerable plaque is responsible for the development of
coronary instability.”
July
2002:
Widespread Coronary Inflammation in Unstable Angina
“Epidemiological
and clinical studies have shown strong
and consistent relationships between markers of
inflammation and the risk of future cardiovascular events.”
and consistent relationships between markers of
inflammation and the risk of future cardiovascular events.”
2004:
Inflammation as a Cardiovascular Risk Factor
Circulation,
Journal of the American Heart Association
“The
physiological processes of thrombosis and
inflammation should not be viewed in isolation because they
greatly influence each other.”
inflammation should not be viewed in isolation because they
greatly influence each other.”
April
2005:
New Links Between Inflammation and Thrombosis
Arteriosclerosis,
Thrombosis, and Vascular Biology, Journal of
the American Heart Association
the American Heart Association
“
In
addition, glycation of LDL and other lipoproteins is quite
common in diabetes, thus making the lipoproteins of
diabetic patients more susceptible to oxidation and more
atherogenic.”
common in diabetes, thus making the lipoproteins of
diabetic patients more susceptible to oxidation and more
atherogenic.”
Feb.
2006:
Atherothrombosis, Inflammation and Diabetes
Sept.
2001:
Role of Inflammatory Biomarkers in
Prediction
of Coronary Heart Disease
“Early
atherosclerosis has an inflammatory component
characterized
by leucocytic infiltration of the vascular
endothelial
wall.”
Inflammation
in Chronic Heart Failure
and Acute Coronary Syndrome
and Acute Coronary Syndrome
The
Lancet
Related
Therapeutic Areas
Different Mechanisms of Action
Different Mechanisms of Action
Alagebrium
Targets
Advanced
Glycation
End
Products
(A.G.E.s)
Alagebrium
breaks
A.G.E.
Crosslinks
Restores
structure
and
function
of tissues
ALT-2074
Lipid
peroxides
cause
inflammation
ALT-2074
metabolizes
lipid
peroxides
Treats
acute
ischemic
injury
A.G.E.s
Induce Inflammation
Results
in
Expression
of
Growth
Factors and
Cytokines
IL-1
TNF
TGFß
NFß
eNOS
Resulting
Pathologies:
Vascular
Stiffening
Chronic
Heart Failure
Nephropathy
Source:
Diabetes,
Brownlee,
Vol.
54, June
2005
Intracellular
protein glycation
AGE
precursors
Glucose
Matrix
Intracellular
transducers
Transcription
factors
Glucose
DNA
Transcription
AGE
receptor
AGE
plasma
proteins
AGE
receptor
ROS
NF-ß
Macrophage
mesangial
cell
mRNA
Proteins
Integrins
Endothelial
cell
RNA
Impaired
filling
(elevated atrial
pressures)
Normal
or impaired
ejection
fraction
30-50%
of all heart
failure cases
70%
of elderly heart
failure
patients
No
current
therapy available
Alagebrium
reverses
ventricular and aortic stiffening associated
with
diastolic
dysfunction
Diastolic
dysfunction in heart failure:
Source:
William H. Luer, M.D.
Tulane
School of Medicine
Rationale
For Alagebrium in Heart Failure
Key
Clinical
Findings for Alagebrium
in Heart Failure
in Heart Failure
Meaningful
reduction in left
ventricular mass (p=0.036), in
ventricular mass (p=0.036), in
unprecedented
timeframe
Marked
improvement
in initial
phase
of left
ventricular diastolic
filling (p=0.045)
filling (p=0.045)
Statistically
significant
improvements in multiple QOL
measurements (p < 0.01)
improvements in multiple QOL
measurements (p < 0.01)
Sickest patient
population (class
III heart failure) benefited most
III heart failure) benefited most
Source:
Kitzman,
Zile, et al; Presented as Poster at Society
of
Geriatric
Cardiology Annual Meeting, 2003
*D
istensibility
Improvement
and
Remo
deling
in Diastolic
Heart
Failure
DIAMOND
Study
Source: Thohan,
Koerner, et al; Presented as Poster at the
American
Heart
Association Annual Meeting, 2005
Patients
with
Impaired Ejection
Fraction and
Diastolic Dysfunction: Efficacy and
Diastolic Dysfunction: Efficacy and
Safety
Trial
of Alagebrium
PEDESTAL
Study
Improvements
observed for:
Diastolic
function
(E/A, DT,
IVRT)
Hemodynamics
(LAP,
PASP)
LV
remodeling (LAV,
LVEDV,
LV
mass)
NYHA
score
No
alterations in
heart rate, blood
pressure
or physical
exam
Alagebrium:
A Novel “Therapeutic
Remodeling”
Agent
Breaks
A.G.E.
Crosslinks
Phase
1 and 2
clinical trials in >1000 patients:
Safe
and well
tolerated
Encouraging
Phase 2
data in CHF in 45 patients
Our
Strategy:
Chronic
heart
failure indication
Diabetic
patients
only
HaptoGuard
diagnostic test identifies highest risk
diabetic
patients
Alagebrium: Phase
2b Study in High Risk
Diabetic Patients With Diastolic Heart Failure
Diabetic Patients With Diastolic Heart Failure
Type Placebo
Control, 3
arm
Screened
with
HaptoGuard
Test
# of
Patients 200
Initiate 4Q
2006/1Q 2007
Duration 6
months dosing
First
Interpretable Q1
2008
Results
Centers 20;
U.S.; Target max
9 month
accrual
Endpoints Cardiac
function,
mass and
pressure,
clinical
endpoints
Source:
Adapted from
Pak H. Chan, J. Cereb Blood Flow Metab. Vol 22, No. 1, 2001
HaptoGuard
Focus: Lipid
Hydroperoxides in Cardiovascular Diseases
Hydroperoxides in Cardiovascular Diseases
Oxidized
lipid peroxides stimulate multiple pathological
inflammatory
and metabolic pathways
HaptoGuard’s
Lead Compound
Metabolizes
Oxidized Lipids
Orally
Dosed Phase 2
Small Molecule
>50 patients in Phase 1 & 2 - anti-inflammation
indication
>50 patients in Phase 1 & 2 - anti-inflammation
indication
Novel
Anti-Inflammatory Mechanism of Action
Glutathione
Peroxidase (GPx) Mimetic
Metabolizes
Lipid
Peroxides
Decreases
over-expression of key cytokines and messengers
Rapid
Action
Restores
Function
Acute,
ischemia-reperfusion protection without
hemodynamic
instability
instability
Source: Diabetes
2005; 54: 2802-2806
HP
1-1
HP
2-2
Haptoglobin
Typing Predicts Clinical Event Rate
Obvious Consequences for Clinical Trials
Obvious Consequences for Clinical Trials
Haptoglobin
Type and 30 Days Post MI Events in Diabetics
HP
1-1
HP
2-2
1-1
1-1
2-2
2-2
ALT-2074
Reduces MI Size in Hp 2-2 DM Mice
Mouse
model for
ischemia
reperfusion
injury
(controlled
heart
attack)
High
risk diabetic
mice,
genetically
engineered to
model
the human
condition
Occlusion
of the
coronary
artery
followed by
restoration
of blood
flow
Infarcts
are
represented
as
Infarct Area/Area
at
risk
0.5mg/kg
to 5mg/kg
of
ALT-2074
yielded
similar
results
Approximately
an 85% reduction in infarct size following
a
single
oral administration of ALT-2074
n=13
in each
group
P=0.001
0
5
10
15
20
25
30
35
40
45
50
Placebo
ALT-2074
Type Placebo-controlled,
2 arm
Initiated May
1, 2006
First
Interpretable Q4
2006
Results
#
of
Patients 60
Duration 5
days
Centers 5-10;
Israel, Czech
Republic
Endpoints Myocardial
Damage
(CK leak)
Holter,
clinical
events
ALT-2074:
Phase 2 Study in
High Risk Diabetic Patients Undergoing PCI
High Risk Diabetic Patients Undergoing PCI
Type Placebo
Controlled,
3-4 arm
Initiate Q3
2006
First
Interpretable Q1
2007
Results
#
Patients 60-80
Duration 28
days
Centers 1-2;
U.S.
Endpoints Safety
and Dose
Dependent
Changes
in
Inflammatory Markers
Status
at Q1
2007 - Increased safety database; dose of
Phase
2b
will be guided by anti-inflammatory marker results
ALT-2074:
Multi-Dose Phase 2 Study in
High Risk Diabetic Patients
High Risk Diabetic Patients
Anticipated
2006 Milestones
Q1
2006 ALT-2074
-
ACC Presentation of Proprietary
Animal
Model
- Completed
Q2
2006 ALT-2074
-
Initiate Phase 2 Study on Cardiac
Protection
Following Angioplasty in ACS
Patients
-Initiated
May 1, 2006
Q3
2006 ALT-2074
-
Initiate Phase 2 Anti-inflammatory
Biomarker
Trial
Q4
2006/ Alagebrium
-
Initiate Phase 2b CHF Trial
Q1
2007
Q4
2006 ALT-2074
-
Post Angioplasty Trial Results
Q1
2007 ALT-2074
-
Anti-inflammatory Biomarker
Trial
Results
ALTEON
This
presentation is copyright 2006 by Alteon Inc.
Any
duplication, use or distribution of this presentation is strictly prohibited
without prior written authorization from Alteon
Inc.
6
Campus
Drive
Parsippany,
NJ 07054
Tel: (201)
934-5000
Fax: (201)
934-8880
AMEX: ALT
www.alteon.com
TM
“The
Anti-A.G.E.ing Company”