EX-99.1 2 ex99_1.htm POWERPOINT PRESENTATION ex99_1.htm
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OneMedForum 2010
January 13, 2010
 
 

 
Forward Looking Statements
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the leader addressing
subclinical zinc deficiency
and
chronic copper toxicity
in the
mature population
Copyright © 2008 Pipex Pharmaceuticals, Inc.
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Copyright © 2008 Pipex Pharmaceuticals, Inc.
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NYSE-Amex Listed: AEN
Founded 2001
$6MM Personally Invested by Chairman
Went Public October 2006
$21MM @$2.00/share 2006-2007
Current Market Cap: $25MM @ $1.19 share
Daily Volume 725,000 shares/day
21MM Primary Outstanding Shares
+3MM Warrants & Options ($1.51 Avg. Exercise Price/Share)
$3,600,000 cash on hand 9/30/09
Average Burn Rate/Qtr. ~$790K
Adeona Corporate Overview
 
 

 
Copyright © 2008 Pipex Pharmaceuticals, Inc.
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    Launch Date/Status
HartLab: CLIA Certified Reference Lab 7/10/09
CopperProof™ Diagnostic Panel   11/9/09
Zinthionein™ ZC GS-150    Q1 2010
Zinc-Monocysteine    GRAS Process
Oral Estriol for MS    Phase II/III
Oral dnaJP1 for RA   Phase II Completed
Oral Flupirtine for FMS Phase II IND Approved
Product Pipeline
 
 

 
Copyright © 2008 Pipex Pharmaceuticals, Inc.
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David A. Newsome, M.D.
President, HealthMine Subsidiary
 Training:
  Duke University, A.B.
  Columbia University, M.D.
  Harvard Medical School, Ophthalmology Residency
   (Massachusetts Eye and Ear Infirmary)
  Harvard Medical School, Retina Disease and Surgery Fellowship
  Bascom Palmer Eye Institute, Retina Disease and Surgery Fellowship
 Research & Faculty Experience:
 – National Eye Institute (NIH)
 • Chief, Retinal Disease Section
 – Johns Hopkins, Wilmer Eye Institute, Associate Professor
 – LSU Eye Center, Professor
• Author, 150 Peer-Reviewed Publications and 2 books
 – Originated Zinc Hypothesis for Age-Related Macular Degeneration
 – 1988, Published First Clinical Trial, “Oral Zinc Supplementation for Age Related
 Macular Degeneration”
 – Currently marked as “Preservision”, “Ocuvite” “iCaps”
 • 2008 Sales ~ $300MM, B&L and Alcon
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Copyright © 2008 Pipex Pharmaceuticals, Inc.
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George J. Brewer, M.D.
Co-Founder, Chair SAB
• Chairman Emeritus, Department of Human Genetics, University of
 Michigan
• Foremost Authority on Chronic Copper Toxicity - Wilson’s disease,
 >500 Publications
• Member, EPA-Convened National Academy of Sciences -
 Committee on Copper in Drinking Water (2000)
• Drawbacks of Galzin®/Wilzin®:
 – Nausea in 90% of Patients, G.I. Irritation in 30% of Patients
 – 3X/day dosing away from meals
• Co-inventor, Adeona Modified-Release Oral Zinc Technology
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Galzin is a registered trademark of Gate Pharmaceuticals Inc.
 
 

 
Copyright © 2008 Pipex Pharmaceuticals, Inc.
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Diseases of Confirmed or Suspected
Copper/Zinc Dyshomeostasis
DISEASE
U.S. PERSONS
Wilson’s Disease
10,000
Dry Age-Related Macular Degeneration
17,000,000
Alzheimer’s Disease
5,800,000
Mild Cognitive Impairment
15,000,000
Parkinson’s Disease
400,000
Complications of Diabetes
23,000,000
 Estimated Total U.S. Persons
50,000,000
 
 

 
Copper’s
Involvement
in
Alzheimer’s
and Mild
Cognitive
Impairment
(COPPER)
(Copper)
(Copper)
(Copper)
(Copper)
(Copper)
Courtesy: NIA;
“Copper” Text Added.
 
 

 
 
 

 
5.3 Million Miles of Copper Tube in U.S.
 
 

 
Current EPA Limit of Copper in Water:
1.3mg/L
Average Home has About 1/10th the EPA Limit
 
 

 
 
 

 
 
 

 
Copper-Containing Multivitamins and
Cognitive Decline in the CHAP Study (2006)
• Chicago Health and Aging Project (CHAP)
• 3718 Chicago Residents over Age 65
• Cognition Tested at 0, 3 and 6 Years
• Copper-Containing Multivitamin Consumption
 Noted and Compared
• Consumers of Copper-Containing
 Multivitamins (i.e. 2mg/day) with a High Fat
 Diet had 6.51 Times the Rate of Cognitive
 Decline than Persons not taking Copper-
 Containing Multivitamins
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Morris MC et. al., Arch. Neurol. Vol. 63;1085-8 (Aug 2006)
Chicago Health and Aging Project (CHAP)
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Serum Copper Dyshomeostasis in AD & MCI
Free Copper Ions
0
0.0001
Homocysteine
<10
<0.5%
Ferroxidase II
<10
<0.5%
Extracellular SOD
<10
<0.5%
Factors V and VIII
<5
<0.5%
Metallothionein
<1
<0.1%
15-60kDa Proteins
40
<0.5%
Small Peptides
35
<0.5%
Albumin
150
 15%
Ceruloplasmin
700
70%
%
µg/L
Copper
Bound
To
Cerulo-
Plasmin
(Cp)
Free
Copper
Copper
Bound
To
Cerulo-
Plasmin
(Cp)
Free
Copper
Normal
Wilson’s
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Copyright © 2007 Pipex Pharmaceuticals, Inc.
Free
Copper
Copper
Bound
To
Cerulo-
Plasmin
(Cp)
 Alzheimer’s
& MCI
Linder et. al.
 
 

 
Serum Copper/Zinc Dyshomeostasis in
Alzheimer’s Disease
• Elevated Percent Serum Free Copper in AD
 – Distinguishes AD from Normals (Squitti et. al. 2005)
 – Prognostic for Cognitive Decline (Squitti et. al Jan. 2009)
 – Correlates with Cognitive Loss (Arnal N, et. al. Dec. 2009)
• Defective Ceruloplasmin (Squitti et. al. Jan. 2008)
 
 

 
CopperProof-1 Study
• 90 Subject Prospective, Observational, IRB-Approved
 Randomized Comparative Study
• Sponsored by Adeona
• The Alzheimer’s Center at Albany Medical Center - P.I. Earl
 Zimmerman, M.D.
• 30 Alzheimer’s, 30 Parkinson’s, 30 Age-Matched Normals
• Patients Recruited 2007-2008. Analysis Q1 2009
• Results Presented at ICAD (International Conference on
 Alzheimer’s Disease) July 15, 2009
 
 

 
• Acquisition by Adeona - July 10, 2009
• CLIA-Certified Laboratory, Chicago
• Launched CopperProof™ Panel - Nov. 2009
• Serum-Based Copper/Zinc Diagnostic Panel
• Diagnose and Grade Patients with
 Copper/Zinc Dyshomeostasis (AMD, AD, MCI,
 PD etc.)
• Dx-Rx Strategy - Zinthionein™ ZC GS-150
 
 

 
Zinthionein™ ZC GS-150 Oral Zinc
Gastroretentitive/Sustained Release Oral High Dose Zinc
Preparation
Convenient Once-a-Day Dosing (vs. 3X Galzin® or 2X
AREDS)
Broad Patent Protection Anticipated
100% GRAS Ingredients
Highest Single Dose Bioavailability of Oral Zinc in Humans
Extended Sustained Serum Zinc Levels Maintained
Proximal Metallothionein Induction
Intended Lower Instance of Nausea and Gastric Irritation
(vs. 90% for Galzin® at 1/3 Dose)
Planned Launch this Quarter
 
 

 
• Medical Foods:
 – Legislation Section 5 of Orphan Drug Act
 – GRAS Ingredients “Intended fro the Dietary
 Management of Disease or Condition not
 Satisfied by Normal Diet Alone”
 – Exempt from NDA Requirements
 – Must be Sold Under Doctors’ Supervision
 • Prescription Product
 • Distributed through Pharmacy Distribution
 Chain
 – Reimbursement Generally Available
Copyright © 2008 Pipex Pharmaceuticals, Inc.
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CopperProof-2 Clinical Trial
• First Controlled Clinical Trial of Zinc therapy for AD or MCI
• 60 Patient, Two Part, Double Blind, Randomized Placebo Controlled
 Trial of Once-Daily Zinthionein™ ZC GS-150 in AD and MCI Patients with
 Impaired Serum Copper/Zinc Status
• P.I. Diana Pollack, Alzheimer’s Center - Clearwater Hospital, Florida
• IRB Approved November 2nd, 2009
• 30 Day Washout Period for Copper Supplements
• Part I: Single Day Comparison to Galzin® and Placebo
 – Endpoint: Improved bioavailability and tolerability
• Part II: 6 Month, Double Blind Randomized Placebo Controlled Study
 – Endpoint: Cognition, MMSE and ADAS-Cog at 3 and 6 months
• Initial Data Expected Next Month (February)
* Zinthionein™ ZC contains 150mg elemental zinc
and does not contain zinc-monocysteine.
 
 

 
 - Issued Composition of Matter Patents
 • U.S. Patent 7,164,035, Issued Jan. 16, 2007
 • U.S. Patent 6,586,611, Issued July 1, 2003
 – Additional pending patents pending
 – Modified Release Zinc - GR, SR, High Dose, Once-Daily
 – Combination formulas
 – Copper-free formulas
 – Pill dispenser that incorporates eye self-test
 – Serum based diagnostic assays
 – Trademarks:
 • Zinthionein®, Eyedaily®, (888) EYE-DAILY,
 www.eyedaily.com
Copyright © 2008 Pipex Pharmaceuticals, Inc.
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ADDITIONAL CLINICAL PROGRAMS
FOR WHICH ADEONA IS SEEKING
BUSINESS DEVELOPMENT
OPPORTUNITIES
 
 

 
TRIMESTATM (oral estriol) for Multiple Sclerosis
• Approved in Europe & Asia for 40 years (No U.S.)
• Oral Version of Endogenous Pregnancy Hormone
 – Estriol or E3
• First Potential Oral Treatment for MS
• Developed by Rhonda Voskuhl M.D.
 – Chair UCLA MS Neurology Center
• Exclusively Licensed from UCLA
• Believed to be Responsible for:
 – Fetal Immune Privilege
 – Spontaneous Remission of Autoimmune Diseases
• Completed 22 Month Phase IIa Clinical Trial under
 funding from the NMSS
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Copyright © 2008 Pipex Pharmaceuticals, Inc.
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79% Reduction in MRI Lesions @ 3 Months (p=0.02)
Lower number of lesions and lower lesion volume while on Trimesta
New Enhancing Lesion Numbers
New Enhancing Lesion Volumes (mm3)
TRIMESTA (19-22)
Post Tx (16-18)
Post Tx (13-15)
Pre Tx (1-6)
*
*
*
*
*
Months Tx
Copyright © 2008 Pipex Pharmaceuticals, Inc.
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Improvement In Cognitive Function By
14% in 6 months (p=0.04)
6 RR Trimesta Tx (month 12)
6 RR Pre Tx (month 3)
4 SP Trimesta Tx (month 12)
4 SP Pre Tx (month 3)
All 10 Trimesta Tx (month 12)
All 10 Pre Tx (month 3)
*
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TRIMESTA™ Phase II/III Clinical Trial
• Phase II/III Clinical Trial In MS
 – 150 Patients, 71 Enrolled
 – 16 U.S. Centers
 – Double-Blind, 1:1 Placebo Design with Copaxone as Standard of Care
 – Female Relapsing-Remitting Patients
 – Funded by $5 Million NIH/National MS Society Grant
 • Largest Clinical Grant Ever Awarded by NMSS
 • Recent Additional $860,000 Grant under ARRA
 – Primary Endpoint
 • Relapse Rate at 2 Years with Interim Analysis at 1 Year
 – Secondary Endpoints
 • Cognitive Tests-PASAT
 • NAA levels
 • MRI
 • Hippocampus volume
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 Oral mucosal route induces immune tolerance
 to the epitope-specific antigens
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•Double-Blind, Placebo-Controlled Phase II Clinical Trial
 •Active RA patients
 •Background Therapy Medications Allowed
•11 Clinical Centers
 •Stanford, UCSD, U. Arizona, John Hopkins, Mayo Clinic
•Daily oral administration, 6 months
•160 patients: 1:1 randomization
•Enrollment criteria based on presence of both immunological reactivity to HSP-
dnaJP1 and clinically active disease
•Endpoints:
 •Clinical Endpoints: ACR 20, ACR50
 • ACR20: FDA approvable endpoint
 •Immunologic Endpoints
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Published Results of Phase II Study
• dnaJP1 appeared to be safe and well-tolerated.
• There was a significant reduction in the percentage of T cells producing the
 proinflammatory cytokine tumor necrosis factor alpha (TNF-alpha) (p < 0.0007).
• The primary efficacy end point (meeting the American College of Rheumatology
 20% improvement criteria at least once on day 112, 140, or 168) showed a
 difference between treatment groups (p=0.09) that became significant in post hoc
 analysis using generalized estimating equations (p=0.04).
• Differences in clinical responses were also found between treatment groups on
 day 140 and at follow up, indicative a durable response following discontinuation
 of therapy.
Arthritis & Rheumatism, Nov. 2009
 
 

 
• Oral flupirtine
 – Developed by Andrew Stoll M.D.
 • Experimental Pharmacology, McLean Hospital/Harvard University
 – Oral flupirtine, marketed in Europe since 1984
 • Potassium Channel Modulator
 • In-direct NMDA receptor antagonist
 • Non-opioid, centrally acting analgesic compound
 • New mechanism of action
 – Issued U.S. Patent, pending international patents
 – Pilot human results in refractory fibromyalgia patients
 • ~24 patients in fibromyalgia
 • ~150 patient clinical results in glaucoma, retinitis pigmentosa, diabetic retinopathy
 – Phase II ready clinical trial in refractory fibromyalgia
 • IND Approved
 • IRB Approval Received
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Steve H. Kanzer, CPA, JD
Chairman
Adeona Pharmaceuticals, Inc.
3930 Varsity Drive
Ann Arbor, Michigan 48108
Phone: (734) 332-7800
Fax: (734) 332-7878
www.adeonapharma.com
Copyright © 2010 Adeona Pharmaceuticals, Inc.
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