Slide 1: OneMedForum 2010
OneMedForum 2010 January 13, 2010
Slide 2: Forward-looking statements
This presentation includes forward-looking statements on Adeona’s current expectations and projections about future events. In some cases forward-looking statements can be identified by terminology such as "may," "should," “potential,” "continue," "expects," "anticipates," "intends," "plans," "belie
Slide 3: The leader addressing subclinical zinc deficiency and chronic copper toxicity
Copyright © 2008 Pipex Pharmaceuticals, Inc. the leader addressing subclinical zinc deficiency and chronic copper toxicity in the mature population
Slide 4: Adeona Corporate Overview
Copyright © 2008 Pipex Pharmaceuticals, Inc. 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 (
Slide 5: Product Pipeline
Copyright © 2008 Pipex Pharmaceuticals, Inc. 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
Slide 6: Copyright
Copyright © 2008 Pipex Pharmaceuticals, Inc.
Slide 7: David A. Newsome, M.D.
AMEX: PP Copyright © 2008 Pipex Pharmaceuticals, Inc. 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 Sur
Slide 8: George J. Brewer, M.D.
AMEX: PP , Inc. 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 Dr
Slide 9: Diseases of Confirmed or Suspected Copper/Zinc Dyshomeostasis
Copyright © 2008 Pipex Pharmaceuticals, Inc. 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 5
Slide 10: Copper's Involvement in Alzheimer's and Mild Cognitive Impairment
(COPPER) (Copper) (Copper) (Copper) (Copper) (Copper) Copper’s Involvement in Alzheimer’s and Mild Cognitive Impairment Courtesy: NIA; “Copper” Text Added.
Slide 11: Annual Alzheimer's-Copper Research Publications
Annual Alzheimer’s-Copper Research Publications —_— 70
Slide 12: 5.3 Million Miles of Copper Tube in U.S.
5.3 Million Miles of Copper Tube in U.S.
Slide 13: Current EPA Limit of Copper in Water
Current EPA Limit of Copper in Water: 1.3mg/L Average Home has About 1/10 th the EPA Limit
Slide 14: Copper-Containing Vitamins
Copper-Containing Vitamins
Slide 15: iiigiar gemma seesne es
iiigiar gemma seesne es —~— : ~ oO & O — Oo oO) = Oo) < ne) S ca) is = © i) muy 2 © la
Slide 16: Copper-Containing Multivitamins and Cognitive Decline in the CHAP Study
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 Multiv
Slide 17: Chicago Health and Aging Project (CHAP)
Morris MC et. al., Arch. Neurol. Vol. 63;1085-8 (Aug 2006) Chicago Health and Aging Project (CHAP)
Slide 18: 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% AMEX: PP Copyright © 2007 Pipex Pharmaceuticals, Inc. Se
Slide 19: Serum Copper/Zinc Dyshomeostasis in Alzheimer's Disease
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 Ceruloplas
Slide 20: CopperProof-1 Study
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
Slide 21: HartLab and CopperProof Panel
• 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
Slide 22: Zinthionein ZC GS-150 Oral Zinc
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
Slide 23: Medical Foods
Copyright © 2008 Pipex Pharmaceuticals, Inc. • 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 • Pres
Slide 24: CopperProof-2 Clinical Trial
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
Slide 25: Issued Composition of Matter Patents
Copyright © 2008 Pipex Pharmaceuticals, Inc. - 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-
Slide 26: Additional Clinical Programs for Which Adeona Is Seeking Business Development Opportunities
ADDITIONAL CLINICAL PROGRAMS FOR WHICH ADEONA IS SEEKING BUSINESS DEVELOPMENT OPPORTUNITIES
Slide 27: Trimesta (oral estriol) for Multiple Sclerosis
AMEX: PP Copyright © 2008 Pipex Pharmaceuticals, Inc. TRIMESTA TM (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
Slide 28: 79% Reduction in MRI Lesions
Copyright © 2008 Pipex Pharmaceuticals, Inc. 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) * * * * * Mont
Slide 29: Improvement in Cognitive Function
* 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)
Slide 30: Trimesta Phase II/III Clinical Trial
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 G
Slide 31: Oral dnaJP1 for Rheumatoid Arthritis
Oral dnaJP1 for Rheumatoid Arthritis Oral, Epitope-Specific Immune Tolerance Therapy for RA Antigenic 16-mer Peptide Responsive to 75% of RA Patients Derived from heat shock protein (HSP) « Elevated during cellular stress in majority of Rheumatoid Arthritis (RA) patients « Found in synovial joints T
Slide 32: Oral mucosal route induces immune tolerance
Oral mucosal route induces immune tolerance to the epitope-specific antigens
Slide 33: Double-Blind, Placebo-Controlled Phase II Clinical Trial
• 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 o
Slide 34: Published Results of Phase II Study
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 Co
Slide 35: Oral flupirtine
• 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
Slide 36: Steve H. Kanzer, Chairman
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.