corporate presentation 2776 university drive coral springs, fl usa phone: (954) 509-0911 fax: (877)...
TRANSCRIPT
CORPORATE PRESENTATION
2776 University DriveCoral Springs, FL USA
Phone: (954) 509-0911Fax: (877) 895-5647
[email protected] www.NutraPharma.com
September 2010
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NSAFE HARBOR
Statements made in the course of this presentation that state the
Company’s or management’s intentions, hopes, beliefs, expectations or
predictions of the future are forward-looking statements. It is important to
note that the Company’s actual results could differ materially from those
projected in such forward-looking statements. Additional information
concerning factors that could cause actual results to differ materially from
those in the forward-looking statements is contained from time to time in
the Company’s SEC filings, including but not limited to the Company’s
report on Form 10-K for the year ended December 31, 2009; the Company’s
report on Form 10-Q for the quarter ended June 30, 2010. Copies of these
filings may be obtained by contacting the Company or the SEC.
OVERVIEW
Nutra Pharma is a biotechnology company specializing
in the acquisition, licensing and commercialization of
pharmaceutical products and technologies for the
management of neurological disorders, cancer,
autoimmune and infectious diseases.
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INTRODUCTION
Nutra Pharma, through its subsidiaries, carries out basic drug discovery
research and clinical development. The Company also manufactures,
through its subsidiary over-the-counter (OTC) drug products for the
treatment of moderate to severe chronic pain. These pain relievers are sold
under the brands Cobroxin and Nyloxin.
Drug Development
In addition to manufacturing Cobroxin and Nyloxin, ReceptoPharm is also developing proprietary therapeutic
protein products primarily for the prevention and treatment of viral and neurological diseases, including
Multiple Sclerosis (MS), Adrenomyeloneuropathy (AMN), and Human Immunodeficiency Virus (HIV), and
pain in humans. Outside of its role as the drug discovery arm for Nutra Pharma, ReceptoPharm provides
contract research services through its ISO class 5 and GMP certified facilities.
Medical Devices
Designer Diagnostics is the wholly-owned medical devices subsidiary of Nutra Pharma. The Company was
established in 2005 for the marketing and sales of rapid diagnostics test kits for infectious diseases,
including Nontuberculous Mycobacteria (NTM) and Tuberculosis (TB).
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MANAGEMENT TEAM
Name
Rik J. Deitsch Chairman and Chief Executive Officer, Nutra Pharma
Paul F. Reid, Ph.D. Chief Executive Officer, ReceptoPharm
Neil Roth President, Designer Diagnostics
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BOARD OF DIRECTORS
Name
Rik J. Deitsch Chairman and Chief Executive Officer, Nutra Pharma
Harold H. Rumph Director
Dr. Stewart Lonky, MD Director
Garry R. Pottruck Director
MARKETED PAIN RELIEVERS
Nutra Pharma manufactures and markets over-the-
counter (OTC) drug products for the treatment of
moderate to severe chronic pain. These products are
sold under the Cobroxin and Nyloxin brands.
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SCOBROXIN OVERVIEW
Cobroxin is the first over-the-counter (OTC) pain reliever clinically proven
to treat Stage 2 (moderate to severe) chronic pain.
Cobroxin was launched in August 2009 and is available as an oral spray for treating lower back pain,
migraines, neck aches, shoulder pain, cramps and neuralgia and as a topical gel for treating joint pain and
pain associated with repetitive stress and arthritis.
Additional Benefits to Cobroxin Include:
• All Natural
• Non-Addictive
• Non-Narcotic
• Non-Opiate
• Long Lasting
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SCOBROXIN OVERVIEW
Cobroxin is currently sold at the following retailers:
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SNYLOXIN OVERVIEW
Nyloxin is available an over-the-counter (OTC) pain reliever clinically
proven to treat Stage 2 (moderate to severe) and Stage 3 (severe) chronic
pain.
Nyloxin was launched in mid-2010 as an oral spray for treating back pain, neck pain, headaches, joint pain,
migraines, and neuralgia, and as topical gel for treating joint pain, arthritis pain and pain from repetitive stress.
Nyloxin is available in both everyday strength and extra strength.
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SMARKET POTENTIAL
Pain is the single most common reason patients seek medical care and
accounts for half of all physician office visits in the United States.
According to the American Pain Foundation, each year, more than 25 million people in the United States
experience acute pain as a result of injury or surgery. Additionally, more than 50 million people in the United
States are affected by ongoing chronic pain.
Both Cobroxin and Nyloxin:
1. Make potent pain relief accessible to:
• People without healthcare insurance (42 million)
• People without prescription coverage
• People afraid of opiate side effects
• People subject to drug screening for work
• People for whom OTC NSAIDs didn’t work and are just living with the pain
• Doctors afraid to prescribe opiates
2. Target consumers not well-served by current products
DRUG DISCOVERY
Nutra Pharma’s wholly-owned drug discovery
subsidiary, ReceptoPharm, conducts research into a
number of products with applications for neurological,
immunological, autoimmune and viral conditions.
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DRUG DISCOVERY OVERVIEW
Nutra Pharma’s wholly-owned subsidiary, ReceptoPharm, is developing
proprietary therapeutic protein products for the billion-dollar biologics
market. The Company has two leading drug candidates: RPI-MN and RPI-
78M.
RPI-MN
RPI-MN inhibits the entry of several viruses that are known to cause severe neurological damage in such
diseases as encephalitis and Human Immunodeficiency Virus (HIV). It is being developed first for the
treatment of HIV.
RPI-78M
RPI-78M is being developed for the treatment of Multiple Sclerosis (MS) and Adrenomyeloneuropathy
(AMN). Other neurological disorders that may be served by RPI-78M include Myasthenia Gravis (MG) and
Amyotrophic Lateral Sclerosis (ALS).
RPI-78M and RPI-MN contain anticholinergic peptides that recognize the same receptors as nicotine
(acetylcholine receptors) but have the opposite effect. In a specific chemical process unique to
ReceptoPharm, the drugs are created through a process of chemical modification.
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BENEFITS OF RPI-MN AND RPI-78M
RPI-MN and RPI-78M possess several desirable properties as drugs:
1. They lack measurable toxicity but are still capable of attaching to and affecting the target site on the nerve cells.
This means that patients cannot overdose.
2. They display no serious adverse side effects following years of investigations in humans and animals.
3. They are extremely stable and resistant to heat, which gives the drugs a long shelf life. The drugs' stability has
been determined to be over 4 years at room temperature. This is extremely unusual for a biologic drug.
4. They are easy to administer.
5. RPI-78M can be administered orally -- a first for a biologic MS drug. This will present MS patients with additional
quality of life benefits by eliminating the requirement for routine injections.
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SPECIFIC BENEFITS OF RPI-MN
Benefits of Nutra Pharma’s HIV/AIDs Treatment
RPI-MN Fuzeon by Roche/Trimeris
Mutations are not Created Mutations are Created
Relatively Inexpensive Very Expensive – Twice Current Therapies
No Significant Adverse Side Effects Adverse Side Effects Present – Some Severe
Long Shelf Life Limited Shelf Life
Patient Does Not Develop Resistance Patient Develops Immune Resistance
Easy to Manufacture Difficult Manufacturing Leads to Limited Use
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SPECIFIC BENEFITS OF RPI-78M
Benefits of Nutra Pharma’s Multiple Sclerosis (MS) Treatment
RPI-78M Competitive Drugs
Disease Progress Stops Disease Progression Only Slows
Patient Condition Improves No Claims Against Patient Improvement
No Significant Adverse Side Effects Adverse Side Effects Present – Some Severe
Long Shelf Life Limited Shelf Life
Resistant to Heat Requires Refrigeration
Patient Does Not Develop Resistance Patient Develops Immune Resistance
Improves Quality of Life No Evidence for Quality of Life Improvement
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RESEARCH & DEVELOPMENT PIPELINE
ReceptoPharm's research and development pipeline consists of several novel
therapies in various stages of development to prevent and/or treat Multiple
Sclerosis (MS), Human Immunodeficiency Virus (HIV), Adrenomyeloneuropathy
(AMN), Herpes, Rheumatoid Arthritis (RA) and Pain.
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PUBLISHED RESEARCH
Cobratoxin Inhibits Pain-Evoked Discharge of Neurons in Thalamic Parafascicular
Nucleus in Rats: Involvement of cholinergic and serotonergic systems // Toxicon (April 2009)
Alpha Cobratoxin as a Possible Therapy for Multiple Sclerosis: A Review of the
Literature leading to Its Development for This Application // Critical Reviews™ in Immunology
(Volume 27 / Issue 4 2007)
Analgesic Effects of Receptin, a Chemically Modified Cobratoxin from Thailand Cobra
Venom // Neuroscience Bulletin (September 2006)
Amelioration of Acute and Relapsing Stages of the Experimental Allergic
Encephalomyelitis by Cobra Toxins // Biomedical Sciences Instrumentation (June 2006)
A Long-Form a-Neurotoxin from Cobra Venom Produces Potent Opioid-Independent
Analgesia // Acta Pharmacologica Sinica (April 2006)
A Short-Chain a-Neurotoxin from Naja naja atra Produces Potent Cholinergic-
Dependent Analgesia // Neuroscience Bulletin (March 2006)
CONTRACT RESEARCH SERVICES
ReceptoPharm has installed the pathways to
develop, produce and supply clinical material for
Phase I and II studies at the highest levels. In
2008, the Company began offering services
catering to small and start-up biotechnology
companies.
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SPARTNERING WITH RECEPTOPHARM
As a clinical stage company specializing in biologics, ReceptoPharm has
cleared many of the hurdles that face emerging biotech companies. Below
are the top reasons that companies choose to partner with ReceptoPharm
as its CRO:
1. Therapeutic experience encompassing infectious disease, autoimmune conditions, neurological disorders
and oncology indications.
2. A renowned team of scientists, led by Dr. Paul Reid, specializing in human and veterinary regulatory
affairs for the United States, Canada, and Europe, and drug applications (pre IND, IND and Orphan),
drug production, new drug development, clinical trial design, patient monitoring, and experimental design.
3. Significant investment in establishing a production facility to meet US and EU standards, including the
installation of quality systems to meet GMP standards and ISO Class 5 certification.
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SA GLOBAL VIEW ON DRUG DEVELOPMENT
ReceptoPharm prides itself on taking a global view on drug development;
whether it’s preparing submissions, protocols, formulations, or organizing
clinical trials internationally.
ReceptoPharm has invested heavily in establishing its own production facility to meet US and EU standards,
including the installation of quality systems to meet GMP standards. Its commitment to maintaining the
highest quality standards can now be used as a resource by other biopharmaceutical companies.
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STOP-RATED DRUG PRODUCTION FACILITIES
Establishing and maintaining a qualified drug production facility can
represent a significant drain on a small company’s resources.
ReceptoPharm understands that its investment in manufacturing and its first-hand knowledge in drug
discovery and development can be very valuable assets to small companies that do not have these
resources or capabilities in-house. Working with ReceptoPharm, through its ISO class 5 and GMP certified
facilities, will allow these companies to avoid considerable clinical development expenses and allow them to
focus on a more important task, expeditiously getting their products to the next stage.
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SPRE-PRODUCTION STUDIES
Stability Studies
Formulation
Adventitious Viral Testing
Preservative Efficacy Testing
Assay Development/Potency Testing
Methods Development
CONTRACT MANUFACTURING SERVICES
US & EU REGULATORY SUPPORT
FDA Drug Applications, IND Preparation
EU Submissions, IMPD Preparation
QUALITY SYSTEMS/GMP CERTIFICATION
Installation of Quality Systems Using Our SOPs
GMP Audits
GMP Training
QA Function
IQ/OQ/PQ
Validations (Equipment and Processes)
STERILE FILLING CAPABILITIES
ReceptoPharm can manually fill a variety of drug
products for your clinical development projects in
the US and EU. While ReceptoPharm specializes in
biologics, including mAbs, natural, recombinant and
synthetic proteins, it can also prepare and fill
pharmaceutical products in its ISO class 5
cleanroom facilities.
Drug Formulation
ISO 5 Sterile Filling Suite, Single and Multi-Dose
Liquids for Injection
Clinical Trial Supplies to FDA & EU Requirements
Packaging and Shipment to Sites
Release Testing and Certification
MEDICAL DEVICES
Nutra Pharma’s wholly-owned drug discovery
subsidiary, Designer Diagnostics, is a biotechnology
sales and marketing company founded for the sale of
diagnostics test kits for infectious diseases.
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LEADING TEST KIT TECHNOLOGY
Designer Diagnostics Test Kits provide a highly cost effective, highly
efficient, low infrastructure solution for identifying and testing sensitivity of
Nontuberculous Mycobacteria (NTM) that are capable of utilizing paraffin
wax as a sole carbon source or those that are hydrophobic. Additionally
Designer Diagnostics provides an efficient solution for the rapid
identification and sensitivity testing of Tuberculosis (TB).Benefits of Test Kit Technology
Ability to Provide Much Earlier Diagnosis (Less than 1 Week)
Long Shelf Life
Can be Stored in Extremely Hostile Environments
Cost Effective Compared to All other Traditional Methods
Does not Require New Large Capital Expenditures
Can be Easily Integrated into Any Lab Environment from the Most Advanced to a Simple Mobile Lab
Results can be Quickly Translated into PCR Testing and Other Antibiotic Sensitivity Testing Techniques
CONTACT NUTRA PHARMA
2776 University DriveCoral Springs, FL 33065
Phone: (954) 509-0911Fax: (877) 895-5647
[email protected] www.NutraPharma.com