CORPORATE PRESENTATION 1537 NW 65th Avenue Plantation, FL 33313 USA Phone: (954) 321-8988 Fax: (954)...

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CORPORATE PRESENTATION 1537 NW 65th Avenue Plantation, FL 33313 USA Phone: (954) 321-8988 Fax: (954) 321-9778 [email protected] www.ReceptoPharm.com

Transcript of CORPORATE PRESENTATION 1537 NW 65th Avenue Plantation, FL 33313 USA Phone: (954) 321-8988 Fax: (954)...

Page 1: CORPORATE PRESENTATION 1537 NW 65th Avenue Plantation, FL 33313 USA Phone: (954) 321-8988 Fax: (954) 321-9778 info@ReceptoPharm.com .

CORPORATE PRESENTATION

1537 NW 65th AvenuePlantation, FL 33313 USA

Phone: (954) 321-8988Fax: (954) 321-9778

[email protected] www.ReceptoPharm.com

Page 2: CORPORATE PRESENTATION 1537 NW 65th Avenue Plantation, FL 33313 USA Phone: (954) 321-8988 Fax: (954) 321-9778 info@ReceptoPharm.com .

OVERVIEW

ReceptoPharm is an innovative biopharmaceutical drug

discovery company developing proprietary therapeutic

protein products and providing specialized contract

services catering to small and start-up biotechnology

companies.

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WIntroduction

ReceptoPharm is a biopharmaceutical drug discovery company based in

Plantation, Florida. The Company is primarily engaged in the discovery and

development of novel and off-patent peptide technologies for the prevention

and treatment of disease in humans. In 2008, ReceptoPharm began offering

a full range of contract services catering to small and start-up

biotechnology companies.

Drug Development

The emphasis of ReceptoPharm's approach to drug discovery and the development of new therapeutic agents is

based upon specialized receptor-binding proteins found in nature. With its' large volume of research and preclinical

data ReceptoPharm believes it has identified a number of therapeutic products that have the capability to provide

significant benefits for patients with neurological, immunological, autoimmune and viral conditions.

CRO Services

ReceptoPharm offers a full range of contract services catering to start-up and small biotechnology companies.

These services include pre-production studies, contract manufacturing services, US & EU regulatory support, and

quality systems/GMP certification.

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WManagement Team

ReceptoPharm’s management is comprised of a team of highly experienced

businesspeople and scientists with over 100 years of combined industry

expertise.

Name

Rik J. Deitsch Chairman and Chief Executive Officer, Nutra Pharma Corporation

Paul F. Reid, Ph.D. Chief Executive Officer, ReceptoPharm

Laurence N. Raymond, Ph.D. Chief Scientific Officer, ReceptoPharm

Harold Rumph Director, ReceptoPharm

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WAdvisors

ReceptoPharm maintains collaborative and research relationships with a

number of noted academic researchers associated with the National

Institutes of Health (NIH), Harvard University, Massachusetts General

Hospital, Yale University, Baylor College of Medicine and Soochow

University.

Name Organization

Dorothy Bray, Ph.D. ImmunoClin Ltd.

Zouhair M. Atassi, Ph.D., D.Sc. Baylor College of Medicine

Zheng-Hong Qin, MD, Ph.D.Harvard University / Massachusetts General Hospital (Boston, Massachusetts) and Soochow University (Suzhou, China)

Thomas L. Lentz, MD Yale University

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DRUG DISCOVERY

ReceptoPharm conducts research into a number of

products with applications for neurological,

immunological, autoimmune and viral conditions. The

Company’s leading drug candidates are RPI-MN and

RPI-78M.

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Drug Discovery Overview

ReceptoPharm is an innovative biopharmaceutical drug discovery company

developing proprietary therapeutic protein products for the billion-dollar

biologics market. The Company has two leading products: 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 ReceptoPharm’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 ReceptoPharm’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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Cobroxin Overview

Cobroxin is the first over-the-counter pain reliever clinically proven to treat

Stage 2 (moderate to severe) chronic pain.

Cobroxin, which was developed by ReceptoPharm, was launched in August 2009 and will be 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

• More Potent than Morphine

• Long Lasting

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Cobroxin Market 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.

The Cobroxin Advantage:

1. Makes 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. Targets consumers not well-served by current products

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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.

Abbreviations: Preclinical (PC), Phase 1 (P-I),

Phase 2 (P-II), Phase 3 (P-III)

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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)

Page 15: CORPORATE PRESENTATION 1537 NW 65th Avenue Plantation, FL 33313 USA Phone: (954) 321-8988 Fax: (954) 321-9778 info@ReceptoPharm.com .

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

Page 20: CORPORATE PRESENTATION 1537 NW 65th Avenue Plantation, FL 33313 USA Phone: (954) 321-8988 Fax: (954) 321-9778 info@ReceptoPharm.com .

CONTACT RECEPTOPHARM

1537 NW 65th AvenuePlantation, FL 33313 USA

Phone: (954) 321-8988Fax: (954) 321-9778

[email protected] www.ReceptoPharm.com