Transcript www.receptopharm.com

CORPORATE PRESENTATION
1537 NW 65th Avenue
Plantation, FL 33313 USA
Phone: (954) 321-8988
Fax: (954) 321-9778
[email protected]
www.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.
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.
OVERVIEW
Introduction
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
OVERVIEW
Management Team
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
OVERVIEW
Advisors
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.
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.
DRUG DISCOVERY
Drug Discovery Overview
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.
DRUG DISCOVERY
Benefits of RPI-MN and RPI-78M
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
DRUG DISCOVERY
Specific Benefits of RPI-MN
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
DRUG DISCOVERY
Specific Benefits of RPI-78M
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
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Non-Addictive
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Non-Narcotic
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Non-Opiate
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More Potent than Morphine
•
Long Lasting
DRUG DISCOVERY
Cobroxin Overview
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.
2.
Makes potent pain relief accessible to:
•
People without healthcare insurance (42 million)
•
People without prescription coverage
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People afraid of opiate side effects
•
People subject to drug screening for work
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People for whom OTC NSAIDs didn’t work and are just living with the pain
•
Doctors afraid to prescribe opiates
Targets consumers not well-served by current products
DRUG DISCOVERY
Cobroxin Market Potential
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)
DRUG DISCOVERY
Research & Development Pipeline
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)
DRUG DISCOVERY
Published Research
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.
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.
CONTRACT RESEARCH SERVICES
Partnering with ReceptoPharm
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.
CONTRACT RESEARCH SERVICES
A Global View on Drug Development
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 inhouse. 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.
CONTRACT RESEARCH SERVICES
Top-Rated Drug Production Facilities
Contract Manufacturing Services
 Stability Studies
 Drug Formulation
 Formulation
 ISO 5 Sterile Filling Suite, Single and Multi-Dose
 Adventitious Viral Testing
Liquids for Injection
 Preservative Efficacy Testing
 Clinical Trial Supplies to FDA & EU Requirements
 Assay Development/Potency Testing
 Packaging and Shipment to Sites
 Methods Development
 Release Testing and Certification
US & EU Regulatory Support
Quality Systems/GMP Certification
 FDA Drug Applications, IND Preparation
 Installation of Quality Systems Using Our SOPs
 EU Submissions, IMPD Preparation
 GMP Audits
 GMP Training
Sterile Filling Capabilities
 QA Function
 IQ/OQ/PQ
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.
 Validations (Equipment and Processes)
CONTRACT RESEARCH SERVICES
Pre-Production Studies
CONTACT RECEPTOPHARM
1537 NW 65th Avenue
Plantation, FL 33313 USA
Phone: (954) 321-8988
Fax: (954) 321-9778
[email protected]
www.ReceptoPharm.com