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.
O VERVIEW Introduction 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.
O VERVIEW Management Team ReceptoPharms management is comprised of a team of highly experienced businesspeople and scientists with over 100 years of combined industry expertise. Name Rik J. DeitschChairman 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 RumphDirector, ReceptoPharm
O VERVIEW Advisors 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. NameOrganization 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, MDYale University
DRUG DISCOVERY ReceptoPharm conducts research into a number of products with applications for neurological, immunological, autoimmune and viral conditions. The Companys leading drug candidates are RPI-MN and RPI-78M.
D RUG D ISCOVERY 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.
D RUG D ISCOVERY 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.
D RUG D ISCOVERY Specific Benefits of RPI-MN Benefits of ReceptoPharms HIV/AIDs Treatment RPI-MN Fuzeon by Roche/Trimeris Mutations are not CreatedMutations are Created Relatively InexpensiveVery Expensive – Twice Current Therapies No Significant Adverse Side EffectsAdverse Side Effects Present – Some Severe Long Shelf LifeLimited Shelf Life Patient Does Not Develop ResistancePatient Develops Immune Resistance Easy to ManufactureDifficult Manufacturing Leads to Limited Use
D RUG D ISCOVERY Specific Benefits of RPI-78M Benefits of ReceptoPharms Multiple Sclerosis (MS) Treatment RPI-78M Competitive Drugs Disease Progress StopsDisease Progression Only Slows Patient Condition ImprovesNo Claims Against Patient Improvement No Significant Adverse Side EffectsAdverse Side Effects Present – Some Severe Long Shelf LifeLimited Shelf Life Resistant to HeatRequires Refrigeration Patient Does Not Develop ResistancePatient Develops Immune Resistance Improves Quality of LifeNo Evidence for Quality of Life Improvement
D RUG D ISCOVERY 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
D RUG D ISCOVERY 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 didnt work and are just living with the pain Doctors afraid to prescribe opiates 2.Targets consumers not well-served by current products
D RUG D ISCOVERY 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)
D RUG D ISCOVERY 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 ) 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.
C ONTRACT R ESEARCH S ERVICES Partnering 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.
C ONTRACT R ESEARCH S ERVICES A Global View on Drug Development ReceptoPharm prides itself on taking a global view on drug development; whether its 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.
C ONTRACT R ESEARCH S ERVICES Top-Rated Drug Production Facilities Establishing and maintaining a qualified drug production facility can represent a significant drain on a small companys 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.
C ONTRACT R ESEARCH S ERVICES Pre-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