history and partner product strategy - premier biomedical...additive vs. subtractive © 2013-15,...

History and Partner Product Strategy

Premier Biomedical stock is traded on the OTCQB under the symbol “BIEI” Visit us at www.premierbiomedical.com

http://www.premierbiomedical.com/

May 2010 –

Company formed

August 2012 – • Mutual Non-Disclosure

Agreement signed with UTEP, PBI, and US Army Clinical Investigation Regulatory Office (CIRO).

2009 - PBI incorporated in Nevada

PBI Timeline

May 2015– Unique breast Cancer antibody Provisional Patent Filed

April 2014–

• Initial Mouse study results presented to AACR Conf.

• Duplication mouse study initiated

August 2014– University of Texas El Paso (UTEP) begins laboratory production of custom monoclonal cancer antibodies.

2009 Dr. Felder develops the theories that make the Felder Doctrine. Patents written and submitted

© 2012-2015, Premier Biomedical Inc.

June 2013 – Successful initial mouse testing of PBI/UTEP breast cancer treatment

July 2013 – Cooperative Research and Development Agreement (CRADA) signed with the Department of Defense (CIRO)

May 2012 – PBI and University of Texas El Paso (UTEP) sign Collaborative Agreement

October 2014 – Feldetrex U.S. Patent granted

©2013-15 Premier Biomedical, Inc.

William A. Hartman phone: (724) 372-5242 email: [email protected]

President and Chief Executive Officer and a member of our Board of Directors. Previously, Mr. Hartman was the COO of NanoLogix, piloting PBI from the earliest start up stages to a publicly listed company. Mr. Hartman has led PBI from its initial inception (2-man company) to the fully reporting public company, with the current dedicated Board of Directors. Prior to his time at NanoLogix, Mr. Hartman launched Greenfield automotive supplier manufacturing facilities in Europe, Mexico, and the US with revenue in excess of $1B annual sales. Academic credentials include a BSME degree from Youngstown State University and a MSIA degree (Industrial Administration/Management) from the University of Michigan. Mr. Hartman is also acting vice-president of the PBI cancer division.

Dr. Mitchell S. Felder phone: (724) 301-1216 email: [email protected]

Chairman of the Board of Directors, Chairman of the Scientific Advisory Board. Dr.

Felder is a Board Certified Neurologist on staff at the William Beaumont Army

Medical Center (WBAMC) in El Paso, TX. Previously he founded the company

Infectech, which eventually became NanoLogix. Dr. Felder is a prolific inventor who

authored or co-authored six publications, three studies and has currently 21 issued

patents and oover 20 provisional patent applications in the area of novel

approaches to curing today’s most insidious diseases. Dr. Felder served as the

Acting Chief of the Department of Neurology at the William Beaumont Army Medical

Center in 2011.

Premier Biomedical Co-Founders Biographies and Contact Information

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Physical removal of the

pathophysiologic basis

of the disease.

The Felder DoctrineTM

7/26/2013 © 2013, Premier Biomedical, Inc. 4

Additive vs. Subtractive

5 © 2013-15, Premier Biomedical, Inc.

According to the World Health Organization (WHO) chronic diseases, such as heart disease, stroke, cancer, chronic respiratory diseases

and diabetes, are by far the leading cause of mortality in the world, representing 63% of all deaths out of the 36 million people who died

in 2008.

To date there is still no cure using the “Additive” medicine method!

Premier’s approach is “Subtractive”.

© 2013-15, Premier Biomedical, Inc. 6

Sequential-Dialysis Technique is a methodology for the removal of molecules which are

harmful and responsible for causing diseases.

– Extracorporeal (outside the body) process to prevent the severe side effects which are normally encountered with other treatments

– The methodology can be used for:

• The treatment of cancer and prevention of metastasis

• Reducing the effects of Traumatic Brain Injuries

• Eliminating the neuropathological changes created by Alzheimer's Disease.

• Preventing the death of anterior motor neurons in ALS

• Eradicating the causations of Infectious Diseases ,e.g., Ebola

The methodology involved in this technique is largely unexplored and has the opportunity to create a huge market share within a $2 trillion industry.

Sequential Dialysis

Sequential Dialysis Model


Filtered Blood/CSF returned to the patient

Patient Dialysis Unit

Patented method for the removal of specific and unique molecules utilizing antibody antigens as a target attraction

Smart Sensor

Outgoing Blood/Cerebral

Spinal Fluid

Pump

For neurological conditions (diseases or concussions) cerebrospinal brain

fluid is removed from the body and sequentially dialyzed.

PBI drug therapy introduction canisters

Smart Sensor (Disease Intensity)

Mixing Chamber

Pressure Monitor

Smart Sensor

Feldetrex®

• A patented drug; PBI has exclusive license

• A unique combination of FDA approved drug components

• Consists of low dose naltrexone, cyclobenzaprine, cyanocobalamin (Vitamin B12), Pyridoxine (Vitamin B6) and Coenzyme Q10 (Co Q10)

• Intended for the treatment of neuropathic pain (fibromyalgia, neuropathy) and the symptoms of Multiple Sclerosis.

©2012 confidential and proprietary. All rights reserved

Feldetrex®

• Naltrexone and its active metabolite 6-β-naltrexol are competitive antagonists at μ- and κ-opioid receptors, and to a lesser extent at δ-opioid receptors.

• Naltrexone reduces inflammatory auto-immune reaction.

• Regular doses of low-dose naltrexone can be used to increase a patient's endorphin and enkephalin levels.

• The interaction of naltrexone with microglia cells within the central nervous system is believed to be how the drug exerts its beneficial effects in individuals who suffer from fibromyalgia; this interaction on microglial cells results in a reduction of proinflammatory cytokines as well as neurotoxic superoxides.

• Naltrexone has an antagonistic effect on Toll-like receptor 4 (TLR4), which are found on microglia, which can modulate the body's response to inflammation.

• Naltrexone was approved by the U.S. Food and Drug Administration (FDA) for the treatment of opioid addiction in 1984 and for alcohol dependence in 1994.


Feldetrex®

• Cyclobenzaprine is a muscle relaxer medication that blocks pain sensations sent to the brain.

• Cyclobenzaprine is FDA-approved to treat muscle spasms associated with acute, painful musculoskeletal conditions.


Feldetrex®

• Cyanocobalamin (B12)- frequently prescribed people suffering from chronic fatigue syndrome and fibromyalgia. This particular use has long been thought by many researchers to aid in several nerve-related disorders, including multiple sclerosis and Alzheimer’s disease.

• Pyridoxine (B6) is required for the human body to bioconvert energy obtained from foods, the production of red blood cells, and proper nerve function.

• Coenzyme Q10 (CoQ10) is a mitochondrial energy coupling, and an essential part of the cellular machinery used to produce adenosine triphosphate (ATP) to assist necessary functioning of muscle contraction and other vital cellular functions.


The PBI R&D Model PBI

DOD ** Academia *

The tripod approach

Coordinate our IP with the lab services of a large research based university (University of Texas El Paso (UTEP) $45 million lab)

Add the remarkable services of the Department of Defense (DOD) with their large, unequalled power of advanced model creation and clinical testing

* Collaborative Agreement signed April, 2012 with University of Texas at El Paso ** Cooperative Research and Development Agreement (CRADA) signed with the Department of Defense (DOD) July, 2013


Currently Available Drugs/Treatments

Feldetrex® - Fibromyalgia

Description:

• Medication for treatment of diseases with symptoms which include nerve pain, demylenation, muscle aches and spasms (i.e., fibromyalgia, MS, auto-immune, depression, etc.)

Plans/Actions:

• Conduct Clinical Trials outside of US under ICH6 guidelines (reciprocity)

• FDA filings for additional treatment uses

Market & Competition:

• Lyrica ® by Pfizer

– $4.7B annual sales in U.S.

– Patent expires in 2016

• Cymbalta® by Eli Lilly

– U.S. Patent expired end of 2013

– $3.9 B annual U.S. sales in 2013

• Savella® by Actavis (Forrest Labs)

Status:

• U.S. Patent issued 4Q14

• Initial submission to FDA 1Q15

• Guidance provided by FDA

13 © 2015, Premier Biomedical, Inc.

Currently Available Drugs/Treatments

Multiple Sclerosis (MS)

Description: • Medication for treatment of

diseases with symptoms which include nerve pain, demylenation, muscle aches and spasms (i.e., fibromyalgia, MS, auto-immune, depression, etc.)

Plans/Actions:

• Submission to FDA in 2015 for treatment of MS

• Clinical trials to be conducted outside of US.


• Affects 400,000 people in the

U.S.

• No cure; only symptom mgmt.

• Numerous symptom treatments

• $20B annual drug treatment

expenditures in U.S. (2014 est.)

Status:

• Potential extension of

Feldetrex® applications under

development

• U.S. Patent issued 4Q14


Drugs/Treatments Under Development

Ebola Sequential Antigen Therapy (ESAT)

Description:

• Device/Treatment for removal

of Ebola Hemorrhagic Fever

target antigens from

patient’s blood.

Plans/Actions:

• Conduct FDA required tests

• Refine ESAT design

• File foreign patent applications


• No FDA approved vaccine or

medicine

• Experimental drugs used to

treat latest outbreak

– ZMapp (Mapp Biopharmaceuticals)

– TKM-Ebola (Tekmira Pharm. Corp.)

Status:

• Provisional Patent filed 4Q14

• FDA submission 4Q14

• FDA testing roadmap defined

• ESAT Device Prototyped



Duchenne Muscular Dystrophy (DMD)

Description:


of target disease antigens

from patient’s blood.

Plans/Actions:

• Prove Safety




• No known cure

• Treatment costs exceed $23B

– 1M cases worldwide

– Less than 4,000 new cases per

year in U.S.

Status:

• Rare Disease designation

received from FDA

• U.S. Patent Application

submitted 3Q14



Neurofibromatosis (NF)

Description:


of disease target antigens

from patient’s blood.

Plans/Actions:

• Prove Safety




• No treatments to stop tumor

growth

• Affects 100,000 in the U.S.

Status:

• U.S. Patent Application

submitted 3Q14

• Awaiting Rare Disease

designation from FDA



Multiple Cancer Types

Description:

• Metronomic anti-CTLA-4

treatment in conjunction

with sequential dialysis

therapy

Plans/Actions:

• Improved anti-CTLA-4/PD-1/

BTLA drug under development

• FDA Application in 2015


• ~$20B annual treatment costs

• Kadcyla®; Roche

– Full treatment course - $94,000

• Herceptin®; Roche

– $6B in annual sales

• Numerous other drugs to

prolong life.

Status: • Duplicated mouse testing

success presented to AACR Conference, April, 2014

• U.S. Provisional Patent Apps filed 2Q14 and May-15



Atherosclerosis Description:

• Target antigen antibodies in

conjunction with sequential

dialysis therapy

Plans/Actions:

• File Supplemental FDA

submission after ESAT

approval.


• Currently no cure

• Leading cause of death in U.S. – 4.6M people in U.S. actively

treating disease

– Est. 50% (est.) of population

affected

• Most prescribed drug treatments – Crestor® (AZ); $5.6B sales (WW)

– Merck products - $4.6B sales

– Lipitor®, Plavix® et.al off-patent

Status:

• Filed for U.S. Patent 2Q14


Table of Contents


1. EXECUTIVE SUMMARY 1.1 Brazil Core Views 1.2 Brazil Political Analysis 1.3 Long Term Political Outlook 1.4 Local Opportunities & Key Risks 1.5 Local Opportunities For PBI 1.6 Economic Brazil Healthcare SWOT Analysis 1.7 Exchange Rates Perspectives 1.8 Fiscal Policy And Federal Incentive Programs 1.9 Customs: How To Import Into Brazil 1.10 Brazil Regulatory Health Agencies: 1.11 Brazil Healthcare Market Overview

2. MARKET ASSESSMENT 2.1 PBI Products & Treatments – Opportunities In Brazil 2.2 Doing Business In Brazil – Fiscal & Market Model 2.3 Technical Assumptions From PBI Global Strategy Info

3. THE PREFESEABILITY STUDY 3.1 PBI Startup In Brazil And South America Countries

3.2 Pbi Brazil/Latam Work Plan

3.3 Key Success Factors For PBI Start Up

3.4 Priorities And South America Pipeline To Ramp Up Sales

4. MARKETING STRATEGY

5. PRICING STRATEGY

6. COMPETITION ANALYSIS

7. CONSIDERATION OF M&A AND PARTNERSHIP OPPORTUNITES

Some Key Advantages for Brazil


• Brazil - seventh largest economy in the world (GDP); fifth by population.

• Since 2003, some 36 million people have risen out of poverty and joined the ranks of middle class.

• Demographic trends appear favorable; median age 30.7 years. • Brazil’s unemployment rate below 5% (2014), an historical low. • Diverse economy with a wide range of natural resources. • Education a top priority; literacy rate is above 90%. • 406,000 physicians in Brazil + 16,000 new/year • 5,565 cities & >7,000 hospitals & 1,100 HMOs • 5% of GDP invested at Public Health Sector • 16 million over 60 years will be 30 millions in 2025 • Demographic Bonus on the next 20 years

Some Key Risks for Brazil • Inflation rate that was under control in the last 20 years appears

like the big challenger at the new economic scenario for 2015 & 2016

• The new international scenario linked to USA economic momentum are pushing dollar rate over R$ 3,00 per dollar and the expectation is close 2015 around R$ 3,5 per dollar.

• To manage the public budget deficit the Federal Government is announcing cuts at federal programs that could affect the social area like healthcare at public sector

• Patents protection related to pharmaceutical products could be a issued In Brazil considering the historical approach to push compulsory licenses to reduce drugs cost and several discussion at public sector regarding public interest priority.


Local Opportunities for PBI

Orphan Drugs

• Incidence rate of < 65 patients / 100,000

• Congressional Bill being examined by Brazil Economic Affairs Committee

• Legislation would

– Allow importation of Orphan Drugs without ANVISA pre-approval

– Streamline ANVISA approval process


Brazil Market Assessment

• Alzheimer’s Disease

– 1.2 M Affected in Brazil

– Increasing to over 2.5 M by 2025 and 4 M by 2050

• Amyotrophic Lateral Sclerosis (ALS)

– 12,000 patients in 2015 (est.)

• Blood Sepsis and Viremia

– High potential for treatments supported by Public Health Campaigns



• Cancer

– Breast Cancer is most common

– 115,000 new cases in Latin America each year

– 50,000 of these in Brazil

• Fibromyalgia

– 6 M Fibromyalgia patients in Brazil

– 25 M patients affected with chronic pain (12% of population



• Multiple Sclerosis (MS)

– Approx. 36,000 patients in Brazil

• Traumatic Brain Injury

– Will surpass many diseases by 2020

– Affects 150 – 170 per 100,000 people

– 300,000 in Brazil


Brazilian Work Plan


Key Success Factors


Priorities & Ramp Up


Business Plan Strategy

• Manufacture and Market Feldetrex®

• Build patentable Sequential Dialysis machines.

• Build patentable antigen-dispersing canisters into the Sequential DialysisTM Machine.

• Lease Machines at cost to Hospitals and Treatment Centers to reduce entry barrier.

• Train technicians (for 2-days) at cost.

• Manufacture antigen cartridges and ship overnight to Hospitals and Treatment Centers.

©2015 Premier Biomedical, Inc.

Brazil Market Introduction

2015 • Feldetrex® - Fibromyalgia & MS

2016

• Sequential Antigen Therapy – Duchenne Muscular Dystrophy; Neurofibromatosis

2017 • Proprietary Breast Cancer Antibody

• Amyotrophic Lateral Sclerosis (ALS)

• Atherosclerosis, Blood Sepsis, et. al.


Product Launch & Revenue Projections


Country HUD +Cancer +Feldetrex +Sequential Dialysis

Full Portfolio Private Market

Full Portfolio Private &

Public Market

2015 2016 2017 2018 2019 2020

Brazil $ 100 K $ 3 M $ 25 M $ 75 M $ 125 M $ 250 M

S. America Countries

$ 100 K $ 3 M $ 25 M $ 50 M $ 75 M $ 150 M

Total South

America $ 200 K $ 6 M $ 50 M $ 125 M $ 200 M $ 400 M

Market Expansion Plan


Brazil

2015

South America

Central America

Asia

North America

Europe

A World Leader in New Biomedical Technology Research & Development

William A. Hartman

President & CEO

Phone: (01)-814-786-8849

Visit us at www.premierbiomedical.com


http://www.premierbiomedical.com/

history and partner product strategy - premier biomedical...additive vs. subtractive © 2013-15,...

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