Globestar Therapeutics

GlobeStar Therapeutics

Multiple Sclerosis Drug Development

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Our Mission - Our Technology

  • GlobeStar Therapeutics Mission: To pioneer biotechnology in transformative therapies for the management of chronic neurodegenerative diseases.
  • GlobeStar Therapeutics is a Clinical Stage Pharmaceutical Company introducing a patented formulation for the treatment of Multiple Sclerosisx utilizing well known and approved drugs.
  • In clinical trials, the drug combination was shown effective in the reduction of Multiple Sclerosis co-morbidities. Significantly enhancing the lives of patients with MS.
  • GlobeStar Therapeutics will initiate discussions with the FDA on clinical trial design in preparation for FDA submission and approval pathway

Current Situation, Multiple Sclerosis (MS)

  • Chronic Neurodegenerative Disease
  • MS Affects Over 800,000 in US. 2.58 Million Globally
  • Diagnosed in People 20 to 50 years of age. 2 of every 3 Patients are Women
  • There is no known cure for any form of Multiple Sclerosis … At any stage
  • $15.3 Billion Annual Pharmaceutical spend in North America
  • Second Highest Chronic Disease Cost in United States
  • $26.1 Billion Annual Global Pharmaceutical Spend.

The Solution – An Oral Combination

GlobeStar Therapeutics Patented Formulation of Currently Available
Drugs: Minocycline, Fluconazole, and Atorvastatin

  • Minocycline
    An oral tetracycline antibiotic. Used to treat bacterial infections including respiratory and urinary tract infections. The drug is currently being studied for relapsing-remitting multiple sclerosis (RRMS) or clinically isolated syndrome (CIS), referring to the first episode of neurologic symptoms that last at least 24-hours and are caused by myelin damage.
  • Fluconazole
    An triazole antifungal. Used to prevent and treat a variety of fungal and yeast infections by stopping the growth of certain types of fungus. Studies using a combination of Minocycline & Fluconazole against candida albicans fungual growths proven effective, in vitro.
  • Atorvastatin
    A Statin, HMG CoA reductase inhibitor. Commonly used to lower blood levels of LDL cholesterol, increase levels of HDL cholesterol and to lower triglycerides. It is also an effective immunomodulatory agent shown to prevent autoimmune encephalomyelitis in animal model studies.
United States Patent: 10610592

Multiple Sclerosis: Stages, Prevalence, Population

  • CIS – Clinically Isolated Syndrome. A single course of MS (immune attack on myelin). The detection of brain lesions shows up to 80% chance of developing MS
  • RRMS – Relapsing & Remitting. Relapses of increased disease activity followed by remissions.
  • SPMS – Secondary Progressive MS. Follows RRMS and affects about 50% of those who have RRMS within 10 years. Reduced or absent relapse, but with periods of stability.
  • PPMS – Primary Progressive MS. Affects about 15% of people diagnosed with MS
  • HARRMS – Highly Active Relapse / Remitting MS. Steady progression with no remissions.
Patient DemographicN America 2020N America 2024N America 2029Global 2020Global 2024Global 2029
Patients with Multiple Sclerosis844,440870,745904,8502,800,0003,106,6103,375,900
Patient Prevalence Annual Incr14,90015,36015,96058,00064,35070,890
Patient Prevalence CAGR1.80%1.80%1.80%2.10%2.10%2.10%
Patients in Stage RRMS - PPMS759,996783,671814,3652,520,0002,795,9493,038,310

Multiple Sclerosis: Current Therapy Regimen

Treatments for MS Relapse (attacks)

  • Corticosteroids – reduce nerve inflammation.
  • Lumbar puncture (spinal tap).
  • Plasma exchange (plasmapheresis) – may be used if the symptoms are new, severe and have not responded to steroids.

Treatments to modify MS progression

  • Injectable Drugs
  • Oral Drugs
  • Infusion Drugs

Treatments for MS signs and symptoms

  • Physical therapy.
  • Muscle relaxants – baclofen (Lioresal, Gablofen), tizanidine (Zanaflex) and cyclobenzaprine may help.
  • Medications to reduce fatigue – Amantadine (Gocovri, Osmolex), modafinil (Provigil) and methylphenidate (Ritalin.
  • Medication to increase walking speed. Dalfampridine (Ampyra) may help to slightly increase walking speed in some people.

Current Situation, Multiple Sclerosis Cost of Therapy

DrugTypeDOTCost/Year
Betaseron (interferon beta-1b)Injectable182$98,759
Interferon beta-1b (biosimilar)Injectable182$64,428
Avonex (interferon beta-1a)Injectable52$90,035
Rebif (interferon beta-1a)Injectable156$98,899
Plegridy (Pegylated interferon beta-1a)Injectable26$90,035
Copaxone (glatiramer acetate)Injectable156$36,992
Glatiramer acetate (generic)Injectable365$23,725
Tysabri (natalizumab)Injectable13$86,062
Lemtrada (alemtuzumab)Injectable8$187,335
Ocrevus (ocrelizumab)Injectable2$65,000
Market Average$84,127
DrugTypeDOTCost/Year
Gilenya (fingolimod)Oral365$98,759
Aubagio (teriflunomide)Oral365$76,614
Tecfidera (dimethyl fumarate)Oral365$82,979
Mavenclad (cladribine)Oral10$87,750
Mayzent (siponimod)Oral365$89,907
Market Average$87,429

Initial Clinical Study

  • The study consisted of 150 volunteers, 90 subjects ages between 25 and 65 years with the MS disease course of a minimum of 5 to a maximum of 20 years including (60 healthy volunteers).
  • The read out of the trial was based on mobility Barthel Index (disability evaluation) before and after the treatment regimen.
  • The second parameter was analysis of muscle imbalance using the Kendall scale before and after the treatment regiment.
  • The subjects received 2 doses per day for 45 days, along with a controlled diet.

The cohort of patients had the following conditions: Multiple Sclerosis Autoimmune Diseases Disseminated or Multiple Sclerosis Nos Multiple Sclerosis, Acute Relapsing Multiple Sclerosis, Primary Progressive Multiple Sclerosis, Chronic Progressive Keywords: Autoimmune Multiple Sclerosis Relapsing Inflammation Chronic disease Demyelinating disease Progressive Remitting Relapsing

Data is based on:

  • A sample of 90 people from a cluster of 150 volunteers;
  • Various degrees of disability in the EDSS;
  • Under regular medical review every 15 days;
  • Received a 45-day treatment based on drug combinations of minocycline, atorvastatin and fluconazole.

Inclusion and Exclusion Criteria

Eligibility:

  • Minimum Age: 18 Years
  • Maximum Age: 65 Years
  • Not Gender Specific, MALE = 35% FEMALE = 67%
  • Clinical diagnosis of Multiple Sclerosis 14
  • EDSS score range from 3 to 7.5

Exclusion Criteria:

  • Liver diseases: GOT GPT ≥ 40
  • Kidney diseases: Creatinine > 1.50
  • Use of psychotropic drugs
  • Other musculoskeletal diagnoses, unstable cardiovascular, respiratory, metabolic
  • Received a course of steroids (IV or oral) within 60 days of screening

The Solution – An Oral Formulation

  • Clinical study indicates a Reduction in Patient Fatigue
  • Clinical study indicates a Recovery of Bladder Function
  • Clinical study indicates a Recovery of Balance
  • Clinical study assessments show a Significant Improvement in EDSS. Measurable through a reduction of the same equal to 1.5 / 2.5 points per enrolled patient.
  • Study of MRI scans indicate a Reduction in Sclerotic Plaque
  •  
  • Clinical Use Parameters:
  • Two 5-40mg oral administrations of the drug combination per day
  • Continuous oral administration 45 days

The observations support 15 claims in the formulation United States Patent: 10610592

GlobeStar Therapeutics Patented Formulation of Currently Available Compounds: Minocycline, Fluconazole, and Atorvastatin.

Parallel Process with FDA Regulatory Pathway

  • KOLs
  • Patient
  • Advocacy Groups
  • Site Selection
    – 3 months
  • Formulation
  • Supply Chain
  • Process
    Development
    6 months
  • Analytical Methods
  • Testing
  • Data Analysis

    -3 months

Pre-IND Meeting

FDA Regulatory Pathway

– 505b
– Orphan Drug Designation
-Nonclinical: Pharmacology
and Toxicology Data
3 months

-Trial Design
-Investigator’s Brochure
-Protocol
-CMC
6 months

– CRO
– # Sites
– Recruit Patients
– Pharma-covigilance
12-18 months

– Lock Data
– Present finding
– Advisory Hearing
– Post Surveillance
– Follow-up studies
and inspections
3 months

Case Assumptions for Revenue Model

Patient DemographicN America 2020N America 2024N America 2029Global 2020Global 2024Global 2029
Patients with Multiple Sclerosis844,440870,745904,8502,800,0003,106,6103,375,900
Patient Prevalence Annual Incr14,90015,36015,96058,00064,35070,890
Patient Prevalence CAGR1.80%1.80%1.80%2.10%2.10%2.10%
Patients in Stage RRMS - PPMS759,996783,671814,3652,520,0002,795,9493,038,310

The Market Opportunity

Global MS Drug Market Spend $26.052 Billion

By Drug Class

Immunomodulation Drugs 64%
Interferons 18%
Immunosuppressors 16%
Others 2%

By Administration Route

Injection 55%
Oral 45%

By Supply Chain Channel

Hospital/Clinic Pharmacy 47%
Retail Pharmacy 36%
Online Pharmacy 17%

GlobeStar Therapeutics Corporation Patented Multiple Sclerosis Formulation Pro Forma Assumptions Years 1 – 5

North America Revenue Projections

Revenue Assumptions – Does not include any upstream revenues from other indications or international markets Forecasted First Revenues (Post Money) 2024.

Patented MS Formulation – GlobeStar Therapeutics

20262027202820292030
North America Drug ReleaseYear 1Year 2Year 3Year 4Year 5
# MS Patients Indicated Stage – US783,670789,900795,890801,260806,300
Forecasted % Market Penetration5%20%30%50%70%
Annual Courses39,184157,980238,767400,630564,410
NSP $ Revenue / Course6500 600055005000 5000
Gross Revenues254,692,750947,880,0001,313,218,5002,003,150,0002,822,050,000
Less: Fees & Admin 4%10,187,71037,915,20052,528,74080,126,000112,882,000
Net Revenues 244,505,040909,964,8001,260,689,7601,923,024,0002,709,168,000
Direct Cost of Sales 50,217,574195,642,432285,374,318461,525,760650,200,320
Gross Profit 194,287,466714,322,368975,315,4421,461,498,2402,058,967,680

GlobeStar Therapeutics Corporation Patented Multiple Sclerosis Formulation Pro Forma Assumptions Years 1 – 5

Rest of World Revenue Projections

Revenue Assumptions – Does not include any upstream revenues from other indications or international markets Forecasted First Revenues (Post Money) 2024.

Patented MS Formulation – GlobeStar Therapeutics

20242025202620272028
North America Drug ReleaseYear 1Year 2Year 3Year 4Year 5
# MS Patients Indicated Stage – US2,012,2802,053,5782,095,9272,139,7152,184,679
Forecasted % Market Penetration10%20%30%40%40%
Annual Courses201,228410,716628,778855,886873,872
NSP $ Revenue / Course39003600330030003000
Gross Revenues784,789,2001,478,576,1602,074,967,7302,567,658,0002,621,614,800
Less: Fees & Admin 4%23,543,67644,357,28562,249,03277,029,74078,648,444
Net Revenues 761,245,5241,434,218,8752,012,718,6982,490,628,2602,542,966,356
Direct Cost of Sales 251,458,533496,505,875734,500,850964,925,876985,202,842
Gross Profit 509,786,991937,713,0011,278,217,8481,525,702,3841,557,763,514

News

Corporate Management Team – GlobeStar Therapeutics

James C. Katzaroff

CEO
Chairman

William J. Farley

Board of Directors Development Officer

Steven F. Penderghast

Board of Directors, Commercial Officer

Robert Chicoski, CPA

Chief Financial Officer