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 Demographic | N America 2020 | N America 2024 | N America 2029 | Global 2020 | Global 2024 | Global 2029 |
|---|---|---|---|---|---|---|
| Patients with Multiple Sclerosis | 844,440 | 870,745 | 904,850 | 2,800,000 | 3,106,610 | 3,375,900 |
| Patient Prevalence Annual Incr | 14,900 | 15,360 | 15,960 | 58,000 | 64,350 | 70,890 |
| Patient Prevalence CAGR | 1.80% | 1.80% | 1.80% | 2.10% | 2.10% | 2.10% |
| Patients in Stage RRMS - PPMS | 759,996 | 783,671 | 814,365 | 2,520,000 | 2,795,949 | 3,038,310 |
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
| Drug | Type | DOT | Cost/Year |
|---|---|---|---|
| Betaseron (interferon beta-1b) | Injectable | 182 | $98,759 |
| Interferon beta-1b (biosimilar) | Injectable | 182 | $64,428 |
| Avonex (interferon beta-1a) | Injectable | 52 | $90,035 |
| Rebif (interferon beta-1a) | Injectable | 156 | $98,899 |
| Plegridy (Pegylated interferon beta-1a) | Injectable | 26 | $90,035 |
| Copaxone (glatiramer acetate) | Injectable | 156 | $36,992 |
| Glatiramer acetate (generic) | Injectable | 365 | $23,725 |
| Tysabri (natalizumab) | Injectable | 13 | $86,062 |
| Lemtrada (alemtuzumab) | Injectable | 8 | $187,335 |
| Ocrevus (ocrelizumab) | Injectable | 2 | $65,000 |
| Market Average | $84,127 |
| Drug | Type | DOT | Cost/Year |
|---|---|---|---|
| Gilenya (fingolimod) | Oral | 365 | $98,759 |
| Aubagio (teriflunomide) | Oral | 365 | $76,614 |
| Tecfidera (dimethyl fumarate) | Oral | 365 | $82,979 |
| Mavenclad (cladribine) | Oral | 10 | $87,750 |
| Mayzent (siponimod) | Oral | 365 | $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 Demographic | N America 2020 | N America 2024 | N America 2029 | Global 2020 | Global 2024 | Global 2029 |
|---|---|---|---|---|---|---|
| Patients with Multiple Sclerosis | 844,440 | 870,745 | 904,850 | 2,800,000 | 3,106,610 | 3,375,900 |
| Patient Prevalence Annual Incr | 14,900 | 15,360 | 15,960 | 58,000 | 64,350 | 70,890 |
| Patient Prevalence CAGR | 1.80% | 1.80% | 1.80% | 2.10% | 2.10% | 2.10% |
| Patients in Stage RRMS - PPMS | 759,996 | 783,671 | 814,365 | 2,520,000 | 2,795,949 | 3,038,310 |
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
| 2026 | 2027 | 2028 | 2029 | 2030 | |
|---|---|---|---|---|---|
| North America Drug Release | Year 1 | Year 2 | Year 3 | Year 4 | Year 5 |
| # MS Patients Indicated Stage – US | 783,670 | 789,900 | 795,890 | 801,260 | 806,300 |
| Forecasted % Market Penetration | 5% | 20% | 30% | 50% | 70% |
| Annual Courses | 39,184 | 157,980 | 238,767 | 400,630 | 564,410 |
| NSP $ Revenue / Course | 6500 | 6000 | 5500 | 5000 | 5000 |
| Gross Revenues | 254,692,750 | 947,880,000 | 1,313,218,500 | 2,003,150,000 | 2,822,050,000 |
| Less: Fees & Admin 4% | 10,187,710 | 37,915,200 | 52,528,740 | 80,126,000 | 112,882,000 |
| Net Revenues | 244,505,040 | 909,964,800 | 1,260,689,760 | 1,923,024,000 | 2,709,168,000 |
| Direct Cost of Sales | 50,217,574 | 195,642,432 | 285,374,318 | 461,525,760 | 650,200,320 |
| Gross Profit | 194,287,466 | 714,322,368 | 975,315,442 | 1,461,498,240 | 2,058,967,680 |
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
| 2024 | 2025 | 2026 | 2027 | 2028 | |
|---|---|---|---|---|---|
| North America Drug Release | Year 1 | Year 2 | Year 3 | Year 4 | Year 5 |
| # MS Patients Indicated Stage – US | 2,012,280 | 2,053,578 | 2,095,927 | 2,139,715 | 2,184,679 |
| Forecasted % Market Penetration | 10% | 20% | 30% | 40% | 40% |
| Annual Courses | 201,228 | 410,716 | 628,778 | 855,886 | 873,872 |
| NSP $ Revenue / Course | 3900 | 3600 | 3300 | 3000 | 3000 |
| Gross Revenues | 784,789,200 | 1,478,576,160 | 2,074,967,730 | 2,567,658,000 | 2,621,614,800 |
| Less: Fees & Admin 4% | 23,543,676 | 44,357,285 | 62,249,032 | 77,029,740 | 78,648,444 |
| Net Revenues | 761,245,524 | 1,434,218,875 | 2,012,718,698 | 2,490,628,260 | 2,542,966,356 |
| Direct Cost of Sales | 251,458,533 | 496,505,875 | 734,500,850 | 964,925,876 | 985,202,842 |
| Gross Profit | 509,786,991 | 937,713,001 | 1,278,217,848 | 1,525,702,384 | 1,557,763,514 |
News
- Globestar Therapeutics Update on Project Amethyst(TM) and Recent Financials
- GlobeStar Therapeutics Enters Into Definitive Agreement With Advanced Innovative Partners To Develop Clinical Studies and Strategies for Multiple Sclerosis Treatment
- Globestar Therapeutics Enters into Definitive Agreement with SMI Healthcare to Manage Clinical Trial, Regulatory Filings, Manufacturing and Sales in MEA Region for Multiple Sclerosis Treatment
- Presenting on the Emerging Growth Conference on July 12 & 13 Register Now
- Globestar Therapeutics Enters into MOU with Advanced Innovative Partners to Develop Clinical Studies for Multiple Sclerosis Treatment
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
Dr. Len Wisneski
Chairman Medical Advisory Board