1
www.mgcpharma.com.au
ASX:MXCOctober 2019
Leading the way in Phytomedicines with a Seed to Pharma Strategy
Leading the way in Phytomedicines with a Seed to Pharma Strategy
Clinical Trials as A Vehicle to Cannabinoid-Based Pharmaceutical Products for the EU Medical Market
The shift to a new Reality – Cannabis MEDICINES
❑Regulated
❑Effective
❑Compliant
❑Standardized
A future for Cannabis that is:
To exist in this future, MGC goal is to become a Bio-Pharma company with a focus on phytocannabinoid based medicines: PHYTOMEDICINES.
The shift to a new Reality – Cannabis MEDICINES
Industrial Recreational Lifestyle Medicinal
The Cannabis industry is divided into four sectors, which should be referred to as:
Cannabis for
And not as “Medical Cannabis”.
The route to a new Reality – Cannabis MEDICINES
Formula Delivery System Medical Device Medicine
CBDDB/THC1:11:245:3Whole Plant Extract
Spray TinctureDropperTabletCapsuleSyringe
CannEpil CogniCannInCannTetrinolSativexEpidiolexMarinol
Controlled Un ControlledBuccal/SublingualOralRectalIntravenousInhalers
SMOKING IS NOT A TREATMENT, OR A VIABLE MEANS OF DELIVERY FOR MEDICINES
The route to a new Reality – Cannabis MEDICINES
CANNABIS
Herbal medicinal products
Stabilize GeneticStabilize Flower
Chemical Preparation products
Single API or *Compounded API’s
Safety and efficacy data from the company's own development or a combination of own
studies and bibliographic data
An Australian company Listed since 2016
MGC Pharmaceuticals (ASX:MXC OTCQB:MGCLF) is a European focused Bio-Pharma company, developing a vertically integrated business through the entire
Cannabinoid-based Medicines value chain with a complete ”Seed to Pharmacy” strategy .
Developing Standardized Cost Effective Affordable Cannabinoids based Medicines.
Who we are
CULTIVATION EXTRACTION &ISOLATION INTO API
CLINICAL TRIALS PRODUCT
DEVELOPMENT DISTRIBUTION
High THC >35% strainsHigh CBD >20% Strains
Super Critical (Co2)Alcohol Extraction
Europe (EMA)Australia (TGA)
EuropeAustralia
EuropeAustraliaSouth America
3 research arms based on experience and large data collections
Neurology Oncology Autoimmune
Lead by Prof Uri KramerEpilepsyDementia Cerebral Palsy
Lead by Dr. Jonathan GrunfeldCachexiaPainFrailtyCancer treatment
Lead by Ass. Prof Nitin Mantri (RMIT) Anti-InflammatoryAnti-Bacterial
MGC Research & Development
• Developing medicines that leverage its proprietary medical cannabis formula through successful clinical trials in Europe, Australia
• This will enable future medical product sales across the EU, Australia and other geographies, following the requisite regulatory approvals
ONCOLOGICAL & CANCER SIDE EFFECTS
AUT0IMMUNE DISEASE – INFLAMMATORY
Tetrinol Treatment of Anorexia Cachexia in Cancer Patients
MXOT02GB01 Treatment of Glioblastoma (NIB)
MXOT02ME01 Treatment of Melanoma Cancer (RMIT/CannaHub)
MXOT02PC01 Treatment of Prostate Cancer (RMIT/CannaHub)
TopiCann Topical treatment of Eczema and inflamed skin (RMIT/CannaHub)
MXAI01AB01 Antibacterial topical cream (RMIT/CannaHub)
Preclinical in process
Study Results: 70% Reduction in 4 weeks
Preclinical in process
Q2
20
16
Q1
20
17
Q3
20
18
Q4
20
18
Q1
20
19
• Establishing research programme
• Building the Scientific Advisory Board
R&D Division Established
Pre-Clinical Programme
Initiated• Collecting clinical data
• Design protocols for first product to market
EU GMP Approved
• First of its kind in the EU –authorised for production
Authorised Prescribers
Approved• First IMP CannEpil authorised for prescription by the TGA in Australia
• Allows advice, drug evaluation and registration with a 100% reduction in fees
EMA SME Qualification
CannEpil Oral oil solution to reduce seizures in drug resistant epilepsy Phase IIB
Neurological
CepaCann Oral Spray to treat Cerebral Palsy Preclinical in process
InCann BiActive capsule for Crone's and IBS Pre CLinical
Pre-clinical research conducted in collaboration with the National Institute of Biology and University Medical Centre Ljubljana
Key Highlights:
• Recent report on pre-clinical research focuses on the development of cannabinoidformulations specifically tailored for the effective treatment of high grade braintumours
• Represents first research to test the effects of cannabinoid compoundformulations on cancerous cells using tissues taken directly from a patient
• This report confirms that cannabinoid preparations can successfully inhibit tumourviability and also cause the significant fraction of glioblastoma cells to die i.e.apoptosis after short time after their application
• Most importantly, cannabinoid formulations are shown to be able to targetglioblastoma stem cells that are considered to be the “roots” of the disease andthe critical target in oncology therapy
• These multi compound cannabinoid formulations are the intellectual property ofMGC Pharmaceuticals
• A diagnostic platform for glioblastoma patients has been developed that is able topredict the response of a tumour to selective multi-cannabinoid compoundformulations, meaning that a targeted treatment plan can be most efficientlyimplemented
Research highlighted the positive impact of using specific cannabinoid formulations in the treatment of glioblastoma, the mostaggressive and so far therapeutically resistant primary brain tumour and, as such can be considered a major scientificbreakthrough in the application of cannabinoid compounds on cancerous cells.
Cannabinoids and Brain Cancer
Phase I
Phase II
Phase III
Pre-Marketing
Marketing Authorization
Targeting specific medical conditions such as epilepsy and dementia
• Oral spray utilising a specific THC:CBD ratio for relief of dementia symptoms
• Based on longitudinal research in Israel
• Phase IIb submitted in Australia, patient recruitment started
• Early access schemes in Australia and UK
• Oral oil solution to treat seizures associated with drug resistant epilepsy
• Based on long term observation research published in Israel by Prof. Uri Kramer
• Phase IIb submitted in Slovenia for EMA
• Early access schemes in Australia and UK
FURTHER PRODUCT PIPELINEPipeline of phytocannaboid based medications, APIs and unique formulations all manufactured under EU-GMP certified facilities to be used in pharmaceutical treatment and research
Epilep
sy
De
me
ntia
Connecting academia & industry
Research & Development – The ENGINE
R&D and IP are the Company’s keys to future success. Bringing together the most experienced and curious minds from around the world, to target and provide formulations for the most pressing medical issues which can be
addressed with phytocannainoids today, is crucial to product development and corporate growth.
The core of MGC‘s Seed to Pharma strategy is focused on medical research and development of the Company’s pharmaceutical product pipeline, which will provide raw materials and appropriately matched genetics to treat patients with a variety of diseases across the globe.
12
MGC Pharma and RMIT are developing a digital research hub for the application of Phytocannabinoid derived medicines including the International Library of Cannabinoids (ILC)
INTERNATIONAL LIBRARY OF CANNABINOIDS
• ILC is the World’s first library of cannabis medicinewhere details of medical cannabis clinical research,cannabinoid sequences and their treatments canbe found
• ILC will collect data from diverse clinical studies,academic publications, patient feedback as well asdiverse cannabinoid strains
• Collected and analysed data from the ILC will assistand enhance the work of doctors and researchersand improve industry efficacy estimates ofcannabinoid treatment of various disorders
• ILC could be utilised for the design andimplementation of clinical trials via its mobile andweb-based applications
ILC provides an interface connecting doctors andpatients with clinical research and information oncannabinoid sequences and their potentialtreatments
ILC
Research & Development – The ENGINE
FROM HACKATHON TO COMMERCIALISATION• Partnership between leading universities and industries wanting for R&I in cannabis medicine
• Lead university partners:
RMIT University and The Hebrew University
• Lead Industry Partners:
- MGC Pharmaceuticals
- Sputnik
- CPG Funds
CannaHUB™
Company Highlights
Holding an euGMP certified production facility for the development and manufacturing (IMP) Phytomedicines.
Clinical Trials program for EMA and TGA registration is underway
Robust R&D platform and positioning, based on more than 10 years accrued experience in phytocannabinoid research and patients treatment
Led by a strong Executive Management and Advisory Board, with years of experience in clinical research and conducting successful human trials with Phytomedicines.
Core strategy includes production, research and development of unique phytocannabinoid pharmaceutical products, centralise in order to minimise the time to market and provide cost effective medicine.
Core strategy revolves around fully integrated in house “Seed to Pharma” operations focused on the production of pharmaceutical products
supported by ongoing research and development activities
Education Patient Access
Responsible Affordable Phytomedicines
CannaHUB™
Research
Education is Everything –
MGC recognized this fact early on – and have applied it throughout our globalexpansion.
Via building relationships with Academia, we are ensuring the next generation ofdoctors, researchers and groundbreakers will have the resources to advance theindustry.
Via educating the public, both patients and the community at large, we are ensuringthat the message of the benefits of phytomedicines is spreading and becoming moreacceptable daily.
Education: for professionals and patients
“All I want to be able to do is access a
product, on a regular basis, that I can
afford to give Liam his life back.”
Every family’s journey with medicinal
cannabis is different.
18
standardized effective and affordable medicinestandardized effective and affordable medicine
