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Corporate Spotlight

MGC Pharmaceuticals Ltd is a medical and cosmetic cannabis company with global operations to supply the legalized markets with cannabis products. The current activities of company include development of non-psychoactive cannabidol (CBD) cosmetic products.
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MGC Pharmaceuticals at CannaTech UK

COMPANY PRESENTATION

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FIRST CANNEPIL TM

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Arrival of first CannEpilTM shipment to United Kingdom

ASX Announcement 7 May 2019 


  • First shipment of CannEpil™  landed in the UK for distribution to medical doctors 
  • Confirms immediate acceptance and increasing interest from pharmacists and prescribing doctors in the United Kingdom (UK) for cannabis derived medicines like CannEpil™ 
  • Official access now in the UK where the market size for cannabis medicinal uses expected to reach €8.8bn1 by 2028 
  • Reinforces MGC Pharma’s strategy of Europe being a major focus in the distribution of its cannabis derived products


MGC Pharmaceuticals Ltd (ASX: MXC, “MGC Pharma” or “the Company”) a leading international integrated cannabinoid bio-pharma company, is pleased to announce the first shipments of CannEpil™, its proprietary formulation used to relieve symptoms such as seizures associated with severe epilepsy cases, has arrived in the UK for immediate distribution to pharmacies, or direct to medical patients. This represents a ground breaking point in the distribution of CannEpil™ and the growing acceptance of cannabis derived products being prescribed by doctors in the UK to treat drug resistant conditions.


CannEpil™ is an oral oil solution used to relieve symptoms such as seizures associated with severe epilepsy cases, where conventional medicines and therapies have failed to control them (Drug Resistant Epilepsy). It was developed by MGC Pharma’s specialist Research and Development division which both grew the relevant cannabis strains and formulated the solution on the back of extensive and long-term observational studies.


The changes in UK regulations on 1 November 2018, which legalised the use of medicinal cannabis, has allowed specialist doctors to prescribe medical cannabis to their patients. Market Access specialists, Grow Biotech PLC and IPS Specials already received initial prescriptions in the UK for CannEpil™ highlighting the increasing interest from doctors and pharmacies looking to use medical cannabis for the relief from symptoms of drug resistant conditions. The estimated value of the medicinal cannabis market in the UK in 2028 post legalisation is €8.8bn1 . The legalisation in the UK of the medicinal use of cannabis derived products adds to a growing number of European jurisdictions where their uses are now legal, catching up with regulation changes already seen in North America.


As recently announced, CannEpil™ is being distributed by Grow Biotech PLC, a British headquartered company developing revolutionary processes, practices, techniques, tools and formulations to bridge the gap between existing cannabis medicines and accepted pharmaceutical standards, and IPS Specials, a company that manufactures unlicensed compounded medications and formulations for community and hospital pharmacists, and dispensing doctors.


Grow Biotech and IPS provide direct, official access into the UK medical cannabis market with an extensive network of some 5,500 pharmacies across the UK.


The Company has developed a number of other products including CogniCann™ specifically formulated for the relief of key Dementia and Alzheimer’s symptoms and improving specific cognitive functions, InCann™ for the relief from symptoms of Chron’s Disease and IBS, and TopiCann™, a topical treatment to reduce psoriasis and eczema appearance.


Roby Zomer, Co-founder and Managing Director of MGC Pharma, commented: 


“The first CannEpil™ shipment landing in the UK represents a true milestone in the history of MGC Pharma and the relief from symptoms of epilepsy. The legalisation of medicinal cannabis passed in the UK only 7 months ago, and the subsequent increasing interest in CannEpil™ leading to orders from medical professionals, is testament to the importance of our products into the fast-growing UK market, and beyond. Over half a million people in the UK suffer from epilepsy2, and CannEpil™ has the potential to significantly enhance the lives of sufferers. We look forward to keeping shareholders updated as we see increased market penetration of our products.” 


Click here to view the full announcement 

DISTRIBUTION AGREEMENT

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Distribution Agreement with Grow Biotech and IPS to provide immediate access to large UK Medical Cannabis Market 

ASX Announcement 6 May 2019 


  • Distribution agreement with Grow Biotech PLC (‘Grow Biotech’) and IPS Specials (‘IPS’) (together ‘the Parties’) provides direct, official access into UK medical cannabis market 
  • The Parties have extensive networks of 5,500 pharmacies across the UK and are established leaders in the UK medical cannabis market 
  • MGC Pharma’s proprietary products including CannEpilTM (epilepsy) and CogniCannTM (dementia and Alzheimer’s) to be registered, imported and delivered directly to the end patient 
  • Initial prescriptions for CannEpilTM already received by Grow Biotech and IPS 
  • Estimated UK market size for cannabis medicinal uses expected to reach €8.8B by 20281 , and over 500,000 people in the UK are currently diagnosed with epilepsy2


MGC Pharmaceuticals Ltd (ASX: MXC, “MGC Pharma” or “the Company”) is pleased to announce that it has signed an exclusive distribution agreement (‘the Agreement’) with UK medical cannabis leaders, Grow Biotech and IPS (‘the Parties’), providing MGC Pharma direct access to their established distribution channels into the growing UK market medical cannabis products.


Under the Agreement, the Parties will provide medical import and distribution services to MGC Pharma, affording UK patients access to the Company’s range of proprietary Investigational Medicinal Products (‘IMPs’), including CannEpilTM targeting epilepsy and CogniCannTM for dementia and Alzheimer’s.


The Board believes that the Parties are ideal partners to facilitate the Company’s expansion into the UK market, as they were the first to import a bulk shipment of medical cannabis to the UK. This was by providing patients medicine direct on 15 February 2019 following UK regulation changes on 1 November 2018, which allowed specialist doctors to prescribe medical cannabis to their patients. Notably, the Parties have a strong distribution network of over 5,500 pharmacies and an on-site pharmacy that can fulfil prescriptions direct to a patient’s door.


The Parties will ensure that MGC Pharma’s products are appropriately registered with all relevant authorities and manage the end-to-end process, from import through to delivery to the end patient at home or selected pharmacy. Grow Biotech will also provide educational support and product information to UK prescribing doctors to support the products’ reception in the UK market, which is expected to be strong based on early indications of interest.


Grow Biotech and IPS have already received initial prescriptions for CannEpilTM. Additionally, MGC Pharma will play an active role in the board Centre for Medical Cannabis, a UK industry membership body, to assist in the construction of a supportive regulatory framework, which will help patients get easy access to cannabis-based medications.


In the UK, the estimated market size of medical cannabis is expected to reach €8.8B by 20283 , representing a key market, which provides a huge opportunity for the Company and the commercialisation of its pipeline of phyto-cannabinoid products. Over 500,000 people in the UK have epilepsy4 , representing a large market of patients who could benefit from the CannEpilTM product alone.


Terms of the Agreement 

  1. Grow Biotech and IPS will be the exclusive importer and distributor of MGC Pharma’s range of proprietary Investigational Medicinal Products (‘IMPs’) in the United Kingdom, there is the ability for the Parties to expand territory to other jurisdictions outside the United Kingdom 
  2. The Parties to provide scientific education services and clinic support during the Agreement duration 
  3. The agreement term is five (5) years unless extended by mutual agreement 
  4. The agreement includes termination rights over aspects of the services if the Parties do not meet MGC Pharma’s agreed expectations and targets over certain time periods 
  5. Success fees are payable by the Company upon specified sales-based milestones based on the number of product prescriptions being achieved by the Parties 
  6. There are no specified minimum contract amounts or volumes under these agreements other than mentioned above.


Roby Zomer, Co-founder and Managing Director of MGC Pharma, commented: 

“This is a significant agreement for MGC Pharma, which provides us with official access into the UK medical cannabis market and an established network of distributors for our product. Partnering with Grow Biotech and IPS places us with proven experts in importing medical cannabis products into the fast-growing UK market, expected to reach €8.8 billion by 2028. Our move into the UK is proving extremely timely, with a change in regulation and increasing interest from doctors and pharmacies keen to explore new ideas particularly involving medical cannabis. With a robust portfolio of exciting products and a strong development pipeline evolving from our R&D and seed to pharma strategy, we look forward to updating shareholders on our progress as we look to build a leading international biopharma company.”


Hari Guliani, COO of Grow Biotech, commented: “In the last two and a half months since our first bulk import of medicinal cannabis, Grow Biotech and IPS have seen increasing numbers of prescriptions for patients in the UK. We are excited to be able to offer MGC Pharma’s range of products in the UK market, which provide new options to the limited range currently available for doctors in the UK. Our agreement with MGC Pharma marks an important step towards being able to help doctors achieve the patient outcomes we are all committed to.“


Click here to view the full announcement 

NEW DISTRIBUTION

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New Distribution Agreements signed for CannEpilTM, CogniCannTM, MXP100 and MXC1:1 products in Australia 

ASX Announcement 2 May 2019 


  • New agreements signed with two leading Australian medicinal cannabis distribution and logistics specialists, Health House International Pty Ltd (‘Health House International’) and Cannvalate Pty Ltd (‘Cannvalate’) 
  • Strategic non-exclusive agreements facilitate the Company’s distribution of medicinal cannabis products in Australia with industry leading distributors 
  • Agreements cover MGC Pharma’s proprietary cannabinoid-based Investigational Medicinal Products (IMPs), specifically CannEpilTM (epilepsy), as well as our other IMPs including CogniCannTM (dementia and Alzheimer’s), MXP100 (straight cannabidiol (CBD)) and MXC1:1 (50% tetrahydrocannabinol (THC) and 50% CBD), which was developed for the relief from symptoms of spasticity and certain types of inflammatory pain. 
  • Agreement with Cannvalate includes partnering for Clinical Research at the Medicinal Cannabis Research Collaboration in Melbourne to increase the body of literature providing further clinical support for MGC Pharma’s cannabinoid pharmaceuticals 
  • Now registered as the official sponsor of its own medicinal cannabis products in Australia, MGC Pharma can take advantage of multiple distribution and logistics partners to make its medicinal cannabis products available to patients under the Special Access Scheme, Authorised Prescriber Scheme or for use in clinical trials. 
  • The Therapeutic Goods Administration (TGA) has recently given MGC Pharma permission to import MXP100 and MXC1:1 into Australia for supply either in a clinical trial or under the Special Access Scheme.


MGC Pharmaceuticals Ltd (ASX: MXC, “MGC Pharma” or “the Company”) is pleased to announce that it has signed two strategic supply agreements with Australian specialist medicinal cannabis distribution and logistics companies, Health House International and Cannvalate.


Health House International is an Australian-based specialist medicinal cannabis company that wholesales and distributes medicinal cannabis products in Australia and the United Kingdom to community and hospital pharmacies. Additionally, Health House has an extensive network of medical professionals who assist doctors with the administrative burden of obtaining Special Access Scheme approvals and provide clinical advice.


Cannvalate is Australia’s largest network of cannabis prescribers and dispensaries (1,000+ doctors and 600+ pharmacies) allowing Licensed Producers immediate and Australia-wide access to patients across all specialties. Cannvalate has already identified several physicians who are keen to start prescribing MGC Pharma’s high-quality pharmaceutical products.


Cannvalate also coordinates one of Australia’s largest medicinal cannabis clinical research facilities and are proudly partnering with MGC Pharma on several clinical trials with this product range to increase the confidence of the prescribing medical community.


Collectively, the two agreements facilitate the availability of MGC Pharma’s phytocannabinoid-based products under the Special Access Scheme via an expanded network of clinics and pharmacies from which Special Access Scheme applications for MGC Pharma products may be derived. This is now possible following the formal registration of the Company as the official sponsor of its own medicinal cannabis products in Australia.


Terms under the Agreements 

Under both the distribution agreement with Health House International and the wholesale/logistics agreement with Cannvalate, the product range includes CannEpilTM, CogniCannTM, MXP100 and MXC1:1 Australia wide. The agreements are also left open to include additional MGC Pharma formulations.


The agreements will ensure the immediate supply and availability of CannEpilTM and CogniCannTM in Australia during 2019 to their existing customer networks, and the additional MGC Pharma formulations following MGC Pharma now having received permission from the Therapeutic Goods Administration (‘TGA’) to import these products for supply for use in either a Clinical Trial or under the Special Access Scheme. These agreements are non-exclusive in these territories, providing MGC Pharma with the ability to enter into other strategic distribution agreements in the future, depending on demand. There are no specified minimum contract amounts or volumes under these agreements.


MGC Pharma increases formulations for distribution in Australia 

Following the recent import permission from the TGA, MGC Pharma will also make two more of its formulations available for supply for clinical trials or under the Special Access Scheme, being MXP100, mainly used for neurological conditions but also for children and people who wish to avoid the psychoactive side effects of THC, and MXC1:1, for relief from symptoms of spasticity and certain types of inflammatory pain. The Company now has CannEpilTM, CogniCannTM, MXP100 and MXC1:1 available in Australia for use either in clinical trials, by an Authorised Prescriber, or under the Special Access Scheme.


The MXP100 and MXC1:1 formulations have been developed following demand from medical professionals in Australia. MXP100 is the Company’s only straight CBD formulation, and therefore falls into Schedule 4 under the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP). MXC1:1 contains 25 mg/mL of both THC and CBD.


These agreements represent the establishment of the key distribution network for CannEpilTM, CogniCannTM, MXP100 and MXC1:1 to the Australian market, and future pharmaceutical products for the Company. The initial distribution of CannEpilTM during Q1 2019 was slower than anticipated due to Australian regulatory and compliance matters which have now been addressed and resolved by the Company over the past few months with the Company’s lawyers and new distributors.


Click here to view the full announcement

VIDEO'S

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MGC PHARMACEUTICALS IN ACTION



Description: CannaTech Conference attended by MGC Pharmaceuticals in London, October 2017.




 Description: Interview of Nitin Mantri, Senior Lecturer at RMIT University, as he discusses the first project of the collaboration between MGC Pharma and RMIT.

(20min delay)
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