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014ec4ae-557 (1).pdf
I don't know why we didn't get this RNS
Please do your own research
https://onedrive.live.com/?authkey=%21AMzs%5FU16z%5FbV%2DUY&cid=69DAE282E3CF7D60&id=69DAE282E3CF7D60%2125542&parId=69DAE282E3CF7D60%2125078&o=OneUp
PART 2
Pricing strategy
The price of Epidiolex is at present approximately US$32,500 (£26,000/AUD$47,000) per patient, per year. However,
this is to treat rare and potentially fatal conditions, such as Dravet syndrome and Lennox Gastaut syndrome.
Given CannEpil® will be treating patients who have no other options,
the Directors have assumed lower pricing of CannEpil® compared to Epidiolex, if marketed in the USA. Given this,
the Directors are targeting an estimated price for CannEpil® in the EU, following both CMA and TGA approval,
of £6,000 – £8,000 (AUD$10,800 – AUD$15,000) per patient, per year34.
https://mgcpharma.com.au/wp-content/uploads/2021/02/MGC-Pharmaceuticals-Prospectus.pdf
PART 1
CannEpil® is currently only being made available to patients in Australia, through the SAS, and in the United Kingdom, as an
unlicensed medicine or “special”, in accordance with the requirements of the MHRA17.
The Group has recently received ethics committee approval from Schneider Children’s Medical Centre of Israel to commence a Phase IIb clinical trial for the Company’s proprietary epilepsy treatment, CannEpil®, with recruitment expected to begin shortly.
Access to patient populations through early access schemes prior to regulatory authorisation represents a unique position
for the Group to observe how the medication might be received post-approval and to establish a market presence. This has
included establishing relationships with leading pharmaceutical distributors to ensure stable product distribution upon CMA in the EU, and approval by the TGA in Australia, being obtained.
The Group intends to continue to leverage this position to generate immediate revenues, establish viable distribution networks, and ensure it remains a leader on price, access and product improvements.
The Group compared a paediatric study of a formulation similar to CannEpil® in 46 drug-resistant epilepsy patients next to
the Epidiolex study conducted by GW Pharma in over 300 patients. In the former, 62% of patients experienced a reduction
of 50% or more in the number of seizures (clinical significance measure), while in the GW Pharma study only 47% of patients
experienced this. However, only 4% were seizure-free versus 9% in the GW Pharma study. This result was also achieved with
a lower average dose than the Epidiolex study27.
Market opportunity
In the United Kingdom, there are over 480,000 people with epilepsy and approximately 25% suffer from drug-resistant epilepsy28.
Since 2001, deaths from epilepsy have risen 70%, and people with the condition now die on average eight years earlier than the rest of the population29.
Globally, over 50 million people suffer from epilepsy, with 1.9 million across Europe and over 200,000 in Australia30, with the statistic of 25% suffering from drug-resistant epilepsy continuing globally. The estimated population at the launch of CMA is over 200,000 people with drug-resistant epilepsy31.
The Directors anticipate that CannEpil® will obtain CMA within the next 4 years.
At present, access to medicinal cannabis products in certain regions is highly restricted and the Group’s projected patient
numbers have assumed a scenario without regulatory hurdles.
The Directors’ believe that peak sales of CannEpil® could reach £1.43 billion (AUD$2.57b) (excluding off-label revenue, which
could be significant during this time) within the EU5, Australia, MENA and Thailand regions32 over the next 4 years, if
extended to paediatric and adult use.
Given there are no other therapy options, CannEpil® could theoretically access 100% of the available patient population. The Group would expect a potential
That's the f@@king problem, you did show us yesterday you can't read it. Even you try to read it but you don't understand the logic behind it.
Question
Do you still think MGC don't have a money to finish the Malta by 2024?
If you don't want to see my post just filter me. Let's see if you can do that or you still coming to reply to my message here.
This is a link for it, I call it MGC Bibel. 190 pages
https://mgcpharma.com.au/wp-content/uploads/2021/02/MGC-Pharmaceuticals-Prospectus.pdf
I'm trying to break it into parts here so we can better know the MGC
PART 4
• Binding Term Sheet signed with IM Cannabis Corp. (IMC) for exclusive importation, sale and distribution of CannEpil®
in Israel for a period of five years;
• Acquisition agreement signed for the disposal of MGC Nutra to Onassis Holdings Corp. in consideration for the issue
to MGC UK of Onassis Holdings Corp. common stock worth US$6,000,000, which is currently expected to be
completed in H1 2021, subject to completion of a capital raising and US regulatory approvals; and
• Distribution agreement executed with Anden Bio Naturals S.A for the exclusive distribution and commercialisation of
its medicines in Peru and Bolivia for five years.
The Group operates in jurisdictions where the cultivation, manufacturing, research and/or patient access of
phytocannabinoid-derived medicines is legal, and in all cases operates in accordance with local law requirements.
The Group has no involvement in the recreational cannabis industry.
PART 3
While COVID-19 is impacting business operations globally in 2020, the Group has seen considerable movement in operational
growth through the year-to-date, with many milestones and achievements being reached:
• Completion of a Phase II placebo controlled clinical trial in Israel and India to evaluate the safety and efficacy of a
natural anti-inflammatory based formulation ArtemiCTM on COVID-19 patients, with interim results on 10 patients indicating significant efficacy, with the full results announced by the Company on 15 December 2020;
• Successful research results on glioblastoma multiforme from an ongoing pre-clinical research program in
collaboration with the National Institute of Biology in Slovenia;
• Ethics committee approval from Schneider Children’s Medical Centre of Israel to commence a Phase IIb clinical trial
for the Group’s proprietary epilepsy treatment, CannEpil®;
• The launch of ‘Mercury Pharma’, a new proprietary ratio-based affordable prescription medicine line, with the full
suite of products available for prescription in Australia and Brazil in September 2020;
• Execution of a binding amendment to the supply and distribution agreement with ONIX Empreendimentos e
Participações, which established a minimum order volume of 20,000 units for year one and a down payment of
A$107,000 (€65,000) was received;
• Significant increase in products sales from 2019, with over 7,000 units sold across Australia, New Zealand, UK and
Brazil;
• Successfully granted a three-year renewal of its GMP Certification for its Slovenian manufacturing facility;
• The Group’s Australian operating subsidiary, MGC Research, was awarded an import licence and a Research
Cultivation Permit for the cannabis research programme with RMIT from the Australian Office of Drug Control,
progressing the Group’s Australian operations and supporting its fully vertically integrated and research orientated,
nature to medicine business model;
• Acquisition of Australian tele-health company, Medical Cannabis Clinics, increasing the Group’s access to patients;
• Binding term sheet signed with a wholly owned division of SK-Pharma Group for the sales and distribution of
ArtemiCTM in Russia, Israel, the CIS and Balkan countries;
PART 2
In 2018, the Group appointed Roby Zomer as Managing Director. During the year the Slovenian facility was granted GMP
certification and the Group obtained the letter of intent from the Maltese Government for a large-scale manufacturing
facility; further to this the first shipment of CannEpil® arrived in Australia. The year also saw progression of clinical research
with CogniCann™, commencing Phase IIb clinical trial with UNDA and CannEpil® research progressing in Slovenia.
In 2019, the Group reached several milestones:
• Signed numerous distribution agreements to bring products into the United Kingdom, Australia, the EU and Brazil;
• Preclinical glioblastoma research was completed with significant results, in that the statistical results showed a level
of significance within the hypothesis test representing probability of efficacy;
• Over 1,000 prescriptions of CannEpil® and MXP100 (the Group’s CBD formula) in Australia and the United Kingdom;
• Cannabis Research Licence obtained by MGC Research to cultivate cannabis for botanical and preclinical research at
RMIT, Australia;
• Site planning was completed on the Group’s 15,720m2 Malta manufacturing facility;
• Completed sale of the Company’s subsidiary MGC Derma to CannaGlobal Canada Co Inc. in consideration for shares
representing up to 10% equity interest;
• Entered into a binding term sheet to form a 50:50 joint venture company with Brazil Invest Global Business and
Development for the retail sale and marketing of the Group’s products in Brazil and the wider Latin American region
(this arrangement was terminated in early 2020); and
• Approval received from Ireland’s Ministry of Health, permitting the sale of CannEpil® under the medical cannabis
access programme.
PART 1
MGC Pharma (UK) Ltd was established in 2015 by leading Israeli medicinal cannabis industry executives, with the vision of
becoming an international leader in the development and supply of phytocannabinoid-derived medicines within the biopharmaceutical industry.
MGC Pharma (UK) Ltd’s founder, Nativ Segev, was CEO of Better Cannabis, one of Israel’s eight official medicinal cannabis
companies, and experienced the limitations of the local market, while recognizing the global impact of the industry was going to have. Mr. Segev recruited, Roby Zomer, whose experience in energy and biofuel projects, large-scale agricultural projects, and global commerce, contributed to founding a business focused on leveraging Israeli knowledge and experience with a globally emerging industry. Segev and Zomer then established an operational base in Slovenia, while creating an
opportunity for the acquisition of MGC Pharma (UK) Ltd by an Australian company, formerly known as Erin Resources Limited, which then became MGC Pharmaceuticals Ltd.
In 2016, the Company was relisted on the ASX through its RTO of Erin Resources Limited. In that same year, it established a
the wider operating group that launched a wholly-owned subsidiary MGC Derma and appointed Dr. Ross Walker to the Board.
Australia legalized medicinal cannabis, allowing the Group to progress its operations there, while also acquiring an interest
in PANAX Pharma s.r.o, allowing it to advance botanical research in the Czech Republic. In this year, leading pediatric epilepsy expert, Prof Uri Kramer, joined the Strategic Advisory Board and launched the Group’s development of its flagship epilepsy medication, CannEpil®.
In 2017, the Group completed construction of the Slovenian manufacturing facility; in addition, the Company signed
agreements with RMIT, progressing the Group’s research and development agenda, and MGC Slovenia appointed Lenis
farmacevtika as the Group’s key distribution and wholesale partner.
hi mazik
Fair enough mate. I use both here and telegram.
I suggest that for CP85 because I can see these spammers here stress him out. so on the telegram group, they can't spam the group chat, and also there are good information passing on and people they are more positive.
CP85
why you don't join the telegram group.
https://t.me/MGCpharma
Listen Pokerchip, I don't know how old are you but I think you are to young that's why you don't know how to read the legal documents.
next time first ask a question nicely before accuse me of giving wrong information or hiding information from people.
let me explain the malta facility for you and other spammers here so hope stops you guys talking about malta.
First part
The date for this document is 4 February 2021.
*** let's read the first section very carefully.
It is expected that the facility in Malta will cost approximately £10 million (A$19m) to complete and, as at the date of this document (prospectus), beyond the Working Capital Period, the Group may need to raise further funds to meet the costs required to have the facility fully constructed, licensed and operational.
**Now read this
18 February 2021
* Minimum three (3) year exclusive worldwide1 supply and distribution agreement signed with leading European nutraceuticals producer and distributor, Swiss PharmaCan AG, for the distribution of ArtemiC™ Rescue as a food supplement
*how much is this distribution agreement worth for the company, around $12 million per year minimum.
Are you with me, let's look at the second part:
However, on 10 September 2020, the Group received the second letter of intent from Malta Enterprise, addressed to MGC UK, confirming that it has approved the allocation of industrial space for the setting up and operation of a facility in Malta for the provision of standard laboratory services to the medical industry in Malta, including process validation, GMP product release, contract research, quality assurance, and in-vitro research, and the setting up and operation of a production line for the manufacture of ArtemiC™.
As a result, the Company has decided to delay the building of the larger single multi-story 15,720m2 facility, and instead build an alternate manufacturing facility for ArtemiC™, which will also undertake clinical research and analytics, and serve as an alternative manufacturing facility (with a faster lead time) for the Group’s phytocannabinoid-derived products.
what that means to us,
it means they try to build an alternate manufacturing facility for ArtemiC™ first as a priority to supply ArtemiC as a food supplement just in case if CimetrATM does not pass phase 3 or if its pass they using in for both.
Construction of this smaller, 480m2 facility, commenced in Q4 2020 and it is anticipated that it will be completed in 2021.
what's next, here you go:
Following its completion, the Company will focus its resources on the construction of the larger 15,720m2 facility, which is expected to be operational in mid-2024.
once complete, will be the primary hub for the Group’s manufacturing operations. The Slovenia facility will be primarily used for research and manufacturing products for use in clinical trials.
you have fun and next time ask for an explanation if you don't understand anybody pos
This documents is for AFC approval, this is against the FCA terms if they claim everything going to be 100% to plan. They try to cover them self against the FCA. This is how all the companies send them documents to FCA. Everything they claim they need to start with "if", "may not" and so on.
Dated 4 February 2021,
This document comprises a prospectus (the “Document”) relating to MGC Pharmaceuticals Limited (the “Company”) prepared in accordance with the Prospectus Regulation Rules of the Financial Conduct Authority (“FCA”) made under section 73A of the Financial Services and Markets Act 2000, as amended (“FSMA”). This Document has been filed with and approved by the FCA and has been made available to the public in accordance with Rule 3.2 of the Prospectus Regulation Rules.
You can f@@k off now.
Now go find out abot FCA
Thanks mate, I will try to add some more info out every day so we can understand how MGC work.
Knowledge is a key always.
Part 2
However, on 10 September 2020, the Group received the second letter of intent from Malta Enterprise, addressed to MGC UK,
confirming that it has approved the allocation of industrial space for the setting up and operation of a facility in Malta for the
provision of standard laboratory services to the medical industry in Malta, including process validation, GMP product release,
contract research, quality assurance, and in-vitro research, and the setting up and operation of a production line for the
manufacture of ArtemiC™.
As a result, the Company has decided to delay the building of the larger single multi-story 15,720m2 facility, and instead build
an alternate manufacturing facility for ArtemiC™, which will also undertake clinical research and analytics, and serve as an
alternative manufacturing facility (with a faster lead time) for the Group’s phytocannabinoid-derived products. Construction of
this smaller, 480m2 facility, commenced in Q4 2020 and it is anticipated that it will be completed in 2021. Following its
completion, the Company will focus its resources on the construction of the larger 15,720m2 facility, which is expected to be
operational in mid-2024.
The Group’s combined facilities in Malta will be significantly larger than its existing facility in Slovenia and, once complete,
will be the primary hub for the Group’s manufacturing operations. The Slovenia facility will be primarily used for research and
manufacturing products for use in clinical trials. At the Malta facilities, the Group expects to employ 27 full-time staff, scaling
up the ability to meet the peak demand expected by the Group.
Once construction is complete and licensing and GMP certification is obtained, the 15,720m2 Maltese facility is expected to
be a sizeable GMP phytocannabinoid-focused manufacturing facility, with production capacity able to satisfy any foreseeable
demand. The Group will be able to utilize existing standard operating procedures and protocols developed and established
in Slovenia, in this new facility in Malta. Once complete and fully operational and licensed, the 15,720m2 facility in Malta, with
GMP-certified processing and production will signal the achievement of a key milestone in the Group’s goal of being an
international supplier of phytocannabinoid-derived medicines.
Part 1
At present, all the Group’s phytocannabinoid-derived investigational medicines are produced at the Group’s Slovenia
the manufacturing facility, which is one of only a few in Europe with a Certificate of GMP Class D non-sterile (demonstrating
compliance with the principles and guidelines of GMP laid down in Directive 2003/94/EC), as well as an EU manufacturing
license to produce GMP certified phytocannabinoid medicinal formulations53
. These allow the Group to formulate and
compound API provided by its third-party partner and pack the Group’s phytocannabinoid-derived medicines for delivery to
pharmacies and patients utilizing the Group’s appointed distributors. Other companies in Europe with the capacity to
manufacture API to GMP are Bionorica (THC+CBD synthetic, THC), Echo Pharmaceuticals (THC, CBD), BSPG (CBD), CBDepot
(CBD), Noramco (THC Synthetic), and non-EU companies: Linea (CBD), NYSK (THC).
Currently, the Group purchases THC and CBD API from GMP certified manufacturers in Europe, which is then compounded
into final dosage form products and bottled in the Slovenian facility. The Slovenian facility currently has 13 full-time staff
members focused on production.
The Group was the first phytocannabinoid-derived medicines developer and producer to obtain a letter of intent from the
Government of Malta, allowing the Group to commence the planning and development of a high-level high output
pharmaceutical manufacturing facility to create a hub for the Group’s global distribution from Malta. The facility is also
designed to allow for the possibility (and licensing) of the cultivation and processing of medicinal cannabis for use in the
Group’s pharmaceutical pipeline, with a minimum commitment of the Group to invest circa £5.4 million (AUD$9.7million) in
improvements to site, plant, machinery, and equipment.
The Group has entered into a long-term emphyteutic deed with Malta Industrial Parks for 6,000m2 of land, on which site
planning has been completed and construction has been authorized of the new facility. The Group planned to construct a
single multi-story 15,720m2 facility, including a 10,480m2 combined use area, designed to include GMP-certified processing
and production capabilities, with a 5,240m2 greenhouse on the roof for cannabis cultivation. This facility in Malta was expected to be operational in mid-2024, subject to the premises and operations being licensed by the Medicines Authority
of Malta under the Production of Cannabis for Medicinal and Research Purposes Act 2018.
https://investi.com.au/api/announcements/mxc/508eb7d5-eda.pdf
Hi all, hope you're well
This video explains why we need something like ArtemiC in future to fight against COVID-19.
Mathematical biologist Dr Kit Yates explains why vaccines alone may not be enough to contain the coronavirus.
https://news.sky.com/video/covid-19-why-new-modelling-from-university-of-warwick-says-vaccinations-may-not-be-enough-12250811