MGC Pharmaceuticals plc (LON:MXC) Chief Executive Officer Roby Zomer caught up with DirectorsTalk for an exclusive interview to discuss what the company does, the first import of Psilocybin, highlights from the last quarter and what investors can expect in the coming months.
Q1: Roby, before we discuss today’s news, could you just remind us of what MGC Pharmaceuticals does?
A1: It’s a pharmaceutical company designated to finding a new innovative formulation, plant-inspired to treat unmet medical needs.
We have core development in the company to develop new formulations, a new drug, and to bring them to the market but as a pharma company where we have everything in-house.
We are also able to provide a services platform to other pharmaceutical companies that want to become a drug owner and to help them to develop their medicines.
Q2: There was an interesting announcement this morning confirming that the first import of Psilocybin, can you tell us more about that and what it means for the company?
A2: As we saw that there is a market emerge and opening to the Psilocybin with a recent announcement in Australia that they are permitting prescription of Psilocybin and MDMA to specific indication, we as a company want to keep relevancy and be in the frontline of development.
We engaged with another pharmaceutical company called Psyence who are developing a product medicine based out of Psilocybin. What we did is we engaged with them and basically gave them a platform to take their product to meet EU standards and then to the next stage where they will be able to develop, research, and market eventually medicine to treat different indications in palliative care based off Psilocybin.
We are able today to demonstrate two capabilities of MGC, first of all that as a pharma company, we were able to deal with all the substances whether they are control or non-control. We’re being able to work with the front end of companies that will bring new innovative products to the market and being able to provide a pharmaceutical platform of research and development to other pharmaceutical companies that want to enter into the pharma industry. We are able to do it through our European and our Slovenia research facilities.
Q3: Now, the company has been very busy recently, could you sum up some of the highlights from the last quarter?
A3: I think that as a pharma company, we have our own two core products which are CannEpil products that are designed to treat refractory epilepsy, also know as drug-resistant epilepsy and CimetrA which is an immune modulation treatment.
CannEpil, just over the last quarter, was able to get approval to be listed under the GMC in the UK which means all specialists – there’s more than 100,000 specialists under the GMC in the UK- will now be able to prescribe CannEpil.
Also CannEpil was prescribed to the first patient enrolling to the RESCAS programme. RESCAS is a Refractory Epilepsy Special Access Scheme by the NHS which means patients that are going onto this programme, if the treatment is valid, eventually we’ll be able to get it covered by the NHS and have it as a suitable treatment for their drug-resistant epilepsy.
So, this was a very key milestone for the company development following last year, the listing under the Irish health system and being covered by the Irish health insurance, opening the UK market as a main market within Europe. First of all, large market for the potential sales of the medicine but also from a regulatory perspective and prestige, this will allow us to open more markets as we move forward and we start to put focus with the first medical symposium to these doctors happened by the end of the recent quarter.
The second product, CimetrA, which was early this quarter got the approval and listed under the OTC by the FDA as a non-licensed drug, meaning it’s opened up the American market as an ‘over the counter’ unlicensed drug. This allows us to get the orders from AMC, the American company that signed with us for the marketing and sales of CimetrA in the United States.
We got and delivered the first million dollar of product and we got a second million dollar order with down payment already received by the company. We are now working on the second million dollar in parallel to the commercial progress.
Of course, we had the clinical progress, we’re able to get more information and more progress on CannEpil and CimetrA. We are now in the final stage to obtain all the pre-clinical, clinical criteria so we’ll be able to progress with an FDA open IND application in the near future which will be as the target as we indicate both of our drug, CannEpil and CimetrA are targeted to go up on the FDA. As I said, CimetrA already has been obtained as an over the counter and listed in the OTC, we will try to push forward to get also CannEpil and CimetrA with open IND in the near future.
So, basically, this is the current stage of the company.
Q4: Just looking at the future, what can investors expect from MCG Pharmaceuticals over the coming months?
A4: I think, first of all, they will continue to see the progress that we have in the UK, Ireland and the United States on the side of the sales, increasing the footprint of the company product in the UK and American and we’re going to see more results coming from the studies of CimetrA.
We’re going to see both progress on the clinical development of these two products alongside commercial sales of these two products in the current market that we are operating in.
