GW Pharmaceuticals has received approval for Epidyolex from the Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of seizures associated with tuberous sclerosis complex.
Epidyolex, the first cannabis-derived medicine to receive a positive NICE recommendation for the treatment of seizures in patients with two rare and severe forms of childhood-onset epilepsy, has now received MHRA approval for the treatment of seizures associated with tuberous sclerosis complex (TSC).
Tuberous Sclerosis Association (TSA) chief executive, Louise Fish, said: “One in every two people living with TSC-related epileptic seizures has difficult to treat epilepsy that does not respond to traditional anti-epileptic drugs.
“We are excited to see this new medicine approved by the MHRA, which gives people living with TSC and their families hope. We desperately need further options for clinicians who are managing seizures associated with TSC, and we, therefore, welcome this decision by the MHRA.”
The approval applies in England, Wales and Scotland and follows the recent approval of the product in all 27 countries of the European Union. Following this approval, GW Pharmaceuticals will work with the relevant stakeholders in the UK, including NICE, to secure reimbursement for eligible patients.
Tuberous sclerosis treatment
TSC, which causes mostly benign tumours to grow in vital organs of the body, affects an estimated 3,700 to 11,000 people in the UK, and causes epilepsy in up to 85% of patients – 60% of which do not respond to standard anti-seizure medications.
The approval is based on data from a positive Phase 3 safety and efficacy study evaluating 25 mg/kg/day of Epidyolex, which met its primary endpoint of the reduction in seizure frequency compared to baseline of cannabidiol vs placebo. Seizure reduction was 49% in patients taking cannabidiol 25 mg/kg/day compared with 27% for placebo.
Speaking on Tuesday, Chris Tovey, executive vice president, chief operating officer and managing director, Europe and international at Jazz Pharmaceuticals, commented: “We are delighted by today’s decision from the MHRA for this new indication, which represents a significant step forward for TSC patients in the UK, many of whom may benefit from this new treatment.
“The UK is a significant country for us for many reasons, and we are proud to be able to offer a medicine, that has been developed and is manufactured here, to even more patients across the UK. This authorisation, expanding the label, is further proof of our continued commitment to the UK and the pioneering research and development into regulatory approved cannabis-based medicines we have conducted here.”
GW Pharmaceuticals, which is now part of Jazz Pharmaceuticals, was initially granted marketing authorisation for the medicine in the UK in 2019 as an adjunctive therapy for seizures associated with Lennox Gastaut syndrome or Dravet syndrome, in conjunction with clobazam, for patients two years of age and older. The medicine also received a positive recommendation from NICE to receive routine reimbursement from NHS England.
Khiron announces opening of first Zerenia medical cannabis clinic in Brazil
The new clinic will increase patient access to medical cannabis.
European medical cannabis group, Khiron, has opened its first Zerenia medical cannabis clinic in Ipanema in Rio de Janeiro, Brazil, as it continues its expansion into the country.
As part of its expansion into a number of jurisdictions across the globe, including Germany and Spain following recent developments, Khiron has now opened its Zerenia Rio clinic.
The clinic will provide physical consultations and telehealth services, connecting patients with medical specialists trained in the ethical, safe and responsible prescription of cannabinoid-based medications.
The medications focus on the treatment of conditions such as chronic pain, neurological pathologies, palliative care, rheumatology, psychiatry, geriatrics, endocrinology, gastroenterology, gynecology, otorhinolaryngology and dermatology.
Located in Ipanema, a city with more than 12 million people, the clinic’s initial phase will have a total capacity of approximately 23,000 patient consults per year.
The clinic will be under the leadership of Dr Eduardo Faveret as medical director and will open with more than 13 doctors for both in-person and telehealth models.
Dr Faveret commented: “Brazil continues to experience exponential growth in prescribing doctors and demand for medical cannabis products by patients. Zerenia Rio, is positioned as a comprehensive and humanised pioneer in patient health service and prevention to improve the quality of life of Brazilian families.
“We have assembled a multidisciplinary medical team that covers diverse medical cannabis specialties and treatments, which makes our Zerenia Rio clinic unique in Brazil.”
Dr Faveret and the Zerenia Rio clinic will be supported by Khiron’s strategic alliances with doctors and patient associations, including CANNAB in Salvador de Bahia, and leading medical distributors such as TAIMIN in Rio de Janeiro and Sao Paulo.
Later this year, Khiron is expecting to launch additional THC medical cannabis products in the country, which will complement its current global portfolio.
CEO and director of Khiron Life Sciences, Alvaro Torres, said: “Khiron has developed a unique, successful, and sustainable model with the implementation of Zerenia in Colombia, Perú, and the United Kingdom.
“Brazil is Latin America´s largest addressable market with more than 210 million people and we believe that our Zerenia model will replicate the success we have experienced around the world.
“We have served more than 25,000 individual patients across the globe through our model, with high peer patient acquisition and retention rates. We have a fantastic team on the ground in Brazil composed of doctors, nurses, patient advocates, and administrative staff in our Zerenia™ Rio clinic that will elevate our patient-first model to new levels.
“Khiron’s Zerenia Rio clinic in Brazil will also allow us to continue to generate more patient-based evidence on the pharmacoeconomic benefits of our Khiron-branded medical cannabis products, and through this data, Khiron could eventually be able to provide insurance benefits for patients as we have done in Colombia.”
Akanda and Cansativa to supply German patients with cannabis flower
The collaboration will see patients have access to two novel cultivars.
Akanda Corp and Cansativa are collaborating to supply the German market with dried flowers from Akanda’s EU-GMP certified indoor grow facility in Sintra, Portugal.
Under the collaboration, Akanda is expected to deliver at least 1,000 kg of flower to Cansativa over the first 12 months of the agreement.
All pharmacies in Germany will be able to purchase the products through the Cansativa platform. Since the award of the Federal Institute for Drugs and Medical Devices (BfArM) in August 2020, Cansativa Group is the only company with approval for the distribution of medical cannabis from German cultivation.
Co-founder and CEO of the Cansativa Group, Benedikt Sons, commented: “We are very glad about this agreement that allows us to introduce two novel medical cannabis flowers to the German market.
“This enables patient access to an additional supplier with a new and innovative range of medical products. This exciting cooperation marks another step in improving the product diversity and security of supply on the German market.
“We look forward to a long-term relationship with Akanda, with whom we share an important part of our mission: We want to enable physicians, pharmacies, and patients by giving them access to an extensive medical product portfolio and help improve the quality of life with the help of medical cannabis.”
CEO of Akanda, Tej Virk, added: “Our prized purpose-built indoor grow facility is the only one of its kind in Portugal that can produce EU-GMP medical cannabis equivalent to the adult-use grades available in North America.
“It has both the quality and scalability to meet the growing demand for medical cannabis in fast-growing markets across the EMEA region, such as Germany.
“We are equally excited to be partnering with the Cansativa Group to bring some of our best strains to Germany through their platform. This supply agreement represents one of the largest agreements in the nascent European medical cannabis industry and is certainly Akanda’s most substantial commercial development to date, enabling new patient experience.”
Khiron gains German distribution capabilities with new acquisition
Khiron Life Sciences has completed the acquisition of Pharmadrug Production GmbH.
Through its acquisition of Pharmadrug Production, Khiron will have access to EU-GMP manufacturing capabilities and a distribution hub for medical cannabis.
It will also allow Khiron to accelerate the expansion of its medical product portfolio with additional exclusive flower varieties and a THC‑dominant full spectrum extract that combines the medicinal properties and areas of application of the established THC isolate formulations (dronabinol) with the specific advantages of a full-spectrum extract.
President of Khiron Europe, Franziska Katterbach, stated: “We are very pleased that we have now received all the necessary permits and licenses in connection with the acquisition and integration of Pharmadrug Production and that we can continue our growth course in Europe on an expedited pace with full control over the value chain up to the pharmacy. We are very excited to take advantage of the Pharmadrug Production’s excellent infrastructure and experienced team, which will enrich us professional and personally.
“After opening our Zerenia clinic in London last year and now adding a powerful asset in Germany, our European force is complete and ready to ramp our sales in Germany.
“Now we expect to sell our products faster and at higher margins directly to German pharmacies, which will save distribution fees. A first signal in this direction is the imminent expansion of our medical portfolio for European patients.
“These are products manufactured exclusively in Europe, and our medical portfolio now covers the entire spectrum of chemotypes and forms of administration. We will provide more detailed information on our new products in a timely manner.”
The development is in line with the Khiron’s strategy to strengthen its foothold in Europe, having also recently welcomed Spain’s progression on the regulation of medical cannabis, stating it is looking forward to bringing its clinical expertise and evidence from Khiron-owned Zerenia Clinics to Spanish patients.
Khiron, which recently reported a record 2022 Q1 with revenue of $4.6m, has stated that additional new products are already in the pipeline, that will comprise the entire spectrum of therapies with medical cannabis to be able to offer the right therapy for every patient.