Akanda will supply Tetra Bio-Pharma with pharmaceutical-grade cannabis for the FDA trials of a new inhaled cannabinoid-based drug for cancer pain.
Akanda is making its first entry into drug cannabinoid development as it partners with Tetra Bio-Pharma to supply medical-grade cannabis for the global commercialisation of a new cannabis-based medicinal product for cancer pain. Tetra’s QIXLEEFTM is a botanical inhaled drug currently being studied in two US Food and Drug Administration (FDA) authorised clinical trials.
Under the multi-year agreement, Akanda will supply the Candian-based company with premium THC and CBD flower, and will provide regulatory, quality and pharmaceutical manufacturing services for the drug’s clinical development and marketing authorisation.
The companies estimate the total addressable market for QIXLEEF™ to be nearly $1.7 billion by 2028.
The supply of cannabis flower starts in the third quarter of 2022 and is anticipated to increase incrementally over the succeeding years based on growing demand and commercialisation of Tetra’s cannabinoid-derived medicines.
Akanda will also act as a contract development and manufacturing organisation (CDMO) for Tetra’s clinical drug and commercial supply programmes.
The international cannabis company said it will provide Tetra with a range of services, including regulatory affairs, quality control and stability testing through Akanda’s internal lab, along with manufacturing capabilities. Upon FDA approval, the anticipated supply commitments could reach over 10 metric tonnes per year.
“This supply agreement with Tetra is a major milestone in Akanda’s journey in becoming a cannabis platform company serving all regulated markets in the EMEA region,” commented Tej Virk, CEO of Akanda. “In supporting a terrific partner with a mission to improve patient health and quality of life through cannabinoid-derived medicine, we are demonstrating that cannabis can fit into the traditional public sector model, with the expectation of reimbursement.
“Simultaneously, we are productively utilising our diverse capabilities to support clinical trials for pharma-grade cannabinoids. If approved, we expect to provide flower for the authorised compound, potentially creating a significant, incremental revenue stream for Akanda. This opportunity could only have been possible with our state-of-the-art facilities that we gained through the acquisition of Holigen in May.”
Tetra, a leader in drug discovery and development for cannabinoid-based medicines, is focusing on therapeutic areas of inflammation, pain, ophthalmology and oncology using multiple delivery systems.
QIXLEEF™ is being used in the phase 2 clinical trial, REBORN, which has been authorised by the FDA to evaluate inhaled cannabinoids against a class of immediate-release oral opioids for the management of breakthrough cancer pain. It is also being used in the FDA-authorised phase 2 clinical trial, PLENITUDE, to evaluate the safety and efficacy of inhaled cannabinoids to relieve uncontrolled pain in patients with advanced cancer.
“Tetra has been looking for quite a while to find a global strategic CDMO partner, and we believe that Akanda is a perfect fit from a vision standpoint,” said Guy Chamberland, MSc, PhD, CEO and chief regulatory officer at Tetra. “This partnership will allow Tetra to secure a robust and trustable source for its clinical drug supply and for QIXLEEF™ commercialisation plans.
“Aside from quality, Akanda will rapidly automate our process and increase our capacity, resulting in a 67% reduction of our cost of goods sold (COGS). Establishing a defined source of high-quality ingredients is important for Tetra, and we are excited to advance a productive collaboration with Akanda as we advance target drugs through the regulatory process.”
The partnership will bring Akanda into the cancer pain medical market for the first time. The company’s president Dr Akkar-Schenkl said the collaboration with Tetra will put both firms on the path to becoming the “ambassadors for cancer pain treatment”.
“This collaboration transitions our Sintra facility into a global CDMO for cannabinoid-based pharmaceuticals as we build up our internal laboratory capacity and manufacturing under EU GMP,” said Dr Akkar-Schenkl. “The pharmaceutical-grade flower and the level of pharmaceutical excellence in manufacturing, quality operations and regulatory affairs we will be providing into these projects is our fundamental commitment to worldwide palliative care in pain treatment in the field of oncology.
“The bioburden quality of the flower we will be providing for this delicate patient population can only be managed under stringent manufacturing conditions, special regulatory and pharmaceutical know-how.”
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.
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