The European Medicines Agency (EMA) has given a positive opinion for Orphan Drug Designation (ODD) for Tetra Bio-Pharma’s QIXLEEF.
Cannabinoid-derived drug discovery company Tetra Bio-Pharma has received a positive opinion from the European Medicines Agency’s Committee for Orphan Medicinal Products (COMP) on its application for ODD for its investigational medicine QIXLEEF as a potential treatment for Complex Regional Pain Syndrome (CRPS), a chronic neuropathic pain condition.
The medicine is a botanical inhaled drug product with a fixed ratio of THC and CBD that provides fast-acting relief from pain, which the company says offers patients a viable, safer, and non-opioid option for pain management.
Tetra CEO and CRO, Dr Guy Chamberland, commented: “The positive opinion issued by the COMP is excellent news as Tetra continues to execute its regulatory strategy in Europe.
“An ODD brings several unique advantages, from a cost reduction in drug development, to an accelerated review process and market exclusivity for 10 years. Such strategy is cost and time-effective and allows the Company to easily gain market shares in a competitive free environment. If granted, this would represent QIXLEEF’s second ODD as a potential treatment for CRPS, in addition to the ODD granted by the US FDA in March 2018.
“We firmly believe that QIXLEEF will be a safe and effective medicine for pain management and an alternative to opioids.”
The positive opinion issued by the COMP will be sent to the European Commission, which is expected to grant the orphan designation within 30 days.
As the medicine will be intended to treat an orphan condition, clinical studies will be preformed with a significantly smaller number of patients and could be entitled to conditional approval through a decentralised procedure resulting in a single decision from the European Commission, valid in all EU Member States, which would shorten the time to market approval.
Cookies and InterCure expand into UK and Austria
Iconic cannabis brand Cookies is expanding into the UK and Austria with the opening of retail locations.
Iconic cannabis brand Cookies has partnered with Israel-based InterCure to expand into Europe.
The partnership will see Cookies and InterCure open retail locations in the UK and Austria in early 2022. The parties entered into a multi-year deal under which InterCure will establish Cookies stores and medical cannabis pharmacies in the countries.
President of Cookies, Parker Berling, commented: “As we focus on new territories, it’s vital our customers continue to count on the quality Cookies is known for, which is a value we share with our partners at InterCure.
“We look forward to reaching audiences in Austria and the United Kingdom and establishing Cookies as a mainstay in each community.”
InterCure, a Cookies’ international partner, is already cultivating, manufacturing and distributing GMP standard, Cookies-branded products through its Cookies national medical cannabis pharmacy chain. InterCure will leverage its licensed international supply chain to serve the growing communities of medical cannabis patients in Europe.
CEO of InterCure, Alexander Rabinovitch, added: “Cookies is one of the most internationally recognized brands in cannabis, and after our mutual success in Israel, it’s only obvious we further our expansion to Europe, providing the highest quality grade cannabis products.”
Cookies recently announced its partnership with The Flowr Corporation to bring its premium strains such as Pink Runtz and Gelatti to the European Union. The partnership will see Flowr’s indirect wholly-owned subsidiary, RPK Biopharma, cultivate and distribute Cookies products in Portugal from its 25,000 square foot indoor EU GMP facility in Sintra.
CiiTECH set to launch its medicinal cannabis range Provacan THC in Israel
Israeli patients will have access to the first Provacan THC oil in January 2022.
CiiTECH and Cannassure have announced a major deal to develop and market Provacan THC products for medical cannabis use in Israel, marking CiiTECH’s long-awaited move into medicinal cannabis.
In addition to offering established consumer CBD brands, CiiTECH‘s flagship brand Provacan is considered one of the most respected in the UK. Clifton Flack, CEO and founder of CiiTECH, intends to bring Provacan’s reputation for quality and consistency to the troubled Israeli medical cannabis market.
“CiiTECH is unique in its approach to the CBD wellness and medicinal cannabis markets. We built an international reputation as a market-leading CBD company by producing pharmacy-trusted CBD oil tinctures and selling them as food supplements before making our move into THC. Our intention is to bring these International standards to the Israeli market,” says Flack, “As a UK company with strong roots in Israel, CiiTECH is well positioned to make its THC debut and there is no better place to do so than in Israel, the epicenter of global cannabis research.
“Cannassure is known for producing high-grade medical cannabis in Israel with an advanced indoor-aeroponic growing system and state-of-the-art extraction.”
“The collaboration with CiiTECH, a leading company in the field of cannabis research and marketing and owner of the leading brand Provacan, is an important step in the field of cannabis oils for us, an area that enjoys significant growth among patients who do not want to consume inflorescence cannabis. We are confident that this collaboration will bring value for us, for CiiTECH and for cannabis patients in Israel, and we believe that it will help us conquer a more significant share of the cannabis oil market in Israel,” added Ran Amir, Cannassure CEO.
As part of its business strategy, CiiTECH seeks and collaborates with best-of-breed cannabis providers up and down the supply chain in multiple geographies. With this agreement, CiiTECH continues to demonstrate its effective business strategy, commitment to quality assurance, and speed of entry into the market that the industry has grown to expect from CiiTECH.
With the help of Cannassure, CiiTECH will help reform, standardise, educate and establish quality, consistency, and reliability in the Israeli medical cannabis market. In order to achieve this goal, CiiTECH is developing a hybrid solution in which a superior quality product is offered to patients and a unique professional enrichment programme is offered to help doctors and pharmacists support patients on a deeper level.
Around 80 per cent of Israel’s 100,000 licensed medical cannabis users smoke, rather than using tinctures. The biggest complaint in those groups is the lack of quality and consistency. It is CiiTECH’s mission to show these users how much better tinctures are than smoking. Provacan ambassadors and users will benefit from comprehensive education courses provided by CiiTECH as part of this re-education so they will feel more confident and better supported while using CiiTECH products.
“As cannabis market experts and our involvement in the cannabis ecosystem in Israel, we understand the nature of the demand and the gaps in the Israeli market. Our new THC tincture will revolutionise the lives of many patients who are currently suffering from inconsistencies in the medical cannabis supply chain, and it will be made to the same strict UK & European guidelines as our current products,” concludes Flack.
Israeli patients will have access to the first Provacan THC oil in January 2022, followed soon thereafter by Brazilian and British patients.
Further drug development agreement for Oxford Cannabinoid Technologies
Dalriada will support the company with R&D activities.
Oxford Cannabinoid Technologies has signed a drug development agreement with Canada-based Dalriada Drug Discovery Inc.
Oxford Cannabinoid Technologies Holdings (OCTP), the holding company of Oxford Cannabinoid Technologies Ltd (OCT), has entered into an agreement with Dalriada to propel OCT’s R&D activities. A goal of the collaboration is the selection of two drug candidates ready for pre-clinical development by the end of 2022.
Dalriada will evaluate cannabinoid derivatives, which includes 335 cannabinoid derivatives, 14 patent families and related intellectual property, acquired under the exclusive licence agreement with Canopy Growth Corporation to advance OCT’s Programmes 3 and 4. These programmes target pain, neurology, and inflammation.
OCTP chief executive, Dr John Lucas, commented: “Whilst our main focus remains pain therapy, the collaboration with Dalriada, in synergy with the strategic collaborations recently announced, will enable us to expand and differentiate our efforts into other therapeutic areas including neurology, oncology and inflammation.
“Working with the team that helped Canopy to develop its library is hugely exciting for OCT and will help us get the very best out of that important acquisition.”
Dalriada designed, synthesised and experimentally tested all of the compounds in the Canopy library, and OCT will be able to leverage Dalriada’s existing knowledge and experience as it continues research and development aimed at identifying multiple drug candidates.
Dalriada chief executive and co-founder, Diana Kraskouskaya, said: “Dalriada looks forward to supporting OCT advance the cannabinoid derivative library we helped discover. Targeting the endogenous cannabinoid system with small molecules holds significant promise in delivering improved therapies and over the years, we have significantly invested in building our expertise and infrastructure in this pharmacology as well as our work with controlled substances.
“Together we are well equipped to rapidly advance OCT’s pipeline through hit-to-lead and lead optimisation.”
The agreement with Dalriada follows another recent agreement with Oxford-based StemTech, which will also be providing support across all four of OCTP’s drug development programmes.