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Panaxia agreement to bring medical cannabis products into Germany

The products are currently being used in Israel for oncology patients for cancer pain, loss of appetite and other side effects related to cancer treatments.

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Panaxia agreement to bring medical cannabis products into Germany

Global pharmaceutical company Panaxia Labs Israel Ltd has signed an agreement with German-based AxioNovo GmbH that will see the company bring its medical cannabis products into Germany.

Specialising in developing, manufacturing and marketing progressive, pharmaceutical-grade medical cannabis products, pharma company Panaxia has entered into an agreement with oncology specialist AxioNovo for the marketing, sale and distribution of a new series of medical cannabis products. 

Supporting German cancer patients

The products will have a unique formulation which has been designed and used in Israel for oncology patients for cancer pain, loss of appetite and other side effects related to cancer treatments. Characterised by designated formulations and new extracts, the development of the products was based on more than a decade’s worth of clinical data and Panaxia’s experience in treating cancer patients.

The five-year agreement, during which Panaxia will be responsible for manufacturing the products under EU-GMP standards, will see the products registered according to regulatory requirements in Germany. 

AxioNovo will head the marketing, sale and distribution of the products to cancer patients through direct purchase in pharmacies, following prescriptions from oncologists at cancer specialised clinics in Germany. 

Dr Dadi Segal, CEO of Panaxia Israel: “We welcome the agreement with AxioNovo GmbH and we are proud of this vote of confidence from a specialised German pharma company in the field of Oncology, which has chosen Panaxia as a strategic partner to make advanced and innovative medical cannabis-based treatments accessible to patients all over Germany, as well as our collaboration with Neuraxpharm on CNS. This is a significant step in recognising our contribution and fulfilling our potential within the largest market in Europe.”

Udo Wieners, CEO of AxioNovo GmbH, added: “As part of PharmaMed Group, we offer various services and products in the field of oncology in Germany. We look forward to launching the Naxiva Panaxol Onko product line in partnership with Panaxia as a part of our already existing portfolio for cancer patients and believe that this is an excellent extension of our holistic approach to treatment.”

First sales of the products in Germany are expected in the third quarter of 2021, subject to obtaining a regulatory approval from the German authorities for marketing and distribution.

Medicinal

European Medicines Agency gives cannabinoid medicine positive opinion

Tetra Bio-Pharma’s has received a positive opinion from the EMA’s Committee for Orphan Medicinal Products on its application for Orphan Drug Designation for QIXLEEF.

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European Medicines Agency gives cannabinoid medicine positive opinion

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. 

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Medicinal

Agreements to advance chronic pain relief for trigeminal neuralgia

Oxford Cannabinoid Technologies has signed agreements to accelerate the development of a pain management solution using phytocannabinoids.

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Agreements to advance chronic pain relief for trigeminal neuralgia

Oxford Cannabinoid Technologies has signed new partnership agreements to target the chronic pain condition trigeminal neuralgia (TN), which causes severe facial pain caused by compression of the trigeminal nerve.

With current treatments for TN having adverse side effects and being only partially effective, Oxford Cannabinoid Technologies Holdings plc (OCTP) is aiming to provide a drug-device combination product for people living with the condition. To facilitate this, the group has signed three service agreements that will accelerate the development of its concept – a combination of unnamed phytocannabinoids that will be administered to the lungs using a metered-dose inhaler.

The group says this type of administration should reduce onset time and the extensive first-pass metabolism associated with oral administration of cannabinoids.

“We are delighted to have further expanded our portfolio. The pain caused by TN can be extremely debilitating and we are looking forward to working towards a pain management solution with our partners,” commented OCTP CEO Dr John Lucas.

“We remain focused on developing our portfolio and increasing our growth potential as we progress our drug development programmes through preclinical and clinical trials.” 

The group’s first supply agreement has been signed with Purisys, which secures ultra-high purity, cannabinoid active pharmaceutical ingredients for the current preclinical drug development and future clinical and commercial supplies for the Group’s Programme 2. A second agreement with Oz-UK Ltd, will facilitate the development of a cannabinoid metered-dose inhaler formulation, which will include studies aiming to identify and define the excipient/formulation components, as well as the selection of the canister, valve, and actuator, and a third agreement with Voisin Consulting Life Sciences will enable the development and regulatory strategy of the Group’s combination product.

OCTP aims to obtain Orphan Drug Designation which will allow it to retain market exclusivity through regulatory protections. The programme is designed for an accelerated route to first-time-in-human (FTiH) with Phase 1 clinical trials planned for Q3 2022.

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Kanabo and Medocann to develop unique cannabis strains for UK and Germany

The deal will see the companies develop new products to target specific medical conditions. 

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Kanabo partners with Medocann
The partnership agreement will focus on the co-development of new and novel products

Kanabo has signed a partnership agreement with Medocann Pharma to develop unique strains for the UK and German markets.

Kanabo, one of Europe’s fastest-growing medical cannabis R&D companies, has partnered with Medocann Pharma Ltd to develop new products that will target specific medical conditions. 

The deal gives Kanabo exclusive distribution rights to the co-developed products into the growing German and UK cannabis markets.

The partnership agreement will focus on the co-development of new and novel products as well as on the co-development of new and unique cannabis strains. 

These new strains and products will be targeted at specific medical indications through the combination of Kanabo’s preclinical data on the effect of cannabis on different illnesses and Medocann’s genetics bank, strain development expertise and innovative cultivation capabilities.

Medocann is an established medical-grade cannabis producer with an indoor, hydroponic facility located in central Israel and has a library of proprietary cannabis genetics. 

According to the announcement, 1,000kg of Medocann’s precisely grown cannabis flowers and extracts will be integrated into  co-branded products that will be available for sale within the first three years of the agreement, which the board estimates will generate sales of up to €9m in aggregate.

Kanabo, the first cannabis company to IPO on the London Stock Exchange this year, focuses on the distribution of cannabis-derived products for medical patients, and non-THC products for CBD consumers. 

The deal will take advantage of Kanabo’s intended acquisition of Materia, which has a state-of-the-art EU GMP certified facility in Malta. 

Materia imports cannabis flower from its global supply network, including non-EU GMP certified producers, and then processes it into EU GMP certified medical cannabis products for subsequent export to distributors across Europe.

Asaf Sella, CEO Medocann commented: “The genetics and the technology used to cultivate medical cannabis make a huge difference in the safety, the quality and the consistency of the medicine patients receive. We are delighted to partner with Kanabo, together we will develop new strains to treat specific indications and provide premium medical cannabis products, all originating in Medocann’s indoor, hi-tech facility.”

Avihu Tamir, CEO Kanabo added: “Medocann’s hydroponic, precisely-grown cannabis is considered to be the best in Israel and often sells out within days. It is the only product on the market that is cultivated without the use of pesticides or insecticides. Kanabo aims to bring these unique strains that target specific medical conditions to patients in the UK and Germany through our Materia Malta production facility.”

 

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