Ethicann & Catalent Sign Development & License Agreement for New Fast-Dissolve Cannabinoid-Based Treatments

Catalent and Ethicann Pharmaceuticals Inc. recently announced the companies had executed a development and license agreement to develop Ethicann’s clinical drug pipeline using Catalent’s proprietary Zydis orally disintegrating tablet (ODT) technology.

Under the terms of the license, financial details of which have not been disclosed, Catalent will look to develop Ethicann’s cannabidiol (CBD) and tetrahydrocannabinol (THC) pharmaceutical products using its Zydis technology in clinical trials across a range of indications including multiple sclerosis (MS) spasticity, chemotherapy-induced nausea and vomiting, chronic pain for cancer, and epilepsy. This agreement follows a feasibility study that showed the Ethicann EPI-002 candidate to treat MS spasticity formulated with Zydis ODT dissolves in approximately three seconds without the need for water and is rapidly absorbed through the lingual and sublingual mucosa into the blood, providing therapeutic advantage by bypassing the liver, which typically removes 30%-45% of cannabinoids absorbed through the stomach. Ethicann anticipates performing a human bioequivalence study of EPI-002 in late 2023-early 2024, which is required for new drug approvals in Canada.

Zydis is a unique, freeze-dried, oral solid dosage form that disperses almost instantly in the mouth, without the need for water and has a dispersion speed of as little as three seconds. Zydis is the world’s fastest and best-in-class orally disintegrating tablet and is used in over 35 drugs approved in 60 countries.

“Ethicann believes that Zydis ODT delivery technology, when incorporated into its cannabinoid drugs, has the potential to provide competitive advantages in the marketplace, as well as enhanced safety profiles,” said Robert Auritt, President/Chief Executive Officer, Ethicann Pharmaceuticals Inc.

“We have been working with Ethicann for several years, and the Zydis technology has shown to be a superior delivery technology for its pipeline candidates, offering the advantages of improved patient acceptance, adherence, and convenience,” added Tom Hawkeswood, President, Division Head of Pharma Product Delivery, Catalent. “Zydis ODT can be used to rapidly administer therapeutic doses of active drug, and we look forward to continuing the relationship and applying all our expertise in developing, launching and supplying new differentiated therapies with the potential to improve patient care across a range of CNS indications.”

Catalent’s 250,000-sq-ft site in Swindon, UK, houses the company’s Zydis development and manufacturing operation, which produces over one billion tablets annually and employs more than 600 people.

Ethicann (Canada/US) has positioned itself as a cost-efficient pharmaceutical development company, using established multinational partners to source ultra-purified APIs and the proprietary sublingual Zydis orally disintegrating tablet (ODT) technology. Ethicann is leveraging these partnerships to formulate and further develop cannabinoid-based pharmaceutical drug products and avoid deploying capital in building and fully staffing its own facilities. This pharma business reformulation strategy coupled with the use of abbreviated regulatory approval pathways in various countries will also be used for rapid development of its Zydis-based pipeline drugs to treat other clinical indications. Ethicann has had successful FDA and Health Canada interactions, which have focused its regulatory developmental and clinical activities. For more information, visit www.ethicann-pharma.com.

Catalent is the global leader in enabling pharma, biotech, and consumer health partners to optimize product development, launch, and full life-cycle supply for patients around the world. With broad and deep scale and expertise in development sciences, delivery technologies, and multi-modality manufacturing, Catalent is a preferred industry partner for personalized medicines, consumer health brand extensions, and blockbuster drugs.

Catalent helps accelerate over 1,000 partner programs and launch over 150 new products every year. Its flexible manufacturing platforms at over 50 global sites supply around 80 billion doses of nearly 8,000 products annually. Catalent’s expert workforce of approximately 18,000 includes more than 3,000 scientists and technicians. Headquartered in Somerset, NJ, the company generated nearly $5 billion in revenue in its 2022 fiscal year. For more information, visit www.catalent.com.