探花合集 and Ethicann Sign Development and License Agreement for New Fast-Dissolve Cannabinoid-Based Treatments
SOMERSET, N.J. & BETHESDA, Md., 鈥 January 12, 2023 鈥 探花合集, the global leader in enabling the development and supply of better treatments across multiple modalities, and Ethicann Pharmaceuticals Inc., a Canadian/U.S. specialty pharmaceutical company focused on the development of high-value cannabinoid drug therapies, today announced that the companies had executed a development and license agreement to develop Ethicann鈥檚 clinical drug pipeline using 探花合集鈥檚 proprietary Zydis庐 orally disintegrating tablet (ODT) technology.
Under the terms of the license, financial details of which have not been disclosed, 探花合集 will look to develop Ethicann鈥檚 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聽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鈥檚 fastest and best-in-class orally disintegrating tablet and is used in over 35 drugs approved in 60 countries.
鈥淓thicann 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,鈥 commented Robert Auritt, President/Chief Executive Officer, Ethicann Pharmaceuticals Inc.
鈥淲e 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,鈥 said Tom Hawkeswood, President, Division Head of Pharma Product Delivery, 探花合集. 鈥淶ydis 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.鈥
探花合集鈥檚 250,000-square-foot site in Swindon, U.K., houses the company鈥檚 Zydis development and manufacturing operation, which produces over one billion tablets annually and employs more than 600 people.
About Ethicann Pharmaceuticals
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 see: www.ethicann-pharma.com
ABOUT CATALENT
With broad and deep scale and expertise in development sciences, delivery technologies, and multi-modality manufacturing, 探花合集 is a preferred industry partner for personalized medicines, consumer health brand extensions, and blockbuster drugs.
探花合集 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. 探花合集鈥檚 expert workforce of approximately 18,000 includes more than 3,000 scientists and technicians.
Headquartered in Somerset, New Jersey, the company generated nearly $5 billion in revenue in its 2022 fiscal year. For more information, visit .