Pharma Focus Asia

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

Friday, January 13, 2023

Catalent, 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’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,” commented 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,” said 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-square-foot site in Swindon, U.K., houses the company’s Zydis development and manufacturing operation, which produces over one billion tablets annually and employs more than 600 people.

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