NEW YORK–(BUSINESS WIRE)–Columbia Care Inc. (NEO: CCHW) (OTCQX: CCHWF) (FSE: 3LP) (“Columbia Care” or the “Company”), one of the largest fully integrated operators in the global medical cannabis industry with licenses across the US and EU, announced today a collaboration with IPS Specials, an experienced compounding pharmaceutical manufacturer, importer and distributor of unlicensed “specials” and licensed medicines in the UK and the rest of the EU, and Grow Biotech, a company bridging the gap between existing cannabis medicines and accepted pharmaceutical standards, to import Columbia Care’s proprietary, broad-spectrum high-cannabidiol (CBD) BeneCeed tablets as a potential investigational medicinal product (IMP) to the United Kingdom (UK) for clinical study. Pending approval by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), BeneCeed would be examined in a late-stage Phase 2b clinical trial and, to the Company’s knowledge, become the first botanical cannabinoid IMP approved for import from the US and the first product from Columbia Care’s proprietary portfolio of cannabis-based products to be studied in randomized clinical trials.
BeneCeed, Columbia Care’s proprietary, long lasting, broad-spectrum CBD 200mg hard pressed tablets, are currently being manufactured under Good Manufacturing Practice (GMP) conditions in the US. The Company’s collaboration with IPS Specials and Grow Biotech enables it to import both BeneCeed tablets as an IMP as well as corresponding placebo tablets for clinical studies. Before the initiation of clinical studies using an IMP, the MHRA first requires submission and acceptance of an Investigational Medicinal Product Dossier (IMPD). IMPD development for BeneCeed is currently underway.
“For years Columbia Care has been working to set the standard in the cannabis industry by building a portfolio of proprietary, precisely formulated, pharmaceutical-quality cannabis-based medicines that patients can rely on to safely and efficiently address their unmet medical needs. With the initiation of the first placebo-controlled clinical trial examining one of our proprietary cannabis-based medicines in a major underserved behavioral health population, I am proud that we are now raising the bar once more with our funding and independent research partners as we move closer to reaching this momentous milestone for our Company,” said Rosemary Mazanet, M.D., Ph.D., chief scientific officer of Columbia Care. “We are delighted to work with IPS Specials, which has nearly two decades of experience facilitating the import of IMPs, and Grow Biotech, a specialist in navigating challenging regulatory frameworks across the world, to coordinate this effort. Looking forward, we are working to submit an IMPD for BeneCeed as a starting point for product approvals, and in doing so, we hope to advance this first product candidate through the clinic to hopefully become one of the only approved cannabinoid medicinal products. Expanding our ability to reach the global marketplace is a strategic imperative and with the most robust portfolio of products suitable for medical applications, we look forward to leading the cannabinoid revolution outside of the United States.”
Hari Guliani, chief operating officer of Grow Biotech, said, “Here in the UK, the regulatory body National Institute for Care Excellence (NICE) have recently recommended that more clinical trials be carried out on medical cannabis before it is made available on the National Health Service (NHS). This unique collaboration with Columbia Care comes at such a fortuitous time and we hope that these clinical trials will be the first step to fulfilling NICE’s guidance.” Guliani continued, saying, “Columbia Care, with its streamlined operations, high-quality products and vast experience collaborating with some of the most renowned research institutions in the world, is an ideal partner. We look forward to supporting BeneCeed as the first botanical cannabinoid IMP to be imported from the US into the UK with a pathway to MRHA approval and inclusion on the NHS formulary.”
About Columbia Care Inc.
Columbia Care Inc. is one of the largest and most experienced multi-state operators in the medical cannabis industry, with licenses in 15 jurisdictions in the US and the EU. With over 1.2 million sales transactions since its inception, Columbia Care is a patient-centered organization setting the standard for compassion, professionalism, quality, caring and innovation, working in collaboration with some of the most renowned and innovative teaching hospitals and medical centers in the world. The Company is committed to providing the type of education and transparency patients deserve and quality of product that clinicians expect. For more information on Columbia Care, please visit www.col-care.com.
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