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Columbia to provide BeneCeed for clinical study in U.K.

2019-08-22 09:29 ET - News Release

Ms. Rosemary Mazanet reports

COLUMBIA CARE ANNOUNCES COLLABORATION WITH IPS SPECIALS AND GROW BIOTECH TO IMPORT BENECEED TABLETS TO THE UNITED KINGDOM FOR CLINICAL STUDY

Columbia Care Inc. has entered a collaboration with IPS Specials, an experienced compounding pharmaceutical manufacturer, importer and distributor of unlicensed specials and licensed medicines in the United Kingdom (U.K.) and the rest of the European Union, 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 for clinical study. Pending approval by the United Kingdom'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 United States 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 200-milligram hard-pressed tablets, are currently being manufactured under good manufacturing practice (GMP) conditions in the United States. 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 under way.

"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, doctor of medicine, doctor of philosophy, 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 co-ordinate 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 U.K., 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." Mr. 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 U.S. into the U.K. with a pathway to MRHA approval and inclusion on the NHS formulary."

About Columbia Care Inc.

Columbia Care is one of the largest and most experienced multistate operators in the medical cannabis industry, with licences in 15 jurisdictions in the United States and the European Union. With over 1.2 million sales transactions since its inception, Columbia Care is a patient-centred 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 centres in the world.

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