Flora Growth Forms Flora Pharma Division, Launches Global Clinical Trials

Rhea-AI Summary

Flora Growth Corp. (NASDAQ: FLGC) has announced the initiation of global clinical trials focusing on cannabinoids for treating fibromyalgia and chronic pain. The trials will be conducted primarily in the US and UK, involving a partnership with the University of Manchester. Flora aims to expedite FDA and NHS processes by running phase trials concurrently. The research is part of their vision to develop pharmaceutical cannabis products, addressing unmet medical needs and enhancing shareholder value through a proprietary drug development platform.

Positive

• Clinical trials targeting fibromyalgia and chronic pain initiated.
• Partnership with University of Manchester for research.
• Aim to expedite FDA and NHS processes by conducting trials in parallel.
• Focus on developing pharmaceutical cannabis products for unmet medical needs.

Negative

• None.

• Flora Pharma will seek to identify scientific gaps in the cannabis industry and ultimately work to translate that to pharmaceutical cannabis products backed by data.
• Flora Pharma’s objective is to create and leverage a proprietary drug development platform in collaboration with an artificial intelligence and machine learning group to identify new bioactive compounds within the cannabis plant that interact with certain gene targets responsible for specific disease states and conditions.
• Through collaborative efforts with top scientists in their respective fields, Flora intends to work with government regulators, as well as academic institutions to initiate academic studies in order to reduce costs and efficiently move through drug discovery, development, and commercialization activities and will work to create the standard for drug development/discovery for cannabinoid medicine.
• Flora will conduct thorough due diligence and honor the traditional FDA and NHS route in scientific processes to ensure consistency, quality, and delivery of cannabinoids for specific disease conditions, backed by data, with an initial focus on fibromyalgia, brain health, pain, and related research.

MIAMI & TORONTO--(BUSINESS WIRE)-- Flora Growth Corp. (NASDAQ: FLGC) (“Flora” or the “Company”), a leading all-outdoor cultivator and manufacturer of global cannabis products and brands, is pleased to announce that it has signed an agreement to begin scientific clinical trials globally. The focus of this study will be on the use of cannabinoids in patients suffering from Fibromyalgia or chronic pain, with the primary research sites located in the United States and the United Kingdom. Flora Pharma expects to fast track traditional FDA and NHS timelines by running phase trials in parallel (in vitro, in vivo, pilot in human, safety/efficacy, etc.). The Human Pilot Study will initiate in the UK in coordination with an internationally recognized clinical research group based at the University of Manchester, while parallel molecular and pharmacokinetic studies will be conducted in the US with key scientists and colleagues of Dr. Annabelle Manalo-Morgan, Flora’s Lead Scientific Advisor. The immediate next steps are to submit data for ethics committee review and approval whereupon acceptance, further details will be provided.

“A paradigm shift is upon us where healthcare practitioners, researchers, patients, and adult-use consumers are starting to understand, accept, and embrace the therapeutic potential offered by phytocannabinoid-based medicine. As such, there is an urgent need for more research to better understand the molecular and biochemical effects of cannabis at the cellular level, to begin to apply its implications as a pharmaceutical drug,” said Dr. Annabelle Manalo-Morgan, Director and Lead Scientific Advisor of Flora Growth. “I’m extremely pleased that our team recognizes the importance and necessity of this research, not only to create and bring to market novel pharmaceutical cannabis products for patients around the world that are more efficacious and have a superior safety profile compared to traditional and incumbent pharmaceutical treatment options, but to also enhance long-term shareholder value. While this may seem like an ambitious and costly endeavor, we will be able to leverage our seed-to-sale platform to supply products for research and commercialization at incredibly favorable and competitive price points, while partnering with established organizations and institutions where additional funding subsidies are available.”

“Our team is incredibly excited to announce our entry into cannabinoid science which will help us achieve our goal of developing pharmaceutical cannabis products while working to advance global cannabinoid research and become a thought leader in the space,” said Luis Merchan, President and CEO of Flora Growth. “Since our inception, the Flora team has successfully navigated significant barriers to enable the development, manufacturing, and commercialization of cannabis products in Colombia. Commercial harvests are well underway and it is now that we’re able to turn our attention to what we believe is the long-term future of our industry and to hedge ourselves further against the commoditization of raw cannabis materials – working to develop a pipeline of regulatory approved, prescription cannabinoid-based medicines, with a focus on clinical indications where we’ve identified a significant unmet medical need. We believe that this initiative will strengthen and broaden our industry-leading cultivation and manufacturing platform by allowing us to create novel downstream pharmaceutical and nutraceutical cannabis products, further diversify our revenue streams, and drive sustainable, long-term value creation opportunities, underpinned by high-margins and covered costs.”

While Flora is focused on its cannabis cultivation and processing operations in Colombia, as well as utilizing those raw materials throughout its premium and mindful global cannabis consumer packaged goods brand and product portfolio, the management team and board of directors has acknowledged and is committed to moving ahead with applied research initiatives in medical cannabis, forming Flora Pharma, in order to become a leader in the discovery, development, manufacturing, and commercialization of novel, phytocannabinoid-based prescription medicines and nutraceutical products to address a broad range of diseases.

About Flora Growth Corp.

Flora is a cannabis company that leverages natural, cost-effective cultivation practices to supply cannabis derivatives to its diverse business divisions of cosmetics, hemp textiles, and food and beverage. As the operator of one of the largest outdoor cultivation facilities, Flora strives to market a higher-quality premium product at below market prices. By prioritizing natural ingredients and value-chain sustainability across its portfolio, Flora creates premium products that help consumers restore and thrive. Visit www.floragrowth.ca or follow @floragrowthcorp on social for more information.

Cautionary Statement Concerning Forward-Looking Statements

This document contains forward-looking statements. In addition, from time to time, we or our representatives may make forward-looking statements orally or in writing. We base these forward-looking statements on our expectations and projections about future events, which we derive from the information currently available to us. Such forward-looking statements relate to future events or our future performance, including: the size of markets for cannabis and cannabis products; Flora’s ability to execute on its research and pharmaceutical strategies; the results of Flora’s research; the collaboration with third parties; and our business prospects and opportunities. You can identify forward-looking statements by those that are not historical in nature, particularly those that use terminology such as “may,” “should,” “expects,” “anticipates,” “contemplates,” “estimates,” “believes,” “plans,” “projected,” “predicts,” “potential,” or “hopes” or the negative of these or similar terms. In evaluating these forward-looking statements, you should consider various factors, including: our ability to change the direction of the Company; our ability to keep pace with new technology and changing market needs; and the competitive environment of our business. These and other factors may cause our actual results to differ materially from any forward-looking statement. Forward-looking statements are only predictions. The forward-looking events discussed in this document and other statements made from time to time by us or our representatives may not occur, and actual events and results may differ materially and are subject to risks, uncertainties and assumptions about us. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of uncertainties and assumptions, or the forward-looking events discussed in this document and other statements made from time to time by us or our representatives not occurring, except as may be required by applicable law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20211006005394/en/

Investor Relations:

Evan Veryard

evan.veryard@floragrowth.ca

Public Relations:

Cassandra Dowell

+1 (858) 264-6600

flora@cmwmedia.com

Source: Flora Growth Corp.

FAQ

What is Flora Growth Corp's latest announcement regarding clinical trials?

Flora Growth Corp. has announced the start of global clinical trials focused on using cannabinoids for fibromyalgia and chronic pain.

Where will Flora Growth's clinical trials be conducted?

The clinical trials will primarily take place in the United States and the United Kingdom.

What diseases is Flora Growth targeting with its new clinical trials?

Flora Growth is targeting fibromyalgia and chronic pain with its new clinical trials.

What is the significance of the partnership with the University of Manchester?

The partnership with the University of Manchester will facilitate the human pilot study and advance Flora's research initiatives.

How does Flora Growth plan to expedite the FDA and NHS approval processes?

Flora Growth plans to run phase trials in parallel to expedite the FDA and NHS approval processes.