Cardiol Therapeutics comments on the Descheduling of Purisys Cannabinoid Ingredients by U.S. Drug Enforcement Agency
Oakville, ON – November 25, 2019
Cardiol Therapeutics Inc. (TSX: CRDL; OTCQX: CRTPF) (“Cardiol” or the “Company”), a leader in the production of pharmaceutical cannabidiol (“CBD”) products and in the development of innovative cannabidiol medicines for heart disease, commented on Purisys, LLC’s news release issued on November 21st which states that the U.S. Drug Enforcement Agency (“DEA”) has removed their cannabinoid ingredients from Schedule I of the Controlled Substances Act (“CSA”). Purisys, LLC (“Purisys”) is Cardiol’s exclusive supplier of ultra-high purity cannabidiol for the Company’s CardiolRx™ formulation. Pharmaceutically produced and cGMP certified, CardiolRx is designed to be the safest and most consistent cannabidiol formulation on the market.
Headquartered in Athens, Georgia, Purisys is a recent spinoff of Cardiol’s cannabidiol supply partner, Noramco, Inc., and was formed to provide pharmaceutical companies with the highest quality active pharmaceutical ingredients (APIs) to support commercialization of cannabinoid formulations around the world. Purisys has been manufacturing ultra-high purity cannabidiol (<0.001% THC) via a patented process since 2016. The cannabinoids produced by Purisys are distinguished by their ultra-low THC concentration, purity, world-scale capacity, exacting quality control, ease of formulation compared to hemp-derived isolates, and strong regulatory support.
“The DEA’s descheduling of Purisys’ pharmaceutical cannabidiol clearly establishes their acknowledgement of the consistent purity and quality of Purisys’ product,” said David Elsley, President and CEO of Cardiol Therapeutics. “This landmark decision underscores Cardiol’s rationale for selecting Purisys to supply the API for our CardiolRx formulation and supports our unwavering commitment to produce the safest and most consistent cannabidiol formulations for patients who should not be exposed to THC.
“At Purisys, we stand ready to back Cardiol Therapeutics’ imminent commercialization of the world’s first pharmaceutical cannabidiol formulation (CardiolRx) with our applications support, cGMP manufacturing, and world-scale supply capability for commercial production, and analytical reference standards,” said Jim Mish, CEO of Purisys. “Now that our ultra-pure pharmaceutical cannabidiol is no longer subject to DEA Schedule I status, Cardiol will also be able to accelerate its ground-breaking research programs aimed at developing important cannabidiol medicines for life-threatening heart disease.”
Cardiol recently announced the completion of manufacturing scale up of its high-concentration pharmaceutical cannabidiol formulation for commercialization in the $1.2 billion-dollar market for medicinal cannabinoids in Canada. The removal of Purisys’ pharmaceutical cannabidiol from the DEA’s Controlled Substance Act now opens up prospects for new commercial opportunities for CardiolRx around the world.
About Cardiol Therapeutics
Cardiol Therapeutics Inc. (TSX: CRDL; OTCQX: CRTPF) is focused on producing pharmaceutical cannabidiol (CBD) products and developing innovative therapies for heart disease, including acute myocarditis and other causes of heart failure. The Company’s lead product, CardiolRx™, is designed to be one of the safest and most consistent CBD formulations on the market. CardiolRx is pharmaceutically produced, cGMP certified, and is THC free. The Company plans to commercialize CardiolRx in the billion-dollar market for medicinal cannabinoids in Canada and is also pursuing distribution opportunities in Europe and Latin America.
In heart failure, Cardiol is planning an international clinical study of CardiolRx in acute myocarditis, a condition caused by inflammation in heart tissue, which remains the most common cause of sudden cardiac death in people less than 35 years of age. The Company is also developing proprietary nanotechnology to uniquely deliver pharmaceutical CBD and other anti-inflammatory drugs directly to sites of inflammation in the heart that are associated with heart failure. Heart failure is the leading cause of death and hospitalization in North America with associated healthcare costs in the U.S. alone exceeding $30 billion. For further information about Cardiol Therapeutics, please visit cardiolrx.com.
Cautionary statement regarding forward-looking information:
This news release contains “forward-looking information” within the meaning of applicable Canadian securities laws. All statements, other than statements of historical fact, that address activities, events or developments that Cardiol Therapeutics Inc. (“Cardiol”) believes, expects or anticipates will, may, could or might occur in the future are “forward- looking information”. Forward-looking information is frequently identified by the use of words such as “plans”, “expects”, “projects”, “intends”, “believes”, “anticipates”, “forecasts”, and other similar words and phrases, including variations (and negative variations) of such words and phrases, or may be identified by statements to the effect that certain actions, events or conditions “may”, “could”, “should”, “would”, or “will” be taken, occur or be achieved. Forward-looking information contained herein may include, but is not limited to, statements with respect to: future events; the future performance or the intended business strategy of Cardiol, including, but not limited to, the plan to commercialize CardiolRx™100 and the planning of an international clinical study of CardiolRx in acute myocarditis; the potential for Cardiol’s licensed drug encapsulation and delivery technologies to enhance the bioavailability of pharmaceuticals; management’s expectations regarding estimated future pharmaceutical research and development opportunities, collaborations and prospects; the success and proposed timing of Cardiol’s product development activities; the ability of Cardiol to develop its product candidates; Cardiol’s plans to research, discover, evaluate and develop additional products; Cardiol’s proposed future collaborations to advance Cardiol’s lead nanoformulations into clinical development; and the potential for Cardiol’s cannabinoid-based products to provide sources of future revenue. Forward-looking information contained herein reflects the current expectations or beliefs of Cardiol based on information currently available to it and is subject to a variety of known and unknown risks and uncertainties and other factors that could cause the actual events or results to differ materially from any future results, performance or achievements expressed or implied by the forward-looking information. These risks and uncertainties and other factors include that the success of Cardiol’s product candidates will require significant capital resources and years of clinical development efforts; the results of clinical testing and trial activities of Cardiol’s products; Cardiol’s ability to obtain regulatory approval and market acceptance of its products; Cardiol’s ability to raise capital and the availability of future financing; Cardiol’s lack of operating history; unforeseeable deficiencies in the development of Cardiol’s product candidates; uncertainties relating to the availability and costs of financing needed in the future for Cardiol’s research and development initiatives; Cardiol’s ability to manage its research, development, growth and operating expenses; the potential failure of clinical trials to demonstrate acceptable levels of safety and efficacy of Cardiol’s product candidates; Cardiol’s ability to retain key management and other personnel; risks related to fluctuations in medicinal cannabinoid markets in Canada and worldwide; uncertainties regarding Cardiol’s ongoing collaborative and manufacturing partnerships; uncertainties regarding results of researching and developing products for human use; Cardiol competes in a highly competitive and evolving industry; Cardiol’s ability to obtain and maintain current and future intellectual property protection; and other risks and uncertainties and factors. These risks, uncertainties and other factors should be considered carefully, and investors should not place undue reliance on the forward-looking information. Any forward-looking information speaks only as of the date on which it is made and, except as may be required by applicable securities laws, Cardiol disclaims any intent or obligation to update or revise such forward-looking information, whether as a result of new information, future events or results or otherwise. Although Cardiol believes that the expectations reflected in the forward-looking information are reasonable, they do involve certain assumptions, risks, and uncertainties and are not (and should not be considered to be) guarantees of future performance. It is important that each person reviewing this news release understands the significant risks attendant to the operations of Cardiol.