Global Wellness’ Shanti Therapeutics Announce Psychedelic Drug Development Agreement
Vancouver, British Columbia, January 20, 2022 – Global Wellness Strategies Inc. (CSE:GWS) (OTCQB: GWSFF) (Frankfurt:O3X4) (“Global” or the “Company”) announces that it has signed an agreement with Next Frontier Pharmaceuticals, Inc.’s subsidiary Benuvia Manufacturing, Inc.; a merger partner of Jupiter Wellness (NASDAQ: JUPW) to work with Shanti Therapeutics as the manager of their novel psychedelic development program using MDMA.
Benuvia, based in Round Rock, Texas, is a leading drug developer and provider of cannabinoid and psychedelic APIs. Benuvia has a growing portfolio of drug products and intellectual property, and an 83,000 square foot synthetic compound manufacturing facility that is permitted by the U.S. DEA for Schedule I to III controlled substances, and is FDA registered. Benuvia also has a platform of drug master files and drug development libraries, manufacturing process technologies, and intellectual property, including patents, for the development and manufacture of organic and synthetic cannabinoids, and has a pending application for quota with the U.S. DEA to manufacture psychedelic APIs. Benuvia has begun focusing on three primary psychedelic ingredients: Psilocybin, N,N-Dimethyl-5-Methoxy-Tryptamine, or DMT, and 3,4-Methylenedioxymethamphetamine, or MDMA.
“Shanti chose Benuvia as its development partner due to its proven track record and best in class status as a developer and manufacturer of synthetic APIs. We are creating a pipeline of novel agonists as a new class of therapeutics designed to treat the root causes of mental illness disorders and chronic pain.” said Meris Kott, CEO, Global Wellness Strategies Inc. “By partnering with Benuvia, Shanti will continue with its strategy of collaborating with the emerging leaders in the field to realize our mission to provide innovative new medicines to patients.”
“We are excited to announce our entry into the global psychedelic market and our partnership program with emerging providers of psychedelic-based drugs focused on mental illness and chronic pain indications,” said Shannon Soqui, Executive Chairman of Next Frontier Pharmaceuticals. “As pharmaceutical companies become more aware of the positive effects of cannabinoids and psychedelic compounds for therapeutic use, the demand for APIs is expected to grow. Our diversified portfolio of APIs and entry into the development of novel psychedelic compounds aims to increase Next Frontier Pharmaceuticals’ and Benuvia’s position as a leading drug developer and provider of APIs focused on cannabinoids and psychedelics.”
As part of its launch into the market, Benuvia has signed an agreement to provide life cycle management services to Shanti Therapeutics for their psychedelic development program which uses MDMA. Benuvia will develop and file intellectual property on formulations of MDMA, and will provide full toxicology, and chemistry, manufacturing and controls, or CMC, and full data analysis. In addition, Benuvia, through its partners, will manage all research and development, manufacturing, analytical methods, intellectual property capture, placebo manufacture, randomization, and assistance with clinical trials. This will enable Benuvia to create custom technologies that allow rapid and cost-effective scale up of commercial operations for production in anticipation of research success.
“We are excited to partner with Shanti Therapeutics as we have a shared vision to develop and commercialize innovative medicines that provide an alternative treatment option for health care providers and their patients,” said Brandon Kidd, Chief Business Development Officer of Next Frontier Pharmaceuticals. “As pharmaceutical companies look to optimize the life cycle management of their cannabinoid and psychedelic drug products, Benuvia is an ideal partner to facilitate all facets of the process from drug development and formulation to manufacturing.”
About Global Wellness Strategies
Global Wellness Strategies is a prospect generator that provides high growth companies with financial, operational, and management assistance in the fast-growing market for wellness consumer products. The focus of the Company is on global wellness, psychedelics, mycology, hemp and CBD, healthcare-related target companies.
About Shanti Therapeutics Pty Ltd
Shanti Therapeutics Pty Ltd, is a subsidiary of Global Wellness Strategies Inc. and is a clinical stage drug development company focused on identifying novel uses for MDMA in the treatment of acute and chronic pain management. Its core strategy involves identifying innovative uses for entheogen drugs and pushing them into in-human clinical trials. Its lead asset is scheduled to commence Phase 2 clinical trials in late 2022.
About Next Frontier Pharmaceuticals, Inc.
Next Frontier Pharmaceuticals, Inc., through its wholly owned subsidiary, Benuvia Manufacturing, Inc., is a leading drug developer and provider of cannabinoid and psychedelic APIs. Benuvia owns the FDA approved cannabinoid drug SYNDROS® (dronabinol oral solution CII), and the largest captive synthetic cannabinoid manufacturing facility in the U.S. SYNDROS® is FDA approved as a prescription drug for the treatment of chemotherapy-induced nausea and vomiting in cancer patients and loss of appetite in AIDS patients who have lost weight. Next Frontier Pharmaceuticals is also pursuing a 505(b)(2) approval pathway with the FDA for six Investigational New Drugs (INDs). The Company’s 83,000 square foot manufacturing facility in Texas is permitted by the U.S. DEA to manufacture and export Schedule I to III controlled substances and is FDA registered. The facility has received millions in manufacturing infrastructure investments and currently operates for Benuvia’s internal capacity needs and as a contract manufacturer of APIs. Next Frontier Pharmaceuticals also has a robust portfolio of patents and patents pending on organic and synthetic cannabinoids and provides life cycle management services for drug development companies focused on cannabinoids and psychedelics.
For further information visit websites:
www.globalwellnessstrategies.com and www.shantitherapeutics.com
Or Contact Meris Kott CEO 604.484.0355 or email to info@globalwellnessstrategies.com
Further information about the Company is available on www.SEDAR.com under the Company’s profile.
Neither the Canadian Securities Exchange nor its Regulation Services Provider (as that term is defined in the policies of the Canadian Securities Exchange) accepts responsibility for the adequacy or accuracy of this release. Certain statements contained in this release may constitute “forward–looking statements” or “forward-looking information” (collectively “forward-looking information”) as those terms are used in the Private Securities Litigation Reform Act of 1995 and similar Canadian laws. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated”, “anticipates” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on the Company’s current belief or assumptions as to the outcome and timing of such future events. Actual future results may differ materially. In particular, this release contains forward-looking information relating to the business of the Company, its financing and certain corporate changes. The forward-looking information contained in this release is made as of the date hereof and the Company is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. Because of the risks, uncertainties and assumptions contained herein, investors should not place undue reliance on forward-looking information. The foregoing statements expressly qualify any forward-looking information contained herein