Publication date: Mar 24, 2020
The same previous designation by the US Drug Enforcement Administration alleviates the typical complexities associated with developing controlled substances throughout North America SAN DIEGO, CA, March 23, 2020 (GLOBE NEWSWIRE) — Emerald Health Pharmaceuticals Inc. (EHP), a clinical-stage company developing medicines based on cannabinoid science, has received the determination from Canada’s Controlled Substances Directorate that its lead product candidate, EHP-101, is not a controlled substance under its Controlled Drug and Substance Act (CDSA).
“The determination in Canada that EHP-101 is not a controlled substance adds to the same determination by the US DEA last year, providing us more flexibility in advancing our clinical program globally,” said Jim DeMesa, M. D., President Chief Executive Officer of EHP.
Among other things, manufacturing facilities do not require controlled substance certification for handling and dispensing the molecules and drug products, it facilitates importation, and it simplifies the conduct of nonclinical and clinical studies, as contracted nonclinical research organizations and clinical sites have less administrative burden.
Its first product candidate, EHP-101, has completed a Phase 1 clinical study and Phase 2 clinical development has been initiated, focusing initially on treating systemic sclerosis (a severe form of scleroderma) and multiple sclerosis.
To the extent statements contained in this news release are not descriptions of historical facts regarding Emerald Health Pharmaceuticals Inc. they should be considered “forward-looking statements,” as described in the private securities litigation reform act of 1995, that reflect management’s current beliefs and expectations.
Forward-looking statements contained in this news release include, but are not limited to, statements regarding: (i) the success and timing of our product development activities and clinical trials; (ii) our ability to develop our product candidates; (iii) our plans to research, discover, evaluate and develop additional potential product, technology and business candidates and opportunities; (iv) the anticipated timing of clinical data availability; (v) our ability to meet our milestones; and (vi) our expectations regarding our ability to obtain and maintain intellectual property protection.
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