SAN DIEGO, Oct. 20, 2017 (GLOBE NEWSWIRE) -- Emerald Health Pharmaceuticals Inc. (EHP), which is developing medications based on cannabinoid science, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for its lead molecule, EHP-101, for the treatment of systemic scleroderma. This chronic autoimmune disease causes severe fibrosis of the skin and internal organs and is associated with significant morbidity and mortality.
"Orphan designation represents an important regulatory milestone for our company as we advance EHP-101 for the treatment of systemic scleroderma," said Jim DeMesa, MD, CEO of EHP. "We are working diligently to address the significant unmet medical need in people suffering from this deadly disease and this designation furthers our mission to develop impactful cannabinoid-derived medicines to improve clinical outcomes for patients with life-threatening diseases."
EHP has two proprietary cannabinoid pharmaceutical drugs in preclinical development. The lead product candidate, EHP-101, is a patented new molecule derived from cannabidiol (CBD) and is being developed for the treatment of multiple sclerosis and systemic scleroderma. The company plans to initiate a Phase I human clinical study in 2018 and potentially initiate Phase 2 studies for multiple sclerosis and systemic scleroderma in 2019.
The FDA grants Orphan Drug Designation status to drugs and biologics that treat rare diseases, which is defined as those affecting fewer than 200,000 people, in the U.S. The FDA Office of Orphan Products Development evaluates scientific and clinical data submissions from sponsors to identify and designate products as promising for rare diseases and to advance scientific development of such promising medical products.
Benefits associated with Orphan Drug Designation include: a seven-year marketing exclusivity period against competition, tax credits for qualifying clinical trials, and federal grants. In addition, a marketing application for a prescription drug product that has received orphan designation is not subject to a prescription drug user fee. The receipt of Orphan Drug Designation status does not change the regulatory requirements or process for obtaining marketing approval.
About Emerald Health Pharmaceuticals Inc.
Emerald Health Pharmaceuticals is focused on developing its library of proprietary, synthetic cannabinoid-derivative drug candidates for the treatment of inflammatory and neurodegenerative diseases. The company has two families of new chemical entities, based on CBD and CBG, that it has modified through rational drug design to affect validated receptors pertinent to targeted diseases. Its first drug candidate, EHP-101, is focused on treating multiple sclerosis and scleroderma. Its second, EHP-102, is focused on treating Huntington’s disease and Parkinson’s disease. The company is advancing preclinical development with the intent to launch a Phase I clinical study in 2018. For more information, visit www.emeraldpharma.life. Emerald Health Pharmaceuticals is part of the Emerald Health group, which comprises multiple companies advancing diverse botanical, nutraceutical and pharmaceutical products that may provide wellness and medical benefits by interacting with the body’s important endocannabinoid system.
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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. You can identify forward-looking statements by words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “hope,” “hypothesis,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “strategy,” “will,” “would,” or the negative of those terms, and similar expressions that convey uncertainty of future events or outcomes. Forward-looking statements contained in these presentations 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 and commercialize our product candidates; (iii) our plans to research, discover, evaluate and develop additional potential product, technology and business candidates and opportunities; (iv) our and our partners’ ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process; (v) the size and growth potential of the markets for our product candidates, and our ability to serve those markets; (vi) the rate and degree of acceptance of our product candidates; (vii) our ability to attract and retain key scientific or management personnel; (viii) the anticipated timing of clinical data availability; (ix) our ability to meet our milestones; (x) our expectations regarding our ability to obtain and maintain intellectual property protection; (xi) the level of our corporate expenditures; (xii) the assessment of our technology by potential corporate partners; and (xiii) the impact of capital market conditions on us. Forward-looking statements are subject to known and unknown factors, risks and uncertainties that may cause actual results to differ materially from those expressed or implied by such forward looking statements. Undue reliance should not be placed on forward-looking statements. We undertake no obligation to update any forward-looking statements. Emerald Health Pharmaceuticals’ investigational drug products have not been approved or cleared by the FDA.